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    10 July 2012, Volume 9 Issue 7 Previous Issue    Next Issue

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    Orginal Article
    Clinical Efficacy Analysis on Sodium Hyaluronate Combined with Compound Betamethasone in Treatment of Traumatic Synovitis of Knee Joint
    NIU Shu-zhen
    2012, 9(7): 385-386. 
    Abstract ( 551 )   PDF (206KB) ( 563 )  
    ObjectiveTo observe the clinical efficacy of sodium hyaluronate combined with compound betamethasone on the treatment of traumatic synovitis of knee joint under the method of knee articular cavity injection. Methods76 cases of traumatic synovitis of knee joint were randomly divided into two groups, the test group patients were given knee articular cavity injection once a week for 5 weeks, and sodium hyaluronate and compound betamethasone were given simultaneously during the 1st and 3rd week, only sodium hyaluronate was given during the 2nd, 4th and 5th week. Whereas the control group only received knee articular cavity injection of sodium hyaluronate once a week for 5 weeks. Observed the knee joint pain, swelling and joint effusion before and after treatment. ResultsThe relief of knee joint pain and improvement of knee joint function in test group were better than those in control group. ConclusionSodium hyaluronate combined with compound betamethasone by knee articular cavity injection is a safe and effective method for the treatment of traumatic synovitis of knee joint, especially for the patients with early or medium-term traumatic synovitis of knee joint, it is worthy to be recommended.
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    The Margin of Safety Study on Anti-inflammatory Effect of Different Components from Fructus Bruceae
    ZHENG Shi-cun, LUAN Yong-fu, LUO Dong, ZHU Lan-lan, XIE Yuan-zhang, SUN Rong
    2012, 9(7): 387-391. 
    Abstract ( 245 )   PDF (628KB) ( 189 )  
    Objective To research therapeutic index(TI) and the margin of safety factor(SF) of anti-inflammatory effect of Fructus Bruceae. Methods Establish tumidness model induced by daubing croton oil and granuloma model induced by subcutaneous injection of agar to explore acute and chronic anti-inflammatory effect of different components from Fructus Bruceae, and acute lethal dose test is also proceeded. Calculate ED50 and ED95 of anti-inflammatory efficacy and LD50 and LD5 of acute toxicity test of the different components from Fructus Bruceae. And then calculate the therapeutic index(TI) and safety factor(SF) of different components from Fructus Bruceae. Results The different components from Fructus Bruceae showed good anti-inflammatory effect and certain dose-effect relationship. The anti-inflammatory effect of alcohol extraction component was better than it of water extraction component. TI of anti-acute inflammatory effect of the water extraction component and the alcohol extraction component from Fructus Bruceae is 35.6207 and 25.3285, and SF is 7.8040 and 3.6645 respectively. And TI of anti-chronic inflammatory effect of the water extracts and the alcohol extracts from Fructus Bruceae is 47.6659 and 32.6431, and SF is 7.5494 and 4.2959 respectively. Conclusion The anti-inflammatory effect of the water extracts is greater than the alcohol extracts from Fructus Bruceae, but the margin of safety from alcohol extracts is greater than the water extracts from Fructus Bruceae. We should pay more attention to the occurrence of adverse reactions and strengthen drug monitoringin in the application of the water extracts from Fructus Bruceae.
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    The Margin of Safety Study on Anti-inflammatory Effect of Different Components from Radix et Rhizome Sophorae Tonkinensis
    LUAN Yong-fu, LUO Dong, ZHENG Li-na, XIE Yuan-zhang, SUN Rong
    2012, 9(7): 392-396. 
