调中益气汤加味治疗非小细胞肺癌表皮生长因子受体-酪氨酸激酶抑制剂相关腹泻脾气亏虚证的临床研究

Clinical study on modified TiaozhongYiqi Decoction on non-small cell lung cancer with epidermal growth factor receptor-tyrosine kinase inhibitor-associated diarrhea of spleen deficiency syndrome

目的观察调中益气汤加味治疗非小细胞肺癌(NSCLC)表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKI)相关腹泻脾气亏虚证的临床疗效。方法将70例NSCLC EGFR-TKI相关腹泻脾气亏虚证患者按照随机数字表法分为2组,治疗组35例予调中益气汤加味治疗,对照组35例予参苓白术颗粒治疗,2组均7天为1个疗程,治疗2个疗程。比较2组腹泻疗效;比较2组中医证候疗效;比较2组治疗前后中医症状评分变化;比较2组Karnofsky功能状态评分(KPS)变化;观察2组腹泻复发情况。结果治疗组腹泻总有效率91.43%(32/35),对照组腹泻总有效率77.14%(27/35),治疗组腹泻疗效优于对照组(P<0.05)。治疗组中医证候总有效率91.43%(32/35),对照组中医证候总有效率68.57%(24/35),治疗组中医证候疗效优于对照组(P<0.05)。除对照组面色萎黄评分外,2组治疗后其余症状评分均较本组治疗前改善(P<0.05)。治疗组治疗后除食后腹胀评分外,其余症状均较对照组改善(P<0.05)。2组治疗后KPS评分比较差异有统计学意义(P<0.05),治疗组优于对照组。治疗组复发率12.50%(4/32),对照组复发率37.04%(10/27),治疗组腹泻复发率低于对照组(P<0.05)。结论调中益气汤加味治疗NSCLC EGFR-TKI相关腹泻脾气亏虚证,能改善患者腹泻症状及其他中医症状,提高体力状况,降低腹泻复发率,疗效确切。

Objective To observe the clinical efficacy of modified TiaozhongYiqi Decoction in the treatment of non-small cell lung cancer(NSCLC)with epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI)-associated diarrhea of spleen deficiency syndrome.Methods Seventy NSCLC patients with EGFR-TKI-associated diarrhea of spleen deficiency syndrome were randomized 1∶1 to receive modified TiaozhongYiqi Decoction(the treatment group)or ShenlingBaizhu Granules(the control group).Two courses of treatment were conducted in the both groups(7 days for a course of treatment),aiming to compare the curative effect of diarrhea and traditional Chinese medicine(TCM)symptom,the changes in the scores of TCM symptom and Karnofsky performance status(KPS),and recurrence rate of diarrhea between groups before and after treatment.Results The curative effect of diarrhea in the treatment group was better than that in the control group(91.43%[32/35]vs 77.14%[27/35],P<0.05).The curative effect of TCM syndromes in the treatment group was superior to the control group(91.43%[32/35]vs 68.57%[24/35],P<0.05).The control group showed improvement in all other symptoms scores after treatment except for the score of sallow complexion(P<0.05),while the treatment group improved after treatment except for the score of postprandial abdominal distension(P<0.05).There was significant difference in KPS score in the both groups between before and after treatment(P<0.05),and which was better in the treatment group than the control group(P<0.05).The recurrence rate of diarrhea in the treatment group was significantly lower than that in the control group(12.50%[4/32]vs 37.04%[10/27],P<0.05).Conclusion For NSCLC patients with EGFR-TKI-associated diarrhea of spleen deficiency syndrome,modified TiaozhongYiqi Decoction can improve the physical condition,and reduce the recurrence rate of diarrhea,and with a definite curative effect.