NOVEMA® NIGHT(苯海拉明+萘普生)治疗疼痛和失眠患者:一项多中心非干预性观察研究的结果

A. B. Danilov, A. A. Pilipovich, M. V. Pyastolova
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引用次数: 0

摘要

疼痛和睡眠障碍是相互关联的问题,严重影响患者的生活质量(QoL)和日常功能。目的:评估苯海拉明+萘普生(NOVEMA® NIGHT)联合用药对急性疼痛综合征或慢性疼痛综合征加重合并睡眠障碍患者的疗效和安全性。该研究纳入了 4365 名患有急性疼痛(肌肉骨骼疼痛、创伤后疼痛、头痛)和睡眠障碍的门诊患者,他们在早晨服用萘普生 275 毫克(1 片),并在睡前服用苯海拉明 25 毫克+萘普生 220 毫克(NOVEMA® NIGHT)5 天。采用视觉模拟量表(VAS)对治疗前后的疼痛强度和睡眠障碍进行评估;采用五点量表对治疗后的生活质量进行评估。在治疗期间,92% 的病例观察到疼痛减轻或完全缓解(治疗前 VAS 为 60 [50; 61] 点,治疗后为 10 [0; 20] 点;p<0.0001),大多数患者的睡眠恢复正常:81% 的患者入睡更快(χ2=9650.2;p<0.0001),总睡眠时间延长--75.5%(χ2=7351.2;p<0.0001),夜间觉醒次数减少--84%的患者(χ2=10568;p<0.0001)。在疗程结束时,大多数患者对自己生活质量的评分为 4 分(满分为 5 分)(4 [4; 5]):41%的患者--"生活质量高";48%--"高于平均水平";11%--"一般";0.09%--"低于平均水平")。没有一名患者的生活质量较低。治疗耐受性良好,没有患者因不良事件(AEs)而中断治疗。睡前服用 275 毫克萘普生和 25 毫克苯海拉明 + 220 毫克萘普生复方制剂(NOVEMA® NIGHT)的短期治疗(5 天)可有效减轻与失眠相关的疼痛综合征。该疗法可明显改善患者的生活质量,且发生AEs的风险较低,因此我们推荐将NOVEMA® NIGHT作为伴有睡眠障碍的患者的额外镇痛药。
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NOVEMA® NIGHT (diphenhydramine + naproxen) in patients with pain and insomnia: results of a multicenter non-interventional observational study
Pain and sleep disorders are interrelated problems that significantly affect patients’ quality of life (QoL) and daily functioning.Objective: to evaluate the efficacy and safety of the use of the combination of diphenhydramine + naproxen (NOVEMA® NIGHT) in patients with acute pain syndrome or exacerbation of chronic pain syndrome and sleep disorders.Material and methods. The study included 4365 outpatients with acute pain (musculoskeletal pain, post-traumatic pain, headache) and sleep disorders who took naproxen 275 mg, 1 tablet in the morning and diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) for 5 days before bedtime. Pain intensity, using a visual analogue scale (VAS), and sleep disorders were assessed before and after treatment; QoL was assessed after treatment using a five-point scale.Results. During treatment, a reduction or complete regression of pain was observed in 92% of cases (60 [50; 61] points on the VAS before treatment versus 10 [0; 20] after treatment; p<0.0001) and normalisation of sleep in most patients: faster falling asleep – in 81% (χ2=9650.2; p<0.0001), an increase in total sleep duration – in 75.5% (χ2=7351.2; p<0.0001), a decrease in the number of nocturnal awakenings – in 84% of patients (χ2=10,568; p<0.0001). At the end of treatment course, the majority of patients rated their quality of life as 4 out of 5 possible points (4 [4; 5]): 41% of patients – “high quality of life”; 48% – “above average”; 11% – “average”; 0.09% – “below average”). None of the patients had a low QoL. The therapy was well tolerated and no patient discontinued treatment due to adverse events (AEs).Conclusion. Short-term treatment (5 days) with naproxen 275 mg and a combination of diphenhydramine 25 mg + naproxen 220 mg (NOVEMA® NIGHT) at bedtime effectively reduces the pain syndrome associated with insomnia. This therapy significantly improves patients’ QoL and has a low risk of AEs, so that we can recommend NOVEMA® NIGHT as an additional analgesic for patients with concomitant sleep disorders.
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