鴉膽子油乳注射液對(duì)晚期NSCLC瘀阻肺絡(luò)證患者GP方案化療輔助作用的臨床觀察
發(fā)布時(shí)間：2018-07-27 13:53
【摘要】：目的:探討鴉膽子油乳注射液對(duì)辨證為瘀阻肺絡(luò)證的晚期非小細(xì)胞肺癌(NSCLC)患者GP方案化療的輔助作用,并對(duì)其有效性、安全性進(jìn)行評(píng)價(jià),以期為臨床醫(yī)師在選用鴉膽子油乳注射液時(shí)提供一定的參考依據(jù)。研究方法:收集2015年11月—2017年3月在福州總醫(yī)院呼吸與危重癥醫(yī)學(xué)科、腫瘤科住院的符合納入及排除標(biāo)準(zhǔn)患者60例,采用隨機(jī)對(duì)照臨床試驗(yàn)設(shè)計(jì)分為對(duì)照組30例(脫落2例)、實(shí)驗(yàn)組30例(脫落1例)。對(duì)照組單純予GP方案(吉西他濱1000mg/m2,d1、d8+順鉑80mg/m2,d1)化療;實(shí)驗(yàn)組在對(duì)照組的治療基礎(chǔ)上聯(lián)合鴉膽子油乳注射液(30ml,d1-d10)治療,21天為一化療周期,2個(gè)化療周期為1評(píng)價(jià)周期。兩組患者分別于化療第1周期的第1天、第2周期的第10天用抗凝管抽取空腹靜脈血,查血常規(guī)、生化、凝血功能、腫瘤標(biāo)志物等指標(biāo),同時(shí)進(jìn)行KPS評(píng)分、生活質(zhì)量評(píng)分、中醫(yī)證候評(píng)分、化療毒副反應(yīng)評(píng)價(jià)等。所有數(shù)據(jù)均運(yùn)用SPSS20.0統(tǒng)計(jì)軟件進(jìn)行分析。結(jié)果:1、各組患者治療前一般資料、凝血功能、腫瘤標(biāo)志物、KPS評(píng)分、肺癌患者生命質(zhì)量測(cè)定量表(QLICP-LU)評(píng)分、中醫(yī)癥候積分等差異無統(tǒng)計(jì)學(xué)意義(P0.05)。2、凝血功能:實(shí)驗(yàn)組血漿D-二聚體、纖維蛋白原(Fib)、血小板(PLT)較治療前下降,活化部分凝血酶原時(shí)間(APTT)較治療前升高,差異均具有統(tǒng)計(jì)學(xué)意義(P0.05);對(duì)照組血漿D-二聚體、Fib較治療前升高,但差異無統(tǒng)計(jì)學(xué)意義(P0.05),APTT、PLT較治療前下降,差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。3、腫瘤標(biāo)志物:兩組治療后癌胚抗原(CEA)、細(xì)胞角蛋白-19片段(Cyfra21-1)較治療前均有所下降,差異具有統(tǒng)計(jì)學(xué)意義(P0.05);實(shí)驗(yàn)組CEA、Cyfra21-1下降較對(duì)照組明顯,但差異無統(tǒng)計(jì)學(xué)意義(P0.05)。4、KPS評(píng)分:實(shí)驗(yàn)組KPS評(píng)分改善率為69%,對(duì)照組KPS評(píng)分改善率為50%,實(shí)驗(yàn)組KPS評(píng)分改善率高于對(duì)照組,但差異無統(tǒng)計(jì)學(xué)意義(P0.05)。5、生活質(zhì)量評(píng)分:兩組治療后軀體功能、心理功能、社會(huì)功能、共同癥狀及副作用、肺癌特異性模塊評(píng)分、總積分均低于治療前,差異具有統(tǒng)計(jì)學(xué)意義(P0.05);實(shí)驗(yàn)組軀體功能、共性癥狀與不良反應(yīng)、肺癌特異性模塊評(píng)分及總積分改善較對(duì)照組明顯,差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。6、中醫(yī)證候評(píng)分:在兩組中醫(yī)證候總積分方面,兩種療法均能降低中醫(yī)證候總積分,實(shí)驗(yàn)組中醫(yī)證候總積分較對(duì)照組降低更明顯,差異具有統(tǒng)計(jì)學(xué)意義(P0.05);在中醫(yī)證候改善率方面,實(shí)驗(yàn)組中醫(yī)證候改善率72%,對(duì)照組中醫(yī)證候改善率43%,差異具有統(tǒng)計(jì)學(xué)意義(P0.05);在各中醫(yī)證侯改善方面,實(shí)驗(yàn)組咳嗽、咳痰、胸痛、胸悶積分較治療前下降,對(duì)照組咳嗽、咳痰積分較治療前下降,差異均具有統(tǒng)計(jì)學(xué)意義(P0.05);實(shí)驗(yàn)組咳嗽、咳痰、胸悶、胸痛等癥狀積分改善較對(duì)照組明顯,差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。7、毒副反應(yīng)評(píng)價(jià):從兩組毒副反應(yīng)發(fā)生的人數(shù)上來看,實(shí)驗(yàn)組化療毒副反應(yīng)人數(shù)發(fā)生率低于對(duì)照組,但差異無統(tǒng)計(jì)學(xué)意義(P0.05);從兩組毒副反應(yīng)發(fā)生的次數(shù)來看,實(shí)驗(yàn)組化療毒副反應(yīng)次數(shù)發(fā)生率低于對(duì)照組,且差異具有統(tǒng)計(jì)學(xué)意義(P0.05);從兩組患者所發(fā)生的具體毒副反應(yīng)來看,實(shí)驗(yàn)組骨髓抑制的發(fā)生率低于對(duì)照組,差異具有統(tǒng)計(jì)學(xué)意義(P0.05),而在肝腎功能損害及皮疹的發(fā)生率方面,實(shí)驗(yàn)組低于對(duì)照組,在惡心嘔吐及腹瀉發(fā)生率方面,實(shí)驗(yàn)組稍高于對(duì)照組,但差異均無統(tǒng)計(jì)學(xué)意義(P0.05)。結(jié)論:鴉膽子油乳注射液聯(lián)合GP方案化療較單純GP方案化療可能具有更好的改善晚期NSCLC瘀阻肺絡(luò)證患者血液高凝狀態(tài)、提高患者生活質(zhì)量、改善中醫(yī)證候評(píng)分、減輕化療骨髓抑制的輔助作用,同時(shí)其可能有降低腫瘤標(biāo)志物水平、改善KPS評(píng)分、減輕化療肝腎功損害及皮疹的趨勢(shì),且未出現(xiàn)嚴(yán)重的不良反應(yīng),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.
【學(xué)位授予單位】：福建中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：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.
【學(xué)位授予單位】：福建中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R734.2
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