复方黄黛片治疗急性早幼粒细胞白血病的系统评价

Compound realgar and natural indigo tablet therapy in acute promyelocytic leukemia： a systematic review and meta-analysis

目的评价复方黄黛片（CRNIT）治疗急性早幼粒细胞白血病（APL）的疗效与安全性。方法计算机检索SinoMed、CNKI、VIP、万方、CBA、PubMed、MEDLINE、EMBASE、Cochrane图书馆临床对照试验资料库，并辅以手工检索，收集国内外公开发表的CRNIT治疗APL的随机对照试验（RCT）文献，检索年限截至2011年3月。按纳入标准与排除标准筛选文献并评价纳入研究的质量，以完全缓解（CR）率、达CR所需时间、复发率、病死率、不良反应率等为评价指标，采用RevMan5．1软件进行Meta分析。结果纳入6项RCT，包括391例APL患者，其中2项RCT研究目的为CRNIT与三氧化二砷（ATO）的比较，4项RCT研究目的为CRNIT与全反式维甲酸（ATRA）的比较，其中1项RCT增设CRNIT＋ATRA与ATRA的比较。达CR所需时间：CRNIT比ATRA、ATO长『加权均数差（WMD）=3．14，95％C10．99～5．29，P=0．004]；头痛发生率：CRNIT低于ATRA（OR=0．10，95％C10．02—0．45，P=0．003）；5年无病生存率：CRNIT优于ATRA（OR=7．22，95％CI1．40～37．25，P=0．02）；CR率、复发率、病死率和4项不良反应指标（胃肠道症状、肝肾功能损害、皮肤损害、发热）的Meta分析结果差异无统计学意义。结论服用CRNIT达CR所需时间比ATRA、ATO长，CRNIT近期疗效与ATRA、ATO相近。服用CRNIT的5年无病生存率可能优于ATRA。

Objective To systematically review the curative effect and safety of compound realgar and natural indigo tablet （CRNIT） therapy in acute promyelocytic leukemia （APL）. Methods The clinical data of randomized trials on SinoMed, CNKI, VIP, WANFANG DATA, CBA, PubMed, MEDLINE, EMBASE, the Cochrane Library were searched by intemet, in addition to manual retrieval and collecting all published literatures randomized controlled trials （RCT） about CRNIT therapy in APL home and abroad. Retrieval line was up to March 2011. According to the inclusion criteria and exclusion criteria, screening all literatures and evaluating their qualities. The rate of complete remission （CR）, time to CR, recurrence rate, mortality, rate of adverse reaction and so on were used as evaluation indicators for meta-analysis by RevMan 5.1. Results Data from six RCTs involving 391 APL patients, including 2 RCTs about comparison of CRNIT and Arsenic Trioxide （ATO）, 4 RCTs about comparison of CRNIT and all-trans retinoic acid （ATRA） （including adding 1 RCT about comparison of CRNIT ＋ ATRA and ATRA）. Time to CR： CRNIT was longer than ATRA and ATO （WMD = 3.14, 95 % CI 0.99-5.29, P= 0.004）. Headache incidence： CRNIT was lower than ATRA （OR = 0.10, 95 % CI 0.02-0.45, P = 0.003）. 5-year disease-free survival rate： CRNIT was better than ATRA （OR = 7.22, 95 % CI 1.40-37.25, P = 0.02）. There were no statistical significance in the rest of the Meta-analysis results. Conclusion The time to CR of CRNIT is longer than that of ATRA and ATO. The short-term effect of CRNIT is similar to that of ATRA and ATO. The 5-year disease-free survival rate of CRNIRT may be higher than that of ATRA.