目的 探究参莲胶囊联用吉西他滨-顺铂（GP）化疗方案对晚期非小细胞肺癌（NSCLC）患者实施临床干预的疗效价值。方法 共纳入2023年3月—2025年3月河南大学第一附属医院收治的106例NSCLC患者，采用简单随机法等比例分配至对照组与治疗组，每组各53例。对照组进行GP化疗（4周期疗法），静脉滴注注射用盐酸吉西他滨1 000～1 250 mg/m²，30 min/次，第1、8天给药，且静脉滴注注射用顺铂75 mg/m²，每周第1、2天给药，21 d为1个周期，连续化疗4个周期。治疗组在对照组基础上口服参莲胶囊，6粒/次，3次/d，化疗期间均服用。观察患者的客观缓解率（ORR）和疾病控制率（DCR），对比两组患者治疗前后的Piper疲乏修订量表、卡氏功能状态（KPS）评分、血清肿瘤标志物[细胞角蛋白19片段21-1（CYFRA21-1）、癌胚抗原（CEA）、神经元特异性烯醇化酶（NSE）和鳞状上皮细胞癌抗原（SCCA）]、免疫功能指标[白细胞分化抗原（CD）3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺和自然杀伤细胞（NK）]和不良反应发生率。结果 治疗组的ORR（64.15%）和DCR（88.68%）均明显高于对照组的41.51%、67.92%（P＜0.05）。与治疗前相比，两组Piper疲乏量表各维度和总分均明显降低，而KPS评分显著升高（P＜0.05），且治疗组的Piper疲乏量表各维度和总分均明显低于对照组，而KPS评分显著高于对照组（P＜0.05）。治疗后，两组血清CYFRA21-1、CEA、NSE、SCCA水平均较治疗前出现明显下调（P＜0.05），且治疗组的上述血清肿瘤标志物水平显著低于对照组（P＜0.05）。治疗后，两组外周血CD3⁺、CD4⁺、CD4⁺/CD8⁺和NK细胞比例均明显低于治疗前，而CD8⁺水平显著高于治疗前（P＜0.05），且治疗组治疗后免疫功能指标的改善程度显著优于对照组（P＜0.05）。治疗组的不良反应总发生率（26.42%）明显低于对照组（45.28%）。结论 参莲胶囊联合GP化疗方案，可显著提升NSCLC患者的临床干预效果，改善癌性疲劳和生活质量，下调血清肿瘤标志物水平，改善免疫抑制状态，不良反应减少。

Objective To investigate the clinical efficacy of Shenlian Capsules combined with GP chemotherapy regimen in treatment of advanced non-small cell lung cancer (NSCLC). Methods A total of 106 patients with NSCLC admitted to the First Affiliated Hospital of Henan University from March 2023 to March 2025 were enrolled. The patients were equally assigned to the control group and the treatment group by simple random sampling, with 53 cases in each group. The control group received 4 cycles of GP chemotherapy. Gemcitabine Hydrochloride for injection was intravenously infused at a dosage of 1 000 — 1 250 mg/m² over 30 minutes on days 1 and 8 of each cycle. Cisplatin for injection was administered intravenously at 75 mg/m² on days 1 and 2. One treatment cycle lasted 21 days, and chemotherapy was conducted for 4 consecutive cycles. On the basis of the chemotherapy regimen used in the control group, patients in the treatment group were po administered with Shenlian Capsules, 6 capsules per time, three times daily throughout the chemotherapy period. The objective response rate (ORR) and disease control rate (DCR) were observed. The two groups were compared regarding the Revised Piper Fatigue Scale scores, Karnofsky Performance Status (KPS) scores, serum tumor markers[cytokeratin 19 fragment 21-1 (CYFRA21-1), carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), squamous cell carcinoma antigen (SCCA)], immune function indicators[cluster of differentiation (CD)3⁺, CD4⁺, CD8⁺, CD4⁺/CD8⁺ ratio, and natural killer (NK) cells], as well as the incidence of adverse reactions before and after treatment. Results The ORR (64.15%) and DCR (88.68%) of the treatment group were remarkably higher than those of the control group (41.51% and 67.92%, respectively) (P < 0.05). Compared with baseline, all dimensional scores and total score of the Piper Fatigue Scale were markedly decreased, whereas KPS scores were obviously elevated in both groups (P < 0.05). The dimensional and total Piper Fatigue Scale scores in the treatment group were significantly lower, while its KPS score was markedly higher than those in the control group (P < 0.05). After treatment, serum levels of CYFRA21-1, CEA, NSE and SCCA were significantly downregulated in both groups (P < 0.05), and these serum tumor marker levels in the treatment group were notably lower than in the control group (P < 0.05). Post-treatment peripheral blood proportions of CD3⁺, CD4⁺, CD4⁺/CD8⁺ ratio and NK cells were significantly reduced, while CD8⁺ levels were increased compared with pretreatment values in both groups (P < 0.05). The improvement of immune function indicators in the treatment group was superior to that in the control group (P < 0.05). The overall incidence of adverse reactions in the treatment group was 26.42%, which was distinctly lower than 45.28% in the control group. Conclusion Shenlian Capsules combined with the GP chemotherapy regimen can markedly enhance clinical therapeutic efficacy in patients with NSCLC, relieve cancer-related fatigue, improve quality of life, reduce serum tumor marker levels, ameliorate the immunosuppressive state, and lower the incidence of adverse reactions.

R974;R979.1

河南省医学科技攻关计划联合共建项目（LHGJ20210573）