{"title":"近红外光生物调制疗法治疗持续时间大于8周的Bell麻痹的非随机试验。","authors":"Dong Wu, Yan-Ling Zhao, Jing-Yi Sun, Ru-Jun Dai, Kai Cao, Rong-Kun Qu, Yu Wang, Yun-Qing Wu","doi":"10.1089/photob.2023.0056","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Objective:</i></b> To determine whether photobiomodulation therapy (PBMT) by class IV Multiwave Locked System laser treatment as an adjunctive therapy could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks. <b><i>Materials and methods:</i></b> This nonrandomized controlled trial was conducted from January 2020 to December 2022. Patients were eligible if they had Bell's palsy with a duration of greater than 8 weeks at the out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The control group consisted of patients recruited between January 1, 2020, and December 31, 2020. The PBMT group consisted of patients recruited between January 1, 2021, and December 31, 2022. In this study, the PBM used has a wavelength of 808 and 905 nm, 1.2 W power (808 nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 8.35 J/cm<sup>2</sup> dosimetry, administered 3 times per week, 72 times of total treatment. The primary outcome measures included the House-Brackmann facial nerve grading system, the Sunnybrook facial grading system, and the Facial Clinimetric Evaluation Scale (FaCE). Secondary outcome measures comprised electroneurography, electromyography, and the blink reflex. <b><i>Results:</i></b> A total of 54 participants were included (27 in the control group and 27 in the photobiomodulation group). After 6 months, the House-Brackmann grading system [risk difference, -0.59, confidence interval (95% CI), -0.81 to -0.38, relative risk, 0.27, 95% CI, 0.13-0.56, <i>p</i> < 0.001], Sunnybrook facial grading system (21.14, 95% CI, 11.71-30.58; <i>p</i> < 0.001), and FaCE (-0.20, 95% CI, 0.41-0.02; <i>p</i> = 0.07) had significant difference between the two groups. Latency of ala nasi muscle (10.92, 95% CI, 5.58-16.27; <i>p</i> < 0.001) was not statistically significant after treatment compared with the control group; however, most of the electrophysiological examinations have significant difference between the two groups, respectively. <b><i>Conclusions:</i></b> The results of this study suggest that PBMT may relieve symptoms for patients with Bell's palsy with a duration of greater than 8 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT05585333.</p>","PeriodicalId":94169,"journal":{"name":"Photobiomodulation, photomedicine, and laser surgery","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Nonrandomized Trial of the Effects of Near-Infrared Photobiomodulation Therapy on Bell's Palsy with a Duration of Greater Than 8 Weeks.\",\"authors\":\"Dong Wu, Yan-Ling Zhao, Jing-Yi Sun, Ru-Jun Dai, Kai Cao, Rong-Kun Qu, Yu Wang, Yun-Qing Wu\",\"doi\":\"10.1089/photob.2023.0056\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Objective:</i></b> To determine whether photobiomodulation therapy (PBMT) by class IV Multiwave Locked System laser treatment as an adjunctive therapy could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks. <b><i>Materials and methods:</i></b> This nonrandomized controlled trial was conducted from January 2020 to December 2022. Patients were eligible if they had Bell's palsy with a duration of greater than 8 weeks at the out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The control group consisted of patients recruited between January 1, 2020, and December 31, 2020. The PBMT group consisted of patients recruited between January 1, 2021, and December 31, 2022. In this study, the PBM used has a wavelength of 808 and 905 nm, 1.2 W power (808 nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 8.35 J/cm<sup>2</sup> dosimetry, administered 3 times per week, 72 times of total treatment. The primary outcome measures included the House-Brackmann facial nerve grading system, the Sunnybrook facial grading system, and the Facial Clinimetric Evaluation Scale (FaCE). Secondary outcome measures comprised electroneurography, electromyography, and the blink reflex. <b><i>Results:</i></b> A total of 54 participants were included (27 in the control group and 27 in the photobiomodulation group). After 6 months, the House-Brackmann grading system [risk