Vitamin B Complex

复合维生素 B
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  • 文章类型: Journal Article
    背景:慢性心力衰竭(CHF)一直对人类的生存和健康构成重大威胁。补充硫胺素对CHF患者的疗效尚不确定。
    目的:接受补充硫胺素可能不会给CHF患者带来益处。
    方法:在Cochrane图书馆进行了全面搜索,PubMed,EMBASE,ClinicalTrials.gov,和WebofScience数据库直到2023年5月,以确定研究补充硫胺素对CHF患者的影响的文章。使用预定义的标准来选择有关研究特征和结果的数据。
    结果:七个随机分组,双盲,纳入总共274例患者的对照试验(5项平行试验和2项交叉试验).汇总这些研究的荟萃分析结果未显示与安慰剂相比,硫胺素治疗对左心室射血分数有任何显着影响(WMD=1.653%,95%CI:-1.098至4.405,p=0.239,I2=61.8%),左心室舒张末期容积(WMD=-6.831mL,95%CI:-26.367至12.704,p=0.493,I2=0.0%),6分钟步行试验(WMD=16.526m,95%CI:-36.582至69.634,p=0.542,I2=66.3%),N末端B型利钠肽前体(WMD=258.150pg/mL,95%CI:-236.406至752.707,p=0.306,I2=21.6%),或纽约心脏协会类别(WMD=-0.223,95%CI:-0.781至0.335,p=0.434,I2=87.1%)。然而,它有效地改善了硫胺素缺乏症(TD)的状况。
    结论:我们的荟萃分析表明,补充硫胺素对CHF没有直接治疗作用,除了修正TD。
    BACKGROUND: Chronic heart failure (CHF) has always posed a significant threat to human survival and health. The efficacy of thiamine supplementation in CHF patients remains uncertain.
    OBJECTIVE: Receiving supplementary thiamine may not confer benefits to patients with CHF.
    METHODS: A comprehensive search was conducted across the Cochrane Library, PubMed, EMBASE, ClinicalTrials.gov, and Web of Science databases up until May 2023 to identify articles investigating the effects of thiamine supplementation in CHF patients. Predefined criteria were utilized for selecting data on study characteristics and results.
    RESULTS: Seven randomized, double-blind, controlled trials (five parallel trials and two crossover trials) involving a total of 274 patients were enrolled. The results of the meta-analysis pooling these studies did not reveal any significant effect of thiamine treatment compared with placebo on left ventricular ejection fraction (WMD = 1.653%, 95% CI:  -1.098 to 4.405, p = 0.239, I2 = 61.8%), left ventricular end-diastolic volume (WMD = -6.831 mL, 95% CI:  -26.367 to 12.704, p = 0.493, I2 = 0.0%), 6-min walking test (WMD = 16.526 m, 95% CI:  -36.582 to 69.634, p = 0.542, I2 = 66.3%), N-terminal pro-B type natriuretic peptide (WMD = 258.150 pg/mL, 95% CI:  -236.406 to 752.707, p = 0.306, I2 = 21.6%), or New York Heart Association class (WMD = -0.223, 95% CI:  -0.781 to 0.335, p = 0.434, I2 = 87.1%). However, it effectively improved the status of thiamine deficiency (TD).
    CONCLUSIONS: Our meta-analysis indicates that thiamine supplementation does not have a direct therapeutic effect on CHF, except for correcting TD.
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  • 文章类型: Journal Article
    抑郁症是一个主要的全球健康问题,预计到2030年将恶化。2019年,有2800万人受到抑郁症的影响。饮食和补充维生素对抑郁症显示出总体有利的预防和治疗效果。B族维生素对神经功能和情绪调节至关重要。这些维生素的缺乏与抑郁症有关。对个体B族维生素的研究表明,在改善抑郁症状方面有希望,尤其是硫胺素,核黄素,烟酸,还有叶酸.维生素C缺乏可能加剧抑郁症状,但是它的确切作用还没有完全理解。季节性情感障碍(SAD)与阳光照射不足和维生素D缺乏有关。SAD的维生素D补充剂由于方法学差异而显示出不一致的结果。需要进一步研究以了解维生素在抑郁症治疗中的作用机制。此外,更多关于SAD和光疗法的功效和涉及光感受器的潜在机制的研究,酶,免疫标记是必需的。尽管饮食和补充维生素对抑郁症具有良好的预防和治疗效果,由于不同的研究设计,治疗精神疾病的营养师面临挑战,很难进行直接比较。因此,本文回顾了目前的文献,以评估饮食和补充维生素在预防和治疗抑郁症中的作用。这篇评论发现,尽管有证据支持B族维生素和维生素C和D在预防和治疗抑郁症中的作用,需要进一步研究以阐明其作用机制并确定最有效的干预策略.
