Ⅰb2和Ⅱa2期子宫颈癌患者以手术为主的不同治疗方案的前瞻性随机对照研究  

Comparison of the clinical efficacy of different treatments based on radical surgery in stage Ⅰb2 andⅡa2 cervical cancer：a prospective randomized control study

作　　者：李雪[1,2] 孔为民[1] 韩超[1] 闫震[1] 赵辉[1] 张为远[1] 王建东[1] 

机构地区：[1]首都医科大学附属北京妇产医院妇瘤科,100006 [2]北京航天总医院妇产科,100076

出　　处：《中华妇产科杂志》2016年第7期524-529,共6页Chinese Journal of Obstetrics and Gynecology

基　　金：北京市科技计划（D09050703570902）

摘　　要：目的：采用前瞻性随机对照研究方法观察不同方案治疗Ⅰb2和Ⅱa2期子宫颈癌的临床疗效。方法选择2009年1月至2012年12月期间首都医科大学附属北京妇产医院收治的有组织病理学诊断的行手术治疗的Ⅰb2及Ⅱa2期子宫颈癌患者，共133例成功入组并随机（采用随机表法）被分为术前放疗组（42例，源旁1 cm放疗剂量为20-30 Gy）、新辅助化疗组（45例，紫杉醇＋卡铂方案化疗2个疗程）及直接手术组（46例），手术方式均为子宫广泛性切除＋盆腔淋巴结切除±腹主动脉旁淋巴结切除术。观察两个术前治疗组患者的近期疗效和副反应，并比较3组患者的手术时间、术中出血量、手术并发症、术后病理高危因素、术后辅助治疗及其副反应、生存情况等。结果（1）术前放疗组、新辅助化疗组的有效率分别为88%（37/42）、82%（37/45），两组比较，差异无统计学意义（P〉0.05）。术前放疗组患者发生副反应者较少，仅5例（12%，5/42）发生Ⅰ-Ⅱ级胃肠道反应，新辅助化疗组患者发生骨髓抑制及胃肠道反应的发生率[分别为76%（34/45）、67%（30/45）]均明显高于术前放疗组（P〈0.05）。（2）直接手术组、术前放疗组、新辅助化疗组3组患者间术中出血量[分别为（711±319）、（678±239）、（625±137）ml]及手术时间[分别为（202±64）、（181±39）、（168±25）min]分别比较，差异均无统计学意义（P〉0.05）；但新辅助化疗组的手术时间明显短于直接手术组（P〈0.05）。直接手术组、术前放疗组、新辅助化疗组3组间淋巴结转移[分别为30%（14/46）、29%（12/42）、29%（13/45）]、子宫颈间质深层受侵[分别为22%（10/46）、31%（13/42）、31%（14/45）]的发生率分别比较，差异均无统计学意义（P〉0.05）；但新辅助化疗组淋巴脉管间隙受侵的发生率明显低于直接手术组[分别为31%（14/45）、57%（26Objective To compare the clinical efficacy of different treatments based on radical＆amp;nbsp;surgery in stage Ⅰ b2 and Ⅱ a2 cervical cancer through prospective randomized controlled study. Methods A total of 133 patients with stage Ⅰb2 and Ⅱa2 cervical cancer treated at Beijing Obstetrics and Gynecology Hospital of Capital Medical University during January 2009 to December 2012 were enrolled and randomly assigned to receive one of the following three treatments： preoperative intracavitary irradiation （PII） group, radical hysterectomy （RH） group, and neoadjuvant chemotherapy （NACT） group. Operation method included uterine extensive resection, pelvic lymph node excision, with or without para-aortic lymph node resection. The recent curative effect and side effect of preoperative treatment were observed. The operation time, intraoperative blood loss, surgical complications, postoperative pathological risk factors and postoperative adjuvant therapy and side effect, the survival situation were evaluated among the 3 groups. Results （1）The response rates were 88%（37/42） and 82%（37/45） respectively of the PII group and NACT group. The difference was insignificant （P=0.528）. Side effects were less in the PII group. Only 5 patients （12%,5/42） had slight gastrointestinal reaction. Myelosuppression and gastrointestinal reaction in NACT group were 76%（34/45） and 67%（30/45） respectively, which were more serious than that in group PII group （P〈0.05）. （2） Intraoperative blood loss and operation time in PII group [（678 ± 239）ml and（181 ± 39）minutes] and NACT group [（625 ± 137）ml and（168 ± 25）minutes] had a decreasing trend compared with that in RH group [（711 ± 319） ml and （202 ± 64） minutes], but the differences were no significant （P〉0.05）. NACT group could shorten operation time compared with the RH group （P〈0.05）. The lymph node metastases rate were 30%（14/46）, 29%（12/42）and 29%（13/45）and the deep stromal invasio

关 键 词：宫颈肿瘤 妇科外科手术 放化疗 辅助 肿瘤治疗方案 前瞻性研究 

分 类 号：R737.33[医药卫生—肿瘤]