Original Article Effect of febuxostat on reducing blood uric acid level and its drug action in patients with hyperuricemia
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Int J Clin Exp Med 2020;13(3):2016-2021 www.ijcem.com /ISSN:1940-5901/IJCEM0098558 Original Article Effect of febuxostat on reducing blood uric acid level and its drug action in patients with hyperuricemia Chunyan Yang1, Yanling Dai2, Xiaomin Guo3 Departments of 1Pharmacy, 2Laboratory, 3Nursing, Chuxiong Medical and Pharmaceutical College, Chuxiong, Yun- nan, China Received June 17, 2019; Accepted October 7, 2019; Epub March 15, 2020; Published March 30, 2020 Abstract: Objective: To explore the therapeutic performance of febuxostat and allopurinol in the treatment of hyper- uricemia. Methods: A total of 82 patients with hyperuricemia admitted to our hospital were enrolled in the study. According to a random number table, the patients were divided into the study group with febuxostat (n = 41) and the control group with allopurinol (n = 41). Six mL of fasting venous blood was taken from the two groups before treatment (T0), 2 months (T1), 4 months (T2), and 6 months after treatment (T3). The serum uric acid, blood urea, serum creatinine and urine nitrogen were detected by a fully automatic biochemical analyzer. The clinical efficacy and adverse reactions of the two groups were observed and analyzed. Results: There was no significant difference in the cure rate between the study group and the control group (P>0.050). However, the effective outcome in the study group was 53.66% (22 cases), which was higher than that (29.27%, 12 cases) in the control group (P = 0.025). The incidence of adverse reactions in the study group was lower than that in the control group (P = 0.023). There was no significant change in blood urea in the two groups (P>0.050). Uric acid, serum creatinine and urine nitrogen decreased with time in both groups. The uric acid, serum creatinine and urinary nitrogen levels in the two groups were highest at T0. The values at T2 were lower than that at T1, and the value at T3 was lower than that at T2 (P
The study of febuxostat’s effect
URAT1 can treat hyperuricemia better than tion or other serious complications; patients
allopurinol. Hu et al [15] showed that (E)-2-(4- with hemodialysis, peritoneal dialysis and kid-
bromophenyl)-1-(2,4-dihydroxyphenyl) ethyl ke- ney transplantation; patients with drug aller-
toxime is a potential therapeutic agent for gies, physical disability, mental illness or who
hyperuricemia. However, as the research has cannot take care of themselves; patients trans-
not been perfected, it is difficult to popularize ferred to other facilities.
in clinical practice.
Methods
Febuxostat is a newly developed xanthine oxi-
dase inhibitor. It not only has a strong inhibitory Both groups of patients were treated with rou-
effect on uric acid synthesis, but also has many tine hyperuricemia. Approach: under the low
elimination approaches. In addition, it has little purine diet, digoxin, diuretics, angiotensin-con-
side effects on patients [16]. At present, it has verting enzyme inhibitors/angiotensin receptor
been shown that febuxostat has a good thera- antagonists, β receptor blockers, and aldoste-
peutic effect on hyperuricemia [17]. However, rone receptor antagonists were administer-
the exact mechanism is not clear, and there is ed. For some patients with coronary heart dis-
still very little research in comparison with allo- ease, statins were used. On the basis of this,
purinol. This experiment provides a more accu- 40 mg/d of febuxostat (Jiangsu Hengrui
rate reference and guidance for clinical applica- Pharmaceutical Co., Ltd., GYZZ H20130081)
tion by comparing the usage of febuxostat and was administered in the research group of
allopurinol in the treatment of hyperuricemia. patients. The uric acid concentration was
observed. After 2 weeks of treatment, if the
Materials and methods uric acid levels still did not reach the normal
standard, the dosage was increased to 80 mg/
General methods time/d. Allopurinol (Guangdong PiDi Pharma-
ceutical Co., Ltd., GYZZ H44021368) was
A total of 82 patients with hyperuricemia admit- added to the control group based on the rou-
ted to Chuxiong Medical and Pharmaceutical tine treatment. The initial dose was 100 mg/
College were enrolled in the study. According to time/d. After 1 week of treatment, the dose
a random number table, the patients were was 100 mg/time, 2 times a day. After 3 weeks
divided into the study group with febuxostat (n of treatment, the dose was 100 mg/time, 3
= 41) and the control group with allopurinol (n = times a day. This dose is administrated until the
41). There were 36 males and 5 females in the end of the course of treatment. The total course
study group, aging from 49 to 69 years. The of treatment in both groups was 6 months. Six
average age was (53.27 ± 8.67) years. There mL of fasting venous blood was taken from the
were 34 males and 7 females in the control two groups before treatment (T0), 2 months of
group, aging from 50 to 69 years. The average treatment (T1), 4 months of treatment (T2), and
age was (53.84 ± 9.12) years old. This experi- 6 months of treatment (T3). It sat for 30 min-
ment was approved by the Ethics Committee of utes at room temperature, and then was centri-
Chuxiong Medical and Pharmaceutical College, fuged for 10 minutes (4,000 rpm). The upper
and all subjects signed informed consent. serum was collected. The serum uric acid,
blood urea nitrogen, serum creatinine and urine
Inclusion and exclusion criteria nitrogen were detected by a fully automatic bio-
chemical analyzer.
