采用聚丙烯网片的阴道前壁修补术治疗阴道前壁脱垂临床效果的荟萃分析

目的:比较聚丙烯网片和传统的前壁修补术对阴道前壁脱垂患者的临床效果及并发症。方法:通过Pubmed数据库、Cochrane图书馆数据库、荷兰医学文摘(EMBASE)、OVID数据库,收集国外已发表的1990年至2013年符合要求的英文随机对照实验,按纳入和排除标准进行筛选和质量评估,采用RevMan 5.2对手术失败率、术后新增压力性尿失禁、新增的性交困难、术后尿储留进行meta分析。结果:经筛选,共纳入10篇符合要求的随机对照文献,共1288例受试者。与传统的前壁修补术比较,使用聚丙烯网片能明显降低手术的失败率(P0.01,RR=0.37,95%CI为0.31~0.45),术后新增的压力性尿失禁和性交困难则无显著差异(P=0.10,RR=1.52,95%CI为0.93~2.48;P=0.16,RR=1.99,95%CI为0.97~4.08),术后尿储留网片发生率较高(P0.05,RR=2.31,95%CI为1.10~4.83)。结论:使用聚丙烯网片能显著降低手术的失败率和术后复发率,但在术后并发症上无特殊优势,并且术后尿储留的发生率略高。     

Combined anterior vaginal wall mesh with sacrospinous ligament fixation or with posterior intravaginal slingplasty for uterovaginal or vaginal vault prolapse

Objective

To evaluate outcomes of anterior vaginal wall mesh augmentation with concomitant sacrospinous ligament fixation (SSLF) or with concomitant posterior intravaginal slingplasty (IVS) for uterovaginal or vaginal vault prolapse.

Study design

Women with symptomatic uterovaginal or vaginal vault prolapse were randomly allocated to SSLF or IVS. All underwent concomitant anterior repair augmented with self-tailored multifilament polypropylene and polyglactin composite mesh. Before and 2, 12, 24 and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of pelvic organ prolapse at stage II or beyond (−1 cm or greater) at any site of the vaginal wall. Secondary outcomes included perioperative and postoperative complications, symptom resolution, reoperation and mesh exposure.

Results

Twenty-two women were recruited from March 2003 to December 2005. At 3-year follow-up3 (2 posterior and 1 apical) out of 14 (21%) in the IVS group had anatomic recurrences of pelvic organ prolapse, and 1 anterior out of 8 (13%) in the SSLF group. Severe operative complications or reoperations did not occur. The proportions of symptomatic patients, including those with dyspareunia, did not differ between the groups. Erosion of the anterior multifilament mesh was found in 2 out of 22 cases (9%; 95% CI 3-28%).

Conclusion

At 3-year follow-up anterior repair reinforced with a composite mesh with concomitant sacrospinous ligament fixation or with concomitant posterior intravaginal slingplasty allowed feasible support in patients with severe pelvic organ prolapse.     

The efficacy of Marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall

OBJECTIVE: The study assesses the efficacy and complications of Marlex mesh in repairing severe recurrent anterior vaginal wall prolapse. STUDY DESIGN: Twenty-four patients with two or more postsurgical recurrences of severe anterior vaginal wall prolapse were divided into control and treatment groups. Transvaginal repair was similar between groups except for reinforcement of the anterior vaginal wall with synthetic mesh. Two examiners graded preoperative and postoperative support over the following 2 years (K = 0.9). Fisher's exact test, log-linear analysis, and analysis of variance were used to compare categoric and continuous variables. RESULTS: Four patients in the control group and none in the treatment group had recurrent anterior vaginal wall prolapse (p < 0.05). Three patients had mesh-related complications. CONCLUSION: Repair with a synthetic mesh decreased the expected incidence of severe recurrent anterior vaginal prolapse but was associated with common complications related to synthetic mesh. Mesh reinforcement is an effective treatment for severe recurrent prolapse of the anterior midvaginal wall. (Am J Obstet Gynecol 1996;175:1472-5.)     

A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up

OBJECTIVE: This study was undertaken to compare tension-free vaginal tape (TVT) with colposuspension as the primary treatment for stress incontinence. STUDY DESIGN: The trial was conducted in gynecology or urology departments in 14 centers in the United Kingdom and Ireland. Three hundred forty-four women with urodynamic stress incontinence were randomly assigned to groups: 175 to TVT and 169 to colposuspension. Patients were assessed using the Short Form-36 health status questionnaire, the Bristol Female Lower Urinary Tract Symptoms questionnaire, clinical examination, and a 1-hour perineal pad test. Unpaired and paired data were analyzed with the Wilcoxon rank sum and matched pairs tests, respectively, and proportions were compared with the Fisher exact test. RESULTS: When data were analyzed on an intention-to-treat basis, assuming patients with missing data to be treatment failures, 63% of the TVT group and 51% of the colposuspension group were objectively cured at 2 years (odds ratio 1.67, 95% CI 1.09-2.58). CONCLUSION: The TVT procedure appears to be as effective as colposuspension for the treatment of urodynamic stress incontinence at 2 years.     

