Original
Pharmacists promote rational use of antibiotic prophylaxis in Type I incision operations via application of drug use evaluation
Qing-ping Shi, Feng Ding, Yan Liu, Ran Sang, Jin-xiu Zhu, Pei-lan Shi, Mu-hua Wang and Hao-yu Yuan
Price
42.00 $
Volume 51 p. 704 - 710
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 9/2013 (704-710)
Pharmacists promote rational use of antibiotic prophylaxis in Type I incision operations via application of drug use evaluation
Qing-ping Shi1,2, Feng Ding1, Yan Liu1, Ran Sang1, Jin-xiu Zhu1, Pei-lan Shi1, Mu-hua Wang1 and Hao-yu Yuan3
1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, Bengbu, 2College of Pharmacy, Bengbu Medical College, Bengbu, and 3Hegongye 416 Hospital, Chengdu, China
Objective: Drug use evaluation (DUE) criteria were established to assess the rational use of antibiotic prophylaxis (RUAP) in Type I incision operations (TOIO) during peri-operation period and to enhance pharmacists’ responsibilities for antibiotic stewardship. Methods: The criteria were set with a threshold based on a literature review and discussions with multidisciplinary experts. Patients who received TOIO from July 2008 to June 2012 were enrolled in the study. The percentage of prescriptions adhering to all items of criteria was 10% at baseline. Results: According to DUEs and interviews by pharmacists, the percentages of prescriptions adhering to all items of criteria of DUE-1, DUE-3, DUE-5, and DUE-8 were 13.3, 20.0, 50.0 and 66.7%, respectively. The study showed that the most common inappropriate therapies were no indications for prophylaxis antibiotic use and inappropriate choices of antibiotics. Pharmacists finally disseminated DUE criteria and reports to prescribe and improve RUAP in TOIO at the hospital through the Drug and Therapeutics Committee (DTC). Conclusion: The study demonstrated that application of pharmacist- directed DUE is a useful strategy to detect, supervise and help correct challenges encountered during antibiotic prophylaxis in TOIO.Correspondence to:
Qing-ping Shi
Department of Pharmacy
The First Affiliated Hospital of Bengbu Medical College
287 Zhihuai Road, Bengbu, 510080, China
Email: [email protected]
Original
Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study
Yang Shen, Xiao-Jun Huang, Jian-Xiang Wang, Jie Jin, Jian-Da Hu, Kang Yu, De-Pei Wu, Shu-Jie Wang, Li Yu, Xie-Qun Chen, Ting Liu, Ying-Ming Liang, Fang-Ping Chen, Yan Li and Zhi-Xiang Shen
Price
42.00 $
Volume 51 p. 738 - 745
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 9/2013 (738-745)
Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study
Yang Shen1, Xiao-Jun Huang2, Jian-Xiang Wang3, Jie Jin4, Jian-Da Hu5, Kang Yu6, De-Pei Wu7, Shu-Jie Wang8, Li Yu9, Xie-Qun Chen10, Ting Liu11, Ying-Ming Liang12, Fang-Ping Chen13, Yan Li14 and Zhi-Xiang Shen1
1Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 2People Hospital of Beijing University, West City District, Beijing, 3Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, 4First Affiliated Hospital of Zhejiang University, Hangzhou, Zhangjiang, 5Fujian Medical University Union Hospital, Gulou, Fuzhou, Fujian, 6Wenzhou Medical College, Lucheng, Wenzhou, Zhejiang, 7First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, 8Beijing Union Medical College Hospital, 9General Hospital of the Chinese People’s Liberation Army, Haidian District, Beijing, 10Xijing Hospital, Xi’an, Shaanxi, 11Huaxi Hospital, Chengdu, Sichuan Province, 12Tangdu Hospital, Xi’an, Shaanxi, 13Xiangya Hospital, Changsha, Hunan, and 14First Affiliated Hospital of China Medical University, Shenyang, Liaoning Province, China
Background: Invasive fungal infection (IFI) is common in neutropenic patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Posaconazole is a broad-spectrum triazole antifungal drug with efficacy in prevention of IFI; however, it has not been previously studied as prophylaxis in a Chinese population. Methods: This multicenter, randomized study in China enrolled AML and MDS patients with persistent chemotherapy-induced neutropenia. Prophylaxis with posaconazole or fluconazole was administered for a maximum of 12 weeks, or until patients recovered from neutropenia and achieved complete remission or an IFI occurred. The primary endpoint was incidence of proven, probable, or possible IFI during treatment. Clinical failure rate, all-cause mortality and time to first systemic antifungal treatment were secondary endpoints. Results: Patients were randomized to receive posaconazole (n = 129) or fluconazole (n = 123); 117 patients in each group were included in the statistical analysis. The incidence of proven, probable or possible IFI was 9.4% (11/117) and 22.2% (26/117) in the posaconazole and fluconazole groups, respectively (p = 0.0114). The clinical failure rate was numerically lower in the posaconazole group (37/117 (31.6%; 95%CI: 23.3 – 40.9)) than in the fluconazole group (49/117 (41.88%; 95% CI: 32.8 – 51.4)) (p = 0.168). Patients receiving posaconazole had a later onset of first systematic antifungal treatment than those receiving fluconazole (p = 0.0139). The most common important adverse events were liver function abnormalities (11 patients (8.8%) on posaconazole and 6 (5.0%) on fluconazole (p = 0.221)). Conclusions: Posaconazole demonstrates efficacy as prophylaxis against IFI in high-risk neutropenic Chinese patients and is well tolerated during long-term use (ClinicalTrials. gov number, NCT00811928).Correspondence to:
