宫颈癌根治术中改良型保留盆腔自主神经术式对膀胱功能及预后的影响

Effects of modified nerve plane sparing radical hysterectomy on postoperative bladder function and prognosis

目的探讨改良型保留盆腔自主神经的宫颈癌根治性手术,即保留神经平面子宫广泛性切除术（NPSRH）对患者膀胱功能及预后的影响。方法收集2007年1月至2010年12月在重庆市江津区中心医院接受NPSRH治疗的51例国际妇产科联盟（FIGO）临床分期为ⅠB1-ⅡA2期的宫颈癌患者为研究对象,纳入NPSRH组。采用Excel 2010软件中随机选取公式,随机选取同期接受常规开腹子宫广泛性切除术（CRH）的102例FIGOⅠB1-ⅡA2期宫颈癌患者纳入CRH组。对两组患者的手术相关指标、术后膀胱功能恢复情况（以术后导尿时间评价术后近期膀胱功能,采用生命质量调查法评价术后远期膀胱功能）及宫颈癌复发、患者生存状况进行统计学分析,并对影响宫颈癌患者预后因素进行单因素与多因素Cox回归模型分析。本研究遵循的程序符合重庆市江津区中心医院人体试验委员会所制定的伦理学标准,得到该委员会批准,征得受试对象的知情同意,并与之签署临床研究知情同意书。两组患者年龄、体质指数、FIGO临床分期、病理类型及术前接受新辅助化疗等相关指标比较,差异均无统计学意义（P〉0.05）。结果 1NPSRH组中位手术时间显著长于CRH组,并且差异有统计学意义（P〈0.01）。两组中位术中出血量、输血率,术后并发症发生率及中位住院时间比较,差异均无统计学意义（P〉0.05）。2NPSRH组术后中位导尿时间显著短于CRH组,并且差异有统计学意义（P〈0.01）。NPSRH组术后远期（手术6个月后）尿频、尿潴留、尿失禁及用力排尿发生率,均显著低于CRH组,并且差异均有统计学意义（P〈0.05）;而两组尿急发生率比较,差异无统计学意义（P=0.111）。3两组术后病理危险因素,如深肌层受侵率、淋巴结转移率、宫旁受侵率及阴道受侵率比较,差异均无统计学意义（P〉0.05）;而NPSRH组淋巴脉管间隙受侵率显著低于CRH组,并且差异有统计学意义（P=0.006）。两组术后接受辅助治疗率比较,差异无统计学意义（P=0.283）。4NPSRH组及CRH组患者3年随访的失访率分别为7.0%（3/43）与4.8%（4/84）,两组比较,差异均无统计学意义（P〉0.05）,病死率分别为7.0%（3/43）与8.3%（7/84）,两组比较,差异均无统计学意义（P〉0.05）。5两组患者随访期间复发率,3年无复发生存（RFS）率,3年总体生存（OS）率比较,差异均无统计学意义（P〉0.05）。6对影响宫颈癌患者预后因素进行单因素Cox回归模型分析结果显示,组织病理学类型、淋巴结转移和淋巴脉管间隙受侵为影响患者3年RFS率和3年OS率的危险因素（3年RFS率：RR=3.47,5.41,3.09;3年OS率：RR=3.49,8.23,3.82;P〈0.05）,而保留神经平面与否,对患者3年RFS率和3年OS率无明显影响（RR=1.12,1.20;P〉0.05）。对影响宫颈癌患者预后因素的多因素Cox回归模型分析结果显示,组织病理学类型、淋巴结转移是影响患者3年RFS率的独立危险因素（RR=2.51,3.68;P〈0.05）;淋巴结转移是影响患者3年OS率的独立危险因素（RR=4.76,P=0.001）。结论 NPSRH治疗可明显改善FIGOⅠB1-ⅡA2期宫颈癌患者术后的膀胱功能,但不影响患者的预后。

Objective To study effects of modified nerve plane sparing radical hysterectomy （NPSRH） on patientsr postoperative bladder function and prognosis. Methods From January 2007 to December 2010, a total of 51 cases of International Federation of Gynecology and Obstetrics （FIGO） clinical stages ⅠA1-ⅡA22 cervical cancer were treated by NPSRH, and they were included into NPSRH group.During the same period, a total of 102 cases of FIGO clinical stages ⅠA1-ⅡA2 who underwent conventional radical hysterectomy （CRH） were randomly selected as CRH group. Operation related index, recovery of bladder function after operation, relapse and survival condition were analyzed. And within 6 months after operation, the bladder function was evaluated by duration of catheterization. While 6 months after operation, it was evaluated by quality of life survey method. Factors affecting the prognosis of patients with cervical cancer were analyzed by single factor and multi factor Cox regression model. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Jiangjin District Center Hospital of Chongqing. Informed consent was obtained from all participants. There were no significant differences between two groups among age, body mass index, FIG（） clinical stage, pathological type, whether or not to accept new adjuvant chemotherapy, and postoperative adjuvant therapy, etc. （P〈0.05）. Results ① The median operation time in NPSRH group was much shorter than that in CRH group, and there was significant difference （P〈0.01）. There were no significant differences between two groups among median intraoperative blood loss volumes, median rates of blood transfusion, incidence rates of postoperative complications, and median durations of hospitalization （P〉0. 05 ）.② The median duration of catheterization in NPSRH group was much shorter than that in CRH group, and there was significant difference （P〈0. 01）. The incidence rates of long-term （6 months after operation） urinary frequency, urinary incontinence, urinary retention and straining to void in NPSRH group were significantly lower than those in CRH group, and all the differences were statistically significant （P〈 0. 05）. There was no significant difference between two groups in rate of urgency （P = 0. 111）. ③ There were no significant differences between two groups in risk factors of histopathologic, such as rate of deep myometrial invasion, lymph node metastasis, parametrial invasion and vaginal invasion （P〉0.05）. But the rate of lymph vascular space invasion rate in NPSRH group was much lower than that in CRH group, and there was significant difference （P= 0. 006）. There was no significant difference between two groups in rate of receiving adjuvant treatment after operation （P=0 283）. ④ A total of 43 cases of patients in NPSRH group and 84 patients in CRH group completed the telephone interview about long-term bladder function. The lost of follow-up rates and case fatality rates of two groups were 7.0% （3/43） and 4.8% （4/84）, 7.0% （3/43） and 8.3% （7/ 84）, respectively. And there were no significant differences among those two rates between two groups （P〉0.05）. ⑤ There were no significant differences between two groups among rates of recurrence, three- year recurrence-free survival （RFS）, three-year overall survival （OS） （P 0. 05）. ⑥ The univariate analysis by Cox regression model showed that pathological type, lymph node metastases, and lymph- vascular space invasion （LVSI） presented the trend for a lower rates of 3-year RFS and OS （rate of 3-year RFS： RR=3.47, 5.41, 3.09; rateof 3 year OS： RR 3.49, 8.23, 3.82; P〈0.05）; Whether reserveing nerve plane or not had no influences on rates of 3 year RFS and OS （RR=1. 12, 1.20; P〉0.05）. The multivariate analysis by Cox regression model showed that both pathological type and lymph node metastases were associated with a lower rate of 3 year RFS （RR=2.51, 3.68 ; P〈0.05）. Lymph node metastases was a significant independent predictor of rate of 3 year OS （RR=4. 76, P=0. 001）. NPSRH was not a significant independent predictor by Cox regression model analysis. Conclusions NPSRH treatment can significantly improve bladder function of cervical cancer patients with FIGO clinical stages ⅠB1-ⅡA2, and does not affect the prognosis of patients.