洛替拉纳滴眼液治疗蠕形螨睑缘炎有效性和安全性的Meta分析

doi:10.5246/jcps.2024.12.081

中国药学(英文版) ›› 2024, Vol. 33 ›› Issue (12): 1118-1128.DOI: 10.5246/jcps.2024.12.081

洛替拉纳滴眼液治疗蠕形螨睑缘炎有效性和安全性的Meta分析

张绮雯¹^,²^,³, 杨晶¹^,³, 杨勇杰¹^,², 鲁憬莉¹^,², 卢晓静¹^,², 刘克锋¹^,², 周奇⁴, 康建¹^,²^,^*()

^1. 郑州大学第一附属医院药学部, 河南郑州 450052
^2. 河南省药品临床综合评价中心, 河南郑州 450052
^3. 河南省精准临床药学重点实验室, 河南郑州 450052
^4. 兰州大学基础医学院循证医学中心, 甘肃兰州 730000

收稿日期:2024-06-21 修回日期:2024-07-15 接受日期:2024-10-13 出版日期:2025-01-07 发布日期:2025-01-06
通讯作者: 康建

Efficacy and safety of lotilaner ophthalmic solution in the treatment of Demodex Blepharitis: a meta-analysis of randomized controlled trials

Qiwen Zhang¹^,²^,³, Jing Yang¹^,³, Yongjie Yang¹^,², Jingli Lu¹^,², Xiaojing Lu¹^,², Kefeng Liu¹^,², Qi Zhou⁴, Jian Kang¹^,²^,^*()

¹ Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China
² Henan Drug Clinical Comprehensive Evaluation Center, Zhengzhou 450052, Henan, China
³ Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, Henan, China
⁴ Evidence-based Medicine Center, School of Basic Medical Sciences of Lanzhou University, Lanzhou 730000, Gansu, China

Received:2024-06-21 Revised:2024-07-15 Accepted:2024-10-13 Online:2025-01-07 Published:2025-01-06
Contact: Jian Kang
Supported by:
National Key R&D Program of China (Grant No. 2020YFC2008304) and Health Commission of Henan Province (Grant No. LHGJ20220426).

摘要/Abstract

摘要：

系统评价洛替拉纳滴眼液治疗蠕形螨睑缘炎(DB)的有效性和安全性, 为临床用药提供循证参考。计算机检索PubMed、Embase、Web of Science、The Cochrane Library、中国知网数据库、万方数据库和中国生物医学文献数据库, 搜集洛替拉纳滴眼液(试验组)对比安慰剂(对照组)治疗DB的随机对照试验(RCT), 检索时限均为建库至2023年11月28日。由两名研究者独立筛选文献、提取资料并评价纳入研究的质量, 采用RevMan 5.4软件进行Meta分析; 采用证据推荐分级的评估、制订与评价系统(GRADE)对结局指标的证据质量进行评价; 绘制倒漏斗图考察发表偏倚。共纳入4项RCT, 合计947名患者。Meta分析结果显示: 与安慰剂相比, 接受洛替拉纳滴眼液治疗的DB患者的蠕形螨根除率更高[RR = 3.61, 95% CI (2.90, 4.49), P < 0.00001]; 基于袖套状分泌物评分的治愈率、基于睑缘充血等级的治愈率、综合治愈率和具有临床意义的治愈率均更高, 效应量分别为[RR = 5.74, 95% CI (4.27, 7.72), P < 0.00001]、[RR = 3.16, 95% CI (2.18, 4.58), P < 0.00001]、[RR = 6.75, 95% CI (3.75, 12.16), P < 0.00001]和[RR = 3.09, 95% CI (2.65, 3.60), P < 0.00001]; 蠕形螨密度[MD = –1.42, 95% CI (–2.09, –0.74), P < 0.0001]和袖套状分泌物评分的降低幅度[MD = –1.51, 95% CI (–1.77, –1.25), P < 0.00001]均更大; 但两组患者的滴眼舒适度比较差异无统计学意义。给药部位疼痛、眼睛疼痛、眼分泌物增多、睑板腺囊肿以及眼睑水肿等与治疗相关的不良反应发生率较高, 但与安慰剂组比较差异无统计学意义。GRADE评价结果显示, 本研究纳入的指标证据总体质量为中等质量。发表偏倚分析结果显示, 本研究存在发表偏倚的可能性较小。当前证据显示, 洛替拉纳滴眼液可以显著降低蠕形螨睑缘炎患者的螨虫感染数量并提高治愈率, 具有较好的依从性和安全性。

