斑蝥酸钠维生素B_6治疗晚期原发性肝癌的前瞻性单中心Ⅲ期临床研究

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。

A perspective and single-center phase III study of cantharidin sodium vitamin B6 injection for pa- tients with advanced primary liver cancer

Objective To observe the efficacy and safety of cantharidin sodium vitamin B6 injection for patients with advanced primary liver cancer. Methods It was a perspective, single-center phase 111 study. The patients had clinic confirmed as advanced primary liver cancer with poor function of liver or per- formance status. They were randomly assigned into treatment group and control group. The patients of treat- ment group received disodium cantharidinate and vitamin B6 injection 40ml daily plus support care ; the pa- tients 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 〈 O. 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 Ther- apy 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 pro- long OS with mild adverse effects. Therefore, further prospective, muhicenter and randomized phase III trial in this area is necessary.