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20 January 2018, Volume 15 Issue 1 Previous Issue    Next Issue

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Study on Hepatotoxicity of Aqueous Extract of Polygoni Multiflori Radix and Its Main Components Based on Zebrafish QUAN Zheng-yang, SUN Zhen-xiao 2018, 15(1): 1-5.  Abstract ( 545 )   PDF (984KB) ( 238 )   Objective To investigate the hepatotoxicity of aqueous extract of Polygoni Multiflori Radix (AEPMR) and major monomer components in it with larvae zebrafish. Methods 72 hpf liver fluorescence transgenic larvae zebrafish (lfabp:dsRed) were treated with different doses of AEPMR and its main monomer components for 2 d respectively with acetaminophen (APAP) as positive drug. Larval zebrafish survival situation, liver morphology, change in size of liver and yolk sac retention, and the liver fluorescence are major factors to evaluate hepatotoxicity. Results Zebrafish all died at 2 mg·mL-1 AEPMR, 2 μg·mL-1 emodin (EM) after 1 d administration and all died at 20 μg·mL-1 emodin-8-O-β-D-glucopyranoside (EG) after 2 d administration. There was no death in the rest doses and other monomer component groups. 10 μg·mL-1, 20 μg·mL-1 aloe-emodin (AE) and 8 mM APAP induced liver degeneration, reduced liver size (P <0.05 or P <0.01) and delayed yolk sac absorption (P <0.05 or P <0.01) in larval zebrafish. The liver fluorescence also decreased in larval zebrafish treated with 10 μg·mL-1、20 μg·mL-1 AE and 8 mmol·L-1 APAP, whereas AEPMR and other monomer component groups had no obvious effect on larval zebrafish liver. Conclusion 10 μg·mL-1, 20 μg·mL-1 AE induced liver toxicity in larval zebrafish, AEPMR and other monomer component groups do not show obvious liver damage. References | Related Articles | Metrics

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Effect of Paracellular Permeability Increasing on Transport of Squamosamide Derivative FLZ Across the in vitro BBB Models under Parkinson's Disease Pathological LIU Qian, HOU Jin-feng, ZHANG Jin-lan, ZHANG Dan, BAO Xiu-qi, SUN Hua 2018, 15(1): 6-11.  Abstract ( 355 )   PDF (1108KB) ( 225 )   Objective To study the effect of paracellular permeability on the transport characteristics of squamosamide derivative FLZ across the physiological and Parkinson's disease (PD) pathological in vitro blood-brain barrier (BBB) models. Methods In vitro BBB models mimicking physiological and PD pathological-related BBB properties were constructed by C6 astroglial cells co-cultured with primary normal or PD rat cerebral microvessel endothelial cells (rCMECs) and in vitro permeability experiments of FLZ were carried out. The effects of P-gp inhibitor zosuquidar and increasing paracellular permeability on the in vitro permeability and efflux ratio of FLZ were also investigated. Results The transport of various concentrations of FLZ (1, 5, 10 μM) through the out of contact co-culture model and in contact co-culture model occurred in both A~B and B~A directions, and Papp B~A transport were significantly higher than those for A~B transport at each FLZ concentration. Upon specific blocking of P-gp using zosuquidar increased intracellular accumulation of FLZ both in the physiological and PD pathological in vitro BBB models and resulted in significantly reduced efflux ratio. Results also showed that more brain penetration of FLZ was detected in the PD pathological model compared to the physiological group with increasing paracellular permeability, but the alter of efflux ratio was not observed as P-glycoproteinon mediated FLZ efflux. Conclusion The poor brain penetration of FLZ are mainly due to the P-gp transport system in the BBB under physiological and PD pathological in vitro BBB models. References | Related Articles | Metrics