Yang Shen
Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine
Shanghai, China
Email: [email protected]
Original
Association of Anthropometric indexes with chronic kidney disease in a Chinese population
Shanying Chen, Bide Wu, Xinyu Liu, Youming Chen, Yongqiang Li, Mi Li, Yan Liang1, Xiaofei Shao, Harry Holthöfer and Hequn Zou
Volume 80 (2013) p. 361 - 369
Abstract
Clinical Nephrology, Vol. 80 – No. 5/2013 (361-369)
Association of Anthropometric indexes with chronic kidney disease in a Chinese population
Shanying Chen1,2*, Bide Wu2*, Xinyu Liu1, Youming Chen3, Yongqiang Li1, Mi Li4, Yan Liang1, Xiaofei Shao1, Harry Holthöfer5 and Hequn Zou1
1Department of Nephrology, the Third Affiliated Hospital of Southern Medical University, Guangzhou, 2Department of Nephrology, Zhangzhou Municipal Affiliated Hospital of Fujian Medical University, Zhangzhou, 3Clinical laboratory, the Third Affiliated Hospital of Southern, Medical University, Guangzhou, 4Blood purification center, No. 5 Affiliated Hospital of Sun Yat-sen University, Zhuhai, China, and 5National Centre for Sensor Research/BioAnalytical Sciences, Dublin City University, Ireland
Objective: Obesity is associated with an increased risk of chronic kidney disease (CKD), but the best anthropometric obesity measure remains controversial. This study aimed to examine the associations of anthropometric indexes with CKD risk and which anthropometric index is a better predictor of CKD. Methods: Data was drawn from a cross-sectional study in China. We used four anthropometric indexes: body mass index (BMI), waist circumference (WC), waist-tohip ratio (WHR), and waist-to-height ratio (WHtR). CKD was defined as estimated glomerular filtration rate (eGFR) < 60 ml/ min/1.73 m2 or urinary albumin to creatinine ratio (ACR) ≥ 30 mg/g. Logistic regressions were used for the analyses. Results: 1,834 participants were included in the analyses. After adjusting for potential confounders, BMI, WC and WHtR were significantly associated with CKD in men and women. The respective odd ratios for BMI (every SD increment), WC (every SD increment), and WHtR (every SD increment) were 1.46, 1.40, and 1.45 in men as well as 1.21, 1.31, and 1.38 in women. After adjusting for potential confounders, WHR was associated with CKD in women but not men. In women, the associations of WC, WHR and WHtR with CKD was independent of other MetS components. No difference in WHtR was observed between men and women. Conclusion: Anthropometric indexes are associated with CKD. The associations of anthropometric indexes with CKD are independent of other MetS components in women but not men. In women, central obesity indexes are better than BMI for predicting of CKD.
*Both authors contributed equally.Correspondence to:
Hequn Zou, MD
Department of Nephrology
The Third Affiliated Hospital of
University of Southern Medical University
183# Zhongshan Dadao, Tianhe district
Guangzhou, 510000 P. R. China
Email: [email protected]
Original Research
A 6-year retrospective study of adverse drug reactions due to drug-drug interactions between nervous system drugs
Qing-ping Shi,, Xian-di He, Mei-ling Yu, Jin-xiu Zhu, Yan Liu, Feng Ding, Rang Sang, Xiao-dong Jiang, and Shu-qiang Zhang
Price
42.00 $
Volume 52 p. 392 - 401
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 5/2014 (392-401)
A 6-year retrospective study of adverse drug reactions due to drug-drug interactions between nervous system drugs
Qing-ping Shi1,2, Xian-di He3*, Mei-ling Yu1, Jin-xiu Zhu1, Yan Liu1, Feng Ding1, Rang Sang1, Xiao-dong Jiang1, and Shu-qiang Zhang4
1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, 2Education and Research Center, Bengbu Medical College, 3Intensive Care Unit, The First Affiliated Hospital of Bengbu Medical College, and 4Center of Adverse Drug Reaction Monitoring, Bengbu Food and Drug Administration, Bengbu, China
Objective: The primary objective of this study was to determine the frequency and characteristics of adverse drug reactions (ADRs) due to drug-drug interactions (DDIs) between nervous system drugs recorded for hospitalized patients in China. The secondary objective was to identify and record the possible mechanisms underlying these DDIs. Methods: In this retrospective study performed from January 2007 to December 2012, we detected and analyzed ADRs caused by potential or actual DDIs between nervous system drugs, by using the Center of Adverse Drug Reaction Monitoring, Bengbu Food and Drug Administration (CADRMBFDA) database. Results: The CADRMBFDA database contained 1,207 reports of ADRs due to nervous system drugs, involving 1,079 hospitalized patients. Of the ADRs reported, 131 (12.14%) were associated with potential and actual DDIs. There were 259 (21.46% of the total ADR reports) reports on potential and actual DDIs. The proportion of serious ADRs (6 out of 131) was significantly higher among actual DDI reports (p < 0.001) than among the remaining reports (6 out of 942). Conclusions: The results of our study confirmed that the CADRMBFDA database was a valuable resource for detecting actual DDIs. Moreover, the database helps identify drugs that can cause serious ADRs, thus indicating focus areas for healthcare education.Correspondence to:
Xian-di He
Intensive Care Unit
The First Affiliated Hospital of Bengbu Medical College
287 Changhuai Road, Bengbu, 233004, China
Email: [email protected]
Original
