阳黄-阴阳黄-阴黄辨证论治联合西药治疗乙型肝炎相关慢加急性肝衰竭患者生存分析
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摘要
目的探讨基于"阳黄-阴阳黄-阴黄"辨证论治联合西药治疗方案对乙型肝炎相关慢加急性肝衰竭(ACLF)患者短期生存率的影响及影响因素。方法采用多中心随机对照临床试验,于2012年5月至2016年7月在全国12个临床试验中心共纳入病例413例,随机分为治疗组237例和对照组176例。对照组采用西医综合治疗,治疗组在对照组基础上采用基于"阳黄-阴阳黄-阴黄"辨证论治模式。治疗8周后比较两组患者生存情况,采用Cox风险比例回归模型筛选影响患者生存时间的独立危险因素。结果治疗组8周平均生存时间长于对照组(P=0. 023); Cox回归模型分析显示:年龄56岁及以上、疾病分期晚期、有肝性脑病是短期内增加患者死亡风险的独立危险因素,相对危险度[Exp (β)]分别为4. 045、4. 279和4. 313;治疗组的中西医结合治疗[Exp (β)为0. 493]、凝血酶原活动度(PTA)> 40%[Exp (β)为0. 146]是降低患者短期病死率的保护因素。结论基于"阳黄-阴阳黄-阴黄"辨证论治的中西医结合治疗方案可以提高乙型肝炎相关ACLF患者的短期生存率,年龄、疾病分期、肝性脑病是影响患者短期生存率的独立危险因素。
Objective To explore the short-term survival rate of patients with hepatitis B virus( HBV)-related acute-on-chronic liver failure( ACLF) based on the syndrome differentiation of "Yang Jaundice-Yin-Yang JaundicesYin Jaundice"and combined with western medicine,and its affecting factors. Methods Using the multicenter and randomized controlled clinical trials,a total of 413 cases were collected from 12 clinical trials centers from May 2012 to July 2016,and they were randomly divided into 237 cases of the treatment group and 176 cases of the control group. The control group was treated with comprehensive western medicine,and the treatment group was treated with syndrome differentiation of "Yang Jaundice-Yin-Yang Jaundices-Yin Jaundice"based on the control group. After 8 weeks of treatment,the survival condition of the 2 groups were compared. Cox risk proportional regression model was used to screen independent risk factors affecting patient's short-term survival rate. Results The average 8 weeks' survival time of the treatment group was longer than that of the control group( P = 0. 023). The Cox regression analysis showed that age over 56 years old,advanced stage and hepatic encephalopathy were independent risk factors that increase short-term mortality. The relative risk [Exp( β) ] of above three independent risk factors were 4. 045,4. 279 and 4. 313 respectively. The integrative Chinese and western medicine treatment [Exp( β) : 0. 493]and prothrombin activity( PTA) [Exp( β) : 0. 146) ]were protective factors that decrease the short-term mortality. Conclusion The integrative Chinese and western medicine based on the syndrome differentiation of"Yang Jaundice-YinYang Jaundices-Yin Jaundice"can increase the short-term survival rate of patients with HBV-related ACLF,and age,clinical stage,hepatic encephalopathy are independent risk factors that influencing the short-term survival rate.
Objective To explore the short-term survival rate of patients with hepatitis B virus( HBV)-related acute-on-chronic liver failure( ACLF) based on the syndrome differentiation of "Yang Jaundice-Yin-Yang JaundicesYin Jaundice"and combined with western medicine,and its affecting factors. Methods Using the multicenter and randomized controlled clinical trials,a total of 413 cases were collected from 12 clinical trials centers from May 2012 to July 2016,and they were randomly divided into 237 cases of the treatment group and 176 cases of the control group. The control group was treated with comprehensive western medicine,and the treatment group was treated with syndrome differentiation of "Yang Jaundice-Yin-Yang Jaundices-Yin Jaundice"based on the control group. After 8 weeks of treatment,the survival condition of the 2 groups were compared. Cox risk proportional regression model was used to screen independent risk factors affecting patient's short-term survival rate. Results The average 8 weeks' survival time of the treatment group was longer than that of the control group( P = 0. 023). The Cox regression analysis showed that age over 56 years old,advanced stage and hepatic encephalopathy were independent risk factors that increase short-term mortality. The relative risk [Exp( β) ] of above three independent risk factors were 4. 045,4. 279 and 4. 313 respectively. The integrative Chinese and western medicine treatment [Exp( β) : 0. 493]and prothrombin activity( PTA) [Exp( β) : 0. 146) ]were protective factors that decrease the short-term mortality. Conclusion The integrative Chinese and western medicine based on the syndrome differentiation of"Yang Jaundice-YinYang Jaundices-Yin Jaundice"can increase the short-term survival rate of patients with HBV-related ACLF,and age,clinical stage,hepatic encephalopathy are independent risk factors that influencing the short-term survival rate.
引文
[1]中华医学会感染病学分会肝衰竭与人工肝学组,中华医学会肝病学分会重型肝病与人工肝学组.肝衰竭诊疗指南[J].中华肝脏病杂志,2006,14(9):643-646.
[2]刘晓燕,胡瑾华,王慧芬,等. 1977例急性、亚急性、慢加急性肝衰竭患者的病因与转归分析[J].中华肝脏病杂志,2008,16(10):772-775.
[3]ASRANI SK,SIMONETTO DA,KAMATH PS. Acute-onchronic liver failure[J]. Clin Gastroenterol H,2015,13(12):2128-2139.
[4]MOREAU R,ARROYO V. Acute-on-chronic liver failure:A new clinical entity[J]. Clin Gastroenterol H,2015,13(5):836-841.