Inclusion criteria: Patients consistent with the
clinical manifestations of hyperuricemia [18]; Outcome measures
patients diagnosed as hyperuricemia by uric
acid examination: male >420 μmol/L, female For the clinical efficacy of treatment in the two
>360 μmol/L; patients with complete medical groups of patients, the hyperuricemia rehabili-
records; patients who were willing to cooperate tation guide was referred to [19]. Markedly
with the medical staff. effective: the patient’s clinical symptoms were
significantly improved, and the blood uric acid
Exclusion criteria: Patients with tumors or other indicator was completely normal; Effective: the
cardiovascular and cerebrovascular diseases; clinical symptoms were improved to some
patients with other chronic diseases; autoim- extent, and the blood uric acid was improv-
mune diseases, organ failure, kidney dysfunc- ed but did not reach the normal standard;
2017 Int J Clin Exp Med 2020;13(3):2016-2021The study of febuxostat’s effect
Table 1. General information [n (%)] (Beijing NDTimes Technology
Study group Control group Co., Ltd.). All the graphs were
T or X2 P drawn using Graphpad8 (Shen-
(n = 41) (n = 41)
Age 53.27 ± 8.67 53.84 ± 9.12 0.290 0.773 zhen Tianruiqi Software Tech-
BMI (cm/kg2) 24.12 ± 4.04 23.70 ± 4.12 0.466 0.642 nology Co., Ltd.) and a secon-
Course of disease (d) 8.42 ± 2.85 8.84 ± 3.16 0.632 0.529
dary proof was performed. The
enumeration data were expre-
Gender 0.391 0.532
ssed in the form of (rate), and
Male 36 (87.80) 34 (82.93)
the chi-square test was used
Female 5 (12.20) 7 (17.07)
for comparison between groups;
Smoking 1.123 0.289 the measurement data was ex-
Yes 38 (92.68) 35 (85.37) pressed in the form of (mean ±
No 3 (7.32) 6 (14.63) standard deviation), and the t-
Drinking 0.249 0.618 test was used for comparison
Yes 31 (75.61) 29 (70.73) between groups. The compari-
No 10 (24.39) 12 (29.27) son among multiple time points
Ethnicity 1.012 0.314 was conducted by Repeated
Han 40 (97.56) 41 (100.00) measure ANOVA with hoc post
Minority 1 (2.44) 0 (0.00) bonferroni test. P0.050), which shows that the two
uric acid level were not improved. groups were comparable (Table 1).
The response rate of the two groups of patients No significant differences in response rate
= (Markedly + effective)/total cases ×100%.
Drug safety in both groups: the adverse reac- There was no statistical significance in the re-
tions during the course of medication were sponse rate between the study group and the
compared between the two groups, including control group (P>0.050). There was no signifi-
rash, liver damage, and cytopenia. The inci- cant difference in the patients assessed with
dence of adverse reactions in the two groups ‘effective’ or ‘ineffective outcomes’ between
was calculated, including, rash, liver damage, the study group and the control group (P>
cytopenia, hyperlipidemia, gastrointestinal re- 0.050). However, the patients assessed with
actions, allergies, cardiovascular diseases, etc.
‘markedly effective’ in the study group was
The incidence of adverse reactions = the num-
53.66% (22 cases), which was higher than that
ber of patients with adverse reactions occurr-
(29.27%, 12 cases) in the control group (P =
ed/the total number of patients ×100%. The
biochemical indicators of the two groups were: 0.025) (Table 2).
serum uric acid, blood urea, serum creatinine
Patients in study group showed less adverse
and urine nitrogen at T0, T1, T2 and T3.
reactions
Statistical method
In the study group, cytopenia occurred in 1
All the experimental results were statistically patient (2.44%), gastrointestinal reaction oc-
calculated using SPSS 24.0 statistical software curred in 1 patient (2.44%), and the incidence
2018 Int J Clin Exp Med 2020;13(3):2016-2021The study of febuxostat’s effect
Table 2. Clinical efficacy [n (%)] was lower than that in the control
Study group Control group group (P0.050). The
uric acid and urine nitrogen in the
Effective 16 (39.02) 24 (58.54) 3.124 0.077
study group at T1, T2 and T3 were
Ineffective 3 (7.32) 5 (12.20) 0.554 0.457 lower than those in the control group
Response rate 92.68 87.80 0.554 0.457 (P0.050). Uric acid, serum the safety of febuxostat in the study group was
creatinine and urine nitrogen decreased with higher than that of the control group. Further
time. It was at the highest level at T0. The value comparison of biochemical indicators showed
at T2 was lower than that at T1, and the value there was no significant difference in blood
at T3 was lower than that at T2 (P0.050). There was no significant dif- purinol in uric acid inhibition and vascular pro-
ference in serum creatinine at T0, T1 and T2 tection. It is worthy of promotion in clinical prac-
between the two groups (P>0.050). The serum tice. The hyperuricemia treating mechanism of
creatinine in the study group at T3 was lower febuxostat is mainly to reduce the occurrence
than that in the control group (P0.050). is similar to the treatment mechanism of the
Urine nitrogen in the study group at T2 and T3 two groups. The efficacy and safety of the study
2019 Int J Clin Exp Med 2020;13(3):2016-2021The study of febuxostat’s effect
Table 4. Comparison of biochemical indicators between the two groups
T0 T1 T2 T3 F P
Study group (n = 41) Uric acid (μmol/L) 529.54 ± 84.51 464.51 ± 76.51a 405.61 ± 69.33a,b 364.54 ± 62.15a,b,c 39.091The study of febuxostat’s effect
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