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08 March 2010, Volume 7 Issue 3 Previous Issue    Next Issue

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Experimental Comparison Study on Mice's Acute Toxicity of Different Composition in Evodia fructus HUANG Wei, ZHAO Yan, SUN Rong 2010, 7(3): 129-134.  Abstract ( 212 )   PDF (494KB) ( 388 )   Objective To compare the acute toxicity of different components in evodia fructus on mice which is all components, water extraction components, alcohol extraction components and volatile oil, make an observation and evaluation of acute toxicity to evodia fructus herbs in order to provide a basis for safe and reasonable medication in clinical. Methods Respectively prepare the all components, water extraction components, alcohol extraction components and volatile oil, and compare the acute toxicity of different components in evodia fructus on mice in accordance with classical acute toxicity test Methods, and the experimental datas are calculated LD50 with the Bliss method,with the continuous administration and observation for 14 days. Results The acute toxicity of different components in evodia fructus on mice is: volatile oil>all components>alcohol extraction components>water extraction components. The LD50 of volatile oil in evodia fructus is 2.70 mL·kg-1·d-1 and the 95% confidence interval is 2.58~2.84 mL·kg-1·d-1; the all volatile oil in evodia fructus are unable to make LD50, MTD Results calculated in accordance with crude drug content were respectively 15.6g·kg-1·d-1、70.6 g·kg-1·d-1 and 80.0 g·kg-1·d-1,which is equal to 242.7 times、1 098.2 times and 1 244.4 times of 70kg people's daily dried medicinal herb expenses. Conclusion The evodia fructus components、water extraction components、alcohol extraction components and ctus herb has a certain toxicity, which is consistent with the pharmacopoeia and documentations. By comparing the acute toxicity of different components in evodia fructus on mice, it is beneficial to make an observation and evaluation of acute toxicity to evodia fructus herbs, provide experimental basis for further toxicity-based parts and toxical substances and provide a basis for safe and reasonable medication in clinical. References | Related Articles | Metrics

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The Effect of Fosfomycin on the Renal Toxicity Induced by Isepamicin in Rat Tissue Cage Infection Model Caused by Ps. Aeruginosa Biofilm FAN Yan, LIU Ru, WANG Rui 2010, 7(3): 135-138.  Abstract ( 166 )   PDF (536KB) ( 246 )   Objective To evaluate the effect of fosfomycin on the renal toxicity induced by isepamicin in rat tissue cage infection model caused by Ps. Aeruginosa biofilm. Methords The tissue cage method was used to establish the animal model of local Ps. Aeruginosa biofilm infection. Rats were randomly divided into 4 groups: control group, negative control group, positive control group(isepamicin 300 mg·kg-1) and fosfomycin and isepamicin group, 6 rats each group. Renal toxicity indexes such as serum creatinine(SCr), blood urea nitrogen(BUN), urinary production(UPD) and urine n-acetyl-β-d-glucosaminidase(NAG) were determined at 0, 2 and 4 weeks after abdominal cavity admi-nistration. At last observed nephridial tissue pathology through light microscope and transmission electron microscope(TEM). Results Tissue cage experiment in rat showed that the level of SCr, BUN and NAG of the combination group were raised up than control groups after administration for 4 weeks but no significant differences statistically(P>0.05), and those of the isepamicin group were raised up remarkably than other groups(P<0.05). At 4 weeks the nephridial tissue pathology Results which were observated through light microscope and TEM showed the level of renal damage induced by the group of fosfomycin and isepamicin were lower than that of the group(P<0.05). Conclusion The animal experiment showed that fosfomycin may relieve renal damage induced by isepamicin. References | Related Articles | Metrics

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Simultaneous Determination of Rhein, Paeonol and Paeoniflorin in Decoction of Rheum and Moutan by HPLC LIU Li, YIN Yun-han, WU Jian, LI Dian-sai, ZHAO Chun-jie 2010, 7(3): 139-141.  Abstract ( 212 )   PDF (434KB) ( 108 )   Objective To determine 3 components in decoction of Rheum and Moutan by HPLC simultaneously. Methods The seperation of 3 ingerdients was achieved on a Kromasil C18 column(250 mm×4.6 mm,5 m) with gradi-ent elution using solvents of acetonitrile 0.1% phosphoric acid solution. The speed of flowing phase was 1.0 mL·min-1.The detection wavelength was at 230 nm. Results The linear range was 1.61~16.1 mg·L-1 for rhein, 1.64~16.4 mg·L-1 for paeonol and 1.54~15.4 mg·L-1 for paeoniflorin. Average recoveries of samples were all over 98.0%, RSD were all below 2.0%. Conclusion The method was simple, accurate and can be used as assessment about quality of Decoction of Rheum and Moutan. References | Related Articles | Metrics

