化療聯(lián)合參麥注射液對晚期非小細胞肺癌患者細胞免疫及腫瘤惡性程度的影響

羅麗華

(河北省秦皇島市第三醫(yī)院腫瘤科,秦皇島,066000)

化療聯(lián)合參麥注射液對晚期非小細胞肺癌患者細胞免疫及腫瘤惡性程度的影響

羅麗華

(河北省秦皇島市第三醫(yī)院腫瘤科,秦皇島,066000)

目的:探討化療聯(lián)合參麥注射液治療晚期非小細胞肺癌(NSCLC)的臨床療效及對患者細胞免疫、腫瘤惡性程度的影響。方法:選取2011年5月至2016年2月秦皇島市第三醫(yī)院收治的NSCLC患者162例,隨機分為觀察組和對照組,每組81例。對照組患者給予單純化療治療,觀察組在對照組的基礎(chǔ)上聯(lián)合參麥注射液治療。治療6個月后統(tǒng)計2組臨床療效;檢測并比較治療前后2組患者血清炎性細胞因子水平及腫瘤標志分子水平;檢測并比較治療前后2組患者全血中T淋巴細胞亞群比例的變化;統(tǒng)計治療期間2組不良反應(yīng)。結(jié)果:治療6個月后觀察組緩解率為79.01%,顯著高于對照組的50.62%(P<0.01);與治療前比較,治療后觀察組患者血清IFN-γ、IL-2、TNF-α水平均明顯升高,且顯著高于對照組(P<0.05或P<0.01);觀察組患者血清IL-6及IL-10水平均明顯降低,且顯著低于對照組(P<0.01);與治療前比較,治療后對照組CD4+比例及CD4+/CD8+均明顯降低(P<0.01),而觀察組CD8+比例明顯降低,CD4+比例、NK細胞比例及CD4+/CD8+均明顯升高(P<0.05或P<0.01),且2組間差異有統(tǒng)計學(xué)意義(P<0.05或P<0.01);與治療前比較,治療后2組血清CEA、CA125、CYFRA21-1、NSE及SCC-Ag水平均明顯降低,且觀察組顯著低于對照組(P<0.01);與對照組比較,觀察組患者惡心、嘔吐,白細胞減少及血小板下降發(fā)生率明顯降低(P<0.05或P<0.01)。結(jié)論:化療聯(lián)合參麥注射液可明顯調(diào)節(jié)晚期NSCLC患者血清細胞因子水平,提高患者細胞免疫功能,并有效降低血清腫瘤標志物水平,降低腫瘤惡性程度,療效顯著優(yōu)于化療單用,同時其也可有效降低患者不良反應(yīng)發(fā)生率,具有較高的安全性。

非小細胞肺癌;化療;參麥注射液;細胞免疫;腫瘤標志物;療效

非小細胞肺癌(Non-small Cell Lungcar Cinoma,NSCLC)屬于肺癌中最為常見的類型,且發(fā)病率和致死率均比較高,約占肺癌總量的80%[1-5]。中晚期NSCLC患者主要臨床癥狀表現(xiàn)為咳嗽、胸部脹痛、氣促、咳痰帶血、低熱等[6-8]。局部晚期NSCLC患者往往無法接受手術(shù)治療,單純化療患者腫瘤負荷較重,療效并不理想,同時化療具有嚴重的不良反應(yīng),影響患者免疫功能,還易引發(fā)骨髓造血功能抑制、血細胞減少等嚴重并發(fā)癥[9-10]。中醫(yī)藥也是治療NSCLC常用的方法之一,為有效減輕化療的不良反應(yīng),可將化療與中醫(yī)藥有機結(jié)合,提高中晚期NSCLC的綜合治療效果[11]。據(jù)報道[12-13],參麥注射液可顯著抑制NSCLC患者腫瘤血管的生長,調(diào)節(jié)患者免疫功能,起到明顯的增效減毒作用,但有關(guān)其與化療聯(lián)合應(yīng)用治療NSCLC的研究尚不充分,因此本研究采用參麥注射液聯(lián)合化療治療晚期NSCLC,旨在探討參麥注射液聯(lián)合化療對改善NSCLC患者細胞免疫及腫瘤惡性程度效果,現(xiàn)將結(jié)果報道如下。

