射频热凝固治疗子宫肌瘤的远期疗效

Long-Term Follow-Up Study of Radiofrequency Thermocoagulation Ablation on Uterine Myomas

目的探讨射频热凝固(RFT)微创治疗子宫肌瘤(UM)的远期疗效。方法选择2001年7月至2011年7月本院收治的符合本研究纳入标准的UM患者1216例为研究对象。根据年龄将其分为:A组(n=476,为生育期与中年患者,包括有生育要求者36例),年龄<45岁,平均为(36.5±8.5)岁(27.0～52.5岁),UM数目平均为(1.7±0.9)个(1～3个),RFT治疗前彩超测量其平均直径为(4.5±1.5)cm[(3.1～6.0)cm],平均体积为47.6cm3[(15.6～113.0)cm3];B组(n=740,为围绝经期患者),年龄≥45岁,平均为(48.5±3.5)岁(45～53岁),UM数目平均为(2.6±1.3)个(1～4个),RFT治疗前彩超测量其平均直径为(5.0±2.5)cm[(3.0～7.5)cm],平均体积为65.4cm3[(14.1～220.8)cm3]。RFT治疗前,对两组患者进行彩超检查、血红蛋白(Hb)测定、宫颈脱落细胞检查(TCT)、宫腔镜检查和子宫内膜诊刮组织病理学诊断。治疗后对其随访12～60个月,平均随访时间为(36.5±11.5)个月。对两组治疗前、后相关结果进行统计学分析(本研究遵循的程序符合本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,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书)。两组UM数目、直径及RFT治疗前相关检查结果比较,差异无统计学意义(P>0.05)。结果①RFT后1,3,6,12和24个月随访结果,彩超显示:A组原主要UM病灶区的UM平均直径分别为3.8cm,3.0cm,2.7cm,2.4cm和2.2cm,病灶区体积缩小率分别为39.8%,70.4%,78.4%,84.8%和88.3%,12个月后,病灶区痕迹影像≤1.5cm者(体积缩减小96.3%)占47.7%(227/476);B组平均直径依次为4.7cm,3.7cm,3.3cm,2.3cm和2.3cm,体积缩小率分别为16.9%,59.5%,71.3%,90.3%和90.3%,12个月后≤1.7cm者(体积缩小96.1%)占58.8%(435/740)。两组治疗3个月后,UM体积均较RFT前显著减小,差异有统计学意义(P<0.01);12个月后,病灶区显示痕迹影像率B组显著高于A组,差异有统计学意义(P<0.05)。②RFT治疗后第3,6和12个月时,Hb水平较治疗前明显提高,差异均有统计学意义(P<0.01)。③A,B组主要并发症均为术中出血(发生率分别为24.4%,28.5%),两组均无其他严重并发症。随访期内,A组RFT治疗后UM再生发生率为10.7%(51/476),显著性高于B组[2.4%(18/740)],差异有统计学意义(P<0.05)。结论 RFT治疗直径≤5.0cmUM是一种较好的微创治疗方法,具有治疗时间短、见效快及疗效高等特点。

Objective To investigate the long-term curative effects of radiofrequency thermocoagulation （RFT） on uterine myomas （UM）. Methods From July 2001 to July 2011, a total of 1216 patients with UM were included in this study. They were divided into two groups according to their ages. Group A （n=476, childbearing period and middle-aged women, including 36 cases had pregnancy desire）, 〈45 year old, and the average age was （36.5±8.5） years old, the average number of UM was 1.7±0.9. The average diameter of UM which was measured by color Doppler ultrasound before RFT treatment was （4.5±1.5） em[（3.1-6.0） cm], and the average volume was 47.6 cm3[（15.6-113.0） cm3]. Group B （n= 740, perimenopausal period women）, ±45 year old, and the average age was （48. 5 ±3.5）years old,the average number of UM was 2.6± 1.3. The average diameter of UM which was measured by color Doppler ultrasound before RFT treatment was （5.0±2.5）cm[-（3.0-7.5） cm], and the average volume was 65.4 cm2 [（14. 1-220.8） cm3]. Before RFT treatment, all the patients received color Doppler ultrasound examination, hemoglobin （Hb）, thin perp cytologic test （TCT）, hysteroscopy, and endometrial pathology. The follow up term was 12-60 monthsEthe average was （36. 5 ± 11. 5） months]. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Jinan Millitary General Hospital. Informed consent was obtained from all participants. There had no statistically significant differences between two groups among the number, diameter and volume of UM and other results of relative examinations before RFT （P〉0.05）. Results ①The follow-up results of color Doppler ultrasound at 1, 3, 6, 12 months after RFT showed, among group A, the average diameters of UM were 3. 8 cm, 3. 0 cm, 2.7 cm, 2.4 em and 2. 2 cm, as well as the decreased percentages of volumes were 39. 8%, 70. 4%, 78.4%, 84.8% and 88. 3%. And the trace-image of focal zone （the diameter≤1. 5 cm and the volume decreased 96.3%）was 47. 7% （227/476） in 12 months after RFT. In group B, the decreased diameters were 4.7 cm, 3.7 cm, 3.3 cm, 2.3 cm and 2.3 era, as well as the decreased percentages of volumes were 16.9%, 59.5%, 71.3%, 90.3% and 90.3% ,and the trace-image of focal zone （the diameter≤1. 7 em and the volume decreased 96.1%）was 58.8± （435/740） in 12 months after RFT. Compared with pre-RFT, the volumes of UM between two groups were statistically decreased in 3 months after RFT treatment （P 〈0.01）, and the percentage of traee-image of group B in 12 months after RFT treatment was much higher than that in group A, with significant differenee （P〈0.05）. ② There had statistically significant difference of Hb levels between pre-RFT and at 3, 6, 12 months after RFT both in groups A and B （P〈0.05）. ③ The main complications of group A and B were bleeding during RFT, and the incidence rates were 24.4% and 28.5%, respectively, without serious complications. The regeneration rate of UM in group A after RFT was 10.7% （51/476）, which was higher than that in group B （2. 4%, 18/740） （P〈0.05）. Conclusions RFT is a simple, safe, effective and minimally invasive procedure for the UM which diameter is less than 5.0cm.