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Comparative analysis of the efficacy of seniprutug (BCD-180) and adalimumab in the treatment of active radiographic axial spondyloarthritis: results of a systematic review and matching-adjusted indirect comparison 塞尼鲁图(BCD-180)与阿达木单抗治疗活动性放射性轴性脊柱关节炎疗效的比较分析:系统综述和匹配调整间接比较的结果
Pub Date : 2024-04-19 DOI: 10.14412/1996-7012-2024-2-33-40
A. Lila, T. Dubinina, D. Tolkacheva, K. V. Sapozhnikov, N. Sableva, M. A. Morozova, P. S. Pukhtinskaia
Objective: to compare the clinical efficacy of seniprutug (BCD-180) and adalimumab (ADA) in the treatment of adults with active radiographic axial spondyloarthritis (r-axSpA).Materials and methods. Based on the results of a previously conducted systematic review, an unanchored matching-adjusted indirect comparison (MAIC) was performed, adjusting for confounding factors. The analysis was based on the results of randomized placebo-controlled clinical trials of seniprutug (BCD-180-2/ELEFTA, NCT05445076) and ADA (ATLAS, NCT00085644) that met the selection criteria. We chose ASAS40 and ASAS20 measurements at week 24 as efficacy outcomes. Initial BASDAI and BASFI indices, proportion of women in the study population, time from disease onset, and baseline C-reactive protein (CRP) levels were considered as confounders.Results and discussion. The MAIC showed a statistically significant advantage in the clinical efficacy of seniprutug (BCD-180) over ADA. When adjusted, the odds ratios (OR) with 95% confidence intervals (CI) for seniprutug (BCD-180)/ADA were 1.86 (1.15; 3.02) and 2.21 (1.34; 3.72) for ASAS40 and ASAS20, respectively, at week 24.Conclusion. The MAIC demonstrated statistically significant superiority of seniprutug (BCD-180) over ADA on the key efficacy endpoints ASAS40 and ASAS20 at week 24 in adults with active r-axSpA. The inclusion of the innovative domestic drug seniprutug into treatment paradigm of active r-axSpA will potentially reduce the socio-economic burden of this disease by providing an affordable, effective and safe therapy while optimizing healthcare costs
目的:比较塞尼鲁特(BCD-180)和阿达木单抗(ADA)治疗活动性放射性轴性脊柱关节炎(r-axSpA)成人患者的临床疗效。根据之前进行的系统综述的结果,进行了非锚定匹配调整间接比较(MAIC),并对混杂因素进行了调整。分析基于符合选择标准的seniprutug(BCD-180-2/ELEFTA,NCT05445076)和ADA(ATLAS,NCT00085644)随机安慰剂对照临床试验的结果。我们选择了第 24 周的 ASAS40 和 ASAS20 作为疗效结果。初始 BASDAI 和 BASFI 指数、研究人群中的女性比例、发病时间和基线 C 反应蛋白 (CRP) 水平被视为混杂因素。MAIC显示,与ADA相比,seniprutug(BCD-180)的临床疗效具有显著的统计学优势。经调整后,在第24周时,seniprutug (BCD-180)/ADA在ASAS40和ASAS20中的几率比(OR)及95%置信区间(CI)分别为1.86 (1.15; 3.02)和2.21 (1.34; 3.72)。MAIC表明,在活动性r-axSpA成人患者中,第24周时,在关键疗效终点ASAS40和ASAS20上,seniprutug(BCD-180)在统计学上明显优于ADA。将国产创新药物 seniprutug 纳入活动性 raxSpA 的治疗范例,将有可能在优化医疗成本的同时提供一种负担得起、有效且安全的疗法,从而减轻该疾病的社会经济负担。
{"title":"Comparative analysis of the efficacy of seniprutug (BCD-180) and adalimumab in the treatment of active radiographic axial spondyloarthritis: results of a systematic review and matching-adjusted indirect comparison","authors":"A. Lila, T. Dubinina, D. Tolkacheva, K. V. Sapozhnikov, N. Sableva, M. A. Morozova, P. S. Pukhtinskaia","doi":"10.14412/1996-7012-2024-2-33-40","DOIUrl":"https://doi.org/10.14412/1996-7012-2024-2-33-40","url":null,"abstract":"Objective: to compare the clinical efficacy of seniprutug (BCD-180) and adalimumab (ADA) in the treatment of adults with active radiographic axial spondyloarthritis (r-axSpA).Materials and methods. Based on the results of a previously conducted systematic review, an unanchored matching-adjusted indirect comparison (MAIC) was performed, adjusting for confounding factors. The analysis was based on the results of randomized placebo-controlled clinical trials of seniprutug (BCD-180-2/ELEFTA, NCT05445076) and ADA (ATLAS, NCT00085644) that met the selection criteria. We chose ASAS40 and ASAS20 measurements at week 24 as efficacy outcomes. Initial BASDAI and BASFI indices, proportion of women in the study population, time from disease onset, and baseline C-reactive protein (CRP) levels were considered as confounders.Results and discussion. The MAIC showed a statistically significant advantage in the clinical efficacy of seniprutug (BCD-180) over ADA. When adjusted, the odds ratios (OR) with 95% confidence intervals (CI) for seniprutug (BCD-180)/ADA were 1.86 (1.15; 3.02) and 2.21 (1.34; 3.72) for ASAS40 and ASAS20, respectively, at week 24.Conclusion. The MAIC demonstrated statistically significant superiority of seniprutug (BCD-180) over ADA on the key efficacy endpoints ASAS40 and ASAS20 at week 24 in adults with active r-axSpA. The inclusion of the innovative domestic drug seniprutug into treatment paradigm of active r-axSpA will potentially reduce the socio-economic burden of this disease by providing an affordable, effective and safe therapy while optimizing healthcare costs","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":" 83","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140683719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is there a “renal-pulmonary syndrome” in rheumatoid arthritis? 类风湿性关节炎是否存在 "肾肺综合征"?
