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  

Clinical Study on Yangzheng Xiaoji Capsules Combined with GP Regimen in Treatment of Advanced Non-small Cell Lung Cancer

作　　者：李邦凯 纪浩南[1] 王馨[1] 郭艺芳 吴辉塔[1] 陈曼玉 张秋华 张益琴 吴炜新[1] 吕霞 肖莉[1] 苏安[1] 潘战和[1] 詹娟 王琳[1] 闵凡锦 LI Bangkai;JI Haonan;WANG Xin;GUO Yifang;WU Huita;CHEN Manyu;ZHANG Qiuhua;ZHANG Yiqin;WU Weixin;LYU Xia;XIAO Li;SU An;PAN Zhanhe;ZHAN Juan;WANG Lin;MIN Fanjin(Zhongshan Hospital Affiliated to Xiamen University, Xiamen 361004, China;School of Medicine, Xiamen University, Xiamen 361004, China;Xiamen Haicang Hospital, Xiamen 361004, China;Xiamen Hongai Hospital, Xiamen 361004, China)

机构地区：[1]厦门大学附属中山医院,福建厦门361004 [2]厦门大学医学院,福建厦门361004 [3]厦门市海沧医院,福建厦门361004 [4]厦门市弘爱医院,福建厦门361004

出　　处：《中国中医药信息杂志》2019年第8期12-17,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：福建省卫生厅中医药科研专项课题(wst201210)

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,

关 键 词：养正消积胶囊 非小细胞肺癌 GP方案 肿瘤标志物 临床研究 

分 类 号：R273.42[医药卫生—中西医结合]