Sowter M C, Lethaby A, Singla A A
Department of Obstetrics and Gynaecology, National Women's Hospital, Claude Road, Epsom, Auckland, New Zealand.
Cochrane Database Syst Rev. 2002(3):CD001124. doi: 10.1002/14651858.CD001124.
BACKGROUND: Menorrhagia is one of the most common reasons for pre-menopausal women to be referred to a gynaecologist. Although medical therapy is generally the first approach, many women will eventually require or request a hysterectomy. Hysterectomy is associated with a significant in-patient hospital stay and a period of convalescence that makes it an unattractive and unnecessarily invasive option for many women. Hysteroscopic endometrial ablation or resection, and more recently "second generation" devices such as balloon or microwave ablation offer a day-case surgical alternative to hysterectomy for these women. They are also cheaper procedures than hysterectomy. Complete endometrial removal or destruction is one of the most important determinants of treatment success. Therefore surgery will be most effective if undertaken when endometrial thickness is less than four mm, in the immediate post-menstrual phase, however there are often difficulties in reliably arranging surgery for this time. The other option is the use of hormonal agents which induce endometrial thinning or atrophy prior to surgery. The most commonly evaluated agents have been goserelin (a GnRH analogue) and danazol. Progestogens and other GnRH analogues have also been studied although less data are available. It has been suggested that the use of these agents, particularly GnRH analogues, will reduce operating time, improve the intra-uterine operating environment, and reduce distension medium absorption (this is the fluid used to distend the uterine cavity during surgery). They may also result in a greater improvement in long term outcomes such as menstrual loss and dysmenorrhoea. OBJECTIVES: To investigate the effectiveness of gonadotrophin-releasing hormone (GnRH) analogues, danazol, and progestogens, when used for endometrial thinning prior to endometrial destruction for menorrhagia, in improving the intra-uterine operating environment and treatment outcome after surgery. SEARCH STRATEGY: The Menstrual Disorders and Subfertility Group search strategy (see Review Group details) was used to identify randomised trials that had compared the use of these drugs with either each other, or placebo, or no pre-operative treatment. An updated search was performed in 2001-2002 to identify new trials. SELECTION CRITERIA: Trials were included if they compared the effects of these agents with each other, or with placebo or no treatment on relevant intra-operative and post-operative treatment outcomes. Only randomised studies were included in this review. DATA COLLECTION AND ANALYSIS: Twelve studies met the inclusion criteria for this review. Five studies compared goserelin (a GnRH analogue) with no treatment or placebo and one study compared decapeptyl (a GnRH analogue) with no treatment. Three studies compared goserelin with danazol. Two studies compared progestogens, danazol and triptorelin or nasal spray nafarelin (both GnRH analogues) with no treatment. Only one study comparing triptorelin with no treatment assessed outcomes after balloon ablation and no studies assessing endometrial thinning agents prior to other second generation ablation techniques were identified. One study assessed the effects of progestogens compared to no treatment. Data were extracted independently by two reviewers. A third reviewer checked data extraction for accuracy and wrote to authors where relevant data was missing or unclear. Intra-operative parameters included endometrial thickness, duration of surgery, ease of surgery, distension medium absorption and complication rate. Post-operative outcomes included the proportion of women with amenorrhoea, post-operative menstrual loss and dysmenorrhoea, and the need for further surgery. Data on side-effects were also recorded. MAIN RESULTS: When compared with no treatment, GnRH analogues are associated with a shorter duration of surgery, greater ease of surgery and a higher rate of post-operative amenorrhoea at 12 months with hysteroscopic resection or ablation. Post-operative dysmenorrhoea also appears to be reduced. The use of GnRH analogues has no effect on intra-operative complication rates and patient satisfaction with this surgery is high irrespective of the use of any pre-operative endometrial thinning agent. GnRH analogues produce more consistent endometrial atrophy than danazol. For other intra-operative and post-operative outcomes, any differences are minimal and there were no benefits of GnRHa pre-treatment in the one small study where women had balloon (second generation ablation). Both GnRH analogues and danazol produce side-effects in a significant proportion of women, though few studies have reported these in detail. Few randomised data are available to assess the effectiveness of progestogens as endometrial thinning agents. The effect of any thinning agent on longer-term results is less certain but where reported the effect of endometrial thinning agents on benefits such as post-operative amenorrhoea appears to reduce with time. REVIEWER'S CONCLUSIONS: Endometrial thinning prior to hysteroscopic surgery in the early proliferative phase of the menstrual cycle for menorrhagia improves both the operating conditions for the surgeon and short term post-operative outcome. Gonadotrophin-releasing hormone analogues produce slightly more consistent endometrial thinning than danazol, though both agents produce satisfactory results. The effect of these agents on longer term post-operative outcomes such as amenorrhoea and the need for further surgical intervention reduces with time.
