清热化湿方治疗慢性乙型肝炎及非酒精性脂肪性肝病湿热证的多中心随机双盲安慰剂对照试验  

The Effect of Qingre Huashi Formula (清热化湿方) on Chronic Hepatitis B or Nonalcoholic Fatty Liver Disease with Damp-heat Syndrome: a Multicenter Randomized Double-blind Placebo-controlled Trial

作　　者：赵超群[1,2] 蔡虹 陈高峰[1,2] 陈龙[2] 朱会明 王成宝 周亮[6] 张如棉[3] 陈建杰 张华[1,3] ZHAO Chaoqun;CAI Hong;CHEN Gaofeng;CHEN Long;ZHU Huiming;WANG Chengbao;ZHOU Liang;ZHANG Rumian;CHEN Jianjie;ZHANG Hua(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,201203;Institute of Liver Diseases,Shanghai University of Traditional Chinese Medicine;Xiamen Hospital,Beijing University of Traditional Chinese Medicine;The Fifth Peopled Hospital of Suzhou City,Jiangsu;Linyi People's Hospital,Shandong;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine)

机构地区：[1]上海中医药大学附属曙光医院,上海市201203 [2]上海中医药大学肝病研究所 [3]北京中医药大学附属厦门医院 [4]江苏省苏州市第五人民医院 [5]山东省临沂市人民医院 [6]上海中医药大学附属岳阳中西医结合医院

出　　处：《中医杂志》2022年第8期745-753,共9页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81673849);国家科技重大专项(2017ZX09304002)。

摘　　要：目的 观察清热化湿方对慢性乙型肝炎(CHB)及非酒精性脂肪性肝病(NAFLD)两种不同疾病相同证候(湿热证)患者的治疗效果。方法 采用多中心、双盲、随机对照临床试验,共纳入144例湿热证患者中CHB、NAFLD患者各72例,再将患者随机分为治疗组及对照组,每组每种疾病患者各36例。治疗组予清热化湿方颗粒剂口服,对照组予清热化湿方安慰剂颗粒剂口服,两组均每日1剂,每日2次,疗程4周。治疗前后比较两组患者中医证候积分、肝功能[包括总胆红素(TBiL)、直接胆红素(DBiL)、间接胆红素(IBiL)、丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)、γ谷氨酰转肽酶(γ-GT)]、血脂[包括总胆固醇(TC)、甘油三酯(TG)]、尿酸(UA)、空腹血糖(FPG)、体重指数(BMI)的变化,并判定中医证候疗效及安全性。再进一步分析同一疾病下两组患者上述指标变化情况及中医证候疗效。结果 最终纳入统计分析127例患者,其中治疗组64例(NAFLD患者34例,CHB患者30例),对照组63例(NAFLD患者33例,CHB患者30例)。所有患者中治疗组中医证候疗效总有效率为84.4%,高于对照组的39.7%;CHB患者中治疗组总有效率为83.3%,高于对照组的40.0%;NAFLD患者中治疗组总有效率为85.3%,高于对照组的39.4%,差异均具有统计学意义(P<0.05)。所有患者中治疗组可明显改善小便短赤、口苦、乏力、舌苔评分与中医证候总积分(P<0.05),且能明显降低TBiL、IBiL、ALT、ALP及BMI水平(P<0.05)。CHB患者治疗组在改善小便短赤、口苦、乏力、舌苔评分和中医证候总积分以及BMI方面明显优于对照组(P<0.05)。NAFLD患者治疗组在改善小便短赤、口苦、大便不爽、舌苔评分及中医证候总积分方面明显优于对照组,并能显著降低ALP及BMI水平(P<0.05)。各组治疗前后血常规及肾功能安全性指标差异均无统计学意义(P>0.05)。结论 清热化湿方可有效改善CHB及NAFLDObjective hepatitis B(CHB)or nonalcoholic fatty liver disease(NAFLD)of the same syndrome(damp-heat syndrome).Methods In a multi-center double-blind randomized controlled trial(RCT),patients with CHB or NAFLD of dampheat syndrome were randomly divided into treatment group and control group,with 36 CHB and 36 NAFLD patients in each group.The treatment group was given Qingre Huashi Formula,and the control group was given placebo,one dose daily by two times,for 4 weeks.The changes of traditional Chinese medicine(TCM)symptom score,liver function indicators including total bilirubin(TBiL),direct bilirubin(DBiL),indirect bilirubin(IBiL),alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),andγ-glutamyl transpeptidase(γ-GT),blood lipid indicators including total cholesterol(TC)and triglycerides(TG),uric acid(UA),fasting blood glucose(FPG),and body mass index(BMI)were assessed,and the effect on TCM symptoms and the safety were evaluated and compared between groups.Results analysis,with 34 NAFLD and 30 CHB in the treatment group and 33 NAFLD and 30 CHB in the control group.The effective rate of TCM syndrome score in the treatment group was 84.4%,significantly higher than 39.7%in the control group;and similar trend was found in CHB(83.3%versus 40.0%)and NAFLD subgroup(85.3%versus39.4%)with significant differences(P<0.05).The treatment group significantly improved the scores of short and dark urine,bitter taste,fatigue and tongue coating,and the total symptom score(P<0.05),and significantly reduced the level of TBiL,IBiL,ALT,ALP,and BMI(P<0.05).In the subgroup of CHB patients,the treatment group was significantly better than the control group in improving the symptoms of short dark urine,bitter taste,fatigue,tongue coating,and the total symptom score,and reducing BMI(P<0.05).In the subgroup of NAFLD patients,the treatment group was significantly better than the control group in improving symptoms of short dark urine,bitter taste,incomplete defecation,tongue coating and the total symptom s

关 键 词：慢性乙型肝炎 非酒精性脂肪性肝病 湿热证 清热化湿方 异病同治 

分 类 号：R259[医药卫生—中西医结合]