英国利物浦热带医学院Duo-Lao Wang团队联合中国人民解放军北部战区总医院陈会生团队比较了远端缺血预适应与常规护理对急性中度缺血性卒中患者神经功能的影响。这一研究成果发表在2022年8月16日出版的《美国医学会杂志》上。

临床前和临床研究表明，远端缺血预适应（RIC）具有神经保护作用，涉及双侧上肢动脉的重复闭塞/释放周期；然而，缺乏缺血性卒中患者的有力证据。

为了评价RIC治疗急性中度缺血性卒中的疗效，2018年12月26日至2021年1月19日，研究组在中国55家医院进行了一项多中心、开放标签、盲终点、随机临床试验，共招募1893名急性中度缺血性卒中患者，最终随访日期为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，其中922名接受RIC治疗（使用气动电子装置，包括5个周期的袖带充气5分钟，放气5分钟，双侧上肢至200mm Hg），为期10至14天，作为基于指南治疗的辅助；971名接受单独基于指南的治疗（n = 971）。主要终点是90天时的良好功能预后，定义为0到1的改良Rankin评分。所有终点均采用盲法评估，并在全分析集上进行分析。

在1893名符合条件的急性中度缺血性卒中患者中，有1776名（93.8%）完成了试验，随机分组患者的平均年龄为65岁；其中606名为女性。RIC组在90天时功能预后良好的人数为582人（67.4%），对照组为566人（62.0%），比值比为1.27，组间差异显著。RIC组出现任何不良事件的患者比例为6.8%（59/863），对照组为5.6%（51/913）。

研究结果表明，对于患有急性中度缺血性卒中的成年人，与常规护理相比，远端缺血预适应治疗显著增加了90天时神经功能优良的可能性。但这些发现需要在另一个试验中重复，才能得出该干预效果。

附：英文原文

Title: Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial

Author: Hui-Sheng Chen, Yu Cui, Xiao-Qiu Li, Xin-Hong Wang, Yu-Tong Ma, Yong Zhao, Jing Han, Chang-Qing Deng, Mei Hong, Ying Bao, Li-Hong Zhao, Ting-Guang Yan, Ren-Lin Zou, Hui Wang, Zhuo Li, Li-Shu Wan, Li Zhang, Lian-Qiang Wang, Li-Yan Guo, Ming-Nan Li, Dong-Qing Wang, Qiang Zhang, Da-Wei Chang, Hong-Li Zhang, Jing Sun, Chong Meng, Zai-Hui Zhang, Li-Ying Shen, Li Ma, Gui-Chun Wang, Run-Hui Li, Ling Zhang, Cheng Bi, Li-Yun Wang, Duo-Lao Wang, RICAMIS Investigators, Shi-Mei Geng, Jing Shi, Ming Sun, Xiao-Feng Qiu, Hai-Tao Jiang, Yu-Jie Zhang, Jing-Yang Chen, Rui-Ping Wang, Fu-Sheng Bai, Jing Li, Xiao-Hui Gong, Ying Bai, Yan-Song Li, Ye-Fang Feng, Chong Ha, Chang-Hao Jiang, Jin-Hua Zhai, Bing Han, Ye Wang, Dong-Yu Wang, Kui-Hua Yang, Hai-Yan Yu, Xiu-Kun Yu, Hong-Bo Xiao, Chun Nie, Zhen Jiao, Jing-Yu Li, Zhao-Min Meng, Shao-Yuan Chen, Xiao-Hong Song, Jun Xu, Li Li, Xiao-Ling Wang, Xiao-Jie Wang, Wen-Xiang Zheng, Wen-Xu Zheng, Ya-Jun Liu, Min Yu, Juan Feng

Issue&Volume: 2022/08/16

Abstract:

Importance  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.

Objective  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.

Interventions  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).

Main Outcomes and Measures  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.

Results  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.

Conclusions and Relevance  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.

DOI: 10.1001/jama.2022.13123

Source: https://jamanetwork.com/journals/jama/article-abstract/2795267