二术解毒汤治疗乙型肝炎肝硬化伴高甲胎蛋白血症的随机、双盲、安慰剂对照研究  

Erzhu Jiedu Decoction in the treatment of hepatitis B cirrhosis with hyperalphafetoproteinemia:A randomized,double-blind and placebo-controlled trial study

作　　者：成扬[1,2] 陈天阳 何胜利[3] 陈建杰 薛建华[2] 奚骏 张银华 龚亚华 CHENG Yang;CHEN Tianyang;HE Shengli;CHEN Jianjie;XUE Jianhua;XI Jun;ZHANG Yinhua;GONG Yahua(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;Shanghai Pudong New Area Infectious Disease Hospital, Shanghai 201299, China;Minhang Branch of Tumor Hospital Affiliated to Fudan University, Shanghai 200240, China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]上海浦东新区传染病医院,上海201299 [3]复旦大学附属肿瘤医院闵行分院,上海200240

出　　处：《现代中西医结合杂志》2021年第21期2290-2294,共5页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：上海市科委项目(17401935000);上海市浦东新区卫计委“中医肝病”临床中医特色学科建设项目(PDZY-2018-0607);上海市浦东新区名中医工作室建设项目(PWRzm2020-14)。

摘　　要：目的观察二术解毒汤治疗乙型肝炎肝硬化伴高甲胎蛋白血症患者的临床疗效及安全性。方法选择2017年7月1日—2019年3月30日在上海中医药大学附属曙光医院、上海浦东新区传染病医院及复旦大学附属肿瘤医院闵行分院治疗的乙型肝炎肝硬化伴高甲胎蛋白血症患者72例,采用随机数字表法将患者随机分为治疗组及对照组各36例。对照组予以二术解毒汤颗粒安慰剂口服,治疗组予以二术解毒汤颗粒剂口服,均每日1剂,2组疗程均为12个月,治疗结束随访6个月。比较2组治疗12个月后疗效,观察2组治疗前及治疗12个月后血清甲胎蛋白(AFP)、甲胎蛋白异质体(AFP-L3)、肝功能指标[丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBil)、谷氨酰转肽酶(GGT)、白蛋白(ALB)]及肝纤维化指标[透明质酸(HA)、层黏连蛋白(LN)、Ⅲ型胶原前肽(PC-III)、Ⅳ型胶原(Ⅳ-C)]变化情况,统计在治疗及随访过程中2组肝癌及肝硬化并发症发生情况。结果最终治疗组32例、对照组30例完成试验,治疗组总有效率为81.3%(26/32),对照组总有效率为40.0%(12/30),治疗组总有效率明显高于对照组(P<0.05)。治疗后,治疗组血清AFP、AFP-L3、ALT、AST、GGT、TBil、HA、LN、Ⅳ-C、PC-Ⅲ水平均明显低于治疗前及对照组(P均<0.05),ALB水平均明显高于治疗前及对照组(P均<0.05);对照组上述指标虽有一定改善,但与治疗前比较差异均无统计学意义(P均>0.05)。至6个月随访结束时,治疗组24例、对照组20例完成6个月随访,治疗组均未发现肝脏占位性病变,对照组2例发生肝脏占位性病变并病理确诊为肝细胞癌;治疗组总的并发症发生率为4.2%(1/24),明显低于对照组的35.0%(7/20),差异有统计学意义(P<0.05)。结论二术解毒汤可显著抑制乙型肝炎肝硬化伴高甲胎蛋白血症患者病情进展,改善患者预后,具有良好的安全性。Objective It is to observe the clinical efficacy and safety of Erzhu Jiedu Decoction in treating patients with hepatitis B cirrhosis and hyperalphafetoproteinemia.Methods A total of 72 patients with hepatitis B cirrhosis associated with hyperalphafetoproteinemia treated in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai Pudong New Area Infectious Disease Hospital,Minhang Branch of Tumor Hospital Affiliated to Fudan University from July 1,2017-March 30,2019 were divided a the treatment group and a control group by a random number method,with 36 cases in each group.The control group was given Erzhu Jiedu Decoction granule placebo,one dose per day,and the treatment group was given Erzhu Jiedu Decoction granule,one dose per day.Both groups were treated for 12 months and followed up for 6 months after treatment.The efficacy after 12 months of treatment were compared between the two groups,the changes in the levels of serum alpha-fetoprotein(AFP),alpha-fetoprotein heterosomes(AFP-L3),liver function indicators[alanine aminotransferase(ALT),radonine aminotransferase(AST),total bilirubin(TBil),glutamyl transpeptidase(GGT),albumin(ALB)]and liver fibrosis indicators[hyaluronic acid(HA),laminin(LN),typeⅢcollagen propeptide(PC-Ⅲ),typeⅣcollagen(Ⅳ-C)]before treatment and after treatment for 12 months were observed in the two groups,and the incidence of liver cancer and cirrhosis complications in the two groups were calculated during the treatment and follow-up.Results There were 62 patients who finally completed the experiment,including 32 patients in the treatment group and 30 patients in the control group.The effective rate of the treatment group was 81.3%(26/32),while the effective rate of the control group was 40%(12/30),the effective rate of the treatment group was significantly higher than that of the control group(P<0.05).After treatment,the serum levels of AFP,AFP-L3,ALT,AST,GGT,TBil,HA,LN,Ⅳ-C,and PC-Ⅲin the treatment group were significantly lower than those befo

关 键 词：二术解毒汤 乙型肝炎肝硬化 高甲胎蛋白血症 预后 

分 类 号：R512.62[医药卫生—内科学]