N-乙酰半胱氨酸作为一种附加疗法可用于治疗椎间盘突出症引起的急性腰根病变:一项随机对照临床试验的结果。

IF 1.4 Q4 PHARMACOLOGY & PHARMACY
Bijan Heidari, Zeinab-Alsadat Seyedian, Maryam Mehrpooya, Davoud Ahmadimoghaddam, Mahtabalsadat Mirjalili, Masood Ghiasian
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引用次数: 0

摘要

背景:现有的实验和临床证据表明,N-乙酰半胱氨酸(NAC)可能在特定的疼痛条件下,特别是神经性疼痛中发挥镇痛作用。因此,我们假设补充NAC也可能有助于减轻急性神经根病患者的疼痛和改善与疼痛相关的残疾。本研究旨在探讨NAC辅助治疗非甾体抗炎药(NSAIDs)在腰椎间盘突出症继发急性神经根病患者中的潜在用途。方法:将62例诊断为急性腰神经根病伴椎间盘突出症的患者随机分为NAC组或安慰剂组。除了每天两次500 mg的萘普生剂量外,基于分配组的参与者开始服用NAC或匹配的安慰剂,每天两次600 mg,持续八周。在基线和治疗的第2、4和8周,通过视觉模拟量表(VAS)测量疼痛严重程度,并通过奥斯韦斯特里残疾指数(ODI)测量疼痛相关残疾。在第8周结束时,还记录了患者和临床整体变化印象(PGIC和CGIC)评定的症状的整体改善。所有分析均在意向治疗(ITT)分析数据集上进行。结果:两组在治疗第2周和第4周的VAS和ODI评分比较没有显示出显著差异。而从第4周到第8周,我们注意到,与安慰剂组相比,NAC组的平均VAS和ODI评分显著降低(p值结论:这项研究表明,NAC可能是治疗急性腰神经根病的辅助治疗的相关候选者。还需要更多的临床试验来验证这些发现。试验注册:该试验在Clinicaltrials.gov上注册(识别码:IRCT2012021 5009014N381)。注册日期:2021-02-06。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
N-Acetyl Cysteine as an Add-on Therapy is Useful in Treating Acute Lumbar Radiculopathy Caused by Disc Herniation: Results of a Randomized, Controlled Clinical Trial.

Background: Available experimental and clinical evidence indicates that N-Acetyl cysteine (NAC) may have an analgesic role in specific pain conditions, particularly neuropathic pain. Thus, we hypothesized that NAC supplementation might be also helpful in decreasing pain and improving pain-related disability in patients with acute radiculopathy. We designed this study to investigate the potential use of NAC-adjunctive treatment to Nonsteroidal Anti- Inflammatory Drugs (NSAIDs) in patients with acute radiculopathy secondary to lumbar intervertebral disc herniation.

Methods: Sixty-two patients diagnosed with acute lumbar radiculopathy associated with disc herniation were randomly allocated to the NAC or the placebo groups. Besides naproxen at a dose of 500 mg twice a day, participants based on their allocation group started with NAC or matched placebo at a dose of 600 mg twice a day for eight weeks. The pain severity, measured by the Visual Analog Scale (VAS), and pain-related disability measured by the Oswestry Disability Index (ODI) were measured at baseline and weeks 2, 4, and 8 of treatment. Global improvement of symptoms rated by Patient and Clinical Global Impressions of Change (PGIC and CGIC) was also recorded at the end of week 8. All analyses were conducted on an Intentionto- Treat (ITT) analysis data set.

Results: A comparison of the VAS and ODI scores at weeks 2 and 4 of the treatment between the two groups did not show a significant difference. In contrast, from week 4 to week 8, we noticed a significantly greater reduction in the mean VAS and ODI scores in the NAC group compared to the placebo group (p-value <0.001 for both variables). In parallel with these results, also, more NAC-treated than placebo-treated patients achieved treatment success defined as ''very much'' or ''much improved'' on CGIC and PGIC scales, and these differences reached a significant level (p-value = .011 and p-value = .043).

Conclusions: This study suggested that NAC might be a relevant candidate for adjunct therapy in managing acute lumbar radiculopathy. Additional clinical trials are needed to validate these findings.

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来源期刊
Reviews on recent clinical trials
Reviews on recent clinical trials PHARMACOLOGY & PHARMACY-
CiteScore
3.10
自引率
5.30%
发文量
44
期刊介绍: Reviews on Recent Clinical Trials publishes frontier reviews on recent clinical trials of major importance. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: important Phase I – IV clinical trial studies, clinical investigations at all stages of development and therapeutics. The journal is essential reading for all researchers and clinicians involved in drug therapy and clinical trials.
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