生脈散加味聯(lián)合DC-CIK對惡性腫瘤患者生存質(zhì)量及免疫指標(biāo)影響的臨床研究
發(fā)布時間：2018-07-16 16:26
【摘要】：研究背景：肺癌的發(fā)病率據(jù)最新統(tǒng)計結(jié)果顯示,居惡性腫瘤的第二位,非小細胞肺癌(non-small cell lung cancer, NSCLC)約占80%。近年來,NSCLC的診斷和治療雖然取得了很大進步,但是晚期NSCLC患者仍占很大比例,死亡率一直居高不下。免疫治療是一種新型的腫瘤治療手段,目前已經(jīng)成為繼手術(shù)、放療、化療后的第四大腫瘤治療方法,是近年來腫瘤研究領(lǐng)域的研究熱點之一。目前,國內(nèi)研究及技術(shù)較為成熟的免疫治療方法包括：細胞因子誘導(dǎo)的殺傷細胞(CIK)、將樹突狀細胞(DC)與CIK共培養(yǎng)后的DC-CIK細胞免疫治療、DC瘤苗、淋巴因子激活的殺傷細胞(LAK)以及腫瘤浸潤淋巴細胞(TIL)等。其中DC-CIK細胞,經(jīng)過體外實驗證實具有高效的增殖能力和抗腫瘤活性,且其有區(qū)別于傳統(tǒng)細胞毒性藥物的治療特點,如安全性高,毒副作用小等,因此被廣泛應(yīng)用于惡性腫瘤綜合治療中。在臨床應(yīng)用中,其且顯示了明顯的治療優(yōu)勢,能夠顯著改善患者生存質(zhì)量,延長患者生存時間等。但隨著研究的深入,越來越多的學(xué)者認識到：免疫治療的治療療效出現(xiàn)的時間較長,當(dāng)應(yīng)用傳統(tǒng)的腫瘤評價方法評價為進展后,仍有可能是免疫治療的反應(yīng)階段,在延長觀察時間后出現(xiàn)病情緩解。因此,傳統(tǒng)腫瘤評價標(biāo)準(zhǔn)并不能準(zhǔn)確的評估免疫治療的療效,我們迫切需要尋找一種新的評估方法。隨著醫(yī)學(xué)模式的轉(zhuǎn)變,生物-心理-社會醫(yī)學(xué)模式已經(jīng)逐漸被患者及醫(yī)療工作者所認同。臨床結(jié)局的評價關(guān)注的不僅僅是腫瘤疾病本身,更應(yīng)包括患者身體健康狀況、心理狀況、社會關(guān)系以及腫瘤相關(guān)癥狀的改善等,尤其是針對腫瘤晚期,身體虛弱,不能耐受積極抗腫瘤治療的NSCLC患者,片面追求腫瘤大小的改變顯然不明智,而生存質(zhì)量評價則意義重大。細胞免疫治療具有安全性高、毒副作用小的特點,可以應(yīng)用于晚期腫瘤患者,提高患者生存質(zhì)量。因此,本研究針對晚期NSCLC患者開展生脈散加減聯(lián)合DC-CIK細胞免疫治療,以生存質(zhì)量為評價指標(biāo)。晚期NSCLC患者,尤其是經(jīng)歷過放療、化療后的患者,極易出現(xiàn)氣陰兩虛證型。經(jīng)過長期中醫(yī)臨床實踐證實,生脈散具有良好的益氣養(yǎng)陰生津作用,加減祛瘀解毒類中藥,對NSCLC晚期氣陰兩虛證患者癥狀的改善有明顯作用,對部分患者氣陰兩虛病理本質(zhì)也有明顯改善,最終提高患者生存質(zhì)量。目的：1.本課題旨在研究生脈散加減聯(lián)合DC-CIK細胞免疫治療對晚期NSCLC患者生存質(zhì)量及中醫(yī)證候的影響,分析基于中醫(yī)理論建立的生存質(zhì)量量表與中醫(yī)證候積分相關(guān)性,為建立科學(xué)、有效的中西醫(yī)結(jié)合治療NSCLC及臨床評價方法提供循證醫(yī)學(xué)證據(jù)。2.通過實驗研究探討了輔助性T細胞17(Th17細胞)在生脈散加減聯(lián)合DC-CIK細胞免疫治療惡性腫瘤前后的變化及意義,為細胞免疫治療患者免疫功能狀態(tài)評價提供新思路。方法：1.臨床試驗部分納入符合納入標(biāo)準(zhǔn)的NSCLC氣陰兩虛證患者60例,分為陽性對照組15例,單純給予DC-CIK細胞免疫治療；中藥對照組30例,給予生脈散加減的中藥湯劑口服治療；聯(lián)合治療組15例,給予以上兩種方法聯(lián)合治療。評價治療前后3組患者KPS評分：生存質(zhì)量評分,包括歐洲癌癥研究與治療組織(EORTC)的生活質(zhì)量核心30問卷調(diào)查(QLQ-C30),以及基于中醫(yī)理論的惡性腫瘤生活質(zhì)量評價體系之共性量表(QLASTCM-GM);中醫(yī)證候積分以及免疫功能狀態(tài)。比較分析QLASTCM-GM和QLQ-C30與中醫(yī)證候積分的相關(guān)性2.實驗研究部分納入中醫(yī)辨證為氣陰兩虛型惡性腫瘤患者30例,治療組15例采用生脈散口服聯(lián)合DC-CIK免疫治療,對照組15例用DC-CIK細胞免疫治療(脫落2例),另外納入健康人8例作為對照組。采用流式細胞儀檢測患者及健康人外周血中Th17細胞。結(jié)果：1.應(yīng)用QLQ-C30評價晚期NSCLC患者生存質(zhì)量,中藥治療和細胞免疫治療均能提高患者軀體功能評分,改善患者疲乏癥狀,從而提高患者生存質(zhì)量。中藥治療改善患者排便困難優(yōu)于細胞免疫治療。細胞免疫治療提高患者睡眠質(zhì)量方面優(yōu)于中藥治療。2.應(yīng)用QLASTCM-GM評價生存質(zhì)量,組間比較在形神一體領(lǐng)域,聯(lián)合治療組較中藥對照組生存質(zhì)量更高(P＝0.020)；組內(nèi)比較,治療后較治療前生存質(zhì)量均有所提高。在天人相應(yīng)領(lǐng)域組間比較無統(tǒng)計學(xué)差異,但中藥對照組與聯(lián)合治療組治療前后比較均有統(tǒng)計學(xué)差異(P0.05)。因此推斷：聯(lián)合中藥治療后,可以更好的提高患者生存質(zhì)量。3.中醫(yī)證候積分比較,聯(lián)合治療組的臨床獲益優(yōu)于中藥對照組,P0.05,有統(tǒng)計學(xué)差異。4.中醫(yī)證候積分與QLASTCM-GM量表形神一體領(lǐng)域有中度相關(guān)的趨勢；與QLQ-C30量表僅在疲乏、呼吸困難以及失眠領(lǐng)域有相關(guān)趨勢。QLASTCM-GM量表中形神一體領(lǐng)域與QLQ-C30量表軀體功能領(lǐng)域有中度相關(guān)趨勢。5.氣陰兩虛型惡性腫瘤患者外周血Thl7表達水平高于健康成年人。細胞免疫治療后,患者外周血表達Th17水平下降。治療組較對照組Th17表達水平有下降更多的趨勢。結(jié)論：1DC-CIK細胞免疫治療可以提高氣陰兩虛型晚期NSCLC患者生存質(zhì)量,與生脈散聯(lián)合應(yīng)用具有協(xié)同效應(yīng)。2.生存質(zhì)量的評價：與QLQ-C30量表相比,QLASTCM-GM量表與中醫(yī)證候積分更相關(guān),值得進一步研究。3.Th17細胞是惡性腫瘤患者免疫紊亂的產(chǎn)物,生脈散聯(lián)合細胞免疫治療后其表達水平明顯下降,表明其對患者免疫功能狀態(tài)的判定有一定的價值,有可能成為免疫治療后評價機體免疫功能狀態(tài)的新指標(biāo)。
[Abstract]:Background: the incidence of lung cancer, according to the latest statistical results, shows that the second cases of malignant tumors, non small cell lung cancer (non-small cell lung cancer, NSCLC) account for about 80%. in recent years. Although great progress has been made in the diagnosis and treatment of NSCLC, the rate of late NSCLC patients still occupies a large proportion and the mortality rate has remained high. Immunotherapy is the same. A new method of tumor therapy has become one of the fourth major tumor treatment methods following surgery, radiotherapy and chemotherapy. It is one of the hotspots in the field of cancer research in recent years. At present, the more mature methods of immunotherapy in China include cytokine induced killer cells (CIK), dendritic cells (DC) and CIK Co cultured DC-CIK cell immunotherapy, DC tumor vaccine, lymphokine activated killer cells (LAK) and tumor infiltrating lymphocyte (TIL), among which DC-CIK cells proved to have high proliferative and antitumor activity in vitro, and they are different from traditional cytotoxic drugs, such as high safety and toxic side effects. It is widely used in the comprehensive treatment of malignant tumor. In clinical application, it shows obvious therapeutic advantage. It can significantly improve the quality of life and prolong the survival time of the patients. However, more and more scholars have realized that the treatment effect of immunotherapy has a long time and is used as an application. The traditional evaluation method of tumor evaluation is still likely to be the reaction stage of immunotherapy, and it is remission after prolonging the observation time. Therefore, the traditional tumor evaluation standard does not accurately evaluate the effect of immunotherapy. We urgently need to find a new evaluation method. With the change of the medical model, the biological psychology is changed. - the social medical model has gradually been recognized by patients and medical workers. The evaluation of clinical outcomes is concerned not only with the tumor itself, but also of the patient's health, mental status, social relations, and the improvement of the tumor related symptoms, especially for the late swelling of the tumor, the weakness of the body, and the inability to tolerate active anti tumor treatment. NSCLC patients who are treated with a one-sided pursuit of the size of the tumor are obviously unwise, and the quality of life is of great significance. Cellular immunotherapy has the characteristics of high safety and small side effects, which can be applied to advanced cancer patients and improve the patient's quality of life. Therefore, this study carries out pulse dispersion plus subtraction combined with DC-CIK for advanced NSCLC patients. Cell immunotherapy, with the quality of life as the evaluation index, the patients with advanced NSCLC, especially after radiotherapy and chemotherapy, are very easy to appear Qi Yin deficiency syndrome type. After long-term clinical practice of traditional Chinese medicine, it has been proved that Shengmai Powder has good effect on Nourishing Yin and nourishing Yin, adding and reducing Chinese medicine of removing stasis and detoxification, and the symptoms of two deficiency syndrome in late NSCLC Qi Yin. The improvement has obvious effect, the pathological nature of Qi and yin deficiency in some patients is also obviously improved, and the quality of life of the patients is improved. Objective: the 1. subject is to study the effect of pulse scatter plus subtraction combined with DC-CIK cell immunotherapy on the quality of life and TCM syndrome in late NSCLC patients, and analyze the quality of life scale based on the theory of traditional Chinese Medicine To provide evidence-based medical evidence for the establishment of a scientific and effective combination of Chinese and Western medicine for the treatment of NSCLC and clinical evaluation methods, and to explore the changes and significance of auxiliary T cell 17 (Th17 cells) in the treatment of malignant tumors by adding or decreasing the pulse dispersion combined with DC-CIK cell immunotherapy for the patients. The immune function status evaluation provided new ideas. Methods: 1. clinical trials were included in 60 cases of NSCLC Qi Yin two deficiency syndrome patients, divided into positive control group, 15 cases, pure DC-CIK cell immunotherapy, 30 cases of traditional Chinese medicine control group, giving Shengmai Powder plus or minus Decoction of traditional Chinese medicine, 15 cases in the combined treatment group were given above. Two methods combined treatment. The KPS score of 3 groups of patients before and after treatment: quality of life score, including the core 30 questionnaire survey (QLQ-C30) for the quality of life of the European cancer research and treatment