1 資料與方法

1.1 一般資料 選取2011年5月至2016年2月本院收治的NSCLC患者162例,將所有患者隨機分為對照組(n=81)及觀察組(n=81),對照組男47例,女34例;年齡31～67歲,平均年齡(50.68±10.24)歲;病理類型:鱗癌27例,腺癌39例,其他15例;臨床分期:ⅢA期43例,ⅢB期38例。觀察組男45例,女36例;年齡32～69歲,平均年齡(49.93±10.14)歲;病理類型:鱗癌26例,腺癌37例,腺鱗癌18例;臨床分期:ⅢA期42例,ⅢB期39例。2組患者性別、年齡、病理類型及臨床分期等方面一般資料比較均差異無統(tǒng)計學(xué)意義(P>0.05),具有可比性。本研究經(jīng)本院醫(yī)學(xué)倫理委員會討論決定且所有患者及家屬均簽署知情同意書。

1.2 診斷標準 所有患者均經(jīng)病理學(xué)或細胞學(xué)證實且均符合《中國常見惡性腫瘤診治規(guī)范》中的相關(guān)診斷標準[14]。

1.2 納入標準 所有患者均為原發(fā)且初次治療,無明顯手術(shù)指征;預(yù)計生存期>6個月;據(jù)國際抗癌聯(lián)盟(UICC)分期標準,均為ⅢA或ⅢB期;據(jù)東部腫瘤協(xié)作組(ECOG)PS評分為0～2分。

1.3 排除標準 腫瘤分期達中晚期及以上者;對本研究所用藥物過敏者;依從性較差者;合并嚴重心、腦等功能障礙及免疫系統(tǒng)疾病者;腫瘤細胞發(fā)生轉(zhuǎn)移者;主支氣管受侵犯者;治療前接受過放/化療治療者。

1.4 治療方法 對照組患者進行單純化療治療:鱗癌患者予以多西他賽37.5 mg/m2加至250 mL生理鹽水中,d 1及d 8靜脈滴注,同時聯(lián)合順鉑75 mg/m2分3 d給予,即d 1至d 3靜脈滴注化療,21 d為1個療程;腺癌及其他類型患者予以培美曲塞500 mg/m2d 1靜脈滴注或紫杉醇75 mg/m2d 1靜脈滴注,同時聯(lián)合順鉑75 mg/m2d 1靜脈滴注化療,21 d為1個療程。觀察組患者進行化療聯(lián)合參麥注射液(四川升和藥業(yè)股份有限公司生產(chǎn),國藥準字Z20043478,規(guī)格:20 mL/支)治療,40 mL/次,1次/d,每個療程連續(xù)靜脈滴注15 d;化療方案同對照組。2組均至少連續(xù)治療2個療程。

1.5 觀察指標 分別于治療前后采集患者空腹靜脈血5 mL,經(jīng)離心分離血清,以ELISA法檢測2組血清IFN-γ、IL-2、TNF-α、IL-6及IL-10等細胞因子水平;另以流式細胞儀檢測2組全血中NK細胞比例及T淋巴細胞比例(CD4+及CD8+),計算CD4+/CD8+;以自動電化學(xué)發(fā)光免疫分析儀檢測2組患者血清癌胚抗原(CEA)、糖類抗原125(CA125)、腫瘤細胞角蛋白19片段(CYFRA21-1)、神經(jīng)元特異性烯醇化酶(NSE)、鱗狀細胞癌相關(guān)抗原(SCC-Ag)等腫瘤標志物水平;統(tǒng)計2組治療期間不良反應(yīng)發(fā)生情況。