网片对比传统阴道修补术治疗盆腔脏器脱垂的系统评价

目的本研究旨在系统评价网片（Mesh）治疗盆腔脏器脱垂与传统阴道修补术的有效性和安全性。方法计算机检索Cochrane Library、PubMed、EMBASE、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库,检索时间截至2011年10月。检索词为pelvic organ prolapsed、POP、Mesh、盆腔脏器脱垂、网片等。纳入传统手术和网片对比治疗盆腔脏器脱垂的随机对照试验,由两名研究员分别独立提取数据和进行文献质量评价,并进行meta分析。结果共纳入5篇RCTs,meta分析结果显示：网片治疗妇女盆腔脏器脱垂并未增加手术成功率[RR=1.09,95%CI（0.58,2.02）,P=0.79]、降低术后POP-Q分度[MD=0.11,95%CI（-0.15,0.36）,P=0.41],同时术后性交困难[OR=1.25,95%CI（0.54,2.87）,P=0.60]和复发率[RR=0.76,95%CI（0.10,5.28）,P=0.78]等并未降低。结论当前证据表明：与传统手术相比,网片并不能增加手术的客观成功率,亦不能降低术后POP-Q分度以及术后感染等,尚需经济学评价及适用性研究以指导临床实践。     

A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence

OBJECTIVE: The purpose of this study was to compare 2 anti-incontinence procedures in women who had severe genital prolapse and potential stress incontinence. STUDY DESIGN: In addition to vaginal reconstructive surgery, 50 patients with stage II or higher anterior defect and a positive stress test result with prolapse reduction received either tension-free vaginal tape or plication of the endopelvic fascia. Preoperative evaluation included history, physical examination, stress test, and urodynamic assessment. Data were analyzed with the Student t test, the Fisher's exact test, and the Wilcoxon signed-rank test. RESULTS: The median follow-up time was similar for both groups, 26 and 24 months. Subjective (96% vs 64%; P=.01) and objective (92% vs 56%; P<.01) continence rates were higher after the tension-free vaginal tape procedure. Time for the resumption of spontaneous voiding, rates of urinary retention, or de novo urge incontinence were similar in the 2 groups. CONCLUSION: Tension-free vaginal tape can be recommended for patients with prolapse and occult stress incontinence.     

Vasoactive intestinal peptide expression in the vaginal anterior wall of patients with pelvic organ prolapse

ObjectivePerimenopausal women are at high risk for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) diseases. In the present study, the expression of VIP in the vaginal epithelium of 70 perimenopausal women was correlated with the severity of POP with or without SUI.Materials and MethodsSeventy biopsy specimens from the anterior vaginal epithelium were obtained from postmenopausal patients. Immunohistochemical labeling for vasoactive intestinal peptide (VIP) and hematoxylin and eosin staining were performed. The VIP innervation was then compared between eight patient groups. Semiquantitative analysis of VIP protein by Western blotting was performed and compared between the eight patient groups.ResultsThe results of the immunohistochemical study showed that the intensity of VIP-immunoreactivity (VIP-ir) in the eight groups was as follows (in decreasing order): Control; POPI; POP II; POP II + SUI; POP III; POP IV and POP III + SUI; and POP IV + SUI. The intensity of VIP-ir was obviously weak and similar among the POP IV, POP III + SUI, and POP IV + SUI groups. This result was validated by the Western blotting analysis. The level of the VIP peptide also deceased in POP patients and was as follows (in decreasing order): Control; POPI; POP II and POP II + SUI; POP III and POP III + SUI; and POP IV and POP IV + SUI.ConclusionThe present study found that reduced VIP innervation in the vaginal epithelium of the perimenopausal women was correlated with the severity of POP with or without SUI.     

