中文摘要：

【目的】观察华蟾素治疗中晚期原发性肝癌过程中乙型肝炎病毒（HBV）DNA含量变化与治疗效果的相关性，并对患者治疗前后的生存质量加以评价。【方法】将120例肝癌患者随机分为治疗组和对照组，每组60例。对照组在一般护肝治疗、对症治疗基础上辨证使用中药汤剂，治疗组在对照组基础上加用华蟾素注射液，连用14d为1个疗程．后间歇7d．开始下一个疗程。共使用2个疗程。观察2组实体瘤近期客观疗效、治疗前后肝功能分级、卡氏评分（Karnofsky评分）分级疗效、HBV—DNA下降疗效、远期疗效和不良反应情况。【结果】华蟾素在稳定瘤体、改善肝功能、改善生存质量、控制HBV—DNA方面较对照组有显著优势．差异有统计学意义（P〈0．05）；但在缩小瘤体方面差异无统计学意义（P〉0．05）。在改善机体功能状态方面，应用华蟾素也有显著优势（P〈0．05）。远期疗效方面：治疗组中位生存期为（178±20．689）d，3个月、半年、1年生存率分别为81％、64％、10％；对照组中位生存期为（168±16．324）d，3个月、半年、1年生存率分别为82％、63％、5％；2组比较差异有统计学意义（P〈0．05）。不良反应方面：治疗组和对照组均未见明显肝肾功能损伤、消化道反应、骨髓抑制，也未见静脉炎等情况出现。【结论】华蟾素治疗HBV—DNA高表达中晚期肝癌患者，能提高生存质量、改善机体功能和延长生存期．充分体现了中医治疗肿瘤“带瘤生存”的特点。

英文摘要：

Objective To investigate the relationship of therapeutic effect of Cinobufacini Injection for middle- and late-stage primary hepatic carcinoma with the content of hepatitis B virus DNA, and to evaluate the quality of life of the patients before and after treatment. Methods One hundred and twenty cases of middle- and late- stage primary liver cancer were equally randomized into treatment group and control group. Both groups were given conventional treatment for protecting liver, symptomatic treatment and Chinese herbal medicine decoction based on syndrome differentiation. Additionally, the treatment group was given Cinobufacini Injection for 14 days, and the next treatment course continued after an interval of 7 days. The treatment lasted two courses. Short-term effect on the solid tumor, hepatic function grading before and after treatment, therapeutic effect grading by Karnofsky performance scale （KPS） scores, HBV-DNA content, long-term effect and side effects were observed. Results Cinobufotalin Injection had markedly effect on stabilizing the tumor mass, improving liver function and the quality of life, decreasing HBV-DNA （P〈0.05 compared with the control group）, but had no significant effect on reducing tumor mass （P〉O.05） . Cinobufotalin Injection also had obvious effect on improving the general body function and liver function （P〈0.05） . As for the long-term effect, the median survival time was 178 ＋ 20.689 days in the treatment group, and was 168 ＋ 16.324 days in the control group; survival rates within 3 months, 6 months and one year were 81%, 64%, 10% in the treatment group respectively, and were 82%, 63%, 5% in the control group respectively, the difference being significant （P〈0.05） . Both groups had no obvious damage of liver or kidney. Side effects of digestive tract, bone marrow depression and phlebitis were not found. Conclusion Cinobufacini Injection is effective and safe for the treatment of middle- and late-stage primary hepatic carcinoma with high expression of HB