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    10 April 2012, Volume 9 Issue 4 Previous Issue    Next Issue

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    Orginal Article
    Study on the Toxicity and Side-effects Accompanied with Analgesic Effect of Different Components from Folium Artemisiae Argyi in Mice
    WANG Hui, HUANG Wei, CHI Xue-jie, ZHANG Ya-nan, SUN Rong
    2012, 9(4): 193-197. 
    Abstract ( 273 )   PDF (409KB) ( 223 )  
    Objective To determine the material basis of the volatile oil and water extracts from Folium Artemisia Argyi, the effective dose range and time range as well as the dose range and the time window occurred with side effects, to lock the target organ of toxicity, in order to provide the experimental data for clinical safety. MethodsAnalgesic effect of the volatile oil and water extracts from Folium Artemisia Argyi were investigated by hot plate test and acetic acid writhing test in mice. The symptoms of mice were observed, the ratios of liver and kidney were calculated, and the levels of ALT, AST, BUN and Cr in blood were detected, for the purpose of inspecting the side effects of the volatile oil and water extracts. ResultsThere were significant differences in the value of hot-plate pain threshold and frequency of the writhing test of each dose group after 1、3 、7 days administration to mice, and there were certain time and dosage dependence relationships, and the analgesic effect of water extracts components was stronger than volatile oil. The indexes detection in serum showed that different dosage group had different increase in the level of ALT、AST、Cr、BUN and the ratio of liver and kidney, and there were certain time and dosage dependence relationships, and the toxicity of volatile oil was stronger than water extracts components. ConclusionThe volatile oil and water extracts from Folium Artemisia Argyi showed certain effect of analgesia, the effective range of analgesia were respectively(34.5 g·kg-1~138 g·kg-1) and (1.17 g·kg-1~4.68 g·kg-1), and showed certain dose-effect and time-effect relationship, and calculated by equivalent amount of crude drug, the analgesic effect of volatile oil was stronger than water extracts components. The side-effects accompanied with analgesic effect were liver function, renal function and viscera indexs, the hepatotoxical injury in particular. The dose ranges of the volatile oil and water extracts produced liver toxicity were(34.5 g·kg-1~138 g·kg-1) and(2.34 g·kg-1~4.68 g·kg-1), it showed certain dose-dependent and time-dependent relationship; while the dose ranges of the volatile oil and water extraction component produced kidney toxicity were(69.0 g·kg-1~138 g·kg-1) and (2.34 g·kg-1~4.68 g·kg-1). At present the Pharmacopoeia recommends that the amount of Folium Artemisia Argyi is 3-9g; as there has been hepatotoxicity and renaltoxicity when the animals were administrated for 7 days, which should be attended in clinical application.
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    Experimental Study on the Long-term Toxicity of Extracts of Phyllanthus Urinaria L. in Rats
    DAI Xue-dong, DAI Xiao-li, MA Yu-kui
    2012, 9(4): 198-201. 
    Abstract ( 246 )   PDF (394KB) ( 219 )  
    Objective To observe the long-term toxicity of the extracts of Phyllanthus urinaria L. in rats by repeated oral administration. MethodsDaily doses of extracts at 4.0 g·kg-1, 1.3 g·kg-1 and 0.5 g·kg-1 for 26 weeks were used for high, mid, and low dose group, respectively. Examinations including haematological indexes, biochemical indexes, and histopathology were performed at 13 weeks, 26 weeks during the administration, and 6 weeks after the withdrawal, respectively. ResultsThe rats in the group apperanced depressed and the fur lack luster during the administration. The levels of WBC, NE%, ALT, AST, and CR in high group were significantly higher than those in control group, and the levels of LY%, PLT, ALB in high group were significantly lower than those in control group at 26 weeks after administration(P <0.05 or P <0.01). Those changed indexes of hematology and blood biochemistery regained normal except NE% and LY% at 6 weeks after withdrawal. The liver of rats in high group and kidney of rats in high and mid group appeared reversible pathological changes. ConclusionRepeated oral administration of the extracts of Phyllanthus urinaria L. at high dose could lead to reversible damage to liver and kidney function and pathology.
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    Influence of CYP2C9 and VKORC1 Genetic Polymorphisms on Maintenance Warfarin Dose in Chinese Pulmonary Embolism Patients
    LOU Ying ,LIU Hong, HAN Lu-lu , XIE Shuang , GAO Xiao-jing ,DUAN Bing, NI Xin-hai ,XIONG Chang-ming , LI Yi-shi ,LIU Zhi-hong
    2012, 9(4): 202-204. 
