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20 November 2017, Volume 14 Issue 11 Previous Issue    Next Issue

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Acquisition and Analysis of Basic Data of Juvenile Sprague-Dawley Rats MU Wen-bo, LI Hui, AN Hui-ping, CHENG Hong-xu, WANG Can, JIN Hong-tao, WEI JIN-feng 2017, 14(11): 641-645.  Abstract ( 433 )   PDF (988KB) ( 177 )   Objective To acquire and analyze the basic data of different weeks juvenile Sprague-Dawley rats and provide scientific basis for nonclinical safety evaluation of pediatric drug products. Methods The 18 biochemical indexes of Sprague-Dawley rats in different ages and sexes were measured by automatic chemistry analyzer. The results were analyzed by SPSS software. Results In the results of 3 weeks old Sprague-Dawley rats, the AST、TBIL、LDH、CK、Na showed statistical significance between male and female group (P <0.05 or P <0.01). In 8 weeks old, the ALB、ALP、UREA、TG、K showed statistical significance between male and female group (P <0.05 or P <0.01). In 11 weeks old, almost all the biochemical indexes showed statistical significance between male and female group except GLU、UA、Na、Cl (P <0.05 or P <0.01). In 20 weeks old, almost all the biochemical indexes showed statistical significance between male and female group except UREA、Na、Cl (P<0.05 or P<0.01). In 32 weeks old, almost all the biochemical indexes showed statistical significance between male and female group except UREA、TG、Na、Cl (P <0.05 or P <0.01). Conclusion The biochemical indexes of Sprague-Dawley rats exhibit difference in different ages and sexes. So, it is necessary to establish the basic data of juvenile Sprague-Dawley rats for nonclinical safety evaluation of pediatric drug products. The results of this research may provide scientific basis for nonclinical safety evaluation of pediatric drug products, and will be helpful for ensuring the safety of drug use in children. References | Related Articles | Metrics

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Acquisition and Analysis of Basic Data of Juvenile Bama Miniature Pigs GUO Xin-miao, WANG Ying, MENG Ye, YU Yang, ZHOU Liang, WANG Can, FAN Xiao-yu, JIN Hong-tao, WEI Jin-feng 2017, 14(11): 646-652.  Abstract ( 247 )   PDF (803KB) ( 151 )   Objective To acquire and analyze the basic data of different day old juvenile Bama miniature pigs, the data mainly include body weight, body length, body temperature, electrocardiograph data, hematological index, blood biochemical indexes, blood coagulation indexes, immunological indexes, urine indexes, tibia length, organ weight and organ coefficient. Methods The 30 juvenile Bama miniature pigs (15 females and 15 males) were fed and managed normally in this experiment. The body weight, body length, body temperature were measured between 8~64 days old every 7 days. The electrocardiograph data were collected at 7, 35, 63 days old. The hematological index, blood biochemical indexes, blood coagulation indexes, T cell subsets and tibia length were measured at 36, 64 days old. 18 Bama miniature pigs (9 females and 9 males) were killed at 36 days old and the other 12 Bama miniature pigs (6 females and 6 males) were killed at 64 days old to measure the organ weight and organ coefficient. The mean value and standard deviation were calculated using SPSS software. Results and Conclusion The research established the basic data of physiological indexes of juvenile Bama miniature pigs at different days old, these data may be helpful to the research of juvenile Bama miniature pigs. References | Related Articles | Metrics

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Experimental Study on Acute and Repeated Dose Toxicity of Traditional Chinese Medicine Kangguan Granule on Juvenile Rats LIN Xiao-qi, GUO Xin-miao, ZHANG Ying-xue, WEI Jin-feng, JIN Hong-tao 2017, 14(11): 653-656.  Abstract ( 360 )   PDF (695KB) ( 153 )   Objective To observe the acute and repeated dose toxicity of Kanggan granule on juvenile rats． Methods The acute toxicity study was conducted with the maximum dose method by oral dose of 36 g·kg-1． For the repeated dose toxicity study, Kanggan granule suspended in 0.5% methylcellulose vehicle was administered via oral gavage, once daily, at doses of 1, 3, 9 g·kg-1 for 30 days and with 4 weeks recovery period．Parameters included daily clinical signs, periodic hematology, clinical chemistry and urinalysis determinations, hormone, histopathology and neurobehavioral examination． Results In acute toxicity study, body weight of female rat increased slowly at the dose of 36 g·kg-1. In repeated dose toxicity study, slightly decreased RBC, HGB and HCV, mild increased reticulocytes were observed at the dose of 9 g·kg-1, while reversible at the end of recovery period． Conclusion In acute toxicity study, the maximum tolerance dose was greater than 36 g·kg-1, for repeated toxicity, the NOEAL was 3 g·kg-1 of Kanggan granule on juvenile rats． References | Related Articles | Metrics

