低频电刺激联合生物反馈治疗宫颈癌术后盆底功能障碍的随机对照研究

发布时间：2018-05-30 01:22

本文选题：低频电刺激 + 生物反馈　；参考：《郑州大学》2017年硕士论文

【摘要】：背景宫颈癌作为女性生殖系统最为大家熟知的常见的恶性肿瘤之一,越来越引起人们的重视。在我国,随着宫颈癌筛查的普及,越来越多的早中期宫颈癌得以发现,并呈年轻化发展趋势。尽管近年国内外发展以来,早期宫颈癌有缩小手术范围的趋势,但是广泛全子宫切除术+盆腔/腹主淋巴结切除术(Piver Ⅲ型)仍为常用术式。因其手术范围较大,耗时长,盆底韧带、血管及神经受到不同程度损伤或切除,导致部分患者出现术后盆底功能障碍(PFD)高发情况。主要表现为尿潴留,泌尿系统的感染,排便障碍,以及性功能障碍等。而尿瘘,盆腔感染,淋巴囊肿,较为少见。宫颈癌术后盆底功能障碍高发,严重影响了人们的生活质量,如何提高宫颈癌术后患者生活质量成为了迫切需要解决的问题。有研究表明盆底电生理功能的变化与PFD之间有相当大的相关性,盆底电生理出现变化早于PFD的出现。因此盆底组织的相应损伤可以通过早期进行电生理检查得以发现;对盆底进行电生理治疗能够预防盆底功能障碍性疾病的发生,并能对其进行治疗。有研究表明,电刺激联合生物反馈治疗盆底功能障碍性疾病的效果优于单一治疗方案。本文将重点阐述低频电刺激联合生物反馈治疗宫颈癌术后盆底功能障碍的临床管理及疗效。目的本次研究采用前瞻性随机对照研究分析低频电刺激联合生物反馈治疗对早中期宫颈癌患者术后盆底功能障碍的防治效果以及对生活质量影响情况。材料和方法1研究对象选自2015年1月至2016年1月在郑州大学人民医院妇产科收治的行广泛性子宫全切除术+盆腔淋巴结清扫术并经病理结果证实为恶性肿瘤的75例宫颈癌患者。入选标准:(1)年龄60岁;(2)宫颈癌临床分期为Ⅰa2-Ⅱa2期;排除标准:(1)术前及术后放化疗者;(2)术前盆腔脏器脱垂者≥Ⅱ期者;(3)年龄≥60岁;(4)术前尿潴留者;(5)术前排便困难者;(6)术前中度以上尿失禁者;(7)具体影响到随访的疾病;(8)不能判定疗效或资料不全影响疗效判定者;中途撤出标准:(1)研究者从医学角度考虑受试者有必要终止试验;(2)患者自己要求停止试验;(3)试验期间出现严重并发症或不良反应者。2研究方法2.1分组:随机数字表法将符合纳入标准的75例宫颈癌患者分为两组,实验组38人,5例失访,2例转入他科继续治疗,1例拒绝随访;对照组37人,3例失访,4例转入他科治疗,故收集病例时,为保持随访资料的完整性,予以淘汰。盆底治疗组:30例,年龄36-59岁,平均年龄(48.93±7.21)岁。对照组:30例,年龄37-59岁,平均年龄(50.93±4.01)岁。2.2具体方法:盆底治疗组和对照组患者均行广泛性全子宫全切术+盆腔淋巴结清扫术。2.2.1术后早期干预方案:盆底治疗组术后第5天给予PHENIX神经肌肉治疗仪8-PLUS电刺激治疗共2天,尿潴留方案为:频率35Hz,脉宽200μs,2次/天,时间为20分钟。电极片放置位置为:一枚置于S3区,另一枚置于膀胱区。电极片选用50*50mm粘性电极片。术后7天拔除尿管查残余尿≤100ml,停止电刺激治疗。残余尿1OOml视为尿潴留,再次置入尿管,继续给予8-PLUS电刺激治疗,一日2次,共7天,14天时再次拔除尿管,测残余尿,若残余尿≥100ml,不再给予8-PLUS电刺激治疗,根据临床常规处理。对照组患者于术后7天拔除尿管行残余尿测定,若残余尿100ml,不予特殊处理;若残余尿≥100ml留置尿管,7天后拔除尿管查残余尿,若残余尿≥100ml留置尿管,按临床常规处理。2.2.2术后中期干预方案:盆底治疗组术后9周起给予盆腹电生理治疗:PHENIX神经肌肉治疗仪8-plus盆腹下肢血管平滑肌电刺激(大循环)6周。刺激方案为血动力激活,2次/周,方案为:频率4Hz,时间20min;电极片:50*90mm粘性电极片,两组(4枚);位置:一组置于左右脚背处,另一组其中一个置于腹总静脉右边处,另一个置于相应的背部同位置。术后13周给予盆底横纹肌电刺激加生物反馈6周,1周2次,共12次,时间30min。电极位置:A1通道盆底肌肉治疗头置于阴道内,A2通道电极片置于腹部,地线标志电极片置于髂骨处。生物反馈:U8内置模拟各种场景训练模块,给予会阴-腹部协调收缩。电极:杉山盆底肌肉治疗头50*50mm粘性电极片。位置:A1通道盆底肌肉治疗头置于阴道内,A2通道电极片置于腹部,地线标志电极片置于髂骨处。对照组术后行常规护理,余无特殊干预措施。2.3具体监测指标2.3.1主观部分:生活质量问卷之盆底障碍功能调查表(PFDI-20)PFDI-20是专门为女性盆底疾病所设计,共有20个问题,分别从排尿症状,排便症状以及盆腔脏器脱垂症状3个部位了解盆底功能障碍性疾病对患者生活质量的影响及评价主观症状的严重程度。总评分为0-300,分数越高,代表对生活影响越大;盆底障碍影响问卷7(PFIQ-7)分别从膀胱,肠道或者阴道影响日常生活三个方面进行检测,计算总分,分值越高,代表对生活影响越大;性功能质量调查问卷,总得分100,分数越高,代表其性生活质量越好。2.3.2客观部分:两组患者术后尿潴留发生率比较。残余尿"g1OOrrh,尿潴留。2.3.3客观部分:拔除尿管时间和住院时间:宫颈癌术后一般拔除尿管时间为7-14天,住院时间越长,相应住院花费较高。2.3.4客观部分:盆底功能检查:主要包括自由尿流率测定(最大尿流率,平均尿流率,达峰时间,排尿时间,残余尿),盆底电生理功能检查(I类肌纤维肌力,Ⅰ类肌纤维疲劳度,Ⅱ类肌纤维肌力,Ⅱ类肌纤维疲劳度,肌电位),盆底控尿功能(A3反馈),盆底性功能检查(性功能反射)。2.3.4.1自由尿流率的测定:最大尿流率Qmax,平均尿流率Qave,排尿时间,达峰时间,以及残余尿测定。正常范围分别是Qmax≥20ml/s,Qave≥20ml/s,排尿时间为排出尿量100ml则10秒为上限,排出尿量400ml则23秒为上限,残余尿测定正常100ml。2.3.4.2盆底电生理功能:Ⅰ类肌纤维肌力分为0-5级,患者阴道内肌肉收缩持续时间达到其最大值的40%。持续0秒为0级,持续1秒为1级,2秒为2级,3秒为3级,4秒为4级,5秒为5级;Ⅱ类肌纤维肌力,患者以最大的力气和速度匀速收缩和放松阴道,能达到最大收缩力1次为1级,2次为2级,3次为3级,4次为4级,5次为5级。Ⅰ,Ⅱ类肌纤维肌力≥3级为正常。从最高到6s终点的最高点之间的下降比率的百分比为疲劳度,正常0%,负值为异常。肌电位正常值为20-30μV,肌电位下降表示参与盆底收缩运动的肌纤维数量减少。2.3.4.3盆底控尿功能主要是A3反馈功能,异常时主要反映的是排尿异常。2.3.4.4盆底性功能检查主要是盆底性功能反射,性功能反射主要表现为正常和异常。2.4仪器设备PHENIX神经肌肉治疗仪8-plus法国VIVALTIS公司,广州杉山公司代理神经修复治疗仪U8 法国VIVALTIS公司,广州杉山公司代理盆底肌肉治疗头法国VIVALTIS公司,广州杉山公司代理彩色多普勒超声检查仪德国西门子3质量控制3.1采用文件管理方法保证数据的真实性和同质性。编写流程图,编写标准化操作流程,设计统一问卷,使用规范的量表;3.2所有患者均由我科高年资医师开展广泛全子宫切除术加盆腔淋巴结清扫术;3.3患者统一使用同款PHENIX神经肌肉治疗仪8-plus及神经修复治疗仪U8,均为广州杉山公司出品。3.4手术人员、数据记录员,PHENIX神经肌肉治疗仪8-plus及神经修复治疗仪U8操作医师,进行培训,统一标准;3.5对手术人员、数据记录员施行盲法;3.6由第三方进行数据的收集、记录。4医学伦理学该研究通过医院医学伦理委员会批审,每一位入组患者均签署知情同意书。