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    08 July 2010, Volume 7 Issue 7 Previous Issue    Next Issue

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    Study on The “Dosage-Time-Toxicity” Relationship of Hepatotoxicity Induced by Different Components of Radix et Rhizoma Sophorae Tonkinensis in Mice
    YANG Qian, ZHENG Li-na, XIE Yuan-zhang, SUN Rong
    2010, 7(7): 385-389. 
    Abstract ( 158 )   PDF (329KB) ( 151 )  
    Objective Study the "dosage-time-toxicity" relationship of hepatotoxicity induced by different components of Radix et Rhizoma Sophorae Tonkinensis(RRST) in mice. Methods Study on the "time-toxicity"relationship: Ig water extract and alcohol extract of RRST of certain dosage to mice and the changes of the level of ALT, AST in serum and organ index of liver,spleen and thoracic gland were tested at different time points after administration, the same time the hepar-pathology test was performed with light microscope. Study on the "dosage-toxicity"relationship: Ig water extract and alcohol extract of RRST of different dosages to mice and the corresponding treatment was performed at 6h/4h after administration in accordance with the method of study on"time-toxicity"relationship. Results The study on the "time-toxicity" relationship indicated that the level of ALT, AST in serum reached to the peak at 6h/4h after once administration of water extract and alcohol extract of RRST of higher dosage and the liver index rised to its topmost both at 12h.They all recovered to normal value at 48h after ig. The study on the "dosage-toxicity" relationship indicated that conspicuous hepartotoxical injury can be induced by water extract of RRST of (1.789~3.494)g·kg-1 and alcohol extract of (2.779~5.427)g·kg-1 and the level of ALT, AST increased significantly with the increase of dosage. Karyopycnosis and degeneration of different degrees of hepatic cells can be seen with the light microscope. Conclusion Once oral administration of water extract and alcohol extract of RRST with large dosage may induce acute hepatotoxical injury in mice and show an obvious "dosage-time-toxicity" relationship.
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    Study on Preparation Process of β-cyclodextrin Inclusion with Volatile Oil of Olibanum and Myrrha and It's Analgesic Effect
    TAN Ying, LEI Yong, ZHOU Kun, BI Bo, CHEN Jin-tang
    2010, 7(7): 390-391. 
    Abstract ( 139 )   PDF (337KB) ( 190 )  
    Objective To explore the feasible preparation process of β-cyclodextrin inclusion with volatile oil of Olibanum and Myrrha and the best conditions, and verify its analgesic effect. Methods To extract volatile oil of Olibanum and Myrrha, compare the rate of yield and utilization whereas the different proportion of inclusion, thus to optimize the preparation process of β-CD inclusion compound. Mice writhing experiment was taken to explore the analgesic effect of crude powder and β-CD inclusion Compound respectively. Results The optimization ratio of volatile oil and β-CD inclusion was 1:10, and the yield rate of inclusion compound was greater than 97%, and the utilization rate was more than 92%. The crude powder and β-CD inclusion Compound respectively had an inhibitory effect on mice writhing induced by acetic acid. Conclusion The process of β-CD inclusion with volatile oil of Olibanum and Myrrha was possible without affecting its analgesic effect.
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    Experimental Comparison Study on Mice's Acute Toxicity of Different Composition in Folium Artemisiae Argyi
    SUN Rong, WANG Hui, HUANG Wei, CHI Xue-jie, MIAO De-yu
    2010, 7(7): 392-396. 
    Abstract ( 155 )   PDF (479KB) ( 268 )  
    Objective To compare the acute toxicity of different components in Artemsia argyi on mice. Methods Respectively prepare the water extraction components, volatile oil, alcohol extraction components and all components to compare the acute toxicity of different components in Artemsia argyi on mice in accordance with classical acute toxicity test Methods. Results The LD50 and 95% confidence limit of water extraction components and volatile oil in Artemsia argyi are respectively 80.2 g·kg-1·d-1(77.4~83.4 g·kg-1·d-1)and 1.67 mL·kg-1·d-1 (1.55~1.80 mL·kg-1·d-1); The MTD of alcohol extraction components and the MLD of all components are respectively 75.6 g·kg-1·d-1 and 24.0 g·kg-1·d-1,which are espectively equal to 588.0 times and 186.7 times of 70kg adult’s daily dried medicinal herb expenses. The main acute toxicity symptoms and signs are negligent respectively equal to 588.0 times and 186.7 times of 70kg adult’s daily dried medicinal herb expenses. The main acute toxicity symptoms and signs are negligent action, nausea, convulsions, tetraplegia, prone fixed. Conclusion The acute toxicity of different components in Artemsia argyi on mice is: volatile oil >water extraction components> alcohol extraction components >all components, but the toxic substances,process of toxicity in vivo,toxicity characteristics,and toxicity mechanism are all not yet entirely clear,and they are all to be further studied.
