青霉胺和氨甲蝶呤联合治疗类风湿关节炎

用青霉胺和氨甲蝶呤联合治疗类风湿关节炎３３例，并与单用青霉胺治疗的５９例患者比较，结果显示临床缓解、显示、有效和无效的发生率在联合治疗组分别为２４．２％，５１．６％，２４．２％和０；及在青霉胺级别为１８．６％、３９．１％、２５．４％和１６．９％，经Ｒｉｄｉｔ分析Ｐ〈０．０５。副作用发生率在两组分别为２１．２％和１６．９％（Ｐ〉０．０５）。结果提示，联合治疗的疗产优于单一青霉胺治疗的效果。     

蛇制剂联用青霉胺治疗类风湿关节炎疗效和安全性研究及其对细胞因子的影响

目的探讨蛇制剂联用青霉胺治疗类风湿关节炎(RA)的疗效、安全性和免疫调节作用。方法采用双盲随机安慰剂对照试验,患者随机分成两组,分别给予蛇制剂和青霉胺,安慰剂和青霉胺治疗,疗程为12周。应用酶联免疫吸附试验(ELISA)方法测定患者治疗前后外周血中白细胞介素(IL)-1!、IL-2、IL-6和肿瘤坏死因子(TNF)-"水平。结果共有60例RA患者完成试验,治疗组和对照组各30例。治疗组ACR20有效为80%,对照组ACR20有效为60%(P<0.05),ACR50和ACR70疗效两组差异无统计学意义;不良反应发生率治疗组13%,对照组37%,差异有统计学意义(P<0.05)。两组均明显降低RA患者TNF-"水平,但治疗组降低的程度要强于对照组,差异有统计学意义(P<0.05)。结论蛇制剂合用青霉胺治疗类风湿关节炎疗效要优于单用青霉胺,并且不良反应发生率低。     

益气活血通络法联合疏血通注射液治疗老年人脑梗死急性期疗效观察

目的观察益气活血通络法联合疏血通注射液治疗老年人脑梗死急性期的临床疗效。方法将66例脑梗死急性期患者随机分为两组。对照组予疏血通注射液治疗,治疗组在对照组治疗基础上加用益气活血通络组方治疗,14 d后评价疗效。结果治疗组愈显率为48.5%,总有效率为93.9%,进展性卒中发生率为0;对照组愈显率为3.0%,总有效率为24.2%,进展性卒中发生率为24.2%。两组比较差异有统计学意义(P<0.05)。治疗组治疗后神经功能缺损评分优于对照组(P<0.01)。结论益气活血通络法配合疏血通注射液治疗老年人脑梗死急性期优于单纯疏血通注射液治疗。     

