Objectives To systematically review the efficacy and safety of certolizumab pegol (CZP) plus methotrexate (MTX) for active rheumatoid arthritis. Methods The Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP and WanFang Data were searched to collect randomized controlled trials (RCTs) on CZP plus MTX vs. MTX plus placebo for active rheumatoid arthritis from inception to May, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, data were analyzed by using Stata 11.0 software. Results Seven RCTs were included. The results of meta-analysis showed the CZP plus MTX group was superior to MTX plus placebo group in ACR20 (CZP400 mg: RR=2.86, 95%CI 1.70 to 4.79, P<0.001; CZP200 mg: RR=3.76, 95%CI 2.59, 5.46, P<0.001), ACR50 (CZP400 mg: RR=3.91, 95%CI 2.10 to 7.27, P<0.001; CZP200 mg: RR=4.86, 95%CI 3.20 to 7.39, P<0.001), and ACR70 (CZP400 mg: RR=5.65, 95%CI 1.99 to 16.06, P=0.001; CZP200 mg: RR=10.08, 95%CI 5.11 to 19.89, P<0.001). The CZP plus MTX group was also superior to MTX plus placebo group in swollen joint counts (SMD=–12.72, 95%CI –15.39 to –10.06,P<0.001), tender joint counts (SMD=–11.54, 95%CI –13.97 to –9.11,P<0.001), doctor's global assessment of disease activity (SMD=–11.78, 95%CI –13.81 to –9.75,P<0.001), patient's global assessment of disease activity (SMD=–9.62, 95%CI –11.09 to –8.15,P<0.001), and patient's assessment of pain (SMD=–9.10, 95%CI –10.91 to –7.30,P<0.001) and HAQ (SMD=–7.74, 95%CI –8.99, –6.49,P<0.001), respectively. However, the incidence of adverse events in CZP plus MTX group was higher than that in MTX plus placebo group. Conclusions CZP plus MTX is superior to MTX plus placebo for treatment of active rheumatoid arthritis but with higher adverse events. Due to limited quantity and quality of the included studies, the above conclusions are still needed to be verified by more high-quality studies.
目的 为红皮病型银屑病患者制定循证治疗方案。 方法 2012年3月收治1例红皮病型银屑病患者，充分评估患者情况后，提出临床问题，计算机检索Cochrane图书馆、 Medline、中文全文期刊医学数据库中相关研究，根据检索结果结合患者实际情况，制定治疗方案。 结果 共检索到相关文献3篇。通过对检索结果进行分析，并结合患者意愿，为患者制定了采用甲氨喋呤的治疗方案。经过6个月的治疗随访，证实该方案适合该患者。 结论 采用循证医学的方法，为红皮病型银屑病患者制定合理的治疗方案，可提高疗效。
ObjectiveTo evaluate the effect of time-related administration of methotrexate (MTX) on neural cell apoptosis in rats after spinal cord injury (SCI) so as to investigate its potential neuroprotective mechanism and appropriate administration time. MethodA total of 120 male Sprague Dawley rats, 247-286 g in weight, were randomly divided into 4 groups (n=30) :sham group (group A), control group (group B), MTX treating group (group C), and MTX prophylaxis group (group D). The SCI model was established in the rats of groups B, C, and D by improved Allen method, and just laminectomy was performed in group A. MTX (0.5 mg/kg) was administered with tail vein injection at 1, 6, 12, 18, and 24 hours after injury in group C, and at 30 minutes before injury and at 6, 12, 18, and 24 hours after injury in group D; the equivalence saline was injected at 1, 6, 12, 18, and 24 hours after injury in groups A and B. Basso-Beattie-Bresnahan (BBB) score was used to evaluate the neural function at 1, 3, 7, 14, and 21 days after injury, HE staining to observe histological changes, immunohistochemical staining and TUNEL method to measure the expression of Caspase-3 and neural cells apoptosis, respectively. ResultsTen rats died during the experiment in groups B, C, and D; 25 rats in each group were included into the experiments at last. BBB score of group A was significantly higher than that of groups B, C, and D at all time points after injury (P<0.05) . BBB score of groups C and D were significantly higher than that of group B at 3, 7, 14, and 21 days (P<0.05) , and BBB score of group D was significantly higher than that of group C at 3, 7, and 14 days (P<0.05) . The histological observation showed normal structure of spinal cord at all time points after injury in group A. While the degree of SCI in group D was lighter than that in groups B and C, and group C was lighter than group B. At 14 days after injury, the degree of SCI in groups B, C, and D tend to keep the same. The number of Caspase-3 and TUNEL positive cells of groups B, C, and D was significantly more than that of group A at all time points after injury (P<0.05) , group B was significantly more than groups C and D (P<0.05) . The number of Caspase-3 positive cells of group C was significantly more than that of group D at 3, 7, and 14 days (P<0.05) . While the number of TUNEL positive cells of group C was significantly more than that of group D at 3 and 7 days (P<0.05) . And the number of Caspase-3 positive cells and TUNEL positive cells was positively correlated in groups B, C, and D (P<0.05) at 1, 3, 7, 14, and 21 days after injury. ConclusionsLow-dose MTX may effectively reduce the degree of the secondary injury of spinal cord by reducing the nerve cell apoptosis. Better effect can be obtained when MTX is used as prevent method than as a way of treatment.
