片仔癀胶囊配合介入化疗治疗原发性肝癌患者临床观察

A clinical trial of combined use of Pien Tze Huang and chemotherapy in the treatment of primary liver cancer

目的:研究片仔癀胶囊合用化疗药治疗肝癌的临床效果。方法按新药Ⅱ期临床研究方法,将纳入的240例病例按随机双盲对照法分为试验组(介入治疗+片仔癀)120例,对照组(介入治疗+安慰剂)120例,符合统计要求的有效病例为试验组102例,对照组105例,介入治疗按介入治疗方案执行,片仔癀胶囊每日3次,每次2粒,4周为一疗程,共用2个疗程。观察治疗后片仔癀胶囊对化疗药介入治疗的减毒增效作用。结果试验组在缩小瘤体、提高病人的生活质量、止痛等方面以及综合疗效明显优于对照组,而由化疗药引起的白细胞减少、恶心呕吐、转氨酶升高等毒副反应明显较对照组轻。结论片仔癀胶囊与化疗药联用用于癌症治疗具有显著的减毒增效作用。

Objectives： We aimed to investigate the therapeutic effect of combined usage of Pien Tze Huang （PTH） on the treatment of primary liver cancer, Methodt This Phase II randomized, double-blind, placebo- controlled clinical trial enrolled 240 patients with primary liver cancer. Patients were randomized to receive either chemotherapy and PTH or chemotherapy and placebo. PTH group was prescribed to 2 pills （for 3 times a day）, for 2 cycles of 4 weeks. 102 cases in PTH group and 105 cases in placebo group were used for statistical analyses. The enhancing effect of PTH on anti-tumorigenesis was assessed. Results： A statistically greater proportion of the PTH group than the placebo group had improvements ha tumor size shrinkage, quality of life, pain relief and therapeutic effect. Moreover, the side effects induced by chemotherapy such as lowering of leukocytes levels, vomiting, increased ALT. AST enzyme were improved in the PTH group.Conclusion： The combined usage of Pien Tze Huang and chemotherapy improve the therapeutic effect on the treatment of primary liver cancer.