口服五灵胶囊治疗代谢相关脂肪性肝病的疗效及安全性研究

Study on the efficacy and safety of oral administration of Wuling Capsules in patients with metabolic dysfunction-associated fatty liver disease

目的 探究口服五灵胶囊对代谢相关脂肪性肝病(metabolic dysfunction-associated fatty liver disease,MAFLD)患者的疗效和安全性。方法 纳入2020年1月至2023年1月治疗的220例MAFLD患者作为研究对象,用随机数字表法分为对照组和试验组,每组110例。2组均接受饮食干预及有氧运动,在此基础上,对照组口服护肝片,试验组口服五灵胶囊,观察2组患者的治疗效果及治疗期间不良反应的发生情况;统计、分析2组治疗前后临床症状、肝功能、受控衰减参数(controlled attenuation parameter,CAP)、体质量指数(body mass index,BMI)的变化情况。结果 治疗后,试验组的总有效率高于对照组(87.27%vs. 73.64%,P<0.05),临床症状(胁肋胀痛、纳呆乏力、腹胀嗳气)改善显著优于对照组(P<0.05)。治疗后,2组CAP、丙氨酸氨基转移酶(alanine aminotransferase,ALT)、天冬氨酸氨基转移酶(aspartate aminotransferase,AST)水平均降低(P<0.05),且试验组降低的幅度均大于对照组(P<0.05)。治疗后,试验组BMI的降低幅度大于对照组(P<0.05)。2组治疗期间所有患者生命体征良好,出现的不良反应均为一般不良事件,患者均可耐受且不影响继续治疗,2组不良反应发生率比较差异无统计学意义(P>0.05)。结论 五灵胶囊可以明显改善MAFLD患者的临床症状及肝功能指标,并且能够降低患者CAP和BMI,且安全性高,治疗效果显著。

Objective To explore the efficacy and safety of oral administration of Wuling Capsules in patients with metabolic dysfunction-associated fatty liver disease(MAFLD).Methods A total of 220 patients with MAFLD treated from January 2020 to January 2023 were included and divided into control group(110 cases)and experimental group(110 cases)by random number table method.The both groups received dietary intervention and aerobic exercise.On this basis,the control group took Hugan Tablets orally,while the experimental group took Wuling Capsules orally.The therapeutic effects and the occurrence of adverse reactions during the treatment were observed in the 2 groups.The changes of clinical symptoms,liver function,controlled attenuation parameters(CAP)and body mass index(BMI)before and after treatment in the 2 groups were statistically analyzed.Results After treatment,the total effective rate of the experimental group was higher than that of the control group(87.27%vs.73.64%,P<0.05),and the improvement of clinical symptoms(swelling and pain in the ribs,poor appetite,fatigue,abdominal distension and belching)was significantly better than that of the control group(P<0.05).After treatment,the CAP,alanine aminotransferase(ALT),and aspartate aminotransferase(AST)liver function indexes in both groups decreased(P<0.05),and the decrease in the experimental group was greater than that in the control group(P<0.05).After treatment,the decrease in BMI in the experimental group was greater than that in the control group(P<0.05).During the treatment,all patients in the 2 groups had good vital signs,and the adverse reactions were all general adverse events.All patients could tolerate and continue the treatment,and there was no significant difference in the incidence of adverse reactions(P>0.05).Conclusion Wuling Capsules can significantly improve the clinical symptoms and liver function indicators of patients with MAFLD,and can reduce the CAP and body quality index of patients,with high safety and significant therapeutic effect.