大黄䗪虫胶囊治疗代偿期乙型肝炎肝硬化瘀血阻络证伴脾大的真实世界回顾性队列研究

Dahuang Zhechong Capsules(大黄䗪虫胶囊)in the Treatment of Compensation Period Liver Cirrhosis after Hepatitis B of the Syndrome of Blood Stasis Blocking Collaterals with Splenomegaly:a Real-world Retrospective Cohort Study

目的观察大黄䗪虫胶囊治疗代偿期乙型肝炎肝硬化瘀血阻络证伴脾大患者的临床疗效。方法基于真实世界研究方法,采用回顾性队列研究,纳入2012年1月至2017年4月于上海中医药大学附属曙光医院就诊的代偿期乙型肝炎肝硬化瘀血阻络证伴脾大患者114例。根据纳入患者是否服用大黄䗪虫胶囊分为对照组(基础治疗包括抗病毒治疗和保肝治疗)61例和治疗组(以基础治疗联合大黄䗪虫胶囊口服)53例。比较两组患者治疗前及治疗1年后脾脏厚度及长度、中医证候积分、肝功能、血常规、肝纤维化指标、门冬氨酸氨基转移酶和血小板比率指数(APRI),判定治疗后临床疗效及安全性。结果治疗后治疗组患者脾脏厚度及长度均较治疗前明显缩小(P<0.05),且以脾脏厚度在50~69mm、脾脏长度在100mm以下患者脾脏缩小最明显(P<0.05)。治疗后治疗组患者中医证候积分明显下降,且较对照组明显降低(P<0.05)。与对照组治疗后比较,治疗组白细胞(WBC)、血红蛋白(Hb)、血小板(PLT)、APRI均明显升高(P<0.05)。治疗组临床疗效总有效率为69.81%,明显高于对照组的13.11%(P<0.05)。采用Logistic回归分析发现,年龄是发生肝硬化失代偿和(或)肝癌的相关危险因素。以是否服用大黄䗪虫胶囊作为暴露因素,分析暴露人群与非暴露人群是否发生肝硬化失代偿和(或)肝癌的相对危险度(RR)为0.35,95%可信区间为(0.12,1.01),表明暴露有益。两组患者均未见不良事件发生。结论大黄䗪虫胶囊具有显著缩小代偿期乙型肝炎肝硬化瘀血阻络证伴脾大患者脾脏,延缓肝硬化,并能改善患者血瘀证症状,临床疗效肯定,且安全性好。

Objective To observe clinical efficacy of Dahuang Zhechong Capsules(大黄䗪虫胶囊)in the treatment of patients with compensated hepatitis B cirrhosis of syndrome of static blood blocking collaterals with splenomegaly.Methods Based on real-world research methods,a retrospective cohort study was conducted to retrieve the patients with compensated hepatitis B cirrhosis and syndrome of static blood blocking collaterals with splenomegaly in Shuguang Hospital,Shanghai University of Traditional Chinese Medicine from January 2012 to April 2017.Finally,a total of 114 cases were enrolled,and were divided into 61 cases in the control group treated with basic treatment including antiviral therapy and liver protection treatment and 53 cases in the treatment group treated with basic treatment combined with Dahuang Zhechong Capsules orally according to whether oral administration of Dahuang Zhechong Capsules was used.The spleen thickness and length,TCM syndrome score,liver function,blood routine examination,liver fibrosis index,aspartate aminotransferase and platelet ratio index(APRI)of both groups of patients were compared before treatment and 1 year after treatment.And clinical efficacy and safety were evaluated.Results After treatment,the thickness and length of spleen of the patients in the treatment group were significantly shrank than those before treatment(P<0.05),and the spleen shrinkage was the most obvious in patients with spleen thickness of 50-69 mm and spleen length of less than 100 mm(P<0.05).After treatment,the TCM syndrome score of patients in the treatment group decreased significantly,and was significantly lower than that in the control group(P<0.05).Compared with the control group after treatment,white blood cells(WBC),hemoglobin(Hb),platelets(PLT),APRI were increased significantly in the treatment group(P<0.05).The total effective rate of clinical efficacy in the treatment group was 69.81%,which was significantly higher than the 13.11%in the control group(P<0.05).Logistic regression analysis showed that age was a related risk factor for decompensated liver cirrhosis and/or liver cancer.Taking Dahuang Zhechong Capsules as the exposure factor,the relative risk value of occurring decompensated liver cirrhosis and/or liver cancer in the exposed and non-exposed was 0.35,95%confidence interval 0.12-1.01,which indicated that the exposure was beneficial.There were no adverse events in both groups.Conclusions Dahuang Zhechong Capsules can significantly reduce the size of spleen in patients with compensated hepatitis B cirrhosis and syndrome of static blood blocking collaterals with splenomegaly,and delay cirrhosis.Dahuang Zhechong Capsules can also improve symptoms of syndrome of blood stasis and has a positive clinical effect and good safety.