Activation of mTOR contributes to foam cell formation in the radial arteries of patients with end-stage renal disease
Kun Ling Ma, Jing Liu, Min Gao, Chang Xian Wang, Jie Ni, Yang Zhang, Xiao Liang Zhang, Hong Liu, Yan Li Wang, and Bi Cheng Liu
Volume 81 (2014) p. 396 - 404
Abstract
Clinical Nephrology, Vol. 81 – No. 6/2014 (396-404)
Activation of mTOR contributes to foam cell formation in the radial arteries of patients with end-stage renal disease
Kun Ling Ma1, Jing Liu1, Min Gao1, Chang Xian Wang2, Jie Ni1, Yang Zhang1, Xiao Liang Zhang1, Hong Liu1, Yan Li Wang1, and Bi Cheng Liu1
1Institute of Nephrology, and 2Department of Infection Management, Zhong Da Hospital, Southeast University School of Medicine, Nanjing City, Jiangsu Province, China
Background: Our previous in-vivo and in-vitro studies demonstrated that inflammation accelerated the progression of atherosclerosis via the dysregulation of the low-density lipoprotein receptor (LDLr) pathway. The current study aimed to investigate the effects and their underlying mechanisms of inflammation on lipid accumulation in the radial arteries of endstage renal disease (ESRD) patients with arteriovenostomy. Methods: 30 ESRD patients with arteriovenostomy were included. The patients were divided into two groups based on their plasma levels of C-reactive protein: a control (n = 16) and an inflamed group (n = 14). The expression of tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein-1 of the radial arteries were increased in the inflamed group. Foam cell formation and lipid droplet accumulation were examined by hematoxylin and eosin (H & E) and Oil Red O staining. Intracellular cholesterol trafficking-related proteins were examined by immunohistochemistry and immunofluorescent staining. Results: There was significant lipid accumulation in the radial arteries of the inflamed group compared with the control. Further analysis demonstrated that this accumulation was correlated with the increased protein expression of LDLr, sterol regulatory element-binding protein-2 (SREBP-2), and SREBP cleavageactivating protein (SCAP). Confocal microscopy showed that inflammation enhanced the translocation of SCAP escorting SREBP-2 from the endoplasmic reticulum to the Golgi, thereby activating LDLr gene transcription. Interestingly, upregulated LDLr expression was positively associated with the increased protein expression of mammalian target of rapamycin (mTOR), which had enhanced coexpression with SREBP-2. This finding suggests that the activation of mTOR may be involved in LDLr pathway disruption through the upregulation of SREBP-2 expression. Conclusion: Inflammation contributed to foam cell formation in the radial arteries of ESRD patients via the dysregulation of the LDLr pathway, which could be modulated by the activation of the mTOR pathway.Correspondence to:
Bi Cheng Liu, MD, PhD
Institute of Nephrology, Zhong Da Hospital
Southeast University School of Medicine
NO.87, Ding Jia Qiao Road
Nanjing City Jiangsu Province, 210009, China
Email: [email protected]
Original
Paeonol inhibited TNF-α-induced GM-CSF expression in fibroblast-like synoviocytes
Yan Li, Pin Li, Shu-huan Lin, Yi-qing Zheng, and Xiang-xiong Zheng
Price
42.00 $
Volume 52 p. 986 - 996
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 11/2014 (986-995)
Paeonol inhibited TNF-α-induced GM-CSF expression in fibroblast-like synoviocytes
Yan Li1,2, Pin Li2, Shu-huan Lin1,2, Yi-qing Zheng1,2, and Xiang-xiong Zheng1,2
1Department of Rheumatology, Union Hospital of Fujian Medical University, Fuzhou, and 2Fujian Institute of Clinical Immunology, Union Hospital of Fujian Medical University, Fuzhou, China
Objectives: Granulocyte macrophage colony-stimulating factor (GM-CSF) has been proved to be among the most important chemokines, playing a key role in rheumatoid arthritis (RA). However, the mechanism underlying the regulation of GM-CSF has not been established clearly yet. The aim of this study was to investigate the influence of paeonol in the expression of GM-CSF in fibroblast-like synoviocytes (FLS). Methods: The expression of GM-CSF was detected both at protein and mRNA levels in FLS after the stimulation of TNF-α at diverse concentrations and times. And then GM-CSF was detected again after pre-treatment with paeonol. Phosphorylation of PI3K/Akt and expression of NF-κB and p-IκBα were detected with western blot. Meanwhile, inhibitors of the pathways were used to investigate the mechanism of regulation of GM-CSF. Results: Recombinant TNF-α up-regulated GM-CSF in a concentration- and time-dependent manner in FLS, which was significantly suppressed by paeonol. Paeonol also exerted its ability to suppress the promoting effects of TNF-α on the phosphorylation of PI3K/Akt and activation of NF-κB pathway. Administration of the inhibitors LY294002, perifosine, BAY11-7082, and SC-514 confirmed the roles of PI3K/Akt and NF-κB on the production of GM-CSF. Furthermore, TNF-α induced proliferation, while paeonol suppressed proliferation of FLS. Conclusion: These results demonstrate that paeonol suppressed TNF-α-induced GM-CSF production via the PI3K/Akt/NF-κB pathway.Correspondence to:
Dr. Xiang-xiong Zheng, MD
Department of Rheumatology
Union Hospital of Fujian Medical University
29 Xinquan Road, Fuzhou, 350001, PR China
Email: [email protected]
Original
The role of the clinical pharmacist in reducing mortality in hospitalized cardiac patients: A prospective, nonrandomized controlled trial using propensity score methods