    Abstract ( 227 )   PDF (510KB) ( 210 )  
    ObjectiveTo research therapeutic index(TI) and the margin of safety factor(SF) of anti-inflammatory effect of Radix et Rhizome Sophorae Tonkinensis. MethodsEstablish tumidness model induced by daubing croton oil and granuloma model induced by subcutaneous injection of agar to explore acute and chronic anti-inflammatory effect of different components from Radix et Rhizome Sophorae Tonkinensis, and acute lethal dose test is also proceeded. Calculate ED50 and ED95 of anti-inflammatory efficacy and LD50 and LD5 of acute toxicity test of the different components from Radix et Rhizome Sophorae Tonkinensis. And then calculate the therapeutic index(TI) and safety factor(SF) of different components from Radix et Rhizome Sophorae Tonkinensis. ResultsThe different components from Radix et Rhizome Sophorae Tonkinensis showed good anti-inflammatory effect and certain dose-effect relationship. The anti-inflammatory effect of alcohol extraction component was better than it of water extraction component. TI of anti-acute inflammatory effect of the water extraction component and the alcohol extraction component from Radix et Rhizome Sophorae Tonkinensis is 34.0185 and 52.8432, and SF is 8.9965 and 16.3049 respectively. And TI of anti-chronic inflammatory effect of the water extracts and the alcohol extracts from Radix et Rhizome Sophorae Tonkinensis is 34.4115 and 53.8510, and SF is 8.5146 and 18.1641 respectively. ConclusionThe anti-inflammatory effect of the water extracts is greater than the alcohol extracts from Radix et Rhizome Sophorae Tonkinensis, but the margin of safety from alcohol extracts is greater than the water extracts from Radix et Rhizome Sophorae Tonkinensis. We should pay more attention to the occurrence of adverse reactions and strengthen drug monitoring in the application of the water extracts from Radix et Rhizome Sophorae Tonkinensis.
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    on Analgestic Effect and Safety Scope of Different Components of Evodia Fructus
    HUANG Wei, SUN Rong
    2012, 9(7): 397-400. 
    Abstract ( 235 )   PDF (466KB) ( 162 )  
    ObjectiveTo research on the therapeutic index(TI) and the safety factor(SF) of different components of Evodia Fructus when playing analgestic effect. MethodsTo make research on the acute toxicity of different components in accordance with classical acute toxicity test methods; to make research on the analgestic effect of different components in accordance with the classical hot plate method; calculating the LD50, LD5, ED50 and ED95 using Bliss method, to calculate the TI and SF of analgestis effect of different components of Evodia Fructus. ResultsThe LD50 of volatile oil in Evodia Fructus was 2.6995 mL ·kg-1 ·d-1, and the LD5 of volatile oil was 1.9853 mL ·kg-1 ·d-1; the ED50 of volatile oil in Evodia Fructus was 0.4625 mL ·kg-1 ·d-1, and the ED95 of volatile oil was 0.9996 mL ·kg-1 ·d-1; TI was 5.837and SF was 1.986. The water extracts of Evodia Fructus are unable to make LD50, MTD results calculated in accordance with crude drug content was 80.0 g ·kg-1 ·d-1, the ED50 was 1.3515 g ·kg-1 ·d-1, and the ED95 was 4.3435 g ·kg-1 ·d-1. ConclusionBoth the water extracts and volatile oil had certain analgestic effect and had certain dose-efficacy relationship, and the safety scope of water extracts was bigger than volatile oil.
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    Field Research on the Disease Coverage of "National Essential Medicines List"
    XIAO Ai-li, YAN Lin, JING Chun-mei
    2012, 9(7): 401-409. 
    Abstract ( 239 )   PDF (606KB) ( 294 )  
    ObjectiveTo understand the varieties of common diseases and frequently encountered diseases among Chinese residents, along with the features of disease coverage, compare the results of this field research with the "National Essential Medicines List"(NEML) in order to provide scientific evidences for a reasonable set of the categories in NEML. MethodsSample survey was conducted at a number of representative medical institutions in five provinces of China. We collected and analyzed the discharged patient record data of the whole year 2008 at fourteen 3A grade hospitals which owned inpatient electronic record system, interviewed the relevant healthcare professionals at 45 community health service centers and township hospitals, understood the diseases involved in the patients there. Resultsand ConclusionThere is a great difference between the disease coverage of field research and that of NEML, so that it's necessary to reconsider and respecify the diseases included by the current NEML.
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    The Experience and Enlightenment of the Establishment of American Hazardous Substances Data Bank
    LI Chun-xiao, LI Ke-xin, WU Zhi-ang
    2012, 9(7): 410-412. 