不同策略治疗rtN236T位点变异的HBeAg阳性慢性乙型肝炎的疗效观察

目的 观察rtN236T位点变异的阿德福韦酯(ADV)耐药HBeAg阳性的慢性乙型肝炎(CHB)患者,ADV分别联合聚乙二醇干扰素(Peg-IFN) α-2a及拉米夫定(LAM)进行治疗的疗效及安全性,并分析影响疗效的因素.方法 收集rtN236T位点变异的ADV耐药HBeAg阳性CHB患者65例,随机分为A组(33例)和B组(32例),A组ADV联合Peg-IFN α-2a治疗,连续48周后停用.B组ADV联合LAM治疗,连续48周后,继续使用24周.在治疗前、治疗后24、48周及随访24周,比较两组HBV DNA载量下降≥2log10拷贝/ml和HBV DNA≤500拷贝/ml患者数及HBeAg阴转率、HBeAg血清学转换率、ALT复常率.比较两组行肝穿刺活组织检查患者治疗前后的肝脏炎症分级、纤维化分期及肝组织学活动指数(HAI)评分.根据数据类型用t检验或x2检验进行统计分析.结果 治疗后24、48周及随访24周时,HBV DNA载量下降≥2log10拷贝/ml的患者,A组分别为81.8％、90.9％、75.8％,B组分别为53.1％、56.2％、59.4％;HBV DNA≤500拷贝/ml的患者,A组分别为48.5％、60.6％、42.4％,B组分别为31.3％、34.4％、31.3％;HBeAg阴转率,A组分别为39.4％、60.6％、54.5％,B组分别为12.5％、37.5％、37.5％;HBeAg血清学转换率,A组分别为27.3％、54.5％、48.5％,B组分别为6.3％、15.6％、18.8％;ALT复常率,A组分别为72.7％、84.8％、78.8％,B组分别为46.9％、56.3％、46.9％;A组均明显高于B组,差异有统计学意义(P值均＜0.05).治疗48周后,A组的肝组织HAI积分、炎症分级及纤维化分期改善情况均明显优于B组(P值均＜ 0.05).除肌酐升高发生率差异无统计学意义外,A组的不良反应发生率均高于B组(P值均＜ 0.05),但未发生终止治疗或危及患者安全的不良反应.A组停药随访24周,5例患者HBVDNA升高≥2log10拷贝/ml,其中4例治疗期间HBV DNA≤500拷贝/ml,此4例患者均发生ALT升高,且均未发生HBeAg血清学转换.结论 rtN236T位点变异的ADV耐药HBeAg阳性CHB患者,ADV联合Peg-IFN α-2a的疗效优于联合LAM,但不良反应发生率更高;未发生HBeAg血清学转换的患者,停药后易出现病毒反跳及ALT升高.     

内镜下组织胶注射联合硬化-套扎术治疗肝硬化食管胃底静脉曲张患者临床研究

目的 探讨内镜下组织胶注射联合硬化-套扎术治疗肝硬化并发食管胃底静脉曲张(EGV)患者的临床疗效。方法 2017年7月～2019年2月我院收治的肝硬化并发EGV患者76例,采用随机数字表法分为对照组38例和观察组38例。在对照组采用内镜下套扎术治疗,在观察组采用内镜下组织胶注射联合硬化-套扎术治疗,术后均随访6个月。结果 在术后第6个月随访时,对照组失访2例(5.3%),死亡5例(13.2%),观察组失访3例(7.9%),死亡2例(5.3%),两组总有效率分别为71.0%对81.8%,差异显著(P<0.05);术后,观察组再出血、吞咽不适和食管狭窄发生率分别为24.2%、18.2%和15.2%,显著低于对照组的41.9%、35.5%和25.8%(P<0.05)。结论 采用内镜下组织胶注射联合硬化-套扎术治疗肝硬化并发食管胃底静脉曲张患者临床疗效满意,不良反应发生率低,值得临床应用和研究。     

加巴喷丁联合神经阻滞治疗老年头面部带状疱疹后神经痛的有效性及安全性

目的 观察加巴喷丁联合神经阻滞治疗老年头面部带状疱疹后神经痛的安全性和有效性.方法 老年头面部带状疱疹后神经痛病人57例随机分为加巴喷丁组和加巴喷丁联合神经阻滞组,两组病人均使用加巴喷丁胶囊1 200～1 800 mg/d,加巴喷丁联合神经阻滞组接受三叉神经分支阻滞和皮损区皮内注射治疗,共6 w.采用视觉模拟评分(VAS)和睡眠质量评分(QS)评价疼痛缓解程度和疼痛对睡眠的影响.结果 治疗前加巴喷丁组和加巴喷丁联合神经阻滞组VAS评分分别为(8.2土1.3)分和(7.9±1.2)分,治疗4w后分别为(2.8±0.5)分和(1.9±0.5)分,6w后分别为(1.6±0.3)分和(0.9±0.3)分,差异均有统计学意义(P＜0.05).加巴喷丁组第2、4、6周有效率分别为31.3％、40.6％、81.3％,加巴喷丁联合神经阻滞组分别为44.0％、64.0％、92.0％,差异均有统计学意义(P＜0.05).加巴喷丁组和加巴喷丁联合神经阻滞组可耐受不良反应发生率为53.1％和60.0％,差异无统计学意义(P＞0.05).结论 加巴喷丁联合神经阻滞治疗老年头面部带状疱疹后神经痛疗效显著,并发症发生率较低.     

