目的：观察复方消化酶胶囊治疗消化不良的疗效及安全性。方法：154 例消化不良患者按随机数字表法分为观察组和对

照组，各77 例。对照组患者行常规治疗，给予多酶片600 mg，tid，餐后30 min服用；观察组患者在常规治疗基础上加用复方消化酶

胶囊600 mg，tid，餐后30 min服用。两组患者均治疗2 周。观察两组患者治疗后消化不良症状改善情况、临床疗效、临床症状评分

及改善时间、不良反应。结果：观察组患者临床治疗总有效率（89.61％）明显高于对照组（74.03％），差异有统计学意义（P＜0.05）；

治疗后，观察组患者腹胀、早饱、嗳气、上腹不适、中上腹痛、上腹烧灼、恶心、呕吐等临床消化不良症状改善情况明显优于对照组，

临床症状评分和改善时间明显低于或短于对照组，差异均有统计学意义（P＜0.05）；观察组患者不良反应发生率（3.90％）与对照组

（5.19％）比较，差异无统计学意义（P＞0.05）。结论：复方消化酶胶囊治疗消化不良的疗效较好，不良反应少。

OBJECTIVE：To observe therapeutic efficacy and safety of Compound digestive enzyme capsule in the treatment of

dyspepsia. METHODS：154 patients with dyspepsia were selected and randomly divided into observation group and control group，

with 77 patients in each group. Control group received routine treatment，Polyzyme tablet 600 mg，tid，30 min after meal；observation

group was additionally given Compound digestive enzyme capsule 600 mg，tid，30 min after meal. Treatment course of 2

groups lasted for 2 weeks. The improvement of dyspepsia，clinical efficacy，clinical manifestation score，improvement duration and

ADR were observed in 2 groups after treatment. RESULTS：The total effective rate of observation group（89.61％）was significantly

higher than that of control group（74.03％），with statistical significance（P＜0.05）. After treatment，the improvement of abdominal

distension，early satiety，belching，epigastric discomfort，epigastrium pain，epigastric burning sensation，nausea，vomiting and

other clinical digestive symptoms in observation group were significantly better than control group，while clinical symptom score

and improvement duration were significantly lower or shorter then control group，with statistical significance（P＜0.05）. There was

no statistically significant difference in the incidence of ADR between observation group（3.90％）and control group（5.19％），

with statistical significance（P＞0.05）. CONCLUSIONS：Compound digestive enzymes capsule has good effect on dyspepsia with

less ADR.