肠胃舒胶囊控制肺癌表皮生长因子受体-酪氨酸激酶抑制剂相关腹泻疗效观察

Effect of Changweishu Capsules on EGFR-TKI-Associated Diarrhea in Lung Cancer Patients

目的:观察肠胃舒胶囊对肺癌患者服用表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKIs)导致腹泻相关症状控制疗效与用药安全性。方法:采用前瞻性、随机对照、多中心临床试验方法,按照2∶1比例设计,采用信封法随机将103例非小细胞肺癌服用EGFR-TKIs导致腹泻的患者分为观察组与对照组。观察组与对照组分别给予肠胃舒胶囊或香连片连续治疗2周后,统计腹泻症状控制疗效与用药安全性。结果:2组病例总体症状积分治疗前后组内比较,与治疗前减治疗后差值的平均值组间比较,差异有统计学意义(P=0.008),肠胃舒胶囊组总体症状积分控制优于香连片组。而2组总体症状疗效比较差异无统计学意义(P=0.063)。2组病例治疗后单项症状积分分别与治疗前比较,差异均有统计学意义(均P<0.001)。2组病例治疗前减治疗后差值的平均值组间比较,腹泻、食少2项症状差异有统计学意义(P=0.024,P=0.009),肠胃舒胶囊组优于香连片组。2组病例单项症状疗效比较,在腹泻、腹胀、食少3项症状控制疗效方面,差异有统计学意义(P=0.019,P=0.034,P=0.005),肠胃舒胶囊组优于香连片组。肠胃舒胶囊组在腹泻3级时症状积分控制优于香连片组(P=0.034)。结论:肠胃舒胶囊对于肺癌患者服用EGFR-TKIs导致腹泻相关症状控制具有满意临床疗效,且患者服药依从性好,无不良反应,值得临床推广应用。

Objective:To evaluate the efficacy and safety of Changweishu Capsules in the treatment of epidermal growth factor receptor(EGFR)-tyrosine kinase inhibitor(TKI)-associated diarrhea in lung cancer patients.Methods:A multicenter prospective randomized controlled clinical trial was conducted,in which 103 non-small cell lung cancer patients with diarrhea caused by EGFR-TKI were randomized into an observationn group and a control group by the closed-envelope method at the ratio of 2:1.The patients in the observation and control groups were administrated with Changweishu Capsules and Xianglian Tablets,respectively,for 2 weeks.The safety and efficacy indicators were measured.Results:The traditional Chinese medicine(TCM)syndrome score showed significant differences between before and after treatment,and the observation group outperformed the control group(P=0.008).The clinical response showed no difference between the two groups(P=0.063).The symptom scores changed significantly after treatment(P<0.001).The differences of diarrhea(P=0.024)and anorexia(P=0.009)between before and after treatment varied between the two groups.In addition,the observation group outperformed the control group in mitigating diarrhea(P=0.019),abdominal distension(P=0.034),and anorexia(P=0.005).The observation group was superior to the control group in treating the grade 3 diarrhea(P=0.034).Conclusion:Changweishu Capsules demonstrated good efficacy with good patient compliance and no adverse reactions for EGFR-TKI-associated diarrhea symptoms in lung cancer patients,being worthy of clinical application and promotion.