organization (EORTC), and the common scale (QLASTCM-GM) for the quality of life evaluation system of malignant tumor based on traditional Chinese medicine (TCM); TCM syndrome score and immune function A comparative analysis of the relationship between QLASTCM-GM and QLQ-C30 and the correlation of TCM syndrome score in the 2. experimental study included 30 cases of Qi and yin deficiency type malignant tumor, 15 cases in the treatment group were treated with Shengmai San combined with DC-CIK immunotherapy, and 15 cases in the control group were treated with DC-CIK cell immunotherapy (2 cases), and 8 cases were included in the healthy people. Th17 cells in the peripheral blood of patients and healthy people were detected by flow cytometry. Results: 1. QLQ-C30 was used to evaluate the quality of life of patients with advanced NSCLC. Both Chinese medicine and cell immunotherapy could improve the body function score, improve the fatigue symptoms and improve the quality of life of the patients. The difficulty is better than the cell immunotherapy. Cell immunotherapy improves the quality of sleep of the patients better than the traditional Chinese medicine treatment.2. application QLASTCM-GM evaluation of the quality of life, the group comparison in the field of physique and God, the combined treatment group is higher than the traditional Chinese medicine control group (P = 0.020); in group comparison, after treatment, the quality of life before treatment is improved. There was no statistical difference between the two groups in the corresponding field, but there was a statistical difference between the Chinese medicine control group and the combined treatment group before and after treatment (P0.05). Therefore, it was concluded that after the combination of traditional Chinese medicine treatment, we can better improve the quality of life of the patients with.3. TCM syndrome score, and the clinical benefit of the combined treatment group is better than that of the traditional Chinese medicine control group, P0.05, Statistical difference.4. TCM syndrome score and QLASTCM-GM scale have a moderate correlation in the field of form and God; and the QLQ-C30 scale is only in fatigue, dyspnea, and insomnia, there is a correlation trend in the.QLASTCM-GM scale and the QLQ-C30 scale and the body function area of the QLQ-C30 scale.5. Qi and yin deficiency type malignant tumor The expression level of Thl7 in peripheral blood of patients was higher than that in healthy adults. After cell immunotherapy, the expression of Th17 in peripheral blood decreased. The expression level of Th17 in the treatment group decreased more than that of the control group. Conclusion: 1DC-CIK cell immunotherapy can improve the quality of life of late NSCLC patients with deficiency of two types of Qi and Yin. The evaluation of the quality of life of the same effect.2.: compared with the QLQ-C30 scale, the QLASTCM-GM scale is more related to the TCM syndrome score. It is worth further studying that the.3.Th17 cell is the product of the immune disorder of the patients with malignant tumor. The expression level of Shengmai Powder Combined with cell immunotherapy is obviously decreased, which indicates that the immune function state of the patients is determined by the same level. The established value may become a new indicator for evaluating immune function after immunotherapy.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2015
【分類號】：R734.2
本文編號：2126951
