Morya Arvind Kumar, Solanki Kanchan, Prakash Sujeet, Samota Monika, Gupta Arushi
Department of Ophthalmology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Department of Ophthalmology, AIIMS, Jodhpur, Rajasthan, India.
Taiwan J Ophthalmol. 2020 Oct 21;11(2):161-167. doi: 10.4103/tjo.tjo_58_20. eCollection 2021 Apr-Jun.
To compare the therapeutic effect of sodium hyaluronate (SH)-trehalose (Trehalube, Microlabs, Bangalore, India, SH 0.1% and trehalose 3%) or SH (0.1% Hylotears, Raymed, Chandigarh, India) alone in patients with dry eye disease (DED).
Patients were randomized into two groups: SH-trehalose (SH 0.1% and trehalose 3%) or SH (0.1% Hylotears) alone. The Ocular Surface Disease Index (OSDI) questionnaire was used to assess patient's symptoms. Patients were followed up at 4 and 8 weeks, and OSDI score, tear film break-up time (TBUT), tear film height (TFH), Schirmer's test, and conjunctival staining were evaluated at each visit.
A total of 384 patients were included in the study, 192 patients in each arm. The mean age of participants was 37.62 + 14.4 years and 225 were women (56%). The improvement in Schirmer's test was significantly better in the SH-trehalose group at 8 weeks (5.26 + 4.3 mm, 95% confidence interval = 4.6-5.9 mm) compared to the SH group (3.71 + 3.9, 95% confidence interval = 3.15-4.28 mm). The TBUT and TFH showed slight improvement at 4 weeks in both groups, but not at 8 weeks. There were no group differences at all-time points in terms of conjunctival staining and OSDI-based grades of DED.
It was found that treating dry eye with SH-trehalose leads to greater improvement in the Schirmer's values and TBUT after 8 weeks of sustained use in patients with DED, and this was more pronounced in those with severe DED.
比较透明质酸钠（SH）-海藻糖（Trehalube，印度班加罗尔Microlabs公司，含0.1% SH和3%海藻糖）或单独使用SH（0.1% Hylotears，印度昌迪加尔Raymed公司）对干眼症（DED）患者的治疗效果。
患者被随机分为两组：SH-海藻糖组（0.1% SH和3%海藻糖）或单独使用SH组（0.1% Hylotears）。使用眼表疾病指数（OSDI）问卷评估患者症状。患者在4周和8周时进行随访，每次随访时评估OSDI评分、泪膜破裂时间（TBUT）、泪膜高度（TFH）、泪液分泌试验和结膜染色情况。
共有384例患者纳入研究，每组192例。参与者的平均年龄为37.62±14.4岁，女性225例（56%）。与SH组（3.71±3.9，95%置信区间=3.15-4.28 mm）相比，SH-海藻糖组在8周时泪液分泌试验的改善情况明显更好（5.26±4.3 mm，95%置信区间=4.6-5.9 mm）。两组在4周时TBUT和TFH均有轻微改善，但在8周时无改善。在结膜染色和基于OSDI的DED分级方面，各时间点两组之间均无差异。
研究发现，对于DED患者，持续使用8周后，用SH-海藻糖治疗干眼症可使泪液分泌试验值和TBUT有更大改善，且在重度DED患者中更为明显。