    Abstract ( 190 )   PDF (390KB) ( 247 )  
    Objective To evaluate the effect of CYP2C9 and VKORC1 polymorphisms on maintenance warfarin dose in Chinese pulmonary embolism patients. MethodsIn 108 Chinese pulmonary embolism patients whose INR had reached the target value stably, we detected VKORC1 and CYP2C9 gene polymorphisms withTaqMan MGB Probe method, and recorded the mean daily maintenance warfarin dose(mg/d-1), gender, age, weight and height.ResultsThe mean maintenance daily doses of warfarin in patients carrying VKORC1-1639A/G or G/G were much higher than patients carrying VKORC1-1639A/A(5.81±1.93 vs. 3.33±1.11mg, P<0.001);CYP2C9*1/*3 or1/*2 carriers had lower mean maintenance daily doses of warfarin than CYP2C9*1/*1 carriers(2.57±1.31 vs. 3.97±1.67mg, P=0.029); warfarin maintenance dose algorithm including gender, age, weight, hight, VKORC1 and CYP2C9 gene polymorphisms could explain about 51.1% individual dose requirement(R2=0.511, P<0.001). ConclusionDetection of CYP2C9 and VKORC1 polymorphisms may have clinical significance to guide the individualized warfarin dosage in Chinese pulmonary embolism patients.
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    Determination of Curcumin in Jianghuang Granules by HPLC
    ZHOU Ying, LIU Yang, CHENG Xu-dong
    2012, 9(4): 205-206. 
    Abstract ( 377 )   PDF (384KB) ( 252 )  
    Objcetive To establish the method for the content determination of curcumin in Jianghuang Granules. Methods HPLC method was adopted. Chromatographic conditions were as follows: Shimpack VP-ODS(150 mm×4.6 mm, 5μm) column was used with mobile phase consisted of acetonitrile-4% phosphoric acid(48∶52) at a flow rate of 1.0 mL·min-1 under a detection wavelength at 430nm. The column temperature was 30℃. Results The linear range of Curcumin was 2.104~105.2 μg·mL-1(r=0.999 8) with an average recovery rate of 99.68%(RSD=1.34%, n=9). Conclusion The method is simple, reliable and accurate, and can be used for the quality control of Jianghuang Granules.
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    Introduction and Inspiration of the Guidance on the Readability of European Union Package Leaflet
    ZHAO Zhi-heng
    2012, 9(4): 207-210. 
    Abstract ( 317 )   PDF (451KB) ( 812 )  
    The readability research of the package leaflet can improve its quality, make readers understand information in it and ensure its safety to patients. The readability research can also help marketing authorisation holders to design a better package leaflet. So the article takes legal system of the readability of European Union package leaflet as the object, Collate and analyze the readability guideline of package leaflet, look forward to promoting our pharmaceutical research and development.
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    Qualitative Analysis and Study of the Microorganisms in Clean Air within Clean Room of the Pharmaceutical Industry
    LV Hong-hao, LI Jun-jie, XU Wei-zhuo
    2012, 9(4): 211-214. 
    Abstract ( 255 )   PDF (529KB) ( 265 )  
    Objective To study the distribution of the microorganisms in clean air within clean room of the pharmaceutical industry. MethodsTest method for settling microbe was used in the clean air of some clean rooms. The microorganisms isolated were analysed by morphological observation, physiological and biochemical tests and 16S rDNA sequence analysis. ResultsA strain of actinomycete, four strains of fungi and ten strains of bacteria were derived in the experiment. ConclusionThe clean air mainly consists of bacteria, a small amount of fungi and actinomycetes. Professionals of enterprise should master the distribution of bacteria, fungi and actinomycetes, analyze the causes of formation of the colony forming unit and take targeted methods of control for the environment of the clean room to guarantee the quality of products.
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    The Complications of Hip Replacement and Its Countermeasures
    LIU Wei
    2012, 9(4): 215-217. 
    Abstract ( 270 )   PDF (499KB) ( 709 )  
    In order to decrease the complications of hip replacement. The databases included Pubmed, Sciencedirect and CNKI were searched, were reviewd. The risk factors and prevent measure of complications were reviewed. from related aticles published in Chinese or English. Infection as the frequent complication can be diminished by aseptic technique, prophylactic antibiotics and antibiotics-containing bone cement. Dislocation can be prevented by large-diameter femoral heads or posterior capsulotendinous repair. Aseptic loosening was related by mechanical factors and biological factors, interlocking revision-stem may be helpful. Deep vein thrombosis can be prevented by low molecular heparin, Continuous Enhanced Circulation Therapy show more promising. In summary, more device refine measure should developed to diminish the complication after hip replacement.
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    A Research on the Risk of Intervention in Antipyretics for Children
    ZHANG Hao, ZHAO Pin, WU Zhi-ang
    2012, 9(4): 218-221. 
