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瑞戈非尼治疗晚期骨肉瘤与软组织肉瘤有效性和安全性Meta分析

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目的 评价瑞戈非尼治疗晚期骨肉瘤与软组织肉瘤的有效性和安全性。方法 采用计算机检索PubMed,Embase,The Cochrane Library,Web of Science及中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献(CBM)数据库中自建库起至2023年11月19日关于瑞戈非尼治疗晚期骨肉瘤与软组织肉瘤的随机对照试验(RCT),采用Cochrane风险评估量表对纳入文献进行质量评价,采用RevMan 5。3软件进行Meta分析。结果 共纳入8项RCT,涉及455例患者。Meta分析结果显示,试验组(予瑞戈非尼)治疗骨肉瘤与软组织肉瘤的疾病控制率[OR=4。18,95%CI(2。59,6。75),P<0。000 01],3 个月无进展生存期(PFS)率[OR=4。18,95%CI(2。69,6。48),P<0。000 01],6个月PFS率[OR=3。99,95%CI(2。29,6。93),P<0。000 01]均显著高于对照组(予安慰剂)。亚组分析结果显示,试验组治疗骨肉瘤的 3 个月 PFS 率[OR=6。22,95%CI(2。93,13。23),P<0。000 01]和 6 个月 PFS 率[OR=3。62,95%CI(1。57,8。38),P=0。003]均显著高于对照组;试验组治疗非脂肪肉瘤的软组织肉瘤的3个月PFS率[OR=6。63,95%CI(3。17,13。86),P<0。000 01]和6个月PFS率[OR=6。84,95%CI(2。57,18。19),P=0。000 1]均显著高于对照组。试验组高血压、手足皮肤反应、腹泻、疲劳的发生率,以及≥3级高血压、手足皮肤反应和腹泻的发生率均显著高于对照组(P<0。05)。结论 瑞戈非尼治疗非脂肪肉瘤的软组织肉瘤和骨肉瘤有效,不良反应发生风险基本可控。
Efficacy and Safety of Regofinib in the Treatment of Advanced Osteosarcoma and Soft Tissue Sarcoma:A Meta-Analysis
Objective To evaluate the efficacy and safety of regofinib in the treatment of advanced osteosarcoma and soft tissue sarcoma.Methods Randomized controlled trials(RCTs)related to regofinib in the treatment of advanced osteosarcoma and soft tissue sarcoma in the PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang,VIP,and CBM databases from their inception to November 19,2023 were searched.The Cochrane risk assessment scale was used to evaluate the quality of the included literature,and RevMan 5.3 software was used for Meta-analysis.Results Eight RCTs were included,involving 455 patients.Meta-analysis results showed that the disease control rate[OR=4.18,95%CI(2.59,6.75),P<0.000 01],3-month progression-free survival(PFS)rate[OR=4.18.95%CI(2.69,6.48),P<0.000 01],and 6-month PFS rate[OR=3.99,95%CI(2.29,6.93),P<0.000 01]in the experimental group(treated with regofinib)were significantly higher than those in the control group(treated with placebo).The sub-group analysis results showed that the 3-month PFS rate[OR=6.22,95%CI(2.93,13.23),P<0.000 01]and 6-month PFS rate[OR=3.62,95%CI(1.57,8.38),P=0.003]of patients with osteosarcoma in the experimental group were significantly better than those in the control group;the 3-month PFS rate[OR=6.63,95%CI(3.17,13.86),P<0.000 01]and 6-month PFS rate[OR=6.84,95%CI(2.57,18.19),P=0.000 1]of patients with soft tissue sarcoma without liposarcoma in the experimental group were significantly higher than those in the control group.The incidence of hypertension,hand-foot skin reactions,and diarrhea,as well as the incidence of grade ≥ 3 hypertension,hand-foot skin reactions,diarrhea,and fatigue in the experimental group were significantly higher than those in the control group(P<0.05).Conclusion Regofinib is effective in the treatment of patients with soft tissue sarcoma and osteosarcoma without liposarcoma,and the risk of adverse reactions is basically controllable.

rigofinibosteosarcomasoft tissue sarcomaefficacysafetyMeta-analysis

唐晶晶、王妤琪、郭亚茹、郭雯雯、吴小进

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江苏省徐州市第一人民医院,江苏徐州 221000

瑞戈非尼 骨肉瘤 软组织肉瘤 有效性 安全性 Meta分析

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(23)