摘要
目的观察利妥昔单抗注射液联合吉西他滨+顺铂+地塞米松(GDP方案)治疗复发难治性弥漫大B细胞淋巴瘤(DLBCL)的临床疗效及安全性。方法将82例复发难治性DLBCL患者随机分为对照组和试验组,每组41例。对照组予以1000 mg·m^(-2)吉西他滨,静脉滴注,第1,2,3天+25 mg·m^(-2)顺铂,静脉滴注,第1天+10~40 mg·d^(-1)地塞米松,静脉滴注,第1~4天;试验组在对照组治疗的基础上,予以375 mg·m^(-2)利妥昔单抗,静脉滴注,每周期前1 d。2组患者1个周期均为21 d,共治疗2~4个周期。比较2组患者的临床疗效,p65、B细胞淋巴瘤因子-6(Bcl-6)和叉头框蛋白P1(FOXP1)的表达水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组总有效率分别为78.05%(32例/41例)和56.10%(23例/41例),1年总体生存率分别为80.49%(33例/41例)和58.54%(24例/41例),2年总体生存率分别为68.29%(28例/41例)和39.02%(16例/41例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组p65阳性表达率分别为12.20%和31.71%,Bcl-6阳性表达率分别为73.17%和51.22%,FOXP1阳性表达率分别为14.63%和34.14%,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贫血、呕吐、腹泻、白细胞下降和血小板减少为主,试验组和对照组的总药物不良反应发生率分别为39.02%和48.78%,差异无统计学意义(P>0.05)。结论利妥昔单抗注射液联合GDP方案治疗复发难治性DLBCL的临床疗效显著优于单用GDP方案,其能够延长患者的生存时间,改善p65、Bcl-6和FOXP1的表达水平,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of rituximab injection combined with gemcitabine ＋ cisplatin ＋ dexamethasone（ GDP） in the treatment of recurrent refractory diffuse large B cell lymphoma（ DLBCL）. Methods A total of 82 patients with recurrent refractory DLBCL were randomly divided into control and treatment group with 41 cases per group. Control group was treated with 1000 mg·m^（-2） gemci-tabine,intravenous drip,1,2,3 day ＋ 25 mg · m^（-2） cisplatin,intravenous drip,1 day ＋ 10-40 mg·d^（-1） dexamethasone,intravenous drip,1-4 day. On the basis of control group,treatment group received375 mg·m^（-2） rituximab,intravenous drip,1 d before every cycle. Two groups were treated for 2-4 cycles with 21 d per cycle. The clinicalefficacy,the expression of p65,B cell lymphoma factor-6（ Bcl-6） and fork frame P1（ FOXP1）,and adverse drug reactions were compared between two groups. Results After treatment,the main indexes in treatment and control groups were compared： the total effective rates were 78. 05%（ 32 cases/41 cases） and 56. 10%（ 23 cases/41 cases）,1-year overall survival rates were 80. 49%（ 33 cases/41 cases） and 58. 54%（ 24 cases/41 cases）,2-year overall survival rates were 68. 29%（ 28 cases/41 cases） and 39. 02%（ 16 cases/41 cases）,there were statistically significant differences（ all P 0. 05）. After treatment,the main indexes in treatment and control groups were also compared： p65 positive expression rates were 12. 20% and 31. 71%,Bcl-6 positive expression rates were 73. 17% and 51. 22%,FOXP1 positive expression rates ware 14. 63% and 34. 14%, the differences were statistically significant（ all P 0. 05）. The adverse drug reactions of two groups were anemia,vomiting,diarrhea,leukocyte decline and thrombocytopenia. The total incidences of adverse drug reactions in two groups were 39. 02% and 48. 78% without significant difference（ P 0. 05）. Conclusion Rituximab injection combined with GDP has a definitive clinical effi
作者
张文军
龚奕
肖春燕
郭冰凌
杨涛
ZHANG Wen-jun;GONG Yi;XIAO Chun-yan;GUO Bing-ling;YANG Tao(Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment,Chongqing University Cancer Hospital ＆ Chongqing Cancer Institute ＆ Chongqing Cancer Hospital,Chongqing 400030,Ghin)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2018年第15期1806-1808,1834,共4页
The Chinese Journal of Clinical Pharmacology
基金
重庆市卫生局医学科研计划重点课题资助项目(2012-1-127)
