荷芪散联合非布司他治疗高尿酸血症伴胰岛素抵抗的临床研究

Clinical Observation of Heqi Powder Combined with Febuxostat in Treating Hyperuricemia with Insulin Resistance

[目的]探讨荷芪散联合非布司他治疗痰湿瘀浊型高尿酸血症(HUA)伴胰岛素抵抗(IR)的临床疗效.[方法]将42例痰湿瘀浊型HUA伴IR患者随机分为观察组和对照组,每组各21例.对照组给予非布司他片治疗,观察组在此基础上给予中药荷芪散加味治疗,疗程3个月并随访3个月.观察2组患者治疗前后中医证候积分、血尿酸(UA)、血肌酐(Scr)、尿素(UREA)、C反应蛋白(CRP)、腰围、空腹血糖(FPG)、空腹胰岛素(FINS)及胰岛素抵抗指标[稳态模型评价胰岛素抵抗指数(HOMA-IR)、胰岛素敏感指数(ISI)]的变化情况,并评价2组疗效及安全性.[结果](1)治疗3个月后,观察组的总有效率为95.2%,对照组为81.0%,观察组的疗效优于对照组(P<0.05).(2)治疗后,2组患者的中医证候积分均较治疗前明显降低(P<0.01),且观察组对中医证候积分的降低作用明显优于对照组(P<0.05).(3)治疗后,2组患者血清UA、Scr、CRP水平均明显降低(P<0.05),且观察组对血清UA、Scr、CRP水平的降低作用明显优于对照组(P<0.05),而UREA水平2组治疗前后及组间比较,差异均无统计学意义(P>0.05).(4)治疗后,2组患者FPG、FINS、HOMA-IR均较治疗前降低,ISI的自然对数(InISI)均较治疗前升高(P<0.05),且观察组对FPG、FINS、HOMA-IR的降低作用和对InISI的升高作用均优于对照组(P<0.05).(5)治疗后,观察组患者腰围较治疗前减小(P<0.05),而对照组变化不明显(P>0.05),观察组对腰围的减小作用优于对照组(P<0.05).(6)治疗期间和治疗结束后的3个月随访,2组患者均未见明显的不良反应.[结论]应用荷芪散加味联合非布司他治疗痰湿瘀浊型HUA伴IR患者的疗效确切,可较好地改善患者临床症状和胰岛素抵抗,调节血尿酸及胰岛素水平,并可有效降低机体炎症反应,其疗效优于单用非布司他.

Objective To investigate the clinical efficacy of Heqi Powder combined with Febuxostat in the treatment of hyperuricemia(HUA)complicated with insulin resistance(IR)and with phlegm-dampness stasis turbidity syndrome.Methods Forty-two HUA-IR patients with phlegm-dampness stasis turbidity syndrome were randomly divided into observation group and control group,21 cases in each group.The control group was treated with Febuxostat Tablets,and the observation group was treated with Heqi Powder combined with Febuxostat Tablets.Both groups were treated for 3 months and were followed up for 3 months.The changes of traditional Chinese medicine(TCM)symptom scores,serum uric acid(UA),serum creatinine(Scr),urea(UREA),C-reactive protein(CRP),waist circumference,fasting plasma glucose(FPG),fasting insulin(FINS)and insulin resistance index(ISI)evaluated with homeostatic model assessment for insulin resistance(HOMA-IR)were observed and compared between the two groups before and after treatment.Meanwhile,the clinical efficacy and safety of the two groups were also observed.Results(1)After 3 months of treatment,the total clinical effective rate of the control group(81.0%)was significantly lower than that of the treatment group(95.2%),and the difference between the two groups was statistically significant(P<0.05).(2)After treatment,TCM symptom scores of the two groups were significantly lower than those before treatment(P<0.01),and the improvement of TCM syndrome scores of the observation group was superior to that of the control group(P<0.01).(3)After treatment,the levels of UA,Scr,and CRP in the two groups were markedly decreased(P<0.05 compared with those before treatment),and the decrease of UA,Scr,and CRP in the observation group was superior to that in the control group(P<0.05).However,the difference of UREA in the two groups before and after treatment as well as the inter-group difference after treatment was insignificant(P>0.05).(4)After treatment,FPG,FINS and HOMA-IR in the two groups were markedly decreased and the natural logarithm of ISI(InISI)was increased(P<0.05 compared with those before treatment),and the decrease of FPG,FINS and HOMA-IR as well as the increase of InISI in the observation group was superior to that in the control group(P<0.05).(5)After treatment,the waist circumference in the observation group was decreased(P<0.05 compared with that before treatment)while the change of waist circumference in the control group was mild(P>0.05),and the decrease of waist circumference in the observation group was superior to that in the control group(P<0.05).(6)During the treatment and 3-month follow-up,no obvious adverse reaction was found in the two groups.Conclusion The combination of Heqi Powder and Febuxostat can improve the clinical symptoms and insulin resistance of HUA-IR patients with phlegm-dampness stasis turbidity,regulate the levels of serum uric acid and insulin,and effectively reduce the inflammatory reaction of the body.Its efficacy is stronger than that of Febuxostat alone.