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目的:评价紫杉醇脂质体(LEP)治疗非小细胞肺癌(NSCLC)的疗效和安全性。方法:检索Medline、Embase、PubMed、万方和中国期刊全文数据库(检索时间均为1980年至2011年7月31日)以及Cochrane图书馆系统评价和临床对照试验数据库(2011年第2期),收集以紫杉醇(PTX)为对照的LET治疗NSCLC的随机对照试验。根据纳入标准对文献进行筛选和评估,并进行meta分析,比较LEP与PTX治疗NSCLC的有效率和不良反应发生率,结果以相对危险系数(RR)、比值比(OR)及其95%可信区间(CI)表示。结果:共检索到相关文献1057篇,经筛选最终纳入符合标准的文献1 1篇,共有NSCLC患者627例,其中LEP组329例,PTX组298例。meta分析结果显示,治疗有效率2组之间差异无统计学意义(RR=1.16,95%CI为0.93～1.46,P=0.19);白细胞减少、血小板减少、贫血以及脱发发生率2组之间差异无统计学意义(P>0.05),而恶心呕吐、皮疹、肌肉痛、周围神经炎和呼吸困难发生率LEP组均低于PTX组,其OR(95%CI)分别为0.48(0.33～0.69)、0.17(0.08～0.40)、0.23(、0.15～0.35)、0.41(0.21～0.81)和0.18(0.06～0.50),差异均有统计学意义(均P<0.01)。结论:LEP具有与PTX相似的疗效,但较PTX有更好的安全性。
Objective: To evaluate the efficacy and safety of paclitaxel liposome (LEP) in the treatment of non-small cell lung cancer (NSCLC). METHODS: Medline, Embase, PubMed, Wanfang and Chinese Journal Full-text Database (searched from 1980 to July 31, 2011) and the Cochrane Library System Evaluation and Clinical Trials Database (Issue 2, 2011) Randomized controlled trials of LET-treated NSCLC with paclitaxel (PTX) as control were collected. According to inclusion criteria, the literature was screened and evaluated, and meta-analysis was performed to compare the efficacy and adverse reactions of LEP and PTX in the treatment of NSCLC. The results were compared with relative risk (RR), odds ratio (OR) and 95% confidence Interval (CI) said. Results: A total of 1057 related literatures were retrieved and screened and finally included in the literature. There were 627 NSCLC patients in total, including 329 in the LEP group and 298 in the PTX group. Meta analysis showed that there was no significant difference between the two groups (RR = 1.16, 95% CI 0.93-1.46, P = 0.19); between the two groups, leukopenia, thrombocytopenia, anemia and hair loss (P> 0.05). However, the incidences of nausea, vomiting, rash, muscle pain, peripheral neuropathy and dyspnea in LEP group were lower than those in PTX group (OR = 95% CI 0.48, 0.33-0.69 ), 0.17 (0.08-0.40), 0.23 (0.15-0.35), 0.41 (0.21-0.81) and 0.18 (0.06-0.50), respectively (all P <0.01). Conclusions: LEP has similar efficacy to PTX, but has better safety than PTX.