痛敏穴刺血加艾灸疗法治疗类风湿关节炎临床疗效研究

摘要 目的：观察痛敏穴刺血加艾灸疗法治疗类风湿关节炎（RA）患者的临床疗效。方法：选取2019年1月~2022年1月44例类风湿关节炎患者随机分为2组,每组22例。对照组予以来氟米特片和塞来昔布胶囊治疗,观察组在对照组基础上采用痛敏穴刺血加艾灸疗法。两组患者治疗前后采用视觉模拟评分法（VAS）和疾病活动评分（DAS-28）进行评估,并检测类风湿因子(RF)、超敏C反应蛋白（hs-CRP）、血沉(ESR)、类风湿因子（RF）、纤维蛋白原（FIB）、D二聚体水平。结果：两组治疗后VAS评分降低（P<0.05）,而研究组较对照组低（P<0.05）。两组治疗后DAS-28评分降低（P<0.05）,而研究组较对照组低（P<0.05）。两组治疗后RF、hs-CRP、FIB、D二聚体水平均明显下降（P<0.05）,而研究组均明显低于对照组（P<0.05）。观察组总有效率（100.00 %）明显高于对照组（72.73 %）（P<0.05）。结论：痛敏穴刺血加艾灸能够提高RA患者的临床疗效,且能够提高机体的抗炎效应。     

温针灸对寒湿痹阻型类风湿关节炎患者血清CXCR16、CCL19和TLR4/NF-κB信号通路的影响

摘要 目的：观察温针灸对寒湿痹阻型类风湿关节炎（RA）患者血清CXC趋化因子配体16（CXCR16）、趋化因子配体19(CCL19)和Toll样受体 4/核转录因子-κB（TLR4/NF-κB）信号通路的影响。方法：选择2020年6月~2022年6月期间佛山健翔骨伤医院收治的80例RA患者。按照随机数字表法将患者分为对照组（接受常规西医治疗,40例）和研究组（对照组的基础上结合温针灸治疗,40例）。对比两组评分[中医证候积分、28个关节疾病活动性评分（DAS28）]、实验室指标[RF、C反应蛋白（CRP）、红细胞沉降率（ESR）、抗环瓜氨酸抗体（抗CCP抗体）]、血清CXCR16、CCL19和TLR4/NF-κB信号通路相关指标的变化情况。结果：治疗后,两组中医证候积分、DAS28评分均下降,且研究组低于对照组,差异有统计学意义（P<0.05）。治疗后,两组类风湿因子（RF）、C反应蛋白（CRP）、红细胞沉降率（ESR）、抗环瓜氨酸抗体（抗CCP抗体）下降,且研究组低于对照组,差异有统计学意义（P<0.05）。治疗后,两组CXCR16、CCL19下降,且研究组低于对照组,差异有统计学意义（P<0.05）。治疗后,两组TLR4信使核糖核酸（mRNA）、NF-κB mRNA下降,且研究组低于对照组,差异有统计学意义（P<0.05）。结论：温针灸能够显著改善寒湿痹阻型RA患者的临床症状,调节血清CXCR16、CCL19水平,同时还可抑制TLR4/NF-κB信号通路激活。     

金乌骨通胶囊联合塞来昔布胶囊治疗强直性脊柱炎的临床研究

摘要 目的：观察金乌骨通胶囊联合塞来昔布胶囊治疗强直性脊柱炎（AS）的临床疗效。方法：选取天津中医药大学第一附属医院2017年4月~2020年4月期间收治的126例AS患者。采用双色球法（红色、绿色）将患者分为对照组（红色）和研究组（绿色）,各63例。对照组接受塞来昔布胶囊治疗,研究组接受金乌骨通胶囊联合塞来昔布胶囊治疗,两组均治疗3个月。治疗3个月后,观察两组疗效,记录治疗期间不良反应发生率,对比两组治疗前、治疗3个月后的临床症状缓解情况、生存质量及实验室指标变化。结果：研究组的临床总有效率高于对照组（P<0.05）。治疗3个月后,研究组巴氏强直性脊柱炎疾病活动指数（BASDAI）、巴氏强直性脊柱炎功能指数（BASFI）评分低于对照组,枕墙距小于对照组,腰椎活动度、胸廓活动度大于对照组（P<0.05）。治疗3个月后,研究组世界卫生组织生存质量简表（WHOQOL-BRIEF）各维度评分高于对照组（P<0.05）。治疗3个月后,研究组血沉（ESR）、C-反应蛋白（CRP）、白介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）低于对照组（P<0.05）。两组不良反应发生率组间比较无统计学差异（P>0.05）。结论：金乌骨通胶囊联合塞来昔布胶囊治疗AS患者,可促进其临床症状及生存质量改善,降低ESR及炎性因子水平,是一种安全有效的治疗方案。     

