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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

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【作者】 王根才杨明均王英刘松山李廷谦黄雅惠王敏刘振斌吴瑜

【Author】 WANG Gen-cai~1 YANG Ming-jun~2 WANG Ying~2 LIU Song-shan~2 LI Ting-qian~3 HUANG Ya-hui~4 WANG Min~5 LIU Zhen-bin~1 WU Yu~1 (1 United Pharmaceutical Company,Ltd.,Wuhan 430070,China; 2 The Hospital Affiliated to Chengdu University of Traditional Chinese Medicine,Chengdu 610072,China; 3 West China Hospital Affiliated to Sichuan University,Chengdu 610041,China; 4 Xi’an Hospital of Traditional Chinese Medicine,Xi’an 710001,China; 5 Guiyang Hospital of Traditional Chinese Medicine,Guiyang 550001,China)

【机构】 武汉联合药业有限责任公司成都中医药大学附属医院四川大学华西医院西安市中医院贵阳中医学院附属医院武汉联合药业有限责任公司 武汉 430070成都 610072成都 670041西安 710001贵阳 550001武汉 430070

【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
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