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目的:通过双盲双模拟对照和开放试验的方法评价国产乙酰半胱氨酸胶囊的安全、有效性。方法:选用羧甲司坦片作双盲双模拟对照,每组各60 例,疗程7 d,按用药前后的症状评分比较判断疗效。结果:乙酰半胱氨酸组临床总有效率为91.67% ,不良反应发生率为11.67% ;对照羧甲司坦组总有效率为90 % ,不良反应发生率为16 .67 % ,以上结果经统计学处理差异无显著性( P>0 .05)。开放试验总有效率为95 % ,不良反应发生率为7.5 % 。结论:乙酰半胱氨酸胶囊与羧甲司坦片具有同等的止咳祛痰作用,同样安全。
OBJECTIVE: To evaluate the safety and efficacy of domestic acetylcysteine capsules by double-blind, double-dummy and open-label test. Methods: Carboxymethyltetrazolium was used as a double-blind, double-dummy control group with 60 cases in each group. The course of treatment was 7 days. The symptom scores before and after treatment were used to judge the curative effect. Results: The total effective rate of acetylcysteine group was 91.67% and the incidence of adverse reactions was 11.67%. The total effective rate of control group was 90% and the incidence of adverse reactions was 16%. 67%. There was no significant difference in the above results by statistical analysis (P> 0.05). The total effective rate of open trials was 95%, the incidence of adverse reactions was 7.5%. Conclusions: Acetylcysteine capsules have the same antitussive and expectorant effect as carbocisteine tablets, and are equally safe.