摘要
背景:研究证明三氧化二砷(arsenic trioxide,ATO)联合全反式维甲酸(all—trans retinoic acid,ATRA)在急性早幼粒细胞白血病(acute promyelocytic leukemia,APL)的治疗中通过不同的分子机制发挥作用,奠定了ATI 和 ATRA 协同或相加作用的分子学基础,并且 ATO 联合 ATRA 方案在临床上也广为应用,但目前尚无明确的高级别循证医学证据证明其疗效和安全性。目的:评价 ATO 联合 ATRA 方案治疗 APL 的疗效。检索策略:检索 Cochrane 图书馆及其对照试验注册资料库(Cochrane Central Register of Controlled Trials,CENTRAL)、MEDLINE、EMBASE、中国生物医学文献数据库、中国期刊网专题全文数据库和中国医学学术会议论文数据库,并辅以手工检索和附加检索,检索时间截至2009年3月。纳入标准:纳入研究 ATO 联合 ATRA 方案治疗 APL 疗效的随机对照试验文献。干预措施包括:(1)ATO联合 ATRA 方案与 ATO 单药比较;(2)ATO 联合 ATRA 方案与 ATRA 单药比较;(3)ATO 联合 ATRA方案与 ATRA 联合化疗比较;④ATO 联合 ATRA 方案与 ATO+ATRA+化疗比较。资料提取与分析:提取完全缓解率、总生存率、无病生存率、开始治疗到完全缓解的时间、复发率、病死率及相关副反应等结局评价指标的数据,按不同数据类型采用相应的统计方法,使用 Cochrane 协作网 RevMan 5.0软件进行 meta 分析。结果:共纳入9项随机对照试验,合并同类研究后,共7项研究纳被入分析,包括392例受试者。其中6项研究存在中度偏倚风险,1项研究存在高度偏倚风险。研究方案包括 ATO 联合 ATRA 方案与 ATO 单药、ATRA 单药和 ATO+ATRA+化疗方案的比较,未能检索到与目前的首选方案(ATRA 联合蒽环类药物)比较的随机对照试验。Meta 分析结果示,与 ATO 单药比较,ATO 联合 ATRA 方案能够改善初治 APL 病人开始治疗到完全缓解的时间和复发率,对其余结局指标影响的差异无统计学意义,以受试者疾病状态
Background： The studies have demonstrated that arsenic trioxide （ATO） in combination with all-trans retinoic acid （ATRA） takes effects in treatment of acute promyelocytic leukemia （APL） through different underlying mechanisms. This has established the molecular foundation of ATO plus ATRA therapy. Currently, ATO plus ATRA has also been widely used in clinical practice.
Objective： To assess the efficacy and safety of ATO in combination with ATRA for APL.
Search strategy： The Cochrane Library （Issue 1, 2009）, Cochrane Central Register of Controlled Trials （from 1970 to January 2009）, MEDLINE （from 1978 to October 2008）, EMBASE （from 1950 to March 2009）, Chinese Biological Medical Literature Database （from 1978 to December 2008）, CNKI （from 1994 to December 2008）, China Medical Academic Conference Database （from 1994 to December 2008） were electronically searched. We also searched the Meta-Register of Controlled Trials, Conference Proceedings of American Society of Hematology （from 1946 to December 2008） and Conference Proceedings of American Society of Clinical Oncology （from 1946 to December 2008） on the internet for grey literature. The authors also hand-searched Chinese periodicals potentially related to the question including Chinese Journal of Hematology, Journal of Experimental Hematology and Journal of Clinical Hematology.
Inclusion criteria： All randomized controlled trials comparing ATO plus ATRA with other regimens for the treatment of APL were included. Intervention and comparison regimens include： 1） ATO plus ATRA vs ATO monotherapy; 2） ATO plus ATRA vs ATRA monotherapy; 3） ATO plus ATRA vs ATRA plus chemotherapy; 4） ATO plus ATRA vs ATO＋ATRA＋chemotherapy.
Data extraction and analysis： Related data concerning complete remission rate, overall survival rate, and disease free survival rate, time to complete remission, relapse rate, mortality and adverse reactions were extracted independently by two reviewers. The different statist
出处
《中西医结合学报》
CAS
2009年第11期1023-1034,共12页
Journal of Chinese Integrative Medicine
基金
国家重点基础研究发展计划(973计划)资助项目(N.2006CB504602)