ObjectiveTo compare the clinical efficacy of methotrexate perfusion combined with interventional treatment and the traditional treatment with methotrexate and mifepristone for cesarean scar pregnancy. MethodA total of 589 patients diagnosed with cesarean scar pregnancy after surgery between January 2012 and March 2015 in our hospital were selected to be our study subjects. The patients were informed of the two kinds of treatment, and based on their own will, they were arranged into corresponding groups. Group A had 234 patients who were willing to undergo the conventional therapy:intramuscular injection of methotrexate (20 mg, once per day for 5 days); oral mifepristone (50 mg once per day for 3 to 5 days); and the continuation of drugs was determined by local pregnancy tissue blood flow on B ultrasound and liver function of the patients. Group B had 255 patients who selected uterine artery perfusion and arterial embolism. There was no significant difference in terms of age, serum human chorionic gonadotrophin (HCG) and uterine incision gestation sac size between the two groups of patients (P>0.05). Then we compared the treatment effect between the two groups. ResultsThe differences in the amount of bleeding, the time of blood HCG dropped to normal, and hospitalization duration between the two groups were significant (P<0.05), while in the rate of hysterectomy, drug-induced liver injury were not (P<0.05). ConclusionsMethotrexate perfusion combined with interventional treatment is better than the traditional treatment with methotrexate and mifepristone for cesarean scar pregnancy in terms of clinical efficacy and safety.
We reported one case of MTX-induced aplastic anemia and reviewed related literature to investigate the mechanism of action of MTX, and summarize the clinical feature, diagnostic criteria, risk factor, and interventions. These were hoped to arouse the attention of clinicians and clinical pharmacists, in order to effectively prevent, diagnose, and treat MTX-induced aplastic anemia.
ObjectivesTo analyze patients’ values and preferences on individualized medication of high-dose methotrexate so as to support the development of the practice guideline for clinical medication of high-dose methotrexate.MethodsA multicenter cross-sectional study involving patients with osteosarcoma or hematological malignancy in 7 hospitals was conducted by questionnaires to evaluate the perception and willingness on detection of gene polymorphisms (MTHFR C677T, MTHFR A1298C, ABCB1 C3435T and RFC1 G80A) related to methotrexate (MTX) and therapeutic drug monitoring (TDM) of MTX. SPSS24.0 software was used to analyze the data.ResultsA total of 124 patients were involved, including 40 (32.26%) with osteosarcoma and 84 (67.74%) with hematological malignancy. 106 (85.48%) and 117 (94.35%) patients agreed on detection of gene polymorphisms and TDM, respectively. There was a significant difference on preference towards TDM between patients with risk factors for MTX and patients in which risk factors for MTX were not discovered (76.19% vs. 95.08%, P=0.003). The ranking of factors that contributed to the two decision-making was consistent (P<0.01), and specific orders of factors were identical. The clinical efficacy was the primary factor (mean rank 3.45 for detection of genetic polymorphisms and 3.52 for TDM), followed by safety (mean rank 3.01 and 3.16, respectively) and comfort (mean rank 1.73 and 1.79, respectively). Cost (mean rank 1.39 and 1.31, respectively) was the least important factor.ConclusionsThe preferences of patients toward detection of gene polymorphisms and TDM were generally similar, with well acceptance. No significant differences were found on the preferences toward detection of gene polymorphisms. However, patients with or without risk factors for MTX may differ significantly when making decisions on TDM, which may impact on clinical decision-making of clinicians and clinical pharmacists. The perception and willingness of patients should be considered adequately during the development of clinical practice guidelines and clinical practice.