双氯芬酸钾栓联合丁溴东莨菪碱治疗肾绞痛疗效观察

目的 观察双氯芬酸钾栓联合丁溴东莨菪碱治疗肾绞痛的疗效.方法 将96例肾绞痛患者随机分为两组,各48例.观察组给予双氯芬酸钾栓1枚（12.5 mg）经直肠给药加丁溴东莨菪碱20 mg肌注,对照组给予杜冷丁50 mg肌注加丁溴东莨菪碱20 mg肌注.用药后45 min观察镇痛效果,观察比较两组不良反应发生情况.结果 观察组与对照组显效率分别为62.5％、64.6％,有效率分别为29.2％、25.0％,无效率分别为8.3％、10.4％,两组比较,P均＞0.05;观察组与对照组8h内疼痛再发率分别为12.5％、27.1％,不良反应发生率分别为16.7％、37.5％,两组相比,P均＜0.05.结论 双氯芬酸钾栓联合丁溴东莨菪碱治疗肾绞痛疗效较好,疼痛再发率低,不良反应少.     

贝前列腺素钠联合阿斯匹林治疗糖尿病足的疗效及不良反应分析

目的探讨贝前列腺素钠联合阿斯匹林治疗糖尿病足的临床疗效。方法选取2015年3月—2017年3月于该院就诊的糖尿病足患者共68例,随机将患者分为联合组(34例)和单一组(34例),单一组患者采用阿斯匹林治疗;联合组患者在单一组药物治疗的基础之上,再联合采用贝前列腺素钠进行治疗,两组患者在接受为期8周的治疗后,比较两组患者的治疗效果及不良反应的发生率。结果联合组治疗有效率和治疗后不良反应发生率分别为88.2%、11.8%,单一组治疗有效率和治疗后不良反应发生率分别为41.2%、38.2%,联合组治疗有效率明显高于单一组且治疗后不良反应的发生率明显低于单一组(P0.05)。结论贝前列腺素钠联合阿斯匹林治疗糖尿病足效果较为明显,同时治疗产生的副反应发生率较低,值得在临床上大量推广使用。     

黄芪桂枝五物汤对奥沙利铂所致神经及血液毒性的治疗效果观察

目的 探讨黄芪桂枝五物汤加减对奥沙利铂引起的神经毒性及血液毒性的治疗效果.方法 将接受奥沙利铂、亚叶酸钙联合替加氟方案化疗的胃肠道肿瘤患者50例分为治疗组28例、对照组22例.化疗首日治疗组服用黄芪桂枝五物汤加减治疗,对照组服用甲钴铵片.化疗4周期后观察两组神经毒性及血液毒性发生情况.结果 治疗组、对照组神经毒性发生率分别为21.4％、50.0％,治疗组神经毒性发生率低于对照组（P＜0.05）.治疗组白细胞减少、血红蛋白降低、血小板减少的发生率分别为35.7％（10/28）、10.7％ （3/28）、25.0％ （7/28）,对照组分别为40.9％ （9/22）、31.8％（7/22）、36.4％（8/22）,治疗组血红蛋白降低的发生率低于对照组（P＜0.05）.结论 黄芪桂枝五物汤加减能减轻奥沙利铂引起的神经毒性及血液毒性反应.     

