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08 March 2014, Volume 11 Issue 3 Previous Issue    Next Issue

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Long-term Toxicity of Zhujie Yiweian Capsule in Rats ZHANG Xue-mei, QIAN Xiu-fang 2014, 11(3): 129-133.  Abstract ( 255 )   PDF (315KB) ( 124 )   ObjectiveTo investigate the long-term toxicity reaction in rats given Zhujie Yiweian Capsule(ZYC) continuously. MethodsSD rats were divided into 4 groups randomly(n=20), namely normal control, ZYC high, medium and low dose groups(150, 85 and 20 g·kg-1, respectively). ZYC was orally administered for 26 weeks. The body weight and food intake were observed and calculated during the administration. The hematology and blood biochemistry analysis were carried out, and organ histopathological changes were also observed under the microscope at the end of the administration and 4 weeks after the administration, respectively. ResultsThe appearance and behavior and body weight in rats of ZYC groups showed no significant difference compared to the normal control group. In hematology analysis, ZYC increased platelet and white blood cell count, decreased red blood cell count and remarkably prolonged the prothrombin time, which should be associated with the antithrombotic effect of ZYC. In biochemistry analysis, ZYC significantly inhibited AST, increased TP and BUN contents. In addition, ZYC elevated the liver and spleen coefficients. In histopathological observation, ZYC showed no apparent influence in organs of rats. No delayed toxicity reaction was showed 4 weeks after the administration. ConclusionZYC(20 to 150 g·kg-1) shows no obvious toxicity in rats for long-term administration. References | Related Articles | Metrics

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Clinical Curative Effect Analysis of Citalopram Combined with Small Dose of Mirtazapine on Post-stroke Depression MA Jin-fang, CHEN Yong-xin 2014, 11(3): 134-136.  Abstract ( 237 )   PDF (354KB) ( 165 )   ObjectiveTo explore the effectiveness and safety of citalopram combined with small dose of mirtazapine for treating post-stroke depression(PSD)． Methods114 patients with post-stroke depression in our hospital were randomly divided into two groups. In the control group, 57 patients were treated with citalopram, and in the observation group, 57 patients received citalopram combined with small dose of mirtazapine．Before treatment and at the end of 6 weeks of treatment, Line Hamilton depression scale(HAMD), daily living skills Barthel index(BI) scale, clinical nerve function defect score(SSS) and adverse reaction symptom scale(TESS) were assessed. ResultsThe treatment for PSD of two groups was effective after 6 weeks. The basic recovery of observation group was 29.82%, the basic recovery of control group was 21.05%.There was significant difference in the basic recovery rate between observation group and the control group(P <0.05)． The total effective rate of observation group(92.98%) was significantly higher than the control group(80.71%). The HADM score and SSS score of the observation group were significantly lower than the control group(P<0.05 or 0.01), and BI score was significantly higher than the control group after 6 weeks. There were no significant difference in TESS score between two groups,but the insomnia and headache or dizziness aspects of observation group were significantly lower than the control group(P<0.01). ConclusionCitalopram in combination with small dose of mirtazapine for post-stroke depression has good efficacy and high safety,and can improve recovery of neurological function and activity of daily living of patients . References | Related Articles | Metrics

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Study and Thought about Establishment Method of Clinical Effect Evaluation System Mode of Diabetes Complications WANG Su-mei, WU Cheng-sheng, LUAN Yong-fu, SUN Rong 2014, 11(3): 137-139.  Abstract ( 238 )   PDF (323KB) ( 148 )   Objective To discuss the thought and method about establishment of clinical efficacy evaluation system mode of diabetes complications under the direction of theory of TCM. Methods By semi-quantitative evaluation method of syndrome curative efficacy of Chinese medicine and bring into index evaluating syndrome of Chinese medicine, the most symptom of syndrome were semi-quantitatively statistically analyzed on the basis of referring to the evaluation system of western medicine. Results The standard of index quantization and marking were proposed, the layered index and mark of syndrome were setted and the quantization and weighting table of efficacy evaluation index of diabetes complications were formed according with dialectic of Chinese medicine. Conclusion Propose the standard of index quantization and marking based on theory of TCM and clinical reality, establish study foundation for further improving the clinical treatment of diabetes complications. References | Related Articles | Metrics