5统计方法采用Epidata3.0建立数据库,由两名经过培训的研究人员独立录入,核对无误后使用SAS9.4统计分析软件进行处理,计量资料采用均数±标准差(x±S)表示集中和离散趋势,用t检验或方差分析进行差异性检验;计数资料采用χ2检验或者Fisher,s确切概率法;多时间点观察资料行重复测量资料的方差分析,比较不满足整体性,采用Kruskal-Wallis秩和检验方法,重复测量方差分析不满足球对称性,采用Greenhouse-Geisser法校正P值,设定检验水准为0.05,P0.05差异有统计学意义。结果1.主观部分盆底治疗组(30人),对照组(30人)两组患者手术后6个月和术后12个月PFDI-20,PFIQ-7得分差异显著,均为P0.0001,有统计学意义;两组患者手术前后PFDI-20,PFIQ-7得分差异显著,盆底治疗组得分显著减少,P0.0001,差异有统计学意义。两组患者手术后12月性生活质量得分差异显著,P0.0001,有统计学意义;两组患者宫颈癌手术前后对比性生活质量得分差异显著,P0.0001,盆底治疗组性生活质量得分明显优于对照组。2.客观部分2.1两组患者术后尿潴留情况:盆底治疗组术后出现尿潴留人数为2人(6.7%),对照组术后尿潴留患者人数为12人(40.0%),盆底治疗组人数明显少于对照组,P=0.002,差异有统计学意义2.2.成功拔除尿管时间和住院时间比较盆底治疗组(30人),成功拔除尿管时间为8.63±13.52天;对照组(30人),成功拔除尿管人数时间为10.73±24.40天,两组成功拔除尿管时间对比P=0.0460.05,差异有统计学意义。盆底治疗组住院时间为11.80±2.23天,对照组住院时间为14.63±3.42天,两组住院时间比较P0.001,差异有统计学意义。2.3自由尿流率测定:盆底治疗组和对照组手术前后自由尿流率比较差异显著,P0.05,差异有统计学意义;两组患者术后8周,术后6月,术后12月最大尿流率,平均尿流率P0.05,差异有统计学意义,两组排尿时间和达峰时间比较P0.05,差异无统计学意义。2.4盆底电生理功能:两组手术前后盆底电生理功能比较差异显著,P0.0001;两组盆底电生理功能术后6月,术后12月差异显著,P0.0001,其中Ⅱ类肌纤维肌力和Ⅱ类肌疲劳度术前差异显著,P0.05。2.5.A3反馈:盆底治疗组手术前后对比差异显著,P0.0001差异有统计学意义,对照组P=0.141,差异无统计学意义,两组手术前后对比差异显著,P0.0001有统计学意义;两组在术后6月,术后12月A3反馈异常率比较差异显著,有统计学意义。性功能测定:盆底治疗组手术前后对比差异显著,P0.0001差异有统计学意义,对照组P=0.2223,差异无统计学意义,两组手术前后对比差异显著,盆底治疗组性功能反射异常率明显低于对照组,P0.0001有统计学意义;两组在术后6月,术后12月性功能异常率比较差异显著,均为P0.05,有统计学意义。结论1.宫颈癌术后早期给予低频电刺激加生物反馈等干预治疗,能够有效的降低其出现尿潴留的机率,能够减少患者留置尿管时间,进一步缩短病人住院时间。2.低频电刺激联合生物反馈治疗,可以有效的改善患者术后盆底自由尿流率功能,电生理功能,控尿功能和性功能反射。3.低频电刺激联合生物反馈治疗,可以有效的减少术后盆底功能障碍对生活的影响,提高宫颈癌术后患者生活质量和性生活质量。
[Abstract]:Background cervical cancer is one of the most commonly known malignant tumors in the female reproductive system, which has attracted more and more attention. In China, with the popularization of cervical cancer screening, more and more early and middle stage cervical cancer can be found, and the trend of development is young. Although the development of early domestic and foreign, early cervical cancer has reduced operation. Extensive total hysterectomy plus pelvic / abdominal main lymph node resection (Piver type III) is still a common operation. The operation range is larger, time consuming, pelvic ligament, blood vessels and nerves are damaged or excised in varying degrees, leading to a high incidence of postoperative pelvic floor dysfunction (PFD) in some patients. The main manifestation is urinary retention. Urinary tract infection, defecation barrier, and sexual dysfunction, etc., while urinary fistula, pelvic infection, and lymphatic cysts are rare. High incidence of pelvic floor dysfunction after cervical cancer has seriously affected people's quality of life. How to improve the quality of life of patients after cervical cancer surgery has become an urgent problem. There is a significant correlation between the changes of function and PFD, and the changes in pelvic floor electrophysiology are earlier than that of PFD. Therefore, the corresponding damage of pelvic floor tissue can be detected by early electrophysiological examination; electrophysiologic treatment of pelvic floor can prevent the occurrence of dysfunctional pelvic diseases and can be treated. The effect of combination of electrical stimulation and biofeedback on pelvic floor dysfunction is better than that of a single treatment. This article will focus on the clinical management and efficacy of low frequency electrical stimulation combined with biofeedback treatment for pelvic floor dysfunction after cervical cancer. Material and methods 1 subjects were selected from January 2015 to January 2016 in the Department of gynaecology and obstetrics of the people's Hospital of Zhengzhou University, which were treated with extensive hysterectomy and pelvic lymph node dissection, and confirmed by pathological results. 