Letter to the Editor
The financial impact of computer systems-based approaches to reducing repeat drug exposure in patients with known drug allergies
Wuan-Jin Leu, Hsiang-Yin Chen, Hsiu-Yu Chien, Hui-Ping Liu, Chuang-Chin Chiueh and You-Meei Lin
Volume 51 p. 232 - 233
Abstract
Intern. Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 3/2013 – Letter to the editor
The financial impact of computer systems-based approaches to reducing repeat drug exposure in patients with known drug allergies
Wuan-Jin Leu1,2, Hsiang-Yin Chen2,3, Hsiu-Yu Chien1,2, Hui-Ping Liu1,2, Chuang-Chin Chiueh1,2 and You- Meei Lin1,2
1Department of Pharmacy, Shuang Ho Hospital, 2School of Pharmacy, College of Pharmacy, and 3Department of Pharmacy, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
Correspondence to:
You-Meei Lin, RPh, MS
Department of Pharmacy, Shuang Ho Hospital
Taipei Medical University, No.291
Zhongzheng Rd., Zhonghe District
New Taipei City, 23561, Taiwan
Email: [email protected]
Original
Correlation study between simple obesity and serum concentrations of essential elements
Hai-Tao Jiao, Ping Liu, Wen-Ting Lu, Meng Qiao, Xiao-Fei Ren, and Zhen Zhang
Price
42.00 $
Volume 31 p. 53 - 59
Abstract
Trace Elements and Electrolytes, Vol. 31 – No. 2/2014 (53-59)
Correlation study between simple obesity and serum concentrations of essential elements
Hai-Tao Jiao, Ping Liu, Wen-Ting Lu, Meng Qiao, Xiao-Fei Ren, and Zhen Zhang
Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, Shandong, China
Objective: The aim of this study was to explore the relationship between simple obesity and serum concentrations of essential elements potassium (K), sodium (Na), calcium (Ca), iron (Fe), copper (Cu), magnesium (Mg) and zinc (Zn) in rats. Methods: 20 male Wistar rats were randomly divided into two groups: the control group was given common forage, and the fat group was given high-fat forage. K, Na, Ca, Mg, Cu, Fe and Zn in serum and forage were determined by flame atomic absorption spectrometry. Results: During this study, there was no significant difference in forage consumption between control group and fat group (p > 0.05), and there was no difference in K, Ca, Mg, Cu, Fe, and Zn levels between common and fat forge (p > 0.05). The serum concentrations of Ca, Mg, Cu, Fe and Zn in control group (Ca 22.75 ± 2.166 mg/dL, Mg 3.452 ± 1.502 mg/dL, Cu 2.490 ± 0.6493 mg/L, Fe 3.5910 ± 1.070 mg/L, Zn 2.146 ± 0.6069 mg/L) were obviously higher than that of fat group (Ca 11.05 ± 1.276 mg/dL, Mg 1.500 ± 0.3824 mg/dL, Cu 1.017 ± 0.4727 mg/L, Fe 1.765 ± 0.4120 mg/L, Zn 1.058 ± 0.2811 mg/L) (p < 0.05 for Mg, Fe, p < 0.01 for Ca, Cu, Zn). The lee’s index of rats negatively correlated with the serum concentrations of Cu, Fe (p < 0.01) and Ca, Zn (p < 0.05). Conclusions: The simple obesity could decrease the serum concentrations of Ca, Fe, Cu and Zn in rats.Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
44 West Wenhua Road Jinan, Shandong, 250012, China
Email: [email protected]
Original
Effects of taurine on the levels of essential elements in the brain of aluminum-exposed rats
Zhen Zhang, Ping Liu, Tong Feng, Jin-yu Hu, and Zheng-qiao Kong
Price
42.00 $
Volume 33 p. 108 - 115
Abstract
Trace Elements and Electrolytes, Vol. 33 – No. 3/2016 (108-115)
Effects of taurine on the levels of essential elements in the brain of aluminum-exposed rats
Zhen Zhang, Ping Liu, Tong Feng, Jin-yu Hu, and Zheng-qiao Kong
Department of Hygiene Detection, College of Public Health, Shandong University, Shandong, China