Pub Date : 2024-04-19 DOI: 10.14412/1996-7012-2024-2-51-55
A. V. Gordeev, E. Galushko, E. V. Matyanova, E. V. Pozhidaev, E. Zotkin, A. Lila
Objective: to compare the course of “rheumatoid disease” in multimorbid patients with and without interstitial lung disease (ILD).Material and methods. Two groups were formed of 1034 patients with active rheumatoid arthritis (RA) who met the 2010 ACR/EULAR criteria: one group with ILD identified by high-resolution computed tomography of the lungs (n=82) and another – without ILD (n=900). In all patients, estimated glomerular filtration rate (eGFR) was determined using the Cockroft–Gault formula. The presence and stage of chronic kidney disease (CKD) was assessed depending on the eGFR level: stage I CKD was diagnosed in eGFR <89 ml/min, stage II (subclinical) – 60
目的:比较患有和未患有间质性肺病(ILD)的多病种患者的 "类风湿病 "病程。将符合2010年ACR/EULAR标准的1034名活动性类风湿性关节炎(RA)患者分为两组:一组通过高分辨率肺部计算机断层扫描确定患有间质性肺病(82人),另一组没有间质性肺病(900人)。所有患者的估计肾小球滤过率(eGFR)均采用 Cockroft-Gault 公式测定。根据 eGFR 水平评估慢性肾脏病(CKD)的存在和分期:eGFR <89 ml/min,诊断为 I 期 CKD;II 期(亚临床)- 60
{"title":"Is there a “renal-pulmonary syndrome” in rheumatoid arthritis?","authors":"A. V. Gordeev, E. Galushko, E. V. Matyanova, E. V. Pozhidaev, E. Zotkin, A. Lila","doi":"10.14412/1996-7012-2024-2-51-55","DOIUrl":"https://doi.org/10.14412/1996-7012-2024-2-51-55","url":null,"abstract":"Objective: to compare the course of “rheumatoid disease” in multimorbid patients with and without interstitial lung disease (ILD).Material and methods. Two groups were formed of 1034 patients with active rheumatoid arthritis (RA) who met the 2010 ACR/EULAR criteria: one group with ILD identified by high-resolution computed tomography of the lungs (n=82) and another – without ILD (n=900). In all patients, estimated glomerular filtration rate (eGFR) was determined using the Cockroft–Gault formula. The presence and stage of chronic kidney disease (CKD) was assessed depending on the eGFR level: stage I CKD was diagnosed in eGFR <89 ml/min, stage II (subclinical) – 60<eGFR <89 ml/min, stage IIIa (clinical) – 45<eGFR<59 ml/min and IIIb – 30<eGFR<45 ml/min.Results and discussion. Arterial hypertension (p=0.004), cerebrovascular disease (p=0.0001), diabetes mellitus (p=0.04), obesity, psoriasis (p=0.009) and stage II–III CKD (p=0.04) were more frequently observed in the group with ILD.Conclusion. The combination of CKD and ILD frequently found in patients with RA and the known similarity and close interrelationship of the pathogenesis of these diseases, suggest a type of “renal-pulmonary syndrome” associated with a specific variant of RA.","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":" 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140684051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus (results of a 6-month study) I 型干扰素受体抑制剂阿尼夫单抗对系统性红斑狼疮患者的疗效和安全性(为期 6 个月的研究结果)
Pub Date : 2024-04-19 DOI: 10.14412/1996-7012-2024-2-16-24
T. Reshetnyak, E. Aseeva, A. Shumilova, N. Nikishina, S. Glukhova, S. Shkireeva, A. Lila
Objective: to evaluate the efficacy and safety of the type I interferon (IFN) receptor inhibitor anifrolumab (AFM, Safnelo®) in patients with systemic lupus erythematosus (SLE) in real-life clinical practice over an observation period of 6 months.Material and methods. The prospective 6-month study included 21 patients with SLE fulfilling the 2012 SLICC criteria, predominantly women (n=17,81%), median age – 31 [27; 46] years, disease duration – 9 [6.0; 11.0] years. Standard laboratory values and immunological markers of SLE were examined in all patients. The SLEDAI-2K index was used to determine the activity of SLE, and the severity of the mucocutaneous syndrome was assessed using the Cutaneous Lupus Disease Area and Severity Index (CLASI) index. Organ damage was assessed using the SLICC/ACR Damage Index (DI). After 6 months, the achievement of low activity was assessed according to the Lupus Low Disease Activity State (LLDAS) indexResults and discussion. At the time of inclusion in the study, the mean SLEDAI-2K activity index for the group was 8 [6.0; 10.0] points, the median CLASI index – 8.6±8.2 points, 81% of patients had skin and mucosal lesions, 66% had non-erosive polyarthritis, and high immunological activity was observed in all cases. Various irreversible organ damage was observed in 86 of patients. The average DI was 2.2±1.5 points. At the start of AFM therapy, all patients received glucocorticoids (GCs) at a mean dose of 10.7±5.6 mg/day, 52% of patients received a dose above 10 mg/day, 76% of patients continued to take hydroxychloroquine, and 33% of patients took immunosuppressants. Significant positive dynamics were observed with AFM therapy. The average CLASI index for the group