1.6 療效判定標準 分別于治療前及治療6個月后對2組患者進行胸部CT掃描,復(fù)查,參照實體瘤療效評價標準(RECIST)[15]評價2組近期臨床療效:完全緩解(CR):腫瘤病灶消失并維持4周;部分緩解(PR):腫瘤組織縮小30%或以上并維持4周;疾病穩(wěn)定(SD):腫瘤病灶體積縮小<30%或增大<20%;疾病進展(PD):腫瘤病灶體積增大>20%或有新病灶。緩解率(RR)=(CR+PR)例數(shù)/總例數(shù)×100%。

2 結(jié)果

2.1 2組患者臨床療效比較 治療6個月后對照組患者PD 13例,SD 27例,PR 18例,CR 23例,RR為50.62%(41/81);觀察組PD 7例,SD 10例,PR 35例,CR 29例,RR為79.01%(64/81);觀察組RR顯著高于對照組(P<0.01)。

2.2 治療前后2組細胞免疫功能比較

2.2.1 治療前后2組血清細胞因子水平比較 治療前2組血清細胞因子水平差異無統(tǒng)計學(xué)意義(P>0.05);與治療前比較,治療后觀察組患者血清IFN-γ、IL-2、TNF-α水平均明顯升高,且顯著高于對照組(P<0.05或P<0.01);觀察組患者血清IL-6及IL-10水平均明顯降低,且顯著低于對照組(P<0.01)。見表1。

2.2.2 治療前后2組T淋巴細胞亞群及NK細胞比例變化 治療前2組T淋巴細胞亞群及NK細胞比例差異無統(tǒng)計學(xué)意義(P>0.05);與治療前比較,治療后對照組CD4+比例及CD4+/CD8+均明顯降低(P<0.01),而觀察組CD8+比例明顯降低,CD4+比例、NK細胞比例及CD4+/CD8+均明顯升高(P<0.05或P<0.01),且2組間差異有統(tǒng)計學(xué)意義(P<0.05或P<0.01)。見表2。

2.3 治療前后2組血清腫瘤標志物水平比較 治療前2組血清腫瘤標志物水平差異均無統(tǒng)計學(xué)意義(P>0.05);與治療前比較,治療后2組血清CEA、CA125、CYFRA21-1、NSE及SCC-Ag水平均明顯降低,且觀察組顯著低于對照組(P<0.01)。見表3。

2.4 不良反應(yīng) 與對照組比較,觀察組患者惡心、嘔吐,白細胞減少及血小板下降發(fā)生率明顯降低(P<0.05或P<0.01)。見表4。

表1治療前后2組血清細胞因子水平的比較

注:與治療前比較,*P<0.05,**P<0.01;與對照組比較,△△P<0.01。

表2 治療前后2組T淋巴細胞亞群及NK細胞比例變化的比較

注:與治療前比較,*P<0.05,**P<0.01;與對照組比較,△P<0.05,△△P<0.01。

表3 治療前后2組血清腫瘤標志水平比較

注:與治療前比較,**P<0.01;與對照組比較,△△P<0.01。

表4 2組不良反應(yīng)比較[n(%)]

注:與對照組比較,*P<0.05,**P<0.01。

3 討論

化療在NSCLC的治療中具有及其重要的作用,是中晚期NSCLC患者的常規(guī)治療方式,但化療藥物在抑制、殺滅腫瘤細胞的同時,也會嚴重影響人體正常細胞,造成一系列化療不良反應(yīng),進一步損害機體自身免疫功能[16-19]。加之,晚期肺癌患者體質(zhì)虛弱,受化療不良反應(yīng)影響機體免疫功能進一步受損,細胞因子水平紊亂,大多數(shù)患者因不能耐受而影響治療,因此單純化療并不能起到預(yù)期的效果,甚至反而會因免疫功能進一步降低而威脅生命安全[20-24]。中藥聯(lián)合化療治療中晚期非小細胞肺癌已在臨床廣泛應(yīng)用,在穩(wěn)定瘤體、降低腫瘤標志物水平等方面取得了較好療效,且中藥與化療有協(xié)同作用,可明顯改善生活質(zhì)量并延長患者生存期,同時還可在一定程度上減輕化療的不良反應(yīng)[25-29]。