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Introduction to Causality Assessment Method of Cosmetic Adverse Reactions in European Union SHEN Lu, LU Chang-fei, LIU Wei, ZHANG Hua, GUO Xue, PENG Li-li, LI Xin-ling 2014, 11(3): 140-143.  Abstract ( 402 )   PDF (461KB) ( 538 )   This article introduced the formulation principles, standards and operation of the causality assessment method of cosmetic adverse reactions in EU. This method has strict and rigorous formulation principles and easily understood evaluation logic. The adopted decision tree mode is the most critical. This method is meaningful for cosmetic adverse reactions monitoring work in China. References | Related Articles | Metrics

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Analysis and Discussion on New and Revised Index of ISO 15197:2013 Standard WU Chuan-song DONG Jin-chun 2014, 11(3): 144-146.  Abstract ( 324 )   PDF (398KB) ( 702 )   AbstractsInternational Organization for Standardization(ISO) recently released "Invitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". The new standard revised the system accuracy and the consensus network error(CEG) and the user performance evaluation, and increased the hematocrit and the interfering substances etc. This article discussed the foundation of the ISO15197 2013 standard, and analysed the difference of the new and revised technical indicators. References | Related Articles | Metrics

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Analysis of the Methods Abroad of Causality of Adverse Events Following Immunization ZHAO Shang-qing, LI Rui-ling, LIU Chun-guang 2014, 11(3): 147-150.  Abstract ( 272 )   PDF (499KB) ( 282 )   The method of causality assessment of Adverse Events Following Immunization(AEFI) is an important part for the vaccine adverse reaction monitoring and evaluation. At present there is not a normative method for causality assessment of AEFI internationally. This article introduced and analyzed three methods from the Global Advisory Committee on Vaccine Safety of WHO, Clinical Epidemiology Research Center of Canada, Clinical Immunization Safety Assessment of US. The suggestions were put forward for the work of causality assessment of AFEI. References | Related Articles | Metrics

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Advance Research on Pharmacological Effect and Toxicity of Senecio Scandens FENG Qun, LI Xiao-yu, SUN Rong 2014, 11(3): 151-153.  Abstract ( 316 )   PDF (523KB) ( 839 )   ObjectiveTo provide literature basis and idea for the research of relevance between efficacy, material basis and toxicity of Senecio scandens. MethodsAncient books, literature in past dynasties and references in the last decades at home and abroad about the efficacy and toxicity of Senecio scandens were collated, analyzed and summarized. ResultsThe efficacy of Senecio scandens is mainly antibacterial, antioxidative, antiviral, antineoplastic and so on. Also the toxicity of it includes hepatotoxicity, skeletal dysplasia, mutagenesis, etc. ConclusionThe toxicity of Senecio scandens should be researched in the process of efficacy-expression. Basis would be provided for consummating safety standards and putting forward early-warning scheme of adverse reaction that can be referred in clinic. In this way Senecio scandens can be ensured to use safely. References | Related Articles | Metrics

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Analysis of the Components in Evodia rutaecarpa（Juss.）Benth Decoction by HPLC-MSn SUN Jian, WEN Qing-hui, MA Yan-yan, ZHANG Li-fu, FAN Bin, Lv Jun-hai 2014, 11(3): 154-157.  Abstract ( 213 )   PDF (595KB) ( 151 )   ObjectiveTo investigate the components in Evodia rutaecarpa(Juss.) Benth by LC-MSn. MethodsThe sample was extracted with water. The structures were detected by LC-MSn. Results14 components were identified from Evodia rutaecarpa(Juss.)Benth. ConclusionThis method can be used for accurate identification of 3 kinds of components in Evodia rutaecarpa(Juss.)Benth. References | Related Articles | Metrics

