摘要
目的全面了解清开灵注射剂不良反应的发生情况及其相关因素,并探索药品上市后再评价的方法。方法收集静脉滴注清开灵注射剂不良反应文献资料,并分为同期对照临床研究、不良反应监测或病案系列报告、个案或典型病例报告3类,进行归类、整理、分析。结果不同研究方法显示清开灵注射剂平均不良反应发生率为3.38%～12.77%,主要表现为过敏反应,且发现多种说明书记载以外的罕见类型。结论清开灵注射剂的不良反应以过敏反应为主,尤其以过敏性休克最为严重;相关文献质量有待提高。
Objective To find out the occurrence rate of adverse drug reactions （ADR） following the intravenous administration of Qingkailing Injection and to understand the relative factors such as the type and constitution of ADR. Furthermore, to preliminarily explore the methods for reevaluation of the drug after appeared on market. Methods A comprehensive collection of literature was carried out, which covered the literature on ADR in intravenous infusion of Qingkailing Injection. The documents were classified into 3 categories, i. e. synchronous clinical study, monitoring of ADR and analysis of medical records, as well as individual or typical case reports, Referring to systemic evaluations and methods for the investigation of ADR, the data were sorted out for quantitative analysis, Results Different study methods indicated that the mean occurrence rate of ADR in Qingkailing Injection was 3.38-12.77%;ADR manifested mainly as anaphylactic reaction. In addition, a variety of rare types of ADR were discovered which were not indicated in the instructions of the product. Conclusion The ADR of Qingkailing Injection represented mainly as anaphylactic reaction, especially with anaphylactic shock.
出处
《中国药业》
CAS
2007年第24期50-52,共3页
China Pharmaceuticals
关键词
清开灵注射剂
药品不良反应
系统评价
上市后再评价
Qingkailing Injection
adverse drug reaction （ADR）
systematic evaluation
reevaluation after appeared on market
