基因多态性分型对复方土茯苓颗粒治疗高尿酸血症患者的降尿酸疗效影响研究

Study on Influence of Gene Polymorphism Genotyping on Uric Acid Reducing Effect in Hyperuricemia Patients Treated by Compound Tufuling Granules

【目的】观察基因多态性分型对复方土茯苓颗粒治疗高尿酸血症患者的降尿酸疗效影响。【方法】将80例高尿酸血症患者随机分为试验组和对照组,每组各40例。试验组给予复方土茯苓颗粒治疗,对照组给予西药别嘌醇片治疗,疗程为8周。观察2组患者治疗前后血尿酸水平的变化情况,评价2组患者的中西医疗效及安全性,并采用Logistic回归分析方法评价基因多态性分型对2组患者降尿酸疗效的影响。【结果】(1)研究过程中,治疗组脱落1例,对照组无脱落病例,最终治疗组39例、对照组40例患者完成试验。(2)试验组的血尿酸达标率和中医证候疗效总有效率均为82.05%(32/39),对照组均为87.50%(35/40),组间比较,差异均无统计学意义(P>0.05)。(3)治疗后,2组患者血尿酸水平均治疗前明显降低(P<0.05),但治疗后组间比较,差异无统计学意义(P>0.05)。(4)Logistic回归分析结果表明,各基因分型对2组疗效的影响差异均无统计学意义(P>0.05)。(5)试验组的肝肾功能副作用发生率均低于对照组,但组间比较,差异均无统计学意义(P>0.05)。【结论】复方土茯苓颗粒可明显降低高尿酸血症患者的血尿酸水平,且其安全性高于别嘌醇片,而基因多态性分型对疗效无明显影响。

Objective To observe the influence of gene polymorphism genotyping on the clinical efficacy of reducing uric acid in hyperuricemia patients treated by Compound Tufuling Granules. Methods Eighty patients with hyperuricemia were randomly divided into trial group and control group,40 cases in each group. The trial group was treated with Compound Tufuling Granules,while the control group was treated with western medicine Allopurinol Tablets for 8 weeks. Before and after treatment, the blood uric acid level in the two groups was observed,and the clinical efficacy and safety of Chinese medicine and Western medicine in the two groups were also evaluated. Logistic regression analysis was used to analyze the influence effects of gene polymorphism typing on the clinical efficacy of reducing uric acid in hyperuricemia patients of the two groups. Results(1)During the trial,one cases from the trial group dropped out while none case from the control group dropped out,and finally a total of39 cases in the trial group and all of the 40 cases in the control group completed the trial.(2)After treatment,the rate of serum uric acid reaching the standard and total effective rate for the traditional Chinese medicine syndrome in the trial group were all 82.05%(32/39),and those in the control group were all 87.50%(35/40). The intergroup comparison showed that the difference was not statistically significant(P>0.05).(3)After treatment,the serum uric acid level in both groups was significantly lower than that before treatment(P < 0.05). But there was no significant difference in uric acid value between the two groups after treatment(P>0.05).(4)The Logistic regression analysis results showed that genotypes of the gene polymorphism had no significant effect on the clinical efficacy of the two groups(P>0.05).(5)The incidences of side effects on the hepatic and renal function in the trial group were lower than that in the control group,but the difference between the two groups was not statistically significant(P>0.05). Conclusion Compound Tufuling Granules can significantly reduce the level of serum uric acid of hyperuricemia patients, and their safety is higher than that of western medicine Allopurinol Tablets.Genotyping of gene polymorphisms has no significant effect on the clinical efficacy of the medicine for the treatment of hyperuricemia patients.