唑来膦酸联合化疗治疗多发性骨髓瘤有效性及安全性的系统评价  

Zoledronic acid combined with chemotherapy for treating patients with multiple myeloma:a systematic review of efficacy and safety

作　　者：马若飞[1] 米登海[2,3] 李征[2,3] 温志震 余新林 李忠信 

机构地区：[1]中南大学湘雅医学院骨科,湖南长沙410013 [2]甘肃省第二人民医院肿瘤科,甘肃兰州730000 [3]兰州大学第一临床医学院,甘肃兰州730000

出　　处：《兰州大学学报（医学版）》2016年第2期38-44,共7页Journal of Lanzhou University（Medical Sciences）

基　　金：甘肃省卫生行业科研计划项目(GSWSKY-2014-14;GWGL-2013-4);甘肃省卫生创新人才工程专项基金项目(甘财社-2006-157号)

摘　　要：目的评价唑来膦酸联合化疗治疗多发性骨髓瘤(MM)的有效性及安全性,为临床实践与研究提供参考。方法计算机检索Cochrane Library、PubMed、EMBASE、Web of Science、中国生物医学文献数据库、中国期刊全文数据库、万方数字化期刊全文数据库和维普中文科技期刊数据库,同时辅以其他检索,收集所有唑来膦酸联合化疗治疗MM的随机对照试验(RCT)。评价员按照研究计划书进行文献筛选和资料提取,对纳入文献进行质量评价后,使用RevMan 5.3软件进行Meta分析。结果共纳入13篇RCT(565例患者)。Meta分析结果显示:联合组的骨痛缓解显效率及总有效率均高于单独化疗组,差异均有统计学意义(P<0.05),合并结果为显效率[OR=3.56,95%CI=(2.27,5.60)],总有效率[OR=4.42,95%CI=(2.77,7.07)];联合组的骨病变和病理性骨折发生率均低于单独化疗组,但只有骨病变发生率的差异有统计学意义(P<0.05),合并结果为骨病变[OR=0.34,95%CI=(0.18,0.64)];联合组的发热、疲劳、恶心、便秘及肾功能损伤的发生率均高于单独化疗组,但只有发热和便秘发生率的差异有统计学意义(P<0.05),合并结果为发热[OR=5.15,95%CI=(2.00,13.26)]、便秘[OR=9.69,95%CI=(1.15,81.81)]。结论相较于单独化疗,唑来膦酸联合化疗治疗MM能显著提高患者骨痛缓解率,降低患者骨病变的发生率,但同时也增加了发热和便秘的风险。Objective To evaluate the clinical efficacy and safety ofzoledronic acid combined with chemotherapy for multiple myeloma （MM）, and to provide the reference for clinical practice and research. Methods Databases as Cochrane Library, PubMed, EMBASE, Web of Science, CBM, CNKI, WanFang and VIP and other sources were searched with computer. All relevant randomized controlled trials （RCTs） related to zoledronic acid com- bined with chemotherapy for treating patients with multiple myeloma were collected. After literature screen- ing, data extraction and quality evaluation were conducted by authors according to the protocol, meta-analyses were performed using the RevMan 5.3 software. Results 13 RCTs with 565 patients were included in this study. Meta-analysis showed： the efficiency and total effective rate of osteodynia relief in combination therapy group were superior to chemotherapy alone group, and there were all significant differences （P 〈 0.05）, efficiency rate [OR=3.56, 95% CI=（2.27, 5.60）], total effective rate [OR=4.42, 95%CI=（2.77, 7.07）]. The incidence of osteopathy and pathological fracture in combination therapy group were lower to chemotherapy alone group, but only the difference in the incidence of osteopathy reached statistically significant （P 〈 0.05）, osteopathy [OR=0.34, 95% CI=（0.18, 0.64）]. The incidence of fever, fatigue, nausea, constipation and renal impairment in combination therapy group were higher to chemotherapy alone group; but there were only significant difference in fever and constipation （P 〈 0.05）; fever [OR=5.15, 95% CI=（2.00, 13.26）], constipation [0R=9.69, 95 % CI=（1.15, 81.81）]. Conclusion Compared with chemotherapy alone, zoledronic acid combined with che- motherapy for MM can significantly alleviate osteodynia, reduce incidence of osteopathy. However, the com- bination therapy with zoledronic acid was associated with a higher incidence of fever and constipation.

关 键 词：多发性骨髓瘤 唑来膦酸 化疗 系统评价 META分析 随机对照试验 

分 类 号：R733.3[医药卫生—肿瘤]