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Effects of Total Flavone of Abelmoschl Manihot Combined with Glipizide on Model Rats of Diabetic Nephropathy LI Meng, SONG Chun-quan, WANG Shuai, XUE Yun, MA Yu-kui 2018, 15(1): 12-15.  Abstract ( 325 )   PDF (903KB) ( 199 )   ：Objective To investigate the effects of total flavone of Abelmoschl manihot(TFA) combined with glipizide on GK model rats of diabetic nephropathy. Methods The GK model rats were induced by high-calorie and high-protein diet. The level of glycosylated hemoglobin, blood fat, indothelin, urinary microalbumin, blood rheology, renal function, indexes and pathology of renal were determined to evaluate the auxiliary therapeutic effects of TFA on model rats of diabetic nephropathy． Results Compared with glipizide group, the level of glycosylated hemoglobin, blood fat, indothelin, urinary microalbumin, BUN, CR, blood viscosity and indexes of renal was decreased, at the same time pathological changes of kidney were alleviated significantly in glipizide plus TFA(50、100 mg·kg-1, i.g) groups． Conclusion TFA has a remarkable auxiliary therapeutic effect on GK model rats of diabetic nephropathy． References | Related Articles | Metrics

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Analysis of Drug Manufacturer on Post-marketing Drug Risk Monitoring and Management Status in China FENG Hong-yun, WU Gui-zhi, FAN Yan, DONG Duo 2018, 15(1): 16-19.  Abstract ( 825 )   PDF (759KB) ( 760 )   Objective To evaluate the drug manufacturer's abilities on the post-marketing drug safety monitoring and risk control at the present stage in China. Methods China adverse drug reaction(ADR) database, the literatures in domestic bibliographic databases, and the risk management measures in CFDA website were analyzed. Results The pharmcovigilance organizational system of drug manufacturers in China were established almost, but the abilities of ADR reports collecting, discovering and identifying the safety signals, and the implementation of the drug safety risk management measures need to be improved. Conclusion Drug manufacturers in China should change the management philosophy, expand the thinking of work, perform the duty of drug risk management practically. References | Related Articles | Metrics

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Analysis of Data Integrity Defects in Drug Manccfacturers YAN Ruo-xi, CAO Yi 2018, 15(1): 20-23.  Abstract ( 681 )   PDF (833KB) ( 410 )   Objective To study data integrity defects of drug manufacturers, in order to provide reference for regulators and pharmaceutical industry. Methods By analyzing the domestic and foreign data management laws and guides, and classifying the common data integrity defects in drug manufacturers, the study makes statistical analysis on the data integrity defects which were found in CFDA GMP unannounced inspection, GMP follow-up inspection and observation of international inspection in 2016. Results The basic requirements of data management are defined. Main data integrity defects which existing in drug manufacturers and causes are identified. Conclusion The paper provides suggestions on improving data management and references to enhance the data management ability in the pharmaceutical industry. References | Related Articles | Metrics

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Exploration on the Model of Provincial ADR Monitoring Support the Drug Supervision LU Chang-fei, CUI Xiao-kang, LIU Wen-wen, LI Yu-ji, WU Shi-fu 2018, 15(1): 24-27.  Abstract ( 451 )   PDF (681KB) ( 337 )   Objective To establish a work model of provincial adverse drug reaction monitoring support the drug supervision. Methods On the basis of the adverse drug reaction monitoring practice in Shandong province, we developed a work model of provincial adverse drug reaction monitoring support the drug supervision, which contains risk discovery, risk discussion, risk control and other links. Results and Conclusion The model can not only ensure the discovery and subsequent disposal of the risk and straighten out the responsibilities of relevant departments, but also provide a new train of thought to enhance the role of adverse drug reaction monitoring. References | Related Articles | Metrics

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Suggestions on Improvement of Administrative Regulations on Narcotic Drugs and Psychotropic Drugs in China FAN Ying-ying, QI Ying-ying, MU Xing-jia, WANG Chen-hui, JIANG Qing-dan, QIAO Ming-juan 2018, 15(1): 28-31.  Abstract ( 480 )   PDF (733KB) ( 252 )   Objective To analyze the status of the administrative supervision and regulation system of narcotic drugs and psychotropic drugs (hereinafter referred to as "the two drugs") in our country since the promulgation and implementation of the Drug Administration Law of the People's Republic of China, so as to explore the shortcomings and deficiencies in the laws and regulations in practice and propose suggestions. Methods A large number of documents were searched and analyzed, legislative evolution of administrative supervision were collected and arranged, The shortcomings and deficiencies of the regulation system were explored. Results The shortcomings and deficiencies in the laws and regulations of administrative supervision could not effectively meet the needs of multiple and complex administrative law enforcement activities. Conclusion It is suggested to analyze the shortcomings and deficiencies of administrative laws and regulations in time, perfect the administrative regulations and improve the administrative supervisioan. References | Related Articles | Metrics

