鸦胆子油乳注射液对晚期NSCLC瘀阻肺络证患者GP方案化疗辅助作用的临床观察
发布时间：2018-07-27 13:53
【摘要】：目的:探讨鸦胆子油乳注射液对辨证为瘀阻肺络证的晚期非小细胞肺癌(NSCLC)患者GP方案化疗的辅助作用,并对其有效性、安全性进行评价,以期为临床医师在选用鸦胆子油乳注射液时提供一定的参考依据。研究方法:收集2015年11月—2017年3月在福州总医院呼吸与危重症医学科、肿瘤科住院的符合纳入及排除标准患者60例,采用随机对照临床试验设计分为对照组30例(脱落2例)、实验组30例(脱落1例)。对照组单纯予GP方案(吉西他滨1000mg/m2,d1、d8+顺铂80mg/m2,d1)化疗;实验组在对照组的治疗基础上联合鸦胆子油乳注射液(30ml,d1-d10)治疗,21天为一化疗周期,2个化疗周期为1评价周期。两组患者分别于化疗第1周期的第1天、第2周期的第10天用抗凝管抽取空腹静脉血,查血常规、生化、凝血功能、肿瘤标志物等指标,同时进行KPS评分、生活质量评分、中医证候评分、化疗毒副反应评价等。所有数据均运用SPSS20.0统计软件进行分析。结果:1、各组患者治疗前一般资料、凝血功能、肿瘤标志物、KPS评分、肺癌患者生命质量测定量表(QLICP-LU)评分、中医症候积分等差异无统计学意义(P0.05)。2、凝血功能:实验组血浆D-二聚体、纤维蛋白原(Fib)、血小板(PLT)较治疗前下降,活化部分凝血酶原时间(APTT)较治疗前升高,差异均具有统计学意义(P0.05);对照组血浆D-二聚体、Fib较治疗前升高,但差异无统计学意义(P0.05),APTT、PLT较治疗前下降,差异具有统计学意义(P0.05)。3、肿瘤标志物:两组治疗后癌胚抗原(CEA)、细胞角蛋白-19片段(Cyfra21-1)较治疗前均有所下降,差异具有统计学意义(P0.05);实验组CEA、Cyfra21-1下降较对照组明显,但差异无统计学意义(P0.05)。4、KPS评分:实验组KPS评分改善率为69%,对照组KPS评分改善率为50%,实验组KPS评分改善率高于对照组,但差异无统计学意义(P0.05)。5、生活质量评分:两组治疗后躯体功能、心理功能、社会功能、共同症状及副作用、肺癌特异性模块评分、总积分均低于治疗前,差异具有统计学意义(P0.05);实验组躯体功能、共性症状与不良反应、肺癌特异性模块评分及总积分改善较对照组明显,差异具有统计学意义(P0.05)。6、中医证候评分:在两组中医证候总积分方面,两种疗法均能降低中医证候总积分,实验组中医证候总积分较对照组降低更明显,差异具有统计学意义(P0.05);在中医证候改善率方面,实验组中医证候改善率72%,对照组中医证候改善率43%,差异具有统计学意义(P0.05);在各中医证侯改善方面,实验组咳嗽、咳痰、胸痛、胸闷积分较治疗前下降,对照组咳嗽、咳痰积分较治疗前下降,差异均具有统计学意义(P0.05);实验组咳嗽、咳痰、胸闷、胸痛等症状积分改善较对照组明显,差异具有统计学意义(P0.05)。7、毒副反应评价:从两组毒副反应发生的人数上来看,实验组化疗毒副反应人数发生率低于对照组,但差异无统计学意义(P0.05);从两组毒副反应发生的次数来看,实验组化疗毒副反应次数发生率低于对照组,且差异具有统计学意义(P0.05);从两组患者所发生的具体毒副反应来看,实验组骨髓抑制的发生率低于对照组,差异具有统计学意义(P0.05),而在肝肾功能损害及皮疹的发生率方面,实验组低于对照组,在恶心呕吐及腹泻发生率方面,实验组稍高于对照组,但差异均无统计学意义(P0.05)。结论:鸦胆子油乳注射液联合GP方案化疗较单纯GP方案化疗可能具有更好的改善晚期NSCLC瘀阻肺络证患者血液高凝状态、提高患者生活质量、改善中医证候评分、减轻化疗骨髓抑制的辅助作用,同时其可能有降低肿瘤标志物水平、改善KPS评分、减轻化疗肝肾功损害及皮疹的趋势,且未出现严重的不良反应,使用安全。
[Abstract]:Objective: To explore the auxiliary effect of Brucea javanica oil emulsion injection on GP regimen chemotherapy for patients with advanced non small cell lung cancer (NSCLC) with stagnation of blood stasis and lung collateral syndrome, and evaluate its effectiveness and safety, so as to provide a reference basis for clinicians to choose javanica oil emulsion injection. Study methods: collect November 2015 - 2017 In March, 60 patients were hospitalized in the Department of respiratory and critical medicine of the General Hospital of Fuzhou, the oncology department was hospitalized in the oncology department. The randomized controlled clinical trials were divided into 30 cases (2 cases) and 30 cases (1 cases) in the experimental group. The control group was treated with GP (1000mg/m2, D1, d8+ cisplatin 80mg/m2, D1); the experimental group was in the experimental group. On the basis of the treatment, the control group combined with 30ml (d1-d10), 21 days as a chemotherapy cycle, and 2 cycles of 1 evaluation cycles. The two groups were treated with anticoagulant tubes for first days in the first cycle of chemotherapy and tenth days in the second cycle with anticoagulant tubes, to check blood routine, biochemical, coagulation function, tumor markers, and other indicators. KPS score, quality of life score, TCM syndrome score, and chemotherapy and side effects were evaluated. All data were analyzed by SPSS20.0 software. Results: 1, the general data, blood coagulation function, tumor markers, KPS score, lung cancer life quality scale (QLICP-LU) score and TCM syndrome score difference were used. No statistical significance (P0.05).2, coagulation function: plasma D- two polymer, fibrinogen (Fib), platelets (PLT) decreased before treatment, activated partial thromboplastin time (APTT) was higher than before treatment, the difference was statistically significant (P0.05); the plasma D- two polymer, Fib was higher than before the treatment, but the difference was not statistically significant (P0.0). 