替莫唑胺联合放疗治疗恶性胶质瘤有效性和安全性的Meta分析

The effectiveness and safety of Temozolomide combined with radiotherapy treatment for malignant glioma: a Meta-analysis

目的系统评价替莫唑胺联合放疗与单纯放疗治疗恶性胶质瘤的有效性和安全性。方法检索Cochrane Database of Systematic Reviews、MEDLINE、EMbase、CNKI、VlP、万方等数据库,对符合质量标准的随机对照试验采用RevMan 5.1和GRAEDprofiler 3.6进行Meta分析。结果最终纳入10个RCT,共包括984例患者,试验组490例,对照组494例。Meta分析结果显示:替莫唑胺化疗联合放疗组与单纯放疗组比较,其总有效率[OR=4.78,95%CI(2.90,7.90)]、1年生存率[OR=4.40,95%CI(2.54,7.62)]、2年生存率[OR=3.79,95%CI(2.69,5.33)]、3年生存率[OR=4.21,95%CI(2.30,7.68)]、血液学Ⅲ、Ⅳ级毒副作用发生率[OR=7.79,95%CI(2.69,22.58)],差异均有统计学意义。替莫唑胺联合放疗引起的Ⅰ、Ⅱ度骨髓抑制发生率[OR=1.77,95%CI(0.42,7.37)]、放射性脑损伤发生率[OR=1.05,95%CI(0.42,2.60)]与单纯放疗相比,差异无统计学意义。结论替莫唑胺联合放疗治疗恶性胶质瘤总体效果优于单纯放疗,但鉴于纳入研究较少,样本量小,且质量不高,故仍需开展大样本、多中心、高质量的随机对照试验,进一步验证替莫唑胺联合放疗治疗恶性胶质瘤的效果。

Objective To evaluate the effectiveness and safety of Temozolomide combined with radiotherapy for malig-nant glioma compared with single radiotherapy. Methods Cochrane Database of Systematic Reviews, MEDLINE, EM-base, CNKI, VIP, Wanfang Data were searched for the randomized controlled trials （RCTs）. The extracted data were analyzed by RevMan 5.1 and GRAEDprofiler 3.6. Results A total of 10 trials were discovered. Of 984 patients, 490 cases were in the treatment group and 494 cases were in the control group. Meta-analysis showed that the total effec-tive rate [OR = 4.78, 95%CI （2.90, 7.90）], the 1-year survial rate [OR = 4.40, 95%CI （2.54, 7.62）], 2-year survival rate [OR = 3.79, 95%CI （2.69, 5.33）], 3-year survival rate [OR = 4.21, 95%CI （2.30, 7.68）] and the incidence rate of grade Ⅲ,Ⅳhematologic toxic effects [OR =7.79, 95%CI （2.69, 22.58）], significant differences were found in the group of Temozolomide combined with radiotherapy for malignant glioma compared with the group of single radiotherapy. There were no differences of the incidence rate of degree Ⅰ, II arrest of bone marrow [OR = 1.77, 95%CI （0.42, 7.37）] and the incidence of radiation-induced brain injury [OR =1.05, 95%CI （0.42, 2.60）] between the group of Temozolomide combined with radiotherapy and the group of single radiotherapy. Conclusion Temozolomide combined with radiothera-py for malignant glioma is better than radiotherapy alone. Due to the limitations of the included studies, more large-sample, high-quality RCTs are required for further study.