75 cases of cervical cancer for malignant tumor: (1) age 60 years; (2) clinical stage of cervical cancer I a2- II A2 stage; exclusion criteria: (1) preoperative and postoperative radiotherapy and chemotherapy; (2) preoperative pelvic organ prolapse more than II stage; (3) age > 60 years of age; (4) preoperative urine retention; (5) preoperative difficulty defecation; (6) moderate urinary incontinence before operation; (7) Specific effects on follow up diseases; (8) failure to determine the effect of the effect or incomplete information on the outcome of the outcome; (1) the researchers considered the need to terminate the test from the medical point of view; (2) the patient himself asked to stop the test; (3) a 2.1 group of.2 research methods for severe complications or adverse reactions during the trial: a random number table 75 patients with cervical cancer were divided into two groups, 38 in the experimental group, 5 in the absence of visits, 2 in his department to continue the treatment, 1 in the refusal of follow-up, 37 in the control group, 3 in the loss of visits and 4 in the treatment of his family, so that the cases were collected to keep the integrity of the follow-up data and be eliminated. 30 cases, 36-59 years of age (48), average age (48) .93 + 7.21 years old. Control group: 30 cases, age 37-59 years old, the average age (50.93 + 4.01) years old.2.2 specific methods: pelvic floor treatment group and the control group were all underwent extensive total hysterectomy plus pelvic lymph node dissection.2.2.1 early intervention program after the pelvic floor treatment group fifth days after the operation to give PHENIX neuromuscular therapy instrument 8-PLUS electrical stimulation therapy 2 Day, the urine retention scheme is: frequency 35Hz, pulse width 200 mu s, 2 times / day, time 20 minutes. The position of electrode placement is: one is placed in S3 area, the other is placed in the bladder area. The electrode plate is selected with 50*50mm sticky electrode. After 7 days of removal, the residual urine is less than 100ml and the electric stimulation treatment is stopped. Residual urine 1OOml is considered as retention of urine and again placed in urinary catheter. Continue to give 8-PLUS electrical stimulation treatment, 2 times a day, a total of 7 days, 14 days to remove the urethral catheter again, test residual urine, if residual urine more than 100ml, no longer give 8-PLUS electrical stimulation treatment, according to the clinical routine treatment. The control group after 7 days after the removal of urethral residual urine determination, if residual urine 100ml, no special treatment; residual urine more than 100ml indwelling catheter, if residual urine is more than 100ml, indwelling catheter, 7 days after the removal of urethral residual urine, if residual urine was more than 100ml and indwelling catheter, the medium-term intervention program after.2.2.2 was treated