A comparative study of laparoscopic sacrocolpopexy and total vaginal mesh procedure using lightweight polypropylene meshes for prolapse repair

ObjectiveUse of vaginal meshes for treatment of pelvic organ prolapse (POP) remains controversial. A trend toward abdominal approaches and the development of new meshes has been noted. We compared the 1-year results of two different approaches using new lightweight meshes.Materials and methodsSixty-nine (95.8%) of 72 women with POP Stage ≥ 2, who underwent laparoscopic sacrocolpopexy (LSC) (n = 39) or a total vaginal mesh (TVM) procedure (n = 30) using lightweight polypropylene meshes, were studied. Baseline and follow-up assessments included a pelvic examination and a composite condition-specific questionnaire. A detailed comparison of 1-year outcomes was made. Data were analyzed using appropriate statistical methods.ResultsCompared to the TVM group, the LSC group was characterized by a younger age (53.7 years vs. 64.1 years, p < 0.001) and a longer operating time (264 minutes vs. 177.6 minutes, p < 0.001). Objective anatomic success (POP Stage ≤ 1) rates were similar between groups after statistical adjustment, i.e., 84.6% (33/39) and 86.7% (26/30) after LSC and TVM (p = 0.94), respectively. However, the dominant recurrence sites were different with anterior (n = 6) most frequent after LSC and apical (n = 4) most frequent after TVM. Reoperations were needed for the four (13.3%) apical recurrences in the TVM group. No serious complications were noted. We found “cystocele as the dominant prolapse” (p = 0.016; odds ratio = 6.94) and “suspension of prolapsed (POP Stage ≥ 2) uterus” (p = 0.025; odds ratio = 7.00) significantly affected recurrence after LSC and TVM, respectively.ConclusionPOP repair by LSC or TVM using the new lightweight polypropylene meshes seems to be safe and has comparable outcomes, but limitations may vary.     

Foley尿管水囊促宫颈成熟用于足月妊娠引产的前瞻性随机对照研究

目的 比较Foley尿管水囊与普贝生栓促宫颈成熟用于足月妊娠引产的安全性和有效性. 方法 采用前瞻性随机对照研究方法,选择2009年6月至12月在本院待产的孕足月、单胎头位、有引产指征、阴道清洁度≤Ⅱ度、胎膜完整、官颈Bishop评分＜6分的初产妇,签署随机对照研究知情同意书后,随机分为2组,最终纳入分析的共126例,分别予Foley尿管水囊(64例)和普贝生栓(62例)促官颈成熟,Foley尿管水囊组与普贝生栓组孕妇的孕周、引产前宫颈评分、引产指征差异无统计学意义.采用t、x2检验或Fisher精确概率法比较2组孕妇的引产成功率、分娩方式、产程时间及母儿结局. 结果 Foley尿管水囊组与普贝生栓组宫颈评分改善、引产成功率、阴道分娩率、总产程、产后出血量差异均无统计学意义(P＞0.05).Foley尿管水囊组较普贝生栓组引产24 h内阴道分娩率低[28.1％(18/64)与56.5％(35/62),t=10.37,P＜0.05],宫缩过频过强发生率也较低[0.0％(0/64)与17.7％(11/62),P＜0.05],但缩宫素使用率高[87.5％(56/64)与21.0％(13/62),x2 =56.27,P＜0.05].2组新生儿Apgar评分、羊水胎粪污染发生率、新生儿体重差异均无统计学意义(P＞0.05).2组孕妇无一例发生产褥感染. 结论 严格掌握Foley尿管水囊促宫颈成熟的指征及执行无菌操作规程,可以取得与普贝生栓相似的促官颈成熟效果及引产母婴结局,未发生过频过强官缩,具有安全性高及成本低廉等优点.     

A randomized trial of open versus closed vaginal vault in the prevention of postoperative morbidity after abdominal hysterectomy

OBJECTIVE: Our purpose was to evaluate the effects of two surgical techniques, closed vaginal vault with two layers of continuous 3-0 polyglactin suture versus open vaginal vault with a locking 3-0 polyglactin suture, after abdominal hysterectomy.STUDY DESIGN: A prospective, randomized trial was performed. During the hospital stay and 4 to 8 weeks after the operation patients were observed for evidence of morbidity.RESULTS: Of the 273 evaluable subjects, 141 had the vaginal vault left open whereas 132 were closed. Ten (7.1%) and eight patients (6.1%) had infections at the operative site (pelvis or abdominal wound) (p = 0.92). A urinary tract infection was diagnosed in three 2.1%) and in four subjects (3.0%) (p = 0.46). A pelvic hematoma developed in two patients of each group (p = 0.66). Vault granulations were recorded in 11% and 12% of subjects (p = 0.97).CONCLUSION: This study failed to show some benefit in favor of either of the two surgical policies. A careful surgical technique and antibiotic prophylaxis seem to remain the most important factors in the prevention of postoperative morbidity.     

