CAJ | 학술논문

探讨国内耳穴贴压治疗原发性失眠临床研究存在的问题。对近五年国内耳穴贴压治疗原发性失眠的研究按疾病诊断标准、试验设计、干预措施、疗效及安全性评定进行分类综述及问题探讨。目前国内耳穴贴压治疗原发性失眠的临床研究主要存在疾病诊断标准不统一导致患者筛选差异明显；试验设计随机、盲法、伦理及注册原则贯彻较差，对照选择落后临床实际，导致试验结果的内在真实性需谨慎对待；疗效评价缺乏金指标，缺乏随访等，导致疗效证据不充分，效应优势不明确。今后耳穴贴压治疗原发性失眠的临床研究需在设计、实施和质量控制方面进一步规范。
탐토국내이혈첩압치료원발성실면림상연구존재적문제。대근오년국내이혈첩압치료원발성실면적연구안질병진단표준、시험설계、간예조시、료효급안전성평정진행분류종술급문제탐토。목전국내이혈첩압치료원발성실면적림상연구주요존재질병진단표준불통일도치환자사선차이명현；시험설계수궤、맹법、윤리급주책원칙관철교차，대조선택락후림상실제，도치시험결과적내재진실성수근신대대；료효평개결핍금지표，결핍수방등，도치료효증거불충분，효응우세불명학。금후이혈첩압치료원발성실면적림상연구수재설계、실시화질량공제방면진일보규범。
Objective To investigate the domestic existing problems of clinical research about auricular acupressure treatment for primary insomnia.Methods We reviewed and investigated the domestic research about auricular acupressure treatment of primary insomnia in recent 5 years in diagnostic criteria , intervention, trial design, efficacy and safety evaluation .Results At present, the domestic research about auricular acupressure treatment of primary insomnia has some major disadvantages .For example,the diagnostic criteria is not unified leading to obvious difference in choosing patients; the trial design random , blind method , sethic and registered principle are implemented badly, controls fall behind the clinical practice , the best intervention is not clear , which leading to the inner authenticity of the test results should be treated with caution; efficacy evaluation lack of the gold standard , long-term follow-up, which leading to therapeutic effect evidence is not sufficient , and effect advantage is uncertain .Conclusion The clinical research program about auricular acupressure treatment for primary insomnia should be further standardized in trial design , implementation, quality control in future.