复方氨酚甲麻口服液治疗普通感冒的多中心随机对照研究

目的：评价复方氨酚甲麻口服液的有效性和安全性。方法：采用多中心随机对照开放的试验设计方法，完成可评估病例125例。其中试验组60例，对照组65例，试验药使用复方氨酚甲麻口服液，给药方法为：试验药，口服，每次18m1，每日4次，连续用药3—5d。对照药选用酚麻美敏口服溶液(泰诺^R)，口服，每次10m1，每日4次，连续用药3—5d。结果：试验药和对照药对普通感冒发热、头痛、鼻塞、流涕和咳嗽有明显的效果，有效率分别为94．2％和92．6％，药物不良反应的发生率分别为13．04％和8．82％。结论：复方氨酚甲麻口服液治疗普通感冒安全、有效。

A Randomized Controlled Multicenter Clinical Trial on The Treatment of Common Cold with Fu-fang-an-fen-jia-ma Fluid

OBJECTIVE: To evaluate clinical efficacy and safety of Fu-fang-an-fen-jia-ma fluid for common cold. METHODS: A total of 125 patients entered a multi-center, randomized, comparative trial. Patients were divided into two groups: one with Fu-fang-an-fen-jia-ma fluid(treatment), po 18ml, once a time, for3 - 5days. Another with Fen-ma-mei-min fluid(Tylenol, control), po 10ml,once a time, for3 -Sdays. RESULTS/The rate of common cold symptoms disappeared were similar in the two groups, the total efficacy rates were 94.2% and 92.6% in the treatment and controlled group,respectively. The incidences of adverse reaction were 13.04% and 8.82% in the two groups. There were no significant differences between the two groups in total efficacy rate and incidence of adverse reaction. CONCLUSION: Fu-fang-an-fen-jia-ma fluid is effective and safe agent in the treatment of common cold.