脑心通胶囊上市后临床安全性文献研究

The clinical safety literature research of Naoxintong capsule

目的:对脑心通胶囊有关临床安全性的文献进行研究,获取临床安全性信息,为临床安全用药提供参考。方法:对脑心通胶囊临床安全性相关文献进行收集、筛选、标化及整合,形成脑心通胶囊不良事件(adverse drug event,ADE)/不良反应(adverse drug reaction,ADR)文献数据库,采用描述性分析方法对ADR发生特点进行梳理分析。结果:共计纳入58篇符合标准的文献,其中临床研究54篇,个案报告2篇,不良事件监测2篇;报告不良反应共计213例,其中ADR的临床表现31个,累及9个器官/系统损害,以胃肠系统损害(67.21%)、中枢及外周神经系统损害(15.79%)和全身性损害(7.69%)为主;有记录的ADR转归及预后情况(141例,66.2%)均良好。结论:通过文献研究可获取脑心通胶囊的ADR临床表现、累及器官/系统损害情况,ADR转归及预后情况;但整体ADR发生情况的描述不够详细,对ADR的发生时间等信息缺失较多,不良反应发生率受文献中临床研究样本量的限制而差别较大;有待规范临床研究文献中对ADE/ADR发生情况描述的内容,提高安全性有效信息的获取;目前描述性文献研究在获取药品临床安全性有效信息中可起到一定的补充作用。

OBJECTIVE To obtain clinical safety information and provide basis for rational drug use in clinic by studying the clinical safety literature of Naoxintong capsule.METHODS The clinical safety literature of Naoxintong capsule was collected,screened,standardized and integrated to form a literature database of adverse drug event(ADE)/adverse drug reaction(ADR)of Naoxintong capsule.The occurrence characteristics of ADR were analyzed by descriptive analysis method.RESULTS Among the 58 eligible literatures,54 were clinical studies,2 were case reports and 2 were ADR/event monitoring.A total of 213 ADR cases were reported.31 ADR clinical manifestations involved 9 organ/system lesions,mainly gastrointestinal system lesions(67.21%),central and peripheral nervous system lesions(15.79%)and systemic lesions(7.69%).Only 16 cases(7.51%)had detailed records of the occurrence time of ADR,141 cases(66.2%)had records of ADR treatment and prognosis,and the incidence of ADR was 4.95%.CONCLUSION The clinical manifestations,organ/system damage involved,ADR outcome and prognosis of ADR of Naoxintong capsule can be obtained through literature study;however,the description of the overall ADR occurrence is not detailed enough,there are many missing information on the occurrence time of ADR,etc.,and the incidence of adverse reactions varies greatly due to the limitation of the sample size of clinical studies in the literature;it is necessary to standardize the content of the description of the occurrence of ADE/ADR in the clinical study literature and improve the acquisition of safe and effective information;the descriptive literature study can play a supplementary role in obtaining effective information on the clinical safety of drugs.