Xiao-bo Zhai, Dan-dan Tian, and Xiao-yan Liu
Price
42.00 $
Volume 53 p. 220 - 229
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 53 – No. 3/2015 (220-229)
The role of the clinical pharmacist in reducing mortality in hospitalized cardiac patients: A prospective, nonrandomized controlled trial using propensity score methods
Xiao-bo Zhai1, Dan-dan Tian2, and Xiao-yan Liu3
1Department of Pharmacy, Shanghai Dongfang Hospital, Affiliated to Tongji University, Shanghai, 2The 371st Central Hospital of PLA Xinxiang City, Henan, and 3Department of Pharmacy, Renji Hospital, affiliated with the School of Medicine, Shanghai Jiaotong University, Shanghai, China
Background: Meta-analyses have suggested that pharmacist-led medication reviews have no discernable effect on patient mortality. These analyses may not have found a statistically significant effect because they did not adequately control for the Objective: To evaluate the impact of the clinical pharmacist as a direct patient-care team member on the mortality of all patients admitted to cardiology units. Methods: A prospective, nonrandomized observational study compared patients who received standard care with patients admitted to a service that included clinical pharmacists. Propensity score matching was applied to enhance the comparability. The primary endpoint of the study was the composite of all-cause mortality in the study group and the control group. Results: Pharmacists were consulted by physicians to correct any drugrelated issues that they suspected may cause or contribute to a fatal outcome in the cardiology ward. A total of 428 interventions were suggested by the clinical pharmacist in the study group; 375 (87.6%) of them were accepted by the cardiology team. All-cause mortality was 1.8% during phase 1 treatment (preintervention) and was reduced to 1.1% during phase 2 treatment postintervention); the difference was statistically significant. There was no statistical difference in allcause mortality in the control unit between phase 1 and phase 2. Results were similar in the propensity score-matched subcohort. Conclusions: Drug-related problems that were suspected to cause or contribute to a possibly fatal outcome were determined by the clinical pharmacist service in patients hospitalized in a cardiology ward. Correction of these drug-related problems by physicians after the pharmacist’s advice caused a significant decrease in mortality as analyzed by propensity score matching. The significant reduction in the mortality rate in this patient population observed in this study is “hypothesis generating” for future randomized studies.Correspondence to:
Xiao-yan Liu
Department of Pharmacy, Renji Hospital,
affiliated with the School of Medicine
Shanghai Jiaotong University
Dongfang Road 1630, Shanghai, 200127, China
Email: [email protected]
Original
Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects
Li Yang, Maria Sunzel, Peng Xu, Timi Edeki, David Wilson, Jianguo Li, and Haiyan Li
Price
42.00 $
Volume 53 p. 681 - 691
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 53 – No. 8/2015 (681-691)
Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects
Li Yang1, Maria Sunzel2, Peng Xu3, Timi Edeki4, David Wilson5, Jianguo Li6, and Haiyan Li1
1Peking University Third Hospital, Beijing, China, 2Contractor at AstraZeneca, Wilmington, DE, USA, 3Formerly at AstraZeneca China, Shanghai, China, 4AstraZeneca, Wilmington, DE, USA, 5AstraZeneca, Alderley Park, Cheshire, UK, and 6AstraZeneca, Waltham, MA, USA
Objectives: Two phase I studies in healthy Chinese (NCT01458743) and Western (NCT01612507) subjects evaluated the pharmacokinetics (PK) and safety of single and multiple ceftaroline fosamil 600 mg infusions administered every 8 or 12 hours (q8h or q12h). Methods: Each study enrolled subjects sequentially into 1 of 2 cohorts (cohort 1: 60-minute infusions; cohort 2: 120-minute infusions). All subjects in the Chinese (n = 26) study received openlabel ceftaroline fosamil; in the Western study, subjects (n = 41) in each cohort were randomized 3 : 1 to ceftaroline fosamil or placebo infusions. Single infusions were administered on days 1 and 8. On days 2 – 7 (3 – 7 for Chinese study, cohort 1) subjects received q12h or q8h infusions. Plasma and urine were collected on days 1 and 8 for PK analysis. Results: Ceftaroline PK was linear and time-independent following single and multiple doses of ceftaroline fosamil. The magnitude and timing of peak plasma concentrations of ceftaroline (active metabolite), ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) varied according to the ceftaroline fosamil dosing schedule (q12h or q8h) and infusion duration (60 minutes or 120 minutes), but overall plasma ceftaroline exposures within the respective dosing intervals were broadly similar across cohorts. The most frequent adverse events were rash/drug eruption, most of which were of mild-moderate intensity and considered related to treatment. Conclusions: Ceftaroline PK was broadly similar in healthy Chinese and Western subjects receiving equivalent dose regimens. The tolerability profile of ceftaroline fosamil in Chinese and Western subjects was consistent with previous clinical trials.Correspondence to:
Professor Haiyan Li
Peking University Third Hospital
49 Huayan North Road, Haidian, Beijing, China
Email: [email protected]
Original Research
