醋酸甲羟孕酮对无创通气治疗的慢性阻塞性肺疾病急性加重患者的疗效及安全性：一项双盲随机临床试验

Efficacy and safety of medroxyprogesterone acetate on noninvasive ventilation -treated exacerbated COPD patients: a double-blind randomized clinical trial.

作者信息

Jelodar Mohsen Gholinataj, Malek-Ahmadi Mohammadreza, Sahebnasagh Adeleh, Mohammadi Farhad, Saghafi Fatemeh

机构信息

Department of Internal Medicine, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

Pharmaceutical Sciences Research Center, School of Pharmacy, Student Research Committee, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

出版信息

BMC Pulm Med. 2025 Mar 10;25(1):107. doi: 10.1186/s12890-024-03462-3.

DOI:10.1186/s12890-024-03462-3

PMID:40065288

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11895356/

Abstract

BACKGROUND

In acute exacerbation periods of chronic obstructive pulmonary disease (COPD), patients may experience hypoxemia or hypercapnia. Noninvasive ventilation (NIV) and respiratory stimulant drugs are used to treat this condition. Medroxyprogesterone acetate (MPA) can cross the blood-brain barrier and cause breathing stimulation and hyperventilation. This study was conducted to investigate the effectiveness of MPA in hypercapnic exacerbated COPD patients and the possibility of faster weaning of patients from NIV.

MATERIALS AND METHODS

This double-blind clinical trial was conducted on consecutive exacerbated COD patients referred to Shahid Rahnemoun Hospital, Yazd, Iran, from February 2022 to August 2022. Through a block randomized sampling method with a 1:1 allocation ratio, 58 eligible patients with hypercapnic exacerbated COPD on NIV were divided into two study groups: the intervention (treated with MPA 10 mg every 8 h) and the control (treated with placebo). The clinical and arterial blood gas (ABG) parameters were investigated in both groups.

RESULTS

Out of 50 patients, 27 and 23 intervention and control arms cases were analyzed. Although there was a significant difference in the amount of ABG parameters during the study in each group, there was no statistically significant difference between the two groups. Also, There was no significant difference in the total weaning rate of the patients in the two groups. Despite the higher number of early weaning in the MPA group, no significant difference was reported between the two groups in this regard. In addition, there was no difference between the two groups in the rate of ICU hospitalization, the length of stay of hospitalization and ICU, and the mortality rate.

CONCLUSION

The administration of MPA has not improved clinical and laboratory results, and MPA is not superior to placebo in the weaning process of patients undergoing NIV.

TRIAL REGISTRATION

IRCT20190810044500N21 (01/02/2022), (https//irct.behdasht.gov.ir/user/trial/59402/view).

摘要

背景

在慢性阻塞性肺疾病（COPD）急性加重期，患者可能会出现低氧血症或高碳酸血症。无创通气（NIV）和呼吸兴奋剂药物用于治疗这种情况。醋酸甲羟孕酮（MPA）可穿过血脑屏障，引起呼吸刺激和过度通气。本研究旨在调查MPA对高碳酸血症加重型COPD患者的有效性以及患者更快撤机的可能性。

材料与方法

本双盲临床试验于2022年2月至2022年8月对转诊至伊朗亚兹德沙希德拉赫内穆恩医院的连续性加重型COPD患者进行。通过1:1分配比例的区组随机抽样方法，将58例符合条件的接受NIV治疗的高碳酸血症加重型COPD患者分为两个研究组：干预组（每8小时给予10mg MPA治疗）和对照组（给予安慰剂治疗）。对两组的临床和动脉血气（ABG）参数进行了研究。

结果

在50例患者中，分析了干预组和对照组的27例和23例病例。尽管每组研究期间ABG参数的量存在显著差异，但两组之间无统计学显著差异。此外，两组患者的总撤机率无显著差异。尽管MPA组早期撤机的人数较多，但在这方面两组之间未报告显著差异。此外，两组在ICU住院率、住院和ICU住院时间以及死亡率方面没有差异。