摘要
目的观察小剂量盐酸雷尼替丁加复方地芬诺酯治疗腹泻型肠易激综合征(D—IBS)的临床疗效。方法采用前瞻性、随机对照临床研究。将符合罗马Ⅱ标准的150例D—IBS患者随机分为观察组74例,对照组76例。观察组给予盐酸雷尼替丁0.15 g加复方地芬诺酯1片,每晚1次口服。对照组给予复方地芬诺酯1片.1日3次。研究包括1周基线期、3周治疗期和随后2周随访期。主要疗效指标为每周总体症状评分,次要疗效指标包括每周腹泻、腹胀、腹痛及其他D-IBS症状的严重程度评分。结果两组患者症状评分总有效率比较.治疗3周时X^2=5.10,P<0.05,2周随访期X^2=28.21,P<0.01,观察组均优于对照组。观察组未发现不良反应,对照组有2例出现头晕、烦躁.1例出现恶心。结论小剂量盐酸雷尼替丁加复方地芬诺酯治疗D—IBS安全、有效、不易复发。
Objective To observe the clinical efficacy of small-dose ranitidine hydrochloride and diphenoxylate compositae in the combined treatment of diarrhea-predominant irritable bowel syndrome(D-IBS). Methods A prospective,randomized controlled clinical trial was designed. 150 D-IBS patients according to Rome Ⅱ criteria were randomly divided into combined treatment group and control group. The combined treatment group(74 patients) received ranitidine hydrochloride, 0.15g, each evening and diphenoxylate compositae, 1 piece, each evening. The control group(76 patients) received diphenoxylate compositae, 1 piece,rid. This study consisted of a 2-week baseline period, a 3-week treatment period, followed by a 2-week follow-up period. The main efficacy variable was assessed by perception of overall symptom during the previous weeks. Secondary efficacy variables included severity of diarrhea,abdominal pain and distention and other symptoms. Results After treatment of 3 weeks,the efficacy of the combined treatment group was better than that of the control group(X^2 = 5.10, P 〈 0.05). During the follow-up period, the improvement of each symptom in the combined treatment group was also better than that in the control group(X^2 = 28.21, P 〈 0.01 ). No adverse effect was found in the combined treatment group. 2 cases had giddy and fidget and 1 case had nausea in the control group. Conclusion The combined therapy of small-dose ranitidine hydrocloride and diphenoxylate eompositae for the treatment of D-IBS is safe,effective and not easy to recur.
出处
《中国基层医药》
CAS
2007年第12期1974-1975,共2页
Chinese Journal of Primary Medicine and Pharmacy
关键词
肠易激综合征
盐酸雷尼替丁
复方地芬诺酯
Irritable bowel syndrome
Ranitidine hydrochloride
Diphenoxylate compositae