国产曲马多胶囊及针剂Ⅲ期临床试用结果  

RESULTS OF PHASE Ⅲ TRIAL OF DOMESTlC TRAMADOL HYDROCHLORIDE CAPSULE/INJECTION

作　　者：罗健 孙燕 

出　　处：《中国新药杂志》1995年第4期26-30,共5页Chinese Journal of New Drugs

摘　　要：对国产盐酸曲马多胶囊及针剂在１４４７例疼痛患者中的应用进行了Ⅲ期临床观察。结果提示该药的镇痛效果（镇痛有效率和缓解时间）及毒副反应率与进口同类剂型及其它国内厂家产品相似（Ｐ＞０．０５）。另外，对其中２３２例长期用药病人资料的分析结果表明：长期应用该药时镇痛效果未增强（Ｐ＞０．０５），毒副反应率却明显增加（Ｐ＜０．０５），尚未发现耐受性、身体依赖性及成瘾现象。证实该药具有较好临床应用价值。最后，应用多元逐步回归分析法，讨论了影响曲马多疗效及毒副作用的几个因素。ln a multi-centre prospective study, a phase Ⅲ clinical observation ofthe analgesic effect of domestic tramadol HCl capsule/injection was carried out in 1447patients with various types and intensities of pain. The data obtained showed that theanalgesic effects and adverse effects of tramadol HCl are similar to those of imported andother domestic tramadol. Of the 1447 patients, 232 patients took the drug continually for 1 week or over 20 times, results from these patients indicated that the analgesic effect(P>0. 05) does not increased but the adverse reactions (P<0. 05) are significantly in-creased and no evidence of tolerance,physical and psychological dependence was ob-served. Based on the multivariate stepwise regression analysis,some key factors affectingtramadol's analgesic and adverse effects were discussed.

关 键 词：盐酸曲马多 胶囊 针剂 Ⅲ期临床 镇痛药 

分 类 号：R971.1[医药卫生—药品]