化疗对老年晚期非小细胞肺癌疗效及预后的影响

目的 探讨化疗对老年晚期非小细胞肺癌疗效及预后的影响.方法 选取60例老年晚期非小细胞肺癌患者作为研究对象,分为两组:联合化疗组30例,接受顺铂联合吉西他滨的两药联合方案化疗,顺铂25 mg/m2,d1～3;吉西他滨1 000 mg/m2,d1、8;21 ～28 d为1个周期,至少治疗2个周期;支持治疗组30例,只接受最佳支持治疗.另选取30例40～ 70岁晚期非小细胞肺癌患者作为对照组,接受联合化疗,方案同联合化疗组.按照RECIST实体瘤客观疗效评价标准进行疗效评价.结果 联合化疗组有效率为40％( 12/30),临床获益率为46.7％(14/30),中位生存期为9.5个月,1年生存率为26.7％;支持治疗组有效率为0(0/30),临床获益率为6.7％(2/30),中位生存期为6.0个月,1年生存率为6.7％;对照组有效率为36.7％(11/30),临床获益率为43.3％(13/30),中位生存期为9.6个月,1年生存率为30％;联合化疗组与支持治疗组有效率、临床获益率、中位生存期和1年生存率均有统计学差异(P＜0.05);联合化疗组与对照组有效率、临床获益率、中位生存期和1年生存率均无统计学差异(P＞0.05).联合化疗组Ⅲ～Ⅳ度骨髓抑制发生率、胃肠道反应发生率和并发感染发生率分别为16.7％、26.7％和6.7％,均高于对照组(P＜0.05).结论 高龄并不影响化疗的疗效和生存期,临床治疗中不应排除70岁以上人群.     

Infliximab treatment maintains employability in patients with early rheumatoid arthritis

OBJECTIVE: To evaluate the impact of infliximab therapy on the employment status of patients with early rheumatoid arthritis (RA). METHODS: Methotrexate (MTX)-naive patients with active early RA were randomly allocated to receive MTX plus placebo or MTX plus infliximab (3 mg/kg or 6 mg/kg) at weeks 0, 2, and 6 and then every 8 weeks through week 46. Data for patients younger than age 65 years were included in the analyses. A patient was categorized as employable if he or she was employed or felt well enough to work if a job were available. RESULTS: The change in actual employment was not significantly different between patients receiving MTX plus infliximab and those receiving MTX plus placebo (0.5% versus 1.3%; P > 0.5). However, the proportion of patients whose status changed from employable at baseline to unemployable at week 54 was smaller in the group receiving MTX plus infliximab compared with that in the group receiving MTX alone (8% versus 14%; P = 0.05). Patients who were treated with infliximab plus MTX had a significantly greater likelihood of improvement rather than deterioration in employability (odds ratio 2.4; P < 0.001); this likelihood was not significantly greater in patients receiving MTX alone. The proportion of employed patients who lost workdays during the trial was smaller in the MTX plus infliximab group than in the MTX-alone group (P = 0.010). CONCLUSION: The actual employment rates among patients in the 2 treatment groups were not different. However, patients with early RA who were treated with MTX plus infliximab had a higher probability of maintaining their employability compared with those who were treated with MTX alone.     

Additive combination of actarit and methotrexate in the treatment of refractory rheumatoid arthritis

The objective of this study was to evaluate the efficacy and safety of an additive combination of a disease-modifying antirheumatic drug (DMARD) actarit and low-dose methotrexate (MTX) in patients with active rheumatoid arthritis (RA) unresponsive to MTX. Thirty-four patients with active RA, who had been unsuccessfully treated with MTX for at least 3 months were enrolled on a 24-week course of actarit (300 mg/day) and MTX (2.5–10 mg/week). Disease activity was evaluated by physical global assessments using conventional measures (Japan Rheumatism Association), and the American College of Rheumatology (ACR) criteria of improvements in RA. Thirty-two patients completed this study. No severe adverse drug reactions were seen. Patients whose RA did not respond to MTX alone responded to the combination therapy, with a significant improvement in the duration of morning stiffness, grip strength, swollen joint counts, patient's articular pain score, modified health assessment questionnaire (M-HAQ) score, score of both patient's and physician's global assessments, and C-reactive proteins (CRP). Sixteen patients (50.0%) and 9 patients (31.0%) showed a significant improvement in overall conventional measures, and ACR response criteria, respectively, and 60.0% of RA patients who received MTX for more than 1 year showed improvement in ACR definition. Patients who responded to the combination treatment within the first 12 weeks showed persistent improvement for the remaining part of the 24 week period. Our results indicate that the additive combination of actarit and MTX is safe, and without serious adverse effects, and has an excellent efficacy in patients with active and refractory RA. Received: July 28, 1999 / Accepted: January 28, 2000     

