Dry eye disease due to meibomian gland dysfunction treated with Pinggan Yuyin Qingre formula: a stratified randomized controlled trial.

Gao Yinli, Lian Haihong, Deng Shijing, Duan Ying, Zhang Peng, Wang Zhiqun, Zhang Yang
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Abstract

Objective: To observe the clinical efficacy on improving the quality of meibum in patients suffer from dry eye disease (DED) due to meibomian gland dysfunction (MGD) with hyperactivity ofdue todeficiency pattern after being treated with Pinggan Yuyin Qingre formula (, PGYYQR).

Methods: Totally 120 patients who met the inclusion criteria were included and stratified into three levels according to the level of MGD (1-3), and patients in each level was randomly allocated into the treatment group and control group according to a 1∶1 ratio. Both groups were treated with sodium hyaluronate eye drops, and the treatment group was also given PGYYQR granules. Both groups were treated continuously for eight weeks. The score of the properties of meibomian gland (MG) secretion, the score of the palpebral margins, the average noninvasive tear breakup time (NITBUTav), lipid layer thickness (LLT), and Traditional Chinese Medicine (TCM) syndrome efficacy were compared between the two groups after treatment.

Results: A total of 116 cases were included in the statistical analysis. The differences were statistically significant in the score of the properties of MG secretion, the score of the palpebral margins, and NITBUTav between the two groups after treatment, the treatment group was superior to the control group; there was no evidence of a difference in LLT. In terms of TCM syndrome efficacy, the total effective rate was 84.7% in the treatment group and 50.9% in the control group, with the statistically significant difference. None of the included cases had adverse reactions.

Conclusions: PGYYQR is effective in improving the quality of meibum, and the tear film stability which thereby relieving the ocular symptoms in MGD-related DED patients with hyperactivity ofdue todeficiency pattern.

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平干玉音清热方治疗睑板腺功能障碍引起的干眼症:分层随机对照试验。
目的观察平干玉屏清热方(PGYYQR)治疗睑板腺功能亢进型干眼症(DED)患者改善睑板腺分泌物质量的临床疗效:方法:纳入符合纳入标准的120例患者,根据MGD的程度(1-3)分为三个级别,每个级别的患者按照1∶1的比例随机分配到治疗组和对照组。两组患者均接受透明质酸钠滴眼液治疗,治疗组还给予 PGYYQR 颗粒。两组均连续治疗八周。比较两组治疗后的睑板腺(MG)分泌特性评分、睑缘评分、平均无创泪液破裂时间(NITBUTav)、脂质层厚度(LLT)和中医证候疗效:结果:共有 116 例病例纳入统计分析。两组治疗后MG分泌特性评分、睑缘评分、NITBUTav差异有统计学意义,治疗组优于对照组;LLT无差异证据。中医证候疗效方面,治疗组总有效率为84.7%,对照组总有效率为50.9%,差异有统计学意义。无一例出现不良反应:结论:PGYYQR能有效改善睑板腺功能亢进相关DED患者的睑板腺质量和泪膜稳定性,从而缓解其眼部症状。
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