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 6 9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 6 9例 ,服用威地美铝碳酸镁片 ,每次 2片 ,1日 4次。总疗程均为 7d ,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 1.4 5 %。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。
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.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2005年第1期44-47,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
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
compound polydimethylsiloxane chewable tablets
hydrotalcid tablets
clinical trials
efficiency
safety
