多中心纵向观察研究药物Alflutop在俄罗斯(消息2)

A. Lila, E. Taskina, L. Alekseeva, N. Kashevarova
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引用次数: 0

摘要

骨关节炎(Osteoarthritis, OA)由于其发病率和致残率的不断增加而成为最重要的医学和社会问题之一。预防、管理风险因素和早期治疗OA至关重要。ISKRA研究的目的是评估Alflutop对不同部位OA和/或腰痛(LBP)伴或不伴疾病患者的疗效。材料和方法。我们选择了11136例年龄在50 - 72岁的特定部位OA患者。研究持续时间为20 - 31天,就诊次数为2次(B1和B2)。Alflutop每日1 ml肌注(IM) No. 20或每隔一天2 ml IM No. 10。根据临床效果(由患者评估疼痛减轻)的开始时间,根据视觉模拟量表(VAS),根据EQ-5D问卷评估生活质量,根据VAS评估患者一般健康状况(PGH),确定研究关节在运动和/或LBP时的疼痛强度动态。我们评估了治疗依从性、非甾体抗炎药(NSAIDs)的需求、治疗满意度(基于VAS)。同时也考虑了合并症的存在。结果和讨论。在手部OA (n=2776)中,根据患者评估,98.6%的病例观察到治疗的积极效果。在治疗过程中,手部运动疼痛明显减轻(根据VAS), PGH和生活质量得到改善(根据EQ-5D)。平均在第9天镇痛效果发展迅速。在髋关节OA (n=6666)中,83.3%的病例(<40 mm)疼痛减轻,大多数患者的PGH和生活质量改善,64.9%的患者对非甾体抗炎药的需求减少。在广泛性骨性关节炎中(n=1694), 97.1%的患者获得了显著的临床改善。在近65%的病例中,疼痛比基线减轻≥50%。老年、骨性关节炎影像学表现较严重、生活质量和依从性较低以及伴随疾病与手部和髋部骨性关节炎治疗效果较低相关。在手OA中,较高的疼痛评分和较差的PGH VAS评分也起作用。女性髋部OA的成功率较低,男性手部OA的成功率较低。在广泛性骨关节炎中,较低的疼痛管理满意度与年龄、女性、高体重指数、骨关节炎病史长、影像学分期较晚、生活质量和依从性较差以及合并症有关。Alflutop在手部和髋部OA及广义OA中的应用结果表明其在实际临床实践中具有广泛的应用价值。考虑和纠正与药物镇痛作用不明显相关的因素,将提高OA治疗的有效性。
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Multicenter Longitudinal Observational Study Pharmaceuticals Alflutop in Russia (message 2)
Osteoarthritis (OA) is one of the most important medical and social problems due to the steady increase in morbidity and disability. Prevention, management of risk factors, and early treatment of OA are critical.Objective of the ISKRA study was to evaluate the efficacy of Alflutop in patients with OA of different locations and/or low back pain (LBP) with or without concomitant diseases.Material and methods. We selected 11,136 patients with OA of specific localizations aged 50 to 72 years. The duration of the study ranged from 20 to 31 days, and the number of visits was 2 (B1 and B2). Alflutop was prescribed 1 ml intramuscularly (IM) daily No. 20 or 2 ml IM every other day No. 10.The efficacy of therapy was determined by the time of onset of clinical effect (pain reduction, as assessed by the patient), the dynamics of pain intensity in the studied joint during movement and/or LBP according to the visual analogue scale (VAS), the assessment of quality of life according to the EQ-5D questionnaire and the patient's general health status (PGH) according to VAS. We assessed treatment adherence, need for nonsteroidal anti-inflammatory drugs (NSAIDs), satisfaction with treatment (based on VAS). The presence of comorbidities was also considered.Results and discussion. In hand OA (n=2776), a positive effect of therapy was observed in 98.6% of cases, according to patients' assessment. During the course of therapy, there was a significant decrease in pain on movement in the hands (according to VAS), improvement in PGH and quality of life (according to EQ-5D). Rapid development of the analgesic effect was seen on average at day 9.In hip OA (n=6666), a decrease in pain was noted in 83.3% of cases (<40 mm), improvement in PGH and quality of life in most patients, and a decrease in the need for NSAIDs in 64.9%.In the generalized form of OA (n=1694), significant clinical improvement was achieved in 97.1% of patients. A pain reduction ≥50% from baseline was noted in nearly 65% of cases.Elderly age, more severe radiographic manifestations of OA, low quality of life and compliance, and concomitant diseases were associated with a lower effect of therapy in hand and hip OA. In hand OA, high pain scores and worse PGH VAS scores also played a role. In hip OA, lower success was observed more often in women, and in hand OA — in men.In the generalized form of OA, lower satisfaction with pain management was associated with age, female sex, high body mass index, long history of OA, advanced radiographic stages, poorer quality of life and compliance, and comorbidity.Conclusion. The results of the use of Alflutop in hand and hip OA and generalized form of OA suggest the usefulness of its wide application in real clinical practice. Consideration and correction of the factors associated with less pronounced analgesic effect of the drug will improve the effectiveness of OA therapy.
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