甲氨蝶呤联合环磷酰胺治疗类风湿关节炎随机单盲对照临床研究

目的 评价甲氨蝶呤(MTX)联合环磷酰胺(CTX)及单独应用MTX、单独应用CTX治疗类风湿关节炎(RA)的疗效和安全性.方法 本研究为随机、单盲、对照的临床试验.符合纳入及排除标准的RA患者随机分为单用MTX(10～15 mg/周)、单用CTX(400 mg/2～3周)及MTX联合CTX治疗组(MTX10～15 mg/周+CTX 400 mg/2～3周).疗程24周,在基线、6、12、24周进行疗效及安全性评估.以美国风湿病学会(ACR)疗效评价指标ACR20为主要疗效指标,ACR50、ACR70、欧洲抗风湿联盟(EULAR)疗效指标、疼痛目视模拟测试表(VAS)评分、患者对自身健康状况的总体评估(PGA)、医生总体评价、压痛关节数(TJC)、压痛关节指数(TJI)、肿胀关节数(SJC)、肿胀关节指数(SJI)、健康评估问卷(HAQ)为次要疗效指标.结果 在第24周,MTX+CTX组达ACR20改善的患者比例(81%)高于MTX组(56%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组达ACR50改善的患者比例高于CTX组(P＜0.05).与MTX组之间差异无统计学意义(P＞0.05).在第24周,MTX+CTX组达到EULAR有效的患者比例(77%)高于MTX组(48%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组在TJC/TJI、SJC/SJI疼痛VAS评分、ESR的改善程度高于MTX组(P＜0.05).在压痛关节数脂数、肿胀关节数/指数、疼痛VAS评分、PGA、医生总体评价、HAQ、ESR的改善程度高于CTX组(P＜0.05).3组之间不良反应发生率差异无统计学意义.结论 MTX联合CTX治疗能显著改善RA的症状、体征和实验室炎性指标,疗效优于单用MTX及单用CTX.两者联合治疗安全耐受性好,与单用MTX及单用CTX相比,并不增加不良反应的发生率.     

Clarithromycin in rheumatoid arthritis: the addition to methotrexate and low-dose methylprednisolone induces a significant additive value—a 24-month single-blind pilot study

To compare the efficacy of the addition of clarithromycin (CM) to methotrexate (MTX) and methylprednisolone (MP) in active rheumatoid arthritis (RA). 32 patients with RA consecutively randomized. Control group: sixteen patients treated for 24 months with MTX 10–15 mg i.m. weekly and MP 4–6 mg daily. CM group: sixteen patients treated with MTX 10–15 mg i.m. weekly and MP 4–6 mg daily for 24 months; CM therapy added in the first month (500 mg twice a day for the first 15 days followed by 500 mg a day for the remaining 15 days). Evaluation of the improvement following ACR criteria was performed at months 1 (primary endpoint), 3 and 6. Patients were furthermore observed after 12, 18 and 24 months from the study beginning. At month 1, following ACR70 improvement criteria, we found a significant additive value in CM group (10/16 = 63 % vs 4/16 = 25 %, p = 0.033—chi-square test). After discontinuation of CM, the difference between groups was anymore evident (month 3: CM group 10/16 = 63 % vs control group 9/16 = 56 %). At month 24, 7/16 (44 %) in control group and 12/16 (75 %) in CM group completed the follow-up. The addition of CM to MTX and MP can induce the remission ACR 70 in the majority of RA patients within 4 weeks, while MTX and MP alone need about 3 months to achieve the same result.     

