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中国药学(英文版) ›› 2017, Vol. 26 ›› Issue (10): 763-770.DOI: 10.5246/jcps.2017.10.086

• 【药事管理与临床药学专栏】 • 上一篇    下一篇

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

赵德华1, 楚明明2, 陈静1, 王继生1*   

  1. 1. 绵阳市第三人民医院(四川省精神卫生中心) 临床药学科, 四川 绵阳 621000
    2. 第三军医大学第二附属医院 临床药学科, 重庆 400037
  • 收稿日期:2017-05-14 修回日期:2017-06-29 出版日期:2017-10-31 发布日期:2017-07-20
  • 通讯作者: Tel:+86-0816-2278591, E-mail: 519425004@qq.com

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

Dehua Zhao1, Mingming Chu2, Jing Chen1, Jisheng Wang1*   

  1. 1. Department of Clinical Pharmacy, The Third Hospital of Mianyang, Mianyang, 621000, China
    2. Department of Clinical Pharmacy, The Second Affiliated Hospital of Third Military Medical University, Chongqing, 400037, China
  • Received:2017-05-14 Revised:2017-06-29 Online:2017-10-31 Published:2017-07-20
  • Contact: Tel:+86-0816-2278591, E-mail: 519425004@qq.com

摘要:

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: 1.082.10, P = 0.02), 而两组的1年生存率则无显著差(OR = 1.27, 95 %CI: 0.901.79, P = 0.18)。在3/4级毒副反应方面, 两组的贫血(OR = 1.84, 95% CI: 0.615.57, P = 0.28)恶心呕吐(OR = 1.15, 95% CI: 0.632.12, 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: 0.430.97, P = 0.04)和血小板减少(OR = 0.37, 95% CI: 0.170.80, 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

关键词: 吉西他滨, 低剂量延时输注, 非小细胞肺癌, Meta分析, 随机对照研究

Abstract:

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 withadvanced 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 meta-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-LDIwas superior in ORR (OR = 1.50, 95% CI: 1.082.10, P = 0.02), but had an equal 1-year SR (OR = 1.27, 95 % CI: 0.901.79, P = 0.18) as compared with 30 min-SDI.For grade 3/4 adverse events, there was no significant difference in anemia (OR = 1.84, 95% CI: 0.615.57, P = 0.28) and nausea/vomiting (OR = 1.15, 95% CI: 0.632.12, P = 0.64) between thetwo treatments. However, patients with P-LDI experiencedless leukopenia (OR = 0.64, 95% CI: 0.430.97, P = 0.04)and thrombocytopenia (OR = 0.37, 95% CI: 0.170.80, P = 0.01). P-LDI was superior in terms of ORR, experienced less grade 3/4thrombocytopenia and leukopenia compared with 30 min-SDI, and could be a viable treatment option for advanced NSCLC.

Key words: Gemcitabine, Prolonged low-dose infusion, Non-small-cell lung cancer, Meta-analysis, Randomized controlled trials

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