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慢性阻塞性呼吸功能不全患者家庭间歇性正压通气治疗对照试验。研究方案与研究现状(作者译)

[A control trial of home I.P.P.B. therapy in patients with chronic obstructive respiratory insufficiency. Protocol and state of the study (author's transl)].

作者信息

Kompalitch M, Brille D, Diaz M, Kauffmann F, Hatzfeld C, Decroix G

出版信息

Rev Fr Mal Respir. 1979 Jul-Aug;7(4):429-32.

PMID:121483
Abstract

Because a previous retrospective study did not allow any conclusion as to the efficacy of home IPPB therapy in patients with chronic airflow obstruction, a control trial has been started. The protocol includes definition of patients, modalities of treatment, criteria for evaluation. Among criteria for a patient to enter the trial is a chronic hypercapnia (with PaCO2 greater than or equal to 48 mmHg) observed over a preliminary period of 4 months. At the end of this period patients are allocated at random into two groups with and without IPPB at home (at least 1 to 2 hours daily through a mouthpiece); medical prescriptions are same in the 2 groups so as surveillance which is planned for 2 years. Evaluation should be based upon 5 predetermined criteria. This trial is in progress.

摘要

由于之前的一项回顾性研究未能就家庭间歇性正压通气(IPPB)治疗对慢性气流阻塞患者的疗效得出任何结论,因此已启动一项对照试验。该方案包括患者的定义、治疗方式、评估标准。患者进入试验的标准之一是在4个月的初步观察期内观察到慢性高碳酸血症(动脉血二氧化碳分压[PaCO2]大于或等于48 mmHg)。在此期间结束时,患者被随机分为两组,一组在家中接受IPPB治疗(每天至少通过接口器进行1至2小时),另一组不接受;两组的药物处方相同,计划进行2年的监测。评估应基于5项预先确定的标准。该试验正在进行中。

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