超声联合手部滑膜炎与腱鞘炎判断RA患者的疾病活动度的可行性

摘要 目的：探究超声联合手部滑膜炎与腱鞘炎判断RA患者的疾病活动度的可行性。方法：选择2018年9月至2019年9月我院收治的103例RA患者,采用GS和PD超声检查患者手部关节和腱鞘,比较超声指标与DAS28-CRP的相关性以及超声检查手部滑膜炎与联合检查手部滑膜炎和腱鞘炎对病情诊断情况的差异。结果：关节GS总分、关节PD总分、腱鞘GS总分、腱鞘PD总分、联合GS总分、联合PD总分与DAS28-CRP均显著相关（P<0.05）。在基于DAS28-CRP的情况下,对比超声只检查手部滑膜炎与超声检查手部滑膜炎和腱鞘炎时发现：只存在腱鞘炎患者共有9名,即9名患者将被认为病情缓解,占所有患者的8.70 %。结论：超声联合手部滑膜炎与腱鞘炎可以更准确地评估患者疾病活动度,减少误诊或遗漏的概率,值得在临床推广使用。     

叶酸抑制宫颈癌进展过程中miR-642a-5p的表达及其对肿瘤细胞的抑制作用研究

摘要 目的：探讨叶酸抑制宫颈癌进展中过程中miR-642a-5p的表达及其对肿瘤细胞的抑制作用。方法：选择宫颈癌细胞株SiHa进行传代培养,采用随机法分为4组：低剂量组、中剂量组、高剂量组分别加入1 μg/mL、10 μg/mL、100 μg/mL的叶酸,而空白对照组未加入叶酸处理。利用实时定量聚合酶链式反应（RT-qPCR）检测miR-642a-5p的表达;采用细胞增殖毒性试验（CCK-8法）、细胞迁移实验（划痕实验）和细胞侵袭实验（Transwell法）分别测量宫颈癌SiHa细胞的增殖活性、迁移和侵袭能力。结果：低、中、高剂量组中叶酸显著抑制了宫颈癌SiHa细胞中miR-642a-5p的表达（P<0.05）,而且随着叶酸浓度升高,其对miR-642a-5p的抑制作用逐渐增强。此外,低、中、高剂量组中叶酸对宫颈癌SiHa细胞的增殖、迁移以及侵袭具有显著抑制作用（P<0.05）,而且叶酸浓度越高,其抑制作用越强。结论：叶酸可以抑制宫颈癌进展过程中miR-642a-5p的表达,而且对宫颈癌SiHa细胞的增殖、迁移和侵袭具有一定的抑制作用。     

