目的 探讨复方苦参注射液替雷利珠单抗和化疗方案对局部晚期不可切除非小细胞肺癌患者的临床疗效。方法 选择2021年3月—2023年12月在天津市宝坻区人民医院接受治疗的96例局部晚期不可切除非小细胞肺癌患者，根据治疗方案的不同将所有患者分为对照组（47例）和治疗组（49例）。对照组于第一天将 200 mg替雷利珠单抗注射液加入至生理盐水中缓慢静脉滴注；同时静脉滴注注射用紫杉醇（白蛋白结合型），于第一天、第八天根据患者身体情况分别给予100 mg/m²，静脉滴注30 min；第一天将一定量的卡铂注射液溶解在5%的葡萄糖注射液中进行静脉滴注，计算卡铂剂量，每21天给药1次。治疗组在对照组的治疗基础上静脉滴注复方苦参注射液，20 mL/次，1次/d，连续用药14 d，停用7 d。两组患者均以21 d为1个疗程，连续观察4个疗程。观察两组患者的临床疗效，比较两组治疗前后肿瘤标志物指标、凝血功能指标、生活质量的变化情况。结果 治疗后，治疗组客观缓解率（ORR）为55.10%，显著高于对照组的31.91%（P＜0.05）。治疗后，治疗组癌胚抗原（CEA）、糖类抗原125（CA125）、鳞状上皮细胞癌抗原（SCCAg）、细胞角蛋白19片段抗原21-1（CYFR21-1）、神经元特异性烯醇化酶（NSE）显著低于治疗前（P＜0.05）；且治疗后，治疗组肿瘤标志物显著低于对照组（P＜0.05）。治疗后，两组患者TT、PT、APTT显著升高，而D-D显著降低（P＜0.05）；治疗后，治疗组TT、PT、APTT水平高于对照组，而D-D水平低于对照组（P＜0.05）。治疗后，两组KPS评分显著高于同组治疗前（P＜0.05）；治疗后，治疗组KPS评分高于对照组（P＜0.05）。结论 对于局部晚期不可切除非小细胞肺癌患者，复方苦参注射液联合替雷利珠单抗和化疗方案取得确切疗效，可抑制肿瘤生长，改善患者凝血功能，提高患者生活质量，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

国家抗肿瘤药物临床应用监测网肿瘤规范化诊疗中青年研究基金项目(DSS-YSF-2023002)