非布索坦在国内上市了吗？

Allopurinol only inhibits reduced XOR, but has a significant inhibitory effect on both oxidized and reduced XOR, so its effect in reducing uric acid is more powerful and long-lasting; febuxostat can reduce the level of uric acid in the blood of gout patients with hyperuricemia. The dosage of febuxostat is 40 mg or 80 mg once a day, but this product is not recommended for gout patients without hyperuricemia. Today we will learn about whether febuxostat is available in the country?

Febuxostat was developed in Japan in 2004, and was approved for marketing by European EMEA in 2008, the US FDA in 2009, and the State Food and Drug Administration of China in 2013.

A phase III clinical trial compared the efficacy of this product (80 and 120 mg/d) with that of allopurinol (300 mg/d). A 1-year study of 760 patients showed that compared with the allopurinol group, more patients in the this product group achieved the main trial efficacy indicator - the sUA concentration was measured below 60 mg/L in the last 3 months (all subjects were gout patients, and the sUA concentration before the test were all above 80 mg/L); after 52 weeks of treatment, this product failed to significantly reduce the area of tophi (tophi is unique to gout) aggregates of urate crystals), but in the high-dose group in the early stages of the trial, this effect was more obvious; in each treatment group, patients with sUA concentrations reaching the target (<60 mg/L) were less likely to have gout attacks, and their tophi area was more significantly reduced; adverse reactions and their incidence rates were similar in each treatment group, including abnormal liver function, diarrhea, headache, joint-related signs and symptoms, and musculoskeletal/connective tissue symptoms.

Febuxostat was started at 10 mg/day for 2 weeks, then increased to 20 mg/day for 4 weeks, then to 40 mg/day. Starting with a low dose and gradually increasing the dose can prevent acute gout attacks caused by initial changes in blood uric acid levels. Treat with febuxostat 40 mg/day for 6 months, and check the uric acid level regularly. Generally, it takes 6 months to clean up excess blood uric acid in the body. 

After 6 months of treatment: (1) If the blood uric acid level remains between 240 umol/l and 360 umol/l, maintain febuxostat 40 mg/day treatment. (2) If the blood uric acid level is higher than 360 umol/l, increase the dose of fexostatin by 60 mg/day, up to a maximum of 80 mg/day, and monitor blood uric acid, liver and kidney function regularly. (3) If the blood uric acid level is lower than 240 umol/l, the dose of febuxostat can be reduced to 20 mg/day and the treatment can be maintained for 6 months.

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