本文選題：安全性 + 非小細(xì)胞肺癌��； 參考：《北京中醫(yī)藥大學(xué)》2017年碩士論文

【摘要】：近年來(lái),非小細(xì)胞肺癌的發(fā)病率和死亡率不斷上升,由于半數(shù)以上患者在首次診斷時(shí)已經(jīng)發(fā)生了遠(yuǎn)處轉(zhuǎn)移或無(wú)法手術(shù)治療,化療成為了目前晚期非小細(xì)胞肺癌治療的重要手段之一。但化療往往帶來(lái)的不良反應(yīng)如骨髓抑制、消化道反應(yīng)、癌性疲乏等也成為了嚴(yán)重影響非小細(xì)胞肺癌患者生活質(zhì)量和治療選擇的重要因素,而目前以對(duì)癥支持治療為主的減毒療效尚不能令人滿(mǎn)意。如何進(jìn)一步提高晚期非小細(xì)胞肺癌化療療效、減輕毒副反應(yīng)和提高生活質(zhì)量已成為現(xiàn)代醫(yī)學(xué)亟待解決的問(wèn)題。中醫(yī)藥治療與化療協(xié)同在晚期非小細(xì)胞肺癌治療中發(fā)揮著增效減毒、提高患者生活質(zhì)量等重要作用。廣安門(mén)醫(yī)院腫瘤科前期承擔(dān)了多項(xiàng)科技攻關(guān)計(jì)劃課題,整合優(yōu)化全國(guó)的優(yōu)勢(shì)力量,制訂了中醫(yī)治療肺癌的綜合治療方案,即《肺癌中醫(yī)臨床指引》。根據(jù)《指引》推薦中醫(yī)綜合方案與化療的聯(lián)合治療在提高化療完成率及療效、改善癥狀、提高生存質(zhì)量均具有獨(dú)特的優(yōu)勢(shì),但國(guó)內(nèi)外臨床研究尚缺乏。目的:驗(yàn)證中醫(yī)綜合方案聯(lián)合晚期非小細(xì)胞肺癌化療增效減毒效果,評(píng)估中醫(yī)綜合方案在聯(lián)合化療治療階段的安全性。方法:本研究通過(guò)多中心、前瞻性隨機(jī)對(duì)照設(shè)計(jì),納入晚期非小細(xì)胞肺癌患者360例,隨機(jī)分為治療組182例,對(duì)照組178例。治療組采用NCCN指南標(biāo)準(zhǔn)化學(xué)治療聯(lián)合以健脾和胃、益氣養(yǎng)血、滋補(bǔ)肝腎為主要原則的中醫(yī)綜合方案,對(duì)照組接受單純NCCN指南標(biāo)準(zhǔn)化療或聯(lián)合使用湯藥但僅可采用二陳湯加減化裁。化療21-28天為一周期,連續(xù)治療2個(gè)周期后,評(píng)估療效。治療應(yīng)達(dá)到2個(gè)周期,完成者為完整病例,未能完成者只做安全性評(píng)價(jià)。使用國(guó)際公認(rèn)的評(píng)效方式:實(shí)體瘤的療效評(píng)價(jià)標(biāo)準(zhǔn)(RECIST1.1標(biāo)準(zhǔn)評(píng)價(jià))、常見(jiàn)不良反應(yīng)事件評(píng)價(jià)標(biāo)準(zhǔn)(NCI-CTCAE3.0)、《中藥新藥臨床指導(dǎo)原則》中肺癌中醫(yī)臨床證候積分評(píng)價(jià)標(biāo)準(zhǔn)、美國(guó)肺癌生存質(zhì)量量表(FACT-L4.0版))對(duì)化療完成率、瘤體緩解、穩(wěn)定情況、腫瘤標(biāo)志物變化、不良反應(yīng)情況、中醫(yī)臨床證候、生活質(zhì)量情況進(jìn)行評(píng)效。采用SPSS20.0進(jìn)行統(tǒng)計(jì)分析。結(jié)果:共納入360例非小細(xì)胞肺癌患者,共完成315例,治療組163例,對(duì)照組150例,兩組患者在性別、年齡、病理類(lèi)型、腫瘤分期、體力狀況、生命體征、治療前實(shí)體瘤大小、腫瘤標(biāo)志物水平(CEA、SCC、CyFRA211)、中醫(yī)證候、生活質(zhì)量各領(lǐng)域積分等方面基線(xiàn)水平均無(wú)統(tǒng)計(jì)學(xué)差異(P0.05),患者疾病基線(xiàn)特征方面,兩組間具有可比性。增效指標(biāo):1、化療完成率:兩組完成率相近,未顯示明顯差異(P0.05);2、實(shí)體瘤療效:兩組客觀緩解率(ORR=CR+PR)相近:治療組有效率13.2%,對(duì)照組有效率13.5%,未顯示明顯差異(P0.05)。臨床獲益率(CBR=CR+PR+SD)治療組為64.8%略?xún)?yōu)于對(duì)照組的62.9%,但兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P0.05);3、腫瘤標(biāo)志物變化評(píng)價(jià):2療后治療組CEA水平低于對(duì)照組,存在統(tǒng)計(jì)學(xué)差異(P0.05);SCC及CyFRA211兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。CEA、SCC、CyFRA211指標(biāo)較基線(xiàn)變化均顯示良好的趨勢(shì),但兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。說(shuō)明中醫(yī)綜合治療在提高化療完成率、腫瘤控制率和降低腫瘤標(biāo)志物水平上具有一定趨勢(shì),但增效效果不著。減毒指標(biāo):1、化療毒副反應(yīng):NCI不良反應(yīng)評(píng)價(jià)顯示治療組在血液系統(tǒng)毒性白細(xì)胞一項(xiàng)中明顯優(yōu)于對(duì)照組,存在統(tǒng)計(jì)學(xué)差異(P0.05);臨床癥狀部分治療組在疲勞(嗜睡、不適、乏力)、食欲下降、惡心、嘔吐4項(xiàng)中明顯優(yōu)于對(duì)照組,可見(jiàn)統(tǒng)計(jì)學(xué)差異(P0.05);2、中醫(yī)證候評(píng)價(jià):2療程后癥狀積分總和兩組間無(wú)統(tǒng)計(jì)學(xué)差異;但治療組積分總和較基線(xiàn)變化情況優(yōu)于對(duì)照組,存在統(tǒng)計(jì)學(xué)差異(P0.05);參照《中藥新藥臨床研究指導(dǎo)原則》中肺癌中醫(yī)臨床證候計(jì)分評(píng)價(jià)標(biāo)準(zhǔn)評(píng)定,治療組總有效率45.1%高于對(duì)照組總有效率29.2%,具有統(tǒng)計(jì)學(xué)差異(P0.05);單項(xiàng)條目對(duì)比中治療組在神疲乏力、胸悶2項(xiàng)中明顯優(yōu)于對(duì)照組,具有統(tǒng)計(jì)學(xué)差異(P0.05);3、生存質(zhì)量評(píng)價(jià):2療程后治療組PWB(生理狀況)、EWB(情感狀況)優(yōu)于對(duì)照組,存在統(tǒng)計(jì)學(xué)差異(P0.05);單項(xiàng)條目對(duì)比中治療組在精力不濟(jì)、感到惡心、在與疾病抗?fàn)幹懈械皆絹?lái)越失望、擔(dān)心可能會(huì)死、擔(dān)心病情會(huì)惡化、能夠面對(duì)疾病、食欲好等條目?jī)?yōu)于對(duì)照組,具有統(tǒng)計(jì)學(xué)差異(P0.05)。說(shuō)明中醫(yī)綜合治療在降低化療毒副反應(yīng)、改善中醫(yī)證候、提高生活質(zhì)量上均具有顯著優(yōu)勢(shì)。安全性評(píng)價(jià):研究中除NCI不良反應(yīng)量表記錄的不良反應(yīng)外,治療組出現(xiàn)不良事件1例(0.5%),對(duì)照組出現(xiàn)不良事件1例(0.6%),判斷與試驗(yàn)藥物無(wú)關(guān)。無(wú)其他不良反應(yīng)記錄。說(shuō)明中醫(yī)綜合治療方案安全性良好,適于臨床推廣。結(jié)論:中醫(yī)綜合治療在提高化療完成率、腫瘤控制率和降低腫瘤標(biāo)志物水平上具有一定作用趨勢(shì),但增效效果不顯著;中醫(yī)綜合治療在降低化療毒副反應(yīng)、改善中醫(yī)證候、提高生活質(zhì)量上均具有顯著優(yōu)勢(shì)。中醫(yī)綜合治療安全性良好,適于臨床推廣。