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

OBJECTIVE: To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX). METHODS: We conducted a prospective, 24-week, followup, multicenter, double-blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment. RESULTS: A total of 236 RA patients were included; 211 patients (89.4%) completed the 24-week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C-reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05). CONCLUSION: CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.     

Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: Results from registered data analyses

Objective: Upper limit of methotrexate (MTX) for patients with rheumatoid arthritis (RA) was recently increased from 8 to 16?mg/week in Japan. We therefore examined the effect of concomitant MTX dose on the efficacy of adalimumab (ADA) in clinical practice.

Method: Sixty-one consecutive RA patients treated with ADA were followed for minimum 52 weeks and retrospectively compared by MTX dose; patients receiving concomitant MTX of 10?mg/week or more (MTX ≥10?mg group) and <10?mg/week (MTX <10?mg group). Disease activity and remission were evaluated by the disease activity score 28 (DAS28) criteria.

Results: The MTX ≥10?mg group consistently showed better improvement in DAS28 and resulted in more patients (52.8%) with DAS28-remission compared with the MTX <10?mg group (26.1%). Multivariate analysis showed that MTX ≥10?mg had a significant effect on DAS28 remission with odds ratio of 5.12. ADA retention rate was 72.2% in MTX ≥10?mg group compared with 52.0% in MTX <10?mg group. Discontinuation of ADA due to adverse events were comparable in the MTX ≥10?mg and MTX <10?mg groups (11.1% vs. 12.0%).

Conclusions: These findings support the critical role of concomitant MTX in the efficacy of ADA, and recommend use of MTX ≥10?mg in Japanese RA patients.     

A randomized,double‐blind,multicenter, controlled clinical trial of chicken type II collagen in patients with rheumatoid arthritis

Objective

To assess the efficacy and safety of chicken type II collagen (CCII) in rheumatoid arthritis (RA) compared with methotrexate (MTX).

Methods

We conducted a prospective, 24‐week, followup, multicenter, double‐blind, controlled study of CCII (0.1 mg/day) versus MTX (10 mg/week) in patients with active RA. Clinical assessments were performed at screening and at 12, 18, and 24 weeks of treatment.

Results

A total of 236 RA patients were included; 211 patients (89.4%) completed the 24‐week followup. In both groups there was a decrease in pain, morning stiffness, tender joint count, swollen joint count, Health Assessment Questionnaire score, and investigator and patient assessment of function; all differences were statistically significant. In the MTX group, erythrocyte sedimentation rate and C‐reactive protein level decreased. Rheumatoid factor did not change in either group. At 24 weeks, 68.57% of patients in the CCII group and 83.02% in the MTX group met the American College of Rheumatology 20% improvement criteria (ACR20), and 40.95% and 57.54%, respectively, met the ACR50 criteria. The ACR20 and ACR50 response rates in the CCII group were lower than those in the MTX group, and this difference was statistically significant (P < 0.05). Gastrointestinal symptoms were common in both groups. There were fewer and milder side effects in the CCII group than the MTX group. The difference in incidence of adverse events between the 2 groups was statistically significant (P < 0.05).

Conclusion

CCII is effective in the treatment of RA. CCII is well tolerated, and the incidence of adverse events of CCII is lower than that of MTX.     

Secondary failure to treatment with recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis

The aim of this study is to assess the efficacy of anakinra, a recombinant human interleukin 1 receptor antagonist, plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) refractory to MTX therapy. A total of 54 patients with active RA, who were taking MTX at a stable dosage, were randomized to receive daily subcutaneous injections of anakinra (80 mg) or placebo. Clinical outcomes were assessed every 4 weeks for 24 weeks by using the criteria of the American College of Rheumatology. After 24 weeks, more patients achieved clinical benefits as determined by the ACR20 improvement treated with anakinra plus MTX compared with MTX alone (64% vs. 17%, P = 0.004). In the anakinra group, an ACR50 response was observed in 38% and an ACR70 response in 17%. None of the patients treated with MTX alone achieved ACR50 or ACR 70 improvement. However, nine of 42 (21.4%) patients in the anakinra group, who showed therapeutic response initially, had secondary drug failure to anakinra therapy thereafter. A significant increase in mean DAS28 from baseline was found in the non-responders to anakinra compared with placebo (0.83 ± 1.38 vs. −1.28 ± 0.78, P < 0.001). Anakinra is effective in the treatment of patients with active RA by blocking IL-1. However, the efficacy of anakinra is soon lost in about one fifth of patients in spite of initial good response.     

重组抗肿瘤坏死因子-α人鼠嵌合单克隆抗体对类风湿关节炎患者RANK/RANKL/骨保护素系统的影响

目的 探讨重组抗肿瘤坏死因子(TNF)-α人鼠嵌合单克隆抗体(Infliximab)对类风湿关节炎(RA)患者外周血核因子κB受体因子(RANK)/核因子κB受体活化因子(RANKL)/骨保护素系统的影响.方法 50例经严格筛选的类风湿关节炎(RA)患者按随机分配原则分为2组.一组患者接受Infliximab(3 mg/kg)+甲氨蝶呤治疗;一组患者接受甲氨蝶呤单独治疗作为对照,分别于0、2、6、14周给药.观察0周与18周Infliximab治疗组与对照组患者相关临床指标的改变,对比外周血中RANK、RANKL mRNA表达情况以及血清中骨保护素蛋白水平的变化.用t检验和x2检验做统计学分析.结果 经Infliximab治疗后,在RA患者关节放射成像中,可以观察到骨破坏程度有减缓趋势.与对照组比较,Infliximab治疗组(病史＞1年)患者骨丢失情况得到控制;Infliximab治疗组(0周:80.25;18周:63.2)与对照组(0周:83.37;18周:30.87)患者外周血中RANK、RANKL mRNA表达水平均下降(P＞0.05);与对照组比较,Infliximab可使RA患者外周血骨保护素/RANKL比值下降趋势减缓.虽然,经甲氨蝶呤或Infliximab+甲氨蝶呤治疗后,对照组[0周:(238±15)pg/ml;18周:(118±l0)pg/ml]和Infliximab治疗组[0周:(223±6)pg/ml;18周:(162±6)pg/ml)]患者血清中骨保护素水平均下降(P＞0.05),但Infliximab治疗组患者血清骨保护素下降趋势得以减缓.结论 RA患者经Infliximab联合甲氨蝶呤治疗后,骨破坏受到抑制,其作用机制可能是部分通过对RANK/RANKL/骨保护素系统的调节来行使的.     

COMPARISON OF METHOTREXATE WITH AZATHIOPRINE OR 6-MERCAPTOPURINE IN REFRACTORY RHEUMATOID ARTHRITIS: A LIFE-TABLE ANALYSIS

Methotrexate (MTX) appears to be useful in patients with rheumatoidarthritis (RA) refractory to othe drugs but its long-term toxicityand efficacy are uncertain. A retrospective study of MTX insuch patients i comparison with the purine analogues, azathioprineand 6-mercaptopurine was made using life-table analysis. Eighty-fourpatients took MTX in a median dose of 7.5 mg/week whilst 55received purin analogues, 100 mg/day (median). By 12 months,19.3% of patients had ceased MTX due to toxicit) compared with29.3% for purine analogues. Toxicity severe enough to warrantstopping therapy wa uncommon after 8 months with either drug.At 12 months 61.5% of the MTX patients had achieve defined criteriaof improvement compared with 25.6% for the purine analogues(p < 0.05). The number c patients improving on purine analoguesdid not increase substantially after 6 months, whereas the numbeimproving with MTX continued to 12 months. MTX in a low-doseregimen is useful in refractory RA an superior to low-dose purineanalogues.