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在体外受精方案中使用白蛋白预防卵巢过度刺激综合征的可疑用途:一项随机安慰剂对照试验。

The questionable use of albumin for the prevention of ovarian hyperstimulation syndrome in an IVF programme: a randomized placebo-controlled trial.

作者信息

Ben-Chetrit A, Eldar-Geva T, Gal M, Huerta M, Mimon T, Algur N, Diamant Y Z, Margalioth E J

机构信息

IVF Unit, Department of Obstetrics and Gynaecology, Shaare Zedek Medical Centre, Ben-Gurion University, Jerusalem 91031, Israel.

出版信息

Hum Reprod. 2001 Sep;16(9):1880-4. doi: 10.1093/humrep/16.9.1880.

Abstract

BACKGROUND

The role of intravenous (IV) albumin administration in the prevention of ovarian hyperstimulation syndrome (OHSS) and in the improvement of IVF conception outcomes was evaluated in a prospective, randomized, placebo-controlled double blind study.

METHODS

Ninety-eight women were enrolled in the study and were consecutively assigned to either a treatment group or a control group. Eleven patients were lost to follow-up after assignment. Of the remaining 87 women, 46 received albumin on the day of oocyte retrieval, and 41 received 0.9% sodium chloride solution as a placebo control. Outcome measures included OHSS incidence rates and pregnancy rates in the two trial groups.

RESULTS

Four of the 46 patients in the study group developed severe OHSS and six developed moderate OHSS. In the control group, one of the 41 developed severe OHSS and five developed moderate OHSS. The difference in OHSS incidence rates between the two groups was not statistically significant [relative risk (RR) = 1.49, 95% CI = 0.59-3.73]. Fourteen patients (30%) in the intervention group conceived, compared with 16 patients (39%) in the control group. The difference in conception rates between the two groups was not statistically significant (RR = 0.78, 95% CI = 0.44-1.39).

CONCLUSIONS

Albumin appears to have no positive effect on OHSS or conception rates, while its use carries the risk of undesirable side effects, including exacerbation of ascites in OHSS, nausea, vomiting, febrile reaction, allergic reaction, anaphylactic shock and risk of virus and prion transmission. We suggest that this form of treatment should not be included in the prevention of OHSS.

摘要

背景

在一项前瞻性、随机、安慰剂对照双盲研究中,评估了静脉注射白蛋白在预防卵巢过度刺激综合征(OHSS)及改善体外受精(IVF)妊娠结局方面的作用。

方法

98名女性纳入该研究,并连续被分配至治疗组或对照组。11名患者在分配后失访。其余87名女性中,46名在取卵日接受白蛋白治疗,41名接受0.9%氯化钠溶液作为安慰剂对照。观察指标包括两个试验组的OHSS发生率和妊娠率。

结果

研究组46名患者中有4名发生严重OHSS,6名发生中度OHSS。对照组41名患者中有1名发生严重OHSS,5名发生中度OHSS。两组OHSS发生率的差异无统计学意义[相对危险度(RR)=1.49,95%可信区间(CI)=0.59 - 3.73]。干预组有14名患者(30%)妊娠,对照组有16名患者(39%)妊娠。两组妊娠率的差异无统计学意义(RR = 0.78,95% CI = 0.44 - 1.39)。

结论

白蛋白似乎对OHSS或妊娠率无积极作用,而其使用存在不良副作用风险,包括OHSS中腹水加重、恶心、呕吐、发热反应、过敏反应、过敏性休克以及病毒和朊病毒传播风险。我们建议这种治疗方式不应纳入OHSS的预防措施中。

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