[Abstract]:In recent years, the incidence and mortality rate of non-small cell lung cancer are increasing, because more than half of the patients have undergone distant metastasis or inoperable treatment at the first diagnosis. Chemotherapy has become one of the most important methods for the treatment of advanced non-small cell lung cancer, but chemotherapy often brings adverse reactions such as bone marrow suppression and digestive tract reactions. Cancer fatigue has also become an important factor affecting the quality of life and the choice of treatment for patients with non-small cell lung cancer. However, the effect of reducing toxicity mainly on symptomatic support is not satisfactory. How to further improve the therapeutic effect of advanced non-small cell lung cancer, reduce the side effects and improve the quality of life has become a modern medicine. In the treatment of advanced non-small cell lung cancer, the cooperation of traditional Chinese medicine and chemotherapy in the treatment of advanced non-small cell lung cancer is playing an important role in improving the quality of life and so on. In the early stage of the Department of oncology in Guanganmen hospital, a number of scientific and technological projects have been undertaken to integrate and optimize the national superior forces, and a comprehensive therapeutic prescription for the treatment of lung cancer in traditional Chinese medicine has been formulated. According to the guideline > the combined treatment of TCM and chemotherapy has unique advantages in improving the completion rate of chemotherapy, improving the curative effect, improving the symptoms and improving the quality of life. However, the clinical research at home and abroad is still lacking. Effect, evaluate the safety of TCM Comprehensive Scheme in the stage of combined chemotherapy. Methods: through multi center, prospective randomized controlled design, 360 patients with advanced non-small cell lung cancer were randomly divided into treatment group (182 cases) and control group (178 cases). The treatment group was treated with NCCN guide standard chemical therapy combined with spleen and stomach, nourishing qi and blood nourishing, nourishing blood. The main principle of supplementing the liver and kidney is the comprehensive plan of traditional Chinese medicine. The control group receives only NCCN guide standard chemotherapy or combined use of decoction but can only use the decoction of second Chen decoction. 21-28 days of chemotherapy is a cycle, after 2 cycles of continuous treatment, the curative effect is evaluated. The treatment should reach 2 cycles, the complete case is complete, and the failure to complete the safety assessment only. Price. Using the internationally recognized evaluation methods: the evaluation standard of the curative effect of solid tumor (RECIST1.1 standard evaluation), the standard of evaluation of common adverse events (NCI-CTCAE3.0), the evaluation standard of the TCM clinical syndromes of lung cancer in the clinical guiding principle of the new medicine, the American Lung Cancer Quality of Life Scale (FACT-L4.0 version), the rate of chemotherapy and the remission of the tumor, The stability, the change of tumor markers, the adverse reaction, the TCM clinical syndrome and the quality of life were evaluated by SPSS20.0. Results: a total of 360 patients with non-small cell lung cancer were included in 315 cases, 163 cases in the treatment group and 150 cases in the control group. The two groups were in sex, age, pathological type, tumor staging and physical condition. The vital signs, the size of the solid tumor before treatment, the level of the tumor markers (CEA, SCC, CyFRA211), the TCM syndromes and