[Abstract]:Background: the incidence of lung cancer, according to the latest statistical results, shows that the second cases of malignant tumors, non small cell lung cancer (non-small cell lung cancer, NSCLC) account for about 80%. in recent years. Although great progress has been made in the diagnosis and treatment of NSCLC, the rate of late NSCLC patients still occupies a large proportion and the mortality rate has remained high. Immunotherapy is the same. A new method of tumor therapy has become one of the fourth major tumor treatment methods following surgery, radiotherapy and chemotherapy. It is one of the hotspots in the field of cancer research in recent years. At present, the more mature methods of immunotherapy in China include cytokine induced killer cells (CIK), dendritic cells (DC) and CIK Co cultured DC-CIK cell immunotherapy, DC tumor vaccine, lymphokine activated killer cells (LAK) and tumor infiltrating lymphocyte (TIL), among which DC-CIK cells proved to have high proliferative and antitumor activity in vitro, and they are different from traditional cytotoxic drugs, such as high safety and toxic side effects. It is widely used in the comprehensive treatment of malignant tumor. In clinical application, it shows obvious therapeutic advantage. It can significantly improve the quality of life and prolong the survival time of the patients. However, more and more scholars have realized that the treatment effect of immunotherapy has a long time and is used as an application. The traditional evaluation method of tumor evaluation is still likely to be the reaction stage of immunotherapy, and it is remission after prolonging the observation time. Therefore, the traditional tumor evaluation standard does not accurately evaluate the effect of immunotherapy. We urgently need to find a new evaluation method. With the change of the medical model, the biological psychology is changed. - the social medical model has gradually been recognized by patients and medical workers. The evaluation of clinical outcomes is concerned not only with the tumor itself, but also of the patient's health, mental status, social relations, and the improvement of the tumor related symptoms, especially for the late swelling of the tumor, the weakness of the body, and the inability to tolerate active anti tumor treatment. NSCLC patients who are treated with a one-sided pursuit of the size of the tumor are obviously unwise, and the quality of life is of great significance. Cellular immunotherapy has the characteristics of high safety and small side effects, which can be applied to advanced cancer patients and improve the patient's quality of life. Therefore, this study carries out pulse dispersion plus subtraction combined with DC-CIK for advanced NSCLC patients. Cell immunotherapy, with the quality of life as the evaluation index, the patients with advanced NSCLC, especially after radiotherapy and chemotherapy, are very easy to appear Qi Yin deficiency syndrome type. After long-term clinical practice of traditional Chinese medicine, it has been proved that Shengmai Powder has good effect on Nourishing Yin and nourishing Yin, adding and reducing Chinese medicine of removing stasis and detoxification, and the symptoms of two deficiency syndrome in late NSCLC Qi Yin. The improvement has obvious effect, the pathological nature of Qi and yin deficiency in some patients is also obviously improved, and the quality of life of the patients is improved. Objective: the 1. subject is to study the effect of pulse scatter plus subtraction combined with DC-CIK cell immunotherapy on the quality of life and TCM syndrome in late NSCLC patients, and analyze the quality of life scale based on the theory of traditional Chinese Medicine To provide evidence-based medical evidence for the establishment of a scientific and effective combination of Chinese and Western medicine for the treatment of NSCLC and clinical evaluation methods, and to explore the changes and significance of auxiliary T cell 17 (Th17 cells) in the treatment of malignant tumors by adding or decreasing the pulse dispersion combined with DC-CIK cell immunotherapy for the patients. The immune function status evaluation provided new ideas. Methods: 1. clinical trials were included in 60 cases of NSCLC Qi Yin two deficiency syndrome patients, divided into positive control group, 15 cases, pure DC-CIK cell immunotherapy, 30 cases of