目的 探讨自体胭绳肌腱植入治疗重度阴道前壁脱垂的安全性和中期疗效。方法 本研究为单臂临床试验，2021年5月开始纳入有症状、要求手术治疗的以阴道前壁重度脱垂为主的盆腔器官脱垂(pelvic organ prolapse，POP)患者，经患者充分知情，自愿选择自体胭绳肌腱添加修补，同时行双侧高位骶韧带悬吊。术后随访盆腔器官脱垂定量分度(pelvic organ prolapse quantification，POP-Q)、盆底不适调查表简表评分(Pelvic Floor Distress Inventory-Short Form 20，PFDI-20)、术后满意度评分、患者整体印象改善评分(Patient Global Impression of Improvement，PGI-I)。观察术后取腱侧下肢功能及术后并发症处理、再手术情况。结果 取腱手术时间(19。7±8。3)min，盆底手术时间(122。1±37。8)min，术中出血量中位数70 ml(50～400 ml)，无术中副损伤和术后病率。12例随访(26。4±2。5)月。Aa、Ba、C术前分别为3(-1～3)、5(2～10)、4(-1～10)，术后24个月分别为-3(-3～3)、-3(-3～3)、-6(-6～3)，差异有显著性(P＜0。05)。12例术前、术后24个月PFDI-20评分分别为88。0(16。7～204。2)、8。3(0～32。3)分，差异有显著性(Z=-2。803，P=0。005);PGI-I问卷11例术后症状明显改善，1例有改善。术后6、24个月满意度评分分别为(4。8±0。4)分和(4。6±0。7)分。1例术后12个月自感阴道脱出物，阴道前壁及顶端脱垂Ⅲ度，复发率8。3％(1/12)。2例分别术后9 d、2周肺栓塞，Clavien-Dindo外科手术并发症分级分别为Ⅱ、Ⅲ级，分别门诊和住院治疗后痊愈。1例阴道顶端局部筋膜暴露，药物治疗好转。所有患者取腱部位切口愈合良好，肌力、下肢活动均正常。无因复发和筋膜条并发症再次手术。结论 自体胭绳肌腱植入治疗重度阴道前壁脱垂手术安全，中期疗效满意。术前需向患者宣教下肢锻炼预防静脉血栓并发症。
Mid-term Efficacy of Autologous Hamstring Tendon Implantation in the Treatment of Severe Anterior Vaginal Wall Prolapse
Objective To explore the safety and mid-term efficacy of autologous hamstring tendon implantation in the treatment of severe anterior vaginal wall prolapse.Methods We performed a prospective single arm clinical study.From May 2021,pelvic organ prolapse(POP)patients with severe anterior vaginal wall prolapse as the main cause who had symptoms and required surgical treatment were included.The patient was fully informed and voluntarily selected autologous hamstring tendon implantation and high sacral ligament suspension.Postoperative follow-ups were carried out on the Pelvic Organ Prolapse Quantification(POP-Q),Pelvic Floor Distress Inventory-Short Form 20(PFDI-20),postoperative satisfaction score,and Patient Global Impression of Improvement(PGI-I).Function of the lower limb on the tendon removal side,as well as postoperative complications and re-operations were recorded.Results The operation time of tendon removal was(19.7±8.3)min,the operation time of pelvic floor was(122.1±37.8)min,the median intraoperative bleeding volume was 70 ml(range,50-400 ml),and there was no intraoperative co-morbidity or postoperative fever.A total of 12 cases were followed up for(26.4±2.5)months.The measured values of Aa,Ba,and C were 3(-1-3),5(2-10),and 4(-1-10)before operation and-3(-3-3),-3(-3-3),and-6(-6-3)at 24 months after operation,respectively,with significant difference(P＜0.05).The PFDI-20 scores of the 12 patients before surgery and at 24 months after surgery were 88.0 points(range,16.7-204.2 points)and 8.3 points(range,0-32.3 points),respectively,with significant difference(Z=-2.803,P=0.005).The PGI-I questionnaire showed 11 patients with significant improvement in postoperative symptoms and 1 patient with improvement.The satisfaction scores at 6 and 24 months after surgery were(4.8±0.4)points and(4.6±0.7)points,respectively.One patient experienced vaginal prolapse at 12 months after surgery,with a Ⅲ degree prolapse of the anterior wall and vaginal vault,the recurrence rate being 8.3％(1/12).Two patients had pulmonary embolism at 9 d and 2 weeks after surgery,with Clavien-Dindo Ⅱ and Ⅲ grades,and recovered after outpatient and hospitalization treatment.One patient was found fascia exposure at the vagina,and had improvement with medication treatment.All the patients had good wound healing at the tendon removal site,with normal muscle strength and lower limb activity.No re-operation was required due to recurrence or complications of tendon surgery.Conclusions Autologous hamstring tendon implantation is safe in the treatment of severe anterior vaginal wall prolapse with satisfactory mid-term efficacy.Before surgery,it is necessary to educate patients on lower limb exercise to prevent complications of venous thrombosis.
万方数据