according to clinical routine: pelvic floor treatment group was given pelvic abdominal electrophysiologic therapy for 9 weeks after operation: PHENIX neuromuscular therapy instrument 8-plus pelvic abdominal and lower limb vascular smooth muscle electrical stimulation (large circulation) for 6 weeks. The stimulus program was activated by blood power, 2 times / week, The scheme was: frequency 4Hz, time 20min; electrode patch: 50*90mm sticky electrode, two groups (4); one group was placed on the back of the left and right feet, the other was placed on the right side of the abdominal total vein, the other was placed in the corresponding back position. 13 weeks after the operation, the electromyography of the pelvic floor and biofeedback for 6 weeks, 1 weeks 2 times, 12 times, time 30min. electrode. Position: A1 channel pelvic floor muscle therapy head is placed in the vagina, A2 channel electrode is placed on the abdomen, and ground wire electrode is placed on the iliac bone. Biofeedback: U8 is built to simulate various scene training modules and give the perineoabdominal coordination contraction. Electrode: the pelvic floor muscle for the treatment of the head 50* 50mm sticky electrode. Position: A1 channel pelvic floor muscle treatment head placement In the vagina, the A2 channel electrode was placed on the abdomen and the ground line marker was placed on the iliac bone. The control group received routine care after the operation, and there was no specific intervention measure of the specific.2.3 monitoring index 2.3.1 subjective part: the quality of life questionnaire (PFDI-20) PFDI-20 was specially designed for the female pelvic floor disease, with 20 problems in total. The effect of pelvic floor dysfunction on the quality of life of the patients and the severity of subjective symptoms were evaluated from 3 parts of urination symptoms, defecation symptoms and pelvic organ prolapse. The total score was 0-300, the higher the score, the greater the impact on life, and the effect of the pelvic floor disorder questionnaire 7 (PFIQ-7) from the bladder, intestine, or Yin, respectively. The greater the total score, the higher the score, the higher the score, the higher the score, the higher the score of the three aspects of daily life. The sexual function quality questionnaire, the total score of 100, the higher the score, the better the objective part of the quality of life of the.2.3.2: the comparison of the postoperative urinary retention in the two groups of patients. The residual urine "g1OOrrh, the objective part of urinary retention.2.3.3: extraction. Urinary catheter time and hospitalization time: 7-14 days after cervical cancer surgery, the longer the hospitalization time, the longer the hospitalization time, the higher the cost of hospitalization.2.3.4 objective part: pelvic floor function examination: mainly including the free urine flow rate (maximum urine flow rate, average urine flow rate, peak time, urination time, residual urine), pelvic floor electrophysiological function examination (I muscle class muscle) Fiber muscle strength, type I muscle fiber fatigue, class II muscle fiber strength, class II muscle fiber fatigue, muscle potential, pelvic floor control (A3 feedback), pelvic floor function examination (sexual function