背景:为了评估量子分子共振(QMR)治疗严重干眼症(DED)患者的疗效和安全性,以及它对房水缺乏(ADDE)的影响,蒸发(EDE),和混合性(MDE)干眼症。
方法:在此前瞻性中,介入研究,81例患者被随机分配到以1周的间隔接受四次QMR治疗(Rexon-Eye®,眼科共振,的里雅斯特,意大利)(QRM组)或眼泪替代品每天四次,含有0.15%透明质酸钠和3%海藻糖(ThealozDuo®,TheaPharma,法国)(SH-TH组)。结果指标包括眼表疾病指数(OSDI)问卷,撕裂弯月面高度(TMH),撕裂破裂时间(TBUT),非侵入性破裂时间(NIBUT),角膜荧光素染色(CFS),脂质层厚度(LLT),泪膜渗透压(OSM),睑板腺功能障碍(MGD)等级,在基线和1个月和3个月随访时进行评估。
结果:在OSDI和SANDE问卷中,QMR组比SH-TH组取得了更好的改善,NIBUT,LLT,和CFS。两组之间的平均差异如下:OSDI(-12.4±0.25分,P=0.01),桑德(10.6±1.7分,P=0.01),NIBUT(2±0.25s,P=0.01),LLT(18.7±0.7nm,P=0.01),和CFS(1.2±0.1分,P=0.02)。在亚组分析中,QMR治疗显示出改善ADDE中DED症状和体征的有益作用,EDE,MDE。
结论:QMR是一种有效且耐受性良好的治疗方法,似乎可以改善重度DED患者的DED症状和体征。然而,需要进一步的研究来证实这一点。
背景:ClinicalTrials.gov标识符NCT06119386。
BACKGROUND: To evaluate the efficacy and safety of Quantum Molecular Resonance (QMR) treatment in patients with severe dry eye disease (DED), as well as its effects on aqueous-deficient (ADDE), evaporative (EDE), and mixed (MDE) dry eye.
METHODS: In this prospective, interventional study, 81 patients were randomly allocated to received four treatment sessions of QMR at 1-week intervals (Rexon-Eye®, Resono Ophthalmic, Trieste, Italy) (QRM group) or tear substitute four times daily, containing 0.15% sodium hyaluronate and 3% trehalose (Thealoz Duo®, Thea Pharma, France) (SH-TH group). Outcome measures included ocular surface disease index (OSDI) questionnaire, tear meniscus height (TMH), tear breakup time (TBUT), non-invasive breakup time (NIBUT), corneal fluorescein staining (CFS), lipid layer thickness (LLT), tear film osmolarity (OSM), and meibomian gland dysfunction (MGD) grade, which were assessed at baseline and 1-month and 3-month follow-up.
RESULTS: The QMR group achieved better improvements than the SH-TH group in OSDI and SANDE questionnaires, NIBUT, LLT, and CFS. The mean differences between the groups were as follows: OSDI (- 12.4 ± 0.25 points, P = 0.01), SANDE (10.6 ± 1.7 points, P = 0.01), NIBUT (2 ± 0.25 s, P = 0.01), LLT (18.7 ± 0.7 nm, P = 0.01), and CFS (1.2 ± 0.1 points, P = 0.02). In subgroups analysis, QMR treatment demonstrated a beneficial role to improve DED symptoms and signs in ADDE, EDE, and MDE.
CONCLUSIONS: QMR is an effective and well-tolerated treatment that seems to improve DED symptoms and signs in patients with severe DED. However, further studies are needed to confirm this.
BACKGROUND: ClinicalTrials.gov identifier NCT06119386.