贝伐珠单抗注射液联合紫杉醇注射液和顺铂注射液治疗卵巢癌的临床研究  

Clinical trial of bevacizumab injection combined with paclitaxel injection and cisplatin injection in the treatment of ovarian cancer

作　　者：马小莲 郑德友 何吉庆[1] MA Xiao-lian;ZHENG D E-you;HE Ji-qing(Department of Obstetrics and Gynecology, Affiliated Hospital of Hangzhou Normal University,Hangzhou 310015, China;Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Zhejiang Chinese Medicine University,Hangzhou 310005, China)

机构地区：[1]杭州师范大学附属医院妇产科,杭州310015 [2]浙江中医药大学附属第三医院妇产科,杭州310005

出　　处：《中国临床药理学杂志》2018年第23期2697-2699,2703,共4页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省医药卫生计划课题资助项目(2011RCA012)

摘　　要：目的观察贝伐珠单抗注射液联合紫杉醇注射液和顺铂注射液治疗卵巢癌的临床疗效及安全性。方法将86例卵巢癌患者随机分为对照组45例和试验组41例。对照组予以紫杉醇每次135 mg·m^(-2),第1天,静脉滴注+顺铂每次75 mg·m^(-2),第2天,静脉滴注;试验组在对照组治疗的基础上,予以贝伐珠单抗每次15 mg·kg^(-1),第1天,静脉滴注。2组患者均治疗3个周期,每个周期21 d。比较2组患者的临床疗效,肿瘤标志物水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的客观缓解率分别为82. 93%(34例次/41例次)和62. 22%(28例次/45例次),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的甲胎蛋白分别为(5. 23±0. 64)和(9. 06±1. 29) ng·m L^(-1),癌胚抗原分别为(3. 28±0. 42)和(4. 92±0. 60) ng·m L^(-1),糖链抗原199分别为(17. 55±2. 23)和(29. 90±5. 34) U·m L^(-1),差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以转氨酶上升、腹痛、恶心呕吐、中性粒细胞减少、白细胞减少和血小板减少为主,试验组和对照组的各类药物不良反应发生率比较,差异均无统计学意义(均P> 0. 05)。结论贝伐珠单抗注射液联合紫杉醇注射液和顺铂注射液可提高卵巢癌化疗中的临床效果,能够下调肿瘤标志物表达,且未明显增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of bevacizumab injection combined with paclitaxel injection and cisplatin injection in the treatment of ovarian cancer. Methods Eighty-six patients with ovarian cancer were randomly divided into treatment group( n = 41 cases) and control group( n = 45 cases). Control group received 135 mg·m^-2 paclitaxel,day 1,intravenous drip; intravenous infusion + cisplatin each time 75 mg · m^-2,the second day; treatment group was based on the treatment of the control group,bevacizumab 15 mg · kg^-1 each time,day 1,intravenous drip. Two groups were treated for 3 cycles,21 days each cycle. The clinical efficacy,tumor markers and adverse drug reactions were compared between two groups. Results After treatment,objective response rates in treatment group and the control group were 82. 93%( 34 cases/45 cases) and 62. 22%( 28 cases/45 cases),there was a statistically significant difference( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared:alpha fetoprotein were( 5. 23 ± 0. 64) and( 9. 06 ± 1. 29) ng·m L-1,carcinoembryonic antigen were( 3. 28 ± 0. 42)and( 4. 92 ± 0. 60) ng·m L-1,carbohydrate antigen 199 were( 17. 55 ± 2. 23) and( 29. 90 ± 5. 34) U·m L-1,there were statistically significant differences( all P < 0. 05). Adverse drug reactions of two groups were increased transaminase,abdominal pain,nausea and vomiting,decreased neutrophil,decreased white blood cell and decreased platelet,and the incidences of adverse drug reactions were no significant difference( all P > 0. 05). Conclusion Bevacizumab injection combined with paclitaxel injection and cisplatin injection can significantly improve the efficacy of ovarian cancer chemotherapy,reduce the expression of tumor markers,without increasing the incidences of adverse drug reactions.

关 键 词：贝伐珠单抗注射液 紫杉醇注射液 顺铂注射液 卵巢癌 安全性评估 

分 类 号：R979.1[医药卫生—药品]