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    Injection Site Pain of Mouse Nervous Growth Factor:A Review of Randomized,Double-Blinded,Parallel Placebo Controlled Phase to Ⅲ Clinical Trials
    HU Hai-tang, LIN Ying-yong, HU Hui-ping
    2010, 7(7): 397-399. 
    Abstract ( 280 )   PDF (357KB) ( 409 )  
    Objective To investigate the agent and influencing factors of injection site pain following intramuscular injection of mouse nervous growth factor. Methods Randomized, double-blinded, parallel placebo controlled Phase to clinical trials. Results 4 of 8 health volunteers developed injection site pain in the phase 1, 32.56%(14/43) optic nerve contused wound subjects in the phase 2 clinical trial and 12.83%(39/304) in the phase 3 at the dose 30 g(15 000AU), which was recommended as clinical therapeutic dose. The duration and severity of the local pain varied in a dose-dependent manner. No life-threatening adverse events was seen at any dose. Conclusion s Injection site pain was the most frequent adverse event, but well tolerated at recommended dose. The pain was induced by mouse nerve growth factor and probably attenuated by prednisone.
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    The Difference of Features about Therapeutic Regimen and Effect between the Senile and Non-senile Depression Disorder
    TIE Chang-le, WANG Chuan-yue
    2010, 7(7): 400-402. 
    Abstract ( 182 )   PDF (406KB) ( 248 )  
    Objective Compare the difference of features about therapeutic regimen and effect between the senile and non-senile depression disorder in hospitalized patients. Methods It is designed for cross section study. We review the medical records of depression disorder patients during 2008, then analysis the data. Results The anxiety symptoms is obviously outstanding in senile patients group; Sertraline was more often used in the senile group(P <0.05)than non-senile group. There isn't significant difference of recovery rate between two groups. Conclusion There isn't significant difference of therapeutic regimen features between two groups. The anxiolytic drug is more often used in the senile patients.
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    Economic Evaluation on Efficacy and Safety of Drugs
    LIU Zhao-lan, SUN Ying, CHEN Wei, LIU Jian-ping
    2010, 7(7): 403-406. 
    Abstract ( 187 )   PDF (438KB) ( 299 )  
    Drugs have two sides with positive and negative, the medical treatment efficacy and the adverse drug reactions. In health economic evaluation of drugs, considering the double influence of adverse drug reactions to costs and outcomes, the analysis of pharmacoeconomics evaluation should pay special attention to adverse reactions. We discussed in this report on several common Methods of analysis and cost measurement in pharmacoeconomics evaluation, and highlighted the influence of adverse drug reaction in economics.
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    The Preliminary Exploration on Adverse Drug Reaction of Interaction between Chinese Herbs and Pharmaceutical Chemicals
    LIU Kai, LUO Hui, LIU Jian-ping
    2010, 7(7): 407-409. 
    Abstract ( 157 )   PDF (617KB) ( 128 )  
    Integrating Traditional Chinese Medicine and western medicine is a special feature in Chinese health care system. The combination of Chinese herbs and western drug is widely used in clinical practice. However, the concerns should be paid attention to the adverse drug reactions caused by the interaction between Chinese herbs and western drugs. This essay discussed the conception of adverse drug reaction of herb-drug interaction, its pharmacological basis, present research situation from literature, management and evaluation methodology, in order to improve the safe use of medications in their combined use.
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    Application of Qualitative Research Methods in the Study of Adverse Drug Reaction(1)
    CAO Hui-juan, FEI Yu-tong, SUN Ying, LIU Jian-ping
    2010, 7(7): 410-413. 
    Abstract ( 161 )   PDF (462KB) ( 268 )  
    Qualitative research Methods, originated from social science, have been used in research on adverse drug reaction(ADR). Different from quantitative research methodology, qualitative research is mainly used to investigate the attitude, recognition, experience and perspectives from health care workers or patients so to have a better understanding of humanity and opinions. This will be significant for understanding of the knowledge and concerns from patients about ADR. The Results from qualitative research can complement the shortage of quantitative research and reflect the ADR in a more comprehensive way so to provide basis for better safe and rationale use of drugs.
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    Bibliometrics Analysis on Adverse Drug Reaction in China
    SONG Yan, BIAN Ying
    2010, 7(7): 414-416. 
