目的 探討復(fù)方苦參注射液替雷利珠單抗和化療方案對局部晚期不可切除非小細(xì)胞肺癌患者的臨床療效。方法 選擇2021年3月—2023年12月在天津市寶坻區(qū)人民醫(yī)院接受治療的96例局部晚期不可切除非小細(xì)胞肺癌患者，根據(jù)治療方案的不同將所有患者分為對照組（47例）和治療組（49例）。對照組于第一天將 200 mg替雷利珠單抗注射液加入至生理鹽水中緩慢靜脈滴注；同時靜脈滴注注射用紫杉醇（白蛋白結(jié)合型），于第一天、第八天根據(jù)患者身體情況分別給予100 mg/m²，靜脈滴注30 min；第一天將一定量的卡鉑注射液溶解在5%的葡萄糖注射液中進行靜脈滴注，計算卡鉑劑量，每21天給藥1次。治療組在對照組的治療基礎(chǔ)上靜脈滴注復(fù)方苦參注射液，20 mL/次，1次/d，連續(xù)用藥14 d，停用7 d。兩組患者均以21 d為1個療程，連續(xù)觀察4個療程。觀察兩組患者的臨床療效，比較兩組治療前后腫瘤標(biāo)志物指標(biāo)、凝血功能指標(biāo)、生活質(zhì)量的變化情況。結(jié)果 治療后，治療組客觀緩解率（ORR）為55.10%，顯著高于對照組的31.91%（P＜0.05）。治療后，治療組癌胚抗原（CEA）、糖類抗原125（CA125）、鱗狀上皮細(xì)胞癌抗原（SCCAg）、細(xì)胞角蛋白19片段抗原21-1（CYFR21-1）、神經(jīng)元特異性烯醇化酶（NSE）顯著低于治療前（P＜0.05）；且治療后，治療組腫瘤標(biāo)志物顯著低于對照組（P＜0.05）。治療后，兩組患者TT、PT、APTT顯著升高，而D-D顯著降低（P＜0.05）；治療后，治療組TT、PT、APTT水平高于對照組，而D-D水平低于對照組（P＜0.05）。治療后，兩組KPS評分顯著高于同組治療前（P＜0.05）；治療后，治療組KPS評分高于對照組（P＜0.05）。結(jié)論 對于局部晚期不可切除非小細(xì)胞肺癌患者，復(fù)方苦參注射液聯(lián)合替雷利珠單抗和化療方案取得確切療效，可抑制腫瘤生長，改善患者凝血功能，提高患者生活質(zhì)量，且安全性高。

Objective To investigating the clinical efficacy of Compound Kushen Injection combined with tirellizumab and chemotherapy in treatment of local advanced unresectable non-small cell lung cancer. Methods A total of 96 patients with locally advanced unresectable non-small cell lung cancer who were treated in Tianjin Baodi District People’s Hospital from March 2021 to December 2023 were selected, and all patients were divided into control group (47 cases) and treatment group (49 cases) according to different treatment plans. Patients in control group were iv administered with 200 mg Tirelizumab Injection, which was added to normal saline on d1 for slow intravenous infusion. At the same time, intravenous infusion of Paclitaxel for Injection(Albumin Bound) was given 100 mg/m² on d1 and d8 according to the patients' physical condition for 30 min. A certain amount of Carboplatin for injection was dissolved in 5% glucose injection for intravenous infusion on d1, and the carboplatin dose was calculated with reference to the literature and administered once every 21 d. On the basis of the treatment of the control group, the treatment group was given Compound Kushen Injection intravenously, 20 mL/time, once daily, continuously for 14 d, and stopped for 7 d. Patients in both groups were treated for 21 d as a course of treatment, and continuously observed for 4 courses. The clinical efficacy of two groups was observed, and the changes of tumor markers, coagulation function indicators and quality of life before and after treatment were compared between two groups. Results After treatment, ORR of treatment group was 55.10%, significantly higher than that of control group (31.91%), (P < 0.05). After treatment, CEA, CA125, SCCAg, CYFR21-1 and NSE in treatment group were significantly lower than before treatment (P < 0.05). After treatment, tumor markers in treatment group were significantly lower than those in control group (P < 0.05). After treatment, TT, PT, and APTT were significantly increased, but D-D was significantly decreased in two groups (P < 0.05). After treatment, TT, PT, and APTT levels in treatment group were higher than those in control group, but D-D levels were lower than those in control group (P < 0.05). After treatment, KPS score in two groups was significantly higher than before treatment (P < 0.05). After treatment, the KPS score of treatment group was higher than that of control group (P < 0.05). Conclusion For patients with locally advanced unresectable non-small cell lung cancer, Compound Kushen Injection combined with combined with tirellizumab and chemotherapy has achieved a definite effect, which can inhibit tumor growth, improve blood coagulation function and improve patients’ quality of life with high safety.

R979.1

國家抗腫瘤藥物臨床應(yīng)用監(jiān)測網(wǎng)腫瘤規(guī)范化診療中青年研究基金項目(DSS-YSF-2023002)