复方苦参注射液联合双膦酸盐辅治恶性肿瘤骨转移疼痛的Meta分析和试验序贯分析  

The Efficacy and Safety of Compound Kushen Injection Combined with Bisphosphonates for Ostealgia in Patients with Metastatic Bone Tumor:a meta-analysis and trial sequential analysis

作　　者：邢利民 丁慧敏 段余钡 徐锋 吴周士 艾金伟 裴斌 XING Li-min;DING Hui-min;DUAN Yu-bei;XU Feng;WU Zhou-shi;AI Jin-wei;PEI Bin(Evidence-Based Medicine Center;Department of Orthopedics, Xiangyang NO. 1 People＇s Hospital, Hubei University Of Medicine, Xiangyang , Hubei ,441000, China)

机构地区：[1]湖北医药学院附属襄阳市第一人民医院循证医学中心,湖北襄阳441000 [2]湖北医药学院附属襄阳市第一人民医院骨科,湖北襄阳441000

出　　处：《湖北医药学院学报》2017年第5期397-403,F0002,F0003,共9页Journal of Hubei University of Medicine

基　　金：湖北省卫生计生项目(WJ2015MB187);湖北省卫生厅重点基金资助项目(HW-2010B-1019);湖北医药学院教研重点项目(2015025);襄阳市科技计划项目(2010GG3A21)

摘　　要：目的:运用Meta分析和试验序贯分析(TSA)的方法探讨复方苦参注射液(CKI)联合双膦酸盐(BPs)辅治恶性肿瘤骨转移性疼痛的安全性和有效性。方法:计算机检索Pub Med、The Cochrane Library(2017年第1期)、Embase、CNKI、CBM、VIP、Wan-Fang数据库中有关CKI联合BPs与BPs比较治疗恶性肿瘤骨转移性疼痛的临床随机对照试验(RCT)。2名研究者独立进行文献筛选、数据资料提取、文献质量评价。运用Rev Man5.3软件进行Meta分析,TSA v0.9软件进行TSA。结果:纳入9个RCT,包含750例恶性肿瘤骨转移患者,其中CKI+BPs组383例,BPs组367例。Meta分析结果显示:与BPs相比,CKI联合BPs在疼痛完全缓解率[OR=2.37,95%CI(1.57,3.57)]、有效率[OR=2.90,95%CI(2.05,4.10)]方面差异有统计学意义,并且能降低恶性肿瘤放化疗并发症率[RR=0.75,95%CI(0.62,0.91)]。疼痛完全缓解率和有效率TSA结果显示累计Z值跨过期望信息量(RIS),并穿越了TSA界值,说明样本量足够、结果可靠;并发症率TSA结果显示累计Z值未跨过RIS,但穿越了TSA界值,提示尽管样本量不足,但无需增大样本量,即可提前得出可靠结论。结论:当前的研究结果显示CKI联合BPs能增加恶性肿瘤转移性骨痛疗效,并能降低治疗过程中并发症率。因纳入研究质量等问题,本研究结论仍需大量高质量RCT予以证实。Objective To assess the efficacy and safety of compound Kushen injection（ CKI） combined with bisphosphonates（ BPs） for ostealgia in patients with metastatic bone tumor by meta-analysis and trial sequential analysis（ TSA）.Methods A randomized controlled trial（ RCT） was performed by computer retrieval of Pub Med,The Cochrane Library（ Issue 1,2017）,EMbase,CNKI,CBM,VIP,and Wan Fang database in the CKI combined with BPs for ostealgia in patients with metastatic bone tumor through inception to February 12,2017. Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies. Then,meta-analysis and TSA analysis were performed using Rev Man5.3 software and TSA v0.9. Results A total of 9 RCTs involving 750 patients（ 383 in CKI ＋ BPs groups and 367 in BPs groups,respectively） were included. The results of meta-analysis showed that there were significant differences between CKI ＋ BPs and BPs group in complete remission rate [OR = 2.37,95%CI（ 1.57,3.57） ]and response rate [OR = 2.90,95%CI（ 2.05,4.10） ],and CKI ＋ BPs showed more effective in reducing adverse effects than BPs in the stage of treatment [RR = 0.75,95% CI（ 0. 62,0. 91） ]. The results of complete remission rate and response rate were very robust and the sample-size were sufficient given that the cumulative Z-curve strode both TSA threshold value and required information size（ RIS） line in TSA. In TSA of adverse effects the Z-curve did not strode the RIS,but it crossed the TSA threshold value,which suggested that there was no need to enlarge the sample-size and a reliable conclusion could be draw early. Conclusion The current evidence showed that the CKI ＋ BPs could increase the therapeutic effects and reduce the rate of complications during the treatments of ostealgia in patients with metastatic bone tumor. Due to the quality of the included studies,more high-quality trials are needed to verify the above conclusions.

关 键 词：复方苦参注射液 二膦酸盐 骨转移瘤 疼痛 Meta分析 

分 类 号：R730.5[医药卫生—肿瘤]