    Abstract ( 214 )   PDF (566KB) ( 147 )  
    Objective To master the research progress in the field of adverse drug reaction(ADR) in China. Methods To search China Journals Full-text Database(CNKI) for literatures related to ADR and then analyze the distributions in time, journal, author and details and etc. Results The research on ADR is increasing year by year and the core authors have been formed. The literatures are mostly from governments as well as hospitals. Five journals, such as Chinese Journal of Pharmacovigilance, are the core journal in this field. And all the literatures can be divided into seven kinds in the content. In addition, the recourses of capital fund are more abundant but focus on the eastern China. Conclusion The research progress of ADR in China developed smoothly. However the research should be expanded in content and the methodology should be improved.
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    Review on the Medication Safety of Children from the Analysis of ADR/ADE Reports by Qingkailing Injection and Instructions
    CHEN Jian-yu, ZHANG Hui-xia
    2010, 7(7): 417-420. 
    Abstract ( 181 )   PDF (639KB) ( 295 )  
    Objective By analyzing 861 ADR/ADE reports of children Qingkailing injection and the drug instructions, to provide reference for reasonably using children medicines and improving the enterprise's drug instruction. Methods Using retrospective research, we counted and analyzed Qingkailing ADR/ADE reports during 2004~2009 from Henan center for drug reevaluation and the drug instructions of nine domestic pharmaceutical enterprises. Results There are 364 cases of child under 3 years of age(42.28%),140 cases of drug combination(16.26%) in which 64 cases are of child under 3 years of age(45.71%), 242 cases of ultra-indications(28.11%). The drug instruction lacks information for children's safety and the dosage. Conclusion It should be concern about the rational use of drug for children, improve the drug instruction, and ensure the medication safety for children.
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    The Using Situation of Antibiotics in Primary Hospital of Yunnan Province
    BAI Li-qin, HAN Hong-sheng, YIN Yuan-yuan, LI Jian-li, DU Juan FU Wen
    2010, 7(7): 421-423. 
    Abstract ( 162 )   PDF (577KB) ( 248 )  
    Objective Make an inquiry into the using situationl of antibiotics in primary hospital of Yunnan. Methods We designed a randomized trail. An investigation was conducted among five Community Health Service Center and five Township hospitals in Yunnan, collected 11 177 outpatient prescription, to analyze the using situationl of antibiotics. Results The percentage of antibiotics prescribed was 71.7%, the average number of drugs per prescription was 1.2, the utility rate of antibiotics was 35.1%, the utility rate of combined use above three kinds of drugs was 15.5%; the utility rate of cephalosporin was in principio,up to 22.9%. Conclusion The using of antibiotics in primary hospital of Yunnan had some problems.We suggested that the consciousness of antibiotics reasonable using should be enhanced and doctors' behavior should be normed to improve the level of antibiotics reasonable using.
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    Problems of Junior Retail Pharmacy in Adverse Drug Reevaluation Monitoring
    WANG Wen-fang, WU Xiu-feng
    2010, 7(7): 424-426. 
    Abstract ( 139 )   PDF (620KB) ( 238 )  
    Junior retail pharmacy as one of the main reporting subjects of adverse drug reaction(ADR), plays an im-portant role in ADR monitoring and reporting work that there are also some problems in china. This paper describes some problems of junior drug retail enterprises in the work of ADR, analyzes and explores its causes, and proposes appropriate countermeasures and suggestions to continuously improve the junior drug retail enterprise’s ADR work.
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    Analysis of Prescription in Male-outpatient
    WANG Yang-qing
    2010, 7(7): 427-429. 
    Abstract ( 119 )   PDF (562KB) ( 178 )  
    Objective To understand the male out-patient hospital use of antimicrobial agents to provide advice for the rational use of antimicrobial agents. Methods 2009 randomly selected male subjects in our hospital outpatient prescriptions by statistical analysis(not including the local administration). Results A total of 2 764 sheets of prescriptions were audited, including the use of antibiotic prescriptions 2 517 sheets. There are still 1 931 sheets of unreasonable prescriptions. Conclusion Our male hospital outpatient prescription have higher rate of antimicrobial drug use. There are a lot of irrational drug use phenomenon and the hospital should further strengthen the management of outpatient antimicrobial drug use, to raise the level of rational use of drugs.
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    Progress in Medical Studies of Bolbostemma paniculatum (Maxim.) Franquet
    SUN Jian, WEN Qing-hui
    2010, 7(7): 430-431. 
