复方苦参注射液治疗进行期寻常性银屑病的临床观察

目的观察复方苦参注射液治疗进行期寻常性银屑病的临床疗效。方法复方苦参注射液治疗进行期寻常性银屑病30例,并与复方青黛胶囊治疗30例作对照,对治疗前后PASI均值及皮损消退时间、总有效率、远期疗效进行对比观察。结果治疗组PASI积分改善率优于对照组,治疗组皮损开始消退时间明显短于对照组,差异均有显著性(P<0.05),治疗组临床总有效率86.7%,对照组临床总有效率65.7%,差异有显著性(P<0.05)。疗程结束半年后随访,治疗组复发率为7.7%,对照组复发率为15%。结论复方苦参注射液治疗进行期寻常性银屑病有显著的临床疗效,且疗效优于复方青黛胶囊。     

阿维A联合复方甘草酸苷治疗银屑病疗效分析

目的观察阿维A胶囊联合复方甘草酸苷胶囊治疗进行期斑块型银屑病的疗效。方法选取诊断为进行期斑块型银屑病患者66例,随机分为治疗组34例,对照组32例。治疗组给予口服阿维A、复方甘草酸苷;对照组给予阿维A治疗,连续治疗8周,用PASI积分评价患者病情严重程度以及疗效,监测其不良反应。结果治疗组的PASI积分显著低于对照组,治疗组总有效率91.2%,高于对照组的62.5%,有效率差别有统计学意义(P0.05)。结论阿维A联合复方甘草酸苷治疗进行期斑块型银屑病疗效较好,复方甘草酸苷可有效降低阿维A胶囊的毒副作用。     

回药活血消疕胶囊治疗寻常型银屑病血瘀证123例疗效观察

目的观察回药活血消疕胶囊治疗寻常型银屑病血瘀证临床疗效,探讨其作用机制。方法将寻常型银屑病血瘀证患者132例,随机分为2组,除去脱落病例,即治疗组61例、对照组62例。治疗组给予活血消疕胶囊口服;对照组给予雷公藤多苷片口服,2组均外擦医用凡士林,疗程12周。对2组前后银屑病皮损面积和严重程度指数(PASI)评分、红斑、鳞屑、浸润程度进行评价,检测治疗前后肝肾功能,临床痊愈患者于治疗结束后第6、12个月进行随访。结果活血消疕胶囊经临床研究表明在治疗12周后与治疗前PASI积分比较,治疗组PASI积分低于对照组,差异有统计学意义(P0.05)。2组12周后进行比较,治疗组和对照组总有效率分别为83.61%、64.52%,治疗组总有效率高于对照组,2组总疗效有统计学意义(P0.05)。随访1年复发率比较,治疗组和对照组复发率分别为13.1%、24.2%,说明治疗组复发率明显低于对照组,差异有统计学意义(P0.05)。结论活血消疕胶囊治疗寻常型银屑病血瘀证,通过对PASI评分、在改善红斑、鳞屑、浸润、防止复发方面疗效显著,其作用机制可能与提高机体免疫力有关,为临床治疗寻常型银屑病血瘀证提供了初步临床依据,开展了新药的临床研究。     

雷公藤治疗进行期寻常型银屑病的随机双盲研究

应用雷公藤及安慰剂治疗进行期寻常型银屑病５２例，采用双盲法，病人随机接受Ａ或Ｂ方案，Ａ方案为雷公藤每日６粒，Ｂ方案为安慰剂每日６粒，患者于第２周末复诊，第４周末评价疗效。结果表明，治疗组２５例患者中痊愈或近愈１６例，显效５例，有效３例，无效１例，痊愈率６４％，总有效率８４％；对照组无１例痊愈或显效，仅３例有效；经Ｒｉｄｉｔ分析，雷公藤治疗进行期寻常型银屑病的疗效与安慰剂相比具有非常显著的差异。     

复方丙酸氯倍他索软膏联合消银颗粒治疗寻常性银屑病疗效观察

目的 观察复方丙酸氯倍他索软膏联合消银颗粒治疗寻常性银屑病的临床疗效.方法 采用随机(1:1)单盲法将100例进行期寻常性银屑病患者分为治疗组、对照组各50例,对照组仅外用复方丙酸氯倍他索软膏,2次/d.治疗组在此基础上同时给予消银颗粒口服,3.5g/次,3次/d.两组疗程均为4周.治疗前后分别评定PASI积分,观察两组患者临床疗效及不良反应.结果 ①两组治疗后PASI积分均降低(P均<0.01),治疗组PASI积分改善优于对照组(P<0.01).②治疗组治愈率62%,有效率84%.对照组分别为40%和60%.治疗组临床疗效优于对照组(P<0.01).结论 复方丙酸氯倍他索软膏联合消银颗粒治疗寻常性银屑病疗效确切.     

