酮咯酸氨丁三醇对比双氯芬酸钾口崩粉治疗重度偏头痛急性发作的随机对照研究。

IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial.

机构信息

Dalessio Headache Center Scripps Clinic Division of Neurology, 10666 North Torrey Pines Rd. MS 313, La Jolla, CA, 92037, USA.

Scripps Green Hospital, SCMG Hospitalists, 10666 N. Torrey Pines Rd, La Jolla, CA, 92037, USA.

出版信息

Neurol Sci. 2020 Mar;41(3):537-542. doi: 10.1007/s10072-019-04157-y. Epub 2019 Dec 12.

DOI:10.1007/s10072-019-04157-y

PMID:31833000

Abstract

BACKGROUND

Diclofenac potassium for oral solution (CAMBIA®) may be an alternative for patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac. CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction. This study assessed for efficacy of CAMBIA® as an alternative outpatient treatment for refractory migraine to parenteral ketorolac.

METHODS

We performed an exploratory, single-center, double-blind, double-dummy randomized controlled trial comparing CAMBIA® with IM ketorolac. Participants were randomized to receive either ketorolac 60 mg IM with dummy oral solution or CAMBIA® 50 mg, together with IM injection of normal saline. The primary endpoint was headache severity, self-rated on a scale 0-3. Secondary endpoints included self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy.

RESULTS

A total of 23 patients were enrolled. Ten patients received the study drug and 13 patients received IM ketorolac as the control. There were no major differences observed with respect to the primary outcome of mean headache severity at successive time points over a 24-h follow-up period. No major differences were found with respect to average disability, nausea, and photo- or phonophobia ratings. No major adverse events were reported.

CONCLUSION

In treatment of refractory migraine headache, CAMBIA® may provide similar benefits as IM ketorolac without increasing the risk of treatment failure, major bleeding, or cardiovascular events. However, larger studies are needed to confirm this finding.

TRIAL REGISTRATION

Clinicaltrials.gov: NCT # 02664116, Titled "IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®) for the Acute Treatment of Severe Migraine". Registered 26 January 2016, https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1.

摘要

背景

口腔用双氯芬酸钾溶液（CAMBIA®）可能是需要在医疗机构接受注射用酮咯酸治疗的患者的替代选择。CAMBIA® 已获得 FDA 批准，用于偏头痛的紧急治疗，并且在偏头痛快速缓解方面优于普通双氯芬酸片剂。本研究评估了 CAMBIA® 作为难治性偏头痛患者替代注射用酮咯酸的门诊治疗药物的疗效。

方法

我们进行了一项探索性、单中心、双盲、双模拟随机对照试验，比较了 CAMBIA® 与 IM 酮咯酸的疗效。参与者被随机分为接受 IM 酮咯酸 60mg 加口服安慰剂或 CAMBIA® 50mg 加 IM 生理盐水组。主要终点是头痛严重程度，使用 0-3 分的自我评分量表评估。次要终点包括自我评估的恶心、残疾和畏光/畏声情况，以及不良反应的发生情况和是否需要额外的解救治疗。

结果

共纳入 23 例患者。10 例患者接受研究药物治疗，13 例患者接受 IM 酮咯酸作为对照。在 24 小时随访期间连续时间点的平均头痛严重程度的主要结局方面，未观察到主要差异。在平均残疾、恶心和畏光/畏声评分方面也未发现主要差异。未报告重大不良事件。

结论

在治疗难治性偏头痛方面，CAMBIA® 可能提供与 IM 酮咯酸相似的疗效，而不会增加治疗失败、大出血或心血管事件的风险。然而，需要更大规模的研究来证实这一发现。

试验注册

Clinicaltrials.gov：NCT # 02664116，题为“IM 酮咯酸与口腔用双氯芬酸钾溶液（CAMBIA®）治疗严重偏头痛的急性发作”。于 2016 年 1 月 26 日注册，https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1。