    Abstract ( 268 )   PDF (550KB) ( 290 )  
    Bolbostemma paniculatum(Maxim.) Franquet is important and valuable medicinal plants.The study showed that the plants contain saponins, organic acids, sterols, alkaloid and other chemical constituents.Pharmacological effects:anti-virus, anti-cancer, inhibition immunity. This article presented a review on chemical components,pharmacological effects, which gave a reference for further research in future.
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    Research Development on Toxicity of Cortex Periplocae Related to Efficacy and Chemical Material Basis
    SUN Rong, BAO Zhi-ye, HUANG Wei
    2010, 7(7): 432-434. 
    Abstract ( 166 )   PDF (556KB) ( 207 )  
    Objective To provide literature evidences asis and research ideas of efficacy and toxicity of the chemical composition of guided separation、control and efficacy, and the research on the "dose-effect relationship" and "dose-toxicity relationship” about the toxicial components. Methods References in the last decades both at home and abroad about Cortex Periplocae were collated, analyzed and summarized. Results At present, Cortex Periplocae for efficacy, and toxicity of the material basis of the study to stay contained on the basis of cardiac glycosides, The pharma-cology and toxicology studies on the Cortex Periplocae not enough depth, whether on the Cortex Periplocae contain other material basis for efficacy and toxicity has been reported rarely. Conclusion The research on Cortex Periplocae about the toxicity and margin of safety control based on the chemical separation and quality control about the effective material basis combined with the process of the effectiveness of expression, so as to provide consummating safety standards and putting forward early-warning scheme of adverse reaction、the early diagnosis and treatment measures that can be referred to clinical usage. Cortex Periplocae will be ensured to use safety as a clinical drug.
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    Retrospective Case Analysis of 471 Patients with Adverse Drug Reaction of Gastrointestinal Tract
    CAO Jun, CHEN Su-ning, WEN Ai-Dong
    2010, 7(7): 435-438. 
    Abstract ( 183 )   PDF (657KB) ( 373 )  
    Objective Over the past five years 471 patients drug-induced adverse drug reaction of gastrointestinal tract in our hospital were retrospectively analyzed to provide reference for the clinical reasonable medication and obviating adverse drug reaction of gastrointestinal tract. Methods 471 adverse drug reaction of gastrointestinal tract cases col-lected from 2005 to 2008 in our hospital were analyzed statistically. Results 471 adverse drug reaction of gastrointestinal tract cases refered to 201 kinds of drugs. Of which anti-infective agents occupied the first place which had 218 cases(46.28%).Followed by the traditional Chinese medicine which had 88 cases(18.68%).The majority of patients(36.94%) were over 55-years-old, and 257 cases(54.57%) were given orally. Conclusion Clinic should attach great importance to the reporting and principle and enhance to the obviating and detection of adverse drug reaction of gastrointestinal tract to reduce or avoid the occurrence of it, and to use reasonably safe and effective medications.
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    Analysis of 212 Adverse Drug Reaction/Event Reports of Fluoroquinolone
    DING Qing-ming, XU Xiao-hua, LU Jin
    2010, 7(7): 439-441. 
    Abstract ( 160 )   PDF (588KB) ( 191 )  
    Objective To analyze relevant factors of the adverse drug reaction/event(ADR/ADE) induced by Fluoro-quinolons. Methods 212 ADR/ADE reports collected by Fluoroquinolones in China-Japan Friendship Hospital from 2004 to 2009 have been analyzed retrospectively. Results ADRs/ADEs induced by injection were most. The female had higher probability of occurrence. The clinical manifestation of ADR/ADE mainly involved system damage, skin and appendages damage, and digestive system damage. Most ADR/ADE cases happened in one day after medication. Conclusion The patients should be intensively warded after the first medication. It's important to diagnose correctly and disposal in time to the new ADR/ADE.
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    Analysis on 97 Adverse Drug Reaction of Yinzhihuang injection
    LI Zuo-fa, ZHANG Wen-dong, ZHANG Xiu-mei
    2010, 7(7): 442-443. 
    Abstract ( 176 )   PDF (575KB) ( 259 )  
    Objective Analyzing the collected information on adverse drug reaction(ADR), to protect the public security agents. Methods 97cases ADR of Yinzhihuang were collected and analized statistically. Results 97 cases of the literature, the proportion of no significant gender differences in the patients,mainly concentrated in the 20 ~ 60 years old. The serious adverse reactions is allergy shock. Conclusion To ensure the public with safe and effective medication, stress on the adverse drug reaction monitoring and raise awareness of the clinical medication safety.
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