长病程低疾病活动度的系统性红斑狼疮患者血清β2-微球蛋白、肌酐水平与心血管疾病风险的相关性研究

摘要 目的：研究长病程低疾病活动度的系统性红斑狼疮患者血清β2-微球蛋白、肌酐表达水平与心血管疾病风险的相关性。方法：回顾性搜集2017年1月至2022年12月于我院风湿免疫科住院治疗的100例长病程低疾病活动度的系统性红斑狼疮患者作为研究组,并纳入同期健康体检者作为阴性对照组。采用Framingham评分将研究组分为高风险组和低风险组。采用酶联免疫吸附实验检测所有研究对象血清β2-微球蛋白（β2-MG）、肌酐（Scr）的表达水平,采用logistics回归模型分析长病程低疾病活动度的系统性红斑狼疮患者发生心血管疾病的危险因素,采用Pearson检验分析β2-MG、Scr水平与Framingham评分相关性。结果：长病程低疾病活动度的系统性红斑狼疮患者血清β2-MG、Scr表达水平明显升高（P<0.05）;高心血管病风险组长病程低疾病活动度的系统性红斑狼疮患者血清β2-MG、Scr表达水平较低风险组明显升高（P<0.05）;预后情况不同,患者β2-MG、Scr表达水平具有显著差异（P<0.05）;预后良好患者β2-MG、Scr表达水平显著低于预后不良者,预后情况越好,β2-MG、Scr表达水平越低;高危组较低危组代谢综合征比例高、胆固醇及甘油三酯表达水平高（P<0.05）;Framingham评分、β2-MG、Scr是长病程低疾病活动度的系统性红斑狼疮患者发生心血管疾病的危险因素;长病程低疾病活动度的系统性红斑狼疮患者β2-MG、Scr表达水平与Framingham评分正相关。结论：长病程低疾病活动度的系统性红斑狼疮患者血清β2-MG、Scr表达水平与心血管疾病风险正相关。     

风湿祛痛胶囊联合塞来昔布胶囊治疗强直性脊柱炎的疗效及对血液流变学和血清炎性因子的影响

摘要 目的：探讨强直性脊柱炎（AS）患者经风湿祛痛胶囊联合塞来昔布胶囊治疗后的疗效及对血液流变学和血清炎性因子的影响。方法：选取2014年8月-2021年12月在联勤保障部队第九八三医院治疗的80例AS患者。按照随机数字表法分为对照组（常规治疗及塞来昔布胶囊治疗，40例）和研究组（常规治疗及风湿祛痛胶囊联合塞来昔布胶囊治疗，40例），两组患者均治疗8周。对比两组血液流变学指标、血清炎性因子指标、视觉模拟评分法（VAS）评分、C反应蛋白（CRP）、巴氏强直性脊柱炎疾病活动指数（BASDAI）评分、红细胞沉降率（ESR），同时记录两组治疗期间不良反应发生情况。结果：研究组治疗8周后BASDAI、VAS评分低于对照组（P<0.05）。研究组治疗8周后CRP、ESR低于对照组（P<0.05）。研究组治疗8周后全血高切黏度、血浆黏度、全血低切黏度、红细胞压积低于对照组（P<0.05）。研究组治疗8周后白介素-23（IL-23）、肿瘤坏死因子-α（TNF-α）、白介素-1β（IL-1β）均低于对照组（P<0.05）。两组不良反应发生率对比无差异（P>0.05）。结论：风湿祛痛胶囊联合塞来昔布胶囊治疗AS，可有效缓解患者的临床症状，抑制疾病进展，可能与调节血液流变学、降低炎性因子水平有关。     

枸橼酸托法替布片联合仙灵骨葆胶囊对类风湿性关节炎合并骨质疏松患者血清炎症细胞因子、骨强度及骨代谢水平影响

摘要 目的：探讨枸橼酸托法替布片联合仙灵骨葆胶囊对类风湿性关节炎（RA）合并骨质疏松患者血清炎症细胞因子、骨强度及骨代谢水平影响。方法：纳入2021年8月至2022年8月期间徐州医科大学附属连云港医院诊治的80例RA合并骨质疏松患者。根据随机数字表法将患者分为对照组（雷公藤多苷片联合仙灵骨葆胶囊治疗）和实验组（枸橼酸托法替布片联合仙灵骨葆胶囊治疗）,各为40例。对比两组疗效、炎症细胞因子、骨强度及骨代谢指标,观察两组不良反应发生率。结果：实验组的临床总有效率高于对照组（P<0.05）。实验组治疗后巨噬细胞集落刺激因子（M-CSF）、白细胞介素-1β（IL-1β）、环氧合酶-2（COX-2）低于对照组同期（P<0.05）。实验组治疗后横截面积（CSA）、横截面转动惯量（CSMI）、截面系数（Z）、皮质厚度（CT）高于对照组同期（P<0.05）。实验组治疗后骨钙素N端中分子（N-MID）、总Ⅰ型胶原氨基端延长肽（T-PINP）、骨钙素（BGP）、Ⅰ型胶原羧基端前肽（PICP）高于对照组同期,β-胶原降解产物（β-CTX）低于对照组同期（P<0.05）。两组治疗后腰椎骨密度和股骨颈骨密度较治疗前升高,且实验组高于对照组同期（P<0.05）。两组治疗后血沉（ESR）、C反应蛋白（CRP）、类风湿关节炎患者病情（DAS28）评分下降,且实验组低于对照组同期（P<0.05）。两组不良反应发生率组间对比无统计学差异（P>0.05）。结论：枸橼酸托法替布片联合仙灵骨葆胶囊应用于RA合并骨质疏松患者,可有效调节骨代谢水平,增强骨强度,降低血清炎症细胞因子水平。     

