尼拉帕利联合贝伐珠单抗治疗卵巢癌患者的临床研究  

Clinical trial of nirapali combined with bevacizumab in the treatment of ovarian cancer patients

作　　者：方佳 谢娅[1] FANG Jia;XIE Ya(Department of Gynecology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 455000,Henan Province,China)

机构地区：[1]郑州大学第一附属医院妇科,河南郑州455000

出　　处：《中国临床药理学杂志》2025年第5期616-620,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察甲苯磺酸尼拉帕利胶囊联合贝伐珠单抗注射液治疗卵巢癌的临床疗效,及其对血清标记物、卵巢血流参数水平的影响。方法将卵巢癌患者按照队列法分为对照A组、对照B组和联合组。对照A组给予甲苯磺酸尼拉帕利胶囊治疗,每次300mg,qd,21d为1个周期;对照B组给予贝伐珠单抗注射液7.5mg·kg治疗,每3天1次,21d为1个周期;联合组给予甲苯磺酸尼拉帕利胶囊和贝伐珠单抗注射液治疗,治疗方法和周期与对照A组和对照B组保持一致。3组患者均治疗4个周期。比较3组的临床疗效、血清肿瘤标志物、卵巢血流参数以及药物不良反应的发生情况和患者的生存情况。结果对照A组、对照B组和联合组分别纳入31例、28例和41例。治疗后,对照A组、对照B组和联合组的总有效率分别为70.97%(22例/31例)、71.43%(20例/28例)和92.68%(38例/41例),联合组均显著高于对照A组和对照B组(均P<0.05)。治疗后,对照A组、对照B组和联合组患者的血清癌胚抗原(CEA)分别为(15.26±2.33)、(14.89±2.34)和(9.74±1.21)μg·L^(-1),搏动指数(PI)分别为1.35±0.24、1.39±0.21和1.82±0.32,联合组的上述指标与对照A组和对照B组比较,在统计学上差异均有统计学意义(均P<0.05)。对照A组的药物不良反应主要有胃肠道反应、脱发、蛋白尿,对照B组的药物不良反应主要有胃肠道反应、脱发、肌肉疼痛,联合组的药物不良反应主要有胃肠道反应、脱发、蛋白尿、肌肉疼痛。对照A组、对照B组和联合组的总药物不良反应发生率分别为25.81%(8例/31例)、25.00%(7例/28例)和26.38%(11例/41例),3组组间在统计学上差异均无统计学意义(均P>0.05)。随访12个月,对照A组、对照B组和联合组生存率分别为70.97%(22例/31例)、67.86%(19例/28例)和90.24%(37例/41例),联合组生存率均显著高于对照A组和对照B组(均P<0.05)。结论甲苯磺酸尼拉帕利胶囊联合贝伐珠单抗注射液治疗卵Objective To observe the clinical efficacy of nilapalil toluene sulfonate capsules,bevacizumab injection,and their combination therapy for ovarian cancer,and to assesstheir impact on serum biomarkers and ovarian blood flow parameters.Methods Ovarian cancer patients were divided into three groups according to a cohort methods:Control A group,control Bgroup,and combined group.Control A group received nilapalil toluene sulfonate capsules,300 mg once daily for 21 days per cycle.Control B group received bevacizumab injection 7.5 mg·kg-,administered every 3 days for 21 days per cycle.The combined group received both nilapalil toluene sulfonate capsules and bevacizumab injection following the same regimen as the control groups.All groups underwent 4 cycles of treatment.Clinical efficacy,serum tumor biomarkers,ovarian blood flow parameters,adverse drug reactions,and patient survival were compared across the three groups.Results A total of 31 patients in control A group,28 patients in control B group,and 41 patients in the combined group were included.After treatment,the total effective rates for control A group,control B group,and the combined group were 70.97%(22 cases/31 cases),71.43%(20 cases/28 cases)and 92.68%(38 cases/41 cases),respectively.The combined group showed a significantly higher effective rate compared to both control A group and control B group(all P<0.05).After treatment,the serum levels of carcinoembryonic antigen(CEA)in control A group,control B group,and the combined group were(15.26±2.33),(14.89±2.34)and(9.74±1.21)μg·L^(-1),respectively;and the pulsatility index(PI)were 1.35±0.24,1.39±0.21 and 1.82±0.32,respectively.The combined group showed significant differences in these parameters compared to both control A group and control B group(all P<0.05).Adverse drug reactions in control A group mainly included gastrointestinal reactions,hair loss,and proteinuria;control B group had gastrointestinal reactions,hair loss,and muscle pain;and the combined group experienced gastrointestinal reactions,

关 键 词：甲苯磺酸尼拉帕利胶囊 贝伐珠单抗注射液 卵巢癌 肿瘤标志物 血流动力学 

分 类 号：R979.1[医药卫生—药品]