Sprung C L, Eidelman L A
Department of Anesthesiology and Critical Care Medicine, Hadassah Hebrew University Medical Center, The Hebrew University of Jerusalem, Israel.
New Horiz. 1997 Aug;5(3):264-7.
To review the literature addressing ethical issues related to clinical research and the pulmonary artery catheter (PAC).
All pertinent English language articles dealing with ethical issues related to clinical research and the PAC were retrieved from 1970 through 1996.
Articles were chosen for review if ethical issues related to clinical research and the PAC were studied or reviewed.
From the articles selected, information was obtained about the ethics of clinical research related to the PAC.
Many current procedures and treatments used on a daily basis have not been proven effective by clinical trials. Studies showing increased mortality with the use of PACs are worrisome. Many clinicians have strong preferences about the use of PACs for various indications and there have been difficulties performing clinical trials. Clinical equipoise occurs when competent physicians are content to have their patients receive any of the various treatments in a randomized trial because, based on available data, none has proven preferable. Clinical equipoise for pulmonary artery catheterization for various indications is unknown. If >70% of experts determine that pulmonary artery catheterization is indicated or contraindicated for specific indications, clinical equipoise does not exist and a trial could not ethically be performed for these indications. Indications and contraindications for pulmonary artery catheterization for these indications, however, should be determined. Clinical equipoise would be present if <70% of experts favor pulmonary artery catheterization for a specific indication and trials could be performed in patients with these disorders.
Randomized clinical trails of pulmonary artery catheterization can ethically be conducted.
回顾关于临床研究及肺动脉导管（PAC）相关伦理问题的文献。
检索1970年至1996年所有涉及临床研究及PAC相关伦理问题的英文相关文章。
若文章对临床研究及PAC相关伦理问题进行了研究或综述，则选择其进行回顾。
从所选文章中获取与PAC相关的临床研究伦理方面的信息。
目前日常使用的许多程序和治疗方法尚未经临床试验证明有效。显示使用PAC会增加死亡率的研究令人担忧。许多临床医生对PAC在各种适应症中的使用有强烈偏好，且进行临床试验存在困难。当有能力的医生愿意让其患者在随机试验中接受任何一种不同的治疗时，就会出现临床 equipoise，因为根据现有数据，没有一种治疗方法被证明更优。对于各种适应症的肺动脉导管插入术的临床 equipoise 尚不清楚。如果超过70%的专家确定肺动脉导管插入术对特定适应症有指征或禁忌，则不存在临床 equipoise，针对这些适应症进行试验在伦理上是不可行的。然而，对于这些适应症的肺动脉导管插入术的指征和禁忌应该确定。如果不到70%的专家支持针对特定适应症进行肺动脉导管插入术，并且可以对患有这些疾病的患者进行试验，那么就会存在临床 equipoise。
在伦理上可以进行肺动脉导管插入术的随机临床试验。
