扶正胶囊改善安罗替尼治疗相关癌因性疲乏临床研究

Clinical Research of Fuzheng Capsule Improving Cancer-Related Fatigue Induced by Anlotinib

目的:观察扶正胶囊改善安罗替尼治疗所致癌因性疲乏的临床疗效。方法:选取满足标准的50例患者,随机分为对照组和治疗组,每组各25例,治疗组在对照组基础上加用扶正胶囊,连续观察2疗程(共计6周)。结果:治疗组改善疲乏症状及减轻临床症状疗效更佳(P<0.05)。治疗组相较于对照组能够在一定程度上提高患者的KPS评分,提高生活质量(P<0.05);治疗组较对照组在CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)的改善方面更优(P<0.05)。对照组及治疗组患者的肝肾功能在治疗前后差异均无统计学意义,说明药物安全性高(P>0.05)。结论:扶正胶囊对患者疲乏等级的降低更有疗效;能减轻患者的中医证候及功能状态;能增加患者的机体免疫能力,且不良反应少,使用安全性高,值得临床推广及进一步研究。

Objective:To observe the clinical curative effect of Fuzheng capsule in improving cancer-related fatigue caused by Anlotinib Hydrochloride.Methods:In this study,50 patients who conformed to the inclusion and exclusion criteria were divided into the control group and the treatment group randomly,with 25 cases in each group.Fuzheng capsule was added to the treatment group on the basis of the control group.Two courses of treatment were observed consecutively(6 weeks).Results:In terms of improving fatigue symptoms and relieving clinical symptoms,the treatment group had better efficacy(P<0.05).In terms of improving the quality of life,compared with the control group,the treatment group could improve the patients'KPS score and the quality of life to a certain extent(P<0.05).In terms of CD immune cell test,the treatment group was better in the improvement of CD3^(+),CD4^(+)and CD4^(+)/CD8^(+)than the control group(P<0.05).In terms of safety indexes,there were no significant differences in liver function and renal function between the control group and the treatment group before and after treatment,indicating high safety(P>0.05).Conclusion:In terms of fatigue symptoms,it was more effective to reduce the fatigue level of patients;In terms of TCM symptoms and functional state,it can reduce the clinical symptoms of patients and improve the functional state of patients;In terms of immune status,the immune capacity of patients can be increased;In terms of drug safety,there are few adverse reactions and high safety,which is worthy of clinical promotion and further study.