Original
The ICNARC model is predictive of hospital mortality in critically ill patients supported by acute dialysis
Jui-Chang Chen, Wei-Jie Wang, Vin-Cent Wu, Tao-Min Huang, Chun-Ying Lai, Wen-Je Ko, Hau-Shin Wu, Mei.Hua Cheng and Sheng-Wen Ko
Price
42.00 $
Volume 77 (2012) p. 392 - 399
Abstract
Clinical Nephrology, Vol. 77 – No. 5/2012 (392-399)
The ICNARC model is predictive of hospital mortality in critically ill patients supported by acute dialysis
Jui-Chang Chen*1,2, Wei-Jie Wang*3,4, Vin-Cent Wu5, Tao-Min Huang5, Chun-Ying Lai1, Wen-Je Ko6, Hau-Shin Wu1, Mei-Hua Cheng7 and Sheng-Wen Ko3, on behalf of the NSARF8 Study Group
1Department of Internal Medicine, Taoyuan General Hospital, Department of Health, Executive Yuan, Taoyuan, 2Center for General Education, Chung Yuan Christian University, Chung Li, 3Division of Nephrology, Department of Internal Medicine, Taoyuan General Hospital, Department of Health, Executive Yuan, Taoyuan, 4Department of Biomedical Engineering, Chung Yuan Christian University, Chung Li, 5Division of Nephrology, Department of Internal Medicine, 6Department of Traumatology and Surgery, National Taiwan University Hospital, Taipei, 7Occupational Therapist, Rehabilitation Department, Taoyuan General Hospital, Department of Health, and 8NSARF: The National Taiwan University Study Group on Acute Renal Failure, Taiwan
*Both authors contributed equally to this work.
Aims: To compare prediction power between ICNARC model and RIFLE classification in postoperative patients receiving acute dialysis. Material and method: Between January 2002 and December 2008, 529 patients received acute dialysis during their ICU stay were enrolled. Patients’ demographic, clinical and laboratory variables were analyzed as predictors of mortality. The RIFLE logistic regression and the ICNARC model on ICU admission were evaluated to predict the patient’s hospital mortality. Results: Hospital mortality for the study group was 29.3%. Between two score systems, the ICNARC model showed better mortality prediction in this patient group by using the area under the receiver operating characteristic curve (ICNARC 0.836, RIFLE 0.702, p < 0.05). Multiple logistic regression analysis indicated that age, surgery category, metastatic carcinoma, ventilator use, and previous history of hypertension were also affecting factors for hospital mortality. Conclusions: The RIFLE classification and the ICNARC model were both correlated with mortality in critically ill patient with acute dialysis. However, the ICNARC model was a better mortality predictor compared to the RIFLE classification.Correspondence to:
Sheng-Wen Ko, MD
No.1492, Zhongshan Rd.
Taoyuan City, Taoyuan County 330, Taiwan
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 Research
Relationship of microRNA 616 gene polymorphism with prognosis of patients with premature coronary artery disease
Yan Zhang, Shijie Wang, Yongqin Li, Chunyan Zhang, Jiahong Xue, Xiaosan Wu, and Congxia Wang
Price
42.00 $
Volume 54 p. 899 - 903
Abstract
arterioInternational Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 11/2016 (899-903)
Relationship of microRNA 616 gene polymorphism with prognosis of patients with premature coronary artery disease
Yan Zhang1, Shijie Wang2, Yongqin Li1, Chunyan Zhang1, Jiahong Xue1, Xiaosan Wu1, and Congxia Wang1
1Department of Cardiology, the Second Hospital of Xi’an Jiaotong University, and 2Department of Physiology and Pathophysiology, Medical School of Xi’an Jiaotong University, Xi’an, Shaanxi, China
Objective: To investigate the relationship of microRNA 616 (has-miR-616) single nucleotide polymorphisms (SNPs) and its target gene paraoxonase 1 (PON 1) with the prognosis of patients with premature coronary artery disease (pCAD). Methods: 266 pCAD cases in the case group and 300 cases in the control group were collected. Using the polymorphism method of polymerase chain reaction and restriction fragment length, the has-miR-616 rs3735590 genotypes of target gene PON 1 were detected. Results: In the changes of rs3735590 C/T SNPs, compared with CC genotypes, the risk of coronary heart disease of the individuals carrying CT and TT genotypes were reduced by 42% and 31%, respectively (p < 0.05). The risk of developing coronary heart disease in individuals carrying CT and TT genotypes were reduced significantly in the population with levels of total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. Conclusion: Target gene PON 1 of hsa-miRNA-616 rs3735590C-T SNPs is associated with the reduced incidence risk of pCAD, and carrying C alleles is an independent risk factor for pCAD.Correspondence to:
Dr. Yongqin Li