    Depression is a major global health concern expected to worsen by 2030. In 2019, 28 million individuals were affected by depressive disorders. Dietary and supplemental vitamins show overall favorable preventative and therapeutic effects on depression. B vitamins are crucial for neurological function and mood regulation. Deficiencies in these vitamins are linked to depression. Studies on individual B vitamins show promise in improving depressive symptoms, particularly thiamin, riboflavin, niacin, and folate. Vitamin C deficiency may heighten depressive symptoms, but its exact role is not fully understood. Seasonal Affective Disorder (SAD) is associated with insufficient sunlight exposure and vitamin D deficiency. Vitamin D supplementation for SAD shows inconsistent results due to methodological variations. Further investigation is needed to understand the mechanisms of vitamins in depression treatment. Moreover, more research on SAD and light therapy\'s efficacy and underlying mechanisms involving photoreceptors, enzymes, and immune markers is needed. Although dietary and supplemental vitamins show overall favorable preventative and therapeutic effects on depression, dietitians treating psychiatric disorders face challenges due to diverse study designs, making direct comparisons difficult. Therefore, this article reviews the current literature to assess the role of dietary and supplemental vitamins in the prevention and treatment of depression. This review found that, although evidence supports the role of B vitamins and vitamins C and D in preventing and treating depression, further research is needed to clarify their mechanisms of action and determine the most effective intervention strategies.
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  • 文章类型: Journal Article
    目的:2型糖尿病(T2D)是一个全球性和复杂的公共卫生挑战,饮食管理被认为是预防疾病的关键。最近的研究强调了微量营养素在T2D病理生理学中的参与;我们的研究旨在评估B族维生素摄入量与T2D风险之间的关系以及炎症的介导作用。
    方法:在前瞻性队列设计中,B族维生素摄入量的数据,包括硫胺素(B1),核黄素(B2),烟酸(B3),吡哆醇(B6),叶酸(B9),和钴胺(B12),是使用经过验证的食物频率问卷(FFQ)获得的,根据标准方案在当地医院对上海郊区成人队列和生物库(SSACB)的44,960名成年人进行基线和血液炎症生物标志物分析。根据医生的诊断或来自电子医疗信息系统的用药记录,确定发生的T2D病例。我们采用logistic和加权分位数和回归模型来探索B族维生素的单一和组合水平与T2D和中介分析的关联,以研究炎症的影响。
    结果:在单次暴露模型中观察到B族维生素和T2D之间的负相关,除了B3。联合暴露(B1,B2,B6,B9和B12)的分析也显示出负相关(OR0.80,95%CI0.71至0.88),其中维生素B6占作用的45.58%。进一步的调解分析表明介导的炎症影响,占关系的6.72%。
    结论:上海居民的饮食摄入B族维生素(B1、B2、B6、B9、B12)与部分由炎症介导的T2D风险降低相关。
    OBJECTIVE: Type 2 diabetes (T2D) is a global and complex public health challenge, and dietary management is acknowledged as critical in its prevention. Recent studies have highlighted the involvement of micronutrients in T2D pathophysiology; our study aims to assess the association between B vitamin intake and T2D risks and the mediating role of inflammation.
    METHODS: In a prospective cohort design, data on B vitamins intake, including thiamine (B1), riboflavin (B2), niacin (B3), pyridoxine (B6), folate (B9), and cobalamin (B12), was obtained using a validated food frequency questionnaire (FFQ), and blood inflammatory biomarkers were analyzed according to standard protocol in the local hospitals at baseline from 44,960 adults in the Shanghai Suburban Adult Cohort and Biobank (SSACB). Incident T2D cases were identified according to a physician\'s diagnosis or medication records from the electronic medical information system. We employed logistic and weighted quantile sum regression models to explore the associations of single and combined levels of B vitamins with T2D and mediation analyses to investigate the effects of inflammation.
