甲氨蝶呤治疗中重度寻常型银屑病的临床疗效观察

目的:评价甲氨蝶呤治疗中重度寻常型银屑病的临床疗效和安全性.方法:将72例中重度寻常型银屑病患者随机分为治疗组和对照组,治疗组36例口服甲氨蝶呤片,每次5 mg,每12小时1次,每周连服3次;对照组36例口服复方氨肽素片,每次5片,每天3次;两组患者均连续治疗8周.结果:治疗组患者治疗后基愈率为44.44%、显效率为38.89%、进步率为16.67%、无效率为0,有效率为83.33%;对照组治疗后基愈率为30.56%、显效率为30.56%、进步率为27.78%、无效率为11.11%,有效率为61.11%.两组有效率比较差异有统计学意义(2=4.43,P=0.035).两组患者均无明显不良反应.结论:甲氨蝶呤治疗中重度寻常型银屑病安全、有效.     

甲氨蝶呤治疗中、重度银屑病的疗效观察

目的:观察甲氨蝶呤(methotrexate,MTX)治疗中、重度银屑病的临床疗效和安全性。方法:41例银屑病患者每周接受MTX5～15mg静脉滴注治疗1次,共20次。结果:41例患者经过10～20周治疗后,痊愈16例(39.0%),显效17例(41.5%),好转7例(17.1%),无效1例(2.4%),有效率为80.5%,不良反应为纳差、恶心、呕吐、头痛、荨麻疹、月经过多、丙氨酸转氨酶轻度升高。结论:MTX5～15mg每周1次静脉滴注治疗中、重度银屑病安全有效。     

甲氨蝶呤治疗银屑病的临床疗效观察

目的：观察甲氨蝶呤（Methotrexate,MTX）治疗银屑病的临床疗效和安全性。方法：80例银屑病患者随机分为两组,治疗组40例患者口服MTX 5～15mg／周治疗,对照组40例患者口服阿维A 0．5～0．65mg／（kg·d^-1）治疗。结果：经过6周治疗后,治疗组总有效率82．5％,副作用发生率为12．5％;对照组总有效率80．0％,副作用发生率为82．5％。结论：MTX 5—15mg／周治疗银屑病是安全有效的。     

甲氨蝶呤与银屑病

甲氨蝶呤(MTX)是一种有效的抗银屑病药物。在我国广泛地用于治疗严重银屑病。针对MTX作用机理、药代动力学和药效学、不良反应、药物相互作用及联合用药的研究进展作简述。     

甲氨蝶呤治疗银屑病的再评价

甲氨蝶呤是一个有效的抗银屑病药物,自1960年以来已广泛地用于治疗严重的、急性泛发性脓疱型、红皮病型、关节病型以及外用药无效的泛发性慢性斑块状银屑病。目前尚无与其它治疗严重银屑病的系统疗法如:环孢素、维A酸或PUVA等光化学疗法的比较资料,但甲氨蝶呤比较便宜,正确使用还是安全的。其重要的不良反应为急性骨髓抑制,特别是老年患者、有肾脏损害和(或)叶酸缺乏者容易发生,也可能是用药过量或药物相互作用等原因造成的。长期用甲氨蝶呤的危险是肝纤维化,其与甲氨蝶呤的累积量相关。     

甲氨蝶呤治疗银屑病的再评价

甲氨蝶呤是一个有效的抗银屑病药物,自１９６０年以来已广泛地用于治疗严重的、急性泛发性脓疱型、红皮病型、关节病理以及外用药无效的泛发性慢性斑块状银屑病。目前尚无与其它治疗严重银屑病的系统疗法如：环孢素、维Ａ酸或ＰＵＶＡ等光化学疗法的比较资料,但甲氨蝶呤比较便宜,正确使用还是安全的。其重要的不良反应为急性骨髓抑制,特别是老年患者、有肾脏损害和（或）叶酸缺乏者容易发生,也可能是用药过量或药物相互作用等原     

阿维A与甲氨蝶呤治疗寻常性银屑病疗效观察

我们应用阿维A治疗寻常性斑块状银屑病,甲氨蝶呤(MTX)作对照观察,现将其疗效及安全性的比较报道如下。1资料与方法1.1病例选择:43例寻常性斑块状银屑病患者均为本科门诊和住院患者,临床表现典型。治疗组24例,年龄22～58岁,平均35.1±10.2岁,男16例,女8例,病程5个月～15年;对照组19例,年龄18～56岁,平均37.2±12.2岁,男12例,女7例,病程5个月至15年;两组的年龄、性别、病情、病程差异无统计学意义(P﹥0.05)。2组患者均无其他系统疾患。1.2治疗方法:治疗组采用阿维A(商品名方希,重庆华邦制药股份有限公司)20～50mg/d,分1～2次口服治疗,见效…     