difference, -0.59, confidence interval (95% CI), -0.81 to -0.38, relative risk, 0.27, 95% CI, 0.13-0.56, <i>p</i> < 0.001], Sunnybrook facial grading system (21.14, 95% CI, 11.71-30.58; <i>p</i> < 0.001), and FaCE (-0.20, 95% CI, 0.41-0.02; <i>p</i> = 0.07) had significant difference between the two groups. Latency of ala nasi muscle (10.92, 95% CI, 5.58-16.27; <i>p</i> < 0.001) was not statistically significant after treatment compared with the control group; however, most of the electrophysiological examinations have significant difference between the two groups, respectively. <b><i>Conclusions:</i></b> The results of this study suggest that PBMT may relieve symptoms for patients with Bell's palsy with a duration of greater than 8 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT05585333.</p>\",\"PeriodicalId\":94169,\"journal\":{\"name\":\"Photobiomodulation, photomedicine, and laser surgery\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2023-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Photobiomodulation, photomedicine, and laser surgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1089/photob.2023.0056\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Photobiomodulation, photomedicine, and laser surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1089/photob.2023.0056","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
摘要
目的:确定IV级多波锁定系统激光辅助光生物调制疗法(PBMT)是否能缓解持续时间超过8周的Bell’s麻痹患者的症状。材料和方法:本非随机对照试验于2020年1月至2022年12月进行。如果患者在北京同仁医院耳鼻喉科门诊患有持续时间超过8周的贝尔麻痹,则符合条件。对照组由2020年1月1日至2020年12月31日期间招募的患者组成。PBMT组由2021年1月1日至2022年12月31日期间招募的患者组成。在本研究中,使用的PBM的波长分别为808和905 nm,1.2 W功率(808 nm为1 W,905 nm为200 mW),连续模式发射(808 nm)和脉冲模式发射(905 nm),8.35 J/cm2剂量测定,每周给药3次,总治疗72次。主要结果测量包括House Brackmann面部神经分级系统、Sunnybrook面部分级系统和面部临床评估量表(FaCE)。次要结果测量包括神经电图、肌电图和眨眼反射。结果:共有54名参与者(对照组27名,光生物调制组27名)。6个月后,House-Brackmann分级系统[风险差异,-0.59,置信区间(95%CI),-0.81至-0.38,相对风险,0.27,95%CI,0.13-0.56,p p p = 0.07)有显著性差异。鼻翼肌的潜伏期(10.92,95%CI,5.58-16.27;p 结论:本研究的结果表明,PBMT可以缓解持续时间超过8周的贝尔麻痹患者的症状。试验注册:ClinicalTrials.gov标识符:NCT05585333。
A Nonrandomized Trial of the Effects of Near-Infrared Photobiomodulation Therapy on Bell's Palsy with a Duration of Greater Than 8 Weeks.
Objective: To determine whether photobiomodulation therapy (PBMT) by class IV Multiwave Locked System laser treatment as an adjunctive therapy could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks. Materials and methods: This nonrandomized controlled trial was conducted from January 2020 to December 2022. Patients were eligible if they had Bell's palsy with a duration of greater than 8 weeks at the out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The control group consisted of patients recruited between January 1, 2020, and December 31, 2020. The PBMT group consisted of patients recruited between January 1, 2021, and December 31, 2022. In this study, the PBM used has a wavelength of 808 and 905 nm, 1.2 W power (808 nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 8.35 J/cm2 dosimetry, administered 3 times per week, 72 times of total treatment. The primary outcome measures included the House-Brackmann facial nerve grading system, the Sunnybrook facial grading system, and the Facial Clinimetric Evaluation Scale (FaCE). Secondary outcome measures comprised electroneurography, electromyography, and the blink reflex. Results: A total of 54 participants were included (27 in the control group and 27 in the photobiomodulation group). After 6 months, the House-Brackmann grading system [risk difference, -0.59, confidence interval (95% CI), -0.81 to -0.38, relative risk, 0.27, 95% CI, 0.13-0.56, p < 0.001], Sunnybrook facial grading system (21.14, 95% CI, 11.71-30.58; p < 0.001), and FaCE (-0.20, 95% CI, 0.41-0.02; p = 0.07) had significant difference between the two groups. Latency of ala nasi muscle (10.92, 95% CI, 5.58-16.27; p < 0.001) was not statistically significant after treatment compared with the control group; however, most of the electrophysiological examinations have significant difference between the two groups, respectively. Conclusions: The results of this study suggest that PBMT may relieve symptoms for patients with Bell's palsy with a duration of greater than 8 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT05585333.