    RESULTS: Negative correlations between B vitamins and T2D were observed in the single-exposure models, except for B3. The analyses of joint exposure (B1, B2, B6, B9, and B12) also showed an inverse association (OR 0.80, 95% CI 0.71 to 0.88), with vitamin B6 accounting for 45.58% of the effects. Further mediation analysis indicated a mediating inflammatory impact, accounting for 6.72% of the relationship.
    CONCLUSIONS: Dietary intake of B vitamins (B1, B2, B6, B9, B12) was associated with a reduced T2D risk partially mediated by inflammation in Shanghai residents.
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  • 文章类型: Journal Article
    探索叶酸代谢基因遗传多态性之间的联系(MTHFR,地铁,和MTRR)和心血管疾病(CVD),这项研究评估了B族维生素补充剂(叶酸甲酯,吡哆醛-5'-磷酸,和甲基钴胺)对高半胱氨酸和脂质水平,潜在的指导个性化CVD风险管理。在一个随机的,双盲,安慰剂对照试验,54名年龄在40-75岁的高半胱氨酸和中度LDL-C水平升高的患者根据MTHFR进行分组,地铁,和MTRR遗传多态性。超过六个月,他们接受了甲基叶酸的组合,P5P,和甲基钴胺,或者安慰剂.在6个月的随访中,治疗组的同型半胱氨酸水平显着降低了30.0%(95%CI:-39.7%至-20.3%),LDL-C显着降低了7.5%(95%CI:-10.3%至-4.7%),与安慰剂相比(全部p<0.01)。在亚组分析中,纯合子小等位基因携带者的同型半胱氨酸水平显着降低(48.3%,95%CI:-62.3%至-34.3%,p<0.01)与混合等位基因携带者(18.6%,95%CI:-25.6%至-11.6%,p<0.01),组间差异显著(29.7%,95%CI:-50.7%至-8.7%,p<0.01)。纯合携带者的LDL-C水平下降了11.8%(95%CI:-15.8%至-7.8%,p<0.01)和混合等位基因携带者的4.8%(95%CI:-6.8%至-2.8%,p<0.01),具有显著的组间差异(7.0%,95%CI:-13.0%至-1.0%,p<0.01)。叶酸甲酯,P5P,和甲基钴胺补充剂针对基因谱定制有效降低了特定MTHFR患者的同型半胱氨酸和LDL-C水平,地铁,和MTRR多态性,特别是具有纯合次要等位基因多态性。
    Exploring the link between genetic polymorphisms in folate metabolism genes (MTHFR, MTR, and MTRR) and cardiovascular disease (CVD), this study evaluates the effect of B vitamin supplements (methylfolate, pyridoxal-5\'-phosphate, and methylcobalamin) on homocysteine and lipid levels, potentially guiding personalized CVD risk management. In a randomized, double-blind, placebo-controlled trial, 54 patients aged 40-75 with elevated homocysteine and moderate LDL-C levels were divided based on MTHFR, MTR, and MTRR genetic polymorphisms. Over six months, they received either a combination of methylfolate, P5P, and methylcobalamin, or a placebo. At the 6 months follow-up, the treatment group demonstrated a significant reduction in homocysteine levels by 30.0% (95% CI: -39.7% to -20.3%) and LDL-C by 7.5% (95% CI: -10.3% to -4.7%), compared to the placebo (p < 0.01 for all). In the subgroup analysis, Homozygous Minor Allele Carriers showed a more significant reduction in homocysteine levels (48.3%, 95% CI: -62.3% to -34.3%, p < 0.01) compared to mixed allele carriers (18.6%, 95% CI: -25.6% to -11.6%, p < 0.01), with a notable intergroup difference (29.7%, 95% CI: -50.7% to -8.7%, p < 0.01). LDL-C levels decreased by 11.8% in homozygous carriers (95% CI: -15.8% to -7.8%, p < 0.01) and 4.8% in mixed allele carriers (95% CI: -6.8% to -2.8%, p < 0.01), with a significant between-group difference (7.0%, 95% CI: -13.0% to -1.0%, p < 0.01). Methylfolate, P5P, and methylcobalamin supplementation tailored to genetic profiles effectively reduced homocysteine and LDL-C levels in patients with specific MTHFR, MTR, and MTRR polymorphisms, particularly with homozygous minor allele polymorphisms.