银屑病亚甲基四氢叶酸还原酶基因多态性与甲氨蝶呤疗效及不良反应的关系

目的:探讨银屑病患者亚甲基四氢叶酸还原酶(MTHFR)基因C677C/T多态性及其与长期小剂量甲氨蝶呤(MTX)方案治疗的疗效和不良反应的相关性。方法:运用聚合酶链反应和限制性片段长度多态性分析(PCR-RFLP)的方法检测120例寻常型银屑病患者及100名健康对照组的MTHFRC677C/T多态性,比较两组间基因型及等位基因频率分布。在MTX治疗用药前,治疗后1、2、4、12周定期检查实验室指标,评价疗效及不良反应。结果:银屑病组MTHFR基因CC、CT、TT基因型分布分别为54.17%、32.50%、13.33%,与健康对照组(分别为43.00%、45.00%、12.00%)比较,差异无统计学意义(2=3.70,P0.05)。有105例银屑病患者纳入疗效评估,各基因型间的疗效比较差异无统计学意义(2=1.45,P0.05)。35.00%(42/120)患者出现不良反应,将有、无不良反应的两组基因型进行比较,差异有统计学意义(2=17.26,P0.05),CT+TT基因型占不良反应组的71.43%,与无不良反应组(32.05%)比较差异有统计学意义(2=17.05,P0.05)。29.17%(35/120)出现肝毒反应,将肝毒性组和无不良反应两组基因型分布比较差异有统计学意义(2=10.02,P0.05),肝毒性组T等位基因出现频率较无不良反应组高,差异有统计学意义(2=7.52,P0.05)。结论:MTHFR基因C677C/T多态性与银屑病的发病和MTX疗效无关,但与MTX治疗后的不良反应和肝毒性有关,T突变基因是不良反应的高危因素。     

环孢素A和甲氨蝶呤治疗重症银屑病的疗效比较

目的：评估环孢素A（CyA）及甲氨蝶呤（MTX）治疗重症银屑病的临床疗效和安全性。方法：采用开放性临床对照研究。将确诊为重症银屑病的32例患者分为A组（121服CyA3—5ms／ks·d）和B组（口服或静脉滴注MTX10～15ms／w）治疗8周,随访〉3个月。以皮损消退、体温下降、关节疼痛减轻、起效时间、复发率及不良反应等作为评价指标。结果：治疗8周后,A组和B组皮损有效率分别为84．6％,79．0％;治疗8周后两组中的关节型银屑病患者关节疼痛均明显减轻及两组患者体温均正常;A组皮损好转时间、体温下降时间、关节疼减轻时间均早于B组,两组不良反应例数及复发例数分别为3例、5例和4例、3例。结论：CyA和MTX治疗重症银屑病均安全有效,CyA起效较快,但应根据患者的临床表现及经济状况选择用药。     

复方甘草酸苷联合抗生素和叶酸治疗儿童寻常型银屑病疗效观察

目的评价复方甘草酸苷联合抗生素等治疗儿童寻常型银屑病的疗效和安全性。方法治疗组43例,用复方甘草酸苷联合抗生素、叶酸治疗;对照组38例,以抗生素、叶酸治疗。疗程1个月。结果治疗组有效率(83.7%)显著高于对照组(63.1%)(P<0.05)。结论复方甘草酸苷联合抗生素等治疗儿童寻常型银屑病具有较高的疗效和安全性。     

The Effect of Folate Supplementation on Methotrexate Efficacy and Toxicity in Psoriasis Patients and Folic Acid Use by Dermatologists in the USA

Background

Methotrexate (MTX) is an effective treatment for psoriasis but its use is limited by its toxicity. Folate supplementation can be used to reduce the adverse effects of MTX, though this may impact efficacy. The frequency of folic acid supplementation is not well characterized.

Purpose

The objective of this study was to review the literature involving the use of folate in patients (in particular those with psoriasis) treated with MTX and analyze trends in folic acid use.

Methods

We searched PubMed from 1 May 1989 through 1 April 2012 using the terms ‘folic acid,’ ‘folinic acid,’ ‘folate,’ ‘supplementation,’ and ‘methotrexate.’ We also used the National Ambulatory Medical Care Survey (NAMCS) database to collect data regarding trends in MTX use and folic acid supplementation by physicians in the USA from 1993 through 2009. We assessed data including the number of MTX visits, rate of folic acid use, diagnoses, physician specialty, and demographics of patients. We used linear regression to analyze the change in folic acid use over time.

Results

Twenty-six published trials were included addressing folic acid supplementation with MTX. The majority found a benefit to folic acid supplementation, but there were only seven studies in psoriasis. Dermatologists were among the highest prescribers of MTX, and psoriasis was commonly treated with MTX. Folic acid supplementation significantly increased over this time period (p < 0.0001). However, dermatologists ranked lowest for their folate use, co-prescribing folate to only 9.1 % of MTX-treated patients.

