安罗替尼胶囊联合培美曲赛注射液和顺铂注射液治疗非鳞状非小细胞肺癌患者的临床研究  

Clinical trail of anlotinib capsules combined with pemetrexed injection and cisplatin injection in the treatment of patients with non-squamous non-small cell lung cancer

作　　者：张群[1] 刘振昌[2] 赵亮[1] 张长生 ZHANG Qun;LIU Zhen-chang;ZHAO Liang;ZHANG Chang-sheng(Department of Laboratory Medicine,Taihe County Hospital of Traditional Chinese Medicine,Taihe 236600,Anhui Province,China;Department of Medical Oncology,Taihe County Hospital of Traditional Chinese Medicine,Taihe 236600,Anhui Province,China;Department of Respiratory Medicine,Nanjing Chest Hospital,Affiliated to Southeast University Medical College,Nanjing 210000,Jiangsu Province,China)

机构地区：[1]太和县中医院检验科,安徽太和236600 [2]太和县中医院肿瘤内科,安徽太和236600 [3]东南大学医学院附属南京胸科医院呼吸内科,江苏南京210000

出　　处：《中国临床药理学杂志》2023年第7期932-935,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 观察安罗替尼胶囊联合培美曲赛注射液和顺铂注射液治疗非鳞状非小细胞肺癌(NSCLC)患者的临床疗效与安全性。方法 将非鳞状NSCLC患者按治疗方法分为对照组和试验组。对照组给予15 mg·kg^(-1)贝伐珠单抗,静脉滴注,第1天+500 mg·m^(-2)培美曲塞,静脉滴注,第1天+75 mg·m^(-2)顺铂,静脉滴注,第3天;试验组给予盐酸安罗替尼胶囊12 mg,连续口服2周,停药1周+500 mg·m^(-2)培美曲塞,静脉滴注,第1天+75 mg·m^(-2)顺铂,静脉滴注,第3天。2组患者均治疗2个疗程,每个疗程均为21 d。比较2组患者的临床疗效,血管内皮生长因子(VEGF)、表皮生长因子(EGF)和癌抗原125(CA125)水平,以及药物不良反应的发生情况。结果 试验组和对照组各纳入42例患者。治疗后,对照组和试验组的疾病控制率分别为52.38%(22例/42例)和78.57%(33例/42例),差异有统计学意义(P<0.05)。治疗后,对照组和试验组的VEGF分别为(91.87±19.75)和(105.92±25.81)pg·mL^(-1),CA125分别为(142.97±21.07)和(93.68±15.91)U·mL^(-1),差异均有统计学意义(P<0.05)。对照组和试验组的骨髓抑制发生率分别为23.81%和21.43%,胃肠道反应发生率分别为21.43%和11.90%,出血或血栓发生率分别为14.29%和9.52%,肝功能异常发生率分别为4.76%和7.14%,差异均无统计学意义(均P>0.05)。结论 安罗替尼胶囊联合培美曲赛注射液和顺铂注射液治疗非鳞状NSCLC的临床疗效确切,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of anlotinib capsules combined with pemetrexed injection and cisplatin injection in the treatment of patients with non-squamous non-small cell lung cancer(NSCLC).Methods The non-squamous NSCLC patients were divided into control group and treatment group according to the treatment method.The Control group was given 15 mg·kg^(-1) bevacizumab,intravenous drip on day 1+500 mg·m^(-2) pemetrexed,intravenous drip on day 1+75 mg·m^(-2) cisplatin,intravenous drip on day 3.The treatment group received anlotinib hydrochloride capsules 12 mg orally for 2 weeks and withdrawal for 1 week+500 mg·m^(-2) pemetrexed,intravenous drip on day 1+75 mg·m^(-2) cisplatin,intravenous drip on day 3. Two groups were treated for 2 courses with 21 days per course. The clinical efficacy,levelsof vascular endothelial growth factor ( VEGF) ,epidermal growth factor ( EGF) and cancer antigen 125 ( CA125) andadverse drug reactions were compared between the two groups. Results Forty - two patients were included in eachgroup. After treatment,the disease control rates of treatment and control groups were 52. 38% ( 22 cases /42 cases)and 78. 57% ( 33 cases /42 cases) with significant difference ( P < 0. 05) . After treatment,the levels of VEGF intreatment and control groups were ( 91. 87 ± 19. 75) and ( 105. 92 ± 25. 81) pg·mL^(-1);the levels of CA125 were( 142. 97 ± 21. 07) and ( 93. 68 ± 15. 91) U·mL^(-1),respectively,and the differences were statistically significant ( allP < 0. 05) . The incidences of bone marrow suppression in treatment and control groups were 23. 81% and 21. 43%,the incidences of gastrointestinal reactions were 21. 43% and 11. 90%,the incidences of bleeding or thrombosis were14. 29% and 9. 52%,the incidences of abnormal liver function were 4. 76% and 7. 14%,respectively,all differenceswere not statistically significant ( all P > 0. 05) . Conclusion Anlotinib capsules combined with pemetrexed injectionand cisplatin injection have a definitive clinical efficacy in the

关 键 词：安罗替尼胶囊 贝伐珠单抗注射液 培美曲赛注射液 顺铂注射液 非鳞状非小细胞肺癌 安全性评价 

分 类 号：R979.1[医药卫生—药品]