Effectiveness of an add-on treatment with the homeopathic medication SilAtro-5-90 in recurrent tonsillitis: An international,pragmatic, randomized,controlled clinical trial

ObjectiveTo investigate the effectiveness and safety of the homeopathic product SilAtro-5-90 in recurrent tonsillitis.MethodsIn this international, pragmatic, controlled clinical trial, 256 patients (6–60 years) with moderate recurrent tonsillitis were randomized to receive either SilAtro-5-90 in addition to standard symptomatic treatment, or to receive standard treatment only. The primary outcome was the mean time period between consecutive acute throat infections (ATI) within 1 year (analyzed via repeated events analysis).ResultsDuring the evaluation year, the risk of getting an ATI was significantly lower (hazard ratio: 0.45, proportional means model, p = 0.0002, ITT) with SilAtro-5-90 compared to control. Tonsillitis-specific symptoms were significantly reduced (p < 0.0001, ITT) and the need of antibiotics to treat acute throat infections (p = 0.0008; ITT) decreased. 3 non-serious adverse drug reactions were reported for SilAtro-5-90.ConclusionsAn integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis.Trial registration: ISRCTN registry: Registration number ISRCTN19016626, registered 23 January 2013.     

A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery

OBJECTIVE: To evaluate the performance and safety of the Kiwi Omnicup and compare it to conventional vacuum cups in routine clinical practice. DESIGN: A randomised controlled trial of the Kiwi Omnicup versus conventional vacuum cups. SETTING: Queen Charlotte's and Chelsea Hospital, a tertiary referral hospital in London from April 2001 to March 2004. POPULATION: Women requiring assisted vaginal delivery by ventouse. METHODS: Women were randomised to the Kiwi Omnicup (n=206) or conventional vacuum cups (n=198). Data regarding maternal demographics, labour, mode of delivery and maternal and neonatal outcome were collected. MAIN OUTCOME MEASURES: Failure of delivery with instrument of first choice. RESULTS: The Kiwi Omnicup was less successful at delivery with instrument of first choice than the conventional ventouse, failure rate 30.1 versus 19.2% (RR 1.58; 95% CI 1.10-2.24). It was associated with a greater number of cup detachments (mean 0.68 compared with 0.28, with 44% compared with 18% having at least one detachment [P<0.0001]). There was no difference in the incidence of severe maternal trauma, and there were no cases of serious neonatal injury. CONCLUSIONS: The Kiwi Omnicup is less successful than conventional ventouse in achieving vaginal delivery, but its safety profile is comparable.     

Thread embedding acupuncture for herniated intervertebral disc of the lumbar spine: A multicenter,randomized, patient-assessor-blinded,controlled, parallel,clinical trial

Backgroundand purpose: Although several studies have reported that thread embedding acupuncture (TEA) is effective for lumbar herniated intervertebral disc (LHIVD), the evidence remains limited because previous studies had a high risk of bias. This study aimed to investigate the efficacy and safety of TEA for LHIVD through a rigorously designed trial.Materials and methodsThis was a randomized, patient-assessor-blinded, sham-controlled trial. Participants were screened according to eligibility criteria, and 70 patients with LHIVD were randomly allocated to the TEA and sham TEA (STEA) groups in a 1:1 ratio. Both groups received TEA or STEA treatment at 23 acupoints once per week for eight weeks. Changes in low back pain, radiating pain, Oswestry disability index, Roland–Morris disability questionnaire, EuroQol 5–Dimensions 5–Levels, and global perceived effect were measured at baseline and at 4, 8, 12, and 16 weeks after screening and compared between the two groups.ResultsTEA showed no significant difference in all outcomes compared to STEA immediately after eight weeks of treatment. After an additional eight weeks of follow-up, TEA showed a more significant effect on the low back pain than STEA (p < 0.05) and showed a better tendency in maintaining or enhancing the improvement of radiating pain, function, and quality of life even after the end of treatment. No serious adverse events were observed.ConclusionTEA is effective in improving low back pain in patients with LHIVD and may help improve function and quality of life, especially in the long term.     

A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

Abstract

Lotus II, a randomized, open-label, multicenter, international study compared the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) gel for luteal support in IVF. A prespecified subgroup analysis was performed on 239 Chinese mainland subjects from the overall study population (n?=?1034), who were randomized to oral dydrogesterone 30?mg or 8% MVP gel 90?mg daily from the day of oocyte retrieval until 12?weeks of gestation. The aim was to demonstrate non-inferiority of oral dydrogesterone to MVP gel, assessed by the presence of a fetal heartbeat at 12?weeks of gestation. In the Chinese mainland subpopulation, there was a numerical difference of 9.4% in favor of oral dydrogesterone, with ongoing pregnancy rates at 12?weeks of gestation of 61.4% and 51.9% in the oral dydrogesterone and MVP gel groups, respectively (adjusted difference, 9.4%; 95% CI: ?3.4 to 22.1); in the overall population, these were 38.7% and 35%, respectively (adjusted difference, 3.7%; 95% CI: ?2.3 to 9.7). In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel. With convenient oral administration, dydrogesterone has potential to transform luteal support treatment.