Department of Cardiology
The Second Hospital of Xi’an Jiaotong University
No. 157 Xuwu Road, Xi’an, Shaanxi 710004, China
Email: [email protected]
Bioavailability Section
Pharmacokinetics and bioequivalence study of tetramethylpyrazine phosphate tablets after single-dose administration in healthy Chinese male subjects
Houli Li, Benjie Wang, Guiyan Yuan, and Ruichen Guo
Price
42.00 $
Volume 56 (2018) p. 387 - 392
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 56 – No. 8/2018 (387-392)
Pharmacokinetics and bioequivalence study of tetramethylpyrazine phosphate tablets after single-dose administration in healthy Chinese male subjects
Houli Li1#2, Benjie Wang2, Guiyan Yuan2, and Ruichen Guo2
1Department of Pharmacy, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, and 2Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan, China
Background: Tetramethylpyrazine, isolated from <i>Ligusticum wallichii</i> Franch., is widely used for the treatment of cerebrovascular and cardiovascular diseases in China. Objective: To assess and compare the pharmacokinetic characteristics and bioequivalence of two tetramethylpyrazine phosphate (TMPP) tablets in healthy Chinese male subjects. Materials and methods: 20 healthy male subjects were randomly divided into two groups according to a two-period crossover design test. A single oral dose of 200 mg test or reference tablets was given with a 7-day washout period under fasting conditions. Blood samples were taken at scheduled time points, and the concentration of TMPP was measured by LC-MS. Drug And Statistical Software-Version 2.0 was used to calculate the pharmacokinetic parameters and assess bioequivalence of the two formulations. Results: 20 subjects were enrolled in the study, and none dropped out. The main pharmacokinetic parameters of test and reference formulations were as follows: T<sub>1/2</sub> was (1.79 ± 0.82) hours and (1.64 ± 0.52) hours, t<sub>max</sub> was (0.76 ± 0.37) hours and (0.94 ± 0.44) hours, C<sub>max</sub> was (961.14 ± 309.64) ng/mL and (1,059.09 ± 350.69) ng/mL, AUC<sub>0–12h</sub> was (1,744.69 ± 643.49) ng×h/mL and (1,726.32 ± 494.11) ng×h/mL, AUC<sub>0–∞</sub> was (1,756.95 ± 643.63) ng×h/mL and (1,740.16 ± 504.89) ng×h/mL, respectively. The relative bioavailability of TMPP tablets was 102.4 ± 26.0%, and no serious adverse events were reported. Conclusion: This single-dose study in healthy Chinese male fasted subjects showed that the TMPP test and reference tablets were bioequivalent.
Correspondence to:
Prof. Ruichen Guo
Institute of Clinical Pharmacology
Qilu Hospital of Shandong University
107 West Wenhua Road, Jinan 250012, China
Email: [email protected]
Original
Changes in the intestinal microbiota of patients with Parkinson’s disease and their clinical significance
Li-Na Zhang, Wen-Ling Yuan, Ming Ye, Liang Yin, and Shi-Jie Wang
Price
42.00 $
Volume 61 (2023) p. 48 - 58
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 61 – No. 2/2023 (48-58)
Changes in the intestinal microbiota of patients with Parkinson’s disease and their clinical significance
Li-Na Zhang1, Wen-Ling Yuan1, Ming Ye1, Liang Yin1, and Shi-Jie Wang2
1Department of Neurology, The First Affiliated Hospital of Bengbu Medical College, and 2Department of General Surgery, The Third People’s Hospital of Bengbu, Bengbu, Anhui, China
Objective: To investigate the differences and their clinical significance in the intestinal microbiota in patients with Parkinson’s disease (PD) in comparison to those in healthy controls.
Materials and methods: 20 patients with PD who received treatment in the First Affiliated Hospital of Bengbu Medical College between January 2019 and December 2019 were selected as the research subjects to form the PD group, while 20 age- and gender-matched healthy volunteers were selected as the control group. Fecal samples from the two groups were collected, and the V4 region of 16S-ribosomal ribonucleic acid was selected for high-throughput sequencing analysis to explore any differences, as well as their significance, in the intestinal microbiota abundance at the class, family, and genus levels between the two study groups.
Results: The operational taxonomic unit cluster analysis revealed a high degree of overlap between the patients with PD and the controls. Compared with the controls, the relative abundance of Coriobacteriia and Coriobacteriaceae was increased in the PD group (p < 0.01), while the relative abundance of Lachnospiraceae was significantly lower (p < 0.01). The relative abundance of Collinsella, Escherichia, and Fusobacterium in the PD group was significantly higher than in the control group (p < 0.05).