中醫(yī)學(xué)認為肺癌屬“咳嗽、痰飲、肺積、肺壅”等范疇,其是因虛而致實、得病,是正虛為本,虛中夾實的疾病。其主要由邪毒乘虛入肺,導(dǎo)致肺臟陰陽失調(diào),宣降失司,氣機不利,血行受阻,致痰凝氣滯,瘀阻絡(luò)脈,邪氣瘀毒膠結(jié),日久形成肺部積塊。故應(yīng)以益氣養(yǎng)陰為主要治療原則[30]。參麥注射液主要由紅參、麥冬組成,麥冬甘寒,可養(yǎng)陰潤肺、益胃生津;紅參甘溫,可補氣滋陰、益血生津;共奏益氣固脫、養(yǎng)陰生津、運脾化濕之功效[31]。據(jù)報道,參麥注射液聯(lián)合化療治療惡性腫瘤具有一定的增效減毒作用。本研究結(jié)果顯示,觀察組RR為79.01%,顯著高于對照組的50.62%;且觀察組患者惡心、嘔吐,白細胞減少及血小板下降發(fā)生率較對照組明顯降低,與相關(guān)研究[32]結(jié)果相吻合,提示參麥注射液可明顯提高NSCLC患者的臨床療效,同時可明顯降低化療的毒副租用,增效減毒作用顯著。

NSCLC患者普遍處于免疫抑制狀態(tài),免疫功能障礙也是導(dǎo)致腫瘤細胞持續(xù)增殖、侵襲的重要原因[33]?，F(xiàn)代藥理研究證實,參麥注射液的有效成分主要有人參皂苷、人參多糖、麥冬皂苷、麥冬多糖及麥冬黃酮等,具有廣泛的免疫藥理活性,可通過抑制巨噬細胞釋放炎性反應(yīng)遞質(zhì)胺減輕機體損傷,有效調(diào)節(jié)機體免疫功能,明顯增加腫瘤患者的抗腫瘤能力,其中人參皂苷具有雙相免疫調(diào)節(jié)作用,可調(diào)節(jié)機體非特異性及特異性免疫功能;麥冬多糖可誘導(dǎo)機體免疫系統(tǒng)產(chǎn)生多種細胞因子,增強機體體液免疫及細胞免疫應(yīng)答[34]。T淋巴細胞是惡性腫瘤免疫監(jiān)視系統(tǒng)中起關(guān)鍵作用的功能細胞,NSCLC患者細胞免疫功能紊亂,表現(xiàn)為CD4+比例及CD4+/CD8+比值下降,且細胞因子水平失衡,其中IL-6及IL-10等Th2型細胞因子占優(yōu)勢地位,而IFN-γ、TNF-α及IL-2等Th1型細胞因子水平較低,T淋巴細胞亞群比例失衡或Th1/Th2偏移越嚴重,機體的免疫抑制反應(yīng)也會隨之加重,且以上變化隨著腫瘤病情加重而進一步發(fā)展[35]。本研究結(jié)果顯示,治療后觀察組患者血清IFN-γ、IL-2、TNF-α水平均明顯升高,而IL-6及IL-10水平均明顯降低,且2組間差異有統(tǒng)計學(xué)意義;此外,治療后對照組CD4+比例及CD4+/CD8+均較治療前明顯降低,而觀察組CD8+比例較治療前明顯降低,CD4+比例、NK細胞比例及CD4+/CD8+均較治療前明顯升高,且2組間差異有統(tǒng)計學(xué)意義,與王蓉等[36]研究結(jié)果相似。腫瘤標志物水平在腫瘤療效評價方面意義重大,其水平升高與腫瘤負荷密切相關(guān),是判斷腫瘤惡性程度的首要指標。CEA主要存在于胚胎性腫瘤組織中的糖蛋白抗原,是動態(tài)監(jiān)測反映肺癌治療效果的公認指標;CA125是一種似黏液糖蛋白復(fù)合物,可普遍用于肺癌、胃癌等的檢出及療效判斷;CYFRA21-1主要存在于肺組織尤其是肺腫瘤上皮細胞的胞質(zhì)中,SCC-Ag屬于鱗狀上皮細胞癌相關(guān)抗原,NSE是肺癌的特異性輔助診斷指標,3者均會隨著患者病情變化而出現(xiàn)明顯波動[37-39]。本研究中治療后2組血清CEA、CA125、CYFRA21-1、NSE及SCC-Ag水平均較治療前明顯降低,且觀察組顯著低于對照組,提示參麥注射液可明顯調(diào)節(jié)NSCLC患者細胞因子水平,增強其細胞免疫功能,有效抑制腫瘤進展,降低機體腫瘤標志物水平,減輕患者惡性程度。