高压氧联合叶酸治疗老年脑小血管病患者认知功能及血浆Hcy变化研究

摘要 目的：研究高压氧联合叶酸治疗老年脑小血管病患者认知功能及血浆Hcy变化。方法：选取2019年1月~2020年6月我院收治的80例老年脑小血管病患者作为研究对象,随机将其分为两组,对照组50例,给予叶酸治疗,研究组30例,给予高压氧联合叶酸治疗,观察两组患者治疗后的疗效、认知功能、血浆Hcy水平、生活质量及不良反应。结果：治疗前,两组的蒙特利尔认知评估量表(Montreal Cognitive Assessment,MoCA)认知功能评分、血浆Hcy水平、日常生活能力量表(Activity of Daily Living Scale,ADL)评分对比无差异（P>0.05）,治疗后两组的MoCA认知功能评分、ADL评分均升高,血浆Hcy水平均降低,且观察组变化优于对照组( P<0.05);治疗期间对照组不良反应发生情况为13.33 %,观察组不良反应发生情况为16.00 %,两组对比差异无统计学意义（P>0.05）;研究组总有效率显著高于对照组（93.33 % vs.74.00 %,P<0.05）。结论：高压氧联合叶酸治疗老年脑小血管病患者疗效显著,能显著改善患者的认知功能和Hcy水平,提高其日常生活能力,且安全性高,值得临床应用。     

昆仙胶囊联合来氟米特治疗狼疮性肾炎临床疗效的回顾性研究

摘要 目的：探讨昆仙胶囊联合来氟米特对狼疮性肾炎患者的治疗效果。方法：回顾性分析2017年1月至2019年7月于本院接受治疗的120例狼疮性肾炎患者的临床资料,按照治疗方案的不同将其分为对照组（n=60）和观察组（n=60）。对照组给予来氟米特治疗,观察组在此基础上联合昆仙胶囊治疗。比较两组患者治疗后的疗效、狼疮疾病活动指数（SLEDAI）评分、肾功能和实验室指标、不良反应和复发情况。结果：治疗后,观察组总有效率为93.33%（56/60）,高于对照组73.33%（44/60）（P<0.05）。治疗后,观察组患者24 h尿蛋白定量（24 h UP）、血肌酐（Scr）、SLEDAI评分、红细胞沉降率（ESR）、C反应蛋白（CRP）显著低于对照组,血浆白蛋白（Alb）、补体C3与C4水平显著高于对照组（P<0.05）;观察组的复发率（8.33%）以及不良反应发生率（13.33%）均显著低于对照组的23.33%、30.00%,差异具有统计学意义（P<0.05）。结论：昆仙胶囊联合来氟米特可以有效治疗狼疮性肾炎,明显改善患者病情活动度和肾功能,同时降低复发率和不良反应发生率,在临床上具有一定的应用价值。     