reflex).2.3.4.1 free urine flow rate: maximum urinary flow rate Qmax, mean urine flow rate Qave, urination time, peak time, and residual urine determination. Normal range score. Qmax > 20ml/s, Qave > 20ml/s, urination time of excretion urine volume 100ml, upper limit of 10 seconds, 23 seconds of excretion urine as upper limit, residual urine for normal 100ml.2.3.4.2 pelvic electrophysiological function: class I muscle muscle strength is divided into 0-5 levels, and the duration of muscle contraction in the vagina to the maximum value of 40%. continues for 0 seconds to 0, sustained 1 Second is 1, 2 seconds is 2, 3 seconds is 3, 4 seconds is 4, 5 seconds is 5. The percentage of descending ratio between points is fatigue, normal 0%, negative value is abnormal. The normal value of muscle potential is 20-30 V. The decrease of muscle potential indicates the decrease of muscle fiber number participating in pelvic floor contraction movement. The function of.2.3.4.3 pelvic floor control is mainly A3 feedback function, and abnormal.2.3.4.4 pelvic floor function examination is mainly reflected in abnormal urination. It is a reflection of pelvic floor function, the main manifestation of sexual function reflex is normal and abnormal.2.4 instrument and equipment PHENIX neuromuscular therapy instrument 8-plus France VIVALTIS, Guangzhou fir hill company agent nerve repair therapy instrument U8 France VIVALTIS company, Guangzhou fir hill company agent pelvic floor muscle treatment head France VIVALTIS company, Guangzhou fir hill company generation Color Doppler ultrasonography, SIEMENS 3, Germany 3 quality control 3.1 used file management to ensure the authenticity and homogeneity of the data. Write flow charts, write standardized operating procedures, design a unified questionnaire, use a standardized scale; 3.2 all patients were performed extensive total hysterectomy and pelvic lymphadenectomy by my senior senior physician. The 3.3 patients used the same PHENIX neuromuscular therapy instrument 8-plus and the nerve repair instrument U8, all of which were the.3.4 operators, the data recorder, the PHENIX neuromuscular therapy instrument 8-plus and the U8 operator of the nerve repair therapy instrument, the training, the unified standard, and the 3.5 for the operator and the data recorder. 3.6 of the data collected by third parties recorded.4 medical ethics. The medical ethics of the hospital was approved by the medical ethics committee of the hospital. Each group of patients signed the informed consent book.5 statistical method using Epidata3.0 to establish the database, and two trained researchers were recorded independently, and the SAS9.4 statistical analysis was used after the verification was unmistakable. The software was processed, and the measurement data used mean number + standard deviation (x + S) to indicate the trend of concentration and dispersion, using t test or variance analysis to test the difference. The counting data were analyzed by x 2 test or Fisher, s exact probability, and the multiple time observation data were analyzed by the variance analysis of repeated measurement data, and Kruskal-Wallis was not satisfied as a whole, and Kruskal-Wallis was used. The rank sum test method, repeated measurement of variance analysis dissatisfied football