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中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (1): 44-47.

• 研究原著 • 上一篇    下一篇

复方二甲基硅油咀嚼片治疗急性消化系统症状的临床研究

徐凌云, 王思元1, 徐可树2, 邓涛3, 曾繁典   

  1. 华中科技大学同济医学院临床药理研究所;
    1附属同济医院消化科, 武汉 430033, 湖北;
    2附属协和医院消化科, 武汉 430022, 湖北;
    3武汉大学人民医院消化科, 武汉, 430060, 湖北
  • 收稿日期:2004-10-08 修回日期:2004-11-30 出版日期:2005-01-26 发布日期:2020-11-19
  • 通讯作者: 曾繁典, 男, 教授, 博导, 研究方向:心血管药理学和临床药理学。Tel:027-83630652 E-mail:fdzeng@163.com
  • 作者简介:徐凌云, 女, 博士生, 主治医师, 研究方向:临床药理学。Tel:13667179870 E-mail:xulingyunen_2001@sina.com

Clinical efficiency and safety of compound polydimethylsiloxane chewable tablets in treatment of patients with some acute gastrointestinal symptoms

XU Ling-yun, WANG Si-yuan1, XU Ke-shu2, DENG Tao3, ZENG Fan-dian   

  1. Institute of Clinical Pharmacology, Tongji Medical College of Huazhong University of Science and Technology;
    1Department of Gastroenterology, the Affiliated Tongji Hospital, Wuhan 430033, Hubei, China;
    2Department of Gastroenterology, the Affiliated Xiehe Hospital, Wuhan 430022, Hubei, China;
    3Department of Gastroenterology, the Affiliated Renmin Hospital, Wuhan University, Wuhan 430060, Hubei, China
  • Received:2004-10-08 Revised:2004-11-30 Online:2005-01-26 Published:2020-11-19

摘要: 目的: 评价复方二甲基硅油咀嚼片治疗急性消化系统症状的有效性和安全性。方法: 采用多中心、随机、双盲、双模拟和对照的试验方法。选择具有2 种或2 种以上消化系统症状的患者138 例, 二甲硅油组69 例, 服用复方二甲硅油咀嚼片, 每次2片, 1 日4 次;铝碳酸镁对照组69 例, 服用威地美铝碳酸镁片, 每次2 片, 1 日4 次。总疗程均为7 d, 评价有效性和安全性的各项指标。结果: 二甲硅油组的痊愈率为33.3 %, 总有效率为85.5 %;铝碳酸镁组的痊愈率为36.2 %, 总有效率为89.8 %。二甲硅油组不良反应发生率为4.35 %, 铝碳酸镁组不良反应发生率为1.45 %。两组临床疗效和不良反应发生率经统计学分析, 均无显著差异。结论: 复方二甲基硅油咀嚼片和国产的铝碳酸镁片治疗急性消化系统症状的疗效相似, 不良反应发生率低。复方二甲基硅油咀嚼片是安全和有效的治疗急性消化系统症状的药物。

关键词: 复方二甲基硅油咀嚼片, 铝碳酸镁片, 临床试验, 有效性, 安全性

Abstract: AIM: To evaluate the efficiency and safety of compound polydimethylsiloxane chewable tablets (CPCT)in treatment of patients with some acute gastrointestinal symptoms.METHODS: CPCT was observed in the multi-center, randomized, double-blind, double-simulated and paralleled-control clinical trail.138 patients with two or over two acute gastrointestinal symptoms were divided into two groups (n=69 in each):the trial group which was treated with CPCT 2 tablets, fourth a day, and the control group which was treated with native hydrotalcid tablet 2 tablets, forth a day.The duration of treatment for both groups was 7 days.RESULTS: The cure rates in trial group and control groups were 33.3 % and 36.2 %, respectively.The total effective rates in trial group and control groups were 85.5 % and 89.8 %, respectively. There was no significant difference between two groups (P>0.05).The adverse drug reaction rates were 4.35 % and 1.45 %, respectively, and there was no significantly statistical differences between two groups.CONCLUSION: Both CPCT and native hydrotalcid tablet has the same efficiency and safety in the treatment of some gastrointestinal symptoms.CPCT is a kind of effective and safe drug.

Key words: compound polydimethylsiloxane chewable tablets, hydrotalcid tablets, clinical trials, efficiency, safety

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