吡硫翁锌气雾剂联合迪银片治疗寻常性银屑病疗效观察

目的观察吡硫翁锌气雾剂联合迪银片治疗寻常性银屑病的临床疗效。方法采用随机(1:1)单盲法将92例寻常性进行期银屑病患者随机分为治疗组、对照组各46例,治疗组给予迪银片口服,5片/次,3次/d;同时外用吡硫翁锌气雾剂2次/d。对照组单服迪银片,用法同上。两组疗程均为4周。治疗前后分别评定PASI积分,观察两组患者临床疗效及不良反应。结果①两组治疗后PASI积分均降低,治疗前后积分差异有显著性(P<0.001)。②治疗组治愈率69.57%,有效率86.96%。对照组分别为15.22%和50.00%。两组治愈率及有效率差异均具有显著性(P<0.005)。两组均无明显不良反应。结论吡硫翁锌气雾剂联合迪银片治疗寻常型银屑病,疗效优于单用迪银片组。     

银屑平丸联合阿维A胶囊治疗寻常型银屑病的疗效观察

目的观察银屑平丸联合阿维A胶囊治疗寻常型银屑病的临床疗效。方法将80例寻常型银屑病的患者随机分为治疗组和对照组各40例,治疗组予以中成药银屑平丸及阿维A胶囊口服,对照组予以阿维A胶囊口服。结果治疗组痊愈15例,显效17例,好转5例,无效3例,总有效率92.50%;对照组痊愈7例,显效11例,好转13例,无效9例,总有效率77.50%,2组PASI评分比较差异有统计学意义(P=0.01),治疗组疗效优于对照组疗效。结论银屑平丸联合阿维A胶囊治疗寻常型银屑病的疗效满意。     

和银饮治疗寻常型银屑病35例疗效观察

目的：观察和银饮治疗寻常型银屑病的临床疗效.方法：将65例寻常型银屑病患者随机分为两组,治疗组35例,对照组30例.治疗组给予和银饮口服,对照组给予雷公藤多甙片口服,两组均给予鱼肝油软膏外用.1个月为1个观察疗程,观察两组疗效及银屑病皮损面积和严重程度指数（PASI）积分.结果：两组临床疗效比较,差异无统计学意义（P〉0.05）.治疗后两组PASI积分均较治疗前显著下降,治疗前后比较,差异均有统计学意义（P〈0.01）;两组治疗后PASI积分比较,差异无统计学意义（P〉0.05）.治疗组不同证型患者治疗后PASI积分均较治疗前显著下降,差异均有统计学意义（P〈0.01）.结论：和银饮治疗寻常型银屑病具有和雷公藤多甙相近的疗效.和银饮联合鱼肝油软膏外用对血热证、血燥证、血瘀证银屑病患者均可以明显降低PASI积分.     

复方甘草酸苷辅助治疗寻常型银屑病疗效观察

目的:探讨复方甘草酸苷辅助治疗进行期寻常型银屑病的临床疗效。方法:将进行期寻常型银屑病患者96例随机分为治疗组与对照组各48例,对照组口服复方氨肽素片、转移因子胶囊,同时外搽艾洛松软膏;治疗组在对照组治疗的基础上,同时静脉注射复方甘草酸苷20 mL,每日1次,共四周。结果:治疗组治愈10例,显效24例,有效率为70.83%;对照组治愈4例,显效16例,有效率为41.67%,两组差异有统计学意义(χ2=5.83,P<0.05)。结论:复方甘草酸苷辅助治疗进行期寻常型银屑病效果确切。     

清热凉血汤治疗进行期寻常型银屑病的近期效果分析

目的 观察清热凉血汤治疗进行期寻常型银屑病的近期效果.方法 选择2019年1月至2020年1月来某医院门诊治疗的83例进行期寻常型银屑病患者,随机分为对照组(41例)和治疗组(42例).对照组采用阿维A胶囊口服联合糠酸莫米松乳膏外涂治疗;治疗组在对照组的基础上增加清热凉血汤治疗,对比两组患者疗效、不良反应及复发情况.结...     

