CAJ | 학술논문

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。
목적：계통평개체막서알연합방료여단순방료치료악성효질류적유효성화안전성。방법검색Cochrane Database of Systematic Reviews、MEDLINE、EMbase、CNKI、VlP、만방등수거고，대부합질량표준적수궤대조시험채용RevMan 5.1화GRAEDprofiler 3.6진행Meta분석。결과최종납입10개RCT，공포괄984례환자，시험조490례，대조조494례。 Meta분석결과현시：체막서알화료연합방료조여단순방료조비교，기총유효솔[OR =4.78，95%CI(2.90，7.90)]、1년생존솔[OR =4.40，95%CI(2.54，7.62)]、2년생존솔[OR =3.79，95%CI(2.69，5.33)]、3년생존솔[OR =4.21，95%CI(2.30，7.68)]、혈액학Ⅲ、Ⅳ급독부작용발생솔[OR =7.79，95%CI(2.69，22.58)]，차이균유통계학의의。체막서알연합방료인기적Ⅰ、Ⅱ도골수억제발생솔[OR =1.77，95%CI(0.42，7.37)]、방사성뇌손상발생솔[OR =1.05，95%CI(0.42，2.60)]여단순방료상비，차이무통계학의의。결론체막서알연합방료치료악성효질류총체효과우우단순방료，단감우납입연구교소，양본량소，차질량불고，고잉수개전대양본、다중심、고질량적수궤대조시험，진일보험증체막서알연합방료치료악성효질류적효과。
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.