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Preliminary Thoughts of the Safety Evaluation System of Pediatric Drug ZHANG Jing, QIN Dan, JIN Hong-tao 2017, 14(11): 657-661.  Abstract ( 463 )   PDF (630KB) ( 268 )   The safety of pediatric drug is an important social and public health problem, which involves all the aspects such as drug development, clinical evaluation, post-marketing reevaluation and pharmacovigilance. This review analyzes the mode exploration of pediatric drug safety evaluation from non clinical to clinical then to post-marketing reevaluation, which focus on the characteristics of pediatric drug and major influence factor of pediatric drug safety. And also this review has listed some internal achievements, hoping to provide some reference to pediatric drug safety evaluation. References | Related Articles | Metrics

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Brief Introduction of Guidance on Pharmacogenomics in the USA and Its Implication for China WANG Tao, SONG Hai-bo, DONG Duo 2017, 14(11): 662-665.  Abstract ( 469 )   PDF (660KB) ( 678 )   Objective To classify and introduce the FDA's guidance on pharmacogenomics and provide suggestions to conduct the application of pharmacogenomics in China. Methods The materials of guidance on pharmacogenomics in FDA official website were researched, and the related literatures were searched and analyzed. Results FDA has issued a series of guidance on genomic sampling, sample coding, data submission, studies in clinical trials and recommendations for labeling to ensure the application of pharmacogenomicsin the USA In this section, the guidance Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling was elaborated as a case here, and three chapters were emphatically introduced. Conclusion The FDA's guidance on pharmacogenomics could give us valuable reference for new drug development and post-marketing drug evaluation. References | Related Articles | Metrics

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How Drug Manufacturers to Establish Pharmacovigilance System PENG Li-li, FAN Yan, LIU Wei, GUO Xue, HU Jun 2017, 14(11): 666-670.  Abstract ( 1167 )   PDF (801KB) ( 1124 )   Objective Through discussing the necessity and factors of drug manufacturers' pharmacovigilance(PV) system, to provide reference and help in building and improving their pharmacovigilance system. Methods By referring the four elements of "human resource, machine, material, law and process" in quality management theory, the drug manufacturers are proposed on how to set up the pharmacovigilance system, at least they should have full-time staff and PV function, enough safety information collection, comprehensive and practical quality management system of documentation, efficient data processing system, and enterprise environment full of "patient safety first". Results and Conclusion With the development of science and technology of society and the continuous improvement of people's living quality requirements, the problem of drug safety are getting more and more attention from us. Drug manufacturers should strengthen their works to commit "the primary responsibility of drug safety" actively. They should strengthen their cognition and understanding of the pharmacovigilance, and establish the Quality Management System, set up PV specific function and full-time personnel to be responsible for the ADR monitoring work, and at the same time increase their internal PV training to establish an efficient PV system and ultimately provide the necessary guarantee for the development of the pharmacovigilance work. References | Related Articles | Metrics

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Discussion on the Strategy of Drug Manufacturers to Deal with the Adverse Drug Event Clustering Signal SUN Jun, HUANG Qian-qian, GAN Ge, WANG Jia-yu 2017, 14(11): 671-674.  Abstract ( 577 )   PDF (749KB) ( 425 )   Objective To improve the ability of drug manufacturers to deal with the adverse drug event clustering signal. Methods Analyze the connotation of adverse drug event clustering signal, discuss the main problems and causes of drug manufacturers in response to the adverse drug event clustering signal. Results The drug manufacturers are limited in their ability to collect information, so they are difficult to find the clustering signal in time. The investigation is based on self-examination, so it's hard to collect the case data of clustering signal. The ability to analysis and evaluation is weak, so it is difficult to assess the risk of adverse drug event clustering signal and therefor lack of prevention and control measures. Conclusion The drug manufacturers should lay the foundation for response to the adverse drug event clustering signal from organization management and system design. Starting with the channels and delivery requirements of the information collection, the adverse drug event clustering signals can be detected by information means. Starting with knowledge update and expert consultation, to improve the ability of evaluation and risk control. References | Related Articles | Metrics

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Conception of Establishing Computerized Quality Assessment System of Adverse Drug Reaction/Event Report in China CHEN Jia-yin, YUAN Li, YANG Yue 2017, 14(11): 674-679.  Abstract ( 425 )   PDF (794KB) ( 391 )   Objective To put forward a conception of computerized identification for quality assessment system of adverse drug reaction/event report in China. Methods By introducing the World Health Organization drug monitoring center's vigiGrade and VigiBase management Methods, ADR/ADE report quality assessment standards and algorithms were described in detail. Results The vigiGrade inputs data in structured format. For each information dimension, a penalty is detracted which varies with causality assessment. The vigiGrade completeness score ranges from 0.07 to 1. We classified reports with C>0.8 as well-documented. Conclusion It is suggested that computerized identification for quality assessment system of adverse drug reaction/event report should be established by using structured report format, each information dimension should be evaluated according to its importance, and the method of addition and subtraction should be replaced by multiplication. References | Related Articles | Metrics

