葡萄糖注射疗法与低强度激光疗法治疗阻塞性睡眠呼吸暂停综合征患者的随机对照试验
Dextrose prolotherapy versus low level laser therapy in the treatment of patients with obstructive sleep apnea syndrome; a randomized controlled trial.
作者信息
Attia Amira A M M, Haggag Mai A, Ahmed Wael Said, El-Saed Aiman, Saleh Mennatalla A M, Saleh Abdelbaset M
机构信息
Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Mansoura 355111, Egypt.
Public Health, Community Medicine, Faculty of Medicine, Mansoura University, Mansoura 35511, Egypt.
出版信息
Sleep Breath. 2025 Aug 12;29(5):272. doi: 10.1007/s11325-025-03428-7.
OBJECTIVE
To compare the effects of Low-level laser therapy (LLLT) versus dextrose prolotherapy injection in the treatment of patients with obstructive sleep apnea (OSA).
METHODS
A hospital-based randomized controlled trial was conducted among 26 OSA patients; 13 in each group. After confirmation with Polysomnography and evaluation by drug induced sleep endoscopy, the patients were randomly allocated to treatment groups. Treatment success was defined as > 50% reduction of apnea-hypopnea index (AHI) with residual AHI < 10. The outcomes were evaluated 3 months after the intervention.
RESULTS
A total of 26 patients completed the study. The average age was 40.1 ± 7.3 years and 73.1% of the participants were males. Compared with LLLT group before intervention, prolotherapy group had higher reduction of sleep apnea measurements including total apnea, total hypopnea, and low O2 saturation but had slightly lower reduction of average O2 saturation and significant increase in minimal O2 saturation. In both groups, the levels of AHI were significantly reduced after intervention without complication (68% reduction, p = 0.001 in the prolotherapy group and 46% reduction, p = 0.001 in LLLT group). In linear models, the reduction was higher in prolotherapy group even after adjusting to baseline AHI (p = 0.011). Treatment success was much higher in the prolotherapy group than LLLT group (53.8% versus 7.7%, p = 0.030). The treatment success was significantly associated with single level obstruction (velum) and partial obstruction.
CONCLUSIONS
Both dextrose prolotherapy and LLLT were successful in reducing sleep parameters associated with OSA, with better reduction in the prolotherapy group. The promising findings need to be confirmed in larger multicenter studies before final recommendation.
TRIAL REGISTRATION
The study was listed on www.
CLINICALTRIALS
gov with registration number (NCT06427161) on 23/05/2024.
目的
比较低强度激光治疗（LLLT）与葡萄糖增殖疗法注射治疗阻塞性睡眠呼吸暂停（OSA）患者的效果。
方法
在26例OSA患者中进行了一项基于医院的随机对照试验；每组13例。经多导睡眠图确认并通过药物诱导睡眠内镜评估后，将患者随机分配至治疗组。治疗成功定义为呼吸暂停低通气指数（AHI）降低>50%且残余AHI<10。在干预3个月后评估结果。
结果
共有26例患者完成研究。平均年龄为40.1±7.3岁，73.1%的参与者为男性。与干预前的LLLT组相比，增殖疗法组在睡眠呼吸暂停测量指标上的降低幅度更大，包括总呼吸暂停、总低通气和低氧饱和度，但平均氧饱和度降低幅度略小，最低氧饱和度显著升高。两组干预后AHI水平均显著降低且无并发症（增殖疗法组降低68%，p = 0.001；LLLT组降低46%，p = 0.001）。在线性模型中，即使调整基线AHI后，增殖疗法组的降低幅度仍更高（p = 0.011）。增殖疗法组的治疗成功率远高于LLLT组（53.8%对7.7%，p = 0.030）。治疗成功与单水平阻塞（软腭）和部分阻塞显著相关。
结论
葡萄糖增殖疗法和LLLT均成功降低了与OSA相关的睡眠参数，增殖疗法组降低效果更好。在最终推荐之前，这些有前景的发现需要在更大规模的多中心研究中得到证实。
试验注册
该研究于2024年5月23日在www.CLINICALTRIALS.gov上列出，注册号为（NCT0642716）。
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