目的:探讨甲氨蝶呤联合依那西普(MTX+ETA)和甲氨蝶呤联合来氟米特(MTX+LEF)治疗重度活动的类风湿关节炎(RA)的疗效差异。方法:收集重度活动的RA患者50例。A组24例,给予MTX 10mg/次,一周一次,口服,联合ETA 25mg/次,一周2次,皮下注射后病情缓解后依那西普减量为25mg/次,1周一次至随访结束;B组26例,给予MTX 10mg一周一次联合来氟米特20mg/d。两组随访时间为24周。定期随访其红细胞沉降率(ESR)、C反应蛋白(CRP)、DSA28评分、sharp评分、RF、ANA、ACR核心标准评定。结果:①A组在治疗半年前后其VAS评分、晨僵时间、关节肿痛个数、DSA28评分、HAQ、患者评分、医生评价、ESR、CRP方面改善明显,有统计学意义(Plt;0.05);B组在治疗半年前后其VAS评分、晨僵时间、关节肿痛个数、DSA28评分、HAQ、患者评分、医生评价方面改善明显,有统计学意义(Plt;0.05);A组和B组在治疗半年后在VAS评分、晨僵时间、关节触痛个数、DSA28评分、HAQ、患者评分、医生评价、ESR、CRP方面改善明显,有统计学意义(Plt;0.05)。②各组ACR20有效率逐步增加,在各随访期内两组的ACR20的达标率的差异无明显的统计学意义(Pgt;0.05);ACR50则在第4、20、24周,A组的达标率为12%、79%、87%与B组的8%、46%、50%差异有统计学意义(Plt;0.05);ACR70虽然在各期A组均高于B组,但差异均无差异性(Pgt;0.05)。③A组在第2、4、12周DSA28指数下降明显,跟前次随访指标的差异有统计学意义(Plt;0.05);B组在第16、24周DSA28指数下降明显,跟前次随访指标的差异有统计学意义(Plt;0.05);而A组与B组同期DSA28的比较发现,A组从第4周起各期DSA28分值均低于B组,且差异均有统计学意义(Plt;0.05)④两种治疗方案不良反应发生情况均低,且两组不良事件发生率差异无统计学意义。结论:ETA+MTX和LEF+MTX联合治疗重度活动的RA均是安全有效的,其中前者常常可以更早期的达到诱导缓解病情的目的。
Objective To investigate the effectiveness, safety and cost-effectiveness of leflunomide for rheumatoid arthritis, and formulate an evidence-based treatment plan for a patient with rheumatoid arthritis. Methods We searched the ACP Journal Club, The Cochrane Library (Issue 2, 2007) and MEDLINE (1990 to 2007), and critically appraised the available evidence. Results The available Level A (high quality) evidence showed that the efficacy and adverse events of leflunomide were comparable to those of methotrexate. The total cost of treating patients with leflunomide was significantly higher when compared to methotrexate. The combination of leflunomide and methotrexate in patients with active rheumatoid arthritis unresponsive to methotrexate monotherapy was less costly and more effective than the strategy excluding leflunomide. Given the current evidence, together with our clinical experience and the patient’s preference, methotrexate was administered to the patient. There was an inadequate response after 6 months of treatment. And then, adding leflunomide to methotrexate attained a remarkable response 3 months later. The patient is still being followed up. Conclusion treatment with leflunomide and methotrexate in RA patients can improve the clinical outcomes. Long-term efficacy and toxicity remain to be established.
目的 探讨子宫动脉化疗栓塞在剖宫产术后子宫切口妊娠治疗中的可行性和安全性。 方法 回顾分析2006年7月－2011年3月收治的152例剖宫产切口瘢痕妊娠行介入治疗的病例资料。 结果 152例子宫动脉化疗栓塞操作均成功。阴道大出血或不规则出血均得到有效控制。人绒毛膜促性腺激素β亚型较术前下降，差异有统计学意义（Z=−9.295，P=0.000），术后2～22 d行清宫术，术中失血3～100 mL，平均27 mL。3例行子宫切除术，子宫切除率2%。1例发生栓子脱落导致左下肢胫前动脉栓塞并发症。 结论 子宫动脉化疗栓塞治疗剖宫产术后切口妊娠可有效控制大出血、降低清宫风险、降低子宫切除风险，是治疗切口妊娠的有效可行方法之一。
ObjectivesTo systematically review the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis.MethodsPubMed, EMbase, The Cochrane Library, VIP, CBM, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) of the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis from inception to June 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 10 RCTs involving 970 patients were included. The results of meta-analysis showed that: there was no statistical difference between iguratimod and methotrexate in ACR20 (RR=1.06, 95%CI 0.91 to 1.23, P=0.49), ACR50 (RR=0.93, 95%CI 0.73 to 1.19, P=0.55), ACR70 (RR=0.92, 95%CI 0.62 to 1.39, P=0.70), morning stiffness time (MD=0.45, 95%CI –0.26 to 1.16, P=0.22), tender joint count (MD=0.07, 95%CI –2.31 to 2.45, P=0.95), swollen joint count (MD=–0.30, 95%CI –1.44 to 0.84, P=0.61), health assessment questionnaire (MD=0.01, 95%CI –0.05 to 0.07, P=0.73) and the rate of adverse effects (RR=0.66, 95%CI 0.41 to 1.07, P=0.09). Meta-analysis of 2 RCTs using double-blind method showed that, iguratimod was superior to methotrexat in the patient (MD=4.11, 95%CI 0.11 to 8.10, P=0.04) and physician (MD=4.81, 95%CI 0.93 to 8.69, P=0.01) global assessment of disease activities.ConclusionsCurrent evidence shows that the efficacy and safety of iguratimod in the treatment of rheumatoid arthritis are similar to methotrexate. And iguratimod is superior in global assessment of disease activities by patients and doctors. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.