    Abstract ( 303 )   PDF (546KB) ( 267 )  
    A comprehensive drug information database is important to drug evaluation. Hazardous Substances Data Bank is rich in the management experience of information and organization, which plays an important part in drug evaluation. On contrast with current condition of China's drug information database and related parts, it suggested the authority of the PRC taking advantage of the experience of Hazardous Substances Data Bank, playing the major role in establishment and improvement of comprehensive drug information database, involving the potential parties. The above effort will give rise to drug evaluation project at home.
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    Overview of Pharmacovigilance Systems in India
    LU Yu-mei
    2012, 9(7): 413-417. 
    Abstract ( 309 )   PDF (628KB) ( 372 )  
    India is the world's fourth largest pharmaceutical market, and it has been continuing to learn advanced supervisory experience from western countries in recent years to improve its drug regulatory environment, thus pharm-
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    Analysis and Reflection on Technological Examination for License Renew Application of Drugs
    LIU Jin-xia
    2012, 9(7): 418-420. 
    Abstract ( 256 )   PDF (553KB) ( 293 )  
    ObjectiveTo improve the examining process of license renew application for supervision and management of drugs. MethodsThe main points of technological examination for drug license renew application were summarized and analyzed, including the range of production permit, quality standards, adverse reactions and so on. Resultsand ConclusionThe improvement of quality of evaluation and policy and regulations play an important role in license renew application.
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    Safety Evaluation of Light-resistant Infusion Sets for Clinical Medication
    YANG Xiao-dong
    2012, 9(7): 421-423. 
    Abstract ( 243 )   PDF (558KB) ( 343 )  
    This article analysis factors influencing safety of clinical medication by focusing on specific characteristics of the light-resistant infusion sets. The evaluation factors which should be considered by manufacturing enterprises are preliminary discussed in order to provide reference for development and evaluation of the light-resistant infusion sets.
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    Literature Analysis on 20 Cases of Adverse Drug Reaction by Reduning Injection
    AYNur ·ReHeMu, JIN Feng, TANG Ren
    2012, 9(7): 424-426. 
    Abstract ( 281 )   PDF (659KB) ( 328 )  
    ObjectiveThrough analysing 20 adverse drug reaction cases by Reduning Injection to explore the rules and causes of adverse reactions, provide a reference for clinical rational use of drugs. MethodsBy searching literature in Chinese journal full-text database from 1995 to 2012, 16 ADR literatures of Reduning Injection involving 20 cases, were statistically analyzed. Resultsand ConclusionADRs induced by Reduning Injection are irrelevant with dose. Serious adverse reaction mostly occurred in the initial treatment, the clinical care should be strengthened so as to prevent the occurrence of adverse reactions.
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    Literature Analysis of 146 Cases of Adverse Drug Reactions Induced by Vitamin-K1 Injection
    HUANG Yuan, WANG Chun-ting, TIAN Yue-jie
    2012, 9(7): 427-430. 
    Abstract ( 278 )   PDF (671KB) ( 333 )  
    Objective We probe into the status, characteristics and influencing factors of ADR cases induced by vitamin-K1 injection, for providing a reference for clinical treatment. Methods Date were collected from domestic published literatures from "China Journal Full-text Database" before December 31, 2011 and 146 case reports of adverse drug reactions induced by vitamin-K1 injection were analyzed retrospectively. Results Adverse drug reactions induced by vitamin-K1 injection may be related to pharmaceutical factors, patients' factors and clinical using factors. Conclusion Vitamin-K1 injection should be used reasonably and attach importance to monitoring of clinical to ensure the safety of medication.
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    Analysis on the Adverse Drug Reactions / Events of Paroxetine
    CHENG Li-ling, XU Zuo-guo
    2012, 9(7): 431-432. 