Objective: Aluminum (Al) is an abundant element in nature, and the toxic effect of excess Al on the nervous system has been demonstrated in other studies. Taurine is one of the most essential amino acids in organs throughout the body. The study aims to discuss the effect of taurine on the levels of essential elements in the brain of rats after Al exposure. Material and methods: 42 Wistar rats were randomly divided into 6 groups: control group (saline for 8 weeks), Al exposure group (281.4 mg/kg/day of AlCl3×6H2O for the first 4 weeks, and saline for the subsequent 4 weeks), taurine (low, medium, and high dose) treatment group (281.4 mg/kg/day of AlCl3×6H2O for the first 4 weeks, and 200, 400, and 800 mg/kg/day of taurine, respectively, for the subsequent 4 weeks), and taurine prevention group (400 mg/kg/day of taurine 4 hours after Al administration as before for the first 4 weeks, and 400 mg/kg/ day of taurine for the subsequent 4 weeks). The contents of brain calcium (Ca), magnesium (Mg), copper (Cu), iron (Fe), zinc (Zn), and Al were determined at the end of the experiment. Results: Al exposure led to a significant increase of the level of Al and to a significant decrease of the Mg, Cu, Fe, and Zn levels in the brain of rats compared with those in the control group (p < 0.05). Taurine (medium and high dose) treatment and preventive treatment all induced a significant increase in the levels of Mg and Zn and a significant decrease of the Al level in the brain compared with the Al exposure group. Moreover, taurine (high dose) treatment induced a significant increase in the level of Fe, and preventive treatment induced a significant increase in the level of Cu in the brain compared with the Al exposure group (p < 0.05). Conclusions: The results show that Al can disturb the balance of some essential elements in the brain, and taurine can prevent the detrimental changes.Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
44 West Wenhua Road Jinan, Shandong, 250012, China
Email: [email protected]
Original
The effects of supplementary taurine on the essential element status and antioxidant indices in the kidney of aluminum-exposed rats
Zhengqiao Kong, Ping Liu, Tingmin Guo, Jinyu Hu, Tiantian Zhang, Yu Sun
Price
42.00 $
Volume 34 (2017) p. 62 - 67
Abstract
Trace Elements and Electrolytes, Vol. 34 – No. 2/2017 (62-67)
The effects of supplementary taurine on the essential element status and antioxidant indices in the kidney of aluminum-exposed rats
Zhengqiao Kong1, Ping Liu1, Tingmin Guo2, Jinyu Hu1, Tiantian Zhang1, Yu Sun1
1Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, and 2Liaocheng Center for Disease Control and Prevention, Liaocheng, Shandong, China
Objective: Our experiment was undertaken to explore the positive effects of taurine (Tau) on the redox system and essential elements in the kidney of aluminum (Al)-exposed rats. Material and methods: The whole experiment included two periods, exposure period and detoxification period, of 4 weeks each (as verified by our previous studies). 42 male Wistar rats were randomly divided into 6 groups: control group (1.0 mL/kg/day, saline, 8 weeks), Al exposure group (281.40 mg/kg/day AlCl3·6H2O for 4 weeks during the exposure period and 1.0 mL/kg/day, saline for 4 weeks during the detoxification period), low-, medium-, and high-dose Tau groups (281.40 mg/kg/day AlCl3·6H2O for 4 weeks during the exposure period and 200 mg/kg/day, 400 mg/kg/day, 800 mg/kg/day Tau, respectively, for 4 weeks during the detoxification period), and Tau prevention group (281.40 mg/kg/day AlCl3·6H2O with 400 mg/kg/day Tau 4 hours after Al administration for 4 weeks during the exposure period and 400 mg/kg Tau for 4 weeks during the detoxification period). Both Al and Tau were dissolved in saline. The markers of oxidative stress, activities of antioxidant enzymes, and essential elements in the kidney were determined. Results: Al exposure caused a significant reduction in the activities of antioxidant enzymes and an elevation of malondialdehyde (MDA) in the kidney (p < 0.05). In addition, Al intake resulted in significant (p < 0.05) deficits of the essential elements copper (Cu), magnesium (Mg), and iron (Fe). However, Tau supplementation showed an improvement of the activities of antioxidant enzymes and of the levels of essential elements, evidenced by increases in glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), levels of Cu, Mg, and Fe as well as by a decrease in MDA (p < 0.05). Conclusions: Tau may be a promising intervention for Al-induced nephrotoxicity through ameliorating the impairment of oxidative stress and modulating the levels of essential elements.
Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
Jinan, Shandong, 250012 China
Email: [email protected]
Original
Effect of deferiprone plus taurine on the antioxidant system, ATPase levels, and metal ion levels in rat livers exposed to aluminum
Jinyu Hu, Ping Liu, Zhengqiao Kong, Tiantian Zhang, Yu Sun
Price
42.00 $
Volume 34 (2017) p. 68 - 73
Abstract
Trace Elements and Electrolytes, Vol. 34 – No. 2/2017 (68-73)
Effect of deferiprone plus taurine on the antioxidant system, ATPase levels, and metal ion levels in rat livers exposed to aluminum
Jinyu Hu, Ping Liu, Zhengqiao Kong, Tiantian Zhang, Yu Sun
Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, Shandong, China
Objectives: To evaluate the protective effect of the chelating agent deferiprone (DFP) with and without taurine (Tau) against aluminum (Al)-induced liver toxicity. Method: 56 male Wistar rats were randomly divided into seven groups: control, Al-treated, low-dose DFP, high-dose DFP, Tau + low-dose DFP and Tau + high-dose DFP. The control group received 1 mL/kg/day saline solution for 8 weeks. The other groups were exposed to Al at a dose of 281.40 mg/kg/day orally for 4 weeks. Then, they were administered with 1 mL/kg/day saline solution, 400 mg/(kg×day) Tau, 13.82 mg/(kg×day) DFP, 27.44 mg/(kg×day) DFP, 400 mg/(kg×day) Tau +13.82 mg/(kg×day) DFP, and 400 mg/(kg×day) Tau +27.44 mg/(kg×day) DFP for 4 weeks. After that, the changes in markers of oxidative stress, activities of antioxidant enzymes, triphosphatase (ATPase) in the liver and the activities of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in serum were determined. Al and iron (Fe), copper (Cu), zinc (Zn), calcium (Ca), and magnesium (Mg) were determined by atomic absorption spectrophotometry. Results: Serum ALT, AST, and liver malondialdehyde (MDA) were significantly higher after Al intake, while the activities of superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), and ATPases were significantly lower compared with the control group (p < 0.05). Al and Cu concentrations in the liver were higher and Fe and Zn concentrations were lower in Al-treated rats (p < 0.05). Treatment with DFP or Tau alone restored MDA, Al, and Fe levels, and activities of GSH-Px, ALT, Na+K+-ATPase, and Mg2+-ATPase to control levels (p < 0.05). Combined DFP and Tau treatment was more effective than DFP or Tau alone (p < 0.05). Conclusion: Combined DFP and Tau treatment alleviated oxidative stress and improved liver function more effectively than DFP alone.
Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
Jinan, Shandong, China
Email: [email protected]
Original
Protective effect of combined application of taurine and 3-hydroxy-1,2-dimethyl-4-pyridone on metal elements and neurotransmitters in brain after aluminum poisoning in rats
Yu Sun, Ping Liu, Tiantian Zhang, Na Ren, and Shuang Nie
Price
42.00 $
Volume 35 (2018) p. 32 - 39
Abstract
Trace Elements and Electrolytes, Vol. 35 – No. 1/2018 (32-39)
Protective effect of combined application of taurine and 3-hydroxy-1,2-dimethyl-4-pyridone on metal elements and neurotransmitters in brain after aluminum poisoning in rats
Yu Sun, Ping Liu, Tiantian Zhang, Na Ren, and Shuang Nie
Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, Shandong, China
