ObjectiveTo observe the efficacy of low-dose methylprednisolone combined with hydroxychloroquine and methotrexate in the treatment of rheumatoid arthritis (RA). MethodsBetween January 2011 and May 2013, 60 RA patients on their first treatment with a disease course of less than or equal to 2 years were randomly divided to control group and treatment group Ⅰ with 30 patients in each. Patients in both the two groups were given hydroxychloroquine and methotrexate therapy, while the control group was treated with meloxicam (7.5 mg/time, 2 times/d) in addition, and the treatment group one was given methylprednisolone (4 mg/time, 2 times/d) in addition. Another 30 RA patients with a disease course of more than 5 years with no standardized treatment were designated into the treatment group Ⅱ. They accepted the same treatment scheme as treatment group Ⅰ. All the patients were evaluated one week after treatment to assess their clinical symptoms. Twelve weeks before and after treatment, the patients were evaluated on their clinical indicators and immunological indicators. ResultsThe clinical symptoms of patients in treatment group Ⅰ and Ⅱ were rapidly relieved within one week after treatment, and the curative effect was significantly higher than that in the control group (P<0.05). Twelve weeks after treatment, the treatment groups were significantly improved compared with the control group in clinical symptoms and DSA28 (P<0.05). The improvement of clinical symptoms and immunological tests in treatment group Ⅰ was more obvious than that in treatment groupⅡ. ConclusionLow-dose methylprednisolone combined with hydroxyl chloroquine and methotrexate can quickly and effectively relieve the clinical symptoms of the patients with RA, and patients with a shorter course of the disease have better clinical efficacy.
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.
Primary vitreoretinal lymphoma (PVRL) is one of the most common type of primary intraocular lymphoma. The current treatment options include local ocular radiotherapy (radiotherapy), systemic chemotherapy (chemotherapy), local ocular chemotherapy, and combination therapy. The treatment options are different at different stages of PVRL, however, there is no uniform treatment guideline. Local ocular chemotherapy can make the drug reach effective therapeutic concentration in the eye, and it can be repeated many times. At the same time, it can avoid the adverse reactions caused by systemic medication or radiotherapy. It is an ideal choice for relieving ocular symptoms. At present, the mainstream ocular local chemotherapeutics are methotrexate (MTX) and rituximab (RTX). The basic consensus about the intravitreal injection of MTX (IVM) is the induction-consolidation-maintenance model, however, the time of each stage and frequency of IVM are diverse. The time interval of intravitreal injection of RTX is also variable, ranging from 1 time/week to 1 time/months and so on. Corneal epithelial lesions caused by frequent MTX injections and the higher recurrence rate after RTX treatment are the main reasons for changing the treatment plan. For patients with primary central nervous system lymphoma and PVRL, combined treatment with neurology department is necessary to save patient's lives, ophthalmology treatment relieves ocular symptoms and improves the patient's quality of life. For patients with PVRL alone without central nervous system involvement, ophthalmology treatment is necessary to control patient's eye symptoms, and close follow-up should be followed to find the involvement of the central nervous system in time, and then combined with neurological treatment to save patient’s lives.
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.
ObjectiveTo evaluate the safety and efficacy of the intravitreal methotrexate treatment in patients with primary vitreoretinal lymphoma (PVRL). MethodsRetrospective non-comparative interventional case series. Fourteen patients (26 eyes) with biopsy-proven PVRL were included in the study. All patients received examination of Snellen chart visual acuity, fundus color photography and optical coherence tomography (OCT). Among the 24 eyes with recordable visual acuity, 17 eyes has initial visual acuity≥0.1 (0.45±0.20) and 7 eyes with initial visual acuity ranged from light perception to hand movement. The vitreous opacities and (or) subretinal yellowish-white lesions and retinal pigment epitheliumuplift were observed in all eyes. All eyes were treated with intravitreal methotrexate (4000 μg/ml, 0.1 ml) injections according to a induction-consolidation-maintenance regimen. For 26 treated eyes, each received an average of (11.5±6.3) injections. Twenty eyes had finished theintraocular chemotherapy, while 6 eyes had not. Eight of 20 eyes were clinically confirmed free of tumor cells by diagnostic vitrectomy, 12 eyes were still with tumor cell involvement.The follow-up was ranged from 2 to 48 months, the mean time was 18 months. The examination of BCVA, fundus color photography and OCT were performed. No tumor cell was defined as clinical remission. Visual acuity was scored as improved or declined obviously (improved or declined 2 lines) or mild improved or declined (changed within 2 lines). ResultsTwenty eyes achieved clinical remission after (3.5±3.6) injections, 12 eyes of 20 eyes with tumor cell involvement before chemotherapy achieved clinical remission after (5.8±3.0) injections. The mean visual acuity of seventeen eyes with initial visual acuity 0.1 in induction phase and at the end of treatment were 0.36±0.23 and 0.56±0.20, respectively. Compared with before treatment, the visual acuity was mild declined in induction phase (t=1.541, P>0.05), but mild improved at the end of treatment (t=2.639, P<0.05). The visual acuity at the end of treatment in 7 eyes with initial visual acuity<0.1 was ranged from no light perception to 0.1. Of 14 patients, 2 patients have been fatal because of brain lesions progression at 42 and 48 months after diagnosis of primary central nervous system lymphoma. No ocular recurrence was noted during the follow-up in 20 eyes who finished intraocular chemotherapy. ConclusionsPVRL patients can achieve clinical remission after (3.5±3.6) injections by intravitreal chemotherapy of methotrexate, and the visual acuity improved mildly. No ocular recurrence was found during follow-up.
