中医辨证方剂序贯非布司他治疗症状性高尿酸血症患者的疗效及安全性分析

The efficacy and safety of TCM syndrome differentiation prescription plus sequential febuxostat on symptomatic hyperuricemia

目的:探讨中医辨证方剂序贯非布司他治疗症状性高尿酸血症患者的疗效及安全性。方法:收集2018年1月-2020年1月肇庆市第二人民医院收治的伴有痛风症状的高尿酸血症患者98例,随机分为两组,各49例。两组患者均给予生活方式指导,西药组予非布司他,酌情加用双氯芬酸钠肠溶片止痛。序贯组根据患者症状结合整体理念进行辨证论治,运用利水渗湿药、清热药和补虚药的相关方剂结合非布司他序贯治疗,并根据每个患者的不同情况调整用药方案。结果:两组患者治疗1个月及3个月后尿酸水平与治疗前相比均有不同程度的下降,且差异均有统计学意义(P<0.05);治疗1个月及治疗3个月后血肌酐、肌钙蛋白-T及丙氨酸氨基转移酶(Alanine Aminotransferase,ALT)与治疗前相比差异无统计学意义(P>0.05)。治疗1个月及3个月后炎症因子白细胞介素-6(Interleukin-6,IL-6)和肿瘤坏死因子-α(Tumor Necrosis Factor-α,TNF-α)较治疗前下降,其中治疗3个月后的炎症因子水平与治疗前的差异有统计学意义(P<0.05)。C反应蛋白(C-reactive Protein,CRP)水平在治疗1个月及3个月后与治疗前相比均下降明显,且治疗3个月后CRP水平与治疗1个月后的差异有统计学意义(P<0.05)。两组治疗过程中肝肾功能、心肌酶、泌尿系超声及心脏彩超均未出现明显异常,西药组有2例出现不良反应。序贯组未出现不良反应。结论:非布司他及中药方剂在高尿酸痛风患者治疗上具有协同作用,均能有效降低血尿酸、炎症因子水平及减轻关节疼痛等症状,用药安全性好。中药方剂可减少非布司他的用量,并能维持血尿酸的降低程度,改善临床症状,但仍需较长时间的临床实践积累来形成理论体系,从而推广应用。

Objective:To investigate the efficacy and safety of TCM syndrome differentiation prescription plus sequential febuxostat on symptomatic hyperuricemia.Methods:98 hyperuricemia patients with gout symptoms from January 2018 to January 2020 were randomly divided into two groups,49 cases in each.Two groups were given lifestyle guidance,the Western medicine group was given febuxostat,and diclofenac sodium enteric-coated tablets were applied appropriately to relieve pain.The sequential group was given TCM syndrome differentiation and treatment according to the patients’symptoms and the overall concept.The related prescriptions of diuretic medicine,heat-clearing medicine,and tonifying medicine were applied,febuxostat sequential treatment was given at the same time,and medication plan was adjusted according to the different conditions of each patient.Results:Compared with before treatment,the uric acid level in the two groups were decreased in varying degrees after 1 month and 3 months of treatment,and the differences were statistically significant(P<0.05).The serum creatinine,troponin-T and ALT levels after 1 month and 3 months of treatment were not statistically different from before treatment(P>0.05).Compared with before treatment,the levels of inflammatory factors IL-6 and TNF-αwere decreased after 1 month and 3 months of treatment,and the inflammatory factor levels after 3 months of treatment were significantly different from those before treatment(P<0.05).Compared with before treatment,the CRP level after 1 month and 3 months of treatment was decreased significantly,and the CRP level after 3 months of treatment was significantly different from that after 1 month of treatment(P<0.05).There was no obvious abnormality in liver and kidney function,myocardial enzymes,urinary system ultrasound and cardiac color ultrasound during the treatment in the groups.There were 2 cases of adverse reactions in the Western medicine group,and there was no adverse reaction in the sequential group.Conclusion:Febuxostat sequential treatment plus TCM formula shows synergistic effect on hyperuricemia patients with gout.They both can effectively reduce the levels of serum uric acid and inflammatory factors,and relieve joint pain of patients,with good safety.TCM formula can reduce the dosage of febuxostat,maintain the decrease of serum uric acid,and relieve clinical symptoms of patients,but it still needs a long time to accumulate clinical practice to form a theoretical system,so as to promote the application.