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08 February 2014, Volume 11 Issue 2 Previous Issue    Next Issue

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Experimental Study on the Long-term Toxicity of Shendanxiong Injection in Rats WU Xiao-fei, HU Yu-chi, CAO Chun-ran, SUN Yuan-yuan, LV Jing 2014, 11(2): 65-69.  Abstract ( 267 )   PDF (325KB) ( 165 )   ObjectiveTo observe the long-term toxicity of shendanxiong injection in rats by intravenous injection. MethodsDaily doses of shendanxiong injection at 342、228、152 mg crude drug·kg-1 for 30 days were used for high, mid, and low dose group, respectively. Clinical observations, examinations of body weight and feed consumption were performed during whole experimental stage. Rats examinations including haematological indexes, biochemical indexes, organ coefficient, and histopathology were performed on the 30th day, and on the 14th day after withdrawal, respectively. ResultsNo abnormity was found in all rats in terms of clinical observation, body weight increase and food consumption. The levels of WBC, GR%, Urea, CR, TBIL and liver coefficient, kidney coefficient, adrenal gland coefficient in high dose group were significantly higher than those in control group, and the levels of GR%, CR, TBIL in mid dose group were significantly higher than those in control group, and LY% level in mid dose group was significantly lower than those in control group on 30th day (P<0.05). Those changed indexes of hematology, blood biochemistry and organ coefficient in high dose group regained normal except CR level and kidney coefficient on the 14th day after withdrawal, and above indexes in mid dose group all regained normal. The kidney of rats in high dose group appeared irreversible pathological changes, but the kidney of rats in mid dose group appeared reversible pathological changes. ConclusionRepeated intravenous injection administration of the shendanxiong injection at mid dose could lead to reversible damage to kidney function and pathology References | Related Articles | Metrics

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Advances in Studies on Toxicity of Herba Leonuri SUN Rong, FENG Qun, ZHAO Qing-hua, LI Xiao-yu, ZHAO Hong 2014, 11(2): 70-73.  Abstract ( 319 )   PDF (611KB) ( 256 )   ObjectiveThe toxicity characteristics, chemical material basis and toxic mechanism of Herba Leonuri were determined and the correlation of its efficacy and toxicity were discussed. The literature evidence and research ideas were provided for making safety standards, and studying its toxicity based on its efficacious substance basis. MethodsLiteratures in latest decades at home and abroad about Herba Leonuri were collated, analyzed and summarized. ResultsAs a commonly used traditional Chinese medicine, Herba Leonuri, which has the efficacy of promoting blood flow for regulating menstruation, diuresis and edema was a traditional Chinese medicine. A number of adverse reactions of Herba Leonuri or Chinese patent drugs containing it were reported. Modern toxicology studies have shown that Herba Leonuri had toxicity, and the dose range, substance basis, site of action and damage mechanism were discussed by toxicology experiment. ConclusionThe Herba Leonuri toxicity and controlling of toxic material basis are studied during the expression of effectiveness and the separation and quality controlling of efficacious material basis, the relationship between the drug efficacy, toxicity and adverse reactions are determined. And we can put forward early-warning scheme and treatment measures of adverse reaction in clinical usage. The safety limitation and standard of content of material basis from Herba Leonuri are established to ensure the safe use of Herba Leonuri as a clinical drug. References | Related Articles | Metrics

