亚砷酸注射液治疗原发性肝癌的Ⅱ期多中心临床研究  

Multicenter phase Ⅱclinical trial of arsenic trioxide injection in the treatment of primary hepatocarcinoma

作　　者：屈凤莲[1] 郝学志[1] 秦叔逵[2] 刘基巍[3] 隋广杰 陈强[5] 屈涛[1] 张和平[1] 孙燕[1] 

机构地区：[1]中国医学科学院北京协和医学院肿瘤医院内科,100021 [2]南京八一医院全军肿瘤中心 [3]大连医学院附属第一医院肿瘤内科 [4]黑龙江省肿瘤医院内科 [5]福建省肿瘤医院肿瘤内科

出　　处：《中华肿瘤杂志》2011年第9期697-701,共5页Chinese Journal of Oncology

摘　　要：目的评价亚砷酸注射液单药治疗原发性肝癌的客观疗效和不良反应，观察亚砷酸注射液在人体内的药代动力学变化。方法111例中晚期原发性肝癌患者接受亚砷酸注射液单药治疗，给药方法为亚砷酸注射液7～8mg／m2，静脉滴注，1次／d，连用14d为1个周期，间歇7～14d，完成2个周期治疗后评价疗效和不良反应。有效和稳定的患者继续治疗到病变进展或不能耐受。结果本组完成治疗且可评价疗效的患者共102例，其中治疗后部分缓解7例，稳定71例，进展24例；客观有效率为6．9％，临床获益率为76．5％；生活质量改善率为22．5％，镇痛有效率为71．7％。102例患者的中位疾病进展时间（TTP）为97d，中位生存时间（MST）为195d。不良反应主要为可逆性的I～Ⅱ度胃肠道反应和骨髓抑制。药代动力学结果显示，亚砷酸注射液在人体内的分布和清除符合二室模型特征，血浆清除半衰期为（23．94±18．39）h。结论亚砷酸注射液治疗原发胜肝癌有一定的疗效，且有明显的镇痛作用，能在一定程度上延长中晚期肝癌患者的TTP和MST，不良反应轻，患者可以耐受。Objective To evaluate the effect and adverse effects of arsenic trioxide （ As2O3 ） in the treatment of primary hepatocarcinoma patients, and conduct the pharmacokinetics study. Methods A total of one hundred and eleven advanced primary hepatocarcinoma patients in five centers were treated with As203 injection 7-8 mg/m2 i.v. qd for ld days and was repeated after 7-14 days. Evaluation of the clinical response and adverse effects was conducted after two cycles of treatment. The patient who had reached partial PR and SD was treated continuously until disease progression or intolerance. Results Among the 102 patients evaluable for clinical efficacy analysis, there were 7 PR, 71 SD and 24 PD, the response rate was 6.9% and the clinical benefit rate was 76.5%. The quality of life was improved in 22.5% of patients. The pain relief rate was 71.7%, time to progress （TTP） was 97 days, and the median survival time （MST） was 195 days. The major adverse effects were reversible WHO Ⅰ-Ⅱ grade gastrointestinal reactions and bone marrow suppression. The results of pharmacokinetic study showed that the distribution and elimination characteristics in vivo was found to be a two-compartment model. The plasma elimination half-life was （23.94 ± 18.39 ） h. Conclusions As2O3 is effective in the management of primary hepatocarcinoma, with a significant analgesic effect. To some extent, it can extend TIP and MST in advanced liver cancer patients, while the treatment is well tolerated in the majority of patients.

关 键 词：亚砷酸注射液 肝肿瘤 治疗效果 药代动力学 

分 类 号：R735.7[医药卫生—肿瘤]