摘要
目的系统评价《国家基本药物目录》(2002年版)中药注射剂类药品及相关同品种不同剂型的临床研究文献,了解和分析其不良反应发生情况。方法系统性评价方法。结果72个药品中有5个药品未检索到文献,17个药品无临床治疗性文献,34个药品报告不良事件/不良反应4156例,其中注射剂4146例,占99.76%;同品种其他剂型10例,占0.24%。结论报告的不良事件/不良反应绝大多数为中药注射剂品种,而同品种其他剂型(如口服液、颗粒剂、胶囊剂、片剂等)则大多未出现或很少出现不良事件/不良反应。不良反应报告不规范,未进行不良反应因果关系判断,且无前瞻性研究,无法获得不良反应发生率。当前中药安全性研究工作重点是加强对中药注射剂的安全性进行监测、评价和研究。
Objective Find outed analyse the adverse drug reaction reports of Traditional Chinese Materia Medica （TCMM） Injection of National Essential Drugs by Systematic Review. Method The papers were serched and collected from the CBMdisc（1981-Dec.002） using the names of 72 TCMMS as the key words. Data were extracted and evaluat ed by two renewers independently with a designed extraction form. Results No published papers of 5 kinds of TCMM in 72 TCMMs List of National Essential Drugs were searched： Among 4156 cases of ADRs/AEs reported in 34 TCMMS. 146 cases （99.76%） were from TCMM injection, only 7cases and 3 cases were from solution and capsule respectively. Conclusion majority of ADRs/aEs case occurs in TCMM injection, but few of ADRs/AEs cases occurs in other dosage （such as solution, granule; capsule, tablet; etc.）. There are shortage in the reporting of ADRs/AEs cases aboved, such as without regard to the GCP guide-line and government regulations, lack of standardization of ADR reports absence of Causality assessment, without conducting the prospective study on ADR;and no incidence of AdRs/AEs.Great efforts Should be to strengthen the safety surveillance of TCMM injection in the postmarketing reevaluation of TCMM.
出处
《中国药物警戒》
2007年第3期137-141,161,共6页
Chinese Journal of Pharmacovigilance
基金
国家食品药品监督管理局药品评价中心"<国家基本药物目录>中药注射剂类药品循证评价研究"课题
关键词
基本药物
中药注射剂
药品不良反应
系统性评价
文献分析
essential drugs
traditional chinese materia medica injection
adverse drug reaction
systematic review
literature anatysis
