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目的:系统评价高级别胶质瘤(high grade glioma,HGG)术后三维适形放疗(three dimensional conformal radiotherapy,3D-CRT)与替莫唑胺(temozolamide,TMZ)同步放化疗的有效性和安全性。方法:计算机检索PubMed、Cochrane Library、EMbase、CBM、VIP、CNKI和万方数据库,收集所有相关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,采用RevMan 5.1软件进行Meta分析,应用GRADE系统对证据质量分级。结果:纳入13个RCT共1 309例患者。Meta分析结果显示,与单纯3D-CRT相比,3D-CRT同步联合TMZ治疗可以提高HGG患者术后的有效率(RR=1.93,95%CI:1.53~2.44,P<0.01)及疾病控制率(RR=1.16,95%CI:1.03~1.30,P=0.01);亦可提高6个月(RR=1.33,95%CI:1.09~1.62,P<0.01)、12个月OS(RR=1.39,95%CI:1.25~1.54,P<0.01)、24个月OS(RR=2.24,95%CI:1.83~2.76,P<0.01)和36个月OS(RR=2.48,95%CI:1.63~3.76,P<0.01)总生存率,同时也增加了胃肠道反应(RR=2.33,95%CI:1.25~4.33,P<0.01)及血液学毒性(RR=1.72,95%CI:1.23~2.41,P<0.01)的发生率,但均无严重性胃肠道反应及血液学毒性报道。提示,3D-CRT同步联合TMZ组优于单纯3D-CRT组。GRADE系统评价结果显示,证据水平均不会高于C级。结论:3D-CRT与TMZ同步放化疗治疗术后HGG是一种有效且安全的治疗方式。基于GRADE系统的证据质量偏低,尚需要更多大样本和高质量的RCT进一步论证。
OBJECTIVE: To evaluate the efficacy and safety of concurrent chemoradiation with three-dimensional conformal radiotherapy (3D-CRT) and temozolamide (TMZ) in patients with high grade glioma (HGG). METHODS: PubMed, Cochrane Library, EMbase, CBM, VIP, CNKI and Wanfang databases were searched by computer. All relevant randomized controlled trials (RCTs) were collected. Data retrieval and quality evaluation were conducted independently by two researchers. Meta-analysis was performed using RevMan 5.1 software, and GRADE system was used to grade the quality of evidence. Results: A total of 1 309 patients were enrolled in the 13 RCTs. Meta-analysis showed that the combination of 3D-CRT and TMZ could improve the postoperative efficiency (RR = 1.93, 95% CI: 1.53-2.44, P <0.01) and disease control rate (RR = 1.33, 95% CI: 1.09-1.62, P <0.01). The 12-month OS (RR = 1.39, CI = 1.03-1.35, P = , 95% CI: 1.25-1.54, P <0.01), 24 months OS (RR = 2.24,95% CI: 1.83-2.76, P <0.01) and 36 months OS ~ 3.76, P <0.01). The overall survival rate also increased in the gastrointestinal tract (RR = 2.33, 95% CI: 1.25-4.33, P <0.01) and hematological toxicity (RR = 1.72, 95% CI: 1.23 ~ 2.41, P <0.01), but no serious gastrointestinal reactions and hematological toxicity were reported. Tip, 3D-CRT synchronized with TMZ group was better than simple 3D-CRT group. GRADE systematic evaluation results show that the level of evidence will not be higher than the C level. Conclusion: 3D-CRT and TMZ concurrent chemoradiotherapy for postoperative HGG is an effective and safe treatment. The low quality of evidence based on the GRADE system still requires further large sample and high quality RCT for further demonstration.