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Research Progress of Clinical Applications and Adverse Reactions of Herba Leonuri FENG Qun, ZHAO Hong, SUN Rong 2014, 11(2): 74-76.  Abstract ( 431 )   PDF (384KB) ( 998 )   ObjectiveThe clinical applications and adverse reactions of Herba Leonuri were determined and the correlation of its efficacy and toxic and side effect were discussed. The literature evidence and research ideas were provided for making safety standards, and studying its safety based on its efficacious substance basis. MethodsAncient books, literature in past dynasties and references in the last decades at home and abroad about the efficacy and adverse reactions of Herba Leonuri were collated, analyzed and summarized. ResultsHerba Leonuri, which has the efficacy of promoting blood flowing, regulating menstruation, diuresis and detumescence, is a commonly used traditional Chinese gynecological medicine. It is always used to diseases of gynecology and diseases caused by immune system and circulatory system. A number of adverse reactions caused by Herba Leonuri and its preparations were reported. The adverse reactions of Herba Leonuri came down to urinary system, reproductive system, etc. And the most common organs damaged by Herba Leonuri were liver and kidney during conventional or excessive dose. ConclusionOnly under the process of efficacy-expression and conferring to the toxicological experiment of Herba Leonuri, can basement be provided for consummating safety standards and putting forward early-warning scheme of adverse reaction that can be referred in clinic. In this way Herba Leonuri can be ensured to be used safely. References | Related Articles | Metrics

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Experimental Research of Influences on Acute Toxicity and Content of Total Alkaloids in Herba Leonuri Caused by Combinations LI Xiao-yu, FENG Qun, LV Li-li, SUN Rong 2014, 11(2): 77-80.  Abstract ( 214 )   PDF (416KB) ( 313 )   ObjectiveTotal alkaloids contents and acute toxicity of Herba Leonuri were researched to probe the influence caused by different combinations. MethodsUV spectrophotometry was used to measure the content of total alkaloids and the classical method of acute toxicity was used to compare the difference of acute toxicity among different combinations. ResultsThe contents of total alkaloids in the samples of Herba Leonuri, Herba Leonuri + Angelica sinensis, Herba Leonuri+ Ligusticum chuanxiong, Herba Leonuri + Aucklandia lappa and the whole formula were separately 0.51%, 0.34%, 0.37%, 0.37%, 0.36%. Calculated by crude drug content of Herba Leonuri, the MTD of Herba Leonuri was 2.34 g·kg-1 and the MLD of other for samples were respectively 3.52, 3.23, 3.60, 3.32 g·kg-1, which were respectively equal to 218.8, 328.8, 301.6, 336.3, 310.0 times of 70 kg person's daily dried medicinal herb expenses. Making continuous observation of 14 days, mice were generally in good condition and only two mice in the group of Herba Leonuri were dead. ConclusionThe content of total alkaloids and the acute toxicity of Herba Leonuri are closely related to compatibilities. The MTD shows the basic security and low toxicity of Herba Leonuri. The combination of Angelica sinensis, Ligusticum chuanxiong or Aucklandia lappa with Herba Leonuri can reduce toxicity via reducing the content of total alkaloids in Herba Leonuri. References | Related Articles | Metrics

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Study on Indicator System for Evaluating Primary Institutions Active Monitoring WANG Xiao-yan, XU Yan, LIN Yu, DENG Jian-xiong, XIONG Hui-yu, YANG Yue 2014, 11(2): 81-84.  Abstract ( 228 )   PDF (444KB) ( 285 )   ObjectiveTo explore the pattern and method of launching ADR active monitoring in primary medical institutions the qualitative and quantitative method. MethodsLiterature study, experts' demonstration and Delphi expert consultation were used to construct indicators and weights of primary medical institutions that launch active monitoring. ResultsIndicator system for evaluating primary medical institutions active monitoring are affected by many factors. ConclusionThis system can be used by regulatory agency as reference for choosing the sentinel hospitals that will launch ADR active surveillance. References | Related Articles | Metrics

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Analysis of Drug Risk Management Deficiencies from Current Status of Using Ketoconazole Oral Formulations HE Yong, CHEN Xiao-mao 2014, 11(2): 85-87.  Abstract ( 231 )   PDF (543KB) ( 146 )   Drug risk management is the important measure to ensure drug use safety of patients, which can minimize the risks and maximize the benefits of drug use. Effective drug risk management can reduce the damage to patients induced by drugs. But there are still some problems in the implementation process as the domestic works of drug risk management lack experience and the system is not perfect. Based on the circulation, sale and use situation of the high-risk oral formulation of ketoconazole and combined with experience of working, the author identified some problems in current domestic drug risk management system and put forward some suggestions for improvement. References | Related Articles | Metrics