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  • 文章类型: Journal Article
    Various diseases of the peripheral nervous system are associated with metabolic disorders of B vitamins. A lack of neurotropic vitamins, which began in the early stages of the development of a bacterial disease, led to its more rapid development. The article analyzes data on B vitamin deficiency in the pathogenesis of the most dangerous diseases of the peripheral nervous system. Information is provided about the dangers of the clinical use of the drug Combilipen for the treatment of such patients.
    Различные заболевания периферической нервной системы ассоциированы с нарушениями обмена витаминов группы B. Недостаток в организме нейротропных витаминов способствует раннему появлению клинических проявлений заболевания, его более быстрому прогрессированию. В статье анализируются данные о роли дефицита витаминов группы B в патогенезе наиболее распространенных заболеваний периферической нервной системы. Приведены сведения о результатах изучения клинического применения препарата Комбилипен для лечения таких больных.
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  • 文章类型: Journal Article
    两栖动物的大规模灭绝需要专门的计划来确保物种的生存。巴尔的摩的马里兰州动物园拥有极度濒危的巴拿马金蛙(Atelopuszeteki)的最大保证种群。然而,这个人群中的个体会经历类似于tetany的综合征,以四肢僵硬/位置不当和跳跃困难为特征,游泳,和扶正。在这项研究中,我们指定了综合征病例定义,并描述了相关的临床体征.然后,我们对四种不同的治疗方法进行了系统评估,以找到最有效的治疗方案,并开始阐明其根本原因.83只青蛙符合病例定义,用葡萄糖酸钙口服治疗14d,氯化镁,补充灌胃喂养,或钙的组合,镁,和复合维生素B.青蛙用定义的评估跳跃的协议进行了测试,Righting,游泳能力。在症状发作时进行测试,每周重复一次,直到出现缓解。分析表明,联合治疗在消除手提综合征的临床症状方面显着更有效。结果显示了治疗这种综合征最有效的方法,但无助于阐明根本原因。未来的工作将侧重于检查因素(例如,饮食,畜牧业),可能会引发该综合征,以便更全面地了解其病因。
    The mass extinction of amphibians necessitates specialized programs to ensure species\' survival. Maryland Zoo in Baltimore houses the largest assurance population of the critically endangered Panamanian golden frog (Atelopus zeteki). However, individuals in this population experience a tetany-like syndrome, characterized by rigid/inappropriately positioned limbs and difficulty hopping, swimming, and righting. In this study, a syndrome case definition was assigned and the associated clinical signs were described. Then, four different treatments were systematically assessed in order to find the most effective protocol for treatment and begin to elucidate its underlying causes. Eighty-three frogs fulfilled the case definition and were treated orally for 14 d with either calcium gluconate, magnesium chloride, supplemental gavage feeding, or combination of calcium, magnesium, and vitamin B complex. Frogs were tested with a defined protocol assessing hopping, righting, and swimming abilities. Testing was performed at symptom onset and repeated weekly until resolution occurred. Analyses revealed that combination treatment was significantly more effective in eliminating clinical signs of tetany syndrome. Results show the most effective way to treat this syndrome, but do not help elucidate the underlying cause. Future work will focus on examining factors (e.g., diet, husbandry) that may elicit the syndrome for a more complete understanding of its etiology.
