激光阴道紧缩LVT阴道松弛综合征新型无创激光疗法.docx

1、激光阴道紧缩LVT阴道松弛综合征新型无创激光疗法Laser Vaginal Tightening (LVT) evaluation of a novelnoninvasive laser treatment for vaginal relaxation syndrome激光阴道紧缩（LVT）-阴道松弛综合征新型无创激光疗法的评估Jorge E. Gaviria P, Jose A. Lanz LAldana Laser Center, Caracas, Venezuela阿尔达纳激光中心， 加拉加斯，委内瑞拉ABSTRACT 摘要The objective of this study was

2、to evaluate the safety and efficacy of a novel laser treatment for vaginal relaxation syndrome. 本研究的目的是评估激光治疗阴道松弛综合征这个新型疗法的安全性和有效性。Method: A pilot study was conducted on 21 patients who received the novel laser treatment (IntimaLase) for vaginal tightening with a 2940 nm Er:YAG laser between June 20

3、11 and January 2012. All patients received two treatment sessions with an interval between sessions of 15 to 30 days. In a non-ablative, thermal-only mode, laser energies of approx. 90 J per treated area in the vaginal canal and of approx. 10 J per treated area at the vestibule and introitus were de

4、livered to the patients vaginal mucosa. A special Laser Vaginal Tightening (LVT) questionnaire was designed for assessing the improvement of vaginal tightness via patient self evaluation and by their sexual partners assessment. POP-Q measurements were also performed prior to both treatment sessions

5、in an attempt to objectively assess the change in vaginal tissue structure. Additionally, a PISQ-12 questionnaire was also used as a standard assessment tool for pelvic organ prolapse, urinary incontinence and sexual gratification. Patients were also asked about treatment discomfort, potential adver

6、se effects, and their general satisfaction with the treatment. 方法： 2011年6月至2012年1月进行了一项试点研究，期间21名患者接受了阴道松弛综合征新型的激光疗法(IntimaLase)，该治疗采用2940 nm Er:YAG 激光治疗机。所有患者都接受了两个阶段的治疗，两次治疗间隔15-30天。在非剥脱热能模式下，针对患者的阴道粘膜进行治疗，阴道腔每个治疗区域激光能量约90J，阴道前庭及阴道口每个治疗区域激光能量约为10J，并进行了一次特别的激光阴道紧缩(LVT)的调查问卷，针对患者自我评估以及他们的性伴侣来评估阴道紧缩改

7、善情况。为了客观的评估阴道组织结构所发生的变化，在上述治疗之前，通过盆底器官脱垂定量分期法（POP-Q）对患者进行了测量。此外，作为标准的评估工具，盆腔脏器脱垂/尿失禁性功能问卷（PISQ-12）也同时被运用。治疗完成后，再次对患者关于治疗中的不适，潜在的副作用以及对治疗的满意情况进行了调查。Results: Twenty of twenty one patients (95%) reported significant (moderate and strong) improvement of their vaginal tightness, and also all of their par

8、tners confirmed an improvement of vaginal tightness during sexual intercourse (85% reported significant improvement and 15% reported mild improvement). All patients but one (95%) reported better sex after the treatment. Five patients had prolapses (of stages 1-3) before receiving the treatment, whic

9、h improved in all of these patients, leaving just two of them with prolapses (one with stage 1 and one with stage 2). Three patients suffering from SUI before the treatment reported significant improvement (2) and complete healing (1). There were no adverse effects and patient discomfort was assesse

10、d as minimal. 结论：20位患者（95%）认为她们的阴道紧缩情况有了非常显著的(中等的和较大的)改善，同时她们的性伴侣也确认了在性交过程中阴道紧缩情况的改善（85%的性伴侣认为有了非常显著的改善，15%的性伴侣认为有一定程度的改善）95%的患者认为治疗以后性生活有了显著的改善，5个患者在接受治疗之前患有阴道脱垂（1至3级），接受治疗后所有患者的病情均有所改善，仅剩下2名患者仍有有阴道脱垂（1至2级）。3个患者在接受治疗之前患有压力性失尿症（SUI）,治疗之后其中2位患者情况有了显著的改善，另外1一个患者彻底治愈。以上治疗没有副作用，病人不适度评估为最低。Conclusions: T

11、he novel laser vaginal tightening therapy (IntimaLase) is an effective and safe method for the treatment of vaginal relaxation syndrome. 总结：新型的激光阴道紧缩(IntimaLase)疗法是一种有效且安全的治疗阴道松弛综合征的方法。Key words: vaginal relaxation syndrome, laser treatment, Er:YAG laser, collagen remodeling and synthesis 关键词： 阴道松弛综