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Clinical Application and Potential Risk of Xylitol-containing Injections XU Xian-xing, YANG Jing-wen, WU Gui-zhi, DONG Duo 2017, 14(11): 680-682.  Abstract ( 331 )   PDF (643KB) ( 165 )   Objective To investigate the potential risks of xylitol-containing injections so as to promote rational use of these products in clinical practice. Methods The valid data of xylitol-containing injections were retrieved from the national database of drug adverse reaction monitoring and literature at home and abroad, and the characteristics and potential risks were analyzed. Results Xylitol-containing injections were widely used as glucose substitutes in our country. Although there are strict restrictions in the indications for such products, off-label use is common, which may increase the incidence of adverse reactions in patients. Additionally, some of the xylitol-containing formulations are not restricted for use in diabetic patients, and substantial intake of xylitol may happen. Conclusion Xylitol-containing injections should be used in accordance with indications, meanwhile, the potential risk of excessive intake of xylitol must be concerned about. References | Related Articles | Metrics

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Literature Review on 163 Cases of Adverse Reactions Induced by Oxcarbazepine CUI Hong-xia, YU Su-wen 2017, 14(11): 683-686.  Abstract ( 312 )   PDF (708KB) ( 165 )   Objective Through investigating the characteristics and mechanism of adverse drug reactions(ADRs) induced by oxcarbazepine, to find its risk factors and provide technical support for safe and rational use of drugs in clinic.Methods Using "oxcarbazepine"、"adverse reaction"and "to"as key words to search and retrieve articles in the Wanfang database、 CNKI database and VIP Chinese full-text database. 29 references which met the inclusion criteria were extracted and analyzed.Results 163 cases were extracted. Adverse reactions occurred in all ages from children to the elderly. The major illness was epilepsy. ADRs occurred more frequently within 3~30d. Systems and organs mainly involved in adverse reactions were skin and its accessory system, nervous and mental system and nutritional disorders etc. Arrhythmia, rash, headache and hyponatremia are the most common reported adverse reactions.Conclusion It is important to pay attention to the adverse reactions caused by oxcarbazepine, strengthen clinical rational use of drugs, in order to ensure the safe drug use in clinic. References | Related Articles | Metrics

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Pharmaceutical Care for Chemotherapy-induced Acute Liver Injury in a Patient with Lung Cancer YOU Li-Na, JIANG Kun 2017, 14(11): 687-690.  Abstract ( 400 )   PDF (663KB) ( 144 )   Objective To explore the methods and significance of providing pharmaceutical care for lung cancer patients with chemotherapy-induced acute liver injury by clinical pharmacist. Methods By participating in drug therapy for a lung cancer patient with chemotherapy-induced acute liver injury, pay close attentions on the patients and make reasonable suggestions as to the adverse drug reactions to guarantee the rational use of drug. Clinical pharmacist provided pharmaceutical care such as selection of hepatoprotective drugs and the reapplication of drugs that cause acute liver injury for patients. Results Clinical pharmacists can assist clinicians to adjust the therapeutic regimen from the perspective of pharmacists, and improve the level of clinical drug treatment. Conclusion In clinical work, clinical pharmacists should play its due role in collaboration with clinicians actively, and carry out the monitoring of adverse drug reactions. In order to promote rational drug use and improve health treatment, we should take effective interventions. References | Related Articles | Metrics

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Literature Analysis of 63 Cases of Adverse Drug Reactions Induced by Compound Fat-soluble Vitamin for Injection CUI Xiao-kang, WU Shi-fu, LI Yu-ji, TIAN Yue-jie, LU Chang-fei, ZHAI Shu-yue 2017, 14(11): 691-696.  Abstract ( 333 )   PDF (819KB) ( 167 )   Objective To explore the general characteristics of adverse drug reactions (ADRs) induced by compound fat-soluble vitamin for injection in order to provide references for rational and safe clinical drug use. Methods ADR cases induced by compound fat-soluble vitamin for injection reported in SinoMed and CNKI during 2000~Jul. 2017 were collected and analyzed statistically. Results Compound fat-soluble vitamin was used in clinic beyond the approved indications and immediate hypersensitivity occurred, which hurted multiple organs and systems including severe allergic reactions and anaphylactic shock. Conclusion Compound fat-soluble vitamin for injection should not be used with unreasonable indications. Medical staff should pay attention to the ADR induced by compound fat-soluble vitamin for injection. Drug manufacturers should strengthen the post-market monitoring of ADR. The domestic drug package inserts need to be further improved and revised. References | Related Articles | Metrics