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  • 文章类型: Journal Article
    B族维生素和益生菌是常用的膳食补充剂,具有良好的健康益处。然而,他们的潜在相互作用仍然知之甚少。本研究旨在通过液相色谱-三重四极杆质谱分析探讨B族维生素和益生菌联合使用的效果和潜在机制,药代动力学建模,和16SrRNA基因测序。通过对健康大鼠(每组n=8)灌胃给予7种B族维生素和3种乳酸菌,我们发现益生菌显著促进维生素B1,B3,B5和B12的吸收(约14.5%~71.2%).通过进行体外实验(每组n=3)和基于伪无菌大鼠模型的药代动力学研究(每组n=6),我们证实,益生菌主要通过肠道微生物群介导的机制增强B族维生素的吸收,而不是直接生产B族维生素。此外,我们通过用空白溶液处理假无菌大鼠来评价B族维生素和益生菌对结肠和肠道菌群的影响,B族维生素,益生菌,和B族维生素+益生菌(每组n=5),分别。组织病理学检查表明,B族维生素和益生菌的组合协同减轻了大鼠结肠损伤。高通量基因测序还揭示了B族维生素和益生菌在调节肠道菌群方面的协同作用,特别是增加了Verrucomicrobia和Akkermansia的丰度。总之,B族维生素和益生菌的联合给药可能比单独使用它们具有更高的疗效。
    B vitamins and probiotics are commonly used dietary supplements with well-documented health benefits. However, their potential interactions remain poorly understood. This study aims to explore the effects and underlying mechanisms of the combined use of B vitamins and probiotics by liquid chromatography-triple quadrupole mass spectrometry analysis, pharmacokinetic modeling, and 16S rRNA gene sequencing. By intragastric administration of seven B vitamins and three Lactobacillus strains to healthy rats (n = 8 per group), we found that probiotics significantly promoted the absorption (by approximately 14.5% to 71.2%) of vitamins B1, B3, B5, and B12. By conducting in vitro experiments (n = 3 per group) and a pseudo-germ-free rat model-based pharmacokinetic study (n = 6 per group), we confirmed that probiotics primarily enhanced the B vitamin absorption through gut microbiota-mediated mechanisms, rather than by directly producing B vitamins. Furthermore, we evaluated the effects of B vitamins and probiotics on the colon and gut microbiota by treating the pseudo-germ-free rats with blank solution, B vitamins, probiotics, and B vitamins + probiotics (n = 5 per group), respectively. Histopathological examination showed that the combination of B vitamins and probiotics synergistically alleviated the rat colon damage. High-throughput genetic sequencing also revealed the synergistic effect of B vitamins and probiotics in modulating the gut microbiota, particularly increasing the abundance of Verrucomicrobia and Akkermansia. In summary, the combined administration of B vitamins and probiotics may have a higher efficacy than using them alone.
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  • 文章类型: Journal Article
    背景:紫杉醇是一种用于治疗乳腺癌的高效化疗药物,卵巢,和其他癌症。同时,紫杉醇在45%-70%的患者中作为副作用引起周围神经病变。
    目的:本研究的目的是研究紫杉醇诱导的周围神经病变对动物唾液腺病理变化发展的影响,并探讨用维生素B/ATP复合物纠正已确定的变化的可能性。
    方法:为了模拟中毒性神经病,给动物注射紫杉醇2mg/kg,持续4天。为了纠正已识别的更改,给大鼠注射I/M维生素B/ATP复合物(1mg/kg)9天。在颌下腺的匀浆中,α-淀粉酶活性,总蛋白水解活性,总抗胰蛋白酶活性,中等质量分子的含量,硫代巴比妥酸反应性物质(TBARS),氧化修饰的蛋白质,并测定过氧化氢酶活性。
    结果:氧化修饰蛋白的含量显着增加,中等质量分子,与完整动物的这些参数相比,在具有毒性神经病变的动物的唾液腺中确定了TBARS的含量以及过氧化氢酶和淀粉酶活性的显着降低。在紫杉醇诱导的神经病变的背景下,服用维生素B/ATP复合物9天导致抗胰蛋白酶活性和淀粉酶活性正常化,氧化修饰蛋白质的含量显着降低,中等质量分子,和TBARS以及与未经治疗的神经病大鼠相比,动物唾液腺中过氧化氢酶活性的显着增加。
    结论:紫杉醇引起的神经病变引起大鼠唾液腺的病理变化,这由羰基氧化应激和受损的蛋白质合成功能证明。使用维生素B/ATP复合物的校正恢复了蛋白质合成功能和蛋白酶抑制剂平衡,抑制了大鼠唾液腺中的氧化应激和自由基过程的正常化。
    BACKGROUND: Paclitaxel is a highly effective chemotherapeutic agent used to treat breast, ovarian, and other cancers. At the same time, paclitaxel causes peripheral neuropathy as a side effect in 45%-70% of patients.