不同剂量瑞舒伐他汀钙治疗脑梗死患者的临床疗效及机制研究

目的:探讨不同剂量瑞舒伐他汀钙治疗脑梗死患者的临床疗效,并分析其疗效机制。方法:将2015年2月至2018年2月医院诊治的脑梗死患者84例按随机数字表法分为观察组(42例)及对照组(42例)。所有患者入院后均给予降血压、降血糖、稳定颅内压以及改善微循环等基本治疗,在此基础上,对照组口服瑞舒伐他汀钙10 mg/d,观察组口服瑞舒伐他汀钙20 mg/d,两组疗程均为14 d。比较两组疗效、治疗前后美国国立卫生研究所卒中量表(NIHSS)评分以及日常生活能力量表(Barthel指数)变化,并比较两组血清白细胞介素-6(IL-6)、白细胞介素-8(IL-8)、高迁移率族蛋白-1(HMGB1)和超敏C反应蛋白(hs-CRP)水平,分析血清HMGB1、IL-6、IL-8和hs-CRP之间的相关性,记录两组患者治疗过程中不良反应发生情况。结果:观察组治疗总有效率为95.24%(40/42),明显高于对照组的80.95%(34/42)(P0.05)。两组治疗后NIHSS评分均低于治疗前,Barthel指数高于治疗前,同时,观察组NIHSS评分降低程度大于对照组,Barthel指数升高程度大于对照组(P0.05)。治疗后两组患者血清IL-6、IL-8、HMGB1、hs-CRP明显降低,且观察组血清IL-6、IL-8、HMGB1、hs-CRP明显低于对照组(P0.05)。Person相关性分析表明患者血清HMGB1与IL-6、IL-8、hs-CRP呈正相关(r=0.306,0.428,0.367,均P0.05),IL-6与IL-8、hs-CRP呈正相关(r=0.327,0.385,P0.05),IL-8与hs-CRP亦呈正相关(r=0.430,P0.05)。治疗期间两组不良反应发生率比较无统计学差异(P0.05)。结论:高剂量瑞舒伐他汀钙治疗脑梗死能够促进神经功能恢复,提高日常生活能力,临床疗效显著,其机制可能与降低脑梗死急性期炎症反应有关。     

Comparison of two different folic acid doses with methotrexate – a randomized controlled trial (FOLVARI Study)

IntroductionThere is reasonable evidence that folic acid 5–10 mg per week leads to reduction in methotrexate (MTX) toxicity in rheumatoid arthritis (RA). However, this is based on studies conducted with lower MTX dosage than used currently. It is unclear whether higher doses of folic acid may be better in reducing toxicity.MethodsThis was a double-blind randomized controlled trial of 24 weeks duration. To be eligible, patients should have rheumatoid arthritis (1987 American College of Rheumatology criteria), be 18–75 years of age, not be on MTX and have active disease as defined by ‘Modified Disease Activity Score using three variables’ (DAS28(3)) > 3.2. MTX was started at 10 mg/week and escalated to 25 mg/week by 12 weeks. Folic acid was given at a dose of 10 mg (FA10) or 30 mg per week (FA30). Co-primary endpoints were incidence of toxicity (undesirable symptoms and laboratory abnormalities) and change in disease activity by 24 weeks. Intention-to-treat and per-protocol analyses were performed.ResultsAmong 100 patients enrolled, 51 and 49 were randomized to FA10 and FA30 respectively. By 24 weeks, there were 6 patient withdrawals in either group and mean(±SD) dose of MTX was 22.8 ± 4.4 and 21.4 ± 4.6 mg per week (p = 0.1). Frequency of patients with undesirable symptoms was non-significantly lower by 7.4 % (95 % confidence interval −27.4 to 12.7 %) in FA10 compared to FA30. There was also no difference in frequency of transaminitis (>Upper limit of normal (ULN)) (42.6, 45.7 %, p = 0.7) or transminitis as per primary endpoint (>2xULN) (10.6, 8.7 %, p = 1.0) or cytopenias (4.3, 4.3 %, p = 0.9). There was no difference in the primary end-point of occurrence of any adverse effect (symptom or laboratory) in FA10 and FA30 (46.8, 54.3 %, p = 0.5). At 24 weeks, DAS28(3) declined in both groups by a similar extent (−1.1 ± 1.0, −1.3 ± 1.0, p = 0.2) and ‘European League Against Rheumatism’ good or moderate response occurred in 56.9 and 67.4 % (p = 0.3).ConclusionsEven with the high doses of MTX used in current practice, there was no additional benefit (or harm) of a higher dose of folic acid (30 mg/week) over a usual dose (10 mg/week).

