养正消积胶囊辅助GP方案治疗晚期非小细胞肺癌临床研究
|
摘要
目的观察养正消积胶囊辅助GP方案治疗晚期非小细胞肺癌(NSCLC)的临床疗效。方法采用随机数字表法将89例晚期NSCLC患者分为对照组44例及观察组45例。2组均采用GP方案;观察组并予养正消积胶囊,每次4粒,每日3次,口服。2组均21d为1个周期,连续治疗2个周期,随访1年。观察2组治疗前后Ki67、Bax、Bcl-2蛋白表达及肿瘤标志物[血管内皮生长因子(VEGF)、骨桥蛋白(OPN)、癌胚抗原(CEA)、糖类抗原199(CA199)]、中医症状评分、生活质量评分,比较2组客观缓解率(ORR)、疾病控制率(DCR)、无进展生存时间(PFS),监测不良反应。结果观察组ORR、DCR明显优于对照组(P<0.05)。与本组治疗前比较,观察组治疗后、随访1年VEGF、OPN、CEA、CA199水平明显降低(P<0.05);对照组治疗后上述指标明显降低(P<0.05),随访1年CEA水平明显降低(P<0.05)。与本组治疗前比较,2组治疗后Ki67、Bcl-2蛋白表达明显降低,Bax蛋白表达明显升高(P<0.05);2组治疗后比较,观察组Ki67、Bcl-2蛋白表达低于对照组(P<0.05),Bax蛋白表达高于对照组(P<0.05)。与本组治疗前比较,2组治疗后中医症状评分(神疲乏力、胃纳少馨、腰膝无力、夜尿频多、头晕目眩)、生活质量评分(躯体功能、认知功能、社会功能、情绪功能)明显改善(P<0.05);2组治疗后比较,观察组上述评分改善明显优于对照组(P<0.05)。观察组PFS明显长于对照组(P<0.05),不良反应明显低于对照组(P<0.05)。结论养正消积胶囊辅助GP方案治疗晚期NSCLC可有效降低患者肿瘤标志物水平,改善生存质量,减少吉西他滨和顺铂的不良反应,提高疗效。
Objective To observe the clinical efficacy of Yangzheng Xiaoji Capsules combined with GP regimen in the treatment of advanced non-small cell lung cancer(NSCLC). Methods Totally 89 patients with advanced NSCLC were divided into control group(44 cases) and observation group(45 cases) according to random number table method. Both groups received GP regimen. The observation group was treated with Yangzheng Xiaoji Capsules additionally, 4 capsules per day, twice a day, orally. Both groups were treated with 21 days as a cycle and 2 cycles as a course of treatment, and 1 year of follow-up. The expressions of Ki67, Bax and Bcl-2 proteins, TCM symptom scores and tumor markers(VEGF, OPN, CEA, CA199), and life quality were analyzed before and after treatment in the two groups. The objective response rate(ORR), disease control rate(DCR) and progression-free survival(PFS) were compared. Adverse reactions were monitored. Results The ORR and DCR in the observation group were significantly better than those of the control group(P<0.05). Compared with before treatment, the levels of CEA, CA199, CA125 and CA153 in the observation group were significantly lower after treatment(P<0.05); The above indexes significantly decreased in the control group(P<0.05), and the CEA level significantly decreased in the 1 year of follow-up(P<0.05). Compared with before treatment, the expressions of Ki67 and Bcl-2 protein significantly decreased and the expression of Bax protein significantly increased in both groups(P<0.05). After treatment, the expressions of Ki67 and Bcl-2 protein in the observation group were lower than those in the control group(P<0.05),and the expression of Bax protein was higher than that in the control group(P<0.05). Compared with before treatment, TCM symptom scores(fatigue, dysfunction of stomach, waist and knee weakness, frequent nocturia, and dizziness) and life quality scores(somatic function, cognitive function, social function, and emotional function) in both groups were improved significantly(P<0.05); After treatment, the improvement of the above scores in the observation group was significantly better than that of the control group(P<0.05). The PFS of the observation group was significantly higher than that of the control group(P<0.05), and the adverse reactions were significantly lower than the control group(P<0.05). Conclusion Yangzheng Xiaoji Capsules combined with GP regimen in the treatment of advanced NSCLC can effectively reduce tumor markers, improve the life quality of patients, and reduce the side effects of gemcitabine and cisplatin, which can enhance efficacy.
