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恩度(重组人血管内皮抑制素)联合标准化疗方案治疗晚期实体瘤的前瞻性、单臂临床试验 被引量:1

Prospective,one-arm clinical trial of Endu(recombinant human endostatin)in combination with standard chemotherapy for advanced solid tumors
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摘要 目的:探讨恩度(重组人血管内皮抑制素)联合标准化疗方案治疗晚期实体瘤的疗效及安全性。方法:采用前瞻性、单中心、单臂临床研究方法,选取定西市人民医院2021年1月至2022年1月收治的晚期实体瘤患者60例为研究对象,所有患者均采用恩度联合标准化疗方案治疗,记录其临床疗效、无疾病进展生存期(PFS)、总生存期(OS)、疾病转归情况及治疗安全性。结果:6个月随访结束,60例患者的治疗总有效率(ORR)为43.33%(26/60),疾病控制率(DCR)为91.67%(55/60);PFS为4(0~5)个月,OS为5(0~6)个月;治愈率为83.33%(50/60),恶化率为1.67%(1/60);安全性评估(治疗期间发生不良反应情况):血小板减少6.67%(4/60)、窦性心动过速8.33%(5/60)、腹泻1.67%(1/60)、肝功能异常3.33%(2/60)、恶心呕吐1.67%(1/60)、脱发1.67%(1/60)、皮肤变态反应1.67%(1/60)。结论:恩度联合标准化疗方案治疗晚期实体瘤能控制患者病情的发展,延长其生存时间,且安全性较好。 Objective:To investigate the efficacy and safety of endostatin(recombinant human endostatin)combined with standard chemotherapy in the treatment of advanced solid tumors.Method:A prospective,single-center,single-arm clinical study method was used to select 60 patients with advanced solid tumor admitted to Dingxi People’s Hospital from January 2021 to January 2022 as research objects.All patients were treated with Endol combined with standard chemotherapy.The clinical efficacy,progression-free survival(PFS),overall survival(OS),disease outcome and treatment safety were recorded.Results:At the end of 6-month follow-up,the total effective rate(ORR)of 60 patients was 43.33%(26/60),and the disease control rate(DCR)was 91.67%(55/60).PFS was 4(0~5)months,OS was 5(0~6)months;The cure rate was 83.33%(50/60)and the deterioration rate was 1.67%(1/60).Safety assessment(adverse reactions during treatment):Thrombocytopenia 6.67%(4/60),sinus tachycardia 8.33%(5/60),diarrhea 1.67%(1/60),abnormal liver function 3.33%(2/60),nausea and vomiting 1.67%(1/60),alopecia 1.67%(1/60),skin allergy 1.67%(1/60).Conclusion:Endu combined with standard chemotherapy in the treatment of advance d solid tumor can control the development of the disease and pr olong the survival time of patients,with good safety.
作者 孙莉 潘新平 SUN Li;PAN Xinping(Department of Oncology,Dingxi People’s Hospital,Dingxi 743000,Gansu,China)
出处 《当代医药论丛》 2023年第11期42-45,共4页
基金 定西市科技计划项目(项目编号:DX2022BZ03)。
关键词 重组人血管内皮抑制素 标准化疗方案 晚期实体瘤 无疾病进展生存期 总生存期 不良反应 recombinant human endostatin Standard chemotherapy regimen Advanced solid tumor Progression-free survival Overall survival Adverse reaction
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