ABSTRACT
Objective::To observe the clinical effect of addition and subtraction therapy of Yiyiren Tang with external application therapy in the patients with acute gouty arthritis (AGA) and damp-heat obstruction syndrome, and to investigate its effect on inflammatory factors. Method::One hundred and fifty-three patients were randomly divided into control group (77 cases) and observation group (76 cases) by random number table. Patients in control group got meloxicam tablets after the meal, 1 tablet/day, 1 time/day, diclofenac sodium gel, 3 times/days. On the basis of meloxicam tablets, patients in observation group additionally received addition and subtraction therapy of Yiyiren Tang by oral and topical applications. The course of treatment was 7 days in both groups. Scores of visual analogue score of pain (VAS) were graded everyday, and the relief time and disappearance time of pain were recorded. Before and after treatment, scores of damp-heat obstruction syndrome were recorded. Levels of uric acid (UA), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), tumor necrosis factor-alpha (TNF-α), serum cyclooxygenase-2 (COX-2), prostaglandin E2 (PGE2), thromboxane B2 (TXB2) and 6-keto-prostatic factor F1alpha (6-keto-PGF1α) were all detected, and the safety was evaluated. Result::The clinical efficacy in observation group was better than that in control group (Z=2.205, P<0.05). The relief time and disappearance time of pain were shorter than those in control group (P<0.01). At the 1st, 3rd, 5th and 7th day after treatment, scores of VAS were lower than those in control group (P<0.01). After treatment, the scores of main symptoms such as joint pain, tenderness, swelling and dyskinesia, scores of the secondary symptoms and the total scores of damp-heat obstruction syndrome were all lower than those in control group (P<0.01). After treatment, levels of ESR, CRP, UA, IL-1β, IL-6, IL-8, TNF-α, COX-2, PGE2 and TXB2 were all lower than those in control group (P<0.01). Conclusion::Based on the treatment of meloxicam, addition and subtraction therapy of Yiyiren Tang by oral and topical administration methods can quickly relieve and eliminate pain, alleviate the main clinical symptoms and inhibit inflammation in patients with damp-heat obstruction syndrome, showing good clinical efficacy and safety.
ABSTRACT
With patients' general situation, medication use, occurrence time of adverse drug reaction/event (ADR/ADE), clinical manifestations and prognosis as reference items, a retrospective study was made for 315 cases with ADR/ADE induced by Gastrodin in Chongqing from January 2008 to June 2014, in order to analyze the characteristics of ADR/ADE and provide reference for rational clinical medication. The results showed that among the 315 cases with ADR/ADE, 143 cases (45.4%) were males and 172 cases (54.6%) were females, most of them (74.9%) were aged above 45; 60 cases (19.0%) with ADE were caused by off-label indications and 66 cases (21.0%) with ADE were caused by over dosage; ADR/ADE cases induced by intravenous drip mainly happened within 30 min (85.5%), ADR/ADE cases induced by oral administration mainly happened within 2 h (74.4%), and all of ADR/ ADE cases induced by intramuscular injection happened within 10 min. Totally 593 ADR/ADE cases were reported, which were mainly damages in gastrointestinal system, skin and its adnexa; And 61.9% of ADR/ADE cases were newly reported. It is suggested that medical workers shall learn about the regularity and characteristics of ADR/ADE induced by gastrodin, apply it in clinic with standards, pay close attention to changes of patients' situations and attach importance to the monitoring of ADR/ADE, so as to enhance the safety of medication.