鸦胆子油联合吉西他滨和顺铂治疗晚期非小细胞肺癌的临床观察
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摘要
目的:观察鸦胆子油联合吉西他滨和顺铂治疗晚期非小细胞肺癌(NSCLC)的临床效果及安全性。方法:选取黄冈市中医医院2014年2月-2016年1月收治的晚期NSCLC患者131例,按照随机数字表法分为观察组(71例)和对照组(60例)。对照组患者给予注射用盐酸吉西他滨(第1、8天)+顺铂注射液(第2天),每21 d重复1次,连续2次为1个疗程;观察组患者在此基础上给予鸦胆子油口服乳液20 m L,po,2~3次/d,连续14 d(于每次化疗前3 d开始给药)。两组患者均治疗87 d,并随访至2016年6月1日。观察两组患者临床疗效、T细胞亚群(CD3+、CD4+、CD8+)水平和生存时间,对生存时间进行单因素和多因素分析,并记录不良反应发生情况。结果:观察组患者的总有效率(32.39%)高于对照组(25.00%),但差异无统计学意义(P>0.05)。治疗前,两组患者CD3+、CD4+和CD8+水平比较,差异均无统计学意义(P>0.05)。治疗后,观察组患者CD3+、CD4+水平较治疗前明显升高,CD8+水平明显降低,且与同期对照组比较,差异均有统计学意义(P<0.05)。观察组患者失访4例,对照组失访3例。观察组患者生存时间[(14.02±4.10)个月]较对照组[(13.21±5.22)个月]长,但差异无统计学意义(P>0.05)。单因素分析结果显示,<70岁患者的生存时间明显长于≥70岁患者,合并胸腔积液患者的生存时间明显短于无胸腔积液患者,差异均有统计学意义(P<0.05)。多因素分析结果显示,是否合并胸腔积液和年龄是晚期NSCLC患者生存时间的影响因素(比值比分别为1.685、0.647,P分别为0.012、0.043)。观察组患者的不良反应发生率(50.70%)与对照组(53.33%)比较,差异无统计学意义(P>0.05)。结论:鸦胆子油联合吉西他滨和顺铂治疗晚期NSCLC,虽不能明显提高疗效,但能提高机体免疫功能。是否合并胸腔积液和年龄是晚期NSCLC患者生存时间的影响因素。
OBJECTIVE:To observe clinical efficacy and safety of Brucea javanica oil combined with gemcitabine and cisplatin in the treatment of advanced non small cell lung cancer(NSCLC). METHODS:Totally 131 advanced NSCLC patients selected from Huanggang Hospital of TCM during Feb. 2014 to Jan. 2016 were divided into observation group(71 cases)and control group(60 cases)according to random number table. Control group was given Gemcitabine for injection(1st and 8th day)+Cisplatin injection(2nd day),every 21 days,twice as a treatment course. Observation group was additionally given Breucea javanica oil oral emulsion 20 m L,po,2-3 times/d,for consecutive 14 d(3 days before chemotherapy). Both groups received treatment for 87 d and followed up until Jul. 1,2016. Clinical efficacy,the levels of T cell subsets(CD3+,CD4+,CD8+),survival time were observed in 2 groups. Single factor and multiple factor analysis was conducted for survival time. The occurrence of ADR was recorded. RESULTS:The total response rate of observation group(32.39%)was higher than that of control group(25.00%),without statistical significance(P>0.05). Before treatment,there was no statistical significance in the levels of CD3+,CD4+and CD8+between 2 groups(P>0.05). After treatment,the levels of CD3+and CD4+in observation group were increased significantly,while CD8+level was decreased significantly;there was statistical significance compared to control group at corresponding period(P<0.05). Four patients withdrew from the study in observation group and 3 patients in control group. The survival time of observation group [(14.02 ± 4.10)months] was longer than control group [(13.21 ± 5.22)months],without statistical significance(P>0.05).Single factor analysis showed that the survival time of patients aged <70 were significantly longer than those of patients aged ≥70;those of patients with pleural effusion were significantly shorter than those of patients without pleural effusion;there was statisticalsignificance(P<0.05). Multiple factor analysis showed that with or without pleural effusion,age were influential factors for survival time of patients with advanced NSCLC(OR=1.685 and 0.647,P=0.012 and 0.043). There was no statisticalsignificance in the incidence of ADR between observation group(50.70%) and control group(53.33%)(P>0.05). CONCLUSIONS: Brucea javanica oil combined with gemcitabine and cisplatin in the treatment of advanced NSCLC patients,although not significantly improve the therapeutic effect,but can significantly improve the cellular immune function. With or without pleural effusion and age are infuential facters for survival time of advanced NSCLC patients.