Objective To observe the clinical efficacy of Yangzheng Xiaoji Capsules combined with GP regimen in the treatment of advanced non-small cell lung cancer(NSCLC). Methods Totally 89 patients with advanced NSCLC were divided into control group(44 cases) and observation group(45 cases) according to random number table method. Both groups received GP regimen. The observation group was treated with Yangzheng Xiaoji Capsules additionally, 4 capsules per day, twice a day, orally. Both groups were treated with 21 days as a cycle and 2 cycles as a course of treatment, and 1 year of follow-up. The expressions of Ki67, Bax and Bcl-2 proteins, TCM symptom scores and tumor markers(VEGF, OPN, CEA, CA199), and life quality were analyzed before and after treatment in the two groups. The objective response rate(ORR), disease control rate(DCR) and progression-free survival(PFS) were compared. Adverse reactions were monitored. Results The ORR and DCR in the observation group were significantly better than those of the control group(P<0.05). Compared with before treatment, the levels of CEA, CA199, CA125 and CA153 in the observation group were significantly lower after treatment(P<0.05); The above indexes significantly decreased in the control group(P<0.05), and the CEA level significantly decreased in the 1 year of follow-up(P<0.05). Compared with before treatment, the expressions of Ki67 and Bcl-2 protein significantly decreased and the expression of Bax protein significantly increased in both groups(P<0.05). After treatment, the expressions of Ki67 and Bcl-2 protein in the observation group were lower than those in the control group(P<0.05),and the expression of Bax protein was higher than that in the control group(P<0.05). Compared with before treatment, TCM symptom scores(fatigue, dysfunction of stomach, waist and knee weakness, frequent nocturia, and dizziness) and life quality scores(somatic function, cognitive function, social function, and emotional function) in both groups were improved significantly(P<0.05); After treatment, the improvement of the above scores in the observation group was significantly better than that of the control group(P<0.05). The PFS of the observation group was significantly higher than that of the control group(P<0.05), and the adverse reactions were significantly lower than the control group(P<0.05). Conclusion Yangzheng Xiaoji Capsules combined with GP regimen in the treatment of advanced NSCLC can effectively reduce tumor markers, improve the life quality of patients, and reduce the side effects of gemcitabine and cisplatin, which can enhance efficacy.
引文
[1]张明云,张菁华,李兴德,等.老年肺癌流行病学及临床治疗现状[J].现代肿瘤医学,2010,18(12):2505-2507.
[2]韩燕鸿,揭珂,张荷,等.参芪扶正注射液联合GP方案治疗非小细胞肺癌的Meta分析[J].中国实验方剂学杂志,2016,22(8):226-230.
[3]段秋立.复方斑蝥胶囊治疗非小细胞肺癌的疗效观察[J].中药药理与临床,2016,32(1):191-192.
[4]李京华,李仝.活血化瘀方联合顺铂治疗晚期非小细胞肺癌临床研究[J].中医学报,2017,32(1):13-17.
[5]况建荣,余丽娟,刘铮.养正消积胶囊联合化疗治疗晚期非小细胞肺癌的疗效及对患者免疫功能的影响[J].中国处方药,2016,14(1):62-63.
[6]中华人民共和国卫生部医政司.常见恶性肿瘤诊治规范[M].北京:中国协和医科大学出版社,1999:773-781.
[7]周际昌.实用肿瘤内科学(第2版)[M].北京:人民卫生出版社,2003:34-35.
[8]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:54-58.
[9]万崇华,陈明清,张灿珍,等.癌症患者生命质量测定量表EORTCQLQ-C30中文版评介[J].实用肿瘤杂志,2005,20(4):353-355.
[10]SUKARI A,NAGASAKA M,ALHASAN R,et al.Cancer site and adverse events induced by immune checkpoint inhibitors:a retrospective analysis of real-life experience at a single institution[J].Anticancer Res,2019,39(2):781-790.
[11]周际昌,谢惠民.新编抗肿瘤药物临床治疗手册[M].北京:中国协和医科大学出版社,2004:237-386.
[12]LE P C.Role of postoperative radiotherapy in resected non-small cell lung cancer:a reassessment based on new data[J].Oncologist,2011,16(5):672-681.
[13]徐立群,张荣华,邹莹,等.参慈胶囊联合顺铂通过PI3K/AKT/m TOR信号通路逆转人肺腺癌顺铂耐药的机制研究[J].中国病理生理杂志,2017,33(3):500-504.
[14]王永顺,王延涛,纪雪华.吉西他滨单药治疗老年晚期非小细胞肺癌的临床观察[J].中国现代医生,2010,48(13):139,141.
[15]尹梅,赖寒,罗朝朗,等.吉西他滨单药治疗老年晚期非小细胞肺癌的临床观察[J].肿瘤药学,2014,4(3):197-198.
[16]KANG S,KOH E S,VINOD S K,et al.Cost analysis of lung cancer management in South Western Sydney[J].J Med Imaging Radiat Oncol,2012,56(2):235-241.
[17]李军,王晓敏,宋张骏,等.非小细胞肺癌中Ki-67和BCL-2表达的临床意义及预后价值[J].临床与实验病理学杂志,2012,28(8):921-924.
