| 1.Objective By observing the curative effect and safety of Jiawei Zhuliangchun Tongfeng Experience Recipe(referring as “Experience Recipe”)and Zhu Liangchun Tongfeng Decoction(referring as “Tongfeng Decoction”)for patients with acute gout,the efficacy difference between the two prescriptions was compared.To provide clinical evidence for promoting Zhu Liangchun's experience in treating gout,and studying differences in gout between Jiangsu and Sichuan.2.Methods A total of 143 patients with gout in the acute stage of dampness-heat syndrome were included in this topic,and 5 patients fell off during treatment.Finally,138 cases were enrolled(46 cases in each of the treatment group,control group A,and control group B).Three groups of patients in terms of gender,age,duration of acute attack,joint symptoms and signs(pain,tenderness,swelling,restricted movement),serum uric acid,laboratory inflammation indicators(leukocytes and neutrophils,C-reactive protein,erythrocyte sedimentation),inflammation Factors(IL-1?,TNF-?)and TCM syndrome scores(main syndrome,concurrent syndrome,tongue vein)were all consistent on the baseline(P> 0.05).All three groups were given general treatment(resting control,diet control,adequate water and sodium bicarbonate tablets 1 g orally bid to make urine alkaline)and loxoprofen sodium tablets 60 mg orally bid as analgesic treatment.On this basis,the treatment group was given Experience Recipe,one dose per day,three times;the control group A was given Tongfeng Decoction with the same usage of the Experience Recipe;and nothing more was added to the control group B,the duration of treatment in all three groups was 7 days.Local symptoms and signs of joints,blood uric acid,inflammation indexes,TCM syndromes and adverse reactions were recorded and compared in each group.3.Results 3.1 General conditions(joint pain,mental state,diet,urine,stool,sleep,general signs,etc.): Joint swelling and pain in the three groups of patients were improved to different degrees than before treatment.During the treatment period,the mental status,diet,urine,stool and sleep of the three groups of patients did not show significant changes compared with before treatment.There were no clinical abnormalities in body temperature,heart rate,breathing,and blood pressure in the three groups of patients.3.2 Joint symptoms and signs: Adding Experience Recipe can further reduce the total score of joint pain,tenderness or joint symptoms and signs of patients;compared with control group A,the joint pain score of the treatment group decreases more significantly,indicating that both the experience prescription and the Tongfeng Decoction can further improve the local clinical manifestations of the joints,and in terms of analgesic effect,the Experience Recipe is more advantageous than the Tongfeng Decoction.3.3 Blood uric acid level: Experience Recipe can reduce the blood uric acid level in patients with acute gout,indicating that it has the effect of reducing uric acid at the same time of treating acute gout.3.4 Inflammatory indicators: Experience Recipe can reduce the peripheral serum IL-1?,while there's no effect on TNF-? levels.The Experience Recipe's anti-inflammatory effect on IL-1? is stronger than that of Tongfeng Decoction.The results show that Experience Recipe possibly improve clinic symptoms by inhibiting the expression of IL-1?.3.5 TCM Syndrome Points: Experience Recipe can further reduce the patient's main syndrome points(joint pain,joint swelling,joint redness,joint movement limitation)and total points;the results show that the Experience Recipe's intervention,will not only strengthen analgesics effect and improve local joints symptoms,but also improve overall patients' TCM syndromes,thus to promote TCM clinical results.3.7 Adverse reactions and safety: All three groups of patients experienced a decrease in heart rate within the normal range after treatment,and no arrhythmia event was seen.This result shows that Experience Recipe has no obvious effect on heart rate.There were no significant changes in red blood cells,hemoglobin,platelets,creatinine,alanine transferase,and aspartate transferase in the three groups of patients compared with before treatment.In terms of adverse reactions,the incidence rate was 4.35% in the treatment group,2.17% in control group A,8.70% in control group B.There was no significant difference.In addition,the results show that the Experience Recipe may have effect of reducing serum urea nitrogen,but further research is needed to confirm it.4.Conclusion(1)Adding Experience Recipe can enhance the efficacy of clinical symptoms such as pain in the acute stage of gout.(2)The Experience Recipe can reduce blood uric acid at the same time when treating the acute stage of gout.(3)The Experience Recipe can enhance the anti-inflammatory effect on acute gout by inhibiting the level of IL-1?.(4)Compared with Tongfeng Decoction,The Experience Recipe has better clinic effects in the treatment of gout in the Sichuan region than Tongfeng Decoction. |
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