the integration of the quality of life were not statistically different (P0.05). The baseline features of the patients were comparable between the two groups. The increase efficiency index: 1, the completion rate of chemotherapy: the two groups had similar completion rates, and did not show significant differences. (P0.05); 2, the effect of solid tumor: two groups of objective remission rate (ORR=CR+PR) similar: the treatment group was effective 13.2%, the control group was 13.5%, no significant difference (P0.05). The clinical benefit rate (CBR=CR+PR+SD) treatment group was 64.8% slightly better than the control group, but there was no statistical difference between the two groups (P0.05); 3, the tumor marker change evaluation: 2 treatment group after the treatment group. The level of CEA was lower than that of the control group (P0.05); there was no statistical difference between the two groups (P0.05).CEA, SCC, and CyFRA211 index showed a good trend compared with the baseline, but there was no statistical difference between the two groups (P0.05). It indicated that the comprehensive treatment of TCM was in the high chemotherapy completion rate, the tumor control rate and the level of tumor markers. There was a certain trend, but the effect was not effective. The detoxification index: 1, the side effects of chemotherapy: the NCI adverse reaction evaluation showed that the treatment group was obviously superior to the control group in the blood system toxic leukocyte, and there was a statistical difference (P0.05); the clinical symptom group was in fatigue (lethargy, discomfort, fatigue), appetite decline, nausea and vomiting. Significantly better than the control group, there was statistical difference (P0.05); 2, TCM Syndrome Evaluation: after the 2 course of treatment, there was no statistical difference between the two groups, but the total score of the treatment group was better than the baseline, and there was a statistical difference (P0.05). Standard evaluation, the total effective rate of the treatment group was 45.1% higher than the control group, the total effective rate was 29.2%, with statistical difference (P0.05). In the single item comparison, the treatment group was obviously superior to the control group in the fatigue and chest tightness in 2 items, with statistical difference (P0.05); 3, the quality of life evaluation: the 2 course of treatment group PWB (physiological condition), EWB (emotional state) is superior to the control Group, there was a statistical difference (P0.05); in the comparison of the single item, the treatment group was disappointing, felt more disappointing in the fight against the disease, worried that it might die, worried that the condition would deteriorate, and could face the disease, and the appetite was better than the control group, with statistical difference (P0.05). In the study, there were 1 cases of adverse events (0.5%) in the treatment group and 1 cases (0.6%) of adverse events in the control group. No other adverse reaction records were recorded. There was no other adverse reaction record. The treatment scheme is safe and suitable for clinical popularization. Conclusion: TCM Comprehensive treatment has a certain role in improving the completion rate of chemotherapy, the rate of tumor control and reducing the level of tumor markers, but the effect is not significant. The comprehensive treatment of traditional Chinese medicine has significant advantages in reducing the side effects of chemotherapy, improving TCM syndromes and improving the quality of life. Comprehensive treatment of Chinese medicine is safe and suitable for clinical promotion.

