奥替溴铵、比特诺尔和复方地芬诺酯治疗肠易激综合征的双盲随机对照研究

Effects of Treatments with Otilonium Bromide, Colloidal BismuthTartrate and Compound Diphenoxylate in the Irritable Bowel Syndrome: A Double-blind Random Controlled Study

目的:观察奥替溴铵、比特诺尔和复方地芬诺酯对IBS的用药安全性。方法:201例IBS腹泻型和腹痛型患者按照双盲随机对照观察分为奥替溴铵组（n=62）、比特诺尔组（n=71）和复方地芬诺酯组（n=68）。所有患者均需进行治疗前、后症状评分。疗效判断标准为:显著、中度、轻度缓解和无效。结果:三组治疗后症状平均积分均显著低于治疗前（P<0.05）。奥替溴铵组和复方地芬诺酯组中度以上缓解率（69.4％和72.1％）显著高于比特诺尔组（50.7％,P<0.05）。奥替溴铵组治疗后腹痛、腹胀、排便异常感和腹部触痛积分均显著性减低（P<0.05～<0.001）,比特诺尔组和复方地芬诺酯组治疗后腹痛、排便异常（排便次数增多、大便性状、粘液便）、腹部触痛积分和组内平均积分显著低于治疗前（P<0.05）。奥替溴铵组不良事件发生率（8.1％）显著低于比特诺尔组（23.9％,P<0.05）和复方地芬诺酯组（35.3％,P<0.001）,其主要是由于比特诺尔组（12.7％）和复方地芬诺酯组（25.0％）便秘发生率增高。结论:上述三种药物对IBS的治疗均有效,其中奥替溴铵选择性作用于腹痛型,比特诺尔和地芬诺酯主要作用于腹泻型。奥替溴铵副作用少,而比特诺尔和复方地芬诺酯长期使用易导致便秘。

OBJECTIVE: To evaluate the efficacy and safety of otilonium bromide, colloidal bismuth tartrate and compound diphenoxylate in the irritable bowel syndrome. METHODS: Two hundred and one patients with irritable bowel syndrome were randomly divided into three groups and treated with oral administration of otilonium bromide (n=62), colloidal bismuth tartrate (n=71) and compound diphenoxylate (n=68). Scores of symptoms were performed in all of the patients before or after treatment. Curative effects were evaluated with the different grades, conspicuous remission, middle, weak and inefficacy. RESULTS: The average symptomatic scores after treatments were significantly decreased than those of the patients in three groups before (P<0.05). Remission rates of both conspicuous and middle in the group with otilonium bromide (69.4%) and with diphenoxylate (72.1%) were increased than that of colloidal bismuth tartrate (50.7%, P< 0.05). After treatment, the scores of symptoms, abdominal pain, distension, abnormal felling of defecation and tenderness, were decreases than before in otilonium bromide (P<0.05-<0.001), and the scores of symptoms, abdominal pain, defecation frequency, character ofstool, mucous stool and tenderness, were decreases significantly than before in the group with colloidal bismuth tartrate and with diphenoxylate (P<0.05). Moreover, the adverse reaction rate was the lowest in otilonium bromide (8.1%), but the highest in the group of diphenoxylate (35.3%), and that of otilonium bromide were less than that of colloidal bismuth (23.9%) and diphenoxylate (P<0.05 and P<0.001), the major adverse reaction from constipation (12.7% of colloidal bismuth, 25.0% of diphenoxylate). CONCLUSION: The symptoms of the patients with IBS may be remitted with above-mentioned drugs, included otilonium bromide selectively acing upon the type of abdominal pain, and colloidal bismuth and diphenoxylate being more effectively for the diarrheal type of IBS. Adverse reaction of otilonium bromide was few, but colloidal bismuth and diphenoxylate can cause the constipation after using for a long time