Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, China.
Department of Neurology, Beipiao Central Hospital, Beipiao, China.
JAMA. 2022 Aug 16;328(7):627-636. doi: 10.1001/jama.2022.13123.
Preclinical and clinical studies have suggested a neuroprotective effect of remote ischemic conditioning (RIC), which involves repeated occlusion/release cycles on bilateral upper limb arteries; however, robust evidence in patients with ischemic stroke is lacking.
To assess the efficacy of RIC for acute moderate ischemic stroke.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, open-label, blinded-end point, randomized clinical trial including 1893 patients with acute moderate ischemic stroke was conducted at 55 hospitals in China from December 26, 2018, through January 19, 2021, and the date of final follow-up was April 19, 2021.
Eligible patients were randomly assigned within 48 hours after symptom onset to receive treatment with RIC (using a pneumatic electronic device and consisting of 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mm Hg) for 10 to 14 days as an adjunct to guideline-based treatment (n = 922) or guideline-based treatment alone (n = 971).
The primary end point was excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. All end points had blinded assessment and were analyzed on a full analysis set.
Among 1893 eligible patients with acute moderate ischemic stroke who were randomized (mean [SD] age, 65 [10.3] years; 606 women [34.1%]), 1776 (93.8%) completed the trial. The number with excellent functional outcome at 90 days was 582 (67.4%) in the RIC group and 566 (62.0%) in the control group (risk difference, 5.4% [95% CI, 1.0%-9.9%]; odds ratio, 1.27 [95% CI, 1.05-1.54]; P = .02). The proportion of patients with any adverse events was 6.8% (59/863) in the RIC group and 5.6% (51/913) in the control group.
Among adults with acute moderate ischemic stroke, treatment with remote ischemic conditioning compared with usual care significantly increased the likelihood of excellent neurologic function at 90 days. However, these findings require replication in another trial before concluding efficacy for this intervention.
ClinicalTrials.gov Identifier: NCT03740971.
临床前和临床研究表明，重复闭塞/释放双侧上肢动脉的远程缺血预处理（RIC）具有神经保护作用；然而，在缺血性脑卒中患者中缺乏有力的证据。
评估 RIC 治疗急性中度缺血性脑卒中的疗效。
设计、地点和参与者：这是一项多中心、开放标签、盲终点、随机临床试验，共纳入 1893 例急性中度缺血性脑卒中患者，于 2018 年 12 月 26 日至 2021 年 1 月 19 日在中国的 55 家医院进行，最后一次随访日期为 2021 年 4 月 19 日。
符合条件的患者在症状出现后 48 小时内随机分配，接受 RIC 治疗（使用气动电子设备，包括双侧上肢充气 5 分钟、放气 5 分钟至 200mmHg 5 个循环），辅助基于指南的治疗，持续 10 至 14 天（n=922），或单独接受基于指南的治疗（n=971）。
主要终点为 90 天时的良好功能结局，定义为改良 Rankin 量表评分为 0 至 1 分。所有终点均采用盲法评估，并在全分析集上进行分析。
在 1893 例符合条件的急性中度缺血性脑卒中患者中，1776 例（平均[标准差]年龄 65[10.3]岁；606 例女性[34.1%]）完成了试验。RIC 组 90 天时功能结局良好的患者有 582 例（67.4%），对照组有 566 例（62.0%）（风险差异 5.4%[95%CI 1.0%-9.9%]；优势比 1.27[95%CI 1.05-1.54]；P=0.02）。RIC 组有 59 例（6.8%）和对照组有 51 例（5.6%）患者发生任何不良事件（P=0.05）。
在急性中度缺血性脑卒中成人患者中，与常规治疗相比，远程缺血预处理治疗可显著提高 90 天时的神经功能良好结局。然而，在得出该干预措施的疗效结论之前，还需要在另一项试验中进行验证。
ClinicalTrials.gov 标识符：NCT03740971。