    Abstract ( 181 )   PDF (584KB) ( 203 )  
    This paper describes the varieties, usage situations and adverse reactions of Antipyretics for children and analyses the sources of risk of the drugs for children. The registration schemes and interventions in the adverse reactions of drugs for children in USA and Europe have been concluded by scanning the official websites of FDA and EMEA. At the end of the paper, the advice related with the risk of antipyretic for children are brought up to contribute to safe use of antipyretics for children in China.
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    The Discussion about Status and Conceptions of Adverse Drug Reaction Monitoring Institution in Prefecture-level City of Guangdong
    LI Liang-hua, DENG Jian-xiong
    2012, 9(4): 222-223. 
    Abstract ( 237 )   PDF (582KB) ( 268 )  
    The status and problems on the adverse drug reaction(ADR) monitoring institutions in Guangdong prefecture-level cities were analyzed and four construction conceptions were also proposed in this paper. The purpose of the selective conception is to provide suggestions for government, further construct ADR monitoring institution in prefecture-level city.
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    How Medical Institutions to Do Adverse Drug Reaction Monitoring Well
    LIU Cui-li, TIAN Chun-hua, FENG Hong-yun
    2012, 9(4): 224-226. 
    Abstract ( 334 )   PDF (571KB) ( 346 )  
    The new revision of Provisions for Adverse Drug Reaciton Reporting and Monitoring was promulgated on May 4 2011. The provisions clearled definy the responsibilities of the medical institutions who are one of the main body of adverse drug reaction reporting.Combined with the provisions, this article aims to introduce how the medical institutions to do adverse drug reaction monitoring well during the new period of monitoring.
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    Common Drugs Causing Dysglycaemia
    XU Yan-li, PU Yan-chun
    2012, 9(4): 227-229. 
    Abstract ( 234 )   PDF (609KB) ( 331 )  
    Dysglycaemia is common disease of endocrine system. In recent years, dysglycaemia cases were repeatedly reported, and these should be paid attention to. This review summarized the type of common drugs causing dysglycaemia, action mechanism, clinical manifestation, prevention and cure measures, expecting to benefit rational drug use and reducing adverse drug reaction.
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    Research Development on Chemical Composition in Rhizoma Menispermi Related with Efficacy and Toxicity
    LUO Dong, LI Xiao-yu, SUN Rong
    2012, 9(4): 230-233. 
    Abstract ( 231 )   PDF (501KB) ( 170 )  
    Objective To identify its effective and toxical composition, offer the accordance and research ideas for further research on the relationship between efficacy, toxicity and chemical composition of Rhizoma Menispermi, by summarizing the current states of chemical composition of Rhizoma Menispermi related with its efficacy and toxicity. Methods The related literatures in the recent 20 years of Rhizoma Menispermi were collated, analyzed and summarized. Results Alkaloids are both the main chemical constituents and the main material basis for efficacy in Rhizoma Menispermi; Rhizoma Menispermi has small toxicity documented in pharmacopoeia and history literature, there have little perfect study reports about Rhizoma Menispermi chemical constituents, especially alkaloid standard toxicity. It is still blank for efficacy and toxicity substances in the body process, pharmacological mechanism and characteristics, and clinical application of correlation. The research for its basis of extraction and separation technology research and quality control are also seldom-reported. Conclusion As a small toxical records of TCM, Rhizoma Menispermi is urgent to be studied, based on the efficacy and chemicals related basic and "keep- efficacy" and "control- toxicity" research to provide experimental basement and literature reference for rational use in clinic.
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    Aanlysis of 12 Cases of Children Drug-induced Hemolytic Anemia Caused by Nafcillin and Ribavirin Combinafion
    CHEN Da-kui, TANG Xiao-xia, ZHU Wen-wen
    2012, 9(4): 234-236. 
    Abstract ( 222 )   PDF (632KB) ( 141 )  
    Objective To analyze and discuss the drug-induced hemolytic anemia on children caused by the combined use of the injections of nafcillin, ribavirin in 12 cases in clinical, and provide evidence for clinical safe use of medicine. MethodsThe uses of the injectable nafcillin in pediatric outpatient department of our hospital between July and August in 2011 were statistically analyzed, and the adverse reactions of drug-induced hemolytic anemia(DHA) occuring during these were analyzed, researched and assessed. ResultsThe adverse reactions of the drug-induced hemolytic anemia caused by the combination uses of the injectable nafcillin, ribavirin due to resistance to infections on children beween 0~5 years old occurred at a rate of 3.3%, and the average time was 5.5 days, the boys incidence rate was 2.39%, and girls incidence rate was 5%. ConclusionNafcillin, ribavirin combined use should be cautious. For the children, especially younger children should be paid attention strictly in accordance with the instructions to the recommended dosage of medication.
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    The Adverse Reaction Analysis of High-dose Methotrexate Used in 30 Cases of Acute Lymphoblastic Leukemia
    AN +Q82:U83Yuan , XING Ying, ZHEN Jie, ZHEN Jian-cun
    2012, 9(4): 237-238. 
