米曲菌胰酶片治疗消化不良症状的多中心、随机、安慰剂交叉对照临床研究

背景：米曲菌胰酶片是含有米曲菌酶和胰酶的口服双层包膜复合消化酶制剂，在国外用于治疗消化不良已有数十年．然而目前国内尚无米曲菌胰酶片治疗消化不良症状疗效和安全性的资料。目的：评价米曲菌胰酶片对中国人群消化不良症状的疗效和安全性。方法：采用多中心、随机、安慰剂交叉对照试验设计，在上海地区7个临床中心，对有消化不良症状的门诊患者先予安慰剂治疗1周，症状积分改善〈50％者中共有151例[男76例，女75例，年龄22～67岁，平均（44．67±6．46）岁]完成疗效观察研究，79例随机进入流程A（予米曲菌胰酶片2片tid，餐后立即服用，治疗2周；1周药物清洗期；再予安慰剂2片tid，餐后立即服用，治疗2周），72例进人流程B（予安慰剂2片tid，餐后立即服用，治疗2周；1周药物清洗期；再予米曲菌胰酶片2片tid，餐后立即服用，治疗2周）。分别于研究流程的第1、8、22、29和43d评估消化不良症状积分。结果：经米曲菌胰酶片治疗2周，患者消化不良症状总积分下降幅度与安慰剂相比差异有统计学意义（从27．64±1．77降至9．72±1．33对从23．99±1．28降至22．03±1．40，P〈0．01）。根据症状积分改善幅度．米曲菌胰酶片改善消化不良症状的效果依次为腹胀、腹泻、嗳气、腹痛、食欲不振和上腹部烧灼感。米曲菌胰酶片治疗消化不良症状的总有效率显著优于安慰剂（89．6％对21．7％，P〈0．01）。研究过程中无与研究药物相关的不良反应发生。结论：米曲菌胰酶片用于治疗中国人群的消化不良症状安全、有效。

Efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients with Dyspepsia:a Multi-center,Randomized,Placebo-controlled Cross-over Study

Background： Combizym, an agent of double-deck pellet containing Oryz-Aspergillus enzyme and panereatin, has been used in patients with dyspepsia for decades in Western countries. However, there is not yet any data of the efficacy and safety of this agent in China. Aims： To evaluate the efficacy and safety of Combizym in Chinese patients with dyspepsia. Methods： A multi-center, randomized, placebo-controlled cross-over trial was carried out. A total of 151 patients （76 male and 75 female, aged 44.67±6.46 years, range： 22-67 years） with dyspepsia whose symptoms could not be relieved by placebo, were recruited ：from seven clinical centers in Shanghai. These patients were divided randomly into group A （79 cases, 2 weeks on Combizym, 2 pellets post-meal, tid; then 1 week wash-out period; and finally, 2 weeks on placebo, 2 pellets post-meal, tid） and group B （72 cases, 2 weeks on placebo, 2 pellets post-meal, tid; then 1 week washout period; and finally, 2 weeks on Combizym, 2 pellets post-meal, tid）. Score of dyspeptic symptoms were assessed at day 1, 8, 22, 29, 43, respectively of the trial. Results： Compared with placebo, 2 weeks on Combizym decreased significantly the total score of dyspeptic symptoms （27.64±1.77 to 9.72±1.33 vs. 23.99±1.28 to 22.03±1.40, P〈0.01）. According to the magnitude of improvement of symptom score, the individual dyspeptic symptoms that could be attenuated by Combizym were in the order of abdominal distension, diarrhea, belching, abdominal pain, loss of appetite, and epigastric burning sensation. The overall efficacy rate of Combizym on dyspeptic symptoms was superior to that of placebo （89.6% vs. 21.7%, P〈0.01）. None of these patients reported drug-related adverse effects during the study. Conclusions： Combizym is a safe and effective drug for the amelioration of dyspeptic symptoms in Chinese patients with dyspepsia.