Ustekinumab in psoriasis: Five‐year real life experience from a single tertiary centre

The efficacy and safety of ustekinumab have been demonstrated in randomized clinical trials; however, there are few real‐life data evaluating ustekinumab. This observational, retrospective follow‐up study included 33 patients with moderate to severe psoriasis vulgaris. Patients were > 18 years old and received at least 16 weeks of ustekinumab. The efficacy of treatment was evaluated as PASI50, PASI75, and PASI90 response rates at 16, 28, 52, 76, and 100 weeks. Side effects associated with ustekinumab were recorded. Of 33 patients, 24 (72.7%) had received 45 mg ustekinumab and 9 (27.3%) 90 mg ustekinumab. At the 16th week of the treatment, 97% of the patients had PASI50, 57.6% had PASI75, and 33.3% had PASI90 response rates. At 16, 28, 52, 76, and 100 weeks, PASI50, 75, and 90 responses were generally higher in naive to biologics and in the 45 mg group than in nonnaive to biologics and in the 90 mg group but the differences were not statistically significant. In conclusion, ustekinumab is an effective and safe treatment option for patients with moderate to severe psoriasis vulgaris. It seems to be more effective in naive to biologics and patients with normal weight.     

重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中重度寻常性银屑病的多中心临床研究

目的 评价用于重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中重度寻常性银屑病的安全性和疗效。 方法 采用多中心、随机、双盲、阳性药物平行对照的临床研究。两组中重度寻常性银屑病患者均接受重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗,试验组用药商品名为安佰诺,对照组为益赛普。在治疗前（W0）、治疗第2周、第6周及治疗后（疗程12周）分别对各观察指标进行评估记录。 结果 5个研究中心共入组病例180例,完成试验174例,采用SAS统计软件包,按分层分段方法产生随机数,其中试验组88例,对照组86例。疗后12周,全分析集（FAS）分析显示,试验组和对照组银屑病皮损面积和严重程度指数（PASI）50、PASI75的患者分别是75.6%（68/90）、51.1%（46/90）和82.2%（74/90）、50.0%（45/90）,两组差异无统计学意义（均P > 0.05）;试验组PASI90达30.0%（27/90）,高于对照组的16.7%（15/90）,差异有统计学意义（χ2 = 4.472,P ＜ 0.05）。与药物有关的不良反应包括转氨酶升高、白细胞减少、上呼吸道感染、注射部位反应、尿常规异常、结核菌素纯蛋白衍化物试验异常等,两组不良反应发生率差异无统计学意义（χ2 = 0.188,P > 0.05）。不良反应一般程度较轻,未经处理或经相应治疗均能恢复正常。 结论 国产重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中重度寻常性银屑病12周安全有效。     

不同浓度配比的他扎罗汀倍他米松乳膏治疗寻常型银屑病的疗效观察

【摘要】 目的 探索不同浓度配比的他扎罗汀倍他米松乳膏治疗寻常型银屑病的疗效和安全性,筛选人体使用的最佳药物配比浓度。方法 采用多中心、随机、双盲、多剂量对照研究设计,2008年12月至2009年4月,中国医学科学院皮肤病医院等7个研究中心共纳入180例寻常型银屑病患者,按1∶1∶1∶1∶1比例随机分配进入4个试验组（他扎罗汀/二丙酸倍他米松浓度配比分别为0.025%/0.025%、0.05%/0.025%、0.025%/0.05%、0.05%/0.05%,简称为试验1、2、3和4组）和对照组（基质）,每日用药1次,持续4周。用药后第1、2、4周分别评价各组药物的疗效和安全性。多组计量资料比较采用方差分析和LSD-t检验,多组分类资料的比较用χ2检验或Fisher精确概率检验,采用CMH法分析各组的银屑病皮损面积和严重程度指数（PASI）反应率数据。结果 用药4周,试验1、2、3、4组和对照组改善达PASI75的患者分别为11例（30.56%）、12例（33.33%）、12例（33.33%）、19例（52.78%）和2例（5.56%）,各试验组达PASI75的患者比例均显著高于对照组（均P < 0.012 7）;此外,试验药物1、2、4组达PASI90的患者比例亦显著高于对照组（均P < 0.012 7）。用药4周,试验1、2、3、4组PASI评分下降率分别达59.52% ± 26.79%、57.19% ± 31.98%、56.85% ± 30.46%和68.21% ± 37.20%,均显著高于对照组（20.07% ± 28.55%）（LSD-t = 5.36、5.05、5.00、6.55,均P < 0.001）。试验4组的综合疗效表现更突出。试验1、2、3、4组和对照组药物耐受性良好,分别发生不良反应11例（30.56%）、8例（22.22%）、2例（5.56%）、4例（11.11%）和2例（5.56%）,试验1组不良反应发生率显著高于对照组（P = 0.012）,试验2、3、4组与对照组比较差异无统计学意义（均P > 0.05）。结论 0.05%/0.05%他扎罗汀倍他米松乳膏可作为后继治疗寻常型银屑病临床研究的推荐配比浓度。     

