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Randomized controlled trial on the efficacy and safety of autologous serum eye drops in dry eye syndrome
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作者 Na Zheng Si-Quan Zhu 《World Journal of Clinical Cases》 SCIE 2023年第28期6774-6781,共8页
BACKGROUND Autologous serum eye drops(ASEDs),a novel treatment derived from blood serum,have emerged as a groundbreaking solution for managing dry eye syndrome(DES).These drops have shown significant promise in reliev... BACKGROUND Autologous serum eye drops(ASEDs),a novel treatment derived from blood serum,have emerged as a groundbreaking solution for managing dry eye syndrome(DES).These drops have shown significant promise in relieving the distressing symptoms of DES.This study aimed to evaluate the safety and effectiveness of ASEDs compared to traditional treatments,which often prove inadequate or result in unwanted side effects,particularly in individuals with moderate-to-severe DES.AIM To evaluate whether ASEDs are safer and more effective than conventional artificial tears in the treatment of moderate-to-severe DES.METHODS This multi-centered randomized controlled trial included 240 patients with moderate-to-severe DES from three ophthalmology clinics in China.They were randomly assigned to receive either ASEDs or artificial tears for 12 wk.The primary outcome was the change in the ocular surface disease index(OSDI)score,with secondary outcomes including tear break-up time(TBUT),Schirmer I test,corneal fluorescein staining(CFS),and conjunctival impression cytology(CIC).Statistics analysis was performed using an analysis of covariance with adjustments made for baseline values.RESULTS Our findings revealed that both ASEDs and artificial tears significantly improved the OSDI score,TBUT,Schirmer I test,CFS,and CIC from baseline to week 12.The ASEDs group showed significantly greater improvement in all these measures than the artificial tears group(all P values<0.05).The average difference in the OSDI score between the two cohorts was-10.3(95%confidence interval:-13.6 to-7.0),indicating a substantial improvement in the ASEDs group.The occurrence of adverse events was comparable between cohorts,with no reports of severe adverse events.CONCLUSION ASEDs are more effective and safer than artificial tears for mitigating symptoms of moderate-to-severe DES.ASEDs could be an alternative/supplementary therapy for patients with DES less responsive to traditional treatments. 展开更多
关键词 autologous serum eye drops Dry eye syndrome SAFETY EFFECTIVENESS Alternative therapy Conventional artificial tears
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