CAJ | 학술논문

目的：系统评价贝伐单抗联合替莫唑胺同步放疗治疗新诊断的多形性胶质母细胞瘤（glioblastoma multiforme，GBM）的有效性和安全性。方法以计算机检索PubMed、Cochrane图书馆、EMBASE和万方数据库并收集所有相关临床研究资料。由两名研究者分别独立检索相关数据库，筛选相关文献并提取相关数据。采用RevMan 5.3统计学软件进行Meta分析。随机对照研究质量评价参考Cochrane系统评价手册推荐的方法。结果纳入4个前瞻性临床研究，共计1773例患者，其中试验组891例，对照组882例。Meta分析结果显示：与单纯替莫唑胺联合放疗相比，贝伐单抗联合替莫唑胺同步放疗治疗新诊断的GBM可以提高患者6个月（RR=0.44，95% CI：0.37~0.52，P<0.001）和12个月（RR=0.78，95%CI：0.73~0.84，P<0.001）的无疾病进展生存时间，同时也显著提高患者12个月（RR=0.86，95% CI：0.74~0.99，P=0.03）的总生存率，但增加了高血压病（RR=3.11，95% CI：2.39~4.06，P<0.001）、出血（RR=1.85，95% CI：1.50~2.27，P<0.001）不良反应的发生率，而血管栓塞性疾病、伤口愈合并发症、内脏穿孔等不良反应发生率比较的差异无统计学意义（P>0.05）。不良反应经治疗后均得以缓解。结论贝伐单抗联合替莫唑胺同步放疗治疗新诊断的GBM可延长患者的无疾病进展生存时间和总生存率，但增加不良反应的发生。
목적：계통평개패벌단항연합체막서알동보방료치료신진단적다형성효질모세포류（glioblastoma multiforme，GBM）적유효성화안전성。방법이계산궤검색PubMed、Cochrane도서관、EMBASE화만방수거고병수집소유상관림상연구자료。유량명연구자분별독립검색상관수거고，사선상관문헌병제취상관수거。채용RevMan 5.3통계학연건진행Meta분석。수궤대조연구질량평개삼고Cochrane계통평개수책추천적방법。결과납입4개전첨성림상연구，공계1773례환자，기중시험조891례，대조조882례。Meta분석결과현시：여단순체막서알연합방료상비，패벌단항연합체막서알동보방료치료신진단적GBM가이제고환자6개월（RR=0.44，95% CI：0.37~0.52，P<0.001）화12개월（RR=0.78，95%CI：0.73~0.84，P<0.001）적무질병진전생존시간，동시야현저제고환자12개월（RR=0.86，95% CI：0.74~0.99，P=0.03）적총생존솔，단증가료고혈압병（RR=3.11，95% CI：2.39~4.06，P<0.001）、출혈（RR=1.85，95% CI：1.50~2.27，P<0.001）불량반응적발생솔，이혈관전새성질병、상구유합병발증、내장천공등불량반응발생솔비교적차이무통계학의의（P>0.05）。불량반응경치료후균득이완해。결론패벌단항연합체막서알동보방료치료신진단적GBM가연장환자적무질병진전생존시간화총생존솔，단증가불량반응적발생。
Objective To assess the efficacy and safety of Bevacizumab combined with Radiotherapy-Temozolomide to treat newly diagnosed glioblastoma. Methods PubMed,The Cochrane Library,EMBASE,and the Wanfang Database were systematically searched for relevant clinical studies. Two researchers assessed trial quality according to the Cochrane Manual and extracted data independently. Data were analyzed using RevMan 5.3. Result Four prospective clinical trials,including two randomized controlled trials,were included in the review;these trials involved 891 patients who received Bevacizumab combined with radiotherapy-temozolomide and 882 control patients who received radiotherapy-temozolomide. Meta-analysis indicated that combination therapy was associated with significantly higher 6-month progression-free survival(PFS;RR 0.44,95%CI 0.37-0.52,P<0.001),12-month PFS(RR 0.78,95%CI 0.73-0.84, P<0.001)and 12-month overall survival (RR 0.86,95%CI 0.74-0.99,P=0.03). At the same time,combination therapy was associated with significantly higher incidence of hypertension(RR 3.11,95%CI 2.39-4.06,P<0.001)and bleeding(RR 1.85,95%CI 1.50-2.27, P<0.001). Incidence of vascular thrombus diseases,wound-healing complications and internal organ perforation was similar for the two therapies. All treatment-related adverse events were easily resolved. Conclusions Bevacizumab combined with radiotherapy-temozolomide can prolong progression-free and overall survival in patients with newly diagnosed glioblastoma,but it increases the risk of some adverse reactions.