Effect of liraglutide vs. NPH in combination with metformin on blood glucose fluctuations assessed using continuous glucose monitoring in patients with newly diagnosed type 2 diabetes
Zejun Ma, Rui Chen, Yan Liu, Pei Yu, and Liming Chen
Price
42.00 $
Volume 53 p. 933 - 939
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 53 – No. 11/2015 (933-939)
Effect of liraglutide vs. NPH in combination with metformin on blood glucose fluctuations assessed using continuous glucose monitoring in patients with newly diagnosed type 2 diabetes
Zejun Ma, Rui Chen, Yan Liu, Pei Yu, and Liming Chen
2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics, Key Laboratory of Hormone and Development (Ministry of Health), Metabolic Disease Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China
Background: To evaluate the effect of liraglutide and NPH on blood glucose fluctuations in patients with newly diagnosed type 2 diabetes mellitus (T2DM). Methods: A total of 63 newly diagnosed T2DM patients were randomized into a liraglutide group and an NPH group. They were treated for 12 weeks. The values of CGM, HbA1C, and BMI were measured and compared before and after treatment. Results: FPG, HbAlc, and MBG were decreased in both groups after 12 weeks of treatment. In the liraglutide group, the MAGE, SDBG, LAGE, BMI, and waist circumference were significantly 1ower than in the NPH group (p < 0.05). Patients in the liraglutide group had a greater incidence of gastrointestinal adverse effects than in the NPH group (p < 0.05). The incidence of hypoglycemia episode in the liraglutide group was significantly lower than in the NPH group (p < 0.05). Conclusions: Liraglutide achieved improvements in overall glycemic control similar to NPH in patients with newly diagnosed T2DM. Liraglutide was associated with less glucose fluctuation than NPH treatment as assessed by CGM. In addition, patients in the liraglutide group had a greater incidence of gastrointestinal adverse effects, a lower incidence of hypoglycemia, and some weight reduction.Correspondence to:
Liming Chen, MD, PhD
2011 Collaborative Innovation Center of Tianjin for Medical Epigenetics
Key Laboratory of Hormone and Development (Ministry of Health)
Metabolic Disease Hospital & Tianjin Institute of Endocrinology
Tianjin Medical University
Tianjin 300070, China
Email: [email protected]
Original
Antipsychotic polypharmacy and quality of life in patients with schizophrenia treated in primary care in China
Cai-Lan Hou, Xin-Rong Ma, Yu Zang, Fu-Jun Jia, Yong-Qiang Lin, Helen F.K. Chiu, Gabor S. Ungvari, Chee H. Ng, Bao-Liang Zhong, Xiao-Lan Cao, Yan Li, Mei-Ying Cai, and Yu-Tao Xiang
Price
42.00 $
Volume 54 p. 36 - 42
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (36-42)
Antipsychotic polypharmacy and quality of life in patients with schizophrenia treated in primary care in China
Cai-Lan Hou1*, Xin-Rong Ma2,3*, Yu Zang4*, Fu-Jun Jia1, Yong-Qiang Lin1, Helen F.K. Chiu5, Gabor S. Ungvari6, Chee H. Ng7, Bao-Liang Zhong5, Xiao-Lan Cao4, Yan Li5, Mei-Ying Cai8, and Yu-Tao Xiang9
1Guangdong Mental Health Center, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 2Southern Medical University, Guangdong Province, 3Ningxia Mental Health Center, Ningxia Ning-An Hospital, Ningxia Province, 4Shenzhen Key Laboratory for Psychological Healthcare & Shenzhen Institute of Mental Health, Shenzhen Kangning Hospital & Shenzhen Mental Health Center, Shenzhen, 5Department of Psychiatry, Chinese University of Hong Kong, Hong Kong SAR, China, 6School of Psychiatry & Clinical Neurosciences, University of Western Australia, Perth, 7Department of Psychiatry, University of Melbourne, Melbourne, Victoria, Australia, and 8Guangzhou Yuexiu Center for Disease Control and Prevention, Guangdong Province, and 9Unit of Psychiatry, Faculty of Health Sciences, University of Macau, Macao SAR, China
Objective: In China, maintenance treatment for clinically stable patients with schizophrenia is usually provided by primary care physicians, but their prescribing patterns have not been studied. This study examined the frequency as well as demographic and clinical correlates of antipsychotic polypharmacy (APP) and its impact on quality of life (QOL) in patients with schizophrenia treated in primary care in China. Method: A total of 623 community-dwelling patients from 18 randomly selected primary care services were interviewed. Patients’ socio-demographic and clinical characteristics, including number of hospitalizations, antipsychotic drug-induced side effects, and QOL were recorded using a standardized protocol and data collection procedure. Results: The rate of APP prescription was 31% (193/623). Of the patients on APP, 89.6% received 2 antipsychotics, 10.4% received 3 or more antipsychotics. Clozapine (35.6%) was the most commonly prescribed second generation antipsychotic (SGA), while perphenazine (17.8%) was the most commonly prescribed first generation antipsychotic (FGA). Multiple logistic regression analyses revealed that patients on APP were more likely to receive SGAs and anticholinergics, had fewer hospitalizations, younger age of onset, and higher doses of antipsychotics. There were no significant differences between the two groups in any of the QOL domains. Conclusions: Approximately a third of Chinese patients with schizophrenia in primary care receive APP. Further examination of the rationale and appropriateness of APP and its alternatives is warranted.