【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R734.2

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 黃芳;許雋穎;;不同化療方案對(duì)晚期非小細(xì)胞肺癌患者骨髓抑制及免疫功能的影響[J];中國(guó)醫(yī)藥指南;2016年18期

2 謝春榮;林尤恩;王曉芬;;肺癌化療應(yīng)對(duì)方式與生活質(zhì)量相關(guān)性的縱向分析[J];現(xiàn)代診斷與治療;2016年06期

3 李康;李秋華;;中藥聯(lián)合化療改善晚期非小細(xì)胞肺癌患者生活質(zhì)量臨床觀察[J];遼寧中醫(yī)雜志;2016年03期

4 徐海平;吳慧娟;石商雙;;尼妥珠單抗靶向治療聯(lián)合常規(guī)化療方案治療晚期非小細(xì)胞肺癌療效分析[J];海南醫(yī)學(xué)院學(xué)報(bào);2016年05期

5 沈盛萍;葉翔峗;徐云華;侯宛昕;李嘉旗;姚嘉麟;畢凌;陸舜;許玲;陳智偉;;晚期非小細(xì)胞肺癌個(gè)體化化療聯(lián)合中藥治療:一項(xiàng)隨機(jī)對(duì)照試驗(yàn)[J];腫瘤;2015年10期

6 李俊;;中藥聯(lián)合同期放化療治療非小細(xì)胞肺癌臨床研究[J];中醫(yī)學(xué)報(bào);2015年01期

7 蘇同義;朱鐵年;高冬梅;張怡梅;趙青蘭;;不同化療方案對(duì)晚期非小細(xì)胞肺癌患者骨髓抑制及免疫功能的影響[J];現(xiàn)代生物醫(yī)學(xué)進(jìn)展;2014年21期

8 崔娣;胡曉冬;夏清青;;中藥聯(lián)合化療治療晚期非小細(xì)胞肺癌療效及對(duì)患者生存期的影響[J];環(huán)球中醫(yī)藥;2014年03期

9 林洪生;楊宗艷;張培彤;侯煒;謝廣茹;解英;嚴(yán)蘇純;富琦;張英;;生血丸治療非小細(xì)胞肺癌脾腎陽(yáng)虛證化療所致血象下降的臨床療效觀察[J];中華中醫(yī)藥雜志;2013年08期

10 蔣益蘭;潘敏求;蔡美;李琳霈;周堅(jiān);劉偉;;肺復(fù)方治療中晚期老年非小細(xì)胞肺癌多中心臨床研究[J];北京中醫(yī)藥大學(xué)學(xué)報(bào);2012年10期

，

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