after 3 months of treatment was 1.2±4.1 points, after 6 months – 0.3±1.2 points (p<0.0001). The SLEDAI-2K index fell significantly in the group on average from 8 [6.0; 10.0] to 2 [2.0; 4.0] points from the 3rd month of treatment (p<0.0001) and remained at the same level after 6 months. At month 6 of treatment, 13 (62%) of 21 patients met the LLDAS criteria for low disease activity. After the 3rd month of treatment, a significant decrease in antibodies against dsDNA was observed, which persisted for 6 months after the start of treatment. In the group as a whole, there were no significant changes in complement fractions values during the observation period. There was no increase in irreversible organ damage (DI – mean 2.2±1.5 points). The mean daily dose of GCs was significantly reduced from 10.7±5.6 mg/day to 7.5±4.0 mg/day (p<0.01) by the 3rd month and to 5.2±2.1 (p<0.001) by the 6th month of treatment. No infusion reactions were observed in any case. Adverse events occurred in 9 (42%) out of 21 patients, mainly herpes infections of varying severity, mainly after the 1st to 3rd infusions. In one case, severe herpes zoster was observed, so the drug was discontinued.Conclusion. At a dose of 300 mg intravenously monthly AFM is a highly effective drug with a relat
目的:评估I型干扰素(IFN)受体抑制剂anifrolumab(AFM,Safnelo®)在系统性红斑狼疮(SLE)患者实际临床实践中的疗效和安全性,观察期为6个月。这项为期 6 个月的前瞻性研究纳入了 21 名符合 2012 SLICC 标准的系统性红斑狼疮患者,其中以女性为主(17.81%),年龄中位数为 31 [27; 46]岁,病程为 9 [6.0; 11.0]年。所有患者均接受了系统性红斑狼疮的标准实验室值和免疫标记物检查。SLEDAI-2K指数用于确定系统性红斑狼疮的活动性,皮肤粘膜综合征的严重程度则用皮肤狼疮疾病面积和严重程度指数(CLASI)来评估。器官损伤采用SLICC/ACR损伤指数(DI)进行评估。6个月后,根据狼疮低疾病活动状态(LLDAS)指数评估低活动状态的实现情况。纳入研究时,该组患者的平均 SLEDAI-2K 活动指数为 8 [6.0; 10.0] 点,CLASI 指数中位数为(8.6±8.2)点,81% 的患者有皮肤和粘膜病变,66% 的患者有非侵蚀性多关节炎,所有病例均观察到高免疫活动性。86例患者出现各种不可逆的器官损伤。平均 DI 为 2.2±1.5 点。在 AFM 治疗开始时,所有患者均接受糖皮质激素(GCs)治疗,平均剂量为(10.7±5.6)毫克/天,52% 的患者接受的剂量高于 10 毫克/天,76% 的患者继续服用羟氯喹,33% 的患者服用免疫抑制剂。AFM疗法观察到了显著的积极动态。治疗 3 个月后,治疗组的平均 CLASI 指数为 1.2±4.1 点,6 个月后为 0.3±1.2 点(P<0.0001)。治疗组的 SLEDAI-2K 指数从治疗第 3 个月起平均从 8 [6.0; 10.0] 点明显下降到 2 [2.0; 4.0] 点(p<0.0001),6 个月后保持在同一水平。治疗第 6 个月时,21 名患者中有 13 人(62%)符合 LLDAS 低疾病活动性标准。治疗第 3 个月后,dsDNA 抗体显著下降,这种情况在治疗开始后持续了 6 个月。在观察期间,全组补体分数值无明显变化。不可逆器官损伤(DI - 平均 2.2±1.5 点)没有增加。治疗第 3 个月时,GCs 的平均日剂量从 10.7±5.6 mg/天大幅降至 7.5±4.0 mg/天(p<0.01),第 6 个月时降至 5.2±2.1 mg/天(p<0.001)。未发现任何输液反应。21例患者中有9例(42%)发生了不良反应,主要是不同程度的疱疹感染,主要发生在第1至第3次输液后。其中一例患者出现了严重的带状疱疹,因此停药。每月静脉注射300毫克的AFM是一种高效药物,对于存在自身抗体且对标准疗法反应不佳的活动性系统性红斑狼疮患者来说,其安全性相对较好。
{"title":"Efficacy and safety of the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus (results of a 6-month study)","authors":"T. Reshetnyak, E. Aseeva, A. Shumilova, N. Nikishina, S. Glukhova, S. Shkireeva, A. Lila","doi":"10.14412/1996-7012-2024-2-16-24","DOIUrl":"https://doi.org/10.14412/1996-7012-2024-2-16-24","url":null,"abstract":"Objective: to evaluate the efficacy and safety of the type I interferon (IFN) receptor inhibitor anifrolumab (AFM, Safnelo®) in patients with systemic lupus erythematosus (SLE) in real-life clinical practice over an observation period of 6 months.Material and methods. The prospective 6-month study included 21 patients with SLE fulfilling the 2012 SLICC criteria, predominantly women (n=17,81%), median age – 31 [27; 46] years, disease duration – 9 [6.0; 11.0] years. Standard laboratory values and immunological markers of SLE were examined in all patients. The SLEDAI-2K index was used to determine the activity of SLE, and the severity of the mucocutaneous syndrome was assessed using the Cutaneous Lupus Disease Area and Severity Index (CLASI) index. Organ damage was assessed using the SLICC/ACR Damage Index (DI). After 6 months, the achievement of low activity was assessed according to the Lupus Low Disease Activity State (LLDAS) indexResults and discussion. At the time of inclusion in the study, the mean SLEDAI-2K activity index for the group was 8 [6.0; 10.0] points, the median CLASI index – 8.6±8.2 points, 81% of patients had skin and mucosal lesions, 66% had non-erosive polyarthritis, and high immunological activity was observed in all cases. Various irreversible organ damage was observed in 86 of patients. The average DI was 2.2±1.5 points. At the start of AFM therapy, all patients received glucocorticoids (GCs) at a mean dose of 10.7±5.6 mg/day, 52% of patients received a dose above 10 mg/day, 76% of patients continued to take hydroxychloroquine, and 33% of patients took immunosuppressants. Significant positive dynamics were observed with AFM therapy. The average CLASI index for the group after 3 months of treatment was 1.2±4.1 points, after 6 months – 0.3±1.2 points (p<0.0001). The SLEDAI-2K index fell significantly in the group on average from 8 [6.0; 10.0] to 2 [2.0; 4.0] points from the 3rd month