| Objective : With the quickening pace of urban life and the improvement of people's living standard,the prevalence rate of gouty arthritis is increasing and the disability rate is increasing progressively year by year.So how to take early and effective treatments of this disease has become a major issue in the medical field.It is hyperuricemia which is the root reason that cause the onset of the gout arthritis.In the acute phase of gout arthritis,non-steroidal anti-inflammatory drugs are commonly used to fight inflammation and pain.But the condition of acute recurrence is prone to relapse when only take symptomatic,such as NSAIDs alone.For the gout arthritis,it is particularly important to take the treatment of reducing uric acid.Through randomized and controlled trials,this paper objectively analyzed the clinical efficacy of Qingre Qushi Tongluo Recipe in the treatment of gout arthritis,and evaluated its safety,explored its formulation principle and theoretical basis,which expected to provide effective methods for the treatment of this disease in traditional Chinese medicine.Methods:(1)This paper collected 72 patients who were treated in the endocrinology department of Hubei Provincial Hospital of Tr aditional Chinese Medicine from October 2017 to June 2019,and a ll of these 72 patients met the diagnostic criteria of gouty ar thritis.According to the clinical symptoms and signs of the pa tients,a total of 72 patients were classified into dampness an d heat accumulating type which was based on the TCM syndrome di fferentiation.Following the principle of randomized control,the 72 patients were divided into the control group and the treatm ent group by the random number table method.There were 36 patie nts in each of the two groups.And the differences between the t wo groups were no statistical significance(P<0.05)in the ag e,gender,course of disease,blood uric acid distribution,and syndrome score before treatment,which was comparable.(2)On the premise of the basic treatment of gouty arthritis,the control group was treated with febuxostat,and the treatment group was treated with Qingre Qushi Tongluo Recipe on the basis of the c ontrol group.The traditional Chinese medicine,decanted by the traditional Chinese medicine pharmacy of Hubei Provincial Hosp ital of Traditional Chinese Medicine,unified to 200 ml,two tim es a day,half an hour after meals in the morning and evening.Four weeks is a course of treatment.Relevant observation data w ere recorded at first diagnosis,4th week,8th week,and 12 th w eek.(3)Observe the changes of blood uric acid value and TCM syn drome scores before and after treatment.After three courses of treatment,recorded the acute attack of gouty arthritis during treatment,in order to see whether the different of two groups' number of acute episides was statistically significant.(4)Analy ze the changes and adverse reactions of vital signs,blood routi ne,urine routine,stool routine,liver functions,kidney function s,the color Doppler ultrasonography of kidney,liver,pancreas,gallbladder and spleen and electrocardiogram of the two groups of patients before and after treatment.In addition,observe wheth er there is any adverse reaction after taking the medicine,all of these are for the sake of conducting safety assessment.Results:(1)Comparison of TCM syndromes efficacy: This study was conducted for 12 weeks,it was evaluated according to TCM syndromes efficacy index and combined with nimodipine analysis.In the control group included 36 patients,the total effective rate was 77.78%.In the treatment group included 36 patients,the total effective rate was 97.22%.The comparison of the total effective of the two groups reveal P(27)0.05,which was statistical significance.The result of the research showed that the combination of Qingre Qushi Tongluo Recipe and western medicine(febuxostat)was better than febuxostat alone on TCM syndromes efficacy.(2)Comparison of TCM symptom scores: before treatment,the TCM symptom scores of two groups were not statistically significant,P(29)0.05.After 12 weeks of treatment,TCM symptoms of the two groups of patients significantly alleviated,and TCM syndrome scores significantly decreased.The two groups were compared with those before treatment,((P(27)0.05),and paired sample t test was performed,which showed that the difference was statistically significant;After 12 weeks of treatment,The comparison between the control group and the treatment group was statistically significant after testing by independent sample t test(P<0.05).The results showed that both Qingre Qushi Tongluo Recipe combined with febuxostat and febuxostat alone could significantly improve patients' symptoms in the treatment of gout,and Qingre Qushi Tongluo Recipe combined with febuxostat was significantly better than febuxostat alone in the improvement of TCM symptom scores.(3)Comparison of blood uric acid level: in the control group,the blood uric acid level at 4 weeks,8 weeks and 12 weeks decreased significantly compared with those before treatment.The treatment group was the same as the control group.Compared with groups,at 4 weeks and 8 weeks,the difference in blood uric acid level between the treatment group and the control group,which was tested by independent sample t test(P> 0.05),was no statistically significant.But the blood uric acid level in the treatment group at 12 weeks was significantly lower than that in the control group.Through independent sample t test,the difference was statistically significant(P(27)0.05).The study showed that both the control group and the treatment group had significant effection of uric acid lowering.But the combination of Qingre Qushi Tongluo Recipe and febuxostat group had more significant effection of lowering uric acid,especially when appropriate extension of treatment time is sufficient.This phenomenon is in line with the thought of my tutor,Xiao Wanze professor,which it is difficult to divide dampness and heat.Long-term application of integrated traditional Chinese and western medicine treatment can be more effective in reducing uric acid.(4)Comparison of acute recurrence of gout:during the treatment period,in the control group,there were 17 patients with no acute recurrence,19 patients with once,twice or three times acunte recurrence.The total recurrence rate was 52.78%.In the treatment group,within the treatment period,there are 26 patients with no acute recurrence,10 patients with once,twice or three times acute recurrence,the total recurrence rate is 27.78%;The difference of total recurrence rate of two groups was tested by c2 test,and the difference was statistically significant(P(27)0.05).The study has shown that the treatment of Qingre Qushi Tongluo Recipe combined with febuxostat is more effective than febuxostat alone,in improving the rate of gout acute recurrence.Conclusion:After observing the remission of clinical symptoms and signs,the decrease of uric acid level in blood,and the improvement of acute recurrence of gout,it can be preliminarily confirmed that comparing with febuxostat alone,the combination of Qingre Qushi Tongluo Recipe and febuxostat has obvious curative effect on patients with dampness and heat accumulating type of gout arthritis.The combination of traditional Chinese and western medicine treatment is more conducive to improving the clinical symptoms of patients,controlling the uric acid stably and improving the quality of life of patients,and the adverse reaction is less,the treatment of combination of traditional Chinese and western medicine is worthy of futher exploration and clinical application. |
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