探讨康彼申片治疗腹腔镜胆囊切除术后消化不良的疗效和安全性。

本前瞻性研究对象为2015年1月至2015年11月在浙江大学医学院附属邵逸夫医院行腹腔镜胆囊切除术后发生消化不良的92例患者。其中男44例，女48例；年龄18～75岁，中位年龄46岁。患者均签署知情同意书，符合医学伦理学规定。根据意愿用药不同将患者分为康彼申组（47例）和对照组（45例）。康彼申组服用康彼申片，对照组服用多酶片，疗程均为12周。比较两组患者治疗后消化不良症状积分变化及疗效，观察药物不良反应事件。两组积分比较采用t检验，率的比较采用χ²检验。

治疗后，康彼申组的上腹痛、上腹烧灼感、餐后饱胀、早饱各症状积分分别为（2.2±0.5）、（2.3±0.5）、（2.4±0.7）、（1.4±0.5）分，均明显低于对照组的（3.4±0.4）、（3.2±0.8）、（3.5±0.7）、（2.4±0.7）分（t=-12.680、-6.501、-7.535、-7.911；P<0.05）。经治疗12周后，康彼申组治愈11例、显效24例、有效9例，对照组分别为6、15、10例，康彼申组总有效率为94%（44/47），明显高于对照组的69%（31/45） （χ²=9.332，P<0.05）。两组患者治疗后均未发生药物不良反应事件。

康彼申片可明显改善腹腔镜胆囊切除术后消化不良症状，且安全性良好。

To investigate the curative effect and safety of combizym tablet in the treatment of dyspepsia after laparoscopic cholecystectomy (LC).

Ninety-two patients with dyspepsia after LC in Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University between January 2015 and November 2015 were enrolled in this prospective study. Among them, 44 were males and 48 were females, aged from 18 to 75 years old with a median age of 46 years old. The informed consents of all patients were obtained and the local ethical committee approval was received. According to the patients' will for drug use, the patients were divided into the combizym group (n=47) and the control group (n=45). The patients were orally treated with combizym tablets in the combizym group while they were treated with polyzyme tablets in the control group. The course of treatment in two groups was both 12 weeks. The integral changes of dyspepsia after treatment and the curative effect were compared between two groups, and adverse events of the drugs were observed. The integral between two groups was compared by t test and the ratio was compared by Chi-square test.

The integral scores of upper abdominal pain, upper abdominal burning sensation, postprandial fullness and early satiety after treatment in the combizym group were respectively 2.2±0.5, 2.3±0.5, 2.4±0.7 and 1.4±0.5, significantly lower than 3.4±0.4, 3.2±0.8, 3.5±0.7 and 2.4±0.7 in the control group (t=-12.680, -6.501, -7.535, -7.911; P<0.05). After 12-week treatment, 11 cases of cure, 24 of obvious effect and 9 of effectivity were observed in the combizym group, while respectively 6, 15, 10 in the control group. The total effective rate in the combizym group was 94%(44/47), significantly higher than 69%(31/45) in the control group (χ²=9.332, P<0.05). No adverse events of drugs were observed in two groups after treatment.

Combizym tablet can significantly improve the symptom of dyspepsia after LC, and the safety is good.