OBJECTIVE:To observe clinical efficacy and safety of Brucea javanica oil combined with gemcitabine and cisplatin in the treatment of advanced non small cell lung cancer(NSCLC). METHODS:Totally 131 advanced NSCLC patients selected from Huanggang Hospital of TCM during Feb. 2014 to Jan. 2016 were divided into observation group(71 cases)and control group(60 cases)according to random number table. Control group was given Gemcitabine for injection(1st and 8th day)+Cisplatin injection(2nd day),every 21 days,twice as a treatment course. Observation group was additionally given Breucea javanica oil oral emulsion 20 m L,po,2-3 times/d,for consecutive 14 d(3 days before chemotherapy). Both groups received treatment for 87 d and followed up until Jul. 1,2016. Clinical efficacy,the levels of T cell subsets(CD3+,CD4+,CD8+),survival time were observed in 2 groups. Single factor and multiple factor analysis was conducted for survival time. The occurrence of ADR was recorded. RESULTS:The total response rate of observation group(32.39%)was higher than that of control group(25.00%),without statistical significance(P>0.05). Before treatment,there was no statistical significance in the levels of CD3+,CD4+and CD8+between 2 groups(P>0.05). After treatment,the levels of CD3+and CD4+in observation group were increased significantly,while CD8+level was decreased significantly;there was statistical significance compared to control group at corresponding period(P<0.05). Four patients withdrew from the study in observation group and 3 patients in control group. The survival time of observation group [(14.02 ± 4.10)months] was longer than control group [(13.21 ± 5.22)months],without statistical significance(P>0.05).Single factor analysis showed that the survival time of patients aged <70 were significantly longer than those of patients aged ≥70;those of patients with pleural effusion were significantly shorter than those of patients without pleural effusion;there was statisticalsignificance(P<0.05). Multiple factor analysis showed that with or without pleural effusion,age were influential factors for survival time of patients with advanced NSCLC(OR=1.685 and 0.647,P=0.012 and 0.043). There was no statisticalsignificance in the incidence of ADR between observation group(50.70%) and control group(53.33%)(P>0.05). CONCLUSIONS: Brucea javanica oil combined with gemcitabine and cisplatin in the treatment of advanced NSCLC patients,although not significantly improve the therapeutic effect,but can significantly improve the cellular immune function. With or without pleural effusion and age are infuential facters for survival time of advanced NSCLC patients.
引文
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[13]何敏,周浴,邝军,等.鸦胆子油乳联合艾迪注射液对非小细胞肺癌化疗患者免疫功能的影响[J].中国现代医学杂志,2015,25(7):47-50.
[14]孙秀红,高平,何义凤,等.鸦胆子油结合GP方案治疗中晚期非小细胞肺癌的临床研究[J].中医学报,2014,29(7):302-302.
[2]Chen C,Chen Z,Chen D,et al.Suppressive effects of gemcitabine plus cisplatin chemotherapy on regulatory T cells in nonsmall-cell lung cancer[J].J Int Med Res,2015,43(2):180-187.
[3]Ettinger DS,Wood DE,Akerley W.NCCN guidelines insights:non-small cell lung cancer,version 4,2016[J].JNatl Compr Canc Netw,2016,14(3):255-264.
[4]杨学宁,吴一龙.实体瘤治疗疗效评价标准:RECIST[J].循证医学,2004,4(2):85-90、111.
[5]聂弘,杨骏,高从荣,等.CEA、CYFRA21-1、SCC-Ag联合检测对非小细胞肺癌的诊断价值[J].安徽医科大学学报,2013,48(12):1506-1508.
[6]彭宇,李峥,熊艳丽,等.晚期非小细胞肺癌不同含铂两药方案一线化疗预后因素的分析[J].第三军医大学学报,2014,36(16):1703-1708.
[7]Park BB,Kim WS,Suh C,et al.Salvage chemotherapy of gemcitabine,dexamethasone,and cisplatin(GDP)for patients with relapsed or refractory peripheral T-cell lymphomas:a consortium for improving survival of lymphoma(CISL)trial[J].Ann Hematol,2015,94(11):1845-1851.
[8]韩冰.顺铂,紫杉醇对肺癌细胞A549,H520中癌基因mdig表达的影响[D].沈阳:中国医科大学,2015.
[9]Chang SS.An open-label,single-arm,non-randomised,phase 2 trial of gemcitabine and cisplatin chemotherapy in combination with sunitinib as first-line treatment for patients with advanced urothelial carcinoma[J].J Urology,2015,194(6):1583-1584.
[10]椰慧楠,秦宝丽,宿朦,等.鸦胆子油乳联合化疗治疗晚期非小细胞肺癌的临床效果[J].中医药导报,2015,21(7):35-38.
[11]Ji ZQ,Huang XE,Wu XY,et al.Safety of Brucea javanica and cantharidin combined with chemotherapy for treatment of NSCLC patients[J].Asian Pac J Cancer Prev,2014,15(20):8603-8605.
[12]王海荣.中药配合GP方案对非小细胞肺癌晚期患者生活质量及免疫功能的影响[J].长春中医药大学学报,2015,31(1):140-142.
[13]何敏,周浴,邝军,等.鸦胆子油乳联合艾迪注射液对非小细胞肺癌化疗患者免疫功能的影响[J].中国现代医学杂志,2015,25(7):47-50.
[14]孙秀红,高平,何义凤,等.鸦胆子油结合GP方案治疗中晚期非小细胞肺癌的临床研究[J].中医学报,2014,29(7):302-302.