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目的:评价放疗联合替莫唑胺治疗与单纯放疗相比,治疗新诊断的多形性成胶质细胞瘤(glioblastoma multiforme,GBM)的有效性及安全性。方法:计算机检索PubMed(1966年1月-2009年12月)、EMBASE(1974年1月-2009年12月)、Cochrane图书馆(2009年第4期)、中国期刊全文数据库(1994年1月-2009年12月)、中国生物医学文献数据库(1978年1月-2009年12月)、中文科技期刊全文数据库(1989年1月-2009年12月)和万方数据库(1997年1月-2009年12月)。纳入放疗联合替莫唑胺治疗新诊断的GBM的临床随机对照试验(randomized controlled trial,RCT),由2名研究者独立进行资料提取和质量评价,纳入文献的方法学质量分析依据Cochrane评价手册5.0.0随机对照试验质量评价标准。采用RevMan5.0软件进行meta分析。结果:最终纳入5个RCT,共包括896例患者。Meta分析结果显示,与单纯放疗相比,放疗联合替莫唑胺治疗可以提高新诊断GBM患者18个月总生存率(overall survival,OS)[相对危险比为2.46(95%的可信区间:1.11~5.46)]和24个月OS[相对危险比为2.88(95%的可信区间:1.95~4.25)],改善6个月无进展生存期(progression-free surviv-al,PFS)[相对危险比为1.48(95%的可信区间:1.22~1.78)]、12个月PFS[相对危险比为3.07(95%的可信区间:2.17~4.34)]、18个月PFS[相对危险比为4.71(95%的可信区间:2.51~8.84)]和24个月PFS[相对危险比为7.47(95%的可信区间:2.67~20.94)],并改善6个月肿瘤进展时间(time to progression,TTP)[相对危险比为1.51(95%的可信区间:1.07~2.13)]和12个月TTP[相对危险比为3.91(95%的可信区间:1.59~9.61)]。放疗联合替莫唑胺治疗引发的3~4级白细胞减少[相对危险比为4.31(95%的可信区间:0.77~24.31)]、3~4级血小板减少[相对危险比为4.03(95%的可信区间:0.70~23.34)]和4级中性粒细胞减少[相对危险比为2.79(95%的可信区间:0.12~67.10]与单纯放疗相比,差异无统计学意义。结论:放疗联合替莫唑胺治疗可以提高新诊断GBM患者的18和24个月OS,改善6、12、18和24个月PFS以及6和12个月TTP。因此,放疗联合替莫唑胺治疗是目前术后治疗新诊断GBM的一种较为合理而有效的综合治疗手段。
OBJECTIVE: To evaluate the efficacy and safety of radiotherapy combined with temozolomide in the treatment of newly diagnosed glioblastoma multiforme (GBM) compared with radiotherapy alone. METHODS: We searched PubMed (January 1966-December 2009), EMBASE (January 1974-December 2009), Cochrane Library (2009), and Chinese Journal Full-text Database (January 1994) - December 2009), China Biomedical Literature Database (January 1978-December 2009), Chinese Science and Technology Periodical Full-text Database (January 1989 - December 2009) and Wanfang Database (January 1997 - December 2009) December 2009). A randomized controlled trial (RCT) of radiotherapy combined with temozolomide in the treatment of newly diagnosed GBM was performed independently by two investigators for data extraction and quality evaluation. The methodological quality of the included literature was based on the Cochrane Review Manual 5.0.0 Control test quality evaluation criteria. RevMan5.0 software for meta-analysis. Results: Five RCTs were eventually enrolled, encompassing 896 patients. Meta-analysis showed that radiotherapy combined with temozolomide treatment improved overall 18-month overall survival (OS) for newly diagnosed GBM patients compared with radiotherapy alone (relative risk ratio, 2.46; 95% confidence interval, 1.11-5.46 ) And 24-month OS [relative risk ratio 2.88 (95% CI: 1.95 to 4.25)], improved progression-free survival at 6 months (PFS) 1.48 to 1.48 (95% confidence interval: 1.22 to 1.78)], 12-month PFS (relative risk ratio, 3.07; 95% confidence interval, 2.17 to 4.34), 18-month PFS 95% CI: 2.51-8.84)] and PFS at 24 months (relative risk ratio 7.47 (95% confidence interval: 2.67-20.94)] and improved 6-month time to progression TTP) with a relative hazard ratio of 1.51 (a 95% confidence interval of 1.07 to 2.13) and a 12-month TTP (relative hazard ratio of 3.91 (95% confidence interval: 1.59 to 9.61)]. Grade 3-4 leukopenia (relative risk ratio: 4.31 (95% confidence interval: 0.77-24.31)] and grade 3-4 thrombocytopenia [relative risk ratio 4.03 (95% confidence interval Interval: 0.70-23.34)] and grade 4 neutropenia (relative risk ratio was 2.79 (95% confidence interval: 0.12-67.10), compared with radiotherapy alone, the difference was not statistically significant.Conclusion: Radiotherapy combined with temozolomide Treatment can improve 18- and 24-month OS in newly diagnosed GBM patients and improve PFS at 6, 12, 18 and 24 months and TTP at 6 and 12 months.Therefore, radiotherapy combined with temozolomide treatment is currently one of the newly diagnosed GBMs for post-operative treatment A more reasonable and effective comprehensive treatment.