阿维A联合润燥止痒胶囊治疗寻常性银屑病临床观察

目的探讨阿维A胶囊与润燥止痒胶囊联合治疗寻常性银屑病的疗效及安全性。方法采用随机分组试验方法将84例患者分为2组。治疗组口服阿维A胶囊联合润燥止痒胶囊,对照组单纯口服阿维A胶囊,同时2组均外用卡泊三醇。疗程均为8周。于治疗前后分别做银屑病严重程度指数(PASI)积分评测。结果①两组治疗后PASI积分均降低,治疗前后积分对比差异有统计学意义(P0.05)。②治疗组有效率为88.1%,对照组为66.7%,两组有效率差异有统计学意义(P0.05);结论阿维A联合润燥止痒胶囊治疗寻常性银屑病疗效确切,能明显减轻阿维A所致的皮肤口唇干燥及瘙痒等不良反应。     

重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗红皮病性银屑病的疗效观察

目的 评价重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc)治疗红皮病性银屑病的疗效.方法 红皮病性银屑病患者23例,给予rhTNFR:Fc 25 mg皮下注射,每周2次,首剂加倍,疗程12周,之后随访至2年.以治疗中不同时间的银屑病面积与严重度指数(PASI)评分达PASI50、PASI75和PASI90的患者比例、肿瘤坏死因子α(TNF-α)值及不良反应等情况为观察指标.用SPSS 19.0版统计软件进行非参数Friedman检验和重复测量方差分析.结果 23例红皮病性银屑病患者PASI评分从治疗前57.35±3.45降至12周时5.57±3.60(P＜0.01),PASI50、PASI75、PASI90改善例数至12周时分别为23例(100％)、22例(95.65％)和14例(60.87％)(均P＜0.01),TNF-α值从治疗前(62.87±15.23) ng/L降至12周时(4.57±2.99) ng/L(P＜ 0.01).未发现不良反应.第24个月随访时,PASI评分与12周时比较差异无统计学意义;PASI50改善例数为23例,PASI75为20例,PASI90为15例;TNF-α值[(3.37±1.62) ng/L]低于12周时(P＜0.05).结论 rhTN FR:Fc是控制红皮病性银屑病急性期炎症的一个有效的药物.     

A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction

BACKGROUND: In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated. OBJECTIVES: To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept. METHODS: In this multicentre 24-week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double-blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks. RESULTS: Five hundred and eighty-three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P < 0.0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open-label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study. CONCLUSIONS: Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction.     

阿达木单抗治疗斑块型银屑病疗效及代谢综合征对疗效的影响

目的：明确阿达木单抗治疗斑块型银屑病患者的疗效。方法：收集2020年9月至2021年3月经阿达木单抗治疗的斑块型银屑病患者,分析经阿达木单抗治疗0、4、8、12周的PASI评分变化及相关性。结果：共收集20例患者,其中1例中断治疗,19例患者中伴和不伴代谢综合征患者分别为11例和8例。经阿达木单抗治疗12周后,19例患者PASI评分自基线时的9.7（2.0,15.6）下降到3.3（0.4,4.2）。伴代谢综合征患者中达到PASI 75/PASI 90患者分别为45%和0%,不伴代谢综合征患者分别为50%和50%。代谢综合征与疗效存在负相关性（r=-0.679,P＜0.01）。结论：阿达木单抗治疗斑块型银屑病有效,代谢综合征影响疗效。     

Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized,double-blind,vehicle-controlled clinical trial