traditional Chinese medicine control group, giving Shengmai Powder plus or minus Decoction of traditional Chinese medicine, 15 cases in the combined treatment group were given above. Two methods combined treatment. The KPS score of 3 groups of patients before and after treatment: quality of life score, including the core 30 questionnaire survey (QLQ-C30) for the quality of life of the European cancer research and treatment organization (EORTC), and the common scale (QLASTCM-GM) for the quality of life evaluation system of malignant tumor based on traditional Chinese medicine (TCM); TCM syndrome score and immune function A comparative analysis of the relationship between QLASTCM-GM and QLQ-C30 and the correlation of TCM syndrome score in the 2. experimental study included 30 cases of Qi and yin deficiency type malignant tumor, 15 cases in the treatment group were treated with Shengmai San combined with DC-CIK immunotherapy, and 15 cases in the control group were treated with DC-CIK cell immunotherapy (2 cases), and 8 cases were included in the healthy people. Th17 cells in the peripheral blood of patients and healthy people were detected by flow cytometry. Results: 1. QLQ-C30 was used to evaluate the quality of life of patients with advanced NSCLC. Both Chinese medicine and cell immunotherapy could improve the body function score, improve the fatigue symptoms and improve the quality of life of the patients. The difficulty is better than the cell immunotherapy. Cell immunotherapy improves the quality of sleep of the patients better than the traditional Chinese medicine treatment.2. application QLASTCM-GM evaluation of the quality of life, the group comparison in the field of physique and God, the combined treatment group is higher than the traditional Chinese medicine control group (P = 0.020); in group comparison, after treatment, the quality of life before treatment is improved. There was no statistical difference between the two groups in the corresponding field, but there was a statistical difference between the Chinese medicine control group and the combined treatment group before and after treatment (P0.05). Therefore, it was concluded that after the combination of traditional Chinese medicine treatment, we can better improve the quality of life of the patients with.3. TCM syndrome score, and the clinical benefit of the combined treatment group is better than that of the traditional Chinese medicine control group, P0.05, Statistical difference.4. TCM syndrome score and QLASTCM-GM scale have a moderate correlation in the field of form and God; and the QLQ-C30 scale is only in fatigue, dyspnea, and insomnia, there is a correlation trend in the.QLASTCM-GM scale and the QLQ-C30 scale and the body function area of the QLQ-C30 scale.5. Qi and yin deficiency type malignant tumor The expression level of Thl7 in peripheral blood of patients was higher than that in healthy adults. After cell immunotherapy, the expression of Th17 in peripheral blood decreased. The expression level of Th17 in the treatment group decreased more than that of the control group. Conclusion: 1DC-CIK cell immunotherapy can improve the quality of life of late NSCLC patients with deficiency of two types of Qi and Yin. The evaluation of the quality of life of the same effect.2.: compared with the QLQ-C30 scale, the QLASTCM-GM scale is more related to the TCM syndrome score. It is worth further studying that the.3.Th17 cell is the product of the immune disorder of the patients with malignant tumor. The expression level of Shengmai Powder Combined with cell immunotherapy is obviously decreased, which indicates that the immune function state of the patients is determined by the same level. The established value may become a new indicator for evaluating immune function after immunotherapy.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：博士
【學(xué)位授予年份】：2015
【分類號】：R734.2
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