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痉痛定胶囊治疗胃脘痛Ⅱ期临床研究
Phase Ⅱ clinical trial of Jingtongding capsules in treatment of stomachache
【摘要】 目的:评价痉痛定胶囊对胃脘痛(消化性溃疡、慢性胃炎)气滞证的止痛疗效及安全性。方法:240例胃脘痛患者随机分为试验组(n=120)和对照组(n=120),试验组服用痉痛定胶囊+模拟山莨菪碱片,对照组口服山莨菪碱片+模拟痉痛定胶囊,治疗1d。结果:试验组和对照组总有效率分别为91.60%和93.28%(P>0.05),即刻止痛疗效的总有效率分别为89.92%和87.39%(P>0.05),试验组不良反应发生率为21.67%,显著低于对照组的52.67%(P<0.05)。结论:痉痛定胶囊对胃脘痛气滞证止痛安全有效。
【Abstract】 Objective:To evaluate efficacy and safety of Jingtongding capsules in treatment of stomachache( digestive ulcer,chronic gastritis).Methods:240 patients with stomachache were random- ized 1:1 to receive Jingtongding capsules and placebo anisodamine tablets(treatment group)or anisodam- ine tablets and placebo Jingtongding capsules(control group)for 1 day.Results:The total efficacy of the treatment and control was 91.60% vs.93.28%(P>0.05),respectively,and impromptu analgesia was 89.92% vs.87.39%(P>0.05),respectively.The incidence of adverse events was 21.67% vs.52.67% (P<0.05).Conclusion:Jingtongding capsules were effective and safe in the relief of stomachache.
- 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2006年12期
- 【分类号】R256.33
- 【下载频次】88