Habib Ashraf S, Gan Tong J
Department of Anesthesiology, Box 3094, Duke University Medical Center, Durham, NC 27710, USA.
J Clin Anesth. 2008 Feb;20(1):35-9. doi: 10.1016/j.jclinane.2007.08.003.
To determine the practice of members of the Society of Ambulatory Anesthesia (SAMBA) in the management of postoperative nausea and vomiting (PONV) before and after the Food and Drug Administration (FDA) black box warning on droperidol.
Survey questionnaire.
The Society of Ambulatory Anesthesia.
After institutional review board approval, a survey was posted on the SAMBA Web site from June 1, 2005, until October 30, 2005. Visitors of the Web site were invited to participate in the survey. The survey was designed to elicit information about the management of PONV, particularly the use of droperidol, before and after the FDA black box warning. Participants were also asked about reasons for not using droperidol in their current practice and whether they believed that the black box warning was justified.
Two hundred ninety-five physicians of 1,179 eligible SAMBA members completed the survey for a 25% response rate. For PONV prophylaxis, the choice of droperidol as a first-line agent decreased from 47% to 5% after the black box warning appeared (P < 0.0001). Similarly, for treatment of established PONV, the choice of droperidol decreased from 38% to 8% during this same period (P < 0.0001). A total of 261 (92%) of responders did not believe that the black box warning was justified.
Although most surveyed practitioners believed that the FDA black box warning on droperidol is not justified, the use of this cost-effective agent has significantly declined.
确定门诊麻醉学会(SAMBA)成员在食品药品监督管理局(FDA)对氟哌利多发布黑框警告前后,在术后恶心呕吐(PONV)管理方面的做法。
调查问卷。
门诊麻醉学会。
经机构审查委员会批准后,于2005年6月1日至2005年10月30日在SAMBA网站上发布了一项调查。邀请该网站的访问者参与调查。该调查旨在获取有关FDA黑框警告前后PONV管理的信息,特别是氟哌利多的使用情况。参与者还被问及在当前实践中不使用氟哌利多的原因,以及他们是否认为黑框警告是合理的。
1179名符合条件的SAMBA成员中有295名医生完成了调查,回复率为25%。对于PONV预防,在黑框警告出现后,氟哌利多作为一线药物的选择从47%降至5%(P<0.0001)。同样,对于已确诊的PONV治疗,在此期间氟哌利多的选择从38%降至8%(P<用0.0001)。共有261名(92%)受访者认为黑框警告不合理。
尽管大多数接受调查的从业者认为FDA对氟哌利多的黑框警告不合理,但这种具有成本效益的药物的使用已显著下降。