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甲羟孕酮对慢性阻塞性肺疾病无创通气治疗患者血气及短期住院结局的有效性评估:一项随机临床试验。

Evaluation of the effectiveness of medroxyprogesterone on blood gases and short-term hospital outcomes in patients with chronic obstructive pulmonary disease treating with noninvasive ventilation: A randomized clinical trial.

作者信息

Sadeghi Somayeh, Ghiasi Farzin, Emamiardestani Mohammad, Nickpour Mina, Gholami Roham, Khaksar Mohammad Saeid, Mansouri Masoud

机构信息

Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

Immunodeficiency Research Center, AL-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Res Med Sci. 2024 Nov 28;29:72. doi: 10.4103/jrms.jrms_198_24. eCollection 2024.

Abstract

BACKGROUND

In the present study, we aimed to evaluate the effects of medroxyprogesterone on hospital short clinical outcomes and ABG parameters in patients with chronic obstructive pulmonary disease (COPD) exacerbation under treatments with noninvasive ventilation (NIV) treated with progesterone 15 mg in comparison with placebo.

MATERIALS AND METHODS

This is a double-blinded clinical trial that was performed in 2020-2021 in Isfahan, Iran, on 60 patients with COPD exacerbation that require NIV. All patients received short-acting beta-agonists, short-acting anticholinergics, systemic corticosteroids, and NIV. Patients in the intervention group received tablets of progesterone 15 mg, every 6 h for 5 days and the control group received a placebo; patients in both groups received routine clinical cares. We collected data regarding the days requiring NIV, hospitalization duration, intubation, intensive care unit (ICU) admission, and death. Furthermore, blood pH, PCO2, O2 saturation, dyspnea score, and NIV hours usage per day were evaluated at the time of admission, 3 and 5 days during admission.

RESULTS

Hospital short clinical outcomes were not differently distributed between the two groups ( > 0.05). Comparing two groups during hospitalization in terms of short clinical outcomes including duration hospitalization, using NIV per day, ICU admission rate, and need to intubation showed that they are comparable ( > 0.05). PH in both groups improved during follow-up ( < 0.001) and patients in intervention groups showed higher improvement ( = 0.006). Mean PCO2 decreased significantly in the intervention group ( < 0.001) but not in the control group ( = 0.198) and totally intervention showed significant improvement in PCO2 compared with the control group ( = 0.047). Although mean O2 saturation was increased in both groups during follow-up period ( < 0.001, for both groups), two groups showed comparable ( = 0.910). Mean NIV using (hours/day) was decreased significantly in the intervention group ( = 0.023); however, it was not significantly higher than that was seen in the control group ( = 0.706). The mean dyspnea score was decreased in both groups ( < 0.001), although a greater decrease was seen in the intervention group ( < 0.001).

CONCLUSION

Administration of medroxyprogesterone in patients with COPD exacerbation that required NIV was associated with significant improvements in blood pH, PCO2, dyspnea, and daily duration of NIV using after 3 and 5 days following hospitalization.

摘要

背景

在本研究中,我们旨在评估甲羟孕酮对慢性阻塞性肺疾病(COPD)急性加重期患者在接受无创通气(NIV)治疗时的短期临床结局和动脉血气(ABG)参数的影响,将15毫克孕酮治疗组与安慰剂组进行比较。

材料与方法

这是一项双盲临床试验,于2020年至2021年在伊朗伊斯法罕对60例需要NIV的COPD急性加重期患者进行。所有患者均接受短效β受体激动剂、短效抗胆碱能药物、全身糖皮质激素和NIV治疗。干预组患者每6小时服用15毫克孕酮片,共5天,对照组服用安慰剂;两组患者均接受常规临床护理。我们收集了关于需要NIV的天数、住院时间、插管、重症监护病房(ICU)入住率和死亡率的数据。此外,在入院时、入院后3天和5天评估血pH值、二氧化碳分压(PCO2)、氧饱和度、呼吸困难评分和每天NIV使用小时数。

结果

两组间医院短期临床结局分布无差异(P>0.05)。在住院期间比较两组的短期临床结局,包括住院时间、每天使用NIV的情况、ICU入住率和插管需求,结果显示两组具有可比性(P>0.05)。两组的pH值在随访期间均有所改善(P<0.001),干预组患者改善更明显(P = 0.006)。干预组的平均PCO2显著降低(P<0.001),而对照组未降低(P = 0.198),总体而言,干预组与对照组相比,PCO2有显著改善(P = 0.047)。虽然两组在随访期间平均氧饱和度均升高(两组P<0.001),但两组具有可比性(P = 0.910)。干预组的平均NIV使用时间(小时/天)显著减少(P = 0.023);然而,与对照组相比并无显著差异(P = 0.706)。两组的平均呼吸困难评分均降低(P<0.001),尽管干预组降低幅度更大(P<0.001)。

结论

对于需要NIV治疗的COPD急性加重期患者,服用甲羟孕酮与住院3天和5天后血pH值、PCO2、呼吸困难及每天NIV使用时间的显著改善相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0139/11702350/6938f2afd02f/JRMS-29-72-g002.jpg

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