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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 curative effect and safety of Aspergillus oryzae trypsin in the treatment of liver cirrhosis with dyspepsia. Methods A prospective, randomized, controlled clinical trial was performed to diagnose cirrhosis with symptoms of upper abdominal pain, upper abdominal burning, postprandial fullness, early fullness, nausea, vomiting, loss of appetite and belching. Two or more patients included in this study, aged 18 to 70 years, gender is not limited. Exclusion criteria: ALT or AST> 200 U / L; T-BIL> 100 μmol / L; liver failure; massive ascites or abdominal infection; gastrointestinal tract organic pathology; gastrointestinal bleeding and hepatic encephalopathy more than third; other serious Comorbidity. The patients were randomly divided into two groups, the control group using conventional treatment (rest, liver protection drugs, complications of treatment), the treatment group on the basis of conventional treatment plus aspergillosis trypsin tablets (3 times a day, 2 times, swallow food or after meals, treatment for 2 weeks). Week 1 and week 2 of treatment were evaluated for improvement of indigestion symptom scores and safety was evaluated. Results A total of 166 patients with cirrhosis were enrolled in this study. There were 124 males and 42 females, ranging in age from 31 to 70 years, with an average of (54.9 ± 8.9) years. Randomly divided into control group of 82 cases, 84 cases of treatment group, the baseline data is comparable. The first week of treatment, the total score of dyspepsia in both groups decreased, and the treatment group (8.8 ± 2.4) points lower than the control group (9.6 ± 2.8), but the difference was not statistically significant (P = 0.064). After 2 weeks of treatment, the total score of dyspepsia symptoms in the two groups was further decreased. [(5.4 ± 2.1) points] in the treatment group was significantly lower than that in the control group [(8.8 ± 2.6) points, P <0.001]. Evaluation of the efficacy of the symptoms of dyspepsia found that treatment for 2 weeks, the treatment group of upper abdominal pain, upper abdominal burning sensation, postprandial fullness, fullness, nausea, vomiting, loss of appetite and belching symptoms were significantly higher than the efficiency The control group, in addition to vomiting, the effective rate was 61.1% ~ 95.2%, the upper abdomen burning sensation and belching the effective rate of up to 90.0%. No adverse drug reactions were observed. Conclusion Aspergillus microtitre is effective in treating cirrhosis with dyspeptic symptoms and has good safety.