洁白胶囊联合阿米替林治疗腹肠易激综合征的临床研究

Clinical trial of Jiebai capsule in combination with amitriptyline in the treatment of diarrhea type irritable bowel syndrome

目的观察洁白胶囊(抗胃肠功能紊乱药)联合阿米替林治疗腹泻型肠易激综合征(D—IBS)的疗效。方法 143例D—IBS患者随机分成3组, 常规治疗组(48例):每次口服洁白胶囊0．8 g,每天3次;联合治疗组(49 例):常规治疗外,睡前加用阿米替林,第1周,每天12．5 mg;第2—4周,每天 25 mg;对照组(46例):服用淀粉片每次1片,每天3次,饭后服用。4周为一疗程。结果治疗1,2,4周后,常规治疗组有效率分别为60．4％,73．9％, 77．8％;联合治疗组分别为65．3％,82．6％,93．2％,均明显高于安慰剂组(P <0．01);而联合组明显高于常规组(P<0．05)。结论洁白胶囊对D—IBS 有较好疗效,阿米替林能明显增加洁白胶囊的治疗效果,且病人耐受性较好。

Objective To study the efficacy of Jiebai capsule in combination with amitriptylineon in the treatment of the diarrhea type irritable bowel syndrome （ D - IBS ）. Methods One hundred and forty - three patients with D - IBS were divided into three groups randomly. It included formal treatmen group （ 48 patients） , combinating treatment group （ 49 patients） and control group （46 patients）. In the formal group , the patients took Jiebai capsule 0.8 gram every time , three times daily. In combimation group , the administration of Jiebai capsule was the same as formal group , amitriptyline was taken before going to bed （in the first week, 12.5 mg daily;from the second to the fourth week, 25 mg daily）. In control group , the patients took starch one tablet every time, three times daily. The treating period was four weeks. The effective rate and side effect were observed after these patients were treated at the first week, the second week and the fourth week. Results After these patients were treated at the first week, the second week and the fourth week, the effective rate in formal group was 60.4% ,73.9% and 77.8%, respectively. The effective rate in combination group was 65.3%, 82.6% and 93.2 %, respectively. The effective rate in the two groups were both higher than that in control group （ P 〈 0.01 ）. The effective rate at the fourth week in combination group was significantly higer than that at the first week in combination group and at the fourth week in formal group. The side effect rate in combination group was higher than that in formal group and control group. The side effect presented to be sleepy, dizziness, dry mouth and so on. Conclusion Jiebai capsule combination amitriptyline had good efficacy and tolerability in the treatment of D -IBS.