自拟消疹方改善EGFR-TKI相关皮疹的临床对照研究

A Clinical Controlled Study of Self-made Xiaozhen Formula on EGFR-TKI-related Rash

目的本临床研究是为初步评估自拟消疹方对表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor tyrosinekinase inhibitors,EGFR-TKIs)相关皮疹的临床疗效。方法以益气养阴,凉血解毒为基本治则出发,观察肺癌口服EGFR-TKI相关皮疹患者64例。以计算机区组法分为对照组和治疗组各32例,对照组出现皮疹后当日即开始使用红霉素软膏外涂,每日2次,14天为一个疗程,总治疗两个疗程(28天)。治疗组患者则以养阴润肺、凉血解毒为基本治则,在使用靶向药物出现皮疹后当日即开始外用红霉素软膏加内服自拟消疹方,红霉素使用方法同对照组,内服消疹方每日口服1剂,分3次口服,14天为一个疗程,总治疗两个疗程。观察两组皮疹程度分级变化、生活质量评分变化及中医证候评分变化。结果治疗结束后,两组的中医证候积分、生活质量评分均较治疗前明显改善;两组患者经治疗后中医证候评分、生活质量评分组间比较也有显著差异,治疗组改善更明显;两组皮疹程度分级均较治疗前下降,且组间比较有显著性差异,治疗组改善程度更明显(P=0.039)。结论以养阴润肺、凉血解毒为基本治法制定的消疹方对EGFR-TKI相关皮疹有较好临床疗效,能减轻此类皮疹的不良反应,使得患者的症状有所改善,生活质量得以提高,值得临床推广应用。

Objective To evaluate the effectiveness of Xiaozhen formula upon skin toxicity caused by epidermal growth factor receptor tyrosinekinase inhibitor(EGFR-TKI).Methods Basic on the principle of nourish Yin,moisten lung,cool blood and detoxify,we observe the 64 cases of lung cancer patients with EGFR-TKI related rash.Computerized randomization was used to randomly allocate patients.A total of 32 patients in the treatment group and 32 patients in the control group were collected.The control group began to use erythromycin ointment on the same day after the rash appeared,twice a dayfor 4 weeks.In the treatment group,the basic principle was to nourish Yin,moisten lung,cool blood and detoxify,they began to use erythromycin ointment plus to take oral self-made Xiaozhen formula on the same day after the rash appeared.The method of erythromycin was the same as that of control group.The Xiaozhen formula was orally taken 1dose daily(3 times a day)for 4 weeks.We observed the changes of rash grade,quality of life and TCM syndrome score in the two groups before and after treatment.Results The results of paired t test showed that the TCM syndrome scores and quality of life scores of the two groups were lower than before treatment.The results of Wilcoxon rank sum test showed that the rash severity of the two groups was lower than before treatment,and there were significant differences between the groups(P<0.05).Through independent t-test analysis,there was also a significant difference between the two groups of patients after treatment with TCM syndrome scores and quality of life scores(P<0.05).Conclusion The Xiaozhen formula which is based on the principles of nourishing Yin,moistening lung,cooling blood and detoxifying has a good effect on the rash caused by EGFR-TKI.It can reduce the adverse reactions of this kind of rash,relieve the symptoms of patients and improve the quality of life.It is worthy of clinical application.