*These authors contributed equally to the paper.Correspondence to:
Dr. Fu-Jun Jia
Guang Dong Mental Health Centre
Guangdong province, China
or
Dr. Yu-Tao Xiang
3/F, Building E12
Faculty of Health Sciences, University of Macau
Avenida da Universidade, Taipa, Macau SAR, China
Email: [email protected]; or [email protected]
Original Research
Warfarin dose requirement with different genotypes of polymorphisms on CYP2C9 and VKORC1 and indications in Han-Chinese patients
Weirong Chen, Luhua Wu, Xin Liu, Yue Shen3, Yan Liang, Jun Zhu, Huiqiong Tan, Yanmin Yang, Qun Liu, Mingsheng Wang, Lisheng Liu, and Xingyu Wang
Price
42.00 $
Volume 55 (2017) p. 126 - 132
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 2/2017 (126-132)
Warfarin dose requirement with different genotypes of polymorphisms on CYP2C9 and VKORC1 and indications in Han-Chinese patients
Weirong Chen1#2*, Luhua Wu1#2*, Xin Liu1#3, Yue Shen3, Yan Liang4, Jun Zhu4, Huiqiong Tan4, Yanmin Yang4, Qun Liu5, Mingsheng Wang5, Lisheng Liu1, and Xingyu Wang1#3
1Beijing Hypertension League Institute, Beijing, 2First Affiliated Hospital, Medical College of Shantou University, Shantou, 3National Research Institute for Family Planning, 4Fu Wai Hospital, and 5Beijing ShiJingShan Hospital, Beijing, China
Aims: To investigate whether genetic variants of CYP2C9 and VKORC1 have different effects on the dose of warfarin in 180 Han Chinese patients who were recruited from the Fu Wai Hospital. All were on maintenance treatment with stable daily warfarin doses for a period of at least 3 months. Methods: DNA was isolated and genotyped using a Warfarin dosage Prediction Kit for single nucleotide polymorphisms (SNPs) of CYP2C9 and VKORC1. Results: The VKORC1 and CYP2C9*3 polymorphisms are significantly associated with warfarin maintenance dosages. Patients with AG&GG genotype in VKORC1 needed higher doses than those with AA genotypes (4.55 ± 1.27 mg/ day vs. 2.90 ± 0.97 mg/day, p < 0.001). Patients with *1/*3 genotype in CYP2C9 need doses lower than those with *1/*1 genotypes (1.73 ± 0.95 mg/day vs. 3.23 ± 1.13 mg/day, p < 0.001). There were no significant differences between the warfarin maintenance dosages in patients with atrial fibrillation (3.09 ± 1.16 mg/day), patients with heart valve replacement (2.95 ± 1.21 mg/day) and those with both atrial fibrillation and heart valve replacement (3.36 ± 1.13 mg/day) (p > 0.05). The mean warfarin daily dose requirements in the genotypes of VKORC1 and CYP2C9 were not dependent on the medical indication(s) present. Conclusions: Genetic variants of CYP2C9, VKORC1, and age are significant determinants of the maintenance dose of warfarin. The medical indications atrial fibrillation, valve replacement, or a combination of both are not determinants of the warfarin dose requirements.
*These authors contributed equally to this work.Correspondence to:
Xingyu Wang, PhD
Beijing Hypertension League Institute
24 Shijingshan Road, Beijing, 100043 China
Email: [email protected]
Original Research
Role of oral propranolol in the treatment of infantile subglottic hemangioma
Xiao-Yan Li, Ying Wang, Lei Jin, and Jia-Rui Chen
Price
42.00 $
Volume 54 p. 675 - 681
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 9/2016 (675-681)
Role of oral propranolol in the treatment of infantile subglottic hemangioma
Xiao-Yan Li, Ying Wang, Lei Jin, and Jia-Rui Chen
Department of Otolaryngology-Head and Neck Surgery, Children’s Hospital of Shanghai, Shanghai, China
Objective: To determine the efficacy of oral propranolol for the treatment of infantile subglottic hemangioma. Methods: 17 children (13 females and 4 males) with a median age at onset of treatment of 5 months were included in this study. Propranolol was administered after the presence of subglottic hemangioma was confirmed by laryngoscopy and a CT scan of the trachea with contrast. Propranolol was started at 1 mg/kg per day divided into 3 doses. Heart rate and blood pressure were monitored during treatment. If no side effects were observed, then the dose was increased to 1.5 mg/kg per day on the second day. Results: 14 patients (82%) showed clinical improvement within 1 week of treatment initiation. In each of these patients, the diameter of the subglottic stenosis caused by the hemangioma decreased, and the hemangioma became lighter in color. Two children with cutaneous hemangiomata also exhibited significant improvements in their cutaneous lesions after treatment. One patient’s treatment was stopped after 2 weeks for personal reasons (family issue). After treatment cessation, this patient’s respiratory symptoms recurred and increased in severity over the next 2 weeks. The patient was restarted on propranolol, and the symptoms disappeared. One patient only partially responded to propranolol. One patient continued with a tracheostomy for 15 months due to the diffuse nature of the lesion and was just recently decannulated. One patient initially did not respond to propranolol and developed residual disease after open resection; this patient finally responded to propranolol after 6 months of therapy and was recently weaned off the drug. Conclusion: Oral propranolol is a safe and effective treatment for infantile subglottic hemangiomata and may be used as a first-line therapeutic modality.Correspondence to:
Jia-Rui Chen, MD
Department of Otolaryngology-Head and Neck Surgery
Children’s Hospital of Shanghai, Shanghai, China
Email: [email protected]
Original
Pharmacokinetics and safety of PC-SOD, a lecithinized recombinant superoxide dismutase, in healthy Chinese subjects: A phase 1, randomized, placebo-controlled, dose-escalation study
Rui Chen, Qian Zhao, Ni Wu, Wen Zhong, Xin Jin, Chunyan Liu, Zhenyu Zhu, and Pei Hu
Price
42.00 $
Volume 57 (2019) p. 596 - 602
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 57 – No. 12/2019 (596-602)
Pharmacokinetics and safety of PC-SOD, a lecithinized recombinant superoxide dismutase, in healthy Chinese subjects: A phase 1, randomized, placebo-controlled, dose-escalation study
Rui Chen1, Qian Zhao1, Ni Wu1, Wen Zhong1, Xin Jin1, Chunyan Liu1, Zhenyu Zhu2, and Pei Hu1
1Clinical Pharmacology Research Center, Peking Union Medical College Hospital, and 2Beijing TIDE Pharmaceutical Co. Ltd., Beijing, China
Objectives: To evaluate the pharmacokinetics of PC-SOD after single intravenous administration and its safety profile in healthy Chinese subjects.
