Kongnyuy Eugene J, Wiysonge Charles Shey
Reproductive Health Solutions, 43 Fowler's Rd, Salisbury, UK, SP1 2QP.
Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.
Benign smooth muscle tumours of the uterus, known as fibroids or myomas, are often symptomless. However, about one-third of women with fibroids will present with symptoms that are severe enough to warrant treatment. The standard treatment of symptomatic fibroids is hysterectomy (that is surgical removal of the uterus) for women who have completed childbearing, and myomectomy for women who desire future childbearing or simply want to preserve their uterus. Myomectomy, the surgical removal of myomas, can be associated with life-threatening bleeding. Excessive bleeding can necessitate emergency blood transfusion. Knowledge of the effectiveness of the interventions to reduce bleeding during myomectomy is essential to enable evidence-based clinical decisions. This is an update of the review published in The Cochrane Library (2011, Issue 11).
To assess the effectiveness, safety, tolerability and costs of interventions to reduce blood loss during myomectomy.
In June 2014, we conducted electronic searches in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL and PsycINFO, and trial registers for ongoing and registered trials.
We selected randomised controlled trials (RCTs) that compared potential interventions to reduce blood loss during myomectomy to placebo or no treatment.
The two authors independently selected RCTs for inclusion, assessed the risk of bias and extracted data from the included RCTs. The primary review outcomes were blood loss and need for blood transfusion. We expressed study results as mean differences (MD) for continuous data and odds ratios for dichotomous data, with 95% confidence intervals (CI). We assessed the quality of evidence using GRADE methods.
Eighteen RCTs with 1250 participants met our inclusion criteria. The studies were conducted in hospital settings in low, middle and high income countries.Blood lossWe found significant reductions in blood loss with the following interventions: vaginal misoprostol (2 RCTs, 89 women: MD -97.88 ml, 95% CI -125.52 to -70.24; I(2) = 43%; moderate-quality evidence); intramyometrial vasopressin (3 RCTs, 128 women: MD -245.87 ml, 95% CI -434.58 to -57.16; I(2) = 98%; moderate-quality evidence); intramyometrial bupivacaine plus epinephrine (1 RCT, 60 women: MD -68.60 ml, 95% CI -93.69 to -43.51; low-quality evidence); intravenous tranexamic acid (1 RCT, 100 women: MD -243 ml, 95% CI -460.02 to -25.98; low-quality evidence); gelatin-thrombin matrix (1 RCT, 50 women: MD -545.00 ml, 95% CI -593.26 to -496.74; low-quality evidence); intravenous ascorbic acid (1 RCT, 102 women: MD -411.46 ml, 95% CI -502.58 to -320.34; low-quality evidence); vaginal dinoprostone (1 RCT, 108 women: MD -131.60 ml, 95% CI -253.42 to -9.78; low-quality evidence); loop ligation of the myoma pseudocapsule (1 RCT, 70 women: MD -305.01 ml, 95% CI -354.83 to -255.19; low-quality evidence); and a fibrin sealant patch (1 RCT, 70 women: MD -26.50 ml, 95% CI -44.47 to -8.53; low-quality evidence). We found evidence of significant reductions in blood loss with a polyglactin suture (1 RCT, 28 women: MD -1870.0 ml, 95% CI -2547.16 to 1192.84) or a Foley catheter (1 RCT, 93 women: MD -240.70 ml, 95% CI -359.61 to -121.79) tied around the cervix. However, pooling data from these peri-cervical tourniquet RCTs revealed significant heterogeneity of the effects (2 RCTs, 121 women: MD (random) -1019.85 ml, 95% CI -2615.02 to 575.32; I(2) = 95%; low-quality evidence). There was no good evidence of an effect on blood loss with oxytocin, morcellation or clipping of the uterine artery.Need for blood transfusion We found significant reductions in the need for blood transfusion with vasopressin (2 RCTs, 90 women: OR 0.15, 95% CI 0.03 to 0.74; I(2) = 0%; moderate-quality evidence); peri-cervical tourniquet (2 RCTs, 121 women: OR 0.09, 95% CI 0.01 to 0.84; I(2) = 69%; low-quality evidence); gelatin-thrombin matrix (1 RCT, 100 women: OR 0.01, 95% CI 0.00 to 0.10; low-quality evidence) and dinoprostone (1 RCT, 108 women: OR 0.17, 95% CI 0.04 to 0.81; low-quality evidence), but no evidence of effect on the need for blood transfusion with misoprostol, oxytocin, tranexamic acid, ascorbic acid, loop ligation of the myoma pseudocapsule and a fibrin sealant patch.There were insufficient data on the adverse effects and costs of the different interventions.
AUTHORS' CONCLUSIONS: At present there is moderate-quality evidence that misoprostol may reduce bleeding during myomectomy, and low-quality evidence that bupivacaine plus epinephrine, tranexamic acid, gelatin-thrombin matrix, a peri-cervical tourniquet, ascorbic acid, dinoprostone, loop ligation and a fibrin sealant patch may reduce bleeding during myomectomy. There is no evidence that oxytocin, morcellation and temporary clipping of the uterine artery reduce blood loss. Further well designed studies are required to establish the effectiveness, safety and costs of different interventions for reducing blood loss during myomectomy.