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01583959","term_id":"NCT01583959"}}NCT01583959 Registered 15 March 2012     

L-carnitine and Zinc supplementation impedes intestinal damage in methotrexate-treated adjuvant-induced arthritis rats: Reinstating enterocyte proliferation and trace elements

BackgroundMethotrexate (MTX), a folic acid analogue, is used as a first-line treatment for rheumatoid arthritis (RA) since it has more therapeutic mechanisms than any other drug. Being an undeniable drug for the treatment of arthritis, even low-dose MTX provokes intestinal toxicity as a primary adverse effect and does not revive an anti-inflammatory element. Thus, our study aims to elucidate the anti-arthritic and prophylactic activity of supplements L-carnitine (L) and zinc (Z) against MTX-mediated intestinal damage in arthritis rats.MethodsThe rats were assessed for arthritic parameters such as body weight, paw volume, x-ray scan, and serum trace elements level. To analyze the toxic effects of MTX in the rats, intestine pH, mucosal weight, digestive enzymes, myeloperoxidase, histopathological, and immunohistochemical analysis were performed.ResultsOur study demonstrated that the arthritic parameters have shown that MTX has an ameliorative effect on arthritic rats. Besides, our findings showed that low-dose MTX (2.5 mg/kg b.w.) given once a week for two weeks during arthritis treatment had toxic effects in the rat's intestine, as evidenced by changes in intestine pH and mucosal weight, decreased digestive enzymes, increased MPO, and degenerative changes in histopathological analysis. Concurrent therapy of LZ with MTX, on the other hand, restored the modifications in these parameters.ConclusionMTX in combination with LZ effectively manages arthritis than monotherapy and significantly prevents MTX-induced intestinal damage in arthritis rats. Thus, LZ could be used as an improved therapeutic and safety for MTX-instigated intestinal damage during arthritis treatments. Therefore, our combination of L-carnitine and zinc with MTX would be promising prophylactic activity for arthritis patients.     

老年类风湿关节炎患者应用MTX或LEF联合糖皮质激素治疗的效果观察

目的:探讨甲氨蝶呤(MTX)或来氟米特(LEF)联合泼尼松(PDN)对老年类风湿关节炎的疗效。方法:选取112例老年RA患者,按随机数表法将患者分为LEF组(n=28)、MTX组(n=28)、LET+PDN组(n=28)、MTX+PDN组(n=28),治疗3个月后统计四组关节肿胀数、关节压痛数、DAS28评分、VAS评分、RF、晨僵时间,并记录不良反应事件。结果:MTX组和LEF组治疗后各项指标均低于治疗前(P0.05);MTX+PDN组与LEF+PDN组治疗后各项指标均明显低于治疗前(P0.001);MTX+PDN组治疗效果明显优于MTX组(P0.001);LEF+PDN组治疗效果明显优于LEF组(P0.001);MTX+PDN组治疗总有效率为53.57%,高于LEF+PDN组的42.86%,但差异无统计学意义(x~2=2.426,P=0.119)。结论:四组对RA均有治疗效果,联合使用效果更佳,且服药后无严重不良反应,安全性较高。     

Active immunization to tumor necrosis factor-α is effective in treating chronic established inflammatory disease: a long-term study in a transgenic model of arthritis

Introduction

Chicken type II collagen (CCII) is a protein extracted from the cartilage of chicken breast and exhibits intriguing possibilities for the treatment of autoimmune diseases by inducing oral tolerance. A 24-week, double-blind, double-dummy, randomized, methotrexate (MTX)-controlled study was conducted to evaluate the efficacy and safety of CCII in the treatment of rheumatoid arthritis (RA).

Methods

Five hundred three RA patients were included in the study. Patients received either 0.1 mg daily of CCII (n = 326) or 10 mg once a week of MTX (n = 177) for 24 weeks. Each patient was evaluated for pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), assessments by investigator and patient, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) by using the standard tools at baseline (week 0) and at weeks 12 and 24. Additionally, rheumatoid factor (RF) was evaluated at weeks 0 and 24. Measurement of a battery of biochemical parameters in serum, hematological parameters, and urine analysis was performed to evaluate the safety of CCII.