symmetry, using Greenhouse-Geisser method to correct P value, set test level 0.05, P0.05 difference was statistically significant. Results 1. subjective part of pelvic floor treatment group (30 people), control group (30 people) two groups of patients after 6 months after operation and 12 months after the operation, PFDI-20, PFIQ-7 scores were significantly different, all For P0.0001, there was statistical significance; the scores of PFDI-20 and PFIQ-7 in the two groups were significantly different before and after the operation. The score of the pelvic floor treatment group was significantly reduced, and the difference was statistically significant. The scores of the sex quality of life in the two groups were significantly different in December, P0.0001, and statistically significant; the two groups of patients with cervical cancer before and after operation were of comparative quality of life. The score of P0.0001, pelvic floor treatment group was significantly better than that of the control group.2. in the objective part of the 2.1 group. The urinary retention was 2 (6.7%) after operation in the pelvic floor treatment group, and the number of patients in the control group was 12 (40%), and the number of the pelvic floor treatment group was significantly less than the control group, P=0.002, the difference. There were statistically significant 2.2. extraction time and time of hospitalization compared with the pelvic floor treatment group (30 people), the successful extraction of urethral catheter time was 8.63 + 13.52 days; the control group (30 people), the number of successful extraction of urinary catheter time was 10.73 + 24.40 days, two groups of successful extraction of urinary catheter time compared P= 0.0460.05, the difference was statistically significant. The time of hospitalization in the pelvic floor treatment group. For 11.80 + 2.23 days, the control group was hospitalized at 14.63 + 3.42 days, the two groups of hospitalization time were P0.001, the difference was statistically significant.2.3 free urine flow rate measurement: the pelvic floor treatment group and the control group were significantly different in the free urine flow rate before and after the operation, P0.05, the difference was statistically significant; the two groups were 8 weeks after operation, June after operation, and the maximum urine flow in December after the operation. Rate, average urinary flow rate P0.05, the difference was statistically significant, two groups of urination time and peak time compared P0.05, the difference was not statistically significant.2.4 pelvic floor electrophysiological function: two groups of pelvic floor electrophysiological function before and after operation was significantly different, P0.0001; two groups of pelvic floor electrophysiological function in June, postoperative December difference was significant, P0.0001, of class II muscle fiber There was a significant difference in dimensional muscle strength and type II muscle fatigue before operation. P0.05.2.5.A3 feedback: there was significant difference in the pelvic floor treatment group before and after operation, P0.0001 difference.
【学位授予单位】：郑州大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R737.33

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