Objective: To investigate the therapeutic effect of combination of taurine (Tau) and 3-hydroxy-1,2-dimethyl-4-pyridone (deferiprone, DFP) in aluminum (Al)-exposed rat brain. Materials and methods: 70 healthy male Wistar rats were randomly divided into seven groups: negative control group, Al-treated group, Tau intervention group, DFP low-dose group, DFP high-dose group, Tau + DFP low-dose group, and Tau + DFP high-dose group. The drugs were given via oral gavage. The animals of the negative control group were administered with saline 1 mL/(kg×d) for 8 weeks, while the other six groups were administered with Al chloride (A1C13·6H2O) 281.40 mg/(kg×d) for the first 4 weeks, then were treated with saline 1 mL/(kg×d), Tau 400 mg/(kg×d), DFP 13.82 mg/(kg×d), DFP 27.44 mg/(kg×d), Tau 400 mg/(kg×d) + DFP 13.82 mg/(kg×d), and Tau 400 mg/(kg×d)+ DFP 27.44 mg/(kg×d), respectively, for another 4 weeks. The contents of metal elements in the brain were detected by inductively coupled plasma-atomic emission spectrometry (ICP-AES), and the content of monoamine neurotransmitters and amino acid neurotransmitters in the brain were detected by high-performance liquid chromatography (HPLC). Results: Al intake caused a significant increase of Al and Zn but a reduction of Mg and Cu in rat brain (p < 0.05). Al exposure also resulted in lower levels of noradrenaline (NE), epinephrine (E), dopamine (DA), 5-hydroxytryptamine (5-HT) and glycine (Gly), γ-aminobutyric acid (GABA), Tau, and higher levels of asparagine acid (Asp) and glutamic acid (Glu) in rat brains compared to the control group (p < 0.05). DFP influenced all the above parameters in the opposite direction except Gly. Tau treatment led to significantly lower levels of Al and Zn, and a significantly higher level of Cu (p < 0.05). Tau also significantly decreased Asp content, and increased contents of GABA and monoamine neurotransmitters except E (p < 0.05). Furthermore, the combined application of Tau and DFP was more effective than Tau and DFP alone. Conclusion: Both Tau and DFP contribute to excrete excess Al and regulate element balance in brain, and to improve the brain neurotransmitter disorder of rats exposed to Al. The combination of Tau and DFP may have neuroprotectives effect on Al-induced nervous dysfunction in rats.
Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
Jinan, Shandong, 250012, China
Email: [email protected]
Original
Effect of trans fatty acids on the antioxidant system, ATPase levels, and essential element levels in the brain of rats
Tiantian Zhang, Ping Liu, Yu Sun, Na Ren, and Shuang Nie
Price
42.00 $
Volume 35 (2018) p. 40 - 46
Abstract
Trace Elements and Electrolytes, Vol. 35 – No. 1/2018 (40-46)
Effect of trans fatty acids on the antioxidant system, ATPase levels, and essential element levels in the brain of rats
Tiantian Zhang, Ping Liu, Yu Sun, Na Ren, and Shuang Nie
Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, Shandong, China
Objective: To demonstrate the effect of trans fatty acids (TFAs) on the antioxidant system, ATPase activities, and essential element levels in the brain of rats. Material and methods: 48 male Wistar rats were randomly divided into 4 groups: control group (corn oil only), low-, medium-, and high-dose TFA groups (50 mg/kg, 100 mg/kg, and 150 mg/kg TFA solution). Rats were administered 0.2 mL/100 g solution for 12 weeks. The activities of antioxidant enzymes, the levels of ATPase, and the levels of essential elements were tested. Results: In rat cortex and serum, the activities of glutathione peroxidase (GSH-Px) in medium- and high-dose TFA groups as well superoxide dismutase (SOD) in all TFA groups were significantly lower than those in the control group (p < 0.05), while the content of malondialdehyde (MDA) after TFA intake was obviously increased (p < 0.05). In addition, the activities of Na+K+-ATPase, Mg2+-ATPase in all TFA groups, and Ca2+-ATPase in the medium- and high-dose TFA groups were significantly decreased compared with the control group. The levels of magnesium (Mg), iron (Fe) in all TFA groups, and zinc (Zn) in the medium- and high-dose TFA groups were significantly decreased (p < 0.05). Conclusion: Long-term intake of TFAs probably induces a dysfunction of the nervous system by affecting antioxidant system, ATPase activities, and essential element levels in the brain of rats.
Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
Jinan, Shandong, 250012, China
Email: [email protected]
Original Research
Predictors of functional outcome and hemorrhagic complications in acute ischemic stroke patients treated with intravenous thrombolysis – A retrospective analysis
Qinqin Zhao, Wenya Shan, Li Liu, Xuchun Fu, Ping Liu, and Yunzhen Hu
Price
42.00 $
Volume 55 (2017) p. 893 - 900
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 12/2017 (893-900)
Predictors of functional outcome and hemorrhagic complications in acute ischemic stroke patients treated with intravenous thrombolysis – A retrospective analysis
Qinqin Zhao1#2#3, Wenya Shan1, Li Liu4, Xuchun Fu5, Ping Liu6, and Yunzhen Hu1
1Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, 2Department of Pharmacy, Tongde Hospital of Zhejiang Province, Hangzhou, 3Department of Pharmacy, The Fourth Affiliated Hospital, College of Medicine, Zhejiang University, Yiwu, 4Department of Library, The First Affiliated Hospital, College of Medicine, Zhejiang University, 5Institute of Materia Medica, Zhejiang University City College, and 6Department of Neurology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
Intravenous thrombolysis (IVT) with recombinant tissue plasminogen activator (rt-PA) within 4.5 hours is an effective and routine therapy for acute ischemic stroke (AIS). The purpose of the study was to identify predictors of functional outcome at 3 months and hemorrhagic complications after IVT. A total of 123 AIS patients treated with intravenous alteplase within 4.5 hours after stroke were enrolled. Baseline clinical characteristics, medication and disease history, radiographic and laboratory data were collected. The clinical functional outcome at 3 months was measured by the modified Rankin Scale dichotomized at 0 – 1 (favorable) vs. 2 – 6 (unfavorable). Hemorrhagic complications were measured within 36 hours after IVT. Univariate and multivariate analysis was applied in the study, and the logistic regression identified the predictors for functional outcome at 3 months and hemorrhagic complications within 36 hours. In univariate analysis, the favorable outcome was significantly associated with short hospitalization, low initial National Institute of Health Stroke Scale scores, previous smoking, previous statin use, and absence of post-stroke cerebral edema or pneumonia. Hemorrhagic complications were significantly associated with high initial NIHSS scores, low platelet count, high D-dimer level, previous atrial fibrillation, and onset seasons (except summer). Multivariate regression analyses identified that seasons (spring and summer), short hospital stays, and absence of post-stroke cerebral edema or pneumonia were the predictors of a favorable functional outcome. Meanwhile, seasons (except summer), low platelet count, and high D-dimer levels were correlation factors for prognosis of high hemorrhagic complications.
Correspondence to:
Yunzhen Hu, MD
Department of Pharmacy
The First Affiliated Hospital, College of Medicine
Zhejiang University
Hangzhou, China
Email: [email protected]
Original
Effects of trans fatty acids intake on essential elements in liver and kidney of rats
Shuang Nie, Ping Liu, Tiantian Zhang, Yu Sun, and Na Ren
Price
42.00 $
Volume 35 (2018) p. 169 - 174
Abstract
Trace Elements and Electrolytes, Vol. 35 – No. 4/2018 (169-173)
Effects of trans fatty acids intake on essential elements in liver and kidney of rats
Shuang Nie, Ping Liu, Tiantian Zhang, Yu Sun, and Na Ren
Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, Shandong, China
Over time, trans fatty acids (TFAs) have appeared more and more in people’s lives, and the harm of TFAs has been gradually discovered and confirmed. Excessive intake of trans fats can cause metabolic disturbance and increase the risk of coronary heart disease (CHD). In addition, TFAs are also closely related to diabetes, Alzheimer’s disease, and certain cancers, and have adverse effects on the health of pregnant women and the growth of infants. Trace elements, as bioactive substances in the organism, play an important role in normal physiological functions and maintaining the normal metabolism of organisms. We aim to investigate possible changes in some essential elements in liver and kidney of rats exposed to long-term intake of TFAs. Rats fed with different doses of TFAs were divided into different dosage groups during 12 weeks, namely low-dose group (50 mg/kg×BW), medium-dose group (100 mg/kg×BW) and high-dose group (150 mg/kg×BW). At the end of the exposure period, the organs were taken from the rats and carefully preserved. The levels of certain elements (Ca, Mg, Zn, Fe, Cu) were measured by using atomic absorption spectrophotometry (AAS). It was found that long-term intake of TFAs was associated with decreased hepatic Ca levels (p < 0.05) and with decreased renal Ca levels (p < 0.05). A statistically significant decrease was found in Cu levels in liver and kidney in the experimental groups compared with the control group (p < 0.05). Moreover, renal Fe levels were significantly decreased in low and medium groups (p < 0.05), while no significant differences were observed in Zn and Mg levels. In summary, the results of this study have shown that long-term intake of TFAs can influence mineral status, causing Cu and Ca deficiency in liver and kidney, but the mechanisms responsible for this phenomenon are unclear and require further investigation.
Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
Jinan, Shandong, 250012, China
Email: [email protected]
Original
Effect of flavonoids on the essential elements in liver and kidney of rats exposed to aluminum
Na Ren, Ping Liu, Shuang Nie, Xuejiao Zhang, and Mengdi Chen
Price
42.00 $
Volume 36 (2019) p. 197 - 203
Abstract
Trace Elements and Electrolytes, Vol. 36 – No. 4/2019 (198-204)
Effect of flavonoids on the essential elements in liver and kidney of rats exposed to aluminum
Na Ren, Ping Liu, Shuang Nie, Xuejiao Zhang, and Mengdi Chen
Department of Hygiene Detection, College of Public Health, Shandong University, Jinan, Shandong, China
Objectives: The aim of the study was to explore the protective effect of the flavonoids rutin, silymarin, and puerarin against aluminum (Al)-induced liver and kidney toxicity. Materials and methods: 80 male rats of SPF grade were randomly divided into 8 groups: control, Al-treated, low-dose rutin, high-dose rutin, low-dose silymarin, high-dose silymarin, low-dose puerarin, and high-dose puerarin. The control group received 1 mL/kg/day saline solution for 12 weeks. The other groups were exposed to Al at a dose of 281.40 mg/kg/day orally for 4 weeks. Then, they respectively received 1 mL/kg/day saline solution, 100 mg/(kg×day) rutin, 200 mg/(kg×day) rutin, 100 mg/(kg×day) silymarin, 200 mg/(kg×day) silymarin, 100 mg/(kg×day) puerarin, and 200 mg/(kg×day) puerarin for 8 weeks. The tested chemicals were given by gavage. At the end of the exposure period, iron (Fe), copper (Cu), zinc (Zn), calcium (Ca), and magnesium (Mg) were determined by atomic absorption spectrophotometry. Results: Compared with the control group, the Al-treated rats’ Fe, Mg, Ca, and Zn concentrations in the liver were lower, and Fe, Mg, and Ca levels were lower in the kidney (p < 0.05). Treatment with rutin, silymarin, or puerarin can improve the content of Fe, Mg, and Ca in liver and kidney of rats exposed to Al (p < 0.05). High-dose flavonoids were more effective than low-dose flavonoids. Conclusion: The flavonoids rutin, silymarin, and puerarin have a protective effect on essential elements in rat liver and kidney exposed to Al.Correspondence to:
Prof. Ping Liu
Department of Hygiene Detection
College of Public Health, Shandong University
Jinan, Shandong, 250012, China
Email: [email protected]
Bioavailability Section
Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial
Yanping Liu, Lang Lü, Man Xu, Juanmin Tao, Yuping Ning, Yan Shi, Yanfen Dong, Qingqing Cao, Jun Ma, and Yan Qiu
Price
42.00 $
Volume 62 (2024) p. 479 - 485
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 62 – No. 10/2024 (479-485)
Bioequivalence study of two formulations of afatinib dimaleate tablets in healthy subjects under fasting conditions: A randomized, open-label, single-dose, crossover trial
Yanping Liu1, Lang Lü2, Man Xu2, Juanmin Tao1, Yuping Ning1, Yan Shi1, Yanfen Dong1, Qingqing Cao1, Jun Ma1, and Yan Qiu1
1Department of Pharmacy, Shanghai Pudong New Area People’s Hospital, Shanghai, and 2Jiangxi Qingfeng Pharmaceutical Co., Ltd, Ganzhou, China
Objective: To evaluate the bioequivalence of two different afatinib dimaleate formulations in healthy Chinese subjects under fasting conditions and to assess their pharmacokinetic and safety profiles.