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: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 explore the clinical effect of intramuscular injection of methotrexate on hysteroscopic treatment of endogenous cesarean scar pregnancy (CSP). Methods A prospective analysis was conducted on 94 patients diagnosed with endogenous CSP who visited the Department of Gynecology in Liuzhou Workers’ Hospital between January 2013 and January 2018, and they were randomly divided into two groups, the intramuscular injection of methotrexate followed by hysteroscopic surgery group (the methotrexate group, n=39) and the direct hysteroscopic surgery group (the non-methotrexate group, n=55). The operation time, intraoperative blood loss, surgical complications, length of hospital stay, hospitalization expenses, the recovery time of blood human chorionic gonadotropin (HCG) and treatment outcomes of the two groups were compared. The normally distributed data were expressed as mean±standard deviation, and the non-normally distributed data were expressed as median (lower quartile, upper quartile). Results There was no statistically significant difference in age, gestational sac diameter, uterine scar thickness, number of cesarean sections, time from cesarean section to present, time of menopause, or preoperative blood HCG value between the two groups (P>0.05). There was no statistically significant difference in intraoperative blood loss [75 (35, 120) vs. 65 (35, 130) mL, P=0.821], incidence of complications (5.1% vs. 5.5%, P=1.000), postoperative blood HCG recovery time [(5.22±2.17) vs. (4.96±1.81) weeks, P=0.559] or the effective rate of treatment (94.9% vs. 90.9%, P=0.747) between the two groups. The methotrexate group had longer operation time [43 (34, 55) vs. 32 (28, 35) min, P=0.001], longer length of hospital stay [(10.89±1.42) vs. (5.82±1.47) d, P<0.001], and higher hospitalization cost [(8596.46±3336.59) vs. (7058.84±2638.49) yuan, P=0.014]. Conclusion For patients with endogenous CSP, intramuscular injection of methotrexate before hysteroscopic surgery is not necessary, for it has no significant impact on the treatment effect, instead, it may prolong the operation time and length of hospital stay, and increase the hospitalization cost.
Objective To analyze the effectiveness of conservative medical treatments for ectopic pregnancy (EP): methotrexate (MTX) + mifepristone + Ectopic Pregnancy II decoction (EP-II) vs. methotrexate + mifepristone. Methods A total of 95 patients with EP in Shenzhen Shajing Affiliated Hospital of Guangzhou Medical University from January 2009 to January 2011 were randomly divided into two groups: 45 patients in the experimental group were treated with MTX, mifepristone and EP II decoction, while the other 50 patients in the control group were treated with MTX and mifepristone. The effectiveness of the two groups was analyzed with SPSS 13.0 software. Results There were significant differences in the time of serum β-HCG return to normal (16.13±8.13 ds vs. 22.05±7.15 ds, Plt;0.05), time of EP mass absorption (30.46±7.56 ds vs. 39.99±18.26 ds, Plt;0.05) and tubal patency rate (80% vs. 75%, Plt;0.05) between the two groups. But there were no significant differences in effective rate (95.56%, 43/45 vs. 94%, 47/50, χ2=0.0809, Pgt;0.05) and side effects. Conclusion The combination of methotrexate, mifepristone and EP II decoction for ectopic pregnancy is more effective than mifepristone and methotrexate in coordinately killing the embryo, shortening the time of serum β-HCG return to normal and the time of EP mass absorption, and improving the function of oviducts.