Conclusion: Compared with the healthy subjects, the abundance of specific microflora was significantly different in the PD patients at the class, family, and genus level. Intestinal flora may act as a potential biomarker for PD and provide a theoretical basis for microflora transplantation therapy.Correspondence to:
Shi-Jie Wang, MM
Department of General Surgery
The Third People’s Hospital of Bengbu
No. 38 of Shenglizhong Road
Bengshan District, Bengbu, Anhui, 233000, China
or
Liang Yin, MM
Department of Neurology
The First Affiliated Hospital of Bengbu Medical College
No. 287 of Changhuai Road
Longzihu District, Bengbu, Anhui, 233000, China
Email: [email protected]; [email protected]
Original
A retrospective study of mineral and bone disorder in kidney transplant recipients: Single-center experience
Li Sun, Hai Zhou, Zhiwang Tang, Zeping Gui, Dengyuan Feng, Dongliang Zhang, Jiawen Liu, Xiang Gao, Qianguang Han, Shuang Fei, Zijie Wang, Zhengkai Huang, Hao Chen, Jun Tao, Zhijian Han, Xiaobing Ju, Min Gu, and Ruoyun Tan
Price
42.00 $
Volume 101 (2024) p. 71 - 81
Abstract
Clinical Nephrology, Vol. 101 – No. 2/2024 (71-81)
A retrospective study of mineral and bone disorder in kidney transplant recipients: Single-center experience
Li Sun1*, Hai Zhou2*, Zhiwang Tang3*, Zeping Gui1, Dengyuan Feng1, Dongliang Zhang2, Jiawen Liu1, Xiang Gao2, Qianguang Han1, Shuang Fei1, Zijie Wang1, Zhengkai Huang1, Hao Chen1, Jun Tao1, Zhijian Han1, Xiaobing Ju1, Min Gu2, and Ruoyun Tan1
1Department of Urology, The First Affiliated Hospital, 2Department of Urology, The Second Affiliated Hospital, Nanjing Medical University, Nanjing, and 3Department of Urology, Huai’an First People’s Hospital, Nanjing Medical University, Huai’an, China
Background: The status of mineral and bone disorder (MBD) after kidney transplantation is not fully understood, and the assessment of abnormal mineral and bone metabolism in kidney transplant recipients (KTRs) has not been standardized.
Materials and methods: We performed a retrospective analysis of 292 KTRs in our center. The levels of biochemical markers of bone metabolism and bone mineral density (BMD) were assessed. We evaluated the influencing factors of BMD using linear regression analysis. And correlation test was used for the correlation analysis between bone metabolism indicators and other indicators.
Results: Postoperative MBD mainly manifested as hypercalcemia (8.9%), hypophosphatemia (27.1%), low levels of 25-hydroxyvitamin D(25(OH)vitD) (67.0%), hyperparathyroidism (50.6%), and high levels of bone turnover markers (BTMs). The prevalence of osteopenia/osteoporosis in the femoral neck (FN) and lumbar spine (LS) was 20.1%/2.8% and 26.1%/3.6%, respectively. Multivariate analysis indicated that FN BMD was positively associated with body mass index (BMI) and negatively associated with acute rejection history (p < 0.05); while LS BMD was positively associated with BMI, and negatively associated with intact parathyroid hormone (iPTH) (p < 0.05). Biochemical markers of bone metabolism were affected by age, sex, preoperative dialysis mode and time, postoperative time, transplanted kidney function, and iPTH levels. LS BMD was negatively correlated with iPTH and BTMs (p < 0.05).
Conclusion: MBD persisted after kidney transplantation. Decreased bone mass was associated with persistent hyperparathyroidism, acute rejection history, low BMI, advanced age, and menopause. Dynamic monitoring of bone metabolism index and BMD helps to assess MBD after kidney transplantation.
