替诺昔康治疗活动性轴型脊柱性关节炎的疗效和安全性

A. Rebrov, N. Nikitina, N. A. Magdeeva, L. R. Bogdalova
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摘要

研究目的:研究替诺昔康(Texared®)治疗活动性轴型脊柱炎的疗效和安全性。材料和方法。研究纳入35例BASDAI≥4.0的活动性轴型脊柱炎患者。患者连续口服替诺昔康(Texared®,Dr. Reddy’s Laboratories),剂量为20mg /天。随后,有5例患者因服药5 - 10天后停药而被排除在研究之外。30例患者纳入最终分析。最初和30天后,为了评估疼痛和僵硬的严重程度,活动,患者使用谷歌表格填写电子问卷,对患者的下背部疼痛和夜间疼痛强度进行一般评估,主观睡眠特征。医生计算BASDAI、ASDAS-CRP、BASMI指标,根据医生意见评价活动度。确定基线血压水平,并发放患者日记,用于30天的早晚动态血压测量。30天后,评估患者的动态血压控制情况。在基线和30天后,研究血液生化参数,包括全血和尿检。结果与结论。在高活动性和非常高活动性的轴性脊柱炎患者中,注意到替诺昔康(Texared®)治疗对疾病活动性的积极作用。Texared®的效果发展与常规使用已经在前2周,4周后,有一个明显的减轻疼痛的严重程度在腰部,减少了持续时间的早晨僵硬。该药耐受性良好,具有良好的安全性,无严重不良事件,副作用少,不需要停药。
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The use of tenoxicam in active axial spondyloarthritis – focus on efficacy and safety
Purpose of the study – to study the efficacy and safety of tenoxicam (Texared®) in patients with active axial spondyloarthritis.Material and methods. The study included 35 patients with active axial spondyloarthritis with BASDAI≥4.0. Patients were given continuous oral tenoxicam (Texared®, Dr. Reddy’s Laboratories) at a dosage of 20 mg/day. Subsequently, 5 patients were excluded from the study due to discontinuation of the drug after 5–10 days of administration. 30 patients were included in the final analysis. Initially and after 30 days, to assess the severity of pain and stiffness, activity, patients filled out questionnaires in electronic form using Google forms, a general assessment of pain in the lower back and the intensity of night pain by the patient, subjective sleep characteristics were carried out. The doctor calculated the BASDAI, ASDAS-CRP, BASMI indices, and evaluated the activity according to the doctor’s opinion. The baseline blood pressure level was determined, and a patient diary was issued for ambulatory blood pressure measurement in the morning/evening for 30 days. After 30 days, the patient’s ambulatory blood pressure control was assessed. At baseline and after 30 days, biochemical blood parameters were studied, including a complete blood and urine test.Results and conclusion. In patients with axial spondyloarthritis with high and very high activity, a positive effect of tenoxicam (Texared®) therapy on disease activity was noted. The effect of Texared® develops with regular use already during the first 2 weeks, and after 4 weeks there is a clear decrease in the severity of pain in the lower back, a decrease in the duration of morning stiffness. The drug is well tolerated, has a favorable safety profile, no serious adverse events and few side effects that do not require discontinuation of therapy.
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