康艾注射液联合化疗治疗急性白血病的Meta分析

Meta Analysis of Kang ai Injection Combined With Chemotherapy in Treatment of Acute Leukemia

目的:定量分析康艾注射液联合化疗治疗急性白血病的疗效和安全性。方法:计算机检索Cochrane Library、Pubmed、EMBASE、Cancer Lit、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库,检索时间从各数据库建库至2015年4月30日,纳入康艾注射液联合化疗方案治疗急性白血病的随机对照试验(RCT),并用Rev Man 5.3软件对数据进行统计分析,运用GRADE方法对各结局指标包含的证据体进行证据质量分级。结果:共纳入5篇RCT,Meta分析结果显示,与单纯化疗比较,康艾注射液联合化疗方案可提高完全缓解率(OR=2.05,95%CI:1.04-4.03,P=0.04),降低化疗后骨髓抑制发生率(OR=0.44,95%CI:0.21-0.94,P=0.03),二者在感染发生率(OR=0.72,95%CI:0.19-2.82,P=0.64)和全因病死率(OR=0.24,95%CI:0.01-6.19,P=0.39)方面差异无统计学意义。结论:康艾注射液联合化疗方案在治疗急性白血病方面优于单纯化疗。

Objective： To compare the clinical response and security of chemotherapy plus Kang Ai injection and chemotherapy. Methods Randomized controlled trials （RCTs） for acute leukemia from Coehrane library, Pubmed, EMBASE, CancerLit, VIP, CBM and CNKI were retrieved. The search was finished in April 30, 2015. We traced the related references and experts in this field to obtain some certain information that has not been found. We evaluated the quality of these included studies and analyzed data by Cochrane Collaboration＇ s RevMan 5.3 software. GRDAE system had been used to evaluate the quality of evidence in the evidence body of outcome. Results a total of 5 RCTs were included. And results from meta analyses indicated that chemotherapy plus Kang Ai injection had a better clinical response and security than chemotherapy alone in relieving the clinical symptoms （ OR = 2.05, 95% CI： 1.04-4.03, P = 0. 04 ） , reducing the incidence rate of myelosuppression （ OR = 0.44, 95% CI： 0.21-0.94, P = 0. 03 ） and decreasing events of gastrointestinal reaction （OR =0. 44, 95% CI： 0.21-0.94 ,P = 0.03 ）, but no statistics difference was found in incidence rate of infection （ OR = 0. 72, 95 % CI ： 0. 19-2.82, P = 0.64 ） and all-cause mortality （ OR = 0. 24, 95 % CI ：0. 01-6. 19, P = 0. 39）. The quality of evidence in these outcomes were low or very low, that is to say we are very uncertainty to these data. Conclusions Chemotherapy plus Kang Ai injection had a better clinical response and security for acute leukemia than chemotherapy alone in relieving the clinical symptoms, reducing the incidence rate of myelosuppression and decreasing events of gastrointestinal reaction. But the credibility of this study will be limited for the poor methodology quality, insufficient sample size and the low quality of evidence.