Limitations

In contrast to rheumatoid arthritis, there is a scarcity of literature describing the effect of folate on MTX toxicity and efficacy in psoriasis patients. NAMCS data only included outpatient visits to non-federally employed physicians, and there is the possibility of healthcare providers not documenting over-the-counter folic acid usage. Lastly, doses of MTX and folic acid were not recorded in the database.

Conclusion

Dermatologists were the least likely specialists to supplement MTX with folic acid. The evidence for supplementation of folic acid is mixed. The literature confirms a reduction in the adverse effects of MTX but less strongly that there may be a reduction in efficacy too. Keeping in mind the potential for folate to reduce MTX efficacy, folic acid supplementation should be considered in MTX-treated patients.     

来氟米特治疗关节病型银屑病疗效观察

目的观察来氟米特治疗关节病型银屑病的临床疗效和不良反应。方法患者给予口服来氟米特片,第1～3天负荷剂量50mg/d,第4天开始20mg/d,连用12周为1疗程,疗程结束时评估疗效及安全性。结果治疗后银屑病皮损和关节疼痛、压痛、肿胀、活动受限及血沉指标均较治疗前得到明显改善,差异有显著性意义(P<0.001);8例患者中,关节炎病情明显进步3例,进步3例,改善2例,无效0例,有效率75.00%。结论来氟米特为治疗关节病型银屑病安全而有效的药物。     

Risk-Benefit Assessment of Methotrexate in the Treatment of Severe Psoriasis

Methotrexate is an established and highly effective systemic treatment for severe psoriasis, including the pustular and erythrodermic forms. It has been widely used during the last 3 decades. For this reason, the long term adverse effects of methotrexate are well known, in contrast to other relatively new systemic treatments like cyclosporin and retinoids. The most frequent adverse effects occurring during methotrexate therapy are abnormal liver function tests, nausea and gastric complaints. The most feared adverse effects are myelosuppression and hepatotoxicity. Because hepatotoxicity is related to a high cumulative dose of methotrexate, rotational therapy or an intermittent instead of a continuous treatment schedule are advised. The histological assessment of liver biopsies, according to the international guidelines, remains the gold standard for detection of liver damage until equally reliable noninvasive screening methods for liver damage — tentatively dynamic hepatic scintigraphy (DHS) or measurement of levels of serum amino-terminal propeptide of type III procollagen — are well evaluated. Low dose methotrexate therapy is relatively well tolerated, provided that there is careful patient selection and regular monitoring for adverse effects and drug interactions during methotrexate therapy is carried out. The long term clinical efficacy and relative safety of methotrexate remain impressive.     

阿维A治疗中重度银屑病30例临床分析

目的观察阿维A治疗中重度银屑病的临床疗效及不良反应。方法根据病情轻重、患者对维甲酸耐受情况,剂量个体化使用阿维A治疗中重度银屑病30例。结果30例病例均获得满意疗效,起效时间多数在于1周之内,4周内完全控制症状。仅1例因肝酶升高被终止治疗,均有不同程度的皮肤干燥、瘙痒、口干及唇炎等不良反应,经处理后能缓解。结论阿维A治疗银屑病疗效好,值得推广使用。     

复方消银膏治疗轻中度寻常型银屑病临床观察

目的观察复方消银膏治疗轻中度寻常型银屑病的临床疗效及安全性。方法采取随机分组法,将符合入选标准的轻中度寻常型银屑病患者92例随机分为复方消银膏组、丙酸氯倍他索乳膏组、消银膏组。在治疗开始前及治疗开始后第1周、2周、4周、8周,对患者皮损进行评估和银屑病皮损面积和严重程度指数(PASI)评分,最终比较3者临床疗效指数、不良反应发生情况。结果 3种药物均在治疗第2周起效,且复方消银膏与激素药膏起效速度相当,均优于消银膏。结论复方消银膏治疗银屑病安全有效,与丙酸氯倍他索乳膏疗效相当,均优于消银膏。     

复方甘草酸苷联合卡介菌多糖核酸治疗银屑病疗效观察

目的观察复方甘草酸苷联合卡介菌多糖核酸治疗银屑病的临床疗效。方法治疗组78例采用复方甘草酸苷注射液40mg/d,加入5%葡萄糖注射液250mL中静脉滴注,同时用卡介菌多糖核酸制剂1mL/隔日1次肌注,治疗36天为1疗程,1个月后开始第2疗程,两个疗程结束后做疗效评价。对照组54例口服迪银片5片/次,2次/d,疗程同治疗组,同时疗程前2周结合抗菌疗法(静滴支链青霉素或头孢二代类药物)。结果治疗组有效率85.90%,对照组有效率50.00%,两组比较差异有显著性(χ2=29.25,P<0.01)。结论复方甘草酸苷联合卡介菌多糖核酸治疗银屑病疗效确切。     

