氯替泼诺联合玻璃酸钠治疗中重度干眼的有效性和安全性的系统评价  

Systematic Review on Efficacy and Safety of Loteprednol Combined with Sodium Hyaluronate in the Treatment of Moderate-Severe Dry Eye

作　　者：郑子恢[1] 李琼[1] 李文英[1] 张白歌 马琳[1] 金鹏飞[1] ZHENG Zihui;LI Qiong;LI Wenying;ZHANG Baige;MA Lin;JIN Pengfei(Dept.of Pharmaceutical,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730

出　　处：《中国医院用药评价与分析》2021年第5期577-583,共7页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：北京市自然科学基金(No.7113164)。

摘　　要：目的:系统评价氯替泼诺联合玻璃酸钠治疗中重度干眼的有效性和安全性,为其临床合理应用提供循证证据。方法:计算机检索the Cochrane Library、PubMed、EMBase、中国知网、万方数据库和中国生物医学文献数据库,纳入氯替泼诺联合玻璃酸钠治疗中重度干眼的随机对照试验(研究组患者的治疗方案为氯替泼诺联合玻璃酸钠滴眼,对照组患者单独使用玻璃酸钠滴眼),检索时限为从建库至2021年2月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.4软件进行荟萃分析(Meta分析)。结果:共纳入8篇文献,包括771例患者(1416只眼),其中研究组患者387例(710只眼),对照组患者384例(706只眼)。Meta分析结果显示,有效性方面,研究组患者的总有效率(OR=3.14,95%CI=1.81~5.45,P<0.0001)、干眼症状评分(MD=-9.49,95%CI=-9.94~-9.04,P<0.00001)、治疗2周后泪膜破裂时间(BUT)(MD=1.92,95%CI=1.72~2.12,P<0.00001)、治疗4周后BUT(MD=3.56,95%CI=3.22~3.91,P<0.00001)、治疗6周后BUT(MD=4.40,95%CI=3.97~4.83,P<0.00001)、治疗8周后BUT(MD=5.14,95%CI=4.81~5.48,P<0.00001)、治疗2周后角膜荧光素染色评分(MD=-2.27,95%CI=-2.58~-1.97,P<0.00001)、治疗6周后角膜荧光素染色评分(MD=-2.42,95%CI=-2.77~-2.06,P<0.00001)、治疗8周后角膜荧光素染色评分(MD=-2.67,95%CI=-2.94~-2.40,P<0.00001)和泪液分泌试验(SchirmerⅠ)结果(MD=0.20,95%CI=0.11~0.29,P<0.00001)均显著优于对照组,差异均有统计学意义;安全性方面,两组患者不良反应发生率的差异无统计学意义(OR=0.76,95%CI=0.37~1.57,P=0.46>0.05)。结论:现有证据表明,氯替泼诺联合玻璃酸钠治疗中重度干眼安全、有效,起效快,较单独使用玻璃酸钠有明显优势。结果证据受纳入研究的数量和质量限制,上述结论有待更多高质量研究予以验证。OBJECTIVE:To systematically review the efficacy and safety of loteprednol combined with sodium hyaluronate in the treatment of moderate-severe dry eye METHODS:Randomized controlled trials on loteprednol combined with sodium hyaluronate in the treatment of moderate-severe dry eye(the research group was given loteprednol combined with sodium hyaluronate for eye-dropping,while the control group was given sodium hyaluronate alone)were retrieved from the Cochrane Library,PubMed,EMBase,CNKI,Wanfang database and CBM from base-building to Feb.2021.After independently literature screening,information extracting and bias evaluation by two researchers,RevMan 5.4 was adopted to conduct Meta-analysis.RESULTS:Totally 8 studies were involved,including 771 patients(1416 eyes),of which 387 patients(710 eyes)were in the research group,and 384 patients(706 eyes)were in the control group.Results of Meta-analysis indicated that in terms of effectiveness,the total effective rate(OR=3.14,95%CI=1.81-5.45,P<0.0001),score of dry eye symptom(MD=-9.49,95%CI=-9.94--9.04,P<0.00001),breakup time of tear film(BUT)at 2 weeks after treatment(MD=1.92,95%CI=1.72-2.12,P<0.00001),BUT at 4 weeks after treatment(MD=3.56,95%CI=3.22-3.91,P<0.00001),BUT at 6 weeks after treatment(MD=4.40,95%CI=3.97-4.83,P<0.00001),BUT at 8 weeks after treatment(MD=5.14,95%CI=4.81-5.48,P<0.00001),score of corneal fluorescein staining at 2 weeks after treatment(MD=-2.27,95%CI=-2.58--1.97,P<0.00001),score of corneal fluorescein staining at 6 weeks after treatment(MD=-2.42,95%CI=-2.77--2.06,P<0.00001),score of corneal fluorescein staining at 8 weeks after treatment(MD=-2.67,95%CI=-2.94--2.40,P<0.00001)and result of Schirmer test(Schirmer Ⅰ)(MD=0.20,95%CI=0.11-0.29,P<0.00001)of research group were significantly higher those of the control group,with statistically significantly differences;in terms of safety,there was no statistical significance in the difference in incidences of adverse drug reactions between two groups(OR=0.76,95%CI=0.37-1.57,P=0.46>0.05).CONCLUSIONS:Presen

关 键 词：氯替泼诺 玻璃酸钠 中重度干眼 META分析 随机对照试验 

分 类 号：R988.1[医药卫生—药品]