复方阿嗪米特治疗化疗后食欲减退的前瞻性随机交叉研究

Prospective,Randomized and Cross-Over Pilot Study of Compound Azintamide in the Treatment of Anorexia After Chemotherapy

目的:探讨复方阿嗪米特对化疗患者食欲减退的预防及治疗作用。方法:选取2021年11月至2022年6月广西医科大学第一附属医院收治的60例非消化道肿瘤患者,首先以随机数字表法分为A组(n=30)和B组(n=30),因为失访或未完成研究脱落18例,最终纳入统计分析的患者为42例,其中A组21例、B组21例。采用自身交叉对照。A组患者第1周期化疗服用复方阿嗪米特,第2周期化疗不服用,B组相反。所有患者以接受化疗后服用复方阿嗪米特的周期作为用药组,接受化疗后未服用复方阿嗪米特的周期作为未用药组,观察用药组和未用药组患者的食欲减退率及食欲减退恢复时间,厌食/恶病质治疗的功能评估(FAACT)量表评分及视觉模拟评分(VAS),恶心呕吐功能性生活指数(FLIE)及欧洲肿瘤研究与治疗组织生存质量问卷(EORTC-QLQ-C30)评分的变化。结果:用药组患者的食欲恢复时间显著短于未用药组,差异有统计学意义[(3.0±3.3)d vs.(6.3±5.8)d,P<0.05];在治疗周期中,用药组患者第7日的FAACT评分高于未用药组,差异有统计学意义[(36.0±6.4)分vs.(30.5±8.7)分,P<0.05];而与治疗前的FAACT评分相比,在经过1周的治疗后,用药组患者的FAACT评分仅降低了(0.9±7.8)分,未用药组患者的FAACT评分降低了(6.1±9.9)分,差异有统计学意义(P<0.05)。从FLIE评分来看,用药组患者的评分均较未用药组评分低,差异有统计学意义[(19.6±2.0)分vs.(25.6±5.9)分,P<0.05]。在培美曲塞联合铂类药物化疗亚组中,用药组患者的食欲减退率显著低于未用药组,差异有统计学意义[58.8%(10/17)vs.88.9%(16/18),P<0.05]。结论:复方阿嗪米特能够安全、有效地预防和治疗化疗引起的食欲减退,缩短患者食欲恢复所需时间,尤其是对接受培美曲塞联合铂类药物化疗的患者,且依从性良好。

OBJECTIVE:To probe into the preventive and therapeutic effects of compound azintamide in the treatment of anorexia in patients undergoing chemotherapy.METHODS:Totally 60 patients with non-digestive tract tumors admitted into the First Affiliated Hospital of Guangxi Medical University from Nov.2021 to Jun.2022 were extracted.All patients were divided into the group A(n=30)and group B(n=30)by the random number table method,18 patients dropped out due to lost to follow-up or did not complete the study,and 42 patients were finally enrolled in the statistical analysis.There were 21 patients in the group A and 21 patients in group B.Self-cross-over control method was adopted.Patients in group A received compound azinomide in the first cycle of chemotherapy,but not in the second cycle of chemotherapy,and group B received the opposite treatment.Patients who took compound azintamide after chemotherapy were taken as the medicated group,and without compound azintamide as non-medicated group.The rate of anorexia,recovery time of anorexia,functional assessment of anorexia/dysoxia therapy(FAACT)scale,visual analogue scale(VAS),functional life index for nausea and vomiting(FLIE),and European organization for research and treatment of oncology quality of life questionnaire(EORTC-QLQ-C30)were observed.RESULTS:The time of appetite recovery in medicated group was significantly shorter than that in non-medicated group[(3.0±3.3)d vs.(6.3±5.8)d,P<0.05].During the treatment cycle,the FAACT score in the medicated group on the 7th day was higher than that in non-medicated group[(36.0±6.4)points vs.(30.5±8.7)points,P<0.05].Compared with the FAACT score before treatment,after one week of treatment,the FAACT score in the medicated group decreased by(0.9±7.8)points,and in non-medicated group decreased by(6.1±9.9)points,with statistically significant differences(P<0.05).In terms of FLIE scores,the scores in the medicated group were lower than those in the non-medicated group,with statistically significant difference[(19.6±2.0)points vs.(25.6±5.9)points,P<0.05].In addition,in the subgroup of pemetrexed combined with platinum chemotherapy,the rate of anorexia in the medicated group was significantly lower than that in the non-medicated group,with statistically significant differences[58.8%(10/17)vs.88.9%(16/18),P<0.05].CONCLUSIONS:Compound azintamide is safe and effective in the prevention and treatment of chemotherapy-induced anorexia,shortening the recovery time of anorexia,especially for patients receiving pemetrexed combined with platinum chemotherapy,with good compliance.