of treatment (p<0.0001) and remained at the same level after 6 months. At month 6 of treatment, 13 (62%) of 21 patients met the LLDAS criteria for low disease activity. After the 3rd month of treatment, a significant decrease in antibodies against dsDNA was observed, which persisted for 6 months after the start of treatment. In the group as a whole, there were no significant changes in complement fractions values during the observation period. There was no increase in irreversible organ damage (DI – mean 2.2±1.5 points). The mean daily dose of GCs was significantly reduced from 10.7±5.6 mg/day to 7.5±4.0 mg/day (p<0.01) by the 3rd month and to 5.2±2.1 (p<0.001) by the 6th month of treatment. No infusion reactions were observed in any case. Adverse events occurred in 9 (42%) out of 21 patients, mainly herpes infections of varying severity, mainly after the 1st to 3rd infusions. In one case, severe herpes zoster was observed, so the drug was discontinued.Conclusion. At a dose of 300 mg intravenously monthly AFM is a highly effective drug with a relat","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":" 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140684241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of the efficacy of complex analgesic therapy, including a combination of B vitamins, in patients with combination of osteoarthritis and chronic non-specific low back pain (results of an open-label pilot clinical trial) 评估复合镇痛疗法(包括 B 族维生素组合)对合并骨关节炎和慢性非特异性腰背痛患者的疗效(开放标签试点临床试验结果
Pub Date : 2024-04-19 DOI: 10.14412/1996-7012-2024-2-56-61
E. Filatova, A. Karateev, E. L. Shakhramanova, D. A. Ghukasyan, S. Y. Shkireeva, A. Lila
The vitamin B1, B6 and B12 complex (VBC) is frequently used to treat acute and chronic low back pain.Objective: to investigate the effect of a combination of a non-steroidal anti-inflammatory drug (NSAID) and a VBC on the main manifestations of nociceptive system dysfunction in patients with combination of osteoarthritis (OA) and chronic non-specific low back pain (NSLBP).Material and methods. The study group consisted of 99 patients (82% women, mean age 63.6±17.2 years) with OA of various localization andNSLBP who had moderate to severe pain (≥4 on a numerical rating scale, NRS 0–10). All patients received etoricoxib 60 mg/day (up to 14 days) and a course of intramuscular (IM) injections of VBC (a drug for parenteral administration containing solutions of thiamine 100 mg, pyridoxine 100 mg, cyanocobalamin 1.0 mg and lidocaine 20 mg) 2.0 ml №10. Treatment outcome was assessed after 14 days.Results and discussion. During treatment, the vast majority of patients showed a significant improvement: the median severity of pain on movement (NRS) decreased from 6.3 [5.0; 8.0] to 3.7 [3.0; 5.0], p=0.0001; functional impairment  –  from 3.8 [2.0; 6.0] to 2.2 [1.0; 3.0], p=0.001; fatigue – from 5.6 [4.0; 8.0] to 3.5 [0.0; 2.0], p=0.0001. 71.6% of patients rated the treatment results as good or excellent. Six patients had adverse reactions: 2 – local pain at the site of the intramuscular injections, 1 – arterial hypertension, 3 – epigastric pain. No serious adverse events were recorded.Conclusion. The combined use of NSAIDs and VBC can provide significant improvement in patients with a combination of OA and NSLBP.
目的:探讨非甾体抗炎药(NSAID)和维生素BC联合应用对骨关节炎(OA)和慢性非特异性腰背痛(NSLBP)患者痛觉系统功能障碍主要表现的影响。研究组由99名患有不同部位的骨关节炎和慢性非特异性腰背痛的患者组成(82%为女性,平均年龄(63.6±17.2)岁),这些患者的疼痛程度为中度至重度(数字评分量表≥4,NRS 0-10)。所有患者均接受依托考昔 60 毫克/天(最多 14 天)和 2.0 毫升№10 的 VBC(一种肠外给药药物,含有硫胺素 100 毫克、吡哆醇 100 毫克、氰钴胺 1.0 毫克和利多卡因 20 毫克)肌肉注射(IM)疗程。14 天后评估治疗效果。在治疗过程中,绝大多数患者的病情都有明显改善:活动时疼痛的中位严重程度(NRS)从 6.3 [5.0; 8.0] 降至 3.7 [3.0; 5.0],p=0.0001;功能障碍--从 3.8 [2.0; 6.0] 降至 2.2 [1.0; 3.0],p=0.001;疲劳--从 5.6 [4.0; 8.0] 降至 3.5 [0.0; 2.0],p=0.0001。71.6%的患者将治疗效果评为 "好 "或 "优"。六名患者出现了不良反应:2例--肌肉注射部位局部疼痛,1例--动脉高血压,3例--上腹部疼痛。无严重不良反应记录。联合使用非甾体抗炎药和 VBC 可显著改善 OA 和 NSLBP 患者的病情。
{"title":"Evaluation of the efficacy of complex analgesic therapy, including a combination of B vitamins, in patients with combination of osteoarthritis and chronic non-specific low back pain (results of an open-label pilot clinical trial)","authors":"E. Filatova, A. Karateev, E. L. Shakhramanova, D. A. Ghukasyan, S. Y. Shkireeva, A. Lila","doi":"10.14412/1996-7012-2024-2-56-61","DOIUrl":"https://doi.org/10.14412/1996-7012-2024-2-56-61","url":null,"abstract":"The vitamin B1, B6 and B12 complex (VBC) is frequently used to treat acute and chronic low back pain.Objective: to investigate the effect of a combination of a non-steroidal anti-inflammatory drug (NSAID) and a VBC on the main manifestations of nociceptive system dysfunction in patients with combination of osteoarthritis (OA) and chronic non-specific low back pain (NSLBP).Material and methods. The study group consisted of 99 patients (82% women, mean age 63.6±17.2 years) with OA of various localization andNSLBP who had moderate to severe pain (≥4 on a numerical rating scale, NRS 0–10). All patients received etoricoxib 60 mg/day (up to 14 days) and a course of intramuscular (IM) injections of VBC (a drug for parenteral administration containing solutions of thiamine 100 mg, pyridoxine 100 mg, cyanocobalamin 1.0 mg and lidocaine 20 mg) 2.0 ml №10. Treatment outcome was assessed after 14 days.Results and discussion. During treatment, the vast majority of patients showed a significant improvement: the median severity of pain on movement (NRS) decreased from 6.3 [5.0; 8.0] to 3.7 [3.0; 5.0], p=0.0001; functional impairment  –  from 3.8 [2.0; 6.0] to 2.2 [1.0; 3.0], p=0.001; fatigue – from 5.6 [4.0; 8.0] to 3.5 [0.0; 2.0], p=0.0001. 71.6% of patients rated the treatment results as good or excellent. Six patients had adverse reactions: 2 – local pain at the site of the intramuscular injections, 1 – arterial hypertension, 3 – epigastric pain. No serious adverse events were recorded.Conclusion. The combined use of NSAIDs and VBC can provide significant improvement in patients with a combination of OA and NSLBP.","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":" 364","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140682454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Results of a non-interventional multicenter study of management of patients with non-radiological axial spondyloarthritis in real-life clinical practice in the Russian Federation (NiSpAR) 俄罗斯联邦现实临床实践中对非放射性轴性脊柱关节炎患者管理的非干预性多中心研究(NiSpAR)结果
Pub Date : 2024-04-19 DOI: 10.14412/19967012-2024-2-41-50
T. Dubinina, A. Lila, E. V. Kvasova, E. Agafonova, I. Andrianova, L. V. Ivanova, D. V. Yurk, N.  A. Garaeva, E. Akulinushkina, A. N. Vedekhina, I. Bashkova, S. A. Lapshina, Y. Y. Grabovetskaya, N. F. Semenova, M. I. Valkova, D. Krechikova, O. S. Mazhaeva, I. B. Vinogradova, O. V. Bugrova, S. M. Voloshenko, G. R. Enikeeva, E. S. Immis, L. F. Timasheva, E. E. Biserova, L. Z. Shaimukhametova, I. Patrikeeva, A. A. Barakat, P. Shesternya, N. M. Nikitina, M. I. Yupatova, O. Anoshenkova, M. A. Korolev, Y. Ubshaeva, E. Vasilenko, E. Zonova, O. Nesmeyanova, E. Bogdanova, V. I. Mazurov, R. Samigullina, I. M. Marusenko
NiSpAR is a non-interventional, multicenter study whose aim was to describe a cohort of patients with non-radiological axial spondyloarthritis (nr-axSpA) and approaches to its diagnosis in the Russian Federation.Material and methods. The study involved 20 research centers in different regions of the Russian Federation. The work consisted of two phases: retrospective data collection 12 months before enrolment in the study and prospective observation of patients in whom the diagnosis of nr-axSpA was confirmed (104 weeks).The study included 272 patients who met the inclusion and exclusion criteria (Full Analysis Set, FAS). The mean age of the FAS-population was 38.7±11.0 years. The diagnosis of nr-axSpA was confirmed in 159 (58.5 %) of the 272 patients. Of the remaining 113 (41.5%) participants, 57 (50.4%) did not have the information required to confirm the diagnosis, 34 (30.1%) did not have pelvic radiographs, and 22 (19.5%) did not fulfil the ASAS criteria for nr-axSpA.Results and discussion. The mean age of patients with nr-axSpA was 37.6±10.4 years, more than half of them (52.8%) were women. The median disease duration was 36 [12; 80] months. In half of the patients the disease duration was more than 2 years, in more than one third – less than 2 years. The median CRP and ESR values were 5.0 [2.0; 12.0] mg/l and 11.0 [5.0; 18.0] mm/h, respectively. The BASDAI averaged 3.5±2.0 and was >4 in more than half of the cases (64.2%). The mean ASDAS-CRP value reached 2.6±1.1. Only 1 in 5 participants (20.8%) had low axSpA activity, while in 61.1% it was high (44.7%) or very high (16.4%). An inactive state was found in a small number of patients (9.4%). Twenty two (13.8%) patients had treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) in anamnesis, and 21 (13.2%) patients were still taking them.Conclusion. The results of the retrospective phase of the study show that in real-life clinical practice in the Russian Federation there is a continued positive trend towards improving the diagnosis of nr-axSpA. The median duration of the disease at the time of enrolment in the study was 3 years. The frequency of use of magnetic resonance imaging has increased by more than 1.8 times. At the same time, practitioners still have difficulties in establishing the diagnosis of nr-axSpA and a shortage of bDMARDs for treatment of these patients.
