【摘要】 目的探讨斑蝥酸钠维生素B6治疗晚期原发性肝癌的有效性和安全性。方法将经临床确诊为晚期原发性肝癌且肝功能Child-Push评分C级或ECOG体力状况评分≥2分的85例患者随机分为两组,治疗组43例,每天给予斑蝥酸钠维生素B6注射液40 ml和对症支持治疗;对照组42例,仅给予对症和支持治疗。评价两组患者症状、生活质量、瘤体的改变、总生存时间和药物不良反应。结果治疗组患者治疗后的症状、肝功能、生活质量和体力状况明显好转,并优于对照组,差异有统计学意义(P<0.05)。治疗组和对照组的疾病控制率分别为54.5%和5.7%,中位总生存时间分别为5.5个月和1.2个月,差异有统计学意义(P<0.05)。治疗组用药时间最长40.3周,平均用药时间15.7周,未见严重不良反应出现,且对转氨酶有降低作用。结论斑蝥酸钠维生素B6治疗晚期原发性肝癌,不但可以减轻临床症状、提高生活质量和延长生存时间,而且不良反应较轻,值得进一步开展大规模的多中心随机对照研究。更多还原

【Abstract】 Objective To observe the efficacy and safety of cantharidin sodium vitamin B6injection for patients with advanced primary liver cancer. Methods It was a perspective,single-center phase Ⅲ study. The patients had clinic confirmed as advanced primary liver cancer with poor function of liver or performance status. They were randomly assigned into treatment group and control group. The patients of treatment group received disodium cantharidinate and vitamin B6 injection 40ml daily plus support care; the patients of control group only received support care. Indexes of evaluation were the improvement of symptoms, function of liver,quality of life,overall survival( OS) and adverse effects. Results Eighty-five eligible patients were recruited and eighty-one were evaluable for efficacy. The improvement of symptoms,function of liver,quality of life and prolongation of life in treatment group were statistically significant( P < 0. 05), which compared with that in control group. The disease control rate was 54. 5% in treatment group and 5. 7% in control group. The median OS was 5. 5 months in treatment group and 1. 2 months in control group. The differences were statistically significant( P < 0. 05). The adverse effects were mild. Conclusions Therapy with disodium cantharidinate and vitamin B6 injection for patients with advanced primary liver cancer shows improvement of symptoms,function of liver,quality of life,encouraging objective response and prolong OS with mild adverse effects. Therefore,further prospective,multicenter and randomized phase III trial in this area is necessary.更多还原