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Role of Drug Manufacturers in Post-marketed Drug Risk Management REN Jing-tian, ZHENG Wen-ke, ZHANG Jun-hua, LEI Xiang, YANG Le, GUO Xiao-xin, SHANG Hong-cai, DU Xiao-xi 2014, 11(2): 88-93.  Abstract ( 357 )   PDF (580KB) ( 427 )   According to the content of risk management guidances in EU and USA, and spirit of ICH document, this paper puts forward that drug risk management includes risk information collection, risk identification, risk evaluation, risk management and evaluation of the effectiveness on risk management measures. This paper also puts emphasis on the responsibility of drug manufacturers, which should be implemented on risk management. References | Related Articles | Metrics

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Reproductive Toxicity of Tripterygium Wilfordii Hook .f: A Systematic Review and Meta-analysis SUN Feng, YANG Xing-hua, MA Dong-mei, ZHAN Si-yan 2014, 11(2): 94-99.  Abstract ( 236 )   PDF (611KB) ( 125 )   ObjectiveTo systematically evaluate the incidence of reproductive toxicity of Tripterygium Wilfordii Hook .f(TWP). MethodsMEDLINE, EMBASE and the Cochrane Library were systematically searched from inception through May 25th, 2013 with the keywords including "Tripterygium wilfordii Hook .f ", "toxicity", "reproductive", "side effect", "adverse", "safety" and "tolerability" for the follow-up studies of patients treated with TWP. Relevant information was extracted and data was analyzed using random-effects model. Meta-analysis was used to analyze the incidence of reproductive toxicity with MetaAnalyst software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. ResultsAccording to inclusion and exclusion criteria, a total of 56 articles were included, involving 60 researches in the analysis. There is a large degree of heterogeneity among the studies, so data was analyzed using random-effects model and the weighted combined incidence of reproductive toxicity was 17.9%(95%CI：14.1%~22.5%),and the incidence of reproductive toxicity of children and adults were 24.4%(95%CI：13.3%~40.3%) and 15.7%(95%CI：11.9%~20.4%),respectively. There were 24 researches with the control group, the result of random effects model showed that the odds ratio(OR) for TWP treatment group was 5.1(OR95% CI: 3.2~8.2) comparing with control group. Three major events of reproductive toxicity: menstrual disorders, amenorrhea and decreased sperm motility, the weighted combined incidence were 17.6%(95% CI: 13.4% ~22.7%), 27.7%(95% CI: 18.4%~39.3% ) and 20.3%(95% CI: 11.3% ~33.7%), respectively. The subgroup analysis showed that the analysis results of follow-up ≥ 12 months and < 6 months group showed no cross-confidence interval, suggesting that the longer the treatment, the higher the risk of menstrual disorders, While the remaining subgroup results were cross-confidence interval, suggesting that the difference was not statistically significant. Sensitivity analysis based on 47 studies with high quality showed the combined value was close to the summary estimate of total 60 studies. ConclusionThe incidence of reproductive toxicity induced by TWP was high. We should pay attention to the prevention and treatment of reproductive toxicity. References | Related Articles | Metrics

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Progress in Safety Evaluation and Usage of Plasticizers in Medical Devices LIN Ni, JIN Hong-tao, WANG Ai-ping 2014, 11(2): 100-103.  Abstract ( 223 )   PDF (566KB) ( 348 )   ObjectiveTo understand the clinical use and the progress in safety evaluation of plasticizers in medical devices. MethodsThe author sorted several species of plasticizers, and briefly summarized the clinical use of plastical medical devices, then collected the latest data and results of the study on toxicity of plasticizers so as to prove that the plasticizer released from medical devices was potentially harmful to human health and summarized the strategy of safety evaluation of plasticizers. ResultsPlastical medical devices are widely used in clinic, and the addition of plasticizers such as DEHP, carries protential risk and has adverse reactions mainly as reproductive toxicity and hepatotoxicity. The risk assessment of plastical medical devices should be based on the release and intake amount of plasticizers. ConclusionThe discussion on use and safety evaluation of medical plasticizers may provide guidance for the risk assessment and the development of new plasticizers. References | Related Articles | Metrics