NiSpAR是一项非介入性多中心研究,旨在描述俄罗斯联邦非放射学轴性脊柱关节炎(nr-axSpA)患者群及其诊断方法。研究涉及俄罗斯联邦不同地区的 20 个研究中心。研究包括两个阶段:研究入选前12个月的回顾性数据收集,以及对确诊为nr-axSpA的患者进行前瞻性观察(104周)。研究包括272名符合纳入和排除标准的患者(全分析集,FAS)。FAS人群的平均年龄为(38.7±11.0)岁。272 名患者中有 159 人(58.5%)确诊为 nr-axSpA。其余113人(41.5%)中,57人(50.4%)没有确诊所需的信息,34人(30.1%)没有骨盆X光片,22人(19.5%)不符合ASAS nr-axSpA标准。nr-axSpA 患者的平均年龄为(37.6±10.4)岁,其中一半以上(52.8%)为女性。中位病程为 36 [12; 80] 个月。半数患者的病程超过 2 年,超过三分之一的患者少于 2 年。CRP 和 ESR 的中位值分别为 5.0 [2.0; 12.0] mg/l 和 11.0 [5.0; 18.0] mm/h。BASDAI 平均值为 3.5±2.0,半数以上病例(64.2%)的 BASDAI 值大于 4。ASDAS-CRP 平均值为 2.6±1.1。每 5 名参与者中只有 1 人(20.8%)的 axSpA 活性较低,而 61.1% 的参与者的 axSpA 活性较高(44.7%)或非常高(16.4%)。少数患者(9.4%)处于非活动状态。22例(13.8%)患者在病史中接受过生物改良抗风湿药(bDMARDs)治疗,21例(13.2%)患者仍在服用这些药物。回顾性阶段的研究结果表明,在俄罗斯联邦的实际临床实践中,改善 nr-axSpA 诊断的积极趋势仍在继续。参加研究时的中位病程为 3 年。磁共振成像的使用频率增加了1.8倍以上。与此同时,医生在确定 nr-axSpA 的诊断方面仍然存在困难,而且用于治疗这些患者的 bDMARDs 药物短缺。
{"title":"Results of a non-interventional multicenter study of management of patients with non-radiological axial spondyloarthritis in real-life clinical practice in the Russian Federation (NiSpAR)","authors":"T. Dubinina, A. Lila, E. V. Kvasova, E. Agafonova, I. Andrianova, L. V. Ivanova, D. V. Yurk, N.  A. Garaeva, E. Akulinushkina, A. N. Vedekhina, I. Bashkova, S. A. Lapshina, Y. Y. Grabovetskaya, N. F. Semenova, M. I. Valkova, D. Krechikova, O. S. Mazhaeva, I. B. Vinogradova, O. V. Bugrova, S. M. Voloshenko, G. R. Enikeeva, E. S. Immis, L. F. Timasheva, E. E. Biserova, L. Z. Shaimukhametova, I. Patrikeeva, A. A. Barakat, P. Shesternya, N. M. Nikitina, M. I. Yupatova, O. Anoshenkova, M. A. Korolev, Y. Ubshaeva, E. Vasilenko, E. Zonova, O. Nesmeyanova, E. Bogdanova, V. I. Mazurov, R. Samigullina, I. M. Marusenko","doi":"10.14412/19967012-2024-2-41-50","DOIUrl":"https://doi.org/10.14412/19967012-2024-2-41-50","url":null,"abstract":"NiSpAR is a non-interventional, multicenter study whose aim was to describe a cohort of patients with non-radiological axial spondyloarthritis (nr-axSpA) and approaches to its diagnosis in the Russian Federation.Material and methods. The study involved 20 research centers in different regions of the Russian Federation. The work consisted of two phases: retrospective data collection 12 months before enrolment in the study and prospective observation of patients in whom the diagnosis of nr-axSpA was confirmed (104 weeks).The study included 272 patients who met the inclusion and exclusion criteria (Full Analysis Set, FAS). The mean age of the FAS-population was 38.7±11.0 years. The diagnosis of nr-axSpA was confirmed in 159 (58.5 %) of the 272 patients. Of the remaining 113 (41.5%) participants, 57 (50.4%) did not have the information required to confirm the diagnosis, 34 (30.1%) did not have pelvic radiographs, and 22 (19.5%) did not fulfil the ASAS criteria for nr-axSpA.Results and discussion. The mean age of patients with nr-axSpA was 37.6±10.4 years, more than half of them (52.8%) were women. The median disease duration was 36 [12; 80] months. In half of the patients the disease duration was more than 2 years, in more than one third – less than 2 years. The median CRP and ESR values were 5.0 [2.0; 12.0] mg/l and 11.0 [5.0; 18.0] mm/h, respectively. The BASDAI averaged 3.5±2.0 and was >4 in more than half of the cases (64.2%). The mean ASDAS-CRP value reached 2.6±1.1. Only 1 in 5 participants (20.8%) had low axSpA activity, while in 61.1% it was high (44.7%) or very high (16.4%). An inactive state was found in a small number of patients (9.4%). Twenty two (13.8%) patients had treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) in anamnesis, and 21 (13.2%) patients were still taking them.Conclusion. The results of the retrospective phase of the study show that in real-life clinical practice in the Russian Federation there is a continued positive trend towards improving the diagnosis of nr-axSpA. The median duration of the disease at the time of enrolment in the study was 3 years. The frequency of use of magnetic resonance imaging has increased by more than 1.8 times. At the same time, practitioners still have difficulties in establishing the diagnosis of nr-axSpA and a shortage of bDMARDs for treatment of these patients.","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":" 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140683220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diet for gout and hyperuricaemia: some important questions 痛风和高尿酸血症的饮食:一些重要问题
Pub Date : 2024-02-21 DOI: 10.14412/1996-7012-2024-1-117-121
O. Zhelyabina, M. S. Eliseev, Y. I. Kuzmina
Diet has traditionally been viewed as playing a leading role in both the pathogenesis and treatment of gout. And although this thesis is controversial today, adherence to certain dietary rules for patients with gout and hyperuricemia (HU) is an integral part of therapy. The review examines the modern theoretical basis of dietary therapy for gout and HU, in particular the mechanisms of increasing serum uric acid levels and the risk of developing arthritis when certain foods are consumed and, conversely, reducing uric acid levels and the risk of gout when a diet containing a range of vitamins and foods in the supplements is followed.