    Abstract ( 222 )   PDF (552KB) ( 532 )  
    Objective The article investigates the clinical features of the adverse reactions caused by high-dose methotrexate in treating the patients of acute lymphocytic leukemia(ALL). MethodsWe collected cases of the adverse reaction reports caused by high-dose methotrexate in treating the patiens of acute ALL from 1994 to 2010 occurred in China, then we analyzed the usage and dosage of methotrexate, the time of the advise reactions occurrence and the characteristics of the adverse reactions. ResultsThe results indicate that in the 30 patients treated with high-dose methotrexate, including 20 male and 8 female, the skin mucosal injury happened most frequently, followed by bone marrow inhibition, renal impairment and neurological damage. ConclusionAdverse events of high does methotrexate should be got more attention in treating the patients of ALL. And when the ADRs occur, being given timely and symptomatic treatment is very important, for the purpose of minimizing the incidence of adverse reactions.
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    Retrospective Analysis of the Adverse Reactions of Cefotiam Hydrochloride for Injection in 548 Cases
    JIANG Yu-mei, WANG Li-xia, YIN Ai-qun
    2012, 9(4): 239-241. 
    Abstract ( 224 )   PDF (515KB) ( 202 )  
    Objective To investigate the adverse reactions and characteristics of cefotiam hydrochloride for injection in clinical practice. Methods A retrospective analysis was conducted on the 548 reported cases with the adverse reactions of cefotiam hydrochloride for injection collected by Shandong Adverse Drug Reaction(ADR) Monitoring Center since 2006 in Shandong province. Results Skin and its appendages lesions(59.49%) and gastrointestinal system damages(14.60%) were the most common adverse reactions of cefotiam hydrochloride for injection, followed by the central and peripheral nervous system damages(10.40%); The ADRs mostly occurred in infants, children and elderly patients. Conclusion It is quite necessary to use cefotiam hydrochloride strictly and rationally in clinical practice to reduce the occurrence of the ADRs.
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    Analysis of 45 Cases of Adverse Drug Reaction Induced by Xiaojinwan and Xiaojinjiaonang
    ZHANG Zheng ZHANG Jia-li
    2012, 9(4): 242-243. 
    Abstract ( 247 )   PDF (678KB) ( 447 )  
    Objective To analyze characteristics of adverse drug reaction(ADR) induced by Xiaojinwan and Xiaojinjiao nang in Chaoyang Hospital. Methods ADR reports of Xiaojinwan and Xiaojinjiaonang from 2008 to 2011 were collected and analyzed. Results For 45 cases collected, the age of patients were mostly over 40, and all the damage due to ADR was rash associated with itching in skin and appendix, the majority appear 0-3 days after dosing. Conclusion The monitoring for adverse reactions and allergen ingredient of Xiaojinwan should be strengthened.Early prevention can reduce the incidence of adverse reactions.
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    Analysis of 42 Cases of Adverse Reactions Caused by Kitasamycin for Injection
    FAN Ping-ping
    2012, 9(4): 244-246. 
    Abstract ( 260 )   PDF (718KB) ( 354 )  
    Objective To investigate the characteristics of adverse drug reactions(ADR) caused by kitasamycin for injection,and provide references of clinical rational and safe use of drug. Methods 42 ADR cases collected in Dalian Medicine Adverse Reaction Monitoring Center from Jan.2009 to Dec. 2011 were analyzed retrospectively. Results Most ADR happened during the first time using kitasamycin for injection, aged patients have a higher incidence. Parts of ADR are not recorded in the drug instructions, central and peripheral nervous system damage most frequently occurs. Conclusion Skin test must be taken before using kitasamycin for injection, medical workers should pay more attention to the patients, and take measures in time when ADR happen.
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    Risk Assessment and Pharmaceutical Care on a Patient with Non-Hodgkin Lymphoma Chemotherapy
    WEN Yu, XIE Fang-wei, OUYANG Xue-nong
    2012, 9(4): 247-248. 
    Abstract ( 233 )   PDF (653KB) ( 223 )  
    Objective To prompt the clinical to pay high attention to chemotherapy in patients with non-Hodgkin's lymphoma risk. MethodsThe clinical pharmacists assessed a recurrence and refractory non-Hodgkin's lymphoma patient during chemotherapy, with the potential risks of tumor dissolve syndrome,activation of hepatitis B virus, bone marrow inhibition, thrombosis, delayed diarrhea, acute and late-occurred vomiting evaluation,and implementation of pharmaceutical care. ResultsThe patient finished this cycle treatment with no serious adverse reactions during chemotherapy. ConclusionThe clinical professionals should be aware of the risks in the process of chemotherapy for non-Hodgkin lymphoma patients and improve the chemotherapy drug safety.
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