复方鳖甲地龙散治疗Child—Pugh B级肝硬化腹水患者的5年期临床观察

Clinical 5-year observation of Fufang Biejia Dilong recipe （复方鳖甲地龙散） in treating ascites with hepatic cirrhosis at Child-Pugh B grade

目的探讨复方鳖甲地龙散对慢性乙型病毒性肝炎（乙肝）中、晚期肝硬化腹水患者长期治疗的临床疗效。方法选择88例肝硬化乙肝病毒脱氧核糖核酸（HBV—DNA）阴性、Child—Pugh B级、以低蛋白腹水为主要表现的患者，按入院时就诊顺序随机分为复方鳖甲地龙散组（治疗组）和冰莲健肝灵组（对照组），每组44例。两组综合治疗方案一致。分别于治疗前及治疗后3个月、0．5年、1年及以后每年1次至5年止检查肝肾功能、凝血功能及肝脏CT或B超、甲胎蛋白（AFP）、HBV—DNA。结果治疗组治疗3个月后血浆白蛋白（A1b）水平及正常率和凝血酶原活动度〉70％的比例均明显高于对照组，AFP水平明显低于对照组，Child—Pugh分级由B级恢复至A级成功率明显高于对照组（P均〈0．01）；而且治疗组5年内需再住院次数、癌变率及病死率均明显低于对照组，5年内无腹水且肝功能正常率明显高于对照组（P均〈0．01）。结论复方鳖甲地龙散能有效改善慢性乙肝中、晚期肝硬化患者的肝功能及临床症状，有效提高其生存质量及延长生存时间。

Objective To study the long term clinical effect of Fufang Biejia Dilong recipe （复方鳖甲地龙散） in treating ascites with chronic hepatitis B and hepatic cirrhosis at moderate and late stages. Methods Eighty-eight patients with hepatic cirrhosis of hepatitis B virus （HBV）-DNA negative, Child-Pugh B grade and low albumin ascites as the major clinical manifestations were randomly divided into two groups in accord to the sequence of their visits： the treatment group （Fufang Biejia Dilong recipe） and control group [Binglian Jianganling （冰莲健肝灵）]. The general therapy for the two groups was the same. Hepatic function, renal function, blood coagulation, hepatic CT or type-B ultrasonic examination, α-fetoprotein （AFP） and HBV-DNA of all these patients were checked before treatment and 3 months, 6 months, and once a year for 5 years after treatment. Results After 3 months of treatment in the treatment group, the plasma albumin level and its normal rate and the ratio of thromhinogen activation 〉70% were significantly higher than those in the control group, while the AFP content was lower than that in the control group; the successful ratio of elevation from Child-Pugh B level to Child-Pugh A level in the treatment group was higher than that in the control group （all P〈0. 01）. In the 5-year observation, the rates of re-hospitalization, canceration and fatality in the treatment group were obviously lower than those in the control group ; the survival rate of patients with normal hepatic function and without ascites was higher in the former group than that in the latter group （all P〈0. 01 ）. Conclusion Fufang Biejia Dilong recipe can effectively improve the hepatic function, clinical symptoms, life quality and life span of patients with cirrhosis of chronic hepatitis B at moderate or late stage.