*These authors have contributed equally to this work.Correspondence to:
Ruoyun Tan, PhD, MD
Department of Urology
No. 300 Guangzhou Road
Nanjing, China
or
Min Gu, PhD, MD
Department of Urology
No. 121 Jiangjiayuan Road
Nanjing, China
Email: [email protected]; [email protected]
Bioavailability Section
Pharmacokinetic and bioequivalence study of apremilast tablets in healthy Chinese subjects under fasting and fed conditions
Pan Lu, Fang Yao, Jie Wang, Yingxia He, Jun Liang, Xuejia Zhai, and Guan Liu
Price
42.00 $
Volume 64 (2026) p. 487 - 497
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 64 – No. 9/2026 (487-497)
Pharmacokinetic and bioequivalence study of apremilast tablets in healthy Chinese subjects under fasting and fed conditions
Pan Lu1, Fang Yao1, Jie Wang1, Yingxia He1, Jun Liang1, Xuejia Zhai2#3, and Guan Liu1
1PhaseI Clinical Research Center, Wuhan Pulmonary Hospital, 2Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and 3Hubei Province Clinical Research Center for Precision Medicine for Critical Illness, Union Hospital, Wuhan, China
Apremilast is a pioneering oral selective phosphodiesterase-4 inhibitor for the treatment of psoriasis. To evaluate and compare the pharmacokinetic properties and bioavailability of apremilast tablets manufactured by Nanjing Haijing Pharmaceutical Company (Nanjing, China) with apremilast tablets certified by Celgene Europe B.V. (Utrecht, The Netherlands), we conducted a randomized, open-label, single-dose, two-period, crossover study in healthy Chinese subjects under fasted and fed conditions. Eligible subjects were randomly assigned to receive reference or test apremilast tablets in the first treatment period and the other formulation in the second period. Serial blood samples were collected for pharmacokinetic analysis. Adverse events were recorded. A total of 28 healthy subjects were enrolled in the fasting cohort and 36 subjects in the fed cohort. The 90% confidence intervals of the geometric mean ratios of the test to reference formulations were 91.56 – 106.18% for Cmax, 96.08 – 108.18% for AUC0–t, and 96.02 – 107.67% for AUC0–∞ in the fasting cohort, and 95.15 – 107.05% for Cmax, 105.13 – 113.45% for AUC0–t, and 104.80 – 111.91% for AUC0–∞ in the fed cohort, all of which were within the bioequivalence range of 80.00 – 125.00%. There were no serious adverse events. The results showed that the test and reference apremilast tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions.Correspondence to:
Guan Liu, MD
Phase | Clinical Research Center
Wuhan Pulmonary Hospital
Wuhan, People’s Republic of China
Email: [email protected]
Original
Sleep apnea–hypopnea in children: Evidence that Lize Tongqi decoction with acupuncture, moxibustion, and Xinwu acupoint stimulation is superior to standard Western treatment using montelucast/mometasone furoate
Yu-Jie Wang, Miao-Yuan Li, Yong Zheng, Bei Wang, Juan Wang, Min Zhang, Huo-Qing Lu, and Qin-Yuan Guo
Price
42.00 $
p. 0 - 12
Abstract
Yu-Jie Wang, Miao-Yuan Li, Yong Zheng, Bei Wang, Juan Wang, Min Zhang, Huo-Qing Lu, and Qin-Yuan Guo
Department of Traditional Chinese Medicine, Liuzhou Maternal and Child Healthcare Hospital, Liuzhou, Guangxi Zhuang Autonomous Region, China
Objective: To assess the clinical efficacy of a modified Lize Tongqi decoction in combination with acupuncture, moxibustion, and local stimulation of the Xinwu acupoint in the treatment of pediatric snoring. Materials and methods: A randomized controlled trial was conducted in a cohort of 60 pediatric patients (mean age of 7.9 years) diagnosed with snoring. Patients were assigned to either a study group (n = 30) or a control group (n = 30). The study group was treated using modified Lize Tongqi decoction, acupuncture, moxibustion, and stimulation of the Xinwu acupoint (twice weekly for 8 weeks) whereas the control group was treated with conventional Western medicine (oral montelukast once nightly and mometasone furoate nasal spray once nightly for 8 weeks). The severity of symptoms including nasal congestion, nocturnal snoring, and breathing through the mouth was assessed prior to, and following the treatment intervention. Changes in the Obstructive Sleep Apnea-18 (OSA-18) quality of life score and the adenoid-to-nasopharyngeal (A/N) ratio were measured and compared between groups. Results: Post-treatment comparisons showed significantly greater improvements in nasal congestion, snoring, and breathing through the mouth in the study group, and the reductions in both OSA-18 scores and A/N ratios were significantly greater. (Between-group differences p < 0.05). No adverse events were observed in either group. Conclusion: The combination of modified Lize Tongqi decoction with acupuncture, moxibustion, and Xinwu acupoint stimulation effectively reduced symptoms of airway obstruction and improved quality of life in pediatric patients with snoring. The combination therapy is a new, non-surgical therapeutic option for the clinical management of this potentially serious disorder.
Correspondence to:
Qin-Yuan Guo, MM, Department of Traditional Chinese Medicine, Liuzhou Maternal and Child Healthcare Hospital, No. 50, Yingshan Street, Chengzhong District, Liuzhou 545001, Guangxi Zhuang Autonomous Region, China
Email: [email protected]
