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短期(24 周)治疗白癜风患者鲁索替尼乳膏的疗效和安全性:系统评价和荟萃分析。

Short-term (24 weeks) treatment efficacy and safety of ruxolitinib cream in participants with vitiligo: a systematic review and meta-analysis.

机构信息

Department of Dermatology, Gansu Provincial Maternity and Child-care Hospital (Gansu Provincial Central Hospital), Lanzhou, 730000, China.

School of Pharmacy, Faculty of Medicine, Macau University of Science and Technology, Macau SAR, China.

出版信息

Syst Rev. 2024 Oct 2;13(1):250. doi: 10.1186/s13643-024-02653-7.

DOI:10.1186/s13643-024-02653-7
PMID:39358803
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11445846/
Abstract

IMPORTANCE

Vitiligo is a chronic skin disorder causing depigmentation. There is a lack of evidence-based medical evidence regarding ruxolitinib efficacy and safety for vitiligo.

OBJECTIVE

To assess the efficacy and safety of ruxolitinib cream in the treatment of vitiligo.

METHODS

The databases of PubMed, Embase, and Cochrane Library were searched. The literature screening was independently conducted by two reviewers.

DATA EXTRACTION AND SYNTHESIS

For continuous variables, weighted mean difference (WMD) along with a 95% confidence interval (CI) was performed. For dichotomous outcomes, we calculated the odds ratios (ORs) or risk ratios (RRs), and their corresponding 95% CIs. The certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE).

MAIN OUTCOMES AND MEASURES

Symptoms, quality of life, and safety were evaluated using various measures, including the Facial Vitiligo Area Scoring Index (F-VASI), Total Vitiligo Area Scoring Index (T-VASI), Facial Body Surface Area (F-BAS), Total Body Surface Area (T-BAS) and Treatment-emergent Adverse Events (TEAEs).

RESULTS

Three trials, involving a total of 830 participants from nine countries were included (female 388, 46.7%, male 442, 53.3%). The meta-analysis demonstrated a significant increase in the likelihood of participants achieving F-VASI75 (OR, 4.34 [95% CI 2.67-7.06]; high), F-VASI50 (OR 4.71 [95% CI 3.24-6.84]; high), T-VASI75 (OR 2.78 [95% CI 1.10-7.00]; moderate), and T-VASI50 (OR 4.47 [95% CI 2.52-7.92]; high) when compared ruxolitinib to vehicle. Ruxolitinib was associated with more lowered percentage change of F-VASI scores (MD - 32.79 [95% CI - 36.37 to - 29.21]; moderate), and T-VASI scores (MD - 20.22 [95% CI - 23.11 to - 17.33]; moderate) from baseline compared to vehicle. There may not be a significant difference in the occurrence of TEAEs between ruxolitinib and vehicle (RR 1.46 [95% CI 0.85-2.49]; high).

CONCLUSIONS

The findings suggest that ruxolitinib cream holds promise as a treatment option for vitiligo. Further long-term studies are needed to assess its sustained efficacy and safety profile.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42023431112.

摘要

重要性

白癜风是一种导致色素脱失的慢性皮肤疾病。目前,关于鲁索替尼乳膏治疗白癜风的疗效和安全性,缺乏基于证据的医学证据。

目的

评估鲁索替尼乳膏治疗白癜风的疗效和安全性。

方法

检索了 PubMed、Embase 和 Cochrane 图书馆的数据库。两位评审员独立进行了文献筛选。

数据提取和综合

对于连续变量,采用加权均数差(WMD)及其 95%置信区间(CI)。对于二分类结局,我们计算了比值比(OR)或风险比(RR)及其相应的 95%CI。使用推荐评估、制定与评价(GRADE)等级评估证据的确定性。

主要结局和措施

使用各种措施评估症状、生活质量和安全性,包括面部白癜风面积评分指数(F-VASI)、总白癜风面积评分指数(T-VASI)、面部体表面积(F-BAS)、总体表面积(T-BAS)和治疗出现的不良事件(TEAEs)。

结果

共纳入来自 9 个国家的 3 项试验,共 830 名参与者(女性 388 名,占 46.7%;男性 442 名,占 53.3%)。荟萃分析表明,与安慰剂相比,鲁索替尼更有可能使参与者达到 F-VASI75(OR,4.34[95%CI 2.67-7.06];高)、F-VASI50(OR,4.71[95%CI 3.24-6.84];高)、T-VASI75(OR,2.78[95%CI 1.10-7.00];中)和 T-VASI50(OR,4.47[95%CI 2.52-7.92];高)。与安慰剂相比,鲁索替尼与 F-VASI 评分(MD-32.79[95%CI-36.37 至-29.21];中)和 T-VASI 评分(MD-20.22[95%CI-23.11 至-17.33];中)的基线百分比变化降低更明显。鲁索替尼与安慰剂治疗的 TEAEs 发生率可能无显著差异(RR 1.46[95%CI 0.85-2.49];高)。

结论

研究结果表明,鲁索替尼乳膏有望成为白癜风的一种治疗选择。需要进一步的长期研究来评估其持续疗效和安全性。

系统评价注册

PROSPERO CRD42023431112。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/5dae02cde3f3/13643_2024_2653_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/6bb7525ba0ed/13643_2024_2653_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/8ca19fbe778c/13643_2024_2653_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/5dae02cde3f3/13643_2024_2653_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/6bb7525ba0ed/13643_2024_2653_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/8ca19fbe778c/13643_2024_2653_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f5d/11445846/5dae02cde3f3/13643_2024_2653_Fig3_HTML.jpg

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本文引用的文献

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J Eur Acad Dermatol Venereol. 2023 Nov;37(11):2222-2230. doi: 10.1111/jdv.19162. Epub 2023 May 15.
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Vitiligo Treatments: Review of Current Therapeutic Modalities and JAK Inhibitors.白癜风治疗:当前治疗方式及JAK抑制剂综述
Am J Clin Dermatol. 2023 Mar;24(2):165-186. doi: 10.1007/s40257-022-00752-6. Epub 2023 Jan 30.
3
Review of Ruxolitinib for Treatment of Non-Segmental Vitiligo.芦可替尼治疗非节段型白癜风的综述
Ann Pharmacother. 2023 Aug;57(8):948-955. doi: 10.1177/10600280221143748. Epub 2022 Dec 23.
4
Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo.两项针对 Ruxolitinib 乳膏治疗白癜风的 3 期、随机、对照临床试验。
N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.
5
Vitiligo prevalence and quality of life among adults in Europe, Japan and the USA.白癜风在欧洲、日本和美国成年人中的患病率和生活质量。
J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1831-1844. doi: 10.1111/jdv.18257. Epub 2022 Jun 14.
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Janus Kinase Inhibitors in the Treatment of Vitiligo: A Review.Janus 激酶抑制剂治疗白癜风:综述。
Front Immunol. 2021 Nov 18;12:790125. doi: 10.3389/fimmu.2021.790125. eCollection 2021.
7
Developing a JAK Inhibitor for Targeted Local Delivery: Ruxolitinib Cream.开发用于靶向局部递送的JAK抑制剂:芦可替尼乳膏。
Pharmaceutics. 2021 Jul 8;13(7):1044. doi: 10.3390/pharmaceutics13071044.
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British Association of Dermatologists guidelines for the management of people with vitiligo 2021.英国皮肤科医师协会2021年白癜风患者管理指南
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BMJ. 2021 Mar 29;372:n71. doi: 10.1136/bmj.n71.
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Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140-6736(20)30609-7.