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高剂量地塞米松减少前列腺动脉栓塞后综合征症状的疗效:一项双盲随机对照试验的结果。

Efficacy of High-Dose Dexamethasone in Reducing the Symptoms of Postembolization Syndrome Following Prostatic Artery Embolization: Results of a Double-Blind Randomized Controlled Trial.

机构信息

Department of Radiology, Rigshospitalet, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2100, Copenhagen, Denmark.

出版信息

Cardiovasc Intervent Radiol. 2024 May;47(5):632-639. doi: 10.1007/s00270-023-03650-4. Epub 2024 Jan 17.

Abstract

PURPOSE

To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization.

MATERIALS AND METHODS

We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity.

RESULTS

Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09-0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI - 2.78-- 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54-161] mg/l control vs 10 [5-33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded.

CONCLUSIONS

Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.

摘要

目的

评估前列腺动脉栓塞术围手术期单次给予地塞米松剂量减少前列腺动脉栓塞后综合征的疗效。

材料与方法

我们进行了一项 2021 年 3 月至 2022 年 5 月的单中心、双盲、随机对照试验(NCT04588857)。参与者被随机分为静脉注射 24mg 地塞米松或生理盐水。主要结局测量为前列腺动脉栓塞后 5 天内的体温、疼痛和生活质量。需要 60 例患者评估主要结局。参与者随访 6 个月,评估各种次要结局指标,包括炎症标志物和下尿路症状严重程度。

结果

由于对照组缺乏临床效果和症状轻微,试验提前终止。纳入并分析了 31 名参与者(16 名地塞米松组和 15 名对照组)。第 1 天观察到平均体温的差异(37.23±0.64°C 对照组 vs 36.74±0.41°C 地塞米松组,p=0.02,95%CI 0.09-0.89)。仅在第 5 天观察到疼痛评分(10 分制)的差异(1.48±1.2 对照组 vs 2.9±2.24 地塞米松组,p=0.04,95%CI-2.78--0.04)。第 2 天观察到 C 反应蛋白值的差异(108[54-161]mg/L 对照组 vs 10[5-33]mg/L 地塞米松组,p<0.01)。其他结局无显著差异。未记录到副作用。

结论

前列腺动脉栓塞术后单次给予 24mg 地塞米松是安全的,但不能减轻前列腺动脉栓塞后综合征。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6cf4/11074011/f4d650b8ed57/270_2023_3650_Fig1_HTML.jpg

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