感冒通片不良反应系统性定量分析

目的 :探索感冒通片 (GMT)所致不良反应 (ADRs)的发生规律 ,评价其应用安全性。方法 :以《中国药学文摘》1990年1月～1999年12月共10年发表的有关GMT的ADRs文摘为线索检索原刊文献 ,收集资料 ,按设定标准进行统计分析。结果 :GMT所致ADRs20种共计568例 ,其中男性355例 ,女性151例 ,不详62例。在568例ADRs中 ,血尿442例 (77 82 % ) ,消化道出血43例(7 57 % ) ,紫癜15例 (2 64 % ) ,血小板减少症14例 (2 46 % ) ,休克、皮疹、哮喘、肝功异常、肾衰等计44例 ,永久性视力障碍2例 ,死亡10例 (1 76 % )。伴随症状25种275例次。超剂量或超疗程应用246例 ,占总数的43 3 %。结论 :GMT在推荐剂量下成人应用发生ADRs为一过性 ,但超剂量滥用可引起严重器官功能障碍甚至引发死亡。14a以下儿童尤其是男童发生药物性血尿较多 ,是否适用于儿童需要深入研究

Systematic and Quantitative Analysis of ADRs of Ganmaotong Tablet

AIM:To find out the regularity of adverse reactions (ADRs) induced by Ganmaotong tablets(GMT) and evaluate the safety of GMT in clinical use METHODS: Data of ADRs of GMT were collected from published articles, which were retrieved from CHINESE PHARMACEUTICAL ABSTRACT issued between January 1990 and December 1999 According the given standard,the data were statistically analysed RESULTS:There were 568 cases who had 20 kinds of ADRs of GMT,of them,355 cases were male,151 female and 62 cases were not clear There were hematuria in 442 cases(77 82%),gastrointestinal bleeding in 43 cases (7 5%),purpura 15(2 64%),thrombocytopenia 14(2 46%),miscellaneous reactions 44 and 10 deaths 246 cases received overdose or overduration of drug use CONCLUSION:The ADRs of GMT were mild and transient in the recommend dose in adults In case of overdose or overduration of use, serious organ dysfunctions and even death might occur Hematuria was apt to occur in children under age of 14,especially in boys