传统观点认为,饮食在痛风的发病和治疗过程中起着主导作用。尽管这一观点在今天还存在争议,但痛风和高尿酸血症(HU)患者遵守一定的饮食规则是治疗不可或缺的一部分。这篇综述探讨了痛风和高尿酸血症饮食疗法的现代理论基础,特别是食用某些食物会增加血清尿酸水平和患关节炎风险的机制,以及反之,食用含有一系列维生素和补充食品的饮食会降低尿酸水平和痛风风险的机制。
{"title":"Diet for gout and hyperuricaemia: some important questions","authors":"O. Zhelyabina, M. S. Eliseev, Y. I. Kuzmina","doi":"10.14412/1996-7012-2024-1-117-121","DOIUrl":"https://doi.org/10.14412/1996-7012-2024-1-117-121","url":null,"abstract":"Diet has traditionally been viewed as playing a leading role in both the pathogenesis and treatment of gout. And although this thesis is controversial today, adherence to certain dietary rules for patients with gout and hyperuricemia (HU) is an integral part of therapy. The review examines the modern theoretical basis of dietary therapy for gout and HU, in particular the mechanisms of increasing serum uric acid levels and the risk of developing arthritis when certain foods are consumed and, conversely, reducing uric acid levels and the risk of gout when a diet containing a range of vitamins and foods in the supplements is followed.","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":"224 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140443480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Modern approaches to the treatment of Takayasu arteritis 治疗高安动脉炎的现代方法
Pub Date : 2024-02-21 DOI: 10.14412/1996-7012-2024-1-101-108
O. N. Egorova, G. Tarasova, G. M. Koylubaeva, A. Y. Sukhanina, I. Guseva, A. Bolotbekova, G. Suyunbai kyzy, A. Turatbekova, A. A. Okunova, A. O. Abdykerimov, T. Reshetnyak
Takayasu arteritis (AT) is a chronic granulomatous systemic vasculitis that affects large vessels and requires a multidisciplinary approach as the clinical signs are non-specific and disease activity is difficult to assess. Early rational drug treatment of AT suppresses both vascular and systemic inflammation, with glucocorticoids and immunosuppressants being of paramount importance. Advances in the understanding of the pathophysiology of AT have contributed to the development of new treatments that target key pro-inflammatory factors and involve the use of biologic disease-modifying antirheumatic drugs.
高安动脉炎(AT)是一种影响大血管的慢性肉芽肿性系统性血管炎,由于临床症状无特异性,且疾病活动性难以评估,因此需要多学科联合治疗。AT 的早期合理药物治疗可抑制血管和全身炎症,其中糖皮质激素和免疫抑制剂至关重要。对 AT 病理生理学认识的进步促进了针对关键促炎因子的新疗法的开发,并涉及到生物改变病情抗风湿药物的使用。
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引用次数: 0
The use of biologic therapy in patients with ankylosing spondylitis and coxitis: dynamics of clinical and laboratory parameters and structural progression 在强直性脊柱炎和关节炎患者中使用生物疗法:临床和实验室参数及结构进展的动态变化
Pub Date : 2024-02-21 DOI: 10.14412/1996-7012-2024-1-109-116
S. Erdes, V. Achikyan, E. Agafonova
Hip joint inflammation (coxitis) occurs in almost half of patients with ankylosing spondylitis (AS) and often leads to early disability. A therapy for this condition has not yet been developed, although it is one of the indications for the initiation of biologic therapy in national recommendations. The review presents data from recent clinical trials on the use of biologics, focusing on the Russian national multicenter study of GO-COX in patients with AS with coxitis.Tumour necrosis factor-α inhibitors have been shown to be effective against inflammatory affection of the hip joint in patients with AS, and their administration over a two-year period inhibits the progression of coxitis.
近一半的强直性脊柱炎(AS)患者会出现髋关节炎症(髋关节炎),并经常导致早期残疾。尽管在国家建议中,髋关节炎是开始使用生物制剂治疗的适应症之一,但针对这种情况的疗法尚未开发出来。肿瘤坏死因子-α抑制剂已被证明对强直性脊柱炎患者髋关节的炎症性病变有效,而且在两年的用药期内可抑制髋关节炎的发展。
{"title":"The use of biologic therapy in patients with ankylosing spondylitis and coxitis: dynamics of clinical and laboratory parameters and structural progression","authors":"S. Erdes, V. Achikyan, E. Agafonova","doi":"10.14412/1996-7012-2024-1-109-116","DOIUrl":"https://doi.org/10.14412/1996-7012-2024-1-109-116","url":null,"abstract":"Hip joint inflammation (coxitis) occurs in almost half of patients with ankylosing spondylitis (AS) and often leads to early disability. A therapy for this condition has not yet been developed, although it is one of the indications for the initiation of biologic therapy in national recommendations. The review presents data from recent clinical trials on the use of biologics, focusing on the Russian national multicenter study of GO-COX in patients with AS with coxitis.Tumour necrosis factor-α inhibitors have been shown to be effective against inflammatory affection of the hip joint in patients with AS, and their administration over a two-year period inhibits the progression of coxitis.","PeriodicalId":18651,"journal":{"name":"Modern Rheumatology Journal","volume":"7 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140443030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical case of systemic sclerosis in a male patient: gender differences and possibilities of capillaroscopy 一名男性患者的系统性硬化症临床病例:性别差异与毛细血管镜检查的可能性
Pub Date : 2024-02-20 DOI: 10.14412/1996-7012-2024-1-84-89
A. S. Trofimova, A. A. Shokhin, E. Trofimov, M. S. Shostak
A patient with a subacute course of systemic sclerosis (SSc) and a three-phase Raynaud's phenomenon at the onset of the disease is described. The diagnosis was made in accordance with the ACR/EULAR 2013 criteria. Within 8 months of disease onset, the patient developed the classic picture of SSc with multiple organ involvement, and nailfold capillaroscopy showed signs of the active stage of scleroderma angiopathy. The factors for an unfavorable course of SSc were analyzed.
