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复方黄黛片治疗急性早幼粒细胞白血病的疗效与安全性的系统评价
作者:董菊1  张晨妍1  许婧娴1  王均琴1  阮秦莉1  吴娟1  娄雅楠2 
单位:1. 南京中医药大学 医学与生命科学院, 江苏 南京 210046;
2. 南京中医药大学 药学院, 江苏 南京 210046
关键词:雄黄 复方黄黛片 急性早幼粒细胞白血病 系统评价 
分类号:R733.71
出版年·卷·期(页码):2018·37·第六期(993-997)
摘要:

目的:系统评价复方黄黛片治疗急性早幼粒细胞白血病(APL)的临床疗效与安全性。方法:采用Cochrane循证医学系统评价的方法,全面检索复方黄黛片治疗APL的随机对照和半随机对照的研究文献,筛选合格的文献进行质量评价,数据采用RevMan5.3进行分析。结果:共鉴定并纳入13个临床研究,合计848例患者。与对照组相比,复方黄黛片组的死亡率[RR 0.42,95%CI(0.25,0.71)]和复发率[RR 0.25,95%CI(0.07,0.85)]明显降低;但无病生存率、完全缓解率、肝功能损害未见有明显改变;复方黄黛片可引起胃肠道不适反应的增加[RR 1.54,95%CI(1.06,2.04)]。结论:现有临床证据表明,复方黄黛片治疗APL可降低死亡率和复发率,但亦可能引起胃肠道不适反应增加。现有证据尚需更多大样本、高质量的随机对照研究予以证实。

Objective:To systematically review the efficacy and safety of Realgar-Indigo naturalis formula(RIF) in treatment of acute promyelocytic leukaemia(APL).Methods:Based on guidelines from the Cochrane collaboration, the randomized or quasi-randomized controlled studies about RIF treating patient with APL were searched overall and the qualified studies were selected to perform data analysis by using RevMan5.3.Results:Thirteen studies (included 848 cases) were enrolled in this study. Compared with the control group, the death rate of the RIF group was significantly reduced[RR 0.42, 95% CI (0.25, 0.71)], the same to the recurrence rate[RR 0.25, 95% CI(0.07, 0.85)]. However, there was no significant change in the disease-free survival rate, complete remission rate and liver damage. In addition, the RIF was found to cause an increase in gastrointestinal distress[RR 1.54, 95% CI(1.06, 2.04)]. Conclusions:The existing clinical evidence indicates that the RIF alone or combined with western medicine treating APL may reduce the death rate and recurrence rate, but may also cause an increase in gastrointestinal discomfort, and more large samples, high quality trials are needed to confirm the available evidence.

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