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Risk Analysis of Pacemaker System Based on Failure Mode and Effect Analysis CHENG Yun-zhang, LUO Wen-xiang, HUANG Fang-fang 2014, 11(2): 104-108.  Abstract ( 281 )   PDF (718KB) ( 281 )   ObjectiveTo investigate issues of the cardiac pacemaker in use process and analyze potential risks caused by these issues, then to analyze and improve parts on highest risk value to ensure the safety and effectiveness of the cardiac pacemaker in the whole life cycle. MethodsUsing FMEA to study the potential risk of the cardiac pacemaker. ResultsThe highest risk value of cardiac pacemaker is wire. The article adopts ANSYS to simulate wire structure to explore some changes in structure features from the micro when it fractures. Then tentative improvement was carried out on the wire according to the theory of wire mechanical property. ConclusionPerformance of wire of the cardiac pacemaker is improved, service life of the cardiac pacemaker is extended. References | Related Articles | Metrics

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Introduction to Work Pattern and Experience of American Research on Adverse Drug Events and Reports SUN Zhong-shi 2014, 11(2): 109-111.  Abstract ( 230 )   PDF (573KB) ( 178 )   Objective To summarize the experience of American Research on Adverse Drug Events and Reports(RADAR), so as to provide reference to pharmacovigilance in China. Methods Through collecting literatures, the achievements of RADAR were summarized, and its work pattern was analyzed. Results and Conclusion Based on clinic, RADAR can make prospective evaluation on cases of adverse drug reactions and discover new adverse drug reactions more quickly. References | Related Articles | Metrics

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Clinical Analysis of 138 Cases of Carthamus Yellow for Injection YOU Peng-cheng, WANG Song 2014, 11(2): 112-113.  Abstract ( 246 )   PDF (585KB) ( 357 )   ObjectiveTo investigate the clinical application of Carthamus Yellow for injection in order to improve the recommended program of clinical application. MethodsA retrospective research was conducted on 138 cases of clinical application of Carthamus Yellow. ResultsIn strict accordance with the drug instructions, only 22.46% of the investigaled cases can be regarded as reasonable application. ConclusionIt's necessary to strengthen the clinical application monitoring of Carthamus Yellow for injection and enhance the level of reasonable use. References | Related Articles | Metrics

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Analysis of 29 Cases of Adverse Reactions of Mannitol Injection GE Wen-chao, LIU Yan, WANG Feng, HUANG Ping 2014, 11(2): 114-116.  Abstract ( 213 )   PDF (688KB) ( 344 )   ObjectiveThrough the analysis of 29 adverse reactions cases caused by mannitol injection to explore the rule and causes of adverse reactions, provide a reference for clinical rational use of drugs. MethodsBy literature search from 1998 ~2012 Chinese journal database, 29 cases of adverse reactions induced by mannitol injection in 17 literature reports were statistically analyzed. ResultsThe adverse reactions of mannitol injection occur in a short time in elderly patients, the mainly adverse reactions were systemic damage etc. Concluision There are some risks in clinical use of mannitol injection, should pay attention to the monitoring and use it rationally. References | Related Articles | Metrics

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Recognition and Analysis of Isoniazid Risk ZHONG Lei, ZHANG Jun, JIAO Li-gong 2014, 11(2): 117-120.  Abstract ( 229 )   PDF (629KB) ( 386 )   Isoniazid is a commonly used drug in clinic for antituberculosis. The adverse reactions of isoniazid have diverse clinical manifestations accompanied with multiple organ injury. The adverse reactions could increase with combination of some drugs. The drug instruction and related references of isoniazid were summarized to recognize and analyze the risk of isoniazid. Several suggestions were put forward for clinical medication. References | Related Articles | Metrics