目的 本研究旨在评估强脉冲光（Intense pulsed light，IPL）治疗原发性干燥综合征相关干眼（Sj?gren’s syndrome -related dry eyes，SS-DE）的临床疗效。 方法 在这项前瞻性随机试验中，75名诊断为SS-DE的患者被随机分配接受右旋糖酐羟甲基纤维素滴眼液和0.05%环孢素A滴眼液的对照组或局部滴眼液加IPL的治疗组。在首次治疗前（基线）以及治疗开始后4、8和12周，评估受试者的眼表疾病指数（Ocular Surface Disease Index，OSDI）评分、泪河高度（Tear meniscus height，TMH）、Schirmer I测试（Schirmer I test，SIT）、角膜荧光素染色（Corneal fluorescein staining，CFS）评分，结膜丽丝胺绿染色（Conjunctiva lisamine green staining，CLGS）评分、非侵入性泪膜破裂时间（Noninvasive tear breakup time，NITBUT）、泪膜脂质层厚度（Lipid layer thickness，LLT）、睑板腺缺失评分、眨眼频率和角膜朗格汉斯细胞密度（Corneal langerhans cell density，CLCD），同时评估患者有无IPL治疗相关并发症的出现。 结果 试验组和对照组治疗前的基线眼表症状和体征均无统计学差异。治疗后，两组患者OSDI评分、CFS评分、眨眼频率、CLCD均明显降低，但试验组下降更为显著，与对照组相比有统计学差异（P＜0.05）。治疗后试验组TMH、SIT、NITBUT显著升高，与对照组相比差异有统计学意义（P＜0.05）。治疗前后试验组的LLT、睑板腺缺失评分、CLGS评分与对照组相比无明显差别（P>0.05）。试验组使用IPL治疗未出现严重的眼部和皮肤并发症。 结论 IPL可显著改善SS-DE患者的眼部症状体征，促进泪液分泌，降低眼表炎症，同时无明显不良反应发生。

Objective This study evaluated the safety and efficacy of Intense Pulsed Light (IPL) therapy in patients with primary Sj?gren's syndrome-related dry eye (SS-DE). Methods In this prospective, randomized trial, seventy-five patients diagnosed with SS-DE were randomly assigned to either a control group receiving dextran hydroxypropyl methylcellulose eye drops and 0.05% cyclosporine A eye drops, or a treatment group receiving the same topical eye drops plus IPL therapy. Assessments were performed at baseline (prior to initial treatment) and at 4, 8, and 12 weeks after treatment initiation. Evaluated parameters included: Ocular Surface Disease Index (OSDI) score, tear meniscus height (TMH), Schirmer I test (SIT), corneal fluorescein staining (CFS) score, lissamine green conjunctival staining (LGCS) score, noninvasive tear breakup time (NITBUT), lipid layer thickness (LLT), meibomian gland loss score (MGLS), blink frequency, and corneal Langerhans cell density (CLCD). Adverse events related to IPL treatment were also recorded. Results Baseline ocular surface parameters did not differ significantly between groups. Following treatment, both groups showed significant reductions in OSDI scores, CFS scores, blink frequency, and CLCD (all P<0.05 vs. baseline). However, the reductions were significantly greater in the IPL group compared to the control group (all P<0.05. The IPL group also demonstrated significant increases in TMH, SIT, and NITBUT (all P<0.05 vs. baseline), which were significantly greater than those observed in the control group (all P<0.05). No significant between-group differences were observed in LLT, MGLS, or LGCS score at any time point (all P>0.05). No severe ocular or cutaneous adverse events were associated with IPL treatment. Conclusion IPL significantly improves ocular signs and symptoms, enhances aqueous tear secretion, and reduces ocular surface inflammation in patients with SS-DE, with no significant adverse reactions observed.

徐州医科大学附属医院临床研究专项（LCZX202408）；徐州市卫生健康委科技项目（XWKYHT20240114）