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.
Rheumatoid arthritis (RA) is one of the most common immune-mediated diseases, and the interaction between the intestinal microbiota and the patient’s immune system may play a role in the occurrence and development of RA. Methotrexate (MTX), as a first-line drug for the treatment of RA, can be directly and indirectly influenced by intestinal microbiota and its enzyme products to affect the bioavailability, clinical efficacy, and toxicity of the drug. Therefore, it is crucial to understand the mechanism by which intestinal microbiota affects RA and the impact of intestinal microbiota on the efficacy of MTX. This article provides a review of the mechanisms by which intestinal microbiota may contribute to the pathogenesis of RA, as well as the role and impact of intestinal microbiota in MTX drug metabolism and treatment response.
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 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.
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.
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.
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.
目的 為紅皮病型銀屑病患者制定循證治療方案。 方法 2012年3月收治1例紅皮病型銀屑病患者，充分評估患者情況后，提出臨床問題，計算機檢索Cochrane圖書館、 Medline、中文全文期刊醫學數據庫中相關研究，根據檢索結果結合患者實際情況，制定治療方案。 結果 共檢索到相關文獻3篇。通過對檢索結果進行分析，并結合患者意愿，為患者制定了采用甲氨喋呤的治療方案。經過6個月的治療隨訪，證實該方案適合該患者。 結論 采用循證醫學的方法，為紅皮病型銀屑病患者制定合理的治療方案，可提高療效。
Objective To evaluate the efficacy and safety of Leflunomide (LEF) in the treatment of Rheumatoid Arthritis (RA), so as to provide scientific proof for applying LEF in China. Methods Randomized controlled trials (RCTs) about the effect of LEF on patients with RA from January 1989 to January 2011 were searched from the following databases, CNKI, WanFang Data, MEDLINE, EMbase and CBM. After two reviewers independently screened the studies according to the inclusion and exclusion criteria, extracted the data and assessed the quality, the data were analyzed by RevMan 5.0 software. Results Among 3247 patients in 16 included RCTs, 1711 patients were in the LEF group, while the other 1536 patients were in the Methotrexate (MXT) group. The results of meta-analyses showed there was no significant difference in the efficacy between LEF and MXT (RR=1.03, 95%CI 0.94 to 1.11, Pgt;0.05), but a significant difference was found in the side reaction (RR=0.67, 95%CI 0.49 to 0.94, Plt;0.05). Conclusion Based on the current studies, Leflunomide is as effective as the commonly-used Methotrexate in the treatment of rheumatiod arthritis at present, much safer than Methotrexate, and thought as a safe and effective SAARD. For the quality restrictions of the included studies, more double blind RCTs with high quality are required to further assess the effects.
目的 探討子宮動脈化療栓塞在剖宮產術后子宮切口妊娠治療中的可行性和安全性。 方法 回顧分析2006年7月－2011年3月收治的152例剖宮產切口瘢痕妊娠行介入治療的病例資料。 結果 152例子宮動脈化療栓塞操作均成功。陰道大出血或不規則出血均得到有效控制。人絨毛膜促性腺激素β亞型較術前下降，差異有統計學意義（Z=?9.295，P=0.000），術后2～22 d行清宮術，術中失血3～100 mL，平均27 mL。3例行子宮切除術，子宮切除率2%。1例發生栓子脫落導致左下肢脛前動脈栓塞并發癥。 結論 子宮動脈化療栓塞治療剖宮產術后切口妊娠可有效控制大出血、降低清宮風險、降低子宮切除風險，是治療切口妊娠的有效可行方法之一。