奥拉帕尼维持疗法联合GP化疗方案及热疗治疗中晚期卵巢癌患者的临床研究  

Clinical trial of olaparib maintenance therapy combined with GP chemotherapy regimen and thermal therapy in the treatment of patients with advanced ovarian cancer

作　　者：邓艳梅 刘玲玲 张勇 DENG Yan-mei;LIU Ling-ling;ZHANG Yong(Schoolof ClinicalMedicine,SouthwestMedicaUl niversity,Luzhou 646000,Sichuan Province,China;Department of Obstetrics and Gynecology,Mianyang Central Hospital,School of Medicine,University of Electronic Science and Technology of China,Mianyang 621000,Sichuan Province,China)

机构地区：[1]西南医科大学临床医学院,四川泸州646000 [2]电子科技大学医学院附属绵阳医院、绵阳市中心医院妇产科,四川绵阳621000

出　　处：《中国临床药理学杂志》2024年第12期1709-1713,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察奥拉帕尼维持疗法联合吉西他滨+顺铂(GP)化疗方案及热疗治疗中晚期卵巢癌患者的临床疗效及预后。方法将中晚期卵巢癌患者按随机数字表法分为对照组和试验组。对照组实施GP化疗方案及热疗治疗,给予吉西他滨1250 mg·m^(-2),静脉滴注,第1、8天,顺铂40 mg·m^(-2),静脉滴注,第1、3天,局部深部热疗,设置温度42℃,化疗第1天开始治疗60 min,qod,21 d为1个疗程,治疗4个疗程;试验组在对照组的基础上增加奥拉帕尼维持治疗,化疗期间持续性口服奥拉帕尼200 mg,bid,21 d为1个疗程,治疗4个疗程。比较2组患者临床疗效、腹膜癌指数(PCI)、外周血淋巴细胞亚群、血清肿瘤标志物[癌胚抗原(CEA)、糖抗原125(CA125)、糖类抗原72-4(CA72-4)、人附睾蛋白4(HE4)]、无进展生存期(PFS)、总生存时间(OS)及药物不良反应发生情况。结果试验组和对照组分别纳入37例和36例。治疗后,试验组和对照组的总有效率分别为54.05%(20例/37例)和30.56%(11例/36例),PCI评分分别为(10.79±2.56)和(12.54±3.17)分,在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的外周血CD4^(+)细胞比例分别为(33.63±3.17)%和(30.06±3.24)%,CD4^(+)/CD8^(+)比值分别为0.78±0.16和0.67±0.13,血清CEA分别为(33.17±6.82)和(39.35±7.51)ng·mL^(-1),CA125分别为(47.64±8.56)和(55.84±10.02)U·mL^(-1),CA72-4分别为(6.35±1.27)和(8.59±1.64)U·mL^(-1),HE4分别为(124.62±20.14)和(141.62±21.43)pmol·mL^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的PFS分别为9.00个月(95%CI:7.79~10.21)和8.00个月(95%CI:7.20~8.80),OS分别为13.00个月(95%CI:12.35~13.65)和11.00个月(95%CI:10.46~11.54),在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心呕吐、高血压、便秘等,对照组的药物不良反应主要有恶心呕吐、口腔炎等。试验组和对照组的药物不良反应发生率分别为32.Objective To observe the clinical efficacy of olaparib maintenance therapy combined with gemcitabine+cisplatin(GP)chemotherapy regimen and thermal therapy in the treatment of advanced ovarian cancer and analyze the prognosis.Methods Patients with advanced ovarian cancer were divided into control group and treatment group according to the random number table method.The control group was treated with GP chemotherapy regimen and thermal therapy,and given intravenous infusion of 1 250 mg·m^(-2) of gemcitabine on the 1^(st) day and 8^(th) day and 40 mg·m^(-2) of cisplatin on the 1^(st) day and 3^(rd)day,and given 60 min of local deep thermal therapy(qod) with temperature at 42℃ on the 1^(st) day of chemotherapy,and the patients were treated for 4 courses with 21 days as a course.The treatment group was additionally given olaparib maintenance therapy on the basis of the control group,and given continuously oral administration of olaparib 200 mg(bid) during chemotherapy,and the patients were treated for 4 courses with 21 days as a course of treatment.The clinical efficacy,peritoneal carcinomatosis index(PCI),peripheral blood lymphocyte subsets,serum tumor markers[carcinoembryonic antigen(CEA),carbohydrate antigen 125(CA125),carbohydrate antigen 72-4(CA72-4),human epididymal protein 4(HE4)],progressive-free survival time(PFS),overall survival(OS) and occurrence of adverse drug reactions were compared between both groups of patients.Results There were 37 cases in treatment group and 36 cases in control group.After treatment,the total effective rates in treatment group and control group were54.05%(20 cases/37 cases) and 30.56%(11 cases/36 cases);the PCI scores were(10.79±2.56) and(12.54±3.17) scores,with significant difference(all P <0.05).After treatment,the proportions of peripheral blood CD4^(+)cell in treatment group and control group were(33.63±3.17) % and(30.06±3.24) %;the ratios of CD4^(+)/CD8^(+)were 0.78±0.16 and 0.67±0.13;serum CEA levels were(33.17±6.82) and(39.35±7.51) ng·mL^(-1);CA125levels were(4

关 键 词：奥拉帕尼 吉西他滨 顺铂 热疗 中晚期卵巢癌 

分 类 号：R979.1[医药卫生—药品]