片仔癀胶囊配合介入化疗治疗原发性肝癌患者临床观察.docVIP

片仔癀胶囊配合介入化疗治疗原发性肝癌患者临床观察【摘要】 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。 关键词：片仔癀胶囊肝癌介入治疗临床 A clinical trial of combined use of Pien Tze Huang and chemotherapy in the treatment of primary liver cancer [Abstract] Objectives: We aimed to investigate the therapeutic effect of combined usage of Pien Tze Huang (PTH) on the treatment of primary liver cancer. Method: 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 in 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. 原发性肝癌在我国发病率较高，属于常见的恶性肿瘤之一，早期发现主要采取手术治疗为主，但由于其发现确诊大多属于中晚期，已错过手术的时机，因此多数病例采取介入治疗包括药物灌注和供血动脉栓塞。介入治疗对肿瘤虽有较好的杀伤作用，但对正常机体组织也产生一定的伤害，造成机体内环境的失调，使其远期疗效不尽如人意。而片仔癀胶囊具有清热解毒、凉血化瘀、消肿镇痛等功效，药理研究证实本品有很好扶正固本(调整免疫)功能，对于癌症的化疗有增效减毒作用，并且在民间将其用于治疗肿瘤或辅助治疗有几十年历史。本研究旨在探讨该药与介入治疗联合应用对肝癌治疗的确切疗效和作用主要方面，现将临床研究结果叙述如下。 1 资料与方法 1.1一般资料 病例选择：本研究的病例为自愿接受本药物试验治疗并签署知情同意书者，有明确诊断的初治原发性肝癌，瘤体2cm以上（CT显示），不能手术或不愿手术的患者，符合中医辨证毒热瘀结证者，各项检查指标结果显示属介入治疗适应症的肝癌患者，年龄在18--70岁的男、女患者，卡氏