He Chang-Zhu, Zeng Zhao-Jun, Liu Jun Qiao, Qiu Qin, He Yu
Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Department of Ophthalmology, Chengdu First People's Hospital/Chengdu Integrated TCM and Western Medicine Hospital, Chengdu, China.
Front Med (Lausanne). 2024 Sep 13;11:1430785. doi: 10.3389/fmed.2024.1430785. eCollection 2024.
Dry eye disease (DED) is highly prevalent worldwide, leading to increased medical costs, economic burdens on families and society, and a diminished quality of life for patients. The utilization of autologous serum eye drops (ASEDs) for the treatment of DED is progressively rising.
To further evaluate the efficacy and safety of ASEDs in the treatment of DED.
A thorough search for randomized controlled trials (RCTs) was conducted across eight databases, including PubMed, EMBASE, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang, SinoMed, and VIP. This search encompassed the inception of each database up to April 1, 2024, with a specific focus on identifying RCTs evaluating the efficacy and safety of ASEDs for the treatment of DED. Data analysis was conducted utilizing Stata 15.0 software and the Cochrane Risk of Bias Assessment Tool was utilized to appraise the literature's quality.
The study encompassed 12 RCTs. In comparison to the use of artificial tears (AT), patients diagnosed with DED who utilized ASEDs displayed elevated the Schirmer test (ST) scores [WMD = 2.35, 95% CI (1.45, 3.24), < 0.001] and tear-film breakup time (TBUT) scores [WMD = 2.83, 95% CI (2.27, 3.39), < 0.001], decreased Corneal fluorescence staining (CFS) scores [SMD = -2.11, 95% CI (-3.07, -1.15), < 0.001] and the Ocular Surface Disease Index (OSDI) scores [WMD = -10.54, 95% CI (-13.31, -7.77), p < 0.001], and experienced a reduced frequency of adverse events [RR = 0.36, 95% CI (0.13, 0.99), = 0.048].
In this study, ASEDs had been shown to enhance tear secretion, extend tear film break-up time, mitigate corneal epithelial damage, ameliorate OSDI scores, and exhibit greater safety compared to AT.
干眼症(DED)在全球范围内高度流行,导致医疗成本增加、家庭和社会经济负担加重,以及患者生活质量下降。自体血清滴眼液(ASED)用于治疗DED的应用正在逐渐增加。
进一步评估ASED治疗DED的疗效和安全性。
在包括PubMed、EMBASE、Cochrane图书馆、科学网、中国知网、万方、中国生物医学文献数据库和维普在内的八个数据库中进行全面的随机对照试验(RCT)检索。该检索涵盖了每个数据库从创建到2024年4月1日的内容,特别关注识别评估ASED治疗DED疗效和安全性的RCT。使用Stata 15.0软件进行数据分析,并使用Cochrane偏倚风险评估工具评估文献质量。
该研究纳入了12项RCT。与使用人工泪液(AT)相比,诊断为DED并使用ASED的患者泪液分泌试验(ST)评分升高[加权均数差(WMD)=2.35,95%置信区间(CI)(1.45,3.24),P<0.001],泪膜破裂时间(TBUT)评分升高[WMD=2.83,95%CI(2.27,3.39),P<0.001],角膜荧光素染色(CFS)评分降低[标准化均数差(SMD)=-2.11,95%CI(-3.07,-1.15),P<0.001],眼表疾病指数(OSDI)评分降低[WMD=-10.54,95%CI(-13.31,-7.77),P<0.001],不良事件发生频率降低[风险比(RR)=0.36,95%CI(0.13,0.99),P= =0.048]。
在本研究中,已证明ASED与AT相比,可增加泪液分泌、延长泪膜破裂时间、减轻角膜上皮损伤、改善OSDI评分,并具有更高的安全性。