12、合征，激光治疗，Er:YAG激光，胶原重组合成Article: J. LAHA, Vol. 2012, No.1; pp. 59-66. Received: April 13, 2012; Accepted: May 04, 2012. Laser and Health Academy. All rights reserved. Printed in Europe. I. INTRODUCTION 简介Vaginal Relaxation Syndrome (VRS) is a quite common medical condition described as a loss of the

13、optimal vaginal structure and is usually associated with vaginal child delivery and natural aging. Multiple pregnancies and deliveries contribute to a worsening of the VSR condition, as well as the onset of menopause, which causes a decline in hormone levels and vaginal atrophy. Most women (and thei

14、r husbands or partners) refer to vaginal relaxation syndrome as “loose vagina” 1, complaining of a loss of vaginal tightness, which is directly related to the reduction of friction during intercourse and thus to a decrease or loss of sexual gratification 2. 阴道松弛综合征(VRS)是一种很常见的丧失阴道最佳结构的疾病，同台常多发于分娩后的妇

15、女和中老年妇女等人群。多次怀孕和分娩导致阴道松弛综合征状况的恶化,以及更年期的发生,导致激素水平的下降和阴道萎缩。大多数女性(和他们的丈夫或伴侣)认为阴道松弛综合征是指“宽松的阴道”1,抱怨阴道紧缩状态的丧失,这是导致在性交中摩擦减少,从而性满足降低或丧失直接的直接原因2.Fig. 1: Tight vs. expanded (relaxed) vagina 图1：紧致的阴道同松弛的阴道对比There is a large spectrum of various VRS treatment options on the market ranging from behavioral (Kegel

16、 exercises) through pharmacological therapies (hormonal, tightening creams and sprays) to various more-or-less invasive surgical procedures. While behavioral and pharmacological therapies are noninvasive and safe, they have limited efficacy. On the other hand, various surgical procedures promise a m

17、uch better final result at the price of higher associated risks. 目前市场上治疗阴道松弛综合症的手段多种多样，从行为治疗（凯格尔体操）到药物疗法(激素、紧缩霜和喷雾剂)，再到各种各样的或多或少侵害性的手术治疗。虽然行为和药物治疗无创、安全,但疗效有限。另一方面,各种手术治疗承诺承诺疗效显著，但价格昂贵，同时相关风险很高。Surgical procedures require the cutting and rearrangement of vaginal and peripheral tissue in order to redu

18、ce the size of the vaginal canal. Operating on or near sensitive vaginal tissue is inherently risky and can cause scarring, nerve damage and decreased sensation. Furthermore, patients require an extended recovery period.手术治疗需要切割和重排阴道和外围组织从而缩小阴道腔的大小。手术治疗是接近敏感的阴道组织或直接作用引导组织上，本质上是有风险的,可以导致瘢痕形成,神经损伤和敏感程

19、度降低。此外,病人需要很长的一段恢复期。The most popular among the surgical procedures are those performed with lasers, where the laser is used instead of scalpel 3. However it is still a relatively aggressive surgery with a long and painful recovery period. 外科手术中最受欢迎的是那些用激光来代替手术刀的手术方法3。但是这种手术仍然是损伤性的而且需要一个漫长而痛苦的恢复过程。Th

20、is is why many clinical researchers are still searching for a non-invasive or minimally invasive treatment method for VRS that would offer good efficacy combined with a high level of safety and a short recovery period. 这就是为什么许多临床研究人员仍在寻找一种无创或微创的高效、高安全度、恢复期短的阴道松弛综合征治疗方法。There are several novel therap

21、ies on the market, among them is IntimaLase - a minimally-invasive, non-ablative Er:YAG laser vaginal tightening procedure utilizing photothermal laser-mucosa tissue interaction. Precisely controlled VSP 4,5 laser energy pulses delivered to the vaginal canal and introitus area cause heating of the t

22、issue and collagen within. Heating of collagen causes its immediate contraction, fibers become shorter and thicker and consequently the irradiated tissue contracts and shrinks 5. Aside from a momentary collagen and tissue shrinkage reaction, the processes of collagen remodeling and neocollagenesis s

23、tart 6-11 and at the end of these processes the treated tissue becomes enriched with new collagen, appearing younger, tighter and more elastic, thus improving vaginal laxity and reducing the effects of vaginal relaxation syndrome. 市场上有一些新颖的治疗方法,其中IntimaLase阴道紧缩术是损伤性较小的，Er:YAG激光器疗法是利用激光的光热效应与阴道粘膜组织相互

