Efficacy And Safety Of Compound Yiren-tongfeng Capsule To Patients With Primary Hyperuricemia

Objective:The aim of this trial was to evaluate the efficacy and safety of compound yiren-tongfeng capsule in patients with primary hyperuricemia by observing the changes of serum uric acid (SUA), insulin resistance index (HOMA-IR), high-sensitivity C-reactive protein (hs-CRP), plasma lipids and other indicators before and after treatment.Methods:A randomized, placebo-controlled, bouble-blind trial was conducted in 83 patients met the preliminary criteria.83 cases were randomly divided into two groups:41 patients were regarded as treatment group,42 patients as control group. Experimental observation time was 17 weeks, including 1-week washout period,8-week treatment period and 8-week follow-up period. During the treatment period, subjects had received therapeutic agent in treatment group or placebo in control group, three pills, three times a day for 8 weeks on the basis of life-style intervention. During follow-up period, two groups adhered to life-style intervention and withdrawed drug. The changes of serum uric acid, insulin resistance index HOMA-IR, inflammatory hs-CRP, plasma lipids were compared before and after 8-week treatment for both groups and adverse drug reactions were simultaneously observed to evaluate the drug safety. During 8 weeks follow-up continuously after drug withdrawal, long-time adverse reactions of compound yiren-tongfeng capsule were observed to evaluate the safety of medicine and flare of gout.Results:(1) A total of 83 patients were enrolled into the trial and 81 patients completed the 17-week trial with a withdraw rate of 2.41%. Two groups loss 1 case respectively. (2) Partial correlational analysis showed that SUA was positively correlated with HOMA-IR, hs-CRP in 83 patients with hyperuricemia (P<0.01). (3)After 8-week treatment, the levels of SUA, HOMA-IR, hs-CRP, TG, HDL-C of treatment group were reduced significantly than before treatment, and were proved statistically significant(P<0.05～0.01). In control group, there was also a significantly lower levels of serum uric acid after treatment than no treatment (P<0.05). After treatment, SUA level in treatment group was significantly lower than in control group (P<0.01), while there were statistics significant difference of HOMA-IR, hs-CRP, TG, HDL levels between treatment group and control group (P<0.05～0.01). (4)Analysis according to intention-to-treat (ITT) and per-protocol (PP) was conducted. In treatment group, the effective rates on the reducing SUA were 87.80% (ITT) and 87.50%(PP), while in control group, there were 54.76%(ITT) and 56.10%(PP). There was significant difference between the two groups (P<0.05). (5)In relation to pharmacological safety,3 adverse events, including dizziness (1 case), diarrhea (2 case) were observed in treatment group, and abdominal distension (1 case) in control group during 8-week treatment period. The incidence of adverse effects was 7.5% in treatment group compared with in 2.5% control group, but the difference of adverse effects in two groups had no statistical significance (P>0.05). After 8weeks of follow-up, adverse events and gout flare were not observed in either groups.Conclusions:Hyperuricemia is associated with insulin resistance and hs-CRP in patients with hyperuricemia. Compound yiren-tongfeng capsule caused significant reduction in SUA, hs-CRP and insulin resistance, plasma lipid, with few adverse effects. The study indicates that Compound yiren-tongfeng capsule has a good efficacy and safety profile.