Kadri Eerik, Teele Kasepalu, Holger Post, Jaan Eha, Mart Kals, Jaak Kals
{"title":"间歇性跛行的每日远程缺血预处理：虚假对照随机试验","authors":"Kadri Eerik, Teele Kasepalu, Holger Post, Jaan Eha, Mart Kals, Jaak Kals","doi":"10.1016/j.ejvs.2024.10.047","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Remote ischaemic preconditioning (RIPC) is a promising non-invasive strategy in which brief episodes of ischaemia and reperfusion can increase skeletal muscle resistance to ischaemia and improve mobility. This study aimed to determine whether 28 consecutive days of RIPC improves intermittent claudication (IC) symptoms compared with sham intervention.</p><p><strong>Methods: </strong>This single centre, parallel, randomised, sham controlled, double blind trial was conducted from January 2022 to April 2023 in outpatient settings. Forty two patients with stable IC Fontaine stage IIa or IIb were randomised to RIPC or sham for 28 days. The prespecified primary outcome was a change in the maximal walking distance (MWD) after 28 days measured with a treadmill test. A > 10% change in MWD was considered clinically significant. Change in intermittent claudication distance (ICD), time to relief from claudication (TRC), and health related quality of life (HRQoL) measured with the VascuQoL-6 questionnaire were the secondary outcomes (ClinicalTrials.gov ID: NCT05084066).</p><p><strong>Results: </strong>Forty one men (RIPC = 23, sham = 18) aged 64.9 ± 7.4 years were analysed. A change of > 10% in MWD occurred in 14 patients in the RIPC group vs. eight patients in the sham group (relative risk 1.37, 95% confidence interval 0.74 - 2.25; p = .35). Changes in ICD, TRC, and HRQoL between the groups were not statistically significant.</p><p><strong>Conclusion: </strong>In this trial, RIPC did not significantly improve MWD, ICD, or TRC compared with treatment with a sham device.</p>","PeriodicalId":55160,"journal":{"name":"European Journal of Vascular and Endovascular Surgery","volume":null,"pages":null},"PeriodicalIF":5.7000,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Daily Remote Ischaemic Preconditioning for Intermittent Claudication: A Sham Controlled Randomised Trial.\",\"authors\":\"Kadri Eerik, Teele Kasepalu, Holger Post, Jaan Eha, Mart Kals, Jaak Kals\",\"doi\":\"10.1016/j.ejvs.2024.10.047\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Remote ischaemic preconditioning (RIPC) is a promising non-invasive strategy in which brief episodes of ischaemia and reperfusion can increase skeletal muscle resistance to ischaemia and improve mobility. This study aimed to determine whether 28 consecutive days of RIPC improves intermittent claudication (IC) symptoms compared with sham intervention.</p><p><strong>Methods: </strong>This single centre, parallel, randomised, sham controlled, double blind trial was conducted from January 2022 to April 2023 in outpatient settings. Forty two patients with stable IC Fontaine stage IIa or IIb were randomised to RIPC or sham for 28 days. The prespecified primary outcome was a change in the maximal walking distance (MWD) after 28 days measured with a treadmill test. A > 10% change in MWD was considered clinically significant. Change in intermittent claudication distance (ICD), time to relief from claudication (TRC), and health related quality of life (HRQoL) measured with the VascuQoL-6 questionnaire were the secondary outcomes (ClinicalTrials.gov ID: NCT05084066).</p><p><strong>Results: </strong>Forty one men (RIPC = 23, sham = 18) aged 64.9 ± 7.4 years were analysed. A change of > 10% in MWD occurred in 14 patients in the RIPC group vs. eight patients in the sham group (relative risk 1.37, 95% confidence interval 0.74 - 2.25; p = .35). Changes in ICD, TRC, and HRQoL between the groups were not statistically significant.</p><p><strong>Conclusion: </strong>In this trial, RIPC did not significantly improve MWD, ICD, or TRC compared with treatment with a sham device.</p>\",\"PeriodicalId\":55160,\"journal\":{\"name\":\"European Journal of Vascular and Endovascular Surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2024-11-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Vascular and Endovascular Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.ejvs.2024.10.047\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Vascular and Endovascular Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.ejvs.2024.10.047","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Daily Remote Ischaemic Preconditioning for Intermittent Claudication: A Sham Controlled Randomised Trial.
Objective: Remote ischaemic preconditioning (RIPC) is a promising non-invasive strategy in which brief episodes of ischaemia and reperfusion can increase skeletal muscle resistance to ischaemia and improve mobility. This study aimed to determine whether 28 consecutive days of RIPC improves intermittent claudication (IC) symptoms compared with sham intervention.
Methods: This single centre, parallel, randomised, sham controlled, double blind trial was conducted from January 2022 to April 2023 in outpatient settings. Forty two patients with stable IC Fontaine stage IIa or IIb were randomised to RIPC or sham for 28 days. The prespecified primary outcome was a change in the maximal walking distance (MWD) after 28 days measured with a treadmill test. A > 10% change in MWD was considered clinically significant. Change in intermittent claudication distance (ICD), time to relief from claudication (TRC), and health related quality of life (HRQoL) measured with the VascuQoL-6 questionnaire were the secondary outcomes (ClinicalTrials.gov ID: NCT05084066).
Results: Forty one men (RIPC = 23, sham = 18) aged 64.9 ± 7.4 years were analysed. A change of > 10% in MWD occurred in 14 patients in the RIPC group vs. eight patients in the sham group (relative risk 1.37, 95% confidence interval 0.74 - 2.25; p = .35). Changes in ICD, TRC, and HRQoL between the groups were not statistically significant.
Conclusion: In this trial, RIPC did not significantly improve MWD, ICD, or TRC compared with treatment with a sham device.
期刊介绍：
The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles.
Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.
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