    OBJECTIVE: The aim of the study was to investigate the effect of paclitaxel-induced peripheral neuropathy on the development of pathological changes in the salivary glands of animals and to explore the possibility of correction of the identified changes with vitamin B/ATP complex.
    METHODS: To simulate toxic neuropathy, animals were injected i/p with paclitaxel 2 mg/kg for 4 days. In order to correct the identified changes, rats were injected i/m with vitamin B/ATP complex (1 mg/ kg) for 9 days. In the homogenate of the submandibular salivary glands, α-amylase activity, total proteolytic activity, total antitryptic activity, the content of medium mass molecules, thiobarbituric acid reactive substances (TBARS), oxidatively modified proteins, and catalase activity were determined.
    RESULTS: A significant increase in the content of oxidatively modified proteins, medium mass molecules, and the content of TBARS and significant decrease in the activity of catalase and amylase were determined in the salivary glands of animals with toxic neuropathy compared to these parameters in intact animals. Administration of vitamin B/ATP complex for 9 days against the background of paclitaxel-induced neuropathy led to normalization of antitryptic activity and amylase activity, a significant decrease in the content of oxidatively modified proteins, medium mass molecules, and TBARS along with a significant increase in catalase activity in the salivary glands of animals compared to the untreated rats with neuropathy.
    CONCLUSIONS: Paclitaxel-induced neuropathy caused the development of pathological changes in the salivary glands of rats, which was evidenced by a carbonyl- oxidative stress and impaired protein synthetic function. The correction with vitamin B/ATP complex restored the protein-synthetic function and the proteinase-inhibitor balance, suppressed the oxidative stress and normalized free radical processes in the salivary glands of rats.
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  • 文章类型: Journal Article
    背景:肌肉骨骼疾病是缺勤的重要原因。临床实践指南建议使用非甾体抗炎药(NSAIDs)治疗I-II级宫颈扭伤。已经使用了硫胺素+吡哆醇+氰钴胺维生素的组合,单独和与NSAIDs联合使用,肌肉骨骼疾病的疼痛和炎症。
    目的:本研究的目的是证明右酮洛芬的镇痛协同作用,和维生素硫胺素+吡哆醇+氰钴胺的组合在固定剂量组合(FDC)中用于治疗由I-II级宫颈扭伤引起的急性疼痛。
    方法:我们进行了多中心,prospective,随机化,双盲,IIIb期临床研究比较两个治疗组:(1)右酮洛芬25毫克/维生素B(硫胺素100毫克,吡哆醇50mg和氰钴胺0.50mg)在FDC(两种或更多种活性成分组合在一个单一的剂型)与(2)右酮洛芬25mg单药治疗(单一药物治疗特定的疾病),口服一个胶囊或片剂,每8小时7天。最终意味着,平均变化,和疼痛感知的百分比变化(使用视觉模拟评分[VAS]测量)与基线进行比较。P值<0.05被认为是统计学上显著的。使用SPSS软件进行分析,v.29.0.
    结果:与单药治疗相比,从FDC治疗的第三天开始观察到疼痛强度的统计学显着降低(-3.1±-1.5和-2.6±-1.1cm,分别)使用VAS(p=0.011)测量。关于残疾程度,使用NorthwickPark颈部疼痛问卷(NPQ),在最终测量中观察到统计学差异(7.5%,四分位数间距[IQR]2.5,10.5;vs.7.9%,IQR5.0,13.8;p=0.028)。使用FDC时报告的不良事件比例较低。
    结论:右酮洛芬/硫胺素+吡哆醇+氰钴胺维生素的FDC与右酮洛芬单药治疗I-II级宫颈扭伤患者的疼痛相比,显示出更好的疗效和更好的安全性。
    背景:NCT05001555,注册于2021年7月29日(https://clinicaltrials.gov/study/NCT05001555)。
    BACKGROUND: Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I-II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders.
    OBJECTIVE: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains.
    METHODS: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0.
    RESULTS: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± - 1.5 and - 2.6 ± - 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC.
    CONCLUSIONS: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains.
    BACKGROUND: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).
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