奥替溴铵、比特诺尔和地芬诺酯治疗肠易激综合征的双盲随机对照研究

Effects of otilonium bromide,colloidal bismuth tartrate and diphenoxylate in the treatment of irritable bowel syndrome:a double-blind random controlled study

目的 探讨奥替溴铵、比特诺尔和地芬诺酯对IBS的治疗作用及副作用。方法 2 0 1例IBS腹泻型和腹痛型患者按照双盲随机对照观察分为A组 (奥替溴铵 )、B组 (比特诺尔 )和C组 (地芬诺酯 )。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 .0 48)。A组和C组中度以上缓解率 (69.4%和 72 .1% )显著高于B组 (5 0 .7% ,P =0 0 2 9,0 0 1)。A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 .0 0 0～ 0 .0 39) ,B组和C组治疗后腹痛、排便异常 (排便次数增多、大便性状、黏液便 )和腹部触痛积分和组内平均积分显著低于治疗前 (P≤ 0 0 47)。A组副作用发生率 (8.1% )显著低于B组 (2 3.9% ,P =0 .0 14 )和C组 (35 .3% ,P =0 0 0 0 ) ,主要由于B组(12 7% )和C组 (2 5 0 % )便秘发生增加。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 。

Aim To evaluate the efficacy of otilonium bromide,colloidal bismuth tartrate and diphenoxylate in the irritable bowel syndrome treatment.Methods Two hundred and one patients with irritable bowel syndrome were randomly divided into three groups and treated with oral administration of otilonium bromide (group A),colloidal bismuth tartrate (group B) and diphenoxylate (group C). Scores of symptoms were performed in all patients before and after treatment. Curative effects were evaluated with the different grades:conspicuous,middle,weak remission and inefficacy. Results The average symptomatic scores after treatments were significantly decreased compared with before treatments ( P ≤0.048). Remission rates of both conspicuous and middle in group A (69.4%) and group C (72.1%) were higher than that of group B (50.7%,P=0 029,0 01).After treatment, the scores of symptoms, abdominal pain?distension?abnormal felling of defecation and tenderness decreased than before in group A (P=0.000～0.039),and the scores of symptoms,abdominal pain?defecation frequency,character of stool, mucous stool and tenderness decreased significantly than before in group B and C ( P ≤0. 047). Moreover, the side-effect was fewest in group A (8.1%) but highest in group C (35.3%),and that of group A were less than of group B (23.9%) and C (P=0.014 and P =0.000),whose major side effect was constipation (12.7% of group B, 25.0% of group C). Conclusion The symptoms of the patients with IBS may be remitted with above mentioned drugs including otilonium bromide selectively act upon the type of abdominal pain,and colloidal bismuth tartrate and diphenoxylate are more effective for the diarrheal type of IBS. Side effect of otilonium bromide is scarce,and colloidal bismuth tartrate and diphenoxylate can cause constipation when they are used for a long time.