Materials and methods: This was a phase 1, randomized, double-blind, placebo-controlled, sequential, single-dose, and dose-escalation study. The study was done in 4 cohorts and a total of 40 subjects received a single dose of PC-SOD (from 20 to 160 mg). There were 12 subjects in each dose group (10 active treatments and 2 placebos), except a 20-mg group, in which all 4 subjects were given active treatment. Serial venous blood samples were collected up to 168 hours after dosing. Serum samples were analyzed using an enzyme-linked immunosorbent assay. Pharmacokinetic parameters of PC-SOD were calculated via noncompartmental analysis using the WinNonlin.
Results: After intravenous administration, PC-SOD reached the peak concentration quickly with a median tmax of 0.5 – 1.3 hours across all dose cohorts. After reaching Cmax, the mean T1/2 was 35.9 – 42.3 hours, which was independent of dose. The CL and Vz were 0.13 L/h and 6.72 L, 0.13 L/h and 7.33 L, and 0.11 L/h and 6.88 L for the 40, 80, and 160 mg dose cohorts, respectively. Over the dose range of 20 – 160 mg, the mean Cmax increased from 5,546.6 to 44,145.2 h×ng/mL and AUClast increased from 117,464.5 to 1,348,209.4 h×ng/mL. The 90% CI for β of AUC or Cmax slightly exceeded the criterion, indicating that there was approximate dose proportionality over the range of 20 – 160 mg or 40 – 160 mg of PC-SOD. Generally, PC-SOD was well tolerated in doses up to 160 mg in healthy Chinese subjects. Reversible elevated blood triglyceride levels were reported in 2 subjects as moderate adverse events, and all other reported adverse events were considered to be mild. The possibility of a drug hypersensitivity syndrome was not high for PC-SOD in Chinese subjects based on current data.
Conclusion: Single intravenous administrations of PC-SOD in doses up to 160 mg were well tolerated in healthy Chinese subjects. The prolonged half-life of PC-SOD was confirmed and independent of dose. Over the range of 20 – 160 mg, PC-SOD showed approximate dose proportionality. These findings suggest that it is worthwhile to investigate PC-SOD in clinical conditions characterized by a high radical overload.
The authors Rui Chen and Qian Zhao contributed equally to the paper: see Erratum. Correspondence to:
Prof. Pei Hu, MD, PhD
Phase I Unit, Clinical Pharmacology Research Center
Peking Union Medical College Hospital
Damucang Hutong 41, Beijing, 100032, China
Email: [email protected]
Original
Are USPD patients suitable for incremental peritoneal dialysis: Yes or no?
Wenjing Zhang, Jia Lv, Yan Li, Yu Liang, and Jiping Sun
Volume 97 (2022) p. 215 - 225
Abstract
Clinical Nephrology, Vol. 97 – No. 4/2022 (215-225)
Are USPD patients suitable for incremental peritoneal dialysis: Yes or no?
Wenjing Zhang, Jia Lv, Yan Li, Yu Liang, and Jiping Sun
Department of Nephrology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shannxi, China
Background: Incremental peritoneal dialysis (IPD) is the practice of initiating PD exchange less than 4 times a day in consideration of residual renal function (RRF). This study determined whether IPD could be used for urgent-start peritoneal dialysis (USPD) patients when starting dialysis, and when compared to full-dose PD, could IPD affect the RRF in USPD patients.
Materials and methods: 169 USPD patients with eGFR between 4 and 6 mL/min/1.73m2 were retrospectively analyzed. The duration of follow-up was 1 year. Patients were divided into an incremental PD (i-PD) group (dialysis dose ≤ 6,000 mL) and a full-dose PD (f-PD) group (dialysis dose ≥ 8,000 mL). The demographics, clinical indices, peritoneal transport function, dialysis adequacy, and complications of peritoneal dialysis were compared between both groups.
Results: (1) 111 patients (average age 45.01 ± 12.84 years) were included in the i-PD group and 58 patients (average age 43.5 ± 15.62 years) in the f-PD group. The demographics and clinical indices of both groups before PD were similar (p < 0.05). (2) During the follow-up period, the dialysis dose in the f-PD group exceeded that of the i-PD group (p < 0.05). The dialysis adequacy of both groups was as expected. (3) During the follow-up period, peritoneal transport function, the RRF, the blood pressure control, correction of anemia, and correction of calcium and phosphorus abnormalities were similar in both groups. (4) The peritoneal dialysis-related infection, mechanical complications, and technical survival rate were similar between groups.
Conclusion: Incremental PD did not cause a rapid decline of RRF in USPD patients. The dialysis effect and complications from it, were similar to full-dose peritoneal dialysis. Thus, USPD patients can be treated by IPD.Correspondence to:
Dr. Jiping Sun, MD
Department of Nephrology
The First Affiliated Hospital of Xi’an Jiaotong University
277 West Yanta Road, Xi’an
Shannxi, 710061, China
Email: [email protected]
Original
An analysis of the relationship of blood pressure and its variability with residual kidney function loss in hemodialysis patients
Feiyan Li, Xu He, and Yongchao Yang
Volume 100 (2023) p. 99 - 106
Abstract
Clinical Nephrology, Vol. 100 – No. 3/2023 (99-106)
An analysis of the relationship of blood pressure and its variability with residual kidney function loss in hemodialysis patients
Feiyan Li1#2#3*, Xu He1#2*, and Yongchao Yang4
1Chengdu Medical College, 2The First Affiliated Hospital of Chengdu Medical College, 3Collaborative Innovation Center of Sichuan for Elderly Care and Health, Chengdu Medical College, Chengdu, 4Department of Nephrology, Baoji traditional Chinese Medicine Hospital, Baoji, China
Aims: This study aims to investigate the relationship of blood pressure (BP) and systolic BP (SBP) variability with residual kidney function (RKF) loss in hemodialysis (HD) patients.
