目的 從miR-204-5p、miR-1269表達(dá)變化方面觀察?？颂婺崧?lián)合TP化療治療晚期非小細(xì)胞肺癌（NSCLC）的臨床有效性和安全性。方法 前瞻性選取2019年2月—2020年12月河北北方學(xué)院附屬第一醫(yī)院胸外科NSCLC患者82例，計(jì)算機(jī)隨機(jī)數(shù)字生成法分為對照組（n＝41）、試驗(yàn)組（n＝41）。對照組給予TP化療，紫杉醇劑量175 mg·m^-2，第1天靜脈滴注；卡鉑劑量300 mg·m^-2，第2天靜脈滴注。4周為1個(gè)周期，治療4個(gè)周期。試驗(yàn)組在對照組TP方案治療基礎(chǔ)上加用?？颂婺幔琓P化療方案及操作同對照組，同時(shí)口服?？颂婺幔看?25 mg，每天3次，當(dāng)患者出現(xiàn)3級(jí)及以上不良反應(yīng)時(shí)，可暫停（1～2周）服用，待癥狀緩解或消失再次恢復(fù)每次125 mg，每天3次。4周為1個(gè)周期，治療4個(gè)周期后進(jìn)行效果評價(jià)。比較兩組臨床療效、不良反應(yīng)發(fā)生情況，分別于治療前、治療2個(gè)周期、治療4個(gè)周期檢測兩組患者肺功能［第1秒呼氣容積（FEV₁）、最大呼氣容積（FVC）］、腫瘤標(biāo)志物［糖類抗原125（CAl25）、癌胚抗原（CEA）、細(xì)胞角蛋白19片段（CYFRA21-1）］、miR-204-5p、miR-1269水平。結(jié)果 治療4個(gè)周期后，試驗(yàn)組客觀緩解率（ORR）為43.90%，疾病控制率（DCR）為82.93%，分別高于對照組的24.39%、63.41%（P<0.05）；治療前兩組患者FEV₁、FVC比較，差異無統(tǒng)計(jì)學(xué)意義（P>0.05）；治療2個(gè)周期、4個(gè)周期后兩組FEV₁、FVC均較治療前升高，且同時(shí)間點(diǎn)試驗(yàn)組高于對照組（P<0.05）。治療前兩組患者CA125、CEA、CYFRA21-1比較，差異無統(tǒng)計(jì)學(xué)意義（P>0.05）；治療2個(gè)周期、4個(gè)周期后兩組CA125、CEA、CYFRA21-1較治療前降低，且同時(shí)間點(diǎn)試驗(yàn)組低于對照組（P<0.05）；治療前兩組患者miR-204-5p、miR-1269表達(dá)水平比較，差異無統(tǒng)計(jì)學(xué)意義（P>0.05）；治療2個(gè)周期、4個(gè)周期后兩組miR-204-5p較治療前升高，miR-1269較治療前降低，且同時(shí)間點(diǎn)試驗(yàn)組miR-204-5p高于對照組，miR-1269低于對照組（P<0.05）。兩組不良反應(yīng)發(fā)生率比較，差異無統(tǒng)計(jì)學(xué)意義（P>0.05）。結(jié)論 埃克替尼聯(lián)合TP化療治療晚期NSCLC效果顯著，可有效改善患者肺功能，降低腫瘤標(biāo)志物水平，調(diào)節(jié)miR-204-5p、miR-1269表達(dá)，且安全性高。

Objective To analyze the effect of icotinib combined with TP chemotherapy in treatment of advanced non-small cell lung cancer (NSCLC) from the expression changes of miR-204-5p and miR-1269 on the basis of previous studies. Methods A total of 82 NSCLC patients in Department of Thoracic Surgery, The First Affiliated Hospital of Hebei North University from February 2019 to December 2020 were prospectively selected. They were divided into control group (n=41) and experimental group (n=41) by computer random number generation method. Patients in the control group were given TP chemotherapy (paclitaxel + carboplatin), paclitaxel dose 175 mg·m^-2, intravenous drip on the first day, carboplatin dose 300 mg·m^-2, intravenous drip on the second day. Four weeks was one cycle, and four cycles of treatment. Patients in the experimental group were given icotinib on the basis of the TP regimen of the control group. The TP chemotherapy regimen and operation were the same as those of the control group. At the same time, icotinib was taken orally, 125 mg each time, three times a day. When patients had grade three or above adverse reactions, they stoped taking (1-2 weeks) and resumed taking 125 mg each time, three times a day, when the symptoms are relieved or disappeared. Four weeks was one cycle, and the effect was evaluated after four cycles of treatment. The clinical efficacy and adverse reactions of two groups were compared. The levels of lung function[first second expiratory volume (FEV₁), maximum expiratory volume (FVC)], tumor markers[carbohydrate antigen 125 (CA25), carcinoembryonic antigen (CEA), cytokeratin 19 fragment (CYFRA21-1)], miR-204-5p and miR-1269 were measured before treatment, two treatment cycles and four treatment cycles respectively. Results After four cycles of treatment, the objective remission rate (ORR) and disease control rate (DCR) of the experimental group were 43.90% and 82.93%, respectively higher than those of the control group (24.39% and 63.41%, P<0.05). There was no significant difference in FEV₁ and FVC between the two groups before treatment (P > 0.05). After two and four cycles of treatment, FEV₁ and FVC in the two groups were higher than those before treatment, and higher than those in the control group at the same time point (P<0.05). There was no significant difference in CA125, CEA and CYFRA21-1 between the two groups before treatment (P > 0.05). After two and four cycles of treatment, CA125, CEA and CYFRA21-1 in the two groups were lower than those before treatment, and at the same time, the levels of CA125, CEA and CYFRA21-1 in the experimental group were lower than those in the control group (P<0.05). There was no significant difference in the expression of miR-204-5p and miR-1269 between the two groups before treatment (P > 0.05). After two and four cycles of treatment, miR-204-5p increased and miR-1269 decreased in the two groups. At the same time, miR-204-5p in the experimental group was higher than that in the control group, and miR-1269 was lower than that in the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion Icotinib combined with TP chemotherapy is effective in treatment of advanced NSCLC. It can effectively improve lung function, reduce the level of tumor markers, regulate the expression of miR-204-5p and miR-1269, and has high safety.

R979.1

河北省醫(yī)學(xué)科學(xué)研究課題（20211359）；張家口市市級(jí)科技計(jì)劃（2021072D）