斑蝥酸钠维生素B6治疗晚期原发性肝癌的Ⅱ期临床研究
Phase II study of disodium cantharidinate and vitamin B6 in advanced primary liver cancer
梁永 1梁维朝 1冯坚1
作者信息
- 1. 广西桂平市人民医院,广西,桂平,537200
- 折叠
摘要
目的 探讨斑蝥酸钠维生素B6治疗晚期肝癌的有效性和安全性.方法 采用前瞻性、单中心的Ⅱ期临床研究,对经临床确诊的肝癌患者每天予斑蝥酸钠维生素B6注射液40 mL治疗,连续使用,直至患者出现病情进展或不可耐受的毒性反应,观察各项临床指标并进行分析.结果 入组31例患者,其中30例可评价.经治疗后,患者乏力、食欲不振、腹痛、腹胀等症状减轻,凝血酶原时间、腹水、白蛋白、总胆红素等4项指标好转,患者的生活质量及体力状况亦明显好转,这些指标与治疗前相比均有显著性差异(P均＜0.05).本组患者疾病控制率64%,中位生存期4.13个月,未见严重不良反应.结论 斑蝥酸钠维生素B6治疗晚期肝癌能减轻症状,改善肝功能,提高生存质量和体力状况,稳定肿瘤,延长生命,而且长时间使用不良反应较轻,值得进一步开展大规模、随机对照的Ⅲ期临床研究.
Abstract
Objective It is to observe the efficacy and safety of disodium cantharidinate and vitamin B 6 in treatment of advanced primary liver cancer. Methods It was a perspective , single-center phase Ⅱ study. The patients with advanced primary liver cancer who had clinic confirmed were received disodium cantharidinate and vitamin B6 injection 40 mL daily, continued up to disease progression or intolerance. Then the clinical indexes were observed and analyzed . Results Thirty-one eligible patients were recruited and thirty were evaluable for efficacy in this study . The symptoms of acratia, poor appetite, abdominal pain and distension were decreased ; and the indexes of liver function include prothrombin time ( PT) , ascites, albumin and total bilirubin levels were improved ; the quality of life or performance status and prolongation of life were significant got better ; there were significant differenceto compared with that of before treatment ( all P < 0. 05). The disease control rate in this study was 64% and the median overall survival was 4. 13 months, the adverse effects were mild. Conclusion The therapy with disodium cantharidinate and vitamin B6 for patients with advanced primary liver cancer shows improvement of symptoms , function of liver and quality of life or performance status , it can prolong overall survival with mild adverse effects . Therefore, further prospective randomized and controlled phase Ⅲ trial in this area is necessary.
关键词
原发性肝癌/斑蝥酸钠维生素B6/Ⅱ期临床研究Key words
primary liver cancer/disodium cantharidinate and vitamin B6 injection/phase Ⅱ study引用本文复制引用
出版年
2013
国家科技期刊平台
NSTL
维普
万方数据