Objective: To evaluate the efficacy and safety of Oryz-Aspergillus enzyme and pancreatin tablets (Combizym(®)) in the treatment of postprandial distress syndrome (PDS) in the elderly, compared with gastrointestinal motility drugs. Methods: A prospective randomized controlled trial was designed and registered in the China Clinical Trials Registry (ChiCTR-IPR-16008185). The elderly patients with PDS were randomly divided into three groups, including Mosapride group with Mosapride citrate tablets 5 mg 3 times per day for 2 weeks; Combizym(®) group with Combizym tablets 244 mg 3 times per day for 2 weeks; combined treatment group with both drugs and same doses for 2 weeks. The modified Nepean dyspepsia index (NDSI) score, discomfort intensity score and PDS score were calculated on patients before treatment, at the end of first and second week of treatment, as well as 4 weeks after treatment finished, respectively. Adverse effects were evaluated. Results: A total of 323 patients from 16 tertiary hospitals in China were enrolled in this study. Among them, 105 patients were in Mosapride group, 109 in Combizym(®) group and 109 in combined treatment group. There were 148 males (45.8%) and 175 females (54.2%) with median age 71.4±9.0 years (60-100 years). Baseline characteristics of three groups were comparable. After treatment, the NDSI scores in three groups all decreased significantly (P<0.001), while they were similar between groups (P>0.05). The discomfort intensity score and PDS score in three groups showed a significant reduction after treatment (P<0.001), especially in the combined treatment group. Compared with Mosapride group, the scores in Combizym(®) group decreased significantly after one or two weeks [discomfort intensity score: after one week, 4.0(2.5, 8.0) vs. 6.0(3.0, 10.0); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 6.0); all P<0.05. PDS score: after one week, 6.0(3.0, 9.0) vs. 7.0(3.5, 10.5); after two weeks, 3.0(0.0, 5.0) vs. 4.0(2.0, 7.0); all P<0.05]. The efficacy rate in all patients after first week of treatment was over 15.0%. The efficacy rates after two weeks were 55.2%, 68.8% and 73.4% in Mosapride group, Combizym(®) group and combined treatment group, respectively. After two week treatment, the efficacy rates in Combizym(®) group (P=0.041) and combined group (P=0.006) were higher than that of Mosapride group. The recurrence rate of Mosapride group was 9.5%, which was significantly higher than that of Combizym(®) group (1.8%, P<0.05) and combined treatment group (1.8%, P<0.05). There were no serious adverse effects in the three groups. Conclusions: The efficacy of Oryz-Aspergillus enzyme and pancreatin tablets is comparable with that of Mosapride in elderly PDS patients, with fewer adverse effects and low recurrence rate. Combination regimen indicates better efficacy than that of Oryz-Aspergillus enzyme and pancreatin tablets or Mosapride alone.
目的： 评估米曲菌胰酶片治疗老年人餐后不适综合征（PDS）的有效性和安全性，及其与促胃肠动力药物的疗效差异。 方法： 采用前瞻性随机对照试验设计。将老年PDS患者用随机数表法抽样分为3组，莫沙必利组采用枸橼酸莫沙必利片治疗（5 mg/次，3次/d，餐前服用，疗程2周），米曲菌胰酶片组采用米曲菌胰酶片治疗（244 mg/次，3次/d，餐中或餐后服用，疗程2周），联合治疗组采用枸橼酸莫沙必利片和米曲菌胰酶片治疗（用法用量同前，疗程2周）。采用改良的尼平消化不良指数（NDSI）评分标准，分别于治疗前和治疗1周、2周、停药4周后，对患者进行NDSI评分、不适强度评分和PDS评分，同时进行疗效分析和药物不良反应评估。 结果： 全国16家三级甲等医院参加本研究，共有323例患者入组，其中，莫沙必利组105例，米曲菌胰酶片组109例，联合治疗组109例。研究对象中，男148例（45.8%），女175例（54.2%），年龄60~100（71.4±9.0）岁；3组的基线特征无差异。治疗后，3组的NDSI评分均明显下降（P<0.001）；不论是米曲菌胰酶片组还是联合治疗组，治疗1周、2周的NDSI评分与莫沙必利组相比差异均无统计学意义（P>0.05）。3组的不适强度评分和PDS评分在治疗后均下降（P<0.001），其中联合治疗组的评分下降最明显；米曲菌胰酶片组第1周和第2周的不适强度评分和PDS评分均低于莫沙必利组[不适强度评分：第1周，4.0（2.8，8.0）分比6.0（3.0，10.0）分；第2周，3.0（0.0，5.0）分比4.0（2.0，6.0）分；P值均<0.05。PDS评分：第1周，6.0（3.0，9.0）分比7.0（3.5，10.5）分；第2周，3.0（0.0，5.0）分比4.0（2.0，7.0）分；P值均<0.05]。莫沙必利组、米曲菌胰酶片组和联合治疗组在治疗1周时的总有效率均超过15.0%，治疗2周时总有效率分别为55.2%、68.8%和73.4%，其中米曲菌胰酶片组和联合治疗组的2周总有效率均高于莫沙必利组（P=0.041和P=0.006）。停药后，莫沙必利组的复发率最高（9.5%），显著高于米曲菌胰酶片组（1.8%，P<0.05）和联合治疗组（1.8%，P<0.05）。3组均未见严重不良反应。 结论： 米曲菌胰酶片可以安全、有效改善老年人PDS症状，其治疗老年人PDS的效果与莫沙必利相近，且不良反应少，复发率低。米曲菌胰酶片联合莫沙必利治疗老年人PDS的效果优于单用一种药物。.
Keywords: Aged; Dyspepsia; Mosapride; Oryz-Aspergillus enzyme and pancreatin tablet; Postprandial discomfort syndrome.