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地舒单抗治疗骨巨细胞瘤的卫生技术评估
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| 篇名： | 地舒单抗治疗骨巨细胞瘤的卫生技术评估 |
| TITLE： | Denosumab in the Treatment of Giant Cell Tumor of Bone ：A Health Technology Assessment |
| 摘要： | 目的：评价地舒单抗治疗骨巨细胞瘤的有效性、安全性和经济性，为临床治疗和决策提供循证依据。方法：系统检索PubMed、Cochrane图书馆、ScienceDirect、中国知网、万方数据和维普网等数据库以及各国卫生技术评估（HTA）机构官网，纳入有关地舒单抗治疗成人和骨骼发育成熟的青少年骨巨细胞瘤患者的HTA报告、随机对照试验（RCT）、单臂试验以及回顾性研究，并对这些证据进行质量评估。采用描述性分析的方法描述纳入的HTA报告，使用R语言3.6.0软件对单臂临床试验和回顾性研究，进行Meta分析。结果：从49篇文献中筛选出HTA报告6篇、单臂试验5篇、回顾性研究3篇，没有RCT研究。各国的HTA报告普遍认为地舒单抗具有良好的有效性和安全性，且法国、澳大利亚等国的HTA报告认为该药具有经济性。在不可手术的骨巨细胞瘤患者中，地舒单抗可为约81％[95％CI（77％，86％）]的患者带来临床获益，完全缓解率约为14％[95％CI（10％，19％）]，部分缓解率约为51％[95％CI（32％，70％）]。在可手术的骨巨细胞瘤患者中，地舒单抗可使35％[95％CI（21％，49％）]的患者免于手术，降低了40％[95％CI（36％，45％）]患者的手术分期；使用地舒单抗后，患者的术后复发率约为19％[95％CI（7％，35％）]，术后中位复发时间约为6.73个月[95％CI（3.92，9.55）]。该药3～4级或高频发作且需治疗的不良事件主要为背痛、四肢疼痛、低磷血症和颌骨坏死。结论：基于现有证据，在本研究涉及的研究和地区中，地舒单抗用于骨巨细胞瘤治疗具有良好的有效性、安全性和经济性。 |
| ABSTRACT： | OBJECTIVE：To provide evidence-ba sed evidence for clinical treatment and decision by evaluating efficacy ，safety and cost-effectiveness of denosumab in the treatment of giant cell tumor of bone （GCTB）. METHODS ：Retrieved from PubMed ， the Cochrane Library ，ScienceDirect，CNKI，Wanfang database and VIP as well as health technology assessment （HTA）organi- zation websites ，HTA reports ，randomized controlled trials （RCTs），single-arm trials and retrospective studies were included about denosumab in the treatment of GCTB in the adults and adolescents with mature bone ，and their qualities were evaluated. HTA reports were analyzed with descriptive analysis qualitatively ；Meta-analysis was conducted for single-arm clinical studies and retrospective studies by using R version 3.6.0 software. RESULTS ：Among 49 screened literatures ，there were 6 HTA reports ，5 single-arm trials and 3 retrospective studies ．No eligible RCTs were retrieved. HTA reports of various countries generally believed that denosumab possessed good efficacy and safety ；HTA reports of France ，Austrila and other contries showed that denosumab possessed economics. For the GCTB patients who was unresectable ，denosumab would bring the clinical benefits to about 81％ [95％CI（77％，86％）] of patients. The complete response rate and partial response rate was around 14％[95％CI（10％，19％）] and 51％[95％CI（32％，70％）]，respectively. For the GCTB patients was resectable ，denosumab would prevent some patients from receiving surgery （35％）[95％CI（21％，49％）] or bring surgical down staging to them （40％）[95％CI（36％，45％）]，the postoperative recurrence rate after experiencing the denosumab therapy was about 19％[95％CI（7％，35％）]，and median relapse time was approximately 6.73 months [ 95％CI（3.92，9.55）] after receiving surgery. Main grade 3-4 or high frequercy ADR requiring treatment was back pain ，limbs pain ，hypophosphatemia and jaw osteonecrosis. CONCLUSIONS ：Based on the currently available evidence，among the studies and regions covered in this study ，denosumab has favorable efficacy ，safety and cost-effectiveness in the treatment of TCTB. |
| 期刊： | 2020年第31卷第16期 |
| 作者： | 芮明军，唐文熙，李洪超 |
| AUTHORS： | RUI Mingjun ，TANG Wenxi ，LI Hongchao |
| 关键字： | 地舒单抗；骨巨细胞瘤；卫生技术评估；有效性；安全性；经济性 |
| KEYWORDS： | Denosumab；Giant cell tumor of bo ne；Health technology assessment ；Efficacy；Safety；Cost-effectiveness |
| 阅读数： | 529 次 |
| 本月下载数： | 7 次 |
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