关键词: 洛替拉纳滴眼液, 蠕形螨睑缘炎, Meta分析, 随机对照试验

Abstract:

In this meta-analysis, our aim was to systematically evaluate the efficacy and safety of lotilaner ophthalmic solution in treating Demodex Blepharitis (DB), with the goal of providing evidence for clinical practice. PubMed, Embase, Web of Science, The Cochrane Library, CNKI, Wanfang, and CBM were searched from inception to November 28, 2023. Randomized controlled trials (RCTs) comparing lotilaner ophthalmic solution (experimental group) with placebo (control group) for the treatment of DB were included. Two researchers independently screened the literature, extracted the data, and assessed the quality of the included studies. Meta-analysis was conducted using RevMan 5.4 software. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to evaluate the evidence quality of outcomes. Publication bias was assessed using a funnel plot. Four RCTs involving 947 patients were included. Meta-analysis revealed that compared to placebo, lotilaner ophthalmic solution significantly increased the rate of mite eradication (RR = 3.61, 95% CI (2.90, 4.49), P < 0.00001). Additionally, lotilaner treatment resulted in higher rates of collarette cure, erythema cure, composite erythema/collarette cure, and clinically meaningful collarette cure; the differences were statistically significant, with effect sizes (RR = 5.74, 95% CI (4.27, 7.72), P < 0.00001), (RR = 3.16, 95% CI (2.18, 4.58), P < 0.00001), (RR = 6.75, 95% CI (3.75, 12.16), P < 0.00001), and (RR = 3.09, 95% CI (2.65, 3.60), P < 0.00001), respectively. Mite density (MD = –1.42, 95% CI (–2.09, –0.74), P < 0.0001) and collarette grade (MD = –1.51, 95% CI (–1.77, –1.25), P < 0.00001) were significantly reduced. Indeed, no discernible discrepancies in the comfort levels experienced with eye drops emerged between the two groups. Although the experimental group did exhibit a slightly higher occurrence of treatment-related adverse events, ranging from instillation site discomfort to eye discharge and eyelid swelling, these variances did not attain statistical significance. Notably, upon GRADE evaluation, the study’s evidence quality was deemed moderate, while scrutiny for publication bias revealed minimal indications thereof. In the realm of treatment, lotilaner ophthalmic solution shined as a beacon of efficacy, effectively combating mite infections and bolstering cure rates among patients with DB. Moreover, its administration was met with commendable compliance and upheld safety standards.

Key words: Lotilaner ophthalmic solution, Demodex Blepharitis, Meta-analysis, Randomized controlled trial

Supporting:

张绮雯, 杨晶, 杨勇杰, 鲁憬莉, 卢晓静, 刘克锋, 周奇, 康建. 洛替拉纳滴眼液治疗蠕形螨睑缘炎有效性和安全性的Meta分析[J]. 中国药学(英文版), 2024, 33(12): 1118-1128.

Qiwen Zhang, Jing Yang, Yongjie Yang, Jingli Lu, Xiaojing Lu, Kefeng Liu, Qi Zhou, Jian Kang. Efficacy and safety of lotilaner ophthalmic solution in the treatment of Demodex Blepharitis: a meta-analysis of randomized controlled trials[J]. Journal of Chinese Pharmaceutical Sciences, 2024, 33(12): 1118-1128.

图/表 10

Table 1. Search strategy in PubMed.

Figure 1. Flow chart of literature screening.

Table 2. Basic characteristics of included studies.

Figure 2. Risk of bias graphs.

Figure 3. Risk of bias summary.

Figure 4. Meta-analysis results of mite eradication in two groups.

Figure 5. Meta-analysis results of cure rate in two groups. (A: Collarette cure; B: Erythema cure; C: Composite erythema/collarette cure).

Table 3. Meta-analysis results of adverse events.

Table 4. Results of GRADE.

Figure 6. Funnel plot of the incidence of mite eradication.

参考文献 20

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洛替拉纳滴眼液治疗蠕形螨睑缘炎有效性和安全性的Meta分析

Efficacy and safety of lotilaner ophthalmic solution in the treatment of Demodex Blepharitis: a meta-analysis of randomized controlled trials

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