子宫良性平滑肌肿瘤,即子宫肌瘤,通常没有症状。然而,约三分之一的子宫肌瘤女性会出现严重到需要治疗的症状。有症状子宫肌瘤的标准治疗方法是,对于已完成生育的女性进行子宫切除术(即手术切除子宫),对于希望未来生育或只想保留子宫的女性进行肌瘤切除术。肌瘤切除术,即手术切除肌瘤,可能会导致危及生命的出血。大量出血可能需要紧急输血。了解减少肌瘤切除术中出血的干预措施的有效性对于做出基于证据的临床决策至关重要。这是对发表在《考科蓝图书馆》(2011年第11期)上的综述的更新。
评估减少肌瘤切除术中失血的干预措施的有效性、安全性、耐受性和成本。
2014年6月,我们在考科蓝月经紊乱与生育力低下组专业注册库、考科蓝对照试验中央注册库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)、护理学与健康领域数据库(CINAHL)和心理学文摘数据库(PsycINFO)中进行了电子检索,并检索了正在进行和已注册试验的试验注册库。
我们选择了将减少肌瘤切除术中失血的潜在干预措施与安慰剂或不治疗进行比较的随机对照试验(RCT)。
两位作者独立选择纳入的RCT,评估偏倚风险,并从纳入的RCT中提取数据。主要综述结果是失血和输血需求。我们将研究结果表示为连续数据的平均差(MD)和二分数据的比值比,并给出95%置信区间(CI)。我们使用GRADE方法评估证据质量。
18项RCT共1250名参与者符合我们的纳入标准。这些研究在低收入、中等收入和高收入国家的医院环境中进行。
我们发现以下干预措施能显著减少失血:阴道用米索前列醇(2项RCT,89名女性:MD -97.88 ml,95%CI -125.52至-70.24;I² = 43%;中等质量证据);肌层内注射血管加压素(3项RCT,128名女性:MD -245.87 ml,95%CI -434.58至-57.16;I² = 98%;中等质量证据);肌层内注射布比卡因加肾上腺素(1项RCT,60名女性:MD -68.60 ml,95%CI -93.69至-43.51;低质量证据);静脉注射氨甲环酸(1项RCT,100名女性:MD -243 ml,95%CI -460.02至-25.98;低质量证据);明胶-凝血酶基质(1项RCT,50名女性:MD -545.00 ml,95%CI -593.26至-496.74;低质量证据);静脉注射维生素C(1项RCT,102名女性:MD -411.46 ml,95%CI -502.58至-320.34;低质量证据);阴道用地诺前列酮(1项RCT,108名女性:MD -131.60 ml,95%CI -253.42至-9.78;低质量证据);肌瘤假包膜环扎术(1项RCT,70名女性:MD -305.01 ml,95%CI -354.83至-255.19;低质量证据);以及纤维蛋白密封剂贴片(1项RCT,70名女性:MD -26.50 ml,95%CI -44.47至-8.53;低质量证据)。我们发现证据表明,用聚乙醇酸缝线(1项RCT,28名女性:MD -1870.0 ml,95%CI -2547.16至1192.84)或Foley导管(1项RCT,93名女性:MD -240.70 ml,95%CI -359.61至-121.79)环绕宫颈可显著减少失血。然而,汇总这些宫颈周围止血带RCT的数据显示,效果存在显著异质性(2项RCT,121名女性:MD(随机)-1019.85 ml,95%CI -2615.02至575.32;I² = 95%;低质量证据)。没有充分证据表明催产素、肌瘤粉碎术或子宫动脉夹闭对失血有影响。
我们发现血管加压素(2项RCT,90名女性:OR 0.15,95%CI 0.03至0.74;I² = 0%;中等质量证据)、宫颈周围止血带(2项RCT,121名女性:OR 0.09,95%CI 0.01至0.84;I² = 69%;低质量证据)、明胶-凝血酶基质(1项RCT,100名女性:OR 0.01,95%CI 0.00至0.10;低质量证据)和地诺前列酮(1项RCT,108名女性:OR 0.17,95%CI 0.04至0.81;低质量证据)可显著减少输血需求,但没有证据表明米索前列醇、催产素、氨甲环酸、维生素C、肌瘤假包膜环扎术和纤维蛋白密封剂贴片对输血需求有影响。
关于不同干预措施的不良反应和成本的数据不足。
目前有中等质量证据表明米索前列醇可能减少肌瘤切除术中的出血,低质量证据表明布比卡因加肾上腺素、氨甲环酸、明胶-凝血酶基质、宫颈周围止血带、维生素C、地诺前列酮、环扎术和纤维蛋白密封剂贴片可能减少肌瘤切除术中的出血。没有证据表明催产素、肌瘤粉碎术和子宫动脉临时夹闭能减少失血。需要进一步设计良好的研究来确定不同干预措施减少肌瘤切除术中失血的有效性、安全性和成本。