| 引用本文:罗美1，张稚淳1，丁皓1，孙鑫2，芦殿荣3，郑智4，田同德5，杨璐1，陈信义1，田劭丹1.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[J].世界中医药,2023,(10):. |
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| 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 |
| 投稿时间：2021-11-29 |
| DOI：10.3969/j.issn.1673-7202.2023.10.014 |
| 中文关键词: 中医 肺癌 表皮生长因子受体酪氨酸激酶抑制剂 肠胃舒胶囊 腹泻 不良反应 香连片 |
| English Keywords:TCM Lung cancer Epidermal growth factor receptor-tyrosine kinase inhibitor Changweishu Capsules Diarrhea Adverse reactions Xianglian Tablets |
| 基金项目:国家科技重大专项项目-重大新药创制专项（2019ZX09201004-002-001） |
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| 中文摘要: |
| 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。 |
| English Summary: |
| 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. |
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