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卡麦角林预防卵巢过度刺激综合征

Cabergoline for preventing ovarian hyperstimulation syndrome.

作者信息

Tang Huilin, Hunter Tamara, Hu Yongfang, Zhai Suo-Di, Sheng Xiaoyan, Hart Roger J

机构信息

Department of Pharmacy, Therapeutic Drug Monitoring and Clinical Toxicology Center of Peking University, Peking UniversityThird Hospital, Beijing, China.

出版信息

Cochrane Database Syst Rev. 2012 Feb 15(2):CD008605. doi: 10.1002/14651858.CD008605.pub2.

Abstract

BACKGROUND

Ovarian hyperstimulation syndrome (OHSS) is a complication resulting from administration of human chorionic gonadotrophin (hCG) in assisted reproduction technology (ART) treatment. Most case are mild, but forms of moderate or severe OHSS appear in 3% to 8% of in vitro fertilisation (IVF) cycles. Recently, the dopamine agonist cabergoline has been introduced as a secondary prevention intervention for OHSS in women at high risk of OHSS who are undergoing ART treatment.

OBJECTIVES

To assess the effectiveness and safety of cabergoline in preventing ovarian hyperstimulation syndrome (OHSS) in high-risk women undergoing ART treatment.

SEARCH METHODS

Major medical databases (Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials, CENTRAL (The Cochrane Library), MEDLINE, EMBASE and PsycINFO) were systematically searched for randomised controlled trials (RCTs) assessing the effect of cabergoline in preventing OHSS. Databases were searched up to September 2011. Registers of clinical trials, abstracts of scientific meetings and reference lists of included studies were searched. No language restrictions were applied.

SELECTION CRITERIA

RCTs which compared cabergoline with placebo, no treatment or another intervention for preventing OHSS in high-risk women were considered for inclusion. Primary outcome measures included incidence of moderate or severe OHSS and live birth rate. Secondary endpoints were clinical pregnancy rate, multiple pregnancy rate, miscarriage rate and any other adverse effects of the treatment.

DATA COLLECTION AND ANALYSIS

Two authors independently screened titles, abstracts and the full text of publications; extracted data; and assessed risk of bias. Any disagreements were resolved by consensus. Pooled results were reported as odds ratio (OR) and 95% confidence interval (95% CI) by the Mantel-Haenszel method.

MAIN RESULTS

Only two trials involving 230 women met the inclusion criteria. Both studies had a moderate risk of bias. Oral cabergoline, 0.5 mg daily, was given as an intervention and compared with a matched placebo. A statistically significant reduction in OHSS was observed in the cabergoline treated group (OR 0.40, 95% CI 0.20 to 0.77; 2 RCTs, 230 women) with a number needed to treat (NTT) of 7. There was a statistically significant difference in the incidence of moderate OHSS, favouring cabergoline (OR 0.38, 95% CI 0.19 to 0.78; 2 RCTs, 230 women) but not in severe OHSS (OR 0.77, 95% CI 0.24 to 2.45; 2 RCTs, 230 women). There was no significant difference in the clinical pregnancy rate (OR 0.94, 95% CI 0.56 to 1.59; 2 RCTs, 230 women), miscarriage rate (OR 0.31, 95% CI 0.03 to 3.07; 1 RCT, 163 women) or any other adverse effects of the treatment (OR 2.07, 95% CI 0.56 to 7.70; 1 RCT, 67 women). However, no data on multiple pregnancy rate or live birth rate were reported in either trial.

AUTHORS' CONCLUSIONS: Cabergoline appears to reduce the risk of OHSS in high-risk women, especially for moderate OHSS. The use of cabergoline does not affect the pregnancy outcome (clinical pregnancy rate, miscarriage rate), nor is there an increased risk of adverse events. Further research should consider the risk of administering cabergoline and the comparison between cabergoline and established treatments (such as intravenous albumin and coasting). Large, well-designed and well-executed RCTs that involve more clinical endpoints are necessary to further evaluate the role of cabergoline in OHSS prevention.

摘要

背景

卵巢过度刺激综合征(OHSS)是辅助生殖技术(ART)治疗中使用人绒毛膜促性腺激素(hCG)引起的一种并发症。大多数病例为轻度,但中度或重度OHSS在3%至8%的体外受精(IVF)周期中出现。最近,多巴胺激动剂卡麦角林已被引入作为对接受ART治疗的OHSS高危女性进行OHSS二级预防的干预措施。

目的

评估卡麦角林在预防接受ART治疗的高危女性卵巢过度刺激综合征(OHSS)中的有效性和安全性。

检索方法

系统检索主要医学数据库(Cochrane月经失调与生育力低下组专业试验注册库、CENTRAL(Cochrane图书馆)、MEDLINE、EMBASE和PsycINFO),以查找评估卡麦角林预防OHSS效果的随机对照试验(RCT)。检索数据库至2011年9月。检索临床试验注册库、科学会议摘要和纳入研究的参考文献列表。不设语言限制。

选择标准

比较卡麦角林与安慰剂、不治疗或其他预防高危女性OHSS干预措施的RCT被考虑纳入。主要结局指标包括中度或重度OHSS的发生率和活产率。次要终点为临床妊娠率、多胎妊娠率、流产率及治疗的任何其他不良反应。

数据收集与分析

两位作者独立筛选出版物的标题、摘要和全文;提取数据;并评估偏倚风险。任何分歧通过协商解决。合并结果采用Mantel-Haenszel方法报告为比值比(OR)和95%置信区间(95%CI)。

主要结果

仅两项涉及230名女性的试验符合纳入标准。两项研究均有中度偏倚风险。干预措施为每日口服0.5mg卡麦角林,并与匹配的安慰剂进行比较。卡麦角林治疗组OHSS发生率有统计学显著降低(OR 0.40,95%CI 0.20至0.77;2项RCT,230名女性),需治疗人数(NTT)为7。中度OHSS发生率有统计学显著差异,支持卡麦角林(OR 0.38,95%CI 0.19至0.78;2项RCT,230名女性),但重度OHSS无差异(OR 0.77,95%CI 0.24至2.45;2项RCT,230名女性)。临床妊娠率(OR 0.94,95%CI 0.56至1.59;两项RCT,230名女性)、流产率(OR 0.

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