本文描述了一名亚急性系统性硬化症(SSc)患者,该患者发病时出现三期雷诺现象。诊断是根据 ACR/EULAR 2013 标准做出的。在发病后的8个月内,患者出现了多器官受累的典型SSc症状,甲襞毛细血管镜检查显示出硬皮病血管病变活动期的迹象。研究分析了导致SSc病情恶化的因素。
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引用次数: 0
Mixed connective tissue disease with juvenile onset: results of a retrospective single-center study 青少年发病的混合性结缔组织病:一项单中心回顾性研究的结果
Pub Date : 2024-02-20 DOI: 10.14412/1996-7012-2024-1-62-69
M. I. Kaleda, I. Nikishina, A. Latypova, N. N. Yudkina, Z. Verizhnikova, A. Shapovalenko, T. Pachkoria
Mixed connective tissue disease (MCTD) is one of the very rare systemic autoimmune diseases; it accounts for 0.1–0.6% of cases in pediatric rheumatologists' practices. MCTD is characterized by a broad spectrum of clinical manifestations and a high frequency of extremely unspecific symptoms at the onset, with the overall picture of the disease forming slowly and gradually. The diagnosis is often delayed and confirmed only at an advanced stage of organ dysfunction with the development of irreversible changes.Objective: to identify a group of patients fulfilling the criteria for MCTD in an open, single-center, continuous retrospective study among anti-ribonucleoprotein (anti-RNP) antibody-positive patients and to analyze their demographic, clinical and laboratory characteristics and therapy.Material and methods. All anti-RNP-positive patients admitted to the pediatric department of V.A. Nasonova Research Institute of Rheumatology from 2019 to 2023 and meeting at least one of the variants of the MCTD criteria (Kasukawa, Alarcуn-Segovia, Kahn and Sharp criteria) were included in the study.Results and discussion. 18 (56.25%, 17 girls and 1 boy) of 32 anti-RNP-positive patients fulfilled criteria for MCTD. Patients most frequently fulfilled a combination of criteria – Sharp and Kahn (n=8) or Alarcуn-Segovia and Kahn (n=8). The median age of onset of MCTD was 12.2 [9.7; 13.9] years. The most common clinical manifestations were arthritis (100%), various skin lesions (94.4 %), Raynaud's phenomenon (88.9%), lymphadenopathy (72.2%) and general constitutional disorders (50%). Sjögren's syndrome (SS) was diagnosed in 17 (94.4%) patients. All patients had antinuclear factor (ANF) 1/1280, and the anti-RNP level was >200 U/ml. There were also antibodies against double-stranded DNA (n=5), Ro- (n=4) and Sm- (n=5) antigens. An IgM rheumatoid factor was detected in 6 patients and hypergammaglobulinemia in 10 patients. Capillaroscopic changes in the nailfold with predominant scleroderma type were found in 77.8% of patients. The most common combination was of Raynaud's phenomenon, arthritis, SS, lymphadenopathy and hypergammaglobulinemia (50%). All patients received glucocorticoids, 9 – hydroxychloroquine, 8 – methotrexate, 3 – mycophenolate mofetil, 1 – cyclophosphamide, 1 – azathioprine. Biologic DMARDs (bDMARDs) were prescribed to 12 (66.7%) patients: 3 – rituximab, 8 – abatacept, 1 – belimumab, with an acceptable safety profile and initial efficacy.Conclusion. Most patients in the study met the Kahn criteria. Only 2 patients met all variants of the criteria, which indicates the need to use a combination of criteria when a MCTD is suspected. A combination of Raynaud's phenomenon, arthritis, SS, lymphadenopathy and hypergammaglobulinemia was observed in half of patients with MCTD. The presence of Raynaud's phenomenon and high ANF titer in children with rheumatic diseases, especially with a polymorphic clinical picture, requires the inclusion of MCTD in differential d
混合结缔组织病(MCTD)是一种非常罕见的系统性自身免疫疾病,在儿科风湿病医生的诊疗中占 0.1-0.6% 的病例。混合型自身免疫性疾病的特点是临床表现范围广泛,发病时极少出现特异性症状,疾病的整体表现缓慢而渐进。目的:在抗核糖核蛋白(anti-RNP)抗体阳性患者中开展一项开放式、单中心、连续性回顾性研究,以确定一组符合 MCTD 标准的患者,并分析其人口统计学、临床和实验室特征及治疗情况。研究纳入了2019年至2023年期间V.A. Nasonova风湿病学研究所儿科收治的所有抗RNP阳性患者,这些患者至少符合MCTD标准的一种变体(Kasukawa标准、Alarcуn-Segovia标准、Kahn标准和Sharp标准)。32 名抗 RNP 阳性患者中有 18 名(56.25%,17 名女孩和 1 名男孩)符合 MCTD 标准。患者最常同时符合两种标准--夏普和卡恩标准(8 人)或阿拉库恩-塞戈维亚和卡恩标准(8 人)。MCTD的中位发病年龄为12.2 [9.7; 13.9]岁。最常见的临床表现为关节炎(100%)、各种皮肤病变(94.4%)、雷诺现象(88.9%)、淋巴结病(72.2%)和一般体质紊乱(50%)。17名患者(94.4%)被诊断出患有斯约格伦综合征(SS)。所有患者的抗核因子(ANF)均为1/1280,抗RNP水平>200 U/ml。此外,还有针对双链 DNA(5 人)、Ro-(4 人)和 Sm-(5 人)抗原的抗体。在 6 名患者中检测到 IgM 类风湿因子,在 10 名患者中检测到高丙种球蛋白血症。77.8%的患者的甲沟出现以硬皮病为主的毛细血管镜变化。最常见的合并症是雷诺现象、关节炎、SS、淋巴结病和高丙种球蛋白血症(50%)。所有患者都接受了糖皮质激素治疗,9 人接受了羟氯喹治疗,8 人接受了甲氨蝶呤治疗,3 人接受了霉酚酸酯治疗,1 人接受了环磷酰胺治疗,1 人接受了硫唑嘌呤治疗。12名患者(66.7%)使用了生物DMARDs(bDMARDs):3名患者使用了利妥昔单抗,8名患者使用了阿帕他赛,1名患者使用了贝利木单抗,其安全性和初步疗效均可接受。研究中的大多数患者都符合卡恩标准。结论:研究中的大多数患者符合卡恩标准,只有 2 名患者符合所有变异标准,这表明在怀疑患有 MCTD 时需要综合使用多种标准。半数 MCTD 患者合并有雷诺现象、关节炎、SS、淋巴结病和高丙种球蛋白血症。风湿性疾病患儿出现雷诺现象和高 ANF 滴度,尤其是临床表现多态,需要将 MCTD 纳入鉴别诊断。初步结果表明,在患有 MCTD 的儿童中使用生物药物是安全的。
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Modern Rheumatology Journal
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