Efficacy and Safety of Adalimumab among Patients with Moderate to Severe Psoriasis with Co-Morbidities

Background: Psoriasis is associated with a variety of major physical and mental co-morbidities. Objective: To assess the incremental burden of co-morbidities on patient-reported outcomes and evaluate the efficacy and safety of adalimumab in psoriasis patients with co-morbidities. Study Design: Data were obtained from the initial 16-week, double-blind treatment period of REVEAL (Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis triAL), a randomized, multicenter, phase III clinical trial. Intervention: Patients with moderate to severe psoriasis were randomized in a 2 : 1 ratio to receive adalimumab 80 mg (two 40 mg injections administered subcutaneously) at baseline followed by one 40 mg injection every other week from week 1 to week 15 or placebo. Main Outcome Measures: Clinical severity (Psoriasis Area and Severity Index [PASI]) and patient-reported outcomes (Dermatology Life Quality Index [DLQI], Short Form 36 [SF-36] health survey, Work Productivity and Activity Impairment [WPAI] questionnaire) were assessed during the trial. The effect of selected co-morbidities (i.e. hypertension, psoriatic arthritis, hyperlipidemia, obesity, depression, other forms of arthritis, diabetes mellitus, and other cardiovascular diseases) on patient-reported outcomes was evaluated using multivariate analysis of covariance models. Subgroup analyses were performed by co-morbidity type to statistically compare the clinical efficacy, patient-reported outcome benefits, and safety of adalimumab with placebo in the presence of these conditions. Results: Study co-morbidities were each independently associated with significantly greater impairment on at least one general patient-reported outcome measured at baseline (all p < 0.05), with the exception of hyperlipidemia. During the 16-week study, adalimumab patients demonstrated significantly greater PASI 75 response rates (defined as a reduction of at least 75% in PASI scores from baseline) compared with placebo patients for all co-morbidity subgroups. Adalimumab provided consistent improvements in DLQI, SF-36 Physical Component Summary and Mental Component Summary scores, and WPAI total scores from baseline to week 16 within co-morbidity subgroups. Rates of serious adverse events (AEs), serious infectious AEs, and AEs leading to discontinuation were comparable between adalimumab and placebo for patients with co-morbidities. Conclusions: Co-morbidities were associated with additionally impaired health-related quality of life and work productivity in patients with psoriasis. Adalimumab significantly improved efficacy and patient-reported outcomes and was well tolerated in patients with co-morbidities.     

The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis

Background: A favorable benefit-risk profile has been established for adalimumab, with up to 5 years of treatment in 13 clinical trials in patients with moderate to severe chronic plaque psoriasis. Objective: The aim of this analysis was to assess the long-term safety of all adalimumab exposure in all psoriasis clinical trials. Methods: A total of six sets of data were analyzed as follows: (i) all cumulative safety data from all exposure for all adalimumab-treated patients in the 13 clinical trials in moderate to severe psoriasis (All Adalimumab Treatment Population) through April 2007, November 2008, and November 2009, respectively; (ii) longitudinal data for 1403 patients treated with adalimumab 40mg every other week (eow) dosing (Every Other Week Population) through June 2007 and April 2010; and (iii) data from placebo-controlled periods of clinical trials. Adverse events that occurred up to 70 days after the final dose of adalimumab were analyzed. Results: During placebo-controlled periods, a total of 572 patients had 173.0 patient-years (PYs) of exposure to placebo and 1188 patients had 370.5 PYs of exposure to adalimumab. Adverse event incidence rates, expressed as events per 100 PYs (events/100 PYs), for placebo- and adalimumab-treated patients for serious adverse events were 7.52 and 8.64, and for serious infectious adverse events were 2.89 and 2.43, respectively. In the 2007, 2008, and 2009 All Adalimumab Treatment Population there were, respectively, 1819 patients (2424.7 PYs), 2197 patients (4351.9 PYs), and 3010 patients (4844.7 PYs), with serious adverse event incidence rates of 6.51, 7.22, and 8.36 events/100 PYs, and serious infectious adverse event rates of 1.32, 1.38, and 1.65 events/100 PYs. In the 2007 and 2010 Every Other Week Population (n = 1403), there were 1883.5 and 2854.1 total PYs of exposure, respectively, with serious adverse event incidence rates of 6.32 and 6.87 events/100 PYs, and serious infectious adverse event rates of 1.33 and 1.37 events/100 PYs, respectively. Conclusions: Multiple lines of evidence from a total of six sets of safety data, with treatment for up to 5 years, including results from all adalimumab-treated patients, and a subset of patients treated with 40mg eow dosing, did not show evidence of cumulative toxicity, and showed adverse event rates that were generally stable or decreased with increased mean per-patient exposure.