吉西他滨标准剂量30分钟快速输注与低剂量延时输注治疗进展期非小细胞肺癌的Meta分析（英文）

Meta-analysis of gemcitabine at 30 min standard-dose infusion versus prolonged low-dose infusion for advanced non-small cell lung cancer

评价吉西他滨标准剂量30分钟快速输注与低剂量延时输注用于治疗进展期非小细胞肺癌的有效性和安全性。以"吉西他滨","低剂量延时输注","非小细胞肺癌"为关键词,系统检索Pubmed,EMbase,Cochrane Library,CBM,知网及维普数据库。采用软件Review Manager 5.3对数据进行meta分析。主要结局指标为客观反应率和1年生存率;次要结局指标为3/4级的血液毒性和恶心呕吐事件。最终纳入了6项随机对照研究,共计637例患者。Meta分析结果表明,低剂量延时输注的客观反应率优于标准剂量30分钟快速输注(OR=1.50,95%CI:1.08–2.10,P=0.02),而两组的1年生存率则无显著差异(OR=1.27,95%CI:0.90–1.79,P=0.18)。在3/4级毒副反应方面,两组的贫血(OR=1.84,95%CI:0.61–5.57,P=0.28)和恶心呕吐(OR=1.15,95%CI:0.63–2.12,P=0.64)事件无统计学差异,但低剂量延时输注组中的中性粒细胞减少(OR=0.64,95%CI:0.43–0.97,P=0.04)和血小板减少(OR=0.37,95%CI:0.17–0.80,P=0.01)事件均低于标准剂量组。由结果可知,吉西他滨低剂量延时输注具有较高的客观反应率和较低的3/4级血液毒性,故可以作为进展期非小细胞肺癌的治疗手段之一。

To evaluate the efficacy and safety of gemcitabine （GEM） at 30 min standard-dose infusion （30 min-SDI） compared with prolonged low-dose infusion （P-LDI） in patients with advanced non-small-cell lung cancer （NSCLC）. Electronic databases including Pubmed, EMbase, Cochrane Library, CNKI, CBM, and VIP were searched using keywords ＂GEM＂, ＂P-LDI＂, and ＂NSCLC＂. Review Manager 5.3 was used to perform the recta-analysis. Primary endpoints were overall response rate （ORR） and 1-year survival rate （1-year SR）. Secondary endpoints were grade 3/4 hematotoxicity and nausea/vomiting. Six randomized controlled trials （RCTs） with a total of 637 patients were included. The results showed that P-LDI was superior in ORR （OR = 1.50, 95% CI： 1.08-2.10, P = 0.02）, but had an equal 1-year SR （OR = 1.27, 95 % CI： 0.90-1.79, P = 0.18） as compared with 30 min-SDl. For grade 3/4 adverse events, there was no significant difference in anemia （OR = 1.84, 95% CI： 0.61-5.57, P = 0.28） and nausea/vomiting （OR = 1.15, 95% CI： 0.63-2.12, P = 0.64） between the two treatments. However, patients with P-LDI experienced less leukopenia （OR = 0.64, 95% CI： 0.43-0.97, P = 0.04） and thrombocytopenia （OR = 0.37, 95% CI： 0.17-0.80, P = 0.01）. P-LDI was superior in terms of ORR, experienced less grade 3/4 thrombocytopenia and leukopenia compared with 30 min-SDI, and could be a viable treatment option for advanced NSCLC.