不同治疗策略对粘多糖病患者的疗效:随机对照试验的系统评价和网络荟萃分析。

IF 3.4 2区 医学 Q2 GENETICS & HEREDITY
Lingling Huang, Jianru Wu, Biyu Tang, Jingying Wu, Fenfang Wei, Hong Qiao Li, Limin Li, Xinru Wang, Bei Wang, Wenyu Wu, Xiang Hong
{"title":"不同治疗策略对粘多糖病患者的疗效:随机对照试验的系统评价和网络荟萃分析。","authors":"Lingling Huang, Jianru Wu, Biyu Tang, Jingying Wu, Fenfang Wei, Hong Qiao Li, Limin Li, Xinru Wang, Bei Wang, Wenyu Wu, Xiang Hong","doi":"10.1186/s13023-025-03735-y","DOIUrl":null,"url":null,"abstract":"<p><p>This systematic review of randomized controlled trials (RCT) was conducted to evaluate the efficacy of enzyme replacement therapy (ERT) for patients with mucopolysaccharidosis (MPS). We systematically searched PubMed, Embase, Web of Science, and Cochrane databases up to August 22, 2023. Study design, interventions, and outcome data were extracted. Continuous variable random-effects network meta-analysis was performed. The review included 23 studies involving 1,047 people with MPS I-VI. In MPS I, urinary glycosaminoglycan (uGAG) level was significantly reduced in patients who took 2 mg/kg/week pentosan polysulfate (-2.66, 95% confidence interval (CI)[-3.86, -1.46]) compared with those who took 1 mg/kg/week. In MPS II, compared with the placebo group, significant reduction were observed in the uGAG (-270.77, 95% CI[-406.57, -139.71]) and the cerebrospinal fluid (CSF) GAG (-1,385.29, 95% CI[-2493.33, -392.65]). In MPS IV, 6-min walking test (6MWT) (40.82, 95% CI[16.19, 64.92]) and 3-min stair climb test (3MSCT) (16.07, 95% CI[12.16, 21.62]) were significantly increased in patients who took elosulfase alfa at a dose of 4.0 mg/kg/week compared with the placebo group. In MPS VI, recombinant human arylsulfatase B (rhASB) and galsulfase (1.0 mg/kg/week) significantly reduced uGAG aggregation compared with the placebo group (-217, 95% CI[-258, -176]) and galsulfase (2.0 mg/kg/week) group (-286.5, 95% CI[-436.5, -136.5]), respectively. Moreover, most studies had high (34.8%) or unclear (43.5%) risk of bias assessments and confidence assessment were low. ERT alleviated symptoms to some extent, but current evidence was insufficient. Hence, further evidence from large-sample RCT is needed.</p>","PeriodicalId":19651,"journal":{"name":"Orphanet Journal of Rare Diseases","volume":"20 1","pages":"211"},"PeriodicalIF":3.4000,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049060/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of different treatment strategies in patients with mucopolysaccharidosis: a systematic review and network meta-analysis of randomized controlled trials.\",\"authors\":\"Lingling Huang, Jianru Wu, Biyu Tang, Jingying Wu, Fenfang Wei, Hong Qiao Li, Limin Li, Xinru Wang, Bei Wang, Wenyu Wu, Xiang Hong\",\"doi\":\"10.1186/s13023-025-03735-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>This systematic review of randomized controlled trials (RCT) was conducted to evaluate the efficacy of enzyme replacement therapy (ERT) for patients with mucopolysaccharidosis (MPS). We systematically searched PubMed, Embase, Web of Science, and Cochrane databases up to August 22, 2023. Study design, interventions, and outcome data were extracted. Continuous variable random-effects network meta-analysis was performed. The review included 23 studies involving 1,047 people with MPS I-VI. In MPS I, urinary glycosaminoglycan (uGAG) level was significantly reduced in patients who took 2 mg/kg/week pentosan polysulfate (-2.66, 95% confidence interval (CI)[-3.86, -1.46]) compared with those who took 1 mg/kg/week. In MPS II, compared with the placebo group, significant reduction were observed in the uGAG (-270.77, 95% CI[-406.57, -139.71]) and the cerebrospinal fluid (CSF) GAG (-1,385.29, 95% CI[-2493.33, -392.65]). In MPS IV, 6-min walking test (6MWT) (40.82, 95% CI[16.19, 64.92]) and 3-min stair climb test (3MSCT) (16.07, 95% CI[12.16, 21.62]) were significantly increased in patients who took elosulfase alfa at a dose of 4.0 mg/kg/week compared with the placebo group. In MPS VI, recombinant human arylsulfatase B (rhASB) and galsulfase (1.0 mg/kg/week) significantly reduced uGAG aggregation compared with the placebo group (-217, 95% CI[-258, -176]) and galsulfase (2.0 mg/kg/week) group (-286.5, 95% CI[-436.5, -136.5]), respectively. Moreover, most studies had high (34.8%) or unclear (43.5%) risk of bias assessments and confidence assessment were low. ERT alleviated symptoms to some extent, but current evidence was insufficient. Hence, further evidence from large-sample RCT is needed.</p>\",\"PeriodicalId\":19651,\"journal\":{\"name\":\"Orphanet Journal of Rare Diseases\",\"volume\":\"20 1\",\"pages\":\"211\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-05-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049060/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Orphanet Journal of Rare Diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13023-025-03735-y\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GENETICS & HEREDITY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Orphanet Journal of Rare Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13023-025-03735-y","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GENETICS & HEREDITY","Score":null,"Total":0}
引用次数: 0

