乌苯美司联合化疗用于恶性肿瘤的系统评价

Ubenimex Combined with Chemotherapy in the Treatment of Malignant Tumor:A Systematic Review

目的:系统评价乌苯美司联合化疗用于恶性肿瘤的疗效和安全性,为临床提供循证参考。方法:计算机检索Central、PubMed、中国期刊全文数据库、中文科技期刊数据库、万方数据库,收集乌苯美司联合化疗(试验组)对比单纯化疗(对照组)用于恶性肿瘤的随机对照试验(RCT),筛选文献、提取资料并采用Cochrane系统评价员手册5.1.0提供的偏倚风险评价标准评价纳入研究质量,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入12项RCT,包括762例患者。Meta分析结果显示,试验组患者近期有效率[RR=1.24,95%CI(1.08,1.43),P=0.002]、生存质量(KPS)评分改善率[RR=1.69,95%CI(1.46,1.95),P<0.001]显著高于对照组,胃肠道毒性发生率[RR=0.74,95%CI(0.57,0.94),P=0.02]和白细胞抑制发生率[Ⅰ°～Ⅳ°(用药≤3个月):RR=0.54,95%CI(0.37,0.79),P=0.002;Ⅲ°～Ⅳ°:RR=0.44,95%CI(0.29,0.68),P<0.001]显著低于对照组,差异均有统计学意义。结论:乌苯美司联合化疗用于恶性肿瘤,可以提高患者的近期疗效,改善生存质量,降低胃肠道毒性和骨髓毒性。

OBJECTIVE： To evaluate therapeutic efficacy and safety of ubenimex combined with chemotherapy in the treatment of malignant tumor, and to provide evidence-based reference in clinic. METHODS： Retrieved from Central, PubMed, CJFD, VIP and Wanfang database, randomized controlled trials （RCTs） about ubenimex combined with chemotherapy （trial group） vs. single chemotherapy （control group） in the treatment of malignant tumor were collected. The quality of studies were evaluated by bias risk evaluation criteria of Cochrane system evaluator manual 5.1.0 after screening literatures and extracting data. Meta-analysis was per- formed by using Rev Man 5.3 statistical software. RESULTS： A total of 12 RCTs were included, involving 762 patients. The re- suits of Meta-analysis showed that： shorter-term response rate [RR = 1.24,95 % CI （ 1.08, 1.43）, P= 0.002] and the improvement rate of life quality Karnofsky score [RR=l.69, 95% CI （1.46, 1.95）, P〈0.001] in trial group were significantly higher than control group; the incidence of gastrointestinal toxicity [RR=0.74,95%CI（0.57,0.94）,P=0.02] and leucocyte suppression rate[Ⅰ°～Ⅳ°（〈 3 months） ： RR----0.54, 95% CI （0.37,0.79）, P=0.002; Ⅲ°～Ⅳ° RR=0.44, 95 % CI （0.29,0.68）, P〈0.001] were significantly lower than control group, with statistical significance. CONCLUSIONS： Ubenimex combined with chemotherapy can improve malignant tumor, shorter-term efficacy and life quality, and reduce gastrointestinal and marrow toxicity.