重组人血管内皮抑制素注射液联合顺铂胸腔内灌注治疗肺癌恶性胸腔积液患者的临床研究  

Clinical trial on intrathoracic perfusion with recombinant human endostatin injection combined with cisplatin in the treatment of patients with lung cancer and malignant pleural effusion

作　　者：林卫佳 张亚平 李峰 项保利[1] 张秀珑[1] 张志华[1] 袁胜芳 LIN Wei-jia;ZHANG Ya-ping;LI Feng;XIANG Bao-li;ZHANG Xiu-long;ZHANG Zhi-hua;YUAN Sheng-fang(Department of Respiratory and Critical Care Medicine,The First Affiliated Hospital of Hebei North University,Zhangjiakou 075000,Hebei Province,China)

机构地区：[1]河北北方学院附属第一医院呼吸与危重症医学科,河北张家口075000

出　　处：《中国临床药理学杂志》2023年第13期1836-1840,共5页The Chinese Journal of Clinical Pharmacology

基　　金：河北省张家口市重点研发计划基金资助项目(2021046D)。

摘　　要：目的 探究重组人血管内皮抑制素注射液联合顺铂胸腔内灌注治疗肺癌恶性胸腔积液(MPE)患者胸腔积液的临床效果。方法 选取肺癌MPE患者为研究对象,按照随机数字表法分为试验组和对照组,2组患者均进行小口径导管微创引流,对照组在此基础上给予顺铂胸腔内灌注治疗,每次50 mg,每周1次,试验组在对照组的基础上加以重组人血管内皮抑制素注射液胸腔内灌注治疗,每次30 mg,每周2次,3周为1个疗程,连续治疗2个疗程。比较2组胸腔积液控制情况、体力改善效果[卡氏功能状态评分量表(KPS)和体力状态量表(ZPS)]、血清白细胞介素27(IL-27)、鳞状细胞癌抗原(SCC)及血管内皮生长因子(VEGF)水平变化情况、药物不良反应及生存情况[总生存期(OS)、无进展生存期(PFS)、1年生存率]。结果 试验过程中共脱落3例,最终试验组和对照组分别纳入46例。治疗后,试验组和对照组的客观缓解率(ORR)分别为41.30%(19例/46例)和21.74%(10例/46例),疾病控制率(DCR)分别为84.78%(39例/46例)和69.56%(32例/46例),差异均有统计学意义(均P<0.05);治疗后,试验组和对照组的KPS评分分别为(84.32±6.38)和(81.28±6.52)分,ZPS评分分别为(1.58±0.35)和(1.74±0.36)分,血清IL-27表达水平分别为(246.34±31.35)和(278.49±34.63)ng·L^(-1),SCC表达水平分别为(4.28±1.06)和(5.13±1.14)ng·mL^(-1),VEGF表达水平为分别为(202.34±26.55)和(231.66±29.16)pg·mL^(-1),试验组上述指标与对照组比较,差异均有统计学意义(均P<0.05);2组1年生存率比较,差异无统计学意义(P>0.05);2组药物不良反应主要白细胞减少、血小板减少、恶心呕吐、乏力,试验组共发生药物不良反应79例次对照组共发生药物不良反应83例次,差异无统计学意义(P>0.05)。结论 重组人血管内皮抑制素注射液联合顺铂胸腔内灌注治疗肺癌并MPE临床疗效明确,对患者体力及血清生化因子改善效果明显,有助于延长患者�Objective To explore the clinical effects of intrathoracic perfusion with recombinant human endostatin injection combined with cisplatin on pleural effusion in the treatment of patients with lung cancer complicated with malignant pleural effusion(MPE).Methods Patients with lung cancer and MPE were selected as the research subjects,and they were divided into treatment group and control group according to the random number table method.The patients in both groups were treated with small-caliber catheter minimally invasive drainage,and the control group was given cisplatin intrathoracic perfusion therapy(50 mg every time,once a week)while the treatment group was additionally given intrathoracic perfusion of recombinant human endostatin injection(30 mg every time,twice a week)on the basis of the control group,and both groups were continuously treated for 2 courses with 3 weeks as a course of treatment.The control of pleural effusion,physical strength improvement effect[Karnofsky performance status scale(KPS),Zubrod-ECOG-WHO score(ZPS)],serum interleukin 27(IL-27),squamous cell carcinoma antigen(SCC)and vascular endothelial growth factor(VEGF)levels,adverse drug reactions and survival status[overall survival(OS),progression-free survival(PFS),1-year survival rate]were compared between the two groups.Results A total of3 cases were lost during the trial,and 46 cases were included in the treatment group and the control groups respectively.After treatment,the objective response rate(ORR)of the treatment group and the control group were41.30%(19 cases/46 cases)and 21.74%(10 cases/46 cases),respectively,and the disease control rate(DCR)were 84.78%(39 cases/46 cases)and 69.56%(32 cases/46 cases),respectively,the differences were statistically significant(all P<0.05).After treatment,the KPS scores of the treatment group and the control group were(84.32±6.38)and(81.28±6.52)points,the ZPS scores were(1.58±0.35)and(1.74±0.36)points,the expression levels of serum IL-27 were(246.34±31.35)and(278.49±34.63)ng·L^(-1),the expre

关 键 词：重组人血管内皮抑制素注射液 顺铂 肺癌 胸腔积液 胸腔灌注 

分 类 号：R979.1[医药卫生—药品]