【摘要】 目的：观察益气养阴病证结合辨治晚期肺腺癌表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）靶向治疗相关症状群的影响。方法：采用多中心、随机对照、双盲试验设计，收集拟接受EGFR-TKI靶向治疗的晚期肺腺癌患者451例，随机分为两组，最后纳入分析病例354例，试验组（中药+EGFR-TKI）185例和对照组（安慰剂+EGFR-TKI）169例。观察治疗前后中医证候总分、各症状评分及不良反应发生率。结果：治疗3、5、7个月时，试验组总有效率（65.79%、73.53%、77.78%）显著优于对照组（45.83%、48.39%、49.04%）(P<0.01)。治疗7个月时，试验组较对照组咳嗽、咯痰、气短、乏力、失眠、腹泻症状群显著改善（P<0.05）；其中试验组总分、腹泻、乏力评分在各时间点均有显著改善（P<0.05,P<0.01）；试验组瘙痒、皮疹发生率较对照组显著减少（P<0.05,P<0.01）。结论：益气养阴病证结合诊疗方案可改善肺腺癌EGFR-TKI靶向治疗相关症状群，减少EGFR-TKI不良反应的发生。更多还原

【Abstract】 Objective: To observe the effects of herbal formula based on disease-syndrome combination of benefiting qi and nourishing yin on symptom clusters associated with epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI)targeted therapy in advanced lung adenocarcinoma. Methods: The study used a multicenter, randomized, controlled, double-blind trial design to collect 451 patients with advanced lung adenocarcinoma who would receive EGFR-TKI targeted therapy and were randomized into two groups, 354 cases who completed the protocol were included in the final analysis: 185 cases in the trial group(herbal formula+EGFR-TKI) and 169 cases in the control group(placebo+EGFR-TKI). The total score, each symptom scores of TCM syndrome scores, and the occurrence of adverse events were dynamically observed before and after treatment. Results: At 3, 5 and 7 months of treatment, the total effective rate of the trial group(65.79%, 73.53% and 77.78%) was significantly better than that of the control group(45.83%, 48.39% and 49.04%)(P<0.01). At 7 months of treatment, the symptoms clusters of cough,sputum, shortness of breath, fatigue, insomnia and diarrhea were significantly improved in the trial group compared with the control group(P<0.05); the total effect, diarrhea, and fatigue scores were statistically different in the trial group at all time points(P<0.05, P<0.01); pruritus and skin rash were significantly reduced in the trial group compared with the control group(P<0.05,P<0.01). Conclusion: The herbal formula based on disease-syndrome combination of benefiting qi and nourishing yin can effectively improve the symptoms associated with EGFR-TKI targeted therapy for lung adenocarcinoma and reduce the occurrence of EGFR-TKI-related adverse event.更多还原