| Objective:By observing the effect of Self-made Gout No.1 Prescription combined with Diclofenac Sodium Sustained Release Capsule on patients with acute gout arthritis with damp-heat accumulation syndrome,evaluate its clinical efficacy and safety,provide a safe and effective new method for the treatment of acute gout arthritis,and provide clinical trial data for the further development and application of Self-made Gout No.1 Prescription.Methods:From November 2021 to December 2022,patients with acute gouty arthritis with damp-heat accumulation syndrome were collected from the outpatient and inpatient departments of the Department of Rheumatology and Immunology of the First People’s Hospital of Yunnan Province,and they were randomly assigned to the treatment group and the matched group with 34 sick persons in each group.The treatment group was treated with Self-made Gout No.1 Prescription(1 bag/time,2 times/day)combined with Diclofenac Sodium Sustained Release Capsule(50 mg/time,2 times/day),while the matched group was only treated with Diclofenac Sodium Sustained Release Capsule(50mg/time,2 times/day).Compare the changes of TCM syndrome score,VAS score,laboratory indicators(serum uric acid,C-reactive protein,ESR,cytokines),and safety indicators(blood routine,liver function,and renal function)of the two groups on the first day of treatment and five days after treatment,and use statistical analysis software to process relevant data to objectively estimate the curative effect and safety of the treatment group and the matched group.Results:1.Total effective rate: The treatment group achieved an impressive 94.12%effectiveness rate,while the matched group’s rate was a mere 85.29%.The treatment group’s overall effect was superior(P<0.05).2.TCM syndrome score: The single TCM syndrome score in the treatment group reduced compared with that before treatment(P<0.05).The treatment group was better than the matched group in improving joint pain,joint swelling,joint movement limitation,joint tenderness,joint skin temperature,thirst,restlessness,short and yellow urine(P<0.05),and there was no statistical difference in fever(P>0.05).3.Pain score: VAS score of joint pain in two groups reduced compared with that before treatment(P<0.05),and the treatment group’s analgesic effect was superior to that of the matched group.(P<0.05).4.Serum uric acid level: The serum uric acid level in the treatment group reduced compared with that before treatment(P<0.05),while the matched group had no obvious effect on lowering serum uric acid(P>0.05).5.Inflammation index: C-reactive protein in two groups reduced compared with that before treatment(P<0.05),and the improvement of C-reactive protein in the treatment group was better than that in the matched group(P<0.05).The improvement of ESR in two groups was not obvious(P>0.05).6.Cytokines: The levels of IL-1β,IL-6 and TNF-α in the treatment group reduced compared with those before treatment(P<0.05),while the levels of IL-4 and IL-10 added(P<0.05).The effect of reducing IL-1β and IL-6 and increasing IL-4 and IL-10 in the treatment group was better than that in the matched group(P<0.05).No statistical distinction in TNF-α was observed between the two groups.(P>0.05).7.Safety indicators: There is no significant change in safety indicators(WBC,RBC,Hb,PLT,AST,ALT,BUN,Cr)of the two groups before and after treatment(P>0.05).Conclusions:1.The Self-made Gout No.1 Prescription combined with Diclofenac Sodium Sustained Release Capsule can effectively improve the levels of serum uric acid,C-reactive protein,cytokines and traditional Chinese medicine syndrome scores in sufferers with acute gouty arthritis of damp heat accumulation syndrome.The curative effect is obviously better than that of diclofenac sodium sustained release capsule.2.The self-made Gout No.1 Prescription has no obvious adverse reaction,high safety and significant effect,which is worthy of farther development and adhibition in clinical practice. |
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