沙利度胺联合化疗治疗中国晚期非小细胞肺癌患者的随机对照试验Meta分析

  目的  通过Meta分析探讨沙利度胺联合化疗在晚期非小细胞肺癌患者中的应用价值。   方法  由两位独立评价者按相同检索策略检索中国生物医学文献库等资源中的文献，根据纳入标准筛选相关随机对照试验，评价研究质量后用RevMan 5.1软件进行分析，分析指标为有效率、临床获益率及不良反应。   结果  共纳入12项研究，总病例数691例。Meta分析显示:沙利度胺联合化疗组在有效率（OR=1.62，95%CI:1.18~2.22）及临床获益率（OR=2.05，95%CI:1.40~3.02）方面优于单纯化疗组。联合治疗组与单纯化疗组相比，血液学毒性发生率差异无统计学意义，恶心呕吐发生率低于后者（P=0.002），外周神经毒性发生率有高于后者的趋势（P=0.05），而便秘、乏力嗜睡、皮疹或瘙痒发生率高于后者（P值分别为0.002、0.000 2、0.001）。   结论  沙利度胺联合化疗可能提高中国患者的治疗有效率与临床获益率，但生存获益尚不明确。联合治疗不增加严重不良反应。 

Meta-analysis of Randomized Clinical Trials of Thalidomide-chemotherapy Combination Regimen for Non-small Cell Lung Cancer Patients in China

  Objective  To investigate the efficacy and adverse reactions of thalidomide-chemotherapy combination regimen in advanced Chinese non-small cell lung cancer patients by meta-analysis.   Methods  Data of randomized controlled trials were collected from different databases by two independent researchers according to inclusion and exclusion criteria. Meta-analysis of the response rate, clinical benefit response, and different adverse reactions between the thalidomide-chemotherapy combination group and chemotherapy-only group was performed using RevMan 5.1 software.   Results  A total of 691 patients in 12 randomized clinical trials were included. The meta- analysis results showed that the thalidomide-chemotherapy group had higher response rate [OR=1.62, 95%CI (1.18-2.22)] and clinical benefit response [OR = 2.05, 95% CI (1.40-3.02)] (P=0.003, P<0.001, respectively). In the thalidomide-chemotherapy group, the incidence of nausea and vomiting were statistically lower (P=0.002), but the incidence of constipation, somnolence, erythra, and peripheral neurotoxicity were statistically higher (P=0.002, 0.000 2, 0.001, and 0.05, respectively). The differences among the marrow suppression incidences were not statistically significant.   Conclusion   Thalidomide addition to chemotherapy can improve the response rate and clinical benefit response of Chinese patients, but their overall survival remains to be explored. No serious adverse reaction was observed in the combination therapy group.