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Practice of Pharmacovigilance Courses Provision at Medical and Pharmaceutical College WAN Bang-xi, XIAO Liang, XU Ju-ping 2018, 15(1): 32-35.  Abstract ( 568 )   PDF (730KB) ( 428 )   Objective With the increasing attention on pharmacovigilance, the pharmacovigilance activities are conducted and developed rapidly. Therefore the problem of pharmacovigilance professionals shortage is gradually emerging. This article summarizes the method and practice of teaching pharmacovigilance in medical college. It attempts to provide pharmacovigilance professionals for the pharmaceutical industry. Methods According to the professional needs of pharmacovigilance in pharmaceutical industry and international education practice, pharmacovigilance courses were set up in a medical college. The curriculum contents and learning hours were arranged and implemented with well prepared teaching Methods. The students also participated in real world working practice activities of pharmacovigilance in a supplier of corresponding services. At the end of courses, the students took an examination for assessment of the learning effects. Results According to the assessment Results, the basic concepts and key points of pharmacovigilance regulations were properly mastered by the students. Some of the students were employed in enterprises and engaged in pharmacovigilance related jobs. The emplyees reflected the understanding of pharmacovigilance from thier cognitions to thier behaviors. The teaching of the courses achieved the purpose of training pharmacovigilance professionals to a certain extent. Conclusion with the deepening of practice and accumulation of experience in pharmacovigilance courses in colleges, college education is expected to become an effective way to solve the problem of professionals shortage. References | Related Articles | Metrics

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ADR Analysis of Oxiracetam Injection in Twelve Sentinel Monitoring Hospitals in Hubei Province ZHAO Li, HUANG Pu, ZHAO Ying, WANG Hui, HUA Xiao-li 2018, 15(1): 36-40.  Abstract ( 529 )   PDF (873KB) ( 400 )   Objective To study using rules and safety of oxiracetam injection and provide reference for clinically reasonable application. Methods In twelve sentinel hospital of Hubei province, all hospitalized patients using oxiracetam injection were monitored centralizedly in observation period (September 1, 2016 to March 31, 2017). The patient's demographic information, clinical diagnosis, drug usage and dosage, course of treatment, solvent, combination and incidence of adverse drug reactions (ADRs) were analyzed, and the risk factors influencing ADRs were studied. Results A total of 6 519 cases were recorded. There were 19 cases of ADRs (0.29%). Patients aged 40 to 90 years accounted for 90.31%. ADRs occur mostly in 3 days after medication (57.89%). 17 ADRs are mild (89.47%), and 2 ADRs are new and serious. Skin and appendages disorders (pruritus) are the most common (36.84%). Statistical analysis showed no significant difference (P>0.05) in incidence rate of ADR between different genders, age groups, allergic history, diseases and dosage form. Conclusion The drug instructions and clinical medication need to further improved. In clinical use of oxiracetam injection, particular attention should be paid to the course of treatment, dosage and solvent. To avoid or reduce ADRs, it is important to closely observe patients' drug reactions and dispose immediately. References | Related Articles | Metrics

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Analysis on 382 Cases of Medication and Drug Adverse Reactions of Protamine Sulfate Injection in a Hospital from 2015 to 2017 ZHAN Hai-yan, YANG Jian 2018, 15(1): 41-44.  Abstract ( 373 )   PDF (696KB) ( 365 )   Objective To analyze the rational uses and adverse reactions of protamine sulfate injection in the clinic, and to provide references for rational drug use. Methods We conducted a retrospective review of 382 inpatients with application of protamine sulfate injection from January 2015 to February 2017 in a hospital, which were collected by China Hospital Pharmcovigilance System (CHPS), and analyzed the characters of the adverse drug reaction/event (ADR/ADE). Results There weren't obviously irrational medication orders except one case that the patient was treated with a single dose of 300 mg protamine sulfate. 8 cases of ADR were obtained, and they were mainly hypotension. And 2 cases of severe ADR were anaphylactic shock and myocardium inhibition. A new batch of the protamine sulfate and dose reduction had positive effects on preventing adverse reactions. Conclusion The use of protamine sulfate injection in this hospital was basically rational, and the ADRs were mainly hypotension. In order to assess the risk of medication and promote clinical rational use of drugs, medical staff should strengthen to write treatment details and actively report ADRs. References | Related Articles | Metrics

