吉西他滨注射剂联合顺铂注射剂治疗非小细胞肺癌患者的临床研究  

Clinical trial of gemcitabine injection combined with cisplatin injection in the treatment of patients with non-small cell lung cancer

作　　者：李向欣[1] 穆新林[2] 李璐[3] LI Xiang-xin;MU Xin-lin;LI Lu(Department of Pulmonary and Critical Care Medicine,Beijing Changping Hospital,Beijing 102200,China;Department of Pulmonary and Critical Care Medicine,Peking University People’s Hospital,Beijing 100044,China;Department of Infectious Diseases,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京市昌平区医院呼吸与危重症医学科,北京102200 [2]北京大学人民医院呼吸与危重症医学科,北京100044 [3]北京大学第三医院感染疾病科,北京100191

出　　处：《中国临床药理学杂志》2020年第11期1446-1449,共4页The Chinese Journal of Clinical Pharmacology

基　　金：北京市"扬帆"计划重点医学专业课题资助项目(ZYLX201805)。

摘　　要：目的观察吉西他滨注射剂联合顺铂注射剂治疗非小细胞肺癌(NSCLC)患者的临床疗效及安全性。方法将100例NSCLC患者随机分为对照组和试验组,每组50例。对照组给予37.5 mg·m^-2多西他赛,第1,8天,静脉滴注+75 mg·m^-2顺铂,第1~3天,静脉滴注;试验组给予900 mg·m^-2吉西他滨,第1,8天,静脉滴注+75 mg·m^-2顺铂,第1~3天,静脉滴注。2组患者均治疗6个周期,每个周期21 d。比较2组患者的临床疗效,转化生长因子-β1(TGF-β1)、基质金属蛋白酶-2(MMP-2)和癌胚抗原(CEA)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为58.00%(29例/50例)和38.00%(19例/50例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的TGF-β1分别为(32.02±3.42)和(35.98±4.11)μg·L^-1,MMP-2分别为(74.51±12.21)和(88.98±14.36)μg·L^-1,CEA分别为(21.41±5.17)和(25.86±6.31)ng·mL^-1,差异均有统计学意义(均P<0.05)。试验组和对照组的恶心呕吐发生率分别为24.00%和30.00%,肝肾功能损害发生率分别为8.00%和12.00%,白细胞下降发生率分别为12.00%和14.00%,腹泻发生率分别为20.00%和28.00%,差异均无统计学意义(均P>0.05)。结论吉西他滨注射剂联合顺铂注射剂治疗NSCLC的临床疗效确切,其能显著地降低肿瘤细胞因子的表达水平,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of gemcitabine injection combined with cisplatin injection in the treatment of patients with non-small cell lung cancer(NSCLC).Methods A total of 100 NSCLC patients were randomly divided into control and treatment groups with 50 cases per group.Control group was given 37.5 mg·m^-2 docetaxel on days 1 and 8,intravenous drip+75 mg·m^-2 cisplatin,from day 1 to day 3,intravenous drip.Treatment group received 900 mg·m^-2 gemcitabine on days 1 and 8,intravenous drip+75 mg·m^-2 cisplatin,from day 1 to day 3,intravenous drip.Two groups were treated for 6 cycles with 21 days per cycle.The clinical efficacy,the levels of transforming growth factor-β1(TGF-β1),matrix metalloproteinase-2(MMP^-2)and carcinoembryonic antigen(CEA),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 58.00%(29cases/50 cases)and 38.00%(19 cases/50 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:TGF-β1 were(32.02±3.42)and(35.98±4.11)μg·L^-1,MMP-2 were(74.51±12.21)and(88.98±14.36)μg·L^-1,CEA were(21.41±5.17)and(25.86±6.31)ng·mL^-1,the differences were statistically significant(all P<0.05).The incidences of nausea and vomiting in treatment and control groups were 24.00%and 30.0%,the incidences of liver and kidney function damage were 8.00%and 12.00%,the incidences of leukopenia were 12.00%and 14.00%,respectively,and the incidences of diarrhea were 20.00%and 28.00%,the differences were not statistically significant(all P>0.05).Conclusion Gemcitabine injection combined with cisplatin injection has a definitive clinical efficacy in the treatment of patients with NSCLC,which can reduce the expression level of tumor factor,without increasing the incidence of adverse drug reactions.

关 键 词：吉西他滨注射剂 顺铂注射液 非小细胞肺癌 安全性评价 

分 类 号：R979.1[医药卫生—药品]