大黄䗪虫丸治疗非酒精性脂肪性肝炎痰瘀互结证的临床疗效与安全性OA北大核心CHSSCDCSTPCD
Clinical Efficacy and Safety of Dahuang Zhechong Pills in the Treatment of Non-alcoholic Steatohepatitis with Syndrome of Intermingled Phlegm and Blood Stasis
目的:观察大黄䗪虫丸治疗非酒精性脂肪性肝炎(NASH)痰瘀互结证的临床疗效与安全性.方法:选取2020年5月11日至2022年1月20日四川大学华西医院收治的NASH患者,均辨证为痰瘀互结证的患者216例作为研究对象,采用区组随机化方法分为对照组和观察组,每组108例,观察组脱失10例,对照组脱失9例.对照组接受健康宣教,根据病情给予降压、降糖、调脂、保肝降酶等标准化基础治疗;观察组在对照组治疗方法基础上,联用大黄䗪虫丸.治疗前及治疗后(治疗1年)对比2组肝活检缓解率、肝纤维化扫描仪(FibroScan)测定的肝纤维化评级缓解率、中医证候积分、体质量指数及肝功能指标[血清谷丙转氨酶(GPT)、血清总胆红素(TB)、血清谷草转氨酶(GOT)]、血脂指标[总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)]、临床疗效及安全性.结果:观察组患者肝活检缓解率高于对照组(x2=14.512,P=0.002),肝纤维化评级改善率高于对照组(x2=15.550,P=0.001).观察组临床中医证候总有效率高于对照组(X2=21.438,P＜0.05).治疗后,2组患者体质量指数及肝功能、血脂指标均较治疗前改善(P＜0.05);治疗后,2组体质量指数及血脂指标比较差异无统计学意义(P＞0.05),观察组肝功能指标(GPT、GOT、TB)低于对照组(P＜0.05).共发生不良事件37例次,均为轻微不良反应,未经处理或对症治疗后缓解,2组不良事件发生率比较差异无统计学意义(P＞0.05).结论:大黄䗪虫丸可改善NASH痰瘀互结证患者的肝纤维化、中医证候与肝功能,安全性良好.
Objective:To observe the clinical efficacy and safety of Dahuang Zhechong Pills in treating non-alcoholic steatohepati-tis(NASH)with a syndrome of intermingled phlegm and blood stasis.Methods:A total of 216 NASH patients with a syndrome of intermingled phlegm and blood stasis admitted to West China Hospital of Sichuan University between May 11,2020,and January 20,2022 were enrolled and randomly divided into a control group and an observation group by block randomization,with 108 pa-tients in each group.After accounting for dropouts(10 in the observation group and 9 in the control group),the control group re-ceived health education and standard treatments including antihypertensives,antidiabetics,lipid regulators,and liver enzyme reduc-ers according to conditions.The observation group received the same treatments with the addition of Dahuang Zhechong Pills.Out-comes were assessed before and after one year of treatment,including liver biopsy resolution rate,liver fibrosis improvement as measured by FibroScan,traditional Chinese medicine(TCM)syndrome scores,body mass index(BMI),liver function indicators[serum alanine aminotransferase(ALT),total bilirubin(TB),serum aspartate aminotransferase(AST)],lipid indicators[total cho-lesterol(TC),high-density lipoprotein cholesterol(HDL-C),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C)],clin-ical efficacy,and safety.Results:The observation group showed higher liver biopsy resolution rates(x2=14.512,P=0.002)and liver fibrosis improvement rates(x2=15.550,P=0.001)than the control group.The total efficacy rate of TCM syndrome relief was also higher in the observation group than in the control group(x2=21.438,P＜0.05).After treatment,both groups showed im-provements in BMI,liver function,and lipid profiles(P＜0.05),with no significant differences in BMI and lipid profiles between groups(P＞0.05).However,the observation group had lower liver function indicators(ALT,AST,TB)than the control group(P＜0.05).A total of 37 mild adverse events occurred,which resolved with or without symptomatic treatment,with no significant differ-ence in adverse event rates between the groups(P＞0.05).Conclusion:Dahuang Zhechong Pills can improve liver fibrosis,TCM syndrome,and liver function in NASH patients with intermingled phlegm and blood stasis syndrome,with good safety.
刘晓隽;费小凡;贺雷;朱林
四川大学华西医院,成都,610041中国人口福利基金会,北京,100081
中医学
大黄廑虫丸非酒精性脂肪性肝炎痰瘀互结证肝纤维化瞬时弹性成像技术随机对照研究临床疗效安全性
Dahuang Zhechong PillsNon-alcoholic steatohepatitisSyndrome of intermingled phlegm and blood stasisLiver fi-brosisInstantaneous elastographyRandomized controlled studyClinical efficacySafety
《世界中医药》 2024 (015)
2323-2328 / 6
国家自然科学基金项目(82060707)
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