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氟比洛芬酯在超声引导下经阴道取卵中提供有效镇痛而不改变妊娠率:一项双盲随机对照试验。

Flurbiprofen Axetil Provides Effective Analgesia Without Changing the Pregnancy Rate in Ultrasound-Guided Transvaginal Oocyte Retrieval: A Double-Blind Randomized Controlled Trial.

机构信息

From the *Department of Anesthesiology and †Reproductive Medical Center, Peking University People's Hospital, Beijing, China.

出版信息

Anesth Analg. 2017 Oct;125(4):1269-1274. doi: 10.1213/ANE.0000000000002025.

DOI:10.1213/ANE.0000000000002025
PMID:28430684
Abstract

BACKGROUND

In this prospective double-blind randomized study, we evaluated the analgesic effect and potential effect on pregnancy rate of the nonsteroidal anti-inflammatory drug flurbiprofen axetil in patients undergoing ultrasound-guided transvaginal oocyte retrieval under propofol-remifentanil anesthesia.

METHODS

A total of 200 patients scheduled to undergo ultrasound-guided transvaginal oocyte retrieval were randomly allocated to receive 1.5 mg/kg of flurbiprofen axetil (FA group) or placebo (control group) 30 minutes before the procedure. Postoperative pain scores, embryo implantation rate, and pregnancy rate were recorded. Neuroendocrine biomarkers and prostaglandin E2 levels in follicular fluid were tested after oocyte retrieval.

RESULTS

Patients in the FA group awakened earlier after surgery than patients in the control group (3.3 ± 2.6 vs 5.3 ± 3.4 minutes, P < .05) and had lower pain scores than patients in the control group (2.0 [0.0, 2.8] vs 5.0 [3.0, 5.0], P< .001). The difference in pregnancy rates between the 2 groups (44%-44%) was 0% (conventional 2-sided 95% confidence interval, -13.8% to 13.8%). The lower limit of the 90% 1-sided confidence interval for this difference was -9.0%, which was within the predefined noninferiority margin of -15.0%. The concentration of prostaglandin E2 in follicular fluid was decreased in the FA group (24.51 ± 1.52 vs 25.15 ± 1.49 pg/mL, P = .039), although the difference does not appear to be clinically important.

CONCLUSIONS

Flurbiprofen axetil given before ultrasound-guided transvaginal oocyte retrieval for patients under propofol-remifentanil general anesthesia relieves pain without any detrimental effect on clinical pregnancy rate.

摘要

背景

在这项前瞻性、双盲、随机研究中,我们评估了非甾体抗炎药氟比洛芬酯在丙泊酚-瑞芬太尼麻醉下经阴道超声引导下取卵术中的镇痛效果及其对妊娠率的潜在影响。

方法

将 200 例拟行经阴道超声引导下取卵术的患者随机分为氟比洛芬酯 1.5mg/kg 组(FA 组)或安慰剂组(对照组),分别于术前 30 分钟给药。记录术后疼痛评分、胚胎着床率和妊娠率。取卵后检测卵泡液中神经内分泌标志物和前列腺素 E2 水平。

结果

FA 组患者术后苏醒时间早于对照组(3.3±2.6 比 5.3±3.4 分钟,P<.05),疼痛评分低于对照组(2.0[0.0,2.8]比 5.0[3.0,5.0],P<.001)。两组妊娠率差异为 0%(常规双侧 95%置信区间,-13.8%至 13.8%)。该差异的 90%单侧置信区间下限为-9.0%,在预设的非劣效性界值-15.0%内。FA 组卵泡液中前列腺素 E2 浓度降低(24.51±1.52 比 25.15±1.49pg/mL,P=.039),但差异似乎无临床意义。

结论

氟比洛芬酯在丙泊酚-瑞芬太尼全身麻醉下经阴道超声引导下取卵术前行给药可缓解疼痛,对临床妊娠率无不良影响。

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