[5]BLASCO-ALGORA S,MASEGOSA-ATAZ J,GUTIERREZ-GARCIA ML,et al. Acute-on-chronic liver failure:Pathogenesis, prognostic factors and management[J].World J Gastroenterol,2015,21(42):12125-12140.
[6] BERNAL W,JALAN R,QUAGLIA A,et al. Acute-onchronic liver failure[J]. Lancet,2015,386(10003):1576-1587.
[7]李晨,游绍莉,辛绍杰. HBV相关慢加急性肝衰竭前期概念及诊疗新进展[J].实用肝脏病杂志,2015,18(1):105-108.
[8]王永炎,鲁兆麟.中医内科学[M].上海:上海科学技术出版社,1999:515-529.
[9]邓勤智,夏邦恩,王世和,等.土茯苓组方在乙型肝炎病毒慢加急性肝衰竭中的应用及疗效分析[J].中华中医药杂志,2015,30(3):739-742.
[10]王国栋,陈斌,王若宇,等.基于数据挖掘的肝瘟病阳黄-阴阳黄-阴黄辨证模式用药规律研究[J].湖南中医药大学学报,2016,36(1):78-80.
[11]孙克伟,陈斌,黄裕红,等.慢性乙型重型肝炎不同黄疸证的临床特点研究[J].中西医结合肝病杂志,2010,20(1):8-11.
[12]赵萍,翟玉峰,张怀宏.血清甲胎蛋白和凝血酶原活动度水平对慢加急性肝衰竭患者预后的预测价值研究[J].实用肝脏病杂志,2017,20(2):230-231.
[13]刘慧敏,王宪波,曾辉,等.乙型肝炎慢加急性肝衰竭患者短期预后的生存分析[J].中华医学杂志,2012,92(1):21-24.
[14]张冬青,陈立,甘巧蓉,等.乙型肝炎相关慢加急性肝衰竭患者的预后因素分析[J].临床肝胆杂志,2012,28(10):740-743.
[15]李磊,丁惠国.急性失代偿期肝硬化与慢加急性肝衰竭的新认识[J].北京医学,2016,38(9):938-939.
[16]石新星,张艳琼,朱鹏,等.乙型肝炎相关慢加急性肝衰竭患者预后的危险因素分析[J].临床肝胆病杂志,2016,32(4):700-705.
[17]夏向群,蒋速文,胡爱荣,等.乙型肝炎相关慢加急性肝衰竭早期及远期预后的影响因素比较分析[J].中华试验和临床病毒学杂志,2016,30(3):293-297.
[2]刘晓燕,胡瑾华,王慧芬,等. 1977例急性、亚急性、慢加急性肝衰竭患者的病因与转归分析[J].中华肝脏病杂志,2008,16(10):772-775.
[3]ASRANI SK,SIMONETTO DA,KAMATH PS. Acute-onchronic liver failure[J]. Clin Gastroenterol H,2015,13(12):2128-2139.
[4]MOREAU R,ARROYO V. Acute-on-chronic liver failure:A new clinical entity[J]. Clin Gastroenterol H,2015,13(5):836-841.
[5]BLASCO-ALGORA S,MASEGOSA-ATAZ J,GUTIERREZ-GARCIA ML,et al. Acute-on-chronic liver failure:Pathogenesis, prognostic factors and management[J].World J Gastroenterol,2015,21(42):12125-12140.
[6] BERNAL W,JALAN R,QUAGLIA A,et al. Acute-onchronic liver failure[J]. Lancet,2015,386(10003):1576-1587.
[7]李晨,游绍莉,辛绍杰. HBV相关慢加急性肝衰竭前期概念及诊疗新进展[J].实用肝脏病杂志,2015,18(1):105-108.
[8]王永炎,鲁兆麟.中医内科学[M].上海:上海科学技术出版社,1999:515-529.
[9]邓勤智,夏邦恩,王世和,等.土茯苓组方在乙型肝炎病毒慢加急性肝衰竭中的应用及疗效分析[J].中华中医药杂志,2015,30(3):739-742.
[10]王国栋,陈斌,王若宇,等.基于数据挖掘的肝瘟病阳黄-阴阳黄-阴黄辨证模式用药规律研究[J].湖南中医药大学学报,2016,36(1):78-80.
[11]孙克伟,陈斌,黄裕红,等.慢性乙型重型肝炎不同黄疸证的临床特点研究[J].中西医结合肝病杂志,2010,20(1):8-11.
[12]赵萍,翟玉峰,张怀宏.血清甲胎蛋白和凝血酶原活动度水平对慢加急性肝衰竭患者预后的预测价值研究[J].实用肝脏病杂志,2017,20(2):230-231.
[13]刘慧敏,王宪波,曾辉,等.乙型肝炎慢加急性肝衰竭患者短期预后的生存分析[J].中华医学杂志,2012,92(1):21-24.
[14]张冬青,陈立,甘巧蓉,等.乙型肝炎相关慢加急性肝衰竭患者的预后因素分析[J].临床肝胆杂志,2012,28(10):740-743.
[15]李磊,丁惠国.急性失代偿期肝硬化与慢加急性肝衰竭的新认识[J].北京医学,2016,38(9):938-939.
[16]石新星,张艳琼,朱鹏,等.乙型肝炎相关慢加急性肝衰竭患者预后的危险因素分析[J].临床肝胆病杂志,2016,32(4):700-705.
[17]夏向群,蒋速文,胡爱荣,等.乙型肝炎相关慢加急性肝衰竭早期及远期预后的影响因素比较分析[J].中华试验和临床病毒学杂志,2016,30(3):293-297.
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