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Determination of Indirubin in Daige Powders LIU Feng 2014, 11(3): 158-159.  Abstract ( 235 )   PDF (605KB) ( 277 )   Objective To develop a HPLC method for determination of indirubin in Daige powders. Methods The optimum HPLC conditions were as follows Hypersil C18 column(4.6 mm× 250 mm,5μm), methanol-water(7030)as mobile phase, detection wavelength 292nm, column temperature 30℃, flow rate 1mL·min-1. Results There was good linearity between peak areas and injection quantity of indirubin within the range of 0.01~0.20μg(r=0.9999).The average recovery was 98.5% for indirubin(RSD=1.00%). Conclusion The method can detect indirubin in Daige powders. The HPLC method is reasonable, stable and accurate. References | Related Articles | Metrics

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Analysis of 60 Cases of Adverse Drug Reactions Caused by Shenfu Injection HE Ding-jin, QU Yan-hong 2014, 11(3): 160-162.  Abstract ( 230 )   PDF (575KB) ( 482 )   Objective To explore the regularity and causes of ADR caused by Shenfu injection in our hospital, and provide a reference for the clinical use of drugs. Methods We analyzed 60 cases of Shenfu injection ADR reported by clinical departments of our hospital from May 2000 to December 2012 in terms of sex, age, usage and dosage, the original illness, ADR time of occurrence, ADR involving system-organs and major clinical manifestations. Results The main ADR of Shenfu injection was skin lesion, followed by digestive system, and has the characteristics of delayed reaction, but no death case was found. Conclusion The ADR of Shenfu injection was related with dose and age, the delayed reaction was worthy to observe and the ADR monitoring of Shenfu injection should be strengthened. References | Related Articles | Metrics

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Literature Analysis of Extract of Adverse Drug Reaction Induced by GinkGgo Biloba Leaves Injection YANG Le DU Xiao-xi GUO Xiao-xing REN Jing-tian SHEN Lu SONG Hai-bo* 2014, 11(3): 163-169.  Abstract ( 369 )   PDF (653KB) ( 809 )   Extract of Ginkgo biloba leaves injection is ginkgo preparation, is widely used in clinic. Retrospective research method is used in the article for key analysis on post-marketing safety information of domestic literature reports. It is found that the main adverse reaction is allergy which is in a rapid reactive type. Using the drug alone or in combination may either cause risks. Serious adverse reactions mainly include digestive system damage, central, peripheral nerve systems damage, skin, its accessories damages, cardiovascular system damage, etc. Main symptoms include gastrointestinal discomfort, nausea, liquid stools, diarrhea, stress ulcer, headache, dizziness, erubescence, sweating, lower blood pressure, palpitation, conjunctival congestion, cerebral hemorrhage, insomnia, etc. Accordingly we propose recommendations on suitable risk control measure for a safer, more rational use of the drug References | Related Articles | Metrics

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Analysis of 54 Cases of Adverse Drug Reactions Induced by Ornidazole Sodium Chloride Injection GAO Yan-Yun, SUN Qing-min, QIU Zhao-juan 2014, 11(3): 170-171.  Abstract ( 287 )   PDF (624KB) ( 494 )   ObjectiveTo investigate the features of adverse drug reaction(ADR) induced by ornidazole sodium chloride injection in order to promote the safe drug use in clinic. MethodsThe ADR cases induced by ornidazole sodium chloride injection were searched between January 2011 and December 2012 in our hospital, and statistical analysis was made based on patients' basic characteristics, ADR time, clinical feature and drug use. ResultsThere were 54 ADR cases induced by ornidazole sodium chloride injection. The female cases were more than the males and patients' age was from 21 to 50 years old. The ADRs mostly occurred in the process of medication, mainly manifested as skin allergy, digestive reactions and phlebitis. There were 3 serious ADR cases, 21 cases had the combination of drug use, and no over-dose phenomenon. ConclusionThe patients treated with ornidazole sodium chloride injection should be closely monitored. The infusion should be scientifically arranged the sequence when multi-drugs are used so as to avoid potential hazards. References | Related Articles | Metrics