Results

Four hundred fifty-four patients (94.43%) completed the 24-week follow-up. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, HAQ, and assessments by investigator and patient, and all differences were statistically significant. In the MTX group, ESR and CRP decreased. RF did not change in either group. At 24 weeks, 41.55% of patients in the CCII group and 57.86% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR-20) and 16.89% and 30.82%, respectively, met the ACR 50% improvement criteria (ACR-50). Both response rates for ACR-20 and ACR-50 in the CCII group were lower than those of the MTX group, and this difference was statistically significant (P < 0.05). The DAS28 (disease activity score using 28 joint counts) values of the two treatment groups were calculated, and there was a statistically significant difference between the two treatment groups (P < 0.05). Gastrointestinal complaints were common in both groups, but there were fewer and milder side effects in the CCII group than in the MTX group. The incidence of adverse events between the two groups was statistically significant (P < 0.05).

Conclusions

CCII is effective in the treatment of RA and is safe for human consumption. CCII exerts its beneficial effects by controlling inflammatory responses through inducing oral tolerance in RA patients.

Trials Registration

Clinical trial registration number: ChiCTR-TRC-00000093.     

沙利度胺联合甲氨喋呤与羟氯喹治疗类风湿关节炎的疗效分析

目的:探讨沙利度胺(THD)联合甲氨喋呤(MTX)、羟氯喹(HCQ)治疗类风湿关节炎(RA)的临床疗效。方法:82例RA患者随机分为观察组(n=41)与对照组(n=41),对照组给予MTX治疗,观察组在对照组基础上加用THD与HCQ,对比两组患者临床疗效。结果:观察组有效率为90.2%,显著高于对照组的70.7%(P0.05);治疗前、治疗后1个月两组患者肿胀关节数、压痛关节数、晨僵时间、ESR、CRP、RF、VAS比较差异无统计学意义(P0.05);治疗后2、3、4、5、6个月比较观察组各观察指标均显著优于对照组(P0.05);两组患者治疗过程中血细胞降低、消化道症状、呼吸道感染、月经紊乱、皮疹、ALT升高、头晕嗜睡、口腔溃疡等不良反应发生率比较无统计学差异(P0.05)。结论:沙利度胺联合甲氨喋呤、羟氯喹用于类风湿关节炎患者的治疗,能够有效延缓病情的进展、缓解患者痛苦,同时减少了药物的不良反应,为临床提供了新的治疗方法。     

A multicenter,double-blind,randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis

Introduction

Chicken type II collagen (CCII) is a protein extracted from the cartilage of chicken breast and exhibits intriguing possibilities for the treatment of autoimmune diseases by inducing oral tolerance. A 24-week, double-blind, double-dummy, randomized, methotrexate (MTX)-controlled study was conducted to evaluate the efficacy and safety of CCII in the treatment of rheumatoid arthritis (RA).

Methods

Five hundred three RA patients were included in the study. Patients received either 0.1 mg daily of CCII (n = 326) or 10 mg once a week of MTX (n = 177) for 24 weeks. Each patient was evaluated for pain, morning stiffness, tender joint count, swollen joint count, health assessment questionnaire (HAQ), assessments by investigator and patient, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) by using the standard tools at baseline (week 0) and at weeks 12 and 24. Additionally, rheumatoid factor (RF) was evaluated at weeks 0 and 24. Measurement of a battery of biochemical parameters in serum, hematological parameters, and urine analysis was performed to evaluate the safety of CCII.

Results

Four hundred fifty-four patients (94.43%) completed the 24-week follow-up. In both groups, there were decreases in pain, morning stiffness, tender joint count, swollen joint count, HAQ, and assessments by investigator and patient, and all differences were statistically significant. In the MTX group, ESR and CRP decreased. RF did not change in either group. At 24 weeks, 41.55% of patients in the CCII group and 57.86% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR-20) and 16.89% and 30.82%, respectively, met the ACR 50% improvement criteria (ACR-50). Both response rates for ACR-20 and ACR-50 in the CCII group were lower than those of the MTX group, and this difference was statistically significant (P < 0.05). The DAS28 (disease activity score using 28 joint counts) values of the two treatment groups were calculated, and there was a statistically significant difference between the two treatment groups (P < 0.05). Gastrointestinal complaints were common in both groups, but there were fewer and milder side effects in the CCII group than in the MTX group. The incidence of adverse events between the two groups was statistically significant (P < 0.05).

