目的：评估强脉冲光(IPL)治疗原发性干燥综合征相关干眼(SS-DE)的临床疗效。

方法：前瞻性随机试验。选取2023年1月至2023年12月就诊于我院并确诊为中重度SS-DE患者82例82眼(双眼均符合标准的情况下，随机选择一眼纳入研究，若单眼符合纳入标准，则选择该眼入组)。随机分为两组：试验组41例41眼使用右旋糖酐羟丙甲纤维素滴眼液+0.05%环孢素滴眼液+IPL治疗； 对照组41例41眼使用右旋糖酐羟丙甲纤维素滴眼液+0.05%环孢素滴眼液治疗。比较两组患者治疗前，治疗后4、8、12 wk眼表疾病指数(OSDI)评分、泪河高度(TMH)、非侵入性泪膜破裂时间(NITBUT)、睑板腺缺失评分、Schirmer Ⅰ测试(SⅠt)、角膜荧光素染色(CFS)评分，结膜丽丝胺绿染色(CLGS)评分、泪膜脂质层厚度(LLT)、眨眼频率和角膜朗格汉斯细胞密度(CLCD)和并发症情况。

结果：试验组失访6例，失访率14.6%，对照组失访人数1例，失访率2.4%，最终获得有效数据的试验组35例35眼，对照组40例40眼。两组患者治疗前一般资料比较均无差异(均P>0.05)。治疗后4、8、12 wk，两组患者OSDI评分、CFS评分、CLGS评分、眨眼频率、CLCD均明显降低，但试验组下降更为显著(均P<0.05)。治疗后4、8、12 wk试验组TMH、SⅠt、NITBUT显著升高，与对照组相比均有差异(均P<0.05)。治疗前后试验组的LLT、睑板腺缺失评分、CLGS评分与对照组相比均无差异(均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。

METHODS:In this prospective randomized trial, 82 cases(82 eyes)diagnosed with moderate-to-severe SS-DE at our hospital from January 2023 to December 2023 were selected. If both eyes meet the criteria, one eye will be randomly selected for inclusion, and if one eye meets the inclusion criteria, the eye will be selected for enrollment. They were randomly assigned to either an experiment group receiving dextran hydroxypropyl methylcellulose eye drops and 0.05% cyclosporine A eye drops plus IPL therapy, or a control group receiving dextran hydroxypropyl methylcellulose eye drops and 0.05% cyclosporine A eye drops. Ocular surface disease index(OSDI)score, tear meniscus height(TMH), noninvasive tear breakup time(NITBUT), meibomian gland loss score, Schirmer I test(SⅠt), corneal fluorescein staining(CFS)score, conjunctival lissamine green staining(CLGS)score, lipid layer thickness(LLT), blink frequency, corneal Langerhans cell density(CLCD)and complications of both groups were assessed at baseline and at 4, 8, and 12 wk after treatment.

RESULTS:There were 6 cases lost to follow-up in the experiment group, with a missing rate of 14.6%, and 1 case was lost to follow-up in the control group, with a missing rate of 2.4%, and valid data were eventually obtained from 35 cases(35 eyes)in the experiment group and 40 cases(40 eyes)in the control group. Baseline parameters did not differ significantly between the two groups of patients(all P>0.05). At 4, 8 and 12 wk after treatment, both groups showed significant reductions in OSDI scores, CFS scores, CLGS score, blink frequency, and CLCD, while the reductions were significantly greater in the experiment group compared to the control group(all P<0.05). The experiment group also demonstrated significant increases in TMH, SⅠt, and NITBUT at 4, 8 and 12 wk after treatment, which were significantly greater than those observed in the control group(all P<0.05). No significant intergroup differences were observed in LLT, meibomian gland loss score in the experiment group at any time point(all P>0.05). Furthermore, no severe ocular or cutaneous complications 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.