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生物制剂在罕见、难治性皮肤病中的应用:疗效与挑战的系统综述与 Meta 分析

开琴 王(自贡市第一人民医院皮肤科,中国;)
慧 姜(滨州医学院烟台附属医院皮肤科,中国;)
文双 李(安宁市中医医院皮肤科,中国;)
永书 桂(文山壮族苗族自治州皮肤病防治所,中国;)

摘要

目的:系统评价生物制剂对比安慰剂治疗中重度化脓性汗腺炎(HS)的短期疗效与安全性。方法:计算机检索PubMed、Embase、Cochrane Library和Web of Science数据库,搜集建库至2025年9月30日的相关随机对照试验(RCT)。由四名研究者独立筛选文献、提取资料并评价偏倚风险后,采用RevMan Web软件进行Meta分析。结果:共纳入9项RCT,合计1974例患者。Meta分析结果显示,与对照组相比,生物制剂能显著提高患者的临床应答率(合并风险比 [RR] = 1.82, 95% CI: [1.47, 2.25], P = 0.003)。总效应的95%预测区间为 [0.93, 2.18],提示未来研究结果仍存在一定不确定性。研究间存在中度异质性(I² = 47%)。定性综合提示临床应用面临疗效衰减、感染风险、经济负担及缺乏预测性生物标志物等挑战。结论:生物制剂能显著提高中重度HS患者的短期临床应答率,但疗效存在异质性,临床应用需综合权衡获益、风险及成本。

关键词

化脓性汗腺炎;生物制剂;Meta分析;随机对照试验;疗效

全文:

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参考

Bechara F G, Podda M, Jemec G B E, et al. Surgery combined with adalimumab for moderate-to-severe hidradenitis suppurativa: the SHARPS randomized controlled trial[J]. British Journal of Dermatology, 2021, 184(5): 893-901.

Glatt S, Jemec G B E, Forman S, et al. Efficacy and safety of bimekizumab in moderate to severe hidradenitis suppurativa: a phase 2, double-blind, placebo-controlled randomized clinical trial[J]. JAMA Dermatology, 2021, 157(11): 1279-1288.

Kimball A B, Giamarellos-Bourboulis E J, Prens E P, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials[J]. The Lancet, 2023, 401(10378): 747-761.

Kimball A B, Okun M M, Williams D A, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa[J]. New England Journal of Medicine, 2016, 375(5): 422-434.(注:此项为PIONEER I & II两项试验的联合报告)

[IFX-1] Study results not yet published in a peer-reviewed journal. Data sourced from clinical trial registry NCT03487276..(注:此为临床试验,非期刊文章)

[Guselkumab] Study results not yet published in a peer-reviewed journal. Data sourced from clinical trial registry NCT03628924..(注:此为临床试验,非期刊文章)

[Risankizumab] Study results not yet published in a peer-reviewed journal. Data sourced from clinical trial registry NCT03926169..(注:此为临床试验,非期刊文章)

Grant A, Gonzalez T, Montgomery M O, et al. Infliximab therapy for patients with moderate to severe hidradenitis suppurativa: a randomized, double-blind, placebo-controlled crossover trial[J]. Journal of the American Academy of Dermatology, 2010, 62(2): 205-217.



DOI: http://dx.doi.org/10.12345/yzlcyxzz.v9i1.35843

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