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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)
纸质出版日期:2021,
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[1]郑子恢,李琼,李文英,张白歌,马琳,金鹏飞.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[J].中国医院用药评价与分析,2021,21(05):577-583.
Systematic Review on Efficacy and Safety of Loteprednol Combined with Sodium Hyaluronate in the Treatment of Moderate-Severe Dry Eye[J]. 2021,21(5):577-583.
[1]郑子恢,李琼,李文英,张白歌,马琳,金鹏飞.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[J].中国医院用药评价与分析,2021,21(05):577-583. DOI: 10.14009/j.issn.1672-2124.2021.05.016.
Systematic Review on Efficacy and Safety of Loteprednol Combined with Sodium Hyaluronate in the Treatment of Moderate-Severe Dry Eye[J]. 2021,21(5):577-583. DOI: 10.14009/j.issn.1672-2124.2021.05.016.
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Rev Man 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(1 416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<0.000 1)、干眼症状评分(MD=-9.49
95%CI=-9.94~-9.04
P<0.000 01)、治疗2周后泪膜破裂时间(BUT)(MD=1.92
95%CI=1.72~2.12
P<0.000 01)、治疗4周后BUT(MD=3.56
95%CI=3.22~3.91
P<0.000 01)、治疗6周后BUT(MD=4.40
95%CI=3.97~4.83
P<0.000 01)、治疗8周后BUT(MD=5.14
95%CI=4.81~5.48
P <0.000 01)、治疗2周后角膜荧光素染色评分(MD=-2.27
95%CI=-2.58~-1.97
P<0.000 01)、治疗6周后角膜荧光素染色评分(MD=-2.42
95%CI=-2.77~-2.06
P<0.000 01)、治疗8周后角膜荧光素染色评分(MD=-2.67
95%CI=-2.94~-2.40
P<0.000 01)和泪液分泌试验(SchirmerⅠ)结果(MD=0.20
95%CI=0.11~0.29
P<0.000 01)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 basebuilding 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
including771 patients( 1 416 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. 000 1)
score of dry eye symptom( MD =-9. 49
95%CI =-9. 94--9. 04
P<0. 000 01)
breakup time of tear film( BUT) at 2 weeks after treatment( MD = 1. 92
95% CI = 1. 72-2. 12
P <0. 000 01)
BUT at 4 weeks after treatment( MD = 3. 56
95% CI = 3. 22-3. 91
P < 0. 000 01)
BUT at 6 weeks after treatment( MD = 4. 40
95%CI = 3. 97-4. 83
P<0. 000 01)
BUT at 8 weeks after treatment( MD = 5. 14
95%CI = 4. 81-5. 48
P<0. 000 01)
score of corneal fluorescein staining at 2 weeks after treatment( MD =-2. 27
95% CI =-2. 58--1. 97
P<0. 000 01)
score of corneal fluorescein staining at 6 weeks after treatment( MD =-2. 42
95%CI =-2. 77--2. 06
P<0. 000 01)
score of corneal fluorescein staining at 8 weeks after treatment( MD =-2. 67
95%CI =-2. 94--2. 40
P<0. 000 01) and result of Schirmer test( Schirmer Ⅰ)( MD = 0. 20
95% CI = 0. 11-0. 29
P < 0. 000 01) 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: Present evidence shows that loteprednol combined with sodium hyaluronate is safe
effective and quickly effected in the treatment of moderate-severe dry eye
which has obvious advantages over sodium hyaluronate alone. The result evidence is limited by the quantity and quality of involved studies
and the above conclusions need to be verified by more high-quality studies.
氯替泼诺玻璃酸钠中重度干眼Meta分析随机对照试验
LoteprednolSodium hyaluronateModerate-severe dry eyeMeta-analysisRandomized controlled trial
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