Materials and methods: This randomized, open-label, 2-period, crossover, bioequivalence study included 32 healthy Chinese subjects. The subjects were assigned to receive a single 40-mg dose of generic or brand-named afatinib dimaleate tablet. Blood samples were collected pre-dose and up to 120 hours after dosing. Healthy subjects orally took the trial preparation (T) (afatinib maleate tablets developed by Jiangxi Shanxiang Pharmaceutical Co., Ltd., Gan Zhou, China) and the reference preparation (R) (afatinib maleate tablets developed by Boehringer Ingelheim Pharma GmbH & Co., Ingelheim, Germany) under fasting conditions in the appropriate period according to the randomization. We measured the blood concentrations, calculated the pharmacokinetic parameters of the two preparations in the human body, and evaluated whether formulations were bioequivalent. Safety of the preparations in healthy subjects was monitored during the whole trial. Safety assessment was conducted by vital signs, physical examination, laboratory examination, and 12-lead electrocardiogram during the study, i.e., from the time the subject received the test drug to the end of the last visit.
Results: Under fasting conditions, the 90% confidence intervals (CIs) of the geometric mean ratios of the test/reference for afatinib dimaleate were 93.34 – 103.92% for AUC0–t, 90.26 – 105.52% for Cmax, and 93.49 – 104.05% for AUC0–∞.
Conclusion: The 90% CI for the geometric mean ratios (test/reference) of Cmax, AUC0–t, and AUC0–∞ were within the range of 80.00 – 125.00%, indicating that the test formulation was equivalent to the reference formulation in healthy Chinese subjects under fasting conditions. Both products were similar in terms of safety.Correspondence to:
Jun Ma, PhD
or
Yan Qiu, PhD
Department of Pharmacy
Shanghai Pudong New Area People’s Hospital
Shanghai 201299, China
Email: [email protected]; [email protected]
Original
Systematic review of risk prediction models for autogenous arteriovenous fistula dysfunction in maintenance hemodialysis patients
Ping Liu, Dan Zhu, and Huimin Mao
Price
42.00 $
Volume 106 (2026) p. 208 - 222
Abstract
Clinical Nephrology, Vol. 106 – No. 3/2026 (208-222)
Systematic review of risk prediction models for autogenous arteriovenous fistula dysfunction in maintenance hemodialysis patients
Ping Liu1#2, Dan Zhu1, and Huimin Mao2
1Department of Critical Care Medicine, West China Hospital, and 2Department of Critical Care Medicine, West China Tianfu Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Si Chuan, China
Objective: To systematically evaluate existing risk prediction models for autogenous arteriovenous fistula (AVF) dysfunction in maintenance hemodialysis (MHD) patients, in order to provide a reference for clinical practice.
Materials and methods: A systematic search was conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, VIP Chinese Science and Technology Journal Database, Chinese Biomedical Literature Database (CBM), PubMed, Web of Science, Embase, and The Cochrane Library ror studies on the development and validation of risk prediction models for autogenous arteriovenous fistula (AVF) dysfunction in MHD patients. The search time was from database inception to November 1, 2025. Two researchers independently screened the literature and extracted data. The Prediction Model Risk of Bias Assessment Tool (PROBAST) was used to evaluate the risk of bias and applicability of the included studies.
Results: A total of 20 articles and 21 prediction models were included. The incidence of autogenous AVF dysfunction in MHD patients ranged from 3.9 to 49.5%, and the area under the ROC curve (AUC) of the models ranged from 0.530 to 0.949. Age, diabetes mellitus, intradialytic hypotension, calcium–phosphorus product, fibrinogen, and platelet count were the most common predictive factors. The quality assessment showed that most studies had a relatively high risk of bias.
Conclusion: Research on risk prediction models for autogenous AVF dysfunction in MHD patients is still in its early stage. Overall, the risk of bias is relatively high, and clinical application is lacking. In the future, researchers may adopt multicenter prospective designs based on machine learning methods to develop high-quality risk prediction models with high accuracy and strong generalizability.Correspondence to:
Huimin Mao, MD
Department of Critical Care Medicine
West China Tianfu Hospital
Sichuan University/West China School of Nursing
Sichuan University, Chengdu, Si Chuan, China
Email: [email protected]