米曲菌胰酶片治疗肝硬化伴消化不良的随机对照研究

Efficacy of oryz-aspergillus enzyme and pancreatin in cirrhotic patients with dyspepsia:a randomized,controlled study

目的评价米曲菌胰酶片治疗肝硬化伴消化不良的疗效和安全性。方法采用前瞻性、随机对照的临床研究方案,将临床诊断为肝硬化并伴有上腹痛、上腹灼烧感、餐后饱胀、早饱、恶心、呕吐、食欲不振及嗳气等消化不良症状两项及以上的患者纳入本研究,年龄18~70岁,性别不限。排除标准:ALT或AST>200 U/L;T-BIL>100μmol/L;肝衰竭;大量腹水或腹腔感染;胃肠道器质性病变;消化道出血及肝性脑病Ⅲ期以上;其他严重合并症。将纳入患者随机分为两组,对照组采用常规治疗(休息、保肝药物、并发症的治疗),治疗组在常规治疗的基础上加用米曲菌胰酶片(每日3次,每次2片,饭中或饭后吞服,疗程2周)。在治疗第1周和第2周评估消化不良症状积分的改善情况并评价其安全性。结果 166例肝硬化患者纳入本研究,男124例,女42例;年龄31~70岁,平均(54.9±8.9)岁。随机分为对照组82例,治疗组84例,基线资料具有可比性。治疗第1周,两组的消化不良症状总积分均有所下降,且治疗组[(8.8±2.4)分]低于对照组[(9.6±2.8)分],但差异无统计学意义(P=0.064);治疗2周,两组消化不良症状总积分进一步降低,治疗组[(5.4±2.1)分]显著低于对照组[(8.8±2.6)分,P<0.001]。对消化不良各症状进行疗效评价发现,治疗2周,治疗组的上腹痛、上腹灼烧感、餐后饱胀、早饱、恶心、呕吐、食欲不振及嗳气症状的有效率均显著高于对照组,除呕吐外,有效率为61.1%~95.2%,对上腹灼烧感和嗳气的有效率可达90.0%以上。未观察到与治疗药物相关的不良反应。结论米曲菌胰酶片治疗肝硬化伴消化不良症状有较好的疗效,且安全性良好。

Objective To evaluate the efficacy and safety of combizym in cirrhotic patients with dyspepsia. Methods This is a prospective, randomized, controlled clinical study. The cirrhotic patients with two or more following symp- toms： upper abdominal pain, epigastria burning sensation, postprandial fullness, early satiety, nausea, vomiting, loss of ap- petite, belching were enrolled. The range of age was 18 to 70 years old and either gender were included. The exclusion cri- teria included ALT or AST〉200 U/L,T-BIL〉100 ~tmol/L; liver failure; massive ascites or abdominal infection; gastrointes- tinal disease; gastrointestinal bleeding and hepatic encephalopathy III stage or more; and other serious complications. Pa- tients were randomly divided into two groups, the control group with regular treatment （rest, liver protective medicine, complication treatment）, the treatment group were treated with combizym tablet（2 tablets tid, with a meal or post meal, for 2 weeks） on the basis of regular treatment. The score of dyspeptic symptoms and the safety were assessed respectively at week 1 and week 2 of the trial. Results A total of 166 cirrhotic patients with dyspepsia were enrolled in the study, 124 were males and 42 were females, and the average age was （54.9±8.9）years old. Patients were randomly divided into the control group （n=82） and the treatment group （n=84）. The baseline data were compared. After 1 week of treatment, the to- tal score of dyspeptic symptoms in both groups declined, and the score in the treatment group （8.8-4-2.4） was lower than that in the control group （9.6±2.8）, but the difference was not statistically significant （P = 0.064）. After 2 weeks, the scores in both groups further reduced, and the score in the treatment group （5.4±2.1） was significantly lower than that in the con- trol group （8.8±2.6） （P 〈 0.001）. Moreover, the efficacy of combizym on abdominal pain, burning sensation in the upperabdomen, postprandial fullness, early satiety, nausea, vomiting, loss of appetite and belching symptoms was significantly better in the treatment group than that in the control group with the effective rates of 61.1%-95.2% except the symptom of vomiting. There was no treatment-related adverse drug reactions during the study. Conclusion Combizym is effective and safe in the treatment of cirrhotic patients with dyspeptic symptoms.