Materials and methods: The demographic and clinical information and data on RKF loss events in HD patients were collected. The baseline characteristics of the patients were compared among groups according to pre- and postdialysis SBP (< 120, 120 – 139, 140 – 159, and ≥ 160 mmHg) and diastolic BP (DBP) (< 80, 80 – 89, 90 – 99, and ≥ 1 00 mmHg). Participants were divided into two groups based on the mean intradialytic and interdialytic SBP variability. Kaplan-Meier analysis and Cox regression analysis were used to evaluate the risk of RKF loss.
Results: A total of 157 participants with an average HD vintage of 35.97 months were included. The group with the lowest predialysis SBP showed the longest duration of residual urine. However, Kaplan-Meier analysis and Cox regression analysis indicated that BP and SBP variability were not independent risk factors for RKF loss. Higher serum albumin levels showed protective effects against RKF loss, and diabetes mellitus (DM) and higher serum calcium were the independent risk factors for RKF loss.
Conclusion: BP and SBP variability were not independent risk factors for RKF loss in HD patients. DM, serum albumin, and calcium were independent factors related to RKF loss.
*These authors contributed equally to this work and share the first authorship.Correspondence to:
Yongchao Yang, MM
Department of Nephrology
Hospital: Baoji Traditional Chinese Medicine Hospital
No.43 Baofu Road, Baoji
Shaanxi, 721000, China
Email: [email protected]
Original
Renoprotective effects of dulaglutide, a GLP-1 agonist, involving regulation of epithelial-mesenchymal transition in patients with type 2 diabetes and diabetic kidney disease
Daoli Jiang, Fandong Meng, Xiaohua Chou, Jiaxin Shen, and Miaoyan Liu
Price
42.00 $
Volume 63 (2025) p. 141 - 153
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 4/2025 (141-153)
Renoprotective effects of dulaglutide, a GLP-1 agonist, involving regulation of epithelial-mesenchymal transition in patients with type 2 diabetes and diabetic kidney disease
Daoli Jiang1, Fandong Meng2, Xiaohua Chou1, Jiaxin Shen3, and Miaoyan Liu3
1Department of Pharmacy, 2Department of Endocrinology, Affiliated Hospital of Xuzhou Medical University, and 3School of Pharmacy, Xuzhou Medical University, Xuzhou, China
Aims: To assess the renoprotective effects of dulaglutide and identify mechanisms of action in patients with type 2 diabetes and diabetic kidney disease (DKD).
Materials and methods: Outpatients/ambulant patients at the Department of Endocrinology, Affiliated Hospital of Xuzhou Medical University between October 2021 and July 2023, with type 2 diabetes and DKD, a urinary albumin-to-creatinine ratio (UACR) ≥ 3 mg/mmol and who were receiving hypoglycemic agents were prescribed dulaglutide at a dose rate of 0.75 – 1.5 mg once weekly (intervention group; n = 70). Patients receiving hypoglycemic agents other than glucagon-like peptide-1 (GLP-1) receptor agonists and who were not prescribed dulaglutide constituted the control group (n = 65).
Observations/outcomes: The primary outcome was a change in the UACR and biomarkers of epithelial-mesenchymal transition (EMT) determined after 12 months of intervention treatment. Adverse events (estimates of tolerability and safety) were recorded during treatment and a follow-up period of 12 months.
Results: UACR changes in the intervention group compared to the control group were significantly lower (p < 0.01 at 6 months and p < 0.05 at 12 months). The frequency of gastrointestinal adverse events in the two groups were not significantly different, and there were no significant increases in the number of hypoglycemic events. Dulaglutide significantly increased the epithelial marker E-cadherin and inhibited the mesenchymal marker periostin.
Conclusion: It is concluded that dulaglutide causes significant reductions in urinary albumin and modulates EMT-related proteins thereby ameliorating the decline in kidney function in patients with type 2 diabetes and DKD.Correspondence to:
Daoli Jiang, MSc, Clinical Pharmacist
Department of Pharmacy
Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006, China
Email: [email protected]
Case
Report
Immune-mediated hepatitis caused by toripalimab: A case report
Taoyan Lin, Ping Zheng, Yilei Li, and Jing Cai
Price
42.00 $
Volume 63 (2025) p. 287 - 292
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 63 – No. 6/2025 (287-292)
Immune-mediated hepatitis caused by toripalimab: A case report
Taoyan Lin1#2, Ping Zheng1#2, Yilei Li1#2, and Jing Cai1#2
1Department of Pharmacy, and 2Clinical Pharmacy Center, Nanfang Hospital, Southern Medical University, Guangzhou, China
Toripalimab, a humanized anti-PD-1 monoclonal antibody, is widely employed in the treatment of non-small cell lung cancer (NSCLC) and various other malignancies. However, there have been no reported cases linking prolonged administration of toripalimab to immune-mediated hepatitis (IMH). Typically, immune checkpoint inhibitor (ICI)-related IMH manifests within the first few weeks or months following the initiation of therapy. In this report, we presented a case of IMH in a patient with NSCLC following ~ 17 months of toripalimab treatment. IMH induced by toripalimab may occur at any time during treatment, underscoring the need for clinicians to remain vigilant in monitoring for adverse reactions. Throughout toripalimab treatment, careful attention must be paid to the symptoms, diagnosis, and pathological features of IMH. Glucocorticoids, such as methylprednisolone, can effectively reduce liver enzyme markers like aspartate aminotransferase and alanine aminotransferase in patients experiencing toripalimab-induced IMH.Correspondence to:
Jing Cai, PharmD
Department of Pharmacy, Nanfang Hospital
Southern Medical University 183
510515 Guangzhou, China
Email: [email protected]
