【摘要】 目的探讨在真实世界研究条件下的ⅠA1(LVSI+)～ⅡA2期子宫颈癌腹腔镜与开腹手术的长期肿瘤学结局。方法基于中国子宫颈癌临床诊疗大数据库,在真实世界研究及1∶1倾向评分匹配条件下,比较匹配前后ⅠA1(LVSI+)～ⅡA2期子宫颈癌腹腔镜与开腹手术5年总体生存率(OS)及无病生存率(DFS)。结果 (1)将中国子宫颈癌临床诊疗大数据库中2009年1月1日至2016年12月31日全部的ⅠA1(LVSI+)～ⅡA2期15 515例子宫颈癌腹腔镜及开腹手术病例纳入研究中,腹腔镜组5205例,开腹组10 310例,两组患者5年OS无差异,5年DFS腹腔镜组低于开腹组(OS:88.7%vs. 90.3%,P=0.678,DFS:84.3%vs. 86.4%,P=0.006),Cox多因素分析提示腹腔镜手术是患者死亡和复发/死亡的独立危险因素(OS:HR=1.233,95%CI 1.073～1.417,P=0.003;DFS:HR=1.314,95%CI1.184～1.458,P<0.001);但两组患者在年龄、组织学类型、分期及术后病理中高危因素等存在差异,再行1∶1匹配后发现腹腔镜组(4317例)与开腹组(4317例)5年OS及DFS腹腔镜组均低于开腹组(OS:89.3%vs. 92.6%,P=0.009,DFS:84.8%vs. 89.1%,P<0.001),且腹腔镜手术是影响患者死亡和复发/死亡的独立危险因素(OS:HR=1.341,95%CI 1.114～1.616,P=0.002;DFS:HR=1.454,95%CI 1.265～1.670,P<0.001)。(2)进一步限定子宫切除类型为QM-B型/C型进行分析,腹腔镜组5019例,开腹组9473例,两组患者5年OS无差异,5年DFS腹腔镜组低于开腹组(OS:89.0%vs. 90.5%,P=0.630,DFS:84.3%vs. 86.6%,P=0.005),Cox多因素分析提示腹腔镜手术是影响患者死亡与复发/死亡的危险因素(OS:HR=1.229,95%CI 1.065～1.418,P=0.005;DFS:HR=1.324,95%CI 1.190～1.474,P=0.005);行1∶1匹配后腹腔镜组(4210例)与开腹组(4210例)5年OS及DFS比较:腹腔镜组均低于开腹组(OS:89.5%vs. 92.1%,P=0.014,DFS:84.2%vs. 88.2%,P<0.001),Cox多因素分析提示腹腔镜手术是影响患者死亡与复发/死亡的独立危险因素(OS:HR=1.330,95%CI 1.109～1.595,P=0.002;DFS:HR=1.404,95%CI 1.226～1.607,P<0.001)。结论在真实世界研究条件下,ⅠA1(LVSI+)～ⅡA2期子宫颈癌腹腔镜组5年OS及DFS均低于开腹组,且腹腔镜手术是影响患者死亡及复发/死亡的独立危险因素。更多还原

【Abstract】 Objective To investigate the long-term oncological outcomes of laparoscopic radical hysterectomy(LRH)and abdominal radical hysterectomy(ARH)in the treatment of stage ⅠA1(LVSI+)-ⅡA2 cervical cancer under the condition of real world study.Methods Based on the large database of clinical diagnosis and treatment of cervical cancer in China,the differences in 5-year overall survival(OS)and disease-free survival(DFS)between LRH and ARH were compared under the condition of real world study and propensity score matching(1∶1 matching).Results(1)A total of 15 515 patients with stage ⅠA1(LVSI +)-ⅡA2 from 2009-01-01 to 2016-12-31 in the large database of clinical diagnosis and treatment of cervical cancer in China were included in this study. There was no significant difference in the outcomes of LRH(n=5205)and ARH(n=10 310)in 5-year OS,but the LRH was associated with a lower rate of 5-year DFS(OS:88.7% vs. 90.3%,P=0.678,DFS:84.3% vs. 86.4%,P=0.006),In Cox multivariate analysis,it was found that laparoscopic surgery was an independent risk factor for death and recurrence/death(OS:HR=1.233,95% CI 1.073～1.417,P=0.003;DFS:HR=1.314,95% CI 1.184～1.458,P<0.001). However,there were differences between the two groups of patients in terms of age,histological type,stage of disease and postoperative pathological risk factors. After 1∶1 matching,the 5-year OS and DFS in LRH(n=4317)were lower than ARH(n=4317)(OS:89.3% vs. 92.6%,P=0.009,DFS:84.8% vs. 89.1%,P<0.001). And laparoscopic surgery was an independent risk factor for death and recurrence/death(OS:HR=1.341,95%CI 1.114～1.616,P=0.002;DFS:HR=1.454,95%CI 1.265～1.670,P<0.001).(2)The type of hysterectomy was further limited to QM-B/C for analysis,there were 5019 cases in the LRH and 9473 cases in ARH. There was no difference in 5-year OS,and the 5-year DFS of LRH were lower than that for ARH(OS:89.0% vs. 90.5%,P=0.630,DFS:84.3% vs. 86.6%,P=0.005).In Cox multivariate analysis,laparoscopic surgery was an independent risk factor for death and recurrence/death(OS:HR=1.229,95%CI 1.065～1.418,P=0.005;DFS:HR=1.324,95%CI 1.190～1.474,P=0.005). After 1∶1 pairing,the 5-year OS and DFS in LRH(n=4210)were lower than in ARH(n=4210)(OS:89.5% vs. 92.1 %,P=0.014,DFS:84.2% vs. 88.2%,P<0.001),and Cox multivariate analysis showed that the surgical approach was an independent risk factor which affected the 5-year OS and DFS(OS:HR=1.330,95%CI 1.109～1.595,P=0.002;DFS:HR=1.404,95%CI 1.226～1.607,P<0.001).Conclusion Under real world study conditions,the 5-year OS and DFS of the laparoscopic group of stage ⅠA1(LVSI +)-ⅡA2 cervical cancer are lower than those of the abdominal group,and laparoscopic surgery is an independent risk factor for patients’ death and recurrence/death.更多还原