綜上所述,參麥注射液聯(lián)合化療可明顯調(diào)節(jié)晚期NSCLC患者血清細胞因子水平,提高患者細胞免疫功能,增強機體抵抗腫瘤的能力,有效降低患者血清腫瘤標志物水平,抑制腫瘤惡性發(fā)展,同時患者不良反應(yīng)明顯減少,提示參麥注射液是一種安全、有效的NSCLC化療輔助治療藥物,可起到明顯的增效減毒作用,值得臨床上推廣使用。

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(2017-03-24收稿 責(zé)任編輯：王明)

Effect of Chemotherapy Combined with Shenmai Injection on Cellular Immunity and Tumor Malignance of Advanced Non-small Cell Lung Cancer Patients

Luo Lihua

(DepartmentofOncology,TheThirdHospitalofQinhuangdao,Qinhuangdao066000,China)

Objective: To investigate the clinical efficacy of chemotherapy combined with Shenmai injection in the treatment of advanced non-small cell lung cancer (NSCLC) and its effect on cellular immunity and tumor malignant degree of patients. Methods: A total number of 162 patients with NSCLC admitted in the hospital from May 2011 to February 2016, and were randomly divided into control group and observation group, with 81 cases in each group. The patients in the control group were treated with chemotherapy, while patients in the observation group were additionally treated with Shenmai Injection. The clinical efficacy of the two groups was evaluated after 6-month treatment. The levels of serum inflammatory cytokines and tumor markers were measured and compared between the two groups before and after the treatment. Changes of T lymphocyte subsets in the whole blood of the two groups were detected and compared before and after treatment. Adverse reactions during the treatment were observed. Results: After 6-month treatment, the remission rate was 79.01% in the observation group, which was significantly higher than that of 50.62% in the control group (P<0.01). The levels of serum IFN-γ, IL-2 and TNF-α in the observation group were significantly higher than those in the control group (P<0.05 orP<0.01). The levels of IL-6 and IL-10 in the observation group were significantly lower than those in the control group (P<0.05 orP<0.01). The proportion of CD4+and CD4+/CD8+in the control group were significantly lower (P<0.01), while the proportion of CD8+in the observation group significantly decreased.CD4+ratio, NK cell ratio and CD4+/CD8+significantly increased (P<0.05 orP<0.01), and there was significant difference between the two groups after the treatment (P<0.05 orP<0.01).The levels of serum CEA, CA125, CYFRA21-1, NSE and SCC-Ag in the two groups were significantly lower and the observation group was significantly lower than the control group after the treatment (P<0.01). The incidence of nausea, vomiting, leukopenia and thrombocytopenia was significantly lower, compared with the control group (P<0.05;P<0.01). Conclusion: Chemotherapy combined with Shenmai injection may significantly regulate the serum cytokine levels in patients with advanced NSCLC, improve the cellular immune function, effectively reduce serum tumor marker level and reduce tumor malignancy. The effect is significantly better than chemotherapy and it may effectively reduce the incidence of adverse reactions with high safety.

Non-small cell lung cancer; Chemotherapy; Shenmai Injection; Cellular immunity; Tumor markers; Efficacy

羅麗華(1978.09—),女,本科,主治醫(yī)師,研究方向:腫瘤內(nèi)科學(xué),E-mail:13933521310@163.com

R273

A

10.3969/j.issn.1673-7202.2017.05.034