摘要
目的中药注射剂(CMI)的不良反应(ADR)/不良事件(AE)屡有发生,临床报告本身的质量直接影响读者对ADR/AE的充分了解。方法计算机检索中国期刊全文数据库(CJN,1994～2009)和中文科技期刊数据库(VIP,1989～2009),获取有关鱼腥草注射剂的ADR/AE报告,用自行设计的中药注射剂ADR/AE报告质量评价表进行质量评价。结果经文献检索共获得与鱼腥草注射液相关的210篇ADR/AE文献,其中ADR/AE病例报告175篇,来自ADR监测中心的报告7篇,医疗单位的综合报告28篇。评价结果发现:针对ADR/AE病例基本项目的报告很不全面,有很多与ADR/AE发生相关的关键数据缺失。结论应尽快建立中药注射剂ADR/AE报告规范;建立ADR/AE的汇报注册制度,为每一例严重中药注射剂ADR/AE独立编号注册,做到有案可查。同时,国家药监部门及期刊杂志应大力宣传ADR/AE发表规范,促进其充分使用,这样才能真正提高ADR/AE文献的质量,避免临床ADR/AE格式不规范、关键信息数据缺失等突出问题。
Objective While reporting of adverse drug reactions（ADR） and adverse drug events（AE） following Chinese medicine injection（CMI） is becoming more common,the reporting quality is of concern.Methods A checklist about the reporting quality of ADR/AE was set up,and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example.Electronic databases Chinese Journal Net（CJN）（1994-2009） and Chinese Science and Technological Journal Net（VIP）（1989-2009） were searched for target literature.Results Based on our search strategy,210 articles were included,with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection（type I report）.There were 7 reports from regional or national ADR monitoring centers（type Ⅱ report）,and 28 summary reports from a single hospital or medical center（type Ⅲ report）.All 210 papers mentioned ＇adverse e ect,＇ ＇safety＇ or related meaning words in their titles,but 199 articles did not have abstract.Patient demographic characteristics were not fully reported in these articles.In type I articles,only 97 cases（43.11%） mentioned whether patients had or did not have a history of allergies,while 128 cases（56.89%） in Type Ⅱ papers and Fourteen（50%） type Ⅲ papers,did not mention allergic history of patients.Only three articles（3/210,1.43%）,all of them type I,mentioned the syndrome type in Chinese medicine.None of the papers gave clear indications of the type and grade of ADR/AE of patients.Most papers did not report details of the CMI procedure,such as the drug company,product serial number,or the drug＇s validity period.Data about the occurrence time and management of ADR/AE was also inadequately reported.Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized.Much fundamental information of ADR/AE following CMI is therefore missing.A standard reporting format for ADR should be developed,and should include the following：1） a title mentio
出处
《中国循证医学杂志》
CSCD
2010年第2期176-181,共6页
Chinese Journal of Evidence-based Medicine
关键词
鱼腥草注射液
不良反应
不良事件
报告质量
Yuxingcao injection
Adverse drug reaction
Adverse event
Reporting quality