背景:月经过多是绝经前女性转诊至妇科医生处的最常见原因之一。尽管药物治疗通常是首选方法,但许多女性最终会需要或要求进行子宫切除术。子宫切除术与较长的住院时间和一段康复期相关,这使其对许多女性来说是一个缺乏吸引力且侵入性不必要的选择。宫腔镜子宫内膜消融或切除术,以及最近的“第二代”设备,如球囊或微波消融,为这些女性提供了一种日间手术替代子宫切除术的方法。它们也是比子宫切除术更便宜的手术。完全去除或破坏子宫内膜是治疗成功的最重要决定因素之一。因此,如果在月经刚结束阶段子宫内膜厚度小于4毫米时进行手术,手术将最有效,然而,在这个时间可靠地安排手术通常存在困难。另一种选择是使用激素药物,在手术前诱导子宫内膜变薄或萎缩。最常评估的药物是戈舍瑞林(一种促性腺激素释放激素类似物)和达那唑。孕激素和其他促性腺激素释放激素类似物也已被研究,尽管可用数据较少。有人认为,使用这些药物,特别是促性腺激素释放激素类似物,将减少手术时间,改善子宫内手术环境,并减少膨胀介质吸收(这是手术期间用于扩张子宫腔的液体)。它们还可能在诸如月经量和痛经等长期结果方面带来更大改善。 目的:研究促性腺激素释放激素(GnRH)类似物、达那唑和孕激素在月经过多的子宫内膜破坏术前用于子宫内膜变薄时,对改善子宫内手术环境和术后治疗结果的有效性。 检索策略:使用月经紊乱和亚生育组的检索策略(见综述组详细信息)来识别比较这些药物相互之间、与安慰剂或无术前治疗的随机试验。在2001 - 2002年进行了更新检索以识别新试验。 选择标准:如果试验比较了这些药物相互之间、与安慰剂或无治疗对相关术中及术后治疗结果的影响,则纳入试验。本综述仅纳入随机研究。 数据收集与分析:十二项研究符合本综述的纳入标准。五项研究比较了戈舍瑞林(一种促性腺激素释放激素类似物)与无治疗或安慰剂,一项研究比较了曲普瑞林(一种促性腺激素释放激素类似物)与无治疗。三项研究比较了戈舍瑞林与达那唑。两项研究比较了孕激素、达那唑和曲普瑞林或鼻喷那法瑞林(均为促性腺激素释放激素类似物)与无治疗。仅有一项比较曲普瑞林与无治疗的研究评估了球囊消融后的结果,未识别出评估其他第二代消融技术前子宫内膜变薄药物的研究。一项研究评估了孕激素与无治疗相比的效果。数据由两位评审员独立提取。第三位评审员检查数据提取的准确性,并在相关数据缺失或不清楚时写信给作者。术中参数包括子宫内膜厚度、手术持续时间、手术难易程度、膨胀介质吸收和并发症发生率。术后结果包括闭经女性的比例、术后月经量和痛经情况,以及进一步手术的需求。还记录了副作用数据。 主要结果:与无治疗相比,GnRH类似物与宫腔镜切除或消融术后手术时间缩短、手术更易于操作以及12个月时更高的术后闭经率相关。术后痛经似乎也有所减轻。GnRH类似物的使用对术中并发症发生率没有影响,并且无论是否使用任何术前子宫内膜变薄药物,患者对该手术的满意度都很高。GnRH类似物比达那唑产生更一致的子宫内膜萎缩。对于其他术中及术后结果,任何差异都很小,并且在一项关于女性接受球囊(第二代消融)的小型研究中,GnRHa预处理没有益处。GnRH类似物和达那唑在相当比例的女性中都会产生副作用,尽管很少有研究详细报道这些。几乎没有随机数据可用于评估孕激素作为子宫内膜变薄药物的有效性。任何变薄药物对长期结果的影响不太确定,但在有报道的情况下,子宫内膜变薄药物对诸如术后闭经等益处的影响似乎会随着时间而降低。 评审员结论:在月经周期的早期增殖期,针对月经过多进行宫腔镜手术前的子宫内膜变薄可改善外科医生的手术条件和短期术后结果。促性腺激素释放激素类似物比达那唑产生的子宫内膜变薄稍更一致,尽管两种药物都产生令人满意的结果。这些药物对诸如闭经和进一步手术干预需求等长期术后结果的影响会随着时间而降低。
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