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Analysis of 325 Adverse Reaction Reports of Children HE Li-mei, PENG Cui-ying, ZHANG Hai-xia, HE Zhou-kang 2014, 11(3): 172-175.  DOI: DOI Abstract ( 219 )   PDF (665KB) ( 208 )   ObjectiveTo study the occurrence of children adverse drug reactions(ADR) in our hospital and its relevant factors in order to improve the rational drug use level in clinic. Methods325 ADR cases collected in our hospital from 2010 to 2012 were categorized and statistically analyzed. ResultsAmong 325 ADR cases, 230 cases(70.77%) were male, and only 95 cases(29.23%) were female. Most of the cases were induced by intravenous injection, accounting for 91.08%(296 cases). 156 cases(48.00%) were induced by 40 kinds of antimicrobials, which were the first category of drugs to cause ADR. The injury of skin and its appendants was the most common ADR, which occupied 77.41%. ConclusionThe occurrence of ADR was related to many factors, such as administration routine and drug varieties. In order to reduce and avoid the occurrence of ADR, we should strengthen the monitoring and publicize ADR knowledge. References | Related Articles | Metrics

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Surveillance on Pathogenic Bacteria and Application of Antimicrobial Agents in Our Hospital from 2008 to 2011 ZHAO Xuan, GUO Jing, CHEN Ning, ZHEN Jian-cun 2014, 11(3): 176-181.  Abstract ( 223 )   PDF (756KB) ( 241 )   ObjectiveTo observe state of epidemic of the pathogenic bacterial and condition of usage of antibiotics in order to provide theoretical basis for reducing drug resistance and evidence for clinicians to choose antibiotics appropriately in our hospital. MethodsTop ten varieties of pathogenic bacterial and results of antimicrobial susceptibility test of positive samples in our hospital from 2008 to 2011 were collected. Defined daily doses(DDDs) of antibiotics which were commonly used were also analyzed. Results7 500 bacterial strains were isolated from 2008 to 2011. The number of top ten pathogenic bacterial strains were 5 066, accounting for 67.55%, in which the ration of gram-negative bacterial and gram-positive bacterial was 74.3% and 25.64%, respectively. Among gram-positive bacteria, staphylococcus aureus and staphylococcus epidermidis were only sensitive to vancomycin and linezolid. They showed low sensitivity to clindamycin, penicillin and erythromycin, among which cross drug resistance existed. A serious drug resistance existed among gram-negative bacterial. The sensitive rate of second-generation,third-generation cephalosporin and quinolones was below 50%, but carbapenems and several synthetic penicillins adding enzyme inhibitor showed a high sensitivity to them.The DDDs of quinolones, cephalosporin, lincosamides which were commonly used in our hospital were kept in the forefront of ranking. Vancomycin, imipenem /cilastatin and linezolid presented a quickly increasing trend. ConclusionOn the whole, the use of antimicrobial drugs in our hospital is rational. But more attention to drug sensitivity and use method of certain bacterial strains should be paid. Pharmacists should periodically concern the prevalence of pathogenic bacteria in their hospital and master the information about distribution of pathogens,drug sensitivity and usage of antibacterial drugs. Communication and cooperation between pharmacists and other healthcare professionals play an important role in promoting the rational use of antimicrobial agents in clinic. References | Related Articles | Metrics

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Practice of High-risk Drug Management Strategies ZHAO Liang, XU Bing-xin, LAN Bing-xin 2014, 11(3): 182-184.  Abstract ( 206 )   PDF (609KB) ( 290 )   ObjectiveTo investigate the management strategies of high-risk drug in medical institutions to ensure that patient medication is safe and effective. MethodsAccording to pertinent literature and the specific measures of high-risk drug management in our hospital, the feasible methods of high-risk drug administration were analyzed. ResultsThrough the application of high-risk drug management strategies and color label management practices in our hospital, a series of effective methods to strengthen the management of high-risk drug were investigated. Furthermore, high-risk drug awareness and operability were improved significantly by physicians, pharmacists and nurses. And drug safety was ensured effectively. ConclusionIt is necessary to strengthen the management and usage of high-risk drug, meantime, introduce color code administration to minimize drug induced hazards. References | Related Articles | Metrics