5), APTT, PLT decreased compared with before treatment, the difference was statistically significant (P0.05).3, tumor marker: two groups after treatment of carcinoembryonic antigen (CEA), cytokeratin -19 fragment (Cyfra21-1) decreased compared with before treatment, the difference was statistically significant (P0.05); experimental group CEA, Cyfra21-1 decreased significantly than the control group, but the difference was not statistically significant (P0.05).4 PS score: the improvement rate of the KPS score in the experimental group was 69%, the improvement rate of the KPS score in the control group was 50%, and the improvement rate of the KPS score in the experimental group was higher than that of the control group, but the difference was not statistically significant (P0.05).5, the quality of life score: the two groups of body function, psychological function, social function, common symptoms and side effects, lung cancer specific module score, and the total score were low Before the treatment, the difference was statistically significant (P0.05). The body function, common symptoms and adverse reactions in the experimental group, the score of lung cancer specific module and the total integral improved significantly compared with the control group. The difference was statistically significant (P0.05).6, TCM syndrome score: in the total score of TCM syndrome in the two groups, the two treatments could reduce the total volume of TCM syndrome. The total score of TCM syndrome in the experimental group was more obvious than that of the control group (P0.05). In the improvement of TCM syndrome, the improvement rate of TCM syndrome in the experimental group was 72%, the improvement rate of TCM syndrome in the control group was 43%, the difference was statistically significant (P0.05); in the improvement of TCM syndrome, the experimental group coughs, expectoration, chest pain and chest tightness. The score of coughing and expectoration decreased in the control group than before the treatment, and the difference was statistically significant (P0.05). The symptoms of cough, expectoration, chest tightness and chest pain in the experimental group were significantly improved than those in the control group. The difference was statistically significant (P0.05).7, and the toxicity and side effects were evaluated: from the number of two groups of side effects, the experimental group The incidence of chemotherapeutic side effects was lower than that of the control group, but the difference was not statistically significant (P0.05). From the number of two groups, the incidence of the number of side reactions in the experimental group was lower than that of the control group, and the difference was statistically significant (P0.05). From the specific side effects of the two groups, the bone marrow suppression in the experimental group was observed. The rate of occurrence was lower than that of the control group (P0.05), but the experimental group was lower than the control group in the liver and kidney function damage and the incidence of rash. The experimental group was slightly higher than the control group in the incidence of nausea and vomiting and diarrhea, but the difference was not statistically significant (P0.05). Conclusion: the combination of Brucea Brucea oil emulsion injection combined with GP regimen chemotherapy was more than that of the control group. GP chemotherapy alone may improve the blood hypercoagulability of patients with late NSCLC stasis syndrome, improve the quality of life, improve TCM syndrome score, reduce the adjuvant effect of chemotherapy on bone marrow suppression, and it may reduce the level of tumor markers, improve the KPS score, and reduce the trend of liver and kidney damage and rash. There is no serious adverse reaction, and it is safe to use.
