摘要
目的系统评价紫杉醇在小细胞肺癌治疗中的临床疗效和安全性。方法采用Cochrane系统评价方法,检索Cochrane图书馆临床对照试验资料库、MEDLINE、EMbase、CBM、CNKI和VIP等电子数据库,检索时间截至2007年。纳入含紫杉醇治疗小细胞肺癌的对照研究。由2名评价者独立评价并交叉核对纳入研究质量,对同质研究采用RevMan4.2.2软件进行Meta分析。结果共纳入9个对照研究,1675例小细胞肺癌患者,5个研究报道采用了随机方法,9个研究均未详细报道是否采用盲法。Meta分析结果表明,PET方案(紫杉醇+顺铂+足叶乙甙)与EP方案(顺铂+足叶乙甙)的反应率相似[OR=1.35,95%CI(0.98,1.85)],PET方案化疗后重度血小板下降[OR=1.68,95%CI(1.12,2.52)]和致死性毒性[OR=4.00,95%CI(1.77,9.04)]高于EP方案,而化疗后重度白细胞下降低于EP方案[OR0.50,95%CI(0.37,0.68)]。所有研究共报道了54例治疗相关性死亡。结论在小细胞肺癌的一线治疗中,紫杉醇与卡铂、足叶乙甙合用可提高无进展生存期,但与EP方案合用并不能提高长期生存率且增加了毒性,紫杉醇作为二线用药有一定疗效。由于本系统评价纳入的研究数量较少,存在偏移的高度可能,影响了结果的论证强度,期待更多高质量的随机双盲对照试验以提供高质量的证据。
Objective To assess the clinical efficacy and safety of paclitaxel in the first-line and second-line treatment of patients with small cell lung cancer （SCLC）. Methods We searched The Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP and etc to collect all clinical controlled trials involving the addition of paclitaxel to chemotherapy in SCLC patients. Two reviewers evaluated the quality of included trials independently. The Cochrane Collaboration＇s software RevMan 4.2.2 was used for meta-analyses. Results Nine trials involving 1675 SCLC patients were included. Five trials were randomized controlled trials, and all trails didn＇t mention the blinding methods. Meta analyses indicated that the PET arm （paclitaxel＋cisplatin＋etoposide） had a similar response rate compared with the EP arm （etoposide＋cisplatin） （OR1.35, 95%CI 0.98 to 1.85）. The incidences of severe thrombocytopenia （OR 1.68, 95%CI 1.12 to 2.52） and lethal toxicity （OR 4.00, 95%CI 1.77 to 9.04） were higher in the PET arm than those in the EP arm, but the incidence of severe leukocytopenia was lower in the PET arm （OR 0.50, 95%CI 0.37 to 0.68）. A total of 54 treatment-related deaths were reported. Conclusion In the first-line treatment of SCLC, the combination of paclitaxel, carboplatin and etoposide improved the progression-free survival, but the combination of paclitaxel and EP did not improve the survival and was more toxic than EP alone. Paclitaxel as the second-line treatment showed some therapeutic effect. Due to the poor quality and small sample size of included trials, more well-designed multi-center randomized controlled trials should be performed.
出处
《中国循证医学杂志》
CSCD
2008年第10期851-860,共10页
Chinese Journal of Evidence-based Medicine
关键词
小细胞肺癌
紫杉醇
疗效
安全性
系统评价
Small cell lung cancer
Paclitaxel
Efficacy
Safety
Systematic review
作者简介
李然，女（1985-），研究生，以临床药理学和肺癌的循证研究为主要研究方向。
通讯作者，Email：wangrui301@rip．sina．com