    Abstract ( 256 )   PDF (576KB) ( 539 )  
    ObjectiveTo investigate the adverse drug reactions of Paroxetine, provide a reference for clinical safe use of drugs. MethodsStatistically analyzed the articles about adverse reactions of Paroxetine published by mental illness journals for the past 10 years and medical records collected by the author. ResultsThe adverse reactions of Paroxetine involve 9 major categories, with 22 kinds of clinical manifestations, mainly including extrapyramidal reactions(27.91%), blood system injury(11.63%) and allergic reactions(13.95%). ConclusionThe adverse drug reactions of Paroxetine are relatively more but gentle, focusing on extrapyramidal injury, hepatic dysfunction, leucopenia and skin allergy.
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    Analysis of 63 Cases of Serious Adverse Drug Reacation /Event of Iohexol Injection
    PENG Yuan, MA Guo-xian, TIAN Hong, KONG Fei, PENG Dan-bing
    2012, 9(7): 433-435. 
    Abstract ( 253 )   PDF (621KB) ( 432 )  
    ObjectiveTo analyze the situation of serious adverse drug reaction/event(SADR/SADE) of Iohexol injection and related factors, provide a reference for clinical medication. MethodsLiterature published in CNKI and Wanfang database from January 1998 to March 2012, according to the literature of pre-established inclusion criteria to collect literature, extract and analyze information involving Iohexol injection SADR/SADE. Results25 literatures were adopted, the level of evidence were 3b or 2b, 63 cases were involved and all cases are adults, which mostly middle-aged patients. The main clinical manifestations of SADR/SADE were contrast nephropathy, shock, and allergic-like reaction. ConclusionsWe should strengthen the monitoring of Iohexol injection. The pharmaceutical factories should carry out large-scale epidemiological studies to explore the protective factors and risk factors about Iohexol injection in clinical use, improve the instructions and provide scientific basis to control the risks in clinical use.
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    Sampling Results and Assessment the Quality of Piracetam Preparation
    WANG Ling-na, DING Jian, ZHU Jing-hua, ZHANG Xiao-dong
    2012, 9(7): 436-438. 
    Abstract ( 257 )   PDF (663KB) ( 170 )  
    ObjectiveTo evaluate the quality status of piracetam preparation and exsisting problems. MethodsAccording to the general requirements of Jiangsu Province assessment programs, use statutory testing methods and combine with the exploratory research to examine samples, evaluate the quality status of piracetam preparation by statistical analysis of the results. ResultsIn 158 batch of samples, 2 batch of unqualified(1.3%), weight difference and particulate matter as the main causes of failure. ConclusionsAt present the preparation quality is generally good. The current standard is feasible, but there needs to be improved at.
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    Research Development on Prepared Method and Theoretical Research of Rhizome Atractylodis
    DU Qing-shan
    2012, 9(7): 439-441. 
    Abstract ( 263 )   PDF (634KB) ( 969 )  
    ObjectiveBy combing pertinent literature and summarizing the current states of the ancient and modern prepared method evolution and theoretical research development, to offer the accordance and ideas for further research on the prepared standardization of Rhizome atactulodis. MethodsThe related references in recent 20 years both at home and abroad about Rhizome atactulodis were analyzed, collated and summarized. ResultsThe prepared methods of Rhizome atactulodis were mainly 19 categories in ancient records, namely the prepared method of vinegar, the prepared method of hogwash, the prepared method of medicine juice, steamed prepared method, the prepared method of soil, the prepared method of pointed, the prepared method of salt, the prepared method of wine, the prepared method of anise, the prepared method of mulberry, the prepared method of milk, the prepared method of honey, baked prepared method, and so on; the modern prepared methods of Rhizome atactulodis were mainly the prepared method of fried coke, wheat fried method, and the prepared method of hogwash. The content of volatile oil and trace elements could be reduced through the prepared method, in order to achieve the restricition of its dry fierce, the ease of medicinal property, the strengthen of efficacy. But the prepared varieties of Rhizome atactulodis in clinic were more and chaos, and the quality differences were bigger and there were no unified prepared technology and quality standard. ConclusionStick to the principle of combining the traditional prepared methods and modern scientific methods, to make research on the optimization of prepared craft and the standardization of quality standard and ensure the clinical medicinal quality, so as to provide basis for the safe and rational usage.
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