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Methods of Controlling Confounding Factors in Adverse Drug Reaction Signal Detection QIAN Wei, YIE Xiao-fei, WANG Chao, HE Jia 2010, 7(3): 142-144.  Abstract ( 268 )   PDF (381KB) ( 449 )   It is impossible to randomize the allocation of people using the drug under the post-marketing condition, so hard to control the confounding bias in signal detection of adverse drug reaction(ADR) databases. This article briefly introduces three widely-used Methods of controlling confounding bias. It give a brief description of the advantages and limitations of each method, and their applications in ADR signal detection in order to provide some effective information for the post-marketing surveillance. References | Related Articles | Metrics

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Association Rules in the Surveillance of Adverse Drug Reaction Signals Detection WANG Chao, YIE Xiao-fei, QIAN Wei, HE Jia 2010, 7(3): 145-147.  Abstract ( 232 )   PDF (476KB) ( 259 )   The signals detection of adverse drug reaction is playing an important part in the pharmacovigilance. With the development of spontaneous reporting(ADR) system, requirements of the knowledge discovery in database are also gradually increased. The article introduces the shortcomings of the other data mining Methods and data mining method of the association rules. By introduce the concepts and algorithms of the association rules, investigate the feasibility of application and the unique advantage in surveillance of the ADR. References | Related Articles | Metrics

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Application of Meta-analysis in the Adverse Drug Reaction Signal Detection YE Xiao-fei, QIAN Wei, HE Jia 2010, 7(3): 148-150.  Abstract ( 326 )   PDF (394KB) ( 358 )   Meta-analysis is a statistical technique for summarizing previous quantitative research with its unique advan-tages. In this article we gave a brief introduction about the concept, steps about meta-analysis. And also illustrated several examples including cardiovascular events caused by TZDs, the incidence of adverse drug reactions(ADR) in hospitalized patients and ethnic differences in risks of adverse reactions. In addition, we also suggested that sensitive analysis, sub-group analysis and model selection should not be ignored while applying Meta-analysis in ADR signal detection. References | Related Articles | Metrics

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Study on the Foreign Drug Safety Information Website and the Enlightenment for Construction of Chinese Drug Safety Information Website LI Ming, SUN Jun, HAI Ying, WANG Ling, XIAO Ai-li, XU Hou-ming, ZHANG Su-lin, NI Min, WANG Jia-yu, GAN Ge, DU Xiao-xi 2010, 7(3): 151-153.  Abstract ( 207 )   PDF (496KB) ( 212 )   Objective By analyzing the well-known drug safety information web site in the world, giving some specific suggestions in building China's drug safety web site. Methods The five websites of the World Health Organization, the United States Food and Drug Administration, Health Canada, British drugs and health products Authority and Uppsala Monitoring Center have been chosen, then the characteristics of their Websites' columns and contents have been analyzed respectively. Results The well-known drug safety information websites in the world have both common features and their own characteristics; give helps to the regulation of drug safety information. Conclusion s Suggested that the "China's drug safety information website" should be defined as a website which authorized by National Center for Adverse Drug Reaction Monitoring in China, mainly for professionals of Medicine industry, and mainly re-lated to the field of drug safety. References | Related Articles | Metrics

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Different Signal Detection Methods Compared in China JIANG Jing, HOU Yong-fang, LIU Xiu-juan, REN Jing-tian, JIN Shao-hong 2010, 7(3): 154-155.  Abstract ( 250 )   PDF (538KB) ( 268 )   Though collected enough data volume to detect adverse drug reaction(ADR) signals in our spontaneous reporting system since the establishment of National Centers for ADR Monitoring. Data detecting Methods are compared in detail about Guangdong, Jiangsu and Shanghai Centers for ADR Monitoring in this article to provide reference for the developments of ADR signal detection systems in China. References | Related Articles | Metrics