24、作用原理来治疗，是没有损伤的。精确控制可变方波脉冲4,5激光能量，传递到阴道腔和阴道口区域内的能量使阴道组织和内部胶原蛋白加热升温。胶原蛋白的加热使其立即收缩,纤维变短加厚,从而使辐射组织收缩变紧5。除了短暂的胶原蛋白和组织收缩反应，胶原蛋白重组和新胶原蛋白生长开始6-11经过激光治疗的组织最后会产生更丰富的新胶原蛋白，看上去更具活力，更紧致富有弹性。从而改善阴道松弛,减少阴道松弛综合征的影响。The purpose of this study was to assess the efficacy and safety of this new laser treatment. 本研究的目的是评

25、估这一新的激光治疗方法的疗效和安全性。II. MATERIALS AND METHODS 材料及方法Twenty one (21) patients suffering from vaginal looseness were submitted to IntimaLase treatment with an Er:YAG 2940 nm laser (XS Dynamis, Fotona, Slovenia). 针对21位受引导松弛困扰的患者进行IntimaLase疗法的治疗，采用的设备是2940 nm波长Er:YAG激光器（XS Dynamis（设备名称）, 欧洲之星, 斯洛文尼亚).All

26、 treatments were executed at a single location, the Aldana Laser Center in Caracas, Venezuela in the period between June 2011 and January 2012. 所有治疗都是在委内瑞拉加拉加斯的阿尔达纳激光中心进行的，治疗时间是在2011年6月至2012年1月之间。a) Inclusion and Exclusion Criteria 入选和排除标准At the baseline consultation visit patients were examined to

27、determine their suitability according to the inclusion and exclusion criteria. All patients submitted to treatment had passed inclusion criteria and had provided written informed consent forms. 前来咨询访问患者都需要通过入选和排除标准来确定其适合与否。提交治疗申请的所有患者需要首先通过入选标准并提交书面知情通知书。All patients testified to suffering from vagi

28、nal relaxation syndrome or had otherwise acquired “loose vagina” and diminished sexual gratification, and expressed their desire to improve their vaginal tightness. 所有被证实患有阴道松弛综合征，有阴道松弛症状，有性满足减少的患者均表示她们希望改善自己的阴道紧缩状况。The inclusion criteria were: normal cell cytology (PAP smear), negative urine cultur

29、e, vaginal canal, introitus and vestibule free of injuries and bleeding, sexual activity at least 1/month. 入选标准为：通过子宫颈抹片检查（巴氏涂片）具有正常细胞，尿液培养液程阴性，阴道腔，阴道口无创伤和出血，性生活每月一次以上。The exclusion criteria were: pregnancy, intake of photosensitive drugs, injury or/and active infection in the treatment area, undiag

30、nosed vaginal bleeding, and active menstruation. 排除标准：怀孕,有光敏药物的摄入,受伤或/和治疗区域有主动（活动性）感染,未确诊的阴道出血,月经活跃。At the beginning of this study patients were aged between 22 and 61 years (average 37.7). A total of 19 (90.5%) were premenopausal and 2 (9.5%) postmenopausal. The patients average body mass index was

31、 24.15 (range 19.25-30.49) and parous status as follows: 13 patients (61.9%) had single or multiple child deliveries, 3 among them (14.3%) with caesarean section, while 8 patients (38.1%) were nulliparous. All patients were sexually active having on average 2 vaginal intercourses per week (ranging f

32、rom 1 in two weeks to 4 times in week). All patients except one (4.8%) were non-smokers. 本研究之初患者年龄为22岁至61岁(平均37.7岁)。期中19人(90.5%)未到绝经期、2人(9.5%)处于绝经期。患者的平均身体质量指数为24.15(19.25 - -30.49)，经产状态为：13个患者（61.9%）有生育过一次或多次生育经历，期中有3个患者（14.3）有过剖腹产经历，有8位患者(38.1%)没有生育史。所有的患者性生活活跃，平均每周两次性生活（范围从每两周1次到每周4次），所有的患者中只有一个是吸烟者。Table 1: Patients demographic data 表1：患者的人口统计学信息BMI 身体质量指数24.15 (19.25-30.49)Parous status 经产状态08 (38.1%)1 2 (9.5%)27 (33.3%)3 3 (14.3%)41 (4.8%)Delivery type 分娩方式Vaginal 顺产10 (47.6%)Caes