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甲状腺相关眼病治疗中不同单克隆抗体有效性与安全性的系统评价再评价

Umbrella review of the efficacy and safety of monoclonal antibodies in the treatment of thyroid-associated ophthalmopathy

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【作者】 刘爽蒋函錞吴晶晶赵荣生

【Author】 LIU Shuang;JIANG Hanchun;WU Jingjing;ZHAO Rongsheng;Department of Pharmacy, Peking University Third Hospital;Institute for Drug Evaluation, Peking University Health Science Center;Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University;

【通讯作者】 赵荣生;

【机构】 北京大学第三医院药学部北京大学医学部药物评价中心北京大学药学院药事管理与临床药学系

【摘要】 目的:全面评估甲状腺相关眼病(thyroidassociated ophthalmopathy,TAO)治疗中利妥昔单克隆抗体(rituximab,RTX)、托珠单克隆抗体(tocilizumab,TCZ)、替妥木单克隆抗体(teprotumumab,TMB)的有效性和安全性。方法:采用系统评价再评价方法,系统检索PubMed、Embase、Cochrane Library数据库中关于TAO治疗的系统评价/Meta分析,检索时间均为建库至2024年1月。分别采用PRISMA 2020声明、AMSTAR 2量表和GRADE工具评估纳入研究的报告质量、方法学质量及证据质量。结果:当前关于TAO治疗中3种单克隆抗体的系统评价在报告规范性、方法学质量和证据质量方面仍存在不足。目前仍缺少3种单克隆抗体直接比较的证据,基于间接比较证据,TCZ可能是最好的治疗方法,其次为TMB和RTX。有效性方面,TCZ、TMB可显著降低临床活动性评分、眼球突出度及生活质量,TCZ显著降低复视发生,RTX显著降低疾病应答,RTX及TCZ显著改善疾病失活率,RTX在复视、眼睑裂变化、NOSPECS评分与生活质量方面无显著差异。安全性方面的结论尚不一致,TCZ和TMB可能增加不良事件的发生率,而RTX在安全性方面与糖皮质激素或安慰剂相比无显著差异。结论:本研究为TAO治疗中3种单克隆抗体的选择提供循证依据。尽管TCZ在有效性方面可能具有优势,但考虑到现有证据的限制性,未来仍需更多高质量研究进一步验证和比较不同单克隆抗体在TAO治疗中的有效性和安全性。

【Abstract】 AIM:To comprehensively evaluate the efficacy and safety of rituximab(RTX), tocilizumab(TCZ), and teprotumumab(TMB) in the treatment of thyroid-associated ophthalmopathy(TAO).METHODS: A systematic search was conducted in PubMed, Embase and Cochrane Library databases for systematic reviews/meta-analyses on TAO treatment, with the search time limited to January2024. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) 2020 statement, Assessment of Multiple Systematic Reviews(AMSTAR) 2 tool, and Grading of Recommendations, Assessment, Development, and Evaluation(GRADE) were used to assess the reporting quality,methodological quality, and evidence quality of the included studies. RESULTS: The current systematic reviews on the three monoclonal antibodies in TAO treatment exhibited deficiencies in reporting quality, methodological quality, and evidence quality. Direct comparative evidence between the three monoclonal antibodies is still lacking. Based on indirect comparative evidence, TCZ appears to be the most promising treatment option, followed by TMB and RTX. In terms of efficacy, TCZ and TMB significantly reduced the Clinical Activity Score(CAS), proptosis, and improved quality of life. TCZ also significantly reduced the incidence of diplopia. RTX significantly reduced disease response, while RTX and TCZ both significantly improved disease inactivation rates. RTX showed no significant difference in diplopia, lid fissure changes, NOSPECS score and quality of life. The conclusions regarding safety are inconsistent, with TCZ and TMB potentially increasing the incidence of adverse events, while RTX showed no significant difference in safety compared to glucocorticoids or placebo. CONCLUSION:This study provides evidence-based insights for the selection of three monoclonal antibodies in the treatment of TAO. While TCZ may have advantages in efficacy, considering the limitations of existing evidence, more high-quality studies are needed to further verify and compare the efficacy and safety of different monoclonal antibodies in TAO treatment.

【基金】 国家自然科学基金项目(72074005)
  • 【文献出处】 中国临床药理学与治疗学 ,Chinese Journal of Clinical Pharmacology and Therapeutics , 编辑部邮箱 ,2024年07期
  • 【分类号】R581;R771.3
  • 【下载频次】81
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