【学位授予单位】：福建中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R734.2
[Abstract]:Objective: To explore the auxiliary effect of Brucea javanica oil emulsion injection on GP regimen chemotherapy for patients with advanced non small cell lung cancer (NSCLC) with stagnation of blood stasis and lung collateral syndrome, and evaluate its effectiveness and safety, so as to provide a reference basis for clinicians to choose javanica oil emulsion injection. Study methods: collect November 2015 - 2017 In March, 60 patients were hospitalized in the Department of respiratory and critical medicine of the General Hospital of Fuzhou, the oncology department was hospitalized in the oncology department. The randomized controlled clinical trials were divided into 30 cases (2 cases) and 30 cases (1 cases) in the experimental group. The control group was treated with GP (1000mg/m2, D1, d8+ cisplatin 80mg/m2, D1); the experimental group was in the experimental group. On the basis of the treatment, the control group combined with 30ml (d1-d10), 21 days as a chemotherapy cycle, and 2 cycles of 1 evaluation cycles. The two groups were treated with anticoagulant tubes for first days in the first cycle of chemotherapy and tenth days in the second cycle with anticoagulant tubes, to check blood routine, biochemical, coagulation function, tumor markers, and other indicators. KPS score, quality of life score, TCM syndrome score, and chemotherapy and side effects were evaluated. All data were analyzed by SPSS20.0 software. Results: 1, the general data, blood coagulation function, tumor markers, KPS score, lung cancer life quality scale (QLICP-LU) score and TCM syndrome score difference were used. No statistical significance (P0.05).2, coagulation function: plasma D- two polymer, fibrinogen (Fib), platelets (PLT) decreased before treatment, activated partial thromboplastin time (APTT) was higher than before treatment, the difference was statistically significant (P0.05); the plasma D- two polymer, Fib was higher than before the treatment, but the difference was not statistically significant (P0.0). 5), APTT, PLT decreased compared with before treatment, the difference was statistically significant (P0.05).3, tumor marker: two groups after treatment of carcinoembryonic antigen (CEA), cytokeratin -19 fragment (Cyfra21-1) decreased compared with before treatment, the difference was statistically significant (P0.05); experimental group CEA, Cyfra21-1 decreased significantly than the control group, but the difference was not statistically significant (P0.05).4 PS score: the improvement rate of the KPS score in the experimental group was 69%, the improvement rate of the KPS score in the control group was 50%, and the improvement rate of the KPS score in the experimental group was higher than that of the control group, but the difference was not statistically significant (P0.05).5, the quality of life score: the two groups of body function, psychological function, social function, common symptoms and side effects, lung cancer specific module score, and the total score were low