[18]INOUE-YAMAUCHI A,JENG P S,KIM K,et al.Targeting the differential addiction to anti-apoptotic BCL-2 family for cancer therapy[J].Nat Commun,2017,8:16078.
[19]马家宝,朱文,周清华.bag-1、bcl-2和bax在非小细胞肺癌中的表达和意义及其与化疗多药耐药相关性的研究[J].中国肺癌杂志,2009,12(10):1089-1094.
[20]KIM C,LEE H S,PARK J,et al.Prognostic role of p53 and Ki-67immunohistochemical expression in patients with surgically resected lung adenocarcinoma:A retrospective study[J].Journal of Thoracic Disease,2015,7(5):822-833.
[21]DOWSETT M,NIELSEN T O,A'HERN R,et al.Assessment of Ki67in breast cancer:recommendations from the International Ki67 in Breast Cancer Working Group[J].J Natl Cancer Inst,2011,103(22):1656-1664.
[2]韩燕鸿,揭珂,张荷,等.参芪扶正注射液联合GP方案治疗非小细胞肺癌的Meta分析[J].中国实验方剂学杂志,2016,22(8):226-230.
[3]段秋立.复方斑蝥胶囊治疗非小细胞肺癌的疗效观察[J].中药药理与临床,2016,32(1):191-192.
[4]李京华,李仝.活血化瘀方联合顺铂治疗晚期非小细胞肺癌临床研究[J].中医学报,2017,32(1):13-17.
[5]况建荣,余丽娟,刘铮.养正消积胶囊联合化疗治疗晚期非小细胞肺癌的疗效及对患者免疫功能的影响[J].中国处方药,2016,14(1):62-63.
[6]中华人民共和国卫生部医政司.常见恶性肿瘤诊治规范[M].北京:中国协和医科大学出版社,1999:773-781.
[7]周际昌.实用肿瘤内科学(第2版)[M].北京:人民卫生出版社,2003:34-35.
[8]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:54-58.
[9]万崇华,陈明清,张灿珍,等.癌症患者生命质量测定量表EORTCQLQ-C30中文版评介[J].实用肿瘤杂志,2005,20(4):353-355.
[10]SUKARI A,NAGASAKA M,ALHASAN R,et al.Cancer site and adverse events induced by immune checkpoint inhibitors:a retrospective analysis of real-life experience at a single institution[J].Anticancer Res,2019,39(2):781-790.
[11]周际昌,谢惠民.新编抗肿瘤药物临床治疗手册[M].北京:中国协和医科大学出版社,2004:237-386.
[12]LE P C.Role of postoperative radiotherapy in resected non-small cell lung cancer:a reassessment based on new data[J].Oncologist,2011,16(5):672-681.
[13]徐立群,张荣华,邹莹,等.参慈胶囊联合顺铂通过PI3K/AKT/m TOR信号通路逆转人肺腺癌顺铂耐药的机制研究[J].中国病理生理杂志,2017,33(3):500-504.
[14]王永顺,王延涛,纪雪华.吉西他滨单药治疗老年晚期非小细胞肺癌的临床观察[J].中国现代医生,2010,48(13):139,141.
[15]尹梅,赖寒,罗朝朗,等.吉西他滨单药治疗老年晚期非小细胞肺癌的临床观察[J].肿瘤药学,2014,4(3):197-198.
[16]KANG S,KOH E S,VINOD S K,et al.Cost analysis of lung cancer management in South Western Sydney[J].J Med Imaging Radiat Oncol,2012,56(2):235-241.
[17]李军,王晓敏,宋张骏,等.非小细胞肺癌中Ki-67和BCL-2表达的临床意义及预后价值[J].临床与实验病理学杂志,2012,28(8):921-924.
[18]INOUE-YAMAUCHI A,JENG P S,KIM K,et al.Targeting the differential addiction to anti-apoptotic BCL-2 family for cancer therapy[J].Nat Commun,2017,8:16078.
[19]马家宝,朱文,周清华.bag-1、bcl-2和bax在非小细胞肺癌中的表达和意义及其与化疗多药耐药相关性的研究[J].中国肺癌杂志,2009,12(10):1089-1094.
[20]KIM C,LEE H S,PARK J,et al.Prognostic role of p53 and Ki-67immunohistochemical expression in patients with surgically resected lung adenocarcinoma:A retrospective study[J].Journal of Thoracic Disease,2015,7(5):822-833.
[21]DOWSETT M,NIELSEN T O,A'HERN R,et al.Assessment of Ki67in breast cancer:recommendations from the International Ki67 in Breast Cancer Working Group[J].J Natl Cancer Inst,2011,103(22):1656-1664.