Conclusions

CCII is effective in the treatment of RA and is safe for human consumption. CCII exerts its beneficial effects by controlling inflammatory responses through inducing oral tolerance in RA patients.

Trials Registration

Clinical trial registration number: ChiCTR-TRC-00000093.     

Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial

IntroductionConsidering a lack of efficacy data in patients with early rheumatoid arthritis (eRA) presenting without classical markers of poor prognosis, we compared methotrexate (MTX) with or without step-down glucocorticoids in the CareRA trial.MethodsDisease-modifying antirheumatic drug–naïve patients with eRA were stratified into a low-risk group based on prognostic markers that included non-erosiveness, anti–citrullinated protein antibodies and rheumatoid factor negativity and low disease activity (Disease Activity Score in 28 joints based on C-reactive protein (DAS28(CRP)) ≤3.2). Patients were randomized to 15 mg of MTX weekly (MTX with tight step-up (MTX-TSU)) or 15 mg of MTX weekly with prednisone bridging, starting at 30 mg and tapered to 5 mg daily from week 6 (COmbinatie therapie bij Reumatoïde Artritis (COBRA Slim)). A TSU approach was applied. Outcomes assessed were DAS28(CRP)-determined remission, cumulative disease activity, Health Assessment Questionnaire (HAQ) scores and adverse events (AEs) after 16 treatment weeks.ResultsWe analyzed 43 COBRA Slim and 47 MTX-TSU patients and found that 65.1% in the COBRA Slim group and 46.8% in the MTX-TSU group reached remission (P = 0.081). Mean ± standard deviation area under the curve values of DAS28(CRP) were 13.84 ± 4.58 and 11.18 ± 4.25 for the MTX-TSU and COBRA Slim patients, respectively (P = 0.006). More COBRA Slim patients had an HAQ score of 0 (51.2% versus 23.4%, P = 0.006) at week 16. Therapy-related AEs between groups did not differ.ConclusionIn patients with low-risk eRA, MTX with step-down glucocorticoid bridging seems more efficacious than MTX step-up monotherapy, with a comparable number of AEs observed over the first 16 treatment weeks.

Trial registration

EU Clinical Trials Register Identifier: EudraCT number 2008-007225-39. Registered 5 November 2008.

Electronic supplementary material

The online version of this article (doi:10.1186/s13075-015-0611-8) contains supplementary material, which is available to authorized users.     

不同剂量及注药方向罗哌卡因对肛肠手术麻醉效果的影响

目的:研究不同剂量及注药方向罗哌卡因对肛肠手术麻醉效果的影响及安全性。方法:选择2015年1月~2016年12月在我院进行肛肠手术治疗的患者148例,按照麻醉方法的不同分为四组,每组各37例,即罗哌卡因8 mg向头注药组、罗哌卡因8mg向尾注药组、罗哌卡因10 mg向头注药组以及罗哌卡因10 mg向尾注药组。比较四组患者的感觉阻滞恢复时间、感觉阻滞起效时间以及运动阻滞恢复时间及恶心呕吐、尿潴留、腰部不适、头痛等术后不良反应的发生情况。结果:罗哌卡因10 mg向头注药与向尾注药的感觉阻滞起效时间比较差异均无统计学意义(P0.05),10 mg向头注药组的运动阻滞恢复时间明显短于10 mg向尾注药组(P0.05),以10 mg向头注药组感觉阻滞恢复时间最短(P0.05),8 mg向尾注药比10 mg向尾注药阻滞起效明显减慢(P0.05),运动以及感觉阻滞恢复时间均明显缩短(P0.05),10 mg向头注药组的感觉阻滞起效时间明显短于8 mg向头注药组(P0.05),运动以及感觉阻滞恢复时间均明显延长(P0.05)。四组均未发生恶心呕吐以及头痛等术后不良反应,罗哌卡因8 mg向尾注药组的尿潴留以及腰部不适的发生率均明显低于其他三组(P0.05)。结论:向尾端迅速注射罗帕卡因8 mg进行蛛网膜下隙阻滞对肛肠手术患者的麻醉效果最好,且安全性最高。