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中国临床药理学与治疗学 ›› 2002, Vol. 7 ›› Issue (2): 150-152.

• 临床研究 • 上一篇    下一篇

国产马来酸曲美布汀治疗功能性消化不良的疗效评价

范竹萍, 曾民德, 许国铭1, 李兆申1, 邹多武1, 王根生2, 竺越2, 保志军2, 陈维雄3   

  1. 上海市第二医科大学附属仁济医院、上海市消化疾病研究所国家药品临床研究基地, 上海 200001;
    1上海长海医院国家药品临床研究基地, 上海 200433;
    2上海市华东医院消化科, 上海 200040;
    3上海市第六人民医院消化科, 上海 200233
  • 收稿日期:2001-12-19 修回日期:2002-02-28 出版日期:2002-04-26 发布日期:2020-11-27
  • 通讯作者: 范竹萍, 女, 博士研究生, 副主任医师, 副教授。Tel:021-6360930-2194 Email: syffpd@online.sh.cn

Evaluation of domestic trimebutine in the treatment of functional dyspepsia

FAN Zhu-Ping, ZENG Min-De, XU Guo-Ming1, LI Zhao-Shen1, ZOU Duo-Wu1, WANG Gen-Sheng2, ZHU Yue2, BAO Zhi-Jun2, CHEN Wei-Xiong3   

  1. Renji Hospital, Shanghai Second Medical University, and National Basis of Drug Clinical Trial, Shanghai Institute of Digestive Disease, Shanghai 200001;
    1National Basis of Drug Clinical Trial, Changhai Hospital, Shanghai 200433;
    2Department of DigestiveDisease, Huadong Hospital, Shanghai 200040;
    3Department of DigestiveDisease, the Sixth Peo-ple's Hospital, Shanghai 200233
  • Received:2001-12-19 Revised:2002-02-28 Online:2002-04-26 Published:2020-11-27

摘要: 目的: 评价国产马来酸曲美布汀(诺为) 治疗功能性消化不良的安全性和疗效。 方法: 采用多中心、开放性试验, 选择在最近一年内具有早饱或上腹胀, 可伴有恶心、呕吐、上腹痛、烧心、厌食、嗳气等症状, 持续或间断发作超过 12 wk 以上的病人, 予诺为(普利马来酸曲美布汀片, 200 mg/片, 一天三次, 口服 2 wk)。 治疗前后分别记录一次以下症状, 包括早饱、上腹胀、恶心、呕吐、上腹痛、烧心、厌食、嗳气、纳差等症状。症状按无、轻、中、重分级。同时治疗前后各检查一次血、尿、粪常规和肝肾功能。结果: 治疗 2wk 后 86例的总改善率为(67.64 ±23.91) %早饱和上腹胀满等其它症状都有非常显著的改善(P<0.01)。 主要症状中的早饱为 72.2%, 上腹胀满为 84.7%, 不良反应发生率为 3.49%。结论: 马来酸曲美布汀(诺为) 治疗功能性消化不良是安全有效的。

关键词: 马来酸曲美布汀, 功能性消化不良, 安全性, 疗效

Abstract: AIM: To evaluate the efficacy and safety of domestic trimebutine in the treatment of functional dys-pepsia.METHODS: As an open multicenter study, the inclusion criteria were the patients with early satiety and bloating which might accompany with nausea, vomiting, abdominal pain, heartburn, anorexia, belch, and the du-ration >12 weeks.Trimebutine was used in these pa-tients for 2weeks.The symptoms, including nausea, vom-iting, abdominal pain, heartburn, early satiety and bloat-ing, anorexia, belch, and bad apetite were observed be-fore and after the treatment.The degree of above symp-toms were classified into no, mild, moderate and severe. The some aboratory indexeswere also tested before and af-ter the treatment.RESULTS: 86 patients completed the whole study by per protocol analysis.The total improved rate were (67.64±23.91) %.There had significant im-provement for the main symptoms like early satiety and bloating (P<0.01).The effective rate of early satiety was 72.7%, bloating was 84.7%, and the rate of side effect was 3.49%.CONCLUSION: Domestic trimebu-tine is effective and safe to treat functional dyspepsia.

Key words: trimebutine, functional dyspepsia sufe-ty, efficacy

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