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Discussion on the Effect of Advense Drug Reaction Data Normalization in Informationalizing of Adverse Drug Reactiion Monitoring HAI Ying, TIAN Chun-hua 2010, 7(3): 156-158.  Abstract ( 213 )   PDF (556KB) ( 248 )   Advense Drug Reaction(ADR) data normalization is not only a important content of informationalizing of ADR monitoring,but also the top priority to improve and develop the ADR monitoring. By analyzing and discusse the targets, effectiveness, to indicate the basic principles, and contents of ADR data normalization。 References | Related Articles | Metrics

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Research Development on Toxicity of Fructus Bruceae Based on Efficacy and Material Basis SUN Rong, YANG Qian 2010, 7(3): 159-161.  Abstract ( 247 )   PDF (556KB) ( 535 )   Objective Provide literature basis and idea for the research of relevance between efficacy, material basis and toxicity. Methods Ancient books ,literature in past dynasties and references in the last decades at home about Fructus Bruceae were collected, analyzed and summarized. Results The efficacy of Fructus Bruceae that was recorded in ancient books and modern references are similar, but it isn't that about toxicity. Many adverse reaction were observed in clinical application. Quassinoide Compounds are the material basis of its toxicity. Conclusion The research about efficacy,material basis and toxicity of Fructus Bruceae is isolated, there is a short of relevance.The toxicity of Fructus Bruceae should be researched in the process of efficacy-expression and material basis-separation. Material basis of toxicity should be controled reasonably and basement would be provided for safe medication in clinical. References | Related Articles | Metrics

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Retrospectively Survey and Analysis of the Adverse Drug Reaction in 216 Patients Using Fluoroquinolones GUO Xiao-ying, LI Qing-shan, CHENG Jing-min 2010, 7(3): 162-163.  Abstract ( 206 )   PDF (543KB) ( 222 )   Objective By analyzing 216 advense drug reaction reports received in a hospital,we explore the clinical manifestations of fluoroquinolones' adverse reactions and their distribution. Mothods In this article we retrospectively survey and analyze the adverse reactions that occur in patients using fluoroquinolones. Results We find Male patients significantly more than female patients, adverse events occurred mainly in the nervous system, allergic reactions, skin and its annexes, and local and oral incidence of adverse reactions was significantly lower than intramuscular injection and intravenous injection.Conlusion Fluoroquinolones should be rationally used. We should strictly control their in-dications, con-traindications and the quantity of separate and combined to avoid unreasonable use. We should make its mechanism clear to decrease the occurrence rate of adverse reactions and play its clinical efficacy better. References | Related Articles | Metrics

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Optimization Practice of The Medical Institutions Adverse Drug Reaction Monitoring Method CHEN Chao, GUO Dai-hong, LIU Gui-yang, ZHU Man, PEI Fei, Ma Liang, WANG Bo 2010, 7(3): 164-167.  Abstract ( 221 )   PDF (630KB) ( 191 )   Objective To form systemic adverse drug reaction monitoring mode of the large-scale medical institution. Methods Practice on the basis of good hospital information system(HIS) operation environment and clinical pharmacy developement. Results The formation of grade 3 monitoring work team, 2 work rules, 6 procedures, a set of drug safety and emergency treatment process, a house journal, a bulletin, obtains ADR data acquisition, evaluation, analysis, early warning and transmission of electronic information, and combining with actual completed a series of drug safety evaluation of applied research. Conclusion Through the rules and process electronic platform construction, develop-ment, data utilization, emergency disposal and intersectorial work missionary training to optimize the exploration and practice of medical institution, obtains the solid outpost of drug safety and risk management. References | Related Articles | Metrics

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Analysis of 371 Adverse Drug Reaction /Event Cases Induced by Out-patient Injection WEI Rui-lian, LAN Qiong-ni, HUANG Shuang-xia 2010, 7(3): 168-171.  Abstract ( 231 )   PDF (720KB) ( 286 )   Objective To analyze the factors which cause the adverse drug reaction/event(ADR/ADE) induced by out-patient injection, and to explore how to control ADR/ADE. Methods ADR/ADE cases collected from the clinic injection room in our hospital have analyzed. Results There were 56 kinds of drugs related with 371 ADR/ADE, and antibiotics were in the first place(185 cases, 49.9%), followed by the Traditional Chinese Medicine injection(88 cases, 23.7%). The shortest time between infusion and ADR/ADE occurrence was five minutes, but 160 ADR/ADE cases (43.1%) occurred in 10~30 minutes after injection, so it is an important stage to inspect ADR/ADE. Lesions of the skin and the appendants is most. Conclusion To reduce the incidence of ADR/ADE induced by out-patient injection, our hospital should establish a strict ADR monitoring system, and take some preventive measures. References | Related Articles | Metrics