摘要

本研究对随机对照试验(RCT)进行了系统回顾,以评估酶替代疗法(ERT)对粘多糖病(MPS)患者的疗效。我们系统地检索了PubMed、Embase、Web of Science和Cochrane数据库,检索时间截止到2023年8月22日。提取了研究设计、干预措施和结果数据。进行连续变量随机效应网络meta分析。该综述包括23项研究,涉及1047名MPS I-VI患者。在MPS I中,与服用1 mg/kg/周的患者相比,服用2 mg/kg/周聚戊聚糖的患者尿糖胺聚糖(uGAG)水平显著降低(-2.66,95%可信区间(CI)[-3.86, -1.46])。在MPS II中,与安慰剂组相比,观察到uGAG (-270.77, 95% CI[-406.57, -139.71])和脑脊液(CSF) GAG (- 1385.29, 95% CI[-2493.33, -392.65])显著降低。在MPS IV中,与安慰剂组相比,服用4.0 mg/kg/周埃洛硫酶的患者6分钟步行试验(6MWT) (40.82, 95% CI[16.19, 64.92])和3分钟爬楼梯试验(3MSCT) (16.07, 95% CI[12.16, 21.62])显著增加。在MPS VI中,与安慰剂组(-217,95% CI[-258, -176])和半乳糖磺化酶(2.0 mg/kg/周)组(-286.5,95% CI[-436.5, -136.5])相比,重组人芳香磺化酶B (rhASB)和半乳糖磺化酶(1.0 mg/kg/周)分别显著降低了ugg聚集。大多数研究偏倚评估风险高(34.8%)或不明确(43.5%),置信度评估低。ERT在一定程度上缓解了症状,但目前证据不足。因此,需要来自大样本随机对照试验的进一步证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of different treatment strategies in patients with mucopolysaccharidosis: a systematic review and network meta-analysis of randomized controlled trials.

This systematic review of randomized controlled trials (RCT) was conducted to evaluate the efficacy of enzyme replacement therapy (ERT) for patients with mucopolysaccharidosis (MPS). We systematically searched PubMed, Embase, Web of Science, and Cochrane databases up to August 22, 2023. Study design, interventions, and outcome data were extracted. Continuous variable random-effects network meta-analysis was performed. The review included 23 studies involving 1,047 people with MPS I-VI. In MPS I, urinary glycosaminoglycan (uGAG) level was significantly reduced in patients who took 2 mg/kg/week pentosan polysulfate (-2.66, 95% confidence interval (CI)[-3.86, -1.46]) compared with those who took 1 mg/kg/week. In MPS II, compared with the placebo group, significant reduction were observed in the uGAG (-270.77, 95% CI[-406.57, -139.71]) and the cerebrospinal fluid (CSF) GAG (-1,385.29, 95% CI[-2493.33, -392.65]). In MPS IV, 6-min walking test (6MWT) (40.82, 95% CI[16.19, 64.92]) and 3-min stair climb test (3MSCT) (16.07, 95% CI[12.16, 21.62]) were significantly increased in patients who took elosulfase alfa at a dose of 4.0 mg/kg/week compared with the placebo group. In MPS VI, recombinant human arylsulfatase B (rhASB) and galsulfase (1.0 mg/kg/week) significantly reduced uGAG aggregation compared with the placebo group (-217, 95% CI[-258, -176]) and galsulfase (2.0 mg/kg/week) group (-286.5, 95% CI[-436.5, -136.5]), respectively. Moreover, most studies had high (34.8%) or unclear (43.5%) risk of bias assessments and confidence assessment were low. ERT alleviated symptoms to some extent, but current evidence was insufficient. Hence, further evidence from large-sample RCT is needed.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Orphanet Journal of Rare Diseases
Orphanet Journal of Rare Diseases 医学-医学:研究与实验
CiteScore
6.30
自引率
8.10%
发文量
418
审稿时长
4-8 weeks
期刊介绍: Orphanet Journal of Rare Diseases is an open access, peer-reviewed journal that encompasses all aspects of rare diseases and orphan drugs. The journal publishes high-quality reviews on specific rare diseases. In addition, the journal may consider articles on clinical trial outcome reports, either positive or negative, and articles on public health issues in the field of rare diseases and orphan drugs. The journal does not accept case reports.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信