Before the treatment, the difference was statistically significant (P0.05). The body function, common symptoms and adverse reactions in the experimental group, the score of lung cancer specific module and the total integral improved significantly compared with the control group. The difference was statistically significant (P0.05).6, TCM syndrome score: in the total score of TCM syndrome in the two groups, the two treatments could reduce the total volume of TCM syndrome. The total score of TCM syndrome in the experimental group was more obvious than that of the control group (P0.05). In the improvement of TCM syndrome, the improvement rate of TCM syndrome in the experimental group was 72%, the improvement rate of TCM syndrome in the control group was 43%, the difference was statistically significant (P0.05); in the improvement of TCM syndrome, the experimental group coughs, expectoration, chest pain and chest tightness. The score of coughing and expectoration decreased in the control group than before the treatment, and the difference was statistically significant (P0.05). The symptoms of cough, expectoration, chest tightness and chest pain in the experimental group were significantly improved than those in the control group. The difference was statistically significant (P0.05).7, and the toxicity and side effects were evaluated: from the number of two groups of side effects, the experimental group The incidence of chemotherapeutic side effects was lower than that of the control group, but the difference was not statistically significant (P0.05). From the number of two groups, the incidence of the number of side reactions in the experimental group was lower than that of the control group, and the difference was statistically significant (P0.05). From the specific side effects of the two groups, the bone marrow suppression in the experimental group was observed. The rate of occurrence was lower than that of the control group (P0.05), but the experimental group was lower than the control group in the liver and kidney function damage and the incidence of rash. The experimental group was slightly higher than the control group in the incidence of nausea and vomiting and diarrhea, but the difference was not statistically significant (P0.05). Conclusion: the combination of Brucea Brucea oil emulsion injection combined with GP regimen chemotherapy was more than that of the control group. GP chemotherapy alone may improve the blood hypercoagulability of patients with late NSCLC stasis syndrome, improve the quality of life, improve TCM syndrome score, reduce the adjuvant effect of chemotherapy on bone marrow suppression, and it may reduce the level of tumor markers, improve the KPS score, and reduce the trend of liver and kidney damage and rash. There is no serious adverse reaction, and it is safe to use.
【学位授予单位】：福建中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R734.2
【相似文献】
相关期刊论文 前10条
1 李丽珍;;GP方案治疗非小细胞肺癌的护理[J];护理研究;2008年12期
2 刘粉霞;;GP方案与放疗联合治疗食管癌纵隔淋巴结转移的临床观察[J];现代肿瘤医学;2009年09期
3 熊平;易贵祥;凌向阳;滕文建;李晖;张彪;朱智华;李程;饶小华;;唑来膦酸联合GP方案治疗非小细胞肺癌骨转移的疗效观察[J];中国肿瘤临床与康复;2014年01期
4 叶金辉;王向明;蔡悦成;练英妮;;GP方案同步放疗治疗Ⅲ期非小细胞肺癌的临床研究[J];热带医学杂志;2008年12期
5 林景辉;陈胜佳;王强;何志勇;林动;徐海鹏;;GP方案治疗30例中晚期非小细胞肺癌的疗效和不良反应[J];海峡药学;2008年02期
6 倪秉洁;GP方案治疗中晚期非小细胞肺癌的疗效观察[J];癌症进展;2005年03期
7 刘小平;陈谦;邓怀慈;;放疗加GP方案化疗治疗中晚期非小细胞肺癌疗效观察[J];现代肿瘤医学;2006年06期
8 李太东;倪武;林育超;;GP方案化疗加手术治疗Ⅲ期非小细胞肺癌疗效观察[J];中国肿瘤临床与康复;2008年06期
9 刘培民;张翼;宋娟;;十二味抑瘤胶囊联合GP方案化疗治疗中晚期非小细胞肺癌30例[J];中医研究;2009年10期
10 晏欣s，
本文编号：2148038
本文链接：https://www.wllwen.com/yixuelunwen/zlx/2148038.html