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Investigating and Analyzing the Orthopedic Implants Administration Events in Guangdong Province WANG Hong, YANG Li-jun, DENG Jian-xiong, XING Xin, LIN Guo-liang, LU Shu-tang 2010, 7(3): 172-174.  Abstract ( 210 )   PDF (594KB) ( 164 )   Objective To investigate some of the hospitals in Guangdong Province of cases involving orthopedic im-plants, concluded the incidence of administration events and characteristics. Methods seven hospitals in Guangdong Province related to orthopedic implants screening of all cases in 2008, the discovery of the 126 cases of suspected adverse events for statistical analysis. Results The incidence of the administration events of the orthopedic implants was 5.87%, which was much higher in the second admitted cases(16.51%) than in the first(2.43%). The administration events incidence of the spinal internal fixation was higher, the others were without statistical difference. The fracture, the loosen, the distortion and the infection were the most familiar manifestation(69%), the material ant the designing factors of the implants were the main causes of the administration events(72.22%). Conclusion There is a large number of omissions phenomenon in clinical administration events of orthopedic implants,, which need to strengthen orthopedic implants, adverse event monitoring. References | Related Articles | Metrics

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The Analysis of Adverse Events of Orthopedic Implants and Control Measures TANG Yong-Gang 2010, 7(3): 175-177.  Abstract ( 253 )   PDF (686KB) ( 445 )   The classification of orthopedic implants and application will be introduced. In this article, many adverse events will be analysized which caused by orthopedic implants. To combined with the adverse events of orthopedic implants of our hospital and the supervision ideas and the adverse events report of Drug Adverse Reaction Moni-toring Center to make some views. References | Related Articles | Metrics

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Discussion on the Investigation Mechanism of Serious Adverse Events of Medical Devices CHEN Ai-min, YANG Tao 2010, 7(3): 178-180.  Abstract ( 234 )   PDF (725KB) ( 189 )   Investigating serious adverse events of medical devices is the important process of evaluating the relevance between medical devices and adverse events, and is the key to provid the evaluation report about serious adverse events of medical devices for the supervision and management department. By reviewing the current situation of medical devices adverse events monitoring and reevaluating, improving the legislation has been proposed to identify the investigation duty of serious adverse events of medical devices, and the investigation mechanism of serious adverse events of medical devices has been discussed . References | Related Articles | Metrics

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Discussion on Significance and Mechanism of Adverse Drug Reaction Monitoring LI Wen-wu 2010, 7(3): 186-187.  Abstract ( 240 )   PDF (686KB) ( 387 )   Objective In order to further clarify the significance and actively explore the work mechanism of adverse drug reaction monitoring. Methods On the basis of work significance and effectiveness of adverse drug reaction monitoring, analyze the current problems existing in the adverse drug reaction monitoring, then pertinently put forward job security mechanism; Results &Conclusion The establishment and implementation of personnel, functions, funds, rewards punishment, participation, coordination, expert consultation, emergency disposal and other work mechanism, will contribute stimulative effect to the current adverse drug reaction monitoring work. Related Articles | Metrics

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The Analysis on the Reasons of Irrational Use of Medicines and Intervention Strategies in Rural Hospitals of Liaoning Province YANG Yue-ming, XIAO Ai-li, GENG Feng-ying, CHENG Gang, WEI Jing, MA Hui, JIN Dan, YANG Hua, WANG Yu-xin, DU Xiao-xi 2010, 7(3): 188-192.  Abstract ( 181 )   PDF (846KB) ( 156 )   Objective Based on a survey of the prescriptions of community health service centers in some cities and some rural hospitals of Liaoning Province and an analysis of grassroots of irrational drug use of some health institutions, this report tries to provide accurate data and countermeasures to promote the rational clinical application of drugs.Methods The report conducts the research using the following Methods: extracting prescriptions of health institutions randomly in 2007, and transcribing them in the survey forms, and then analyzing the rational drug use according to WHO(World Health Organization) index. Results The following problems exist in health institutions: the number and costs of average prescribed medicines are high; the use of basic drugs is low; the use of antibiotics, hormones, injections is not rational; there exists the irregular and irrational phenomena of combination of various drugs, among which the phenomenon in rural hospitals is more serious. Conclusion The health institutions shall further enhance the rational drug use level to ensure the public of their secure, economic and effective drug use. References | Related Articles | Metrics