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Analysis of Adverse Drug Reactions about 141 Cases of Dextran 40 and Amino Acids Injection WANG Lin, LI Shuang, LI Hua-bin, JU Yong-jing 2018, 15(1): 45-48.  Abstract ( 401 )   PDF (745KB) ( 215 )   Objective To analyze adverse drug reactions(ADRs) of dextran 40 and amino acids injection(DAAI) reported by safety monitoring system in our hospital and promote clinical rational use of drugs. Methods From January 2010 to June 2017, there are totally 141 cases of ADRs, they were analyzed in respects of the patients' age, gender, department distribution, occurrence time, ADR manifestations and severity, and the number reported in recent years. Results Of the 141 reports, the ration of female was higher than male who experienced ADRs, 58.87% of patients were between 21 and 40 years old and 45.71% of patients come from obstetrical department. The adverse reactions of DAAI mainly appeared in less 30 minutes on the first day. The most common ADRs occurred in skin and its appendants(24.9%) and respiratory system(23.69%). Serious adverse events occurred in 43 patients(30.50%). The number of ADR reports was increased on the first half of 2017. Conclusion With high incidence and high application risk, the DAAI ' ADR must be drawned attention, and DAAI should be properly used to reduce the adverse reactions. References | Related Articles | Metrics

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Analysis of 89 Cases of Adverse Reactions Induced by Telmisartan HAN Bao-xia, QU Hong, GOU Xiao-jun 2018, 15(1): 49-51.  Abstract ( 438 )   PDF (706KB) ( 360 )   Objective To explore the general regulation and characteristics of adverse drug reactions(ADR) induced by telmisartan, and provide reference for clinical rational drug use. Methods 89 cases of telmisartan related ADR were extracted from the adverse drug reaction monitoring and management system for drug adverse reactions in our district from January 2014 to December 2016, and comprehensively analyzed by retrospective classified statistics. Results Among the 89 ADR patients, the incidence of female was higher than that of male, and the age mainly distributed in the range of 61 to 70 years old (40.45％). The mainly involved organs/systems were digestive system (44.92%) and skin and its accessories (25.84%), the main clinical manifestations were nausea, vomiting, abdominal pain, diarrhea, eczema, itching, genital swelling, genital itching, lips swelling, facial edema, eyelid edema, etc. Conclusion Telmisartan has good safety and tolerability, enhance medication monitoring, and reduce ADR occurrence in order to ensure drug safety during clinical application. References | Related Articles | Metrics

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Literature Analysis of 56 Cases of Adverse Reactions Induced by Rituximab ZHU Hui, ZHOU Feng, JIN Jian 2018, 15(1): 52-56.  Abstract ( 386 )   PDF (808KB) ( 233 )   Objective To discuss the regularity and characteristics of rituximab adverse reactions in clinical use, and to provide reference for clinical drug use. Methods A total of 56 ADR cases using rituximab were reported from 2006 to June 2017 in CNKI, Wanfang database and PUBMED. Then we analyzed the general condition, drug use and the incidence of ADR of patients. Results Of the 56 cases of ADR cases caused by rituximab, 34 cases (60.71%) were male patients, 22 cases (39.29%) were female patients, and the proportion of patients aged 60 to 69 was the largest (33.93%). The incidence of ADR mostly occurred in the intravenous infusion within 60 min and infusion within six months after the completion. The main clinical manifestations are respiratory damage and systemic damage. Conclusion We should pay attention to the ADR of rituximab clinically, and strengthen the monitoring of therapy, and adhere to the rational application. References | Related Articles | Metrics