BACKGROUND: Calcipotriol and betamethasone dipropionate are both widely used, effective treatments for psoriasis. Vitamin D analogues and topical corticosteroids have different mechanisms of action in the treatment of psoriasis. A new vehicle has been developed in order to contain both calcipotriol (50 micro g g-1) and betamethasone dipropionate (0.5 mg g-1) in an ointment form. By using calcipotriol and a corticosteroid together, greater efficacy may be achieved than by using either compound alone. OBJECTIVES: The present study was conducted in order to compare the clinical efficacy and safety of the combined ointment formulation used once daily with the vehicle ointment used twice daily, calcipotriol ointment used twice daily and the combined formulation used twice daily in psoriasis vulgaris. METHODS: This was an international, multicentre, prospective, randomized, double-blind, vehicle-controlled, parallel group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Patients were randomized to one of four treatment groups: combined formulation once daily, combined formulation twice daily, calcipotriol twice daily or vehicle twice daily. Efficacy and safety were assessed. RESULTS: There was no statistically significant difference in the mean percentage change in the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment between the two combined formulation groups, but the difference in PASI reduction was significantly higher in the combined formulation groups (68.6% once daily, 73.8% twice daily) than in both the twice daily calcipotriol group (58.8%) and the vehicle group (26.6%). Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group. The proportion of patients with lesional/perilesional adverse reactions was less in the combined formulation groups and vehicle group than in the calcipotriol group (9.9% combined formulation once daily, 10.6% combined formulation twice daily, 19.8% calcipotriol, 12.5% vehicle). CONCLUSIONS: No statistically significant nor clinically relevant difference in efficacy was seen between the combined formulation used once daily and twice daily. When compared to vehicle ointment or calcipotriol ointment alone, the combined formulation was shown to be clearly more efficacious.     

Etanercept use for psoriasis in Taiwan: a case series study

Background The reported efficacy and safety of some biologic agents for psoriasis vary between Caucasians and Asians. Few reports of etanercept exist in psoriasis patients within the Asia‐Pacific region. Objectives The study aims to report our clinical experience of etanercept in the treatment of patients with moderate‐to‐severe psoriasis in Taiwan. Methods A retrospective analysis of 59 patients with moderate‐to‐severe psoriasis who received etanercept was conducted in a tertiary referral center. Results Etanercept therapy resulted in a reduction of mean Psoriasis Area and Severity Index (PASI) of 47% at week 12 and 61% at week 24. After 12 weeks of treatment, 48%, 26%, and 3.4% of the patients achieved at least PASI50, 75 and 90 response, respectively. At week 24, the proportion of patients achieving at least PASI50, 75 and 90 response was 59%, 37%, and 14%, respectively. Etanercept efficacy in achieving PASI75 improvement was, however, lower than that reported in previous pivotal placebo‐controlled trials. No cases of active tuberculosis, viral hepatitis or malignancies were observed during the observation period. Conclusion Our case series demonstrated the efficacy and safety of etanercept for the management of moderate‐to‐severe psoriasis in Taiwan.     

Fixed combination of tazarotene and betamethasone dipropionate for treatment of psoriasis vulgaris: The result of a phase 3, multicenter,randomized controlled trial

Long-term use of corticosteroids or local use of tazarotene (TAZ) alone for the treatment of psoriasis cause safety issues and low compliance rates. Combining these two may optimize their efficacy and minimize safety concerns. This study aimed to evaluate the clinical efficacy and safety of a fixed combination of TAZ 0.05% and betamethasone dipropionate 0.05% (BM) for psoriasis vulgaris. A multicenter, randomized, single-blinded, controlled phase 3 clinical trial was conducted. A total of 600 Chinese subjects with psoriasis vulgaris were randomized (3:1:1) to TAZ/BM cream, TAZ gel or BM cream groups for 6 weeks with an 8-week follow up. The primary efficacy assessment end-point was 75% improvement in Psoriasis Area and Severity Index (PASI-75) at 6 weeks. Secondary outcome assessments included PASI-90, percentage of PASI decrease and so forth. Safety and treatment-related adverse events were monitored throughout the study. Our results demonstrated that the TAZ/BM group exhibited statistically significant superiority in PASI-75 over TAZ (6.74% vs 1.67%) within 2 weeks. After 6 weeks of treatment, PASI-75 was 44.94% in the TAZ/BM group while 19.17% and 35.00% in the TAZ and BM group, respectively. At the 8-week follow up, the relapse rate of the TAZ/BM group was significantly lower than the BM group (10.62% vs 29.63%, P = 0.0269) though comparable with the TAZ group (10.00%). The most frequently reported treatment-related adverse event was mild to moderate level of skin irritation events. TAZ/BM combination has significant advantages over TAZ, including satisfying efficacy, rapid onset and reduced local stimulation. Meanwhile, compared with BM, it has the advantages of longer relief time and reduced clinical relapse rate. The TAZ/BM combination drug provides psoriatic patients an alternative drug with high efficacy and low relapse rate and safety concerns.