清热解毒汤联合他扎罗汀倍他米松乳膏治疗寻常型银屑病疗效观察

目的 观察清热解毒汤联合他扎罗汀倍他米松乳膏治疗血热证寻常型银屑病疗效和不良反应.方法 将60例血热证寻常型银屑病患者随机分为治疗组(联合用药)、对照组1(单用他扎罗汀倍他米松乳膏)、对照组2(单用清热解毒汤),每组20例.疗程4周,观察3组患者的疗效差异及不良反应.结果 治疗4周后,治疗组有效率(80％)显著高于对照...     

阿维A胶囊口服联合外用他扎罗汀倍他米松乳膏治疗斑块型银屑病疗效观察

目的 观察阿维A联合外用他扎罗汀倍他米松乳膏治疗斑块型银屑病的临床疗效.方法 71例符合条件的患者随机分为2组,对照组32例口服阿维A胶囊30 mg/次,1次/d,外用卡泊三醇软膏、地奈德软膏、尿素软膏,同时口服活血化瘀中药,治疗组39组口服阿维A胶囊30 mg/次,1次/d,外用他扎罗汀倍他米松乳膏每晚1次,尿素软膏...     

他扎罗汀倍他米松乳膏治疗斑块状银屑病后两种延长治疗方案的疗效和安全性的多中心临床观察

目的 探索使用他扎罗汀倍他米松乳膏治疗斑块状银屑病4周后有效但未达基愈患者的后续用药方案.方法 本研究采用多中心、随机、开放、平行、对照设计.232例完成0.05％/0.05％他扎罗汀倍他米松乳膏4周治疗,银屑病面积与严重性指数(PASI评分)改善在50％ ～ 90％但未达基愈的斑块状银屑病受试者,在第5周时1:1随机...     

他扎罗汀凝胶治疗寻常性银屑病疗效观察

目的　探讨他扎罗汀治疗寻常性银屑病的临床疗效。方法　两组患者各为 45例 ,分别用他扎罗汀和氯松霜外用 ,根据皮损变化判定疗效。结果　他扎罗汀治疗寻常性银屑病有效率 82 .2 % ,斑块型的有效率 92 .0 % ,均高于氯松霜组 ( 6 2 .2 %、6 0 .7% )。结论　他扎罗汀治疗寻常性银屑病疗效较好 ,尤其适用于斑块型。     

他扎罗汀凝胶治疗寻常型银屑病疗效观察

我们自2002年1～12月用他扎罗汀凝胶(重庆华邦制药有限公司生产)治疗寻常型银屑病55例，取得了满意的疗效，现总结如下。临床资料病例选择：入选患者共55例，男32例，女23例，年龄16～65岁，平均41岁，病程3个月～30年，平均12．5年。排除可能妊娠、哺乳期妇女；红皮病型、脓疱型、关节病型银屑病；对他扎罗汀高度敏感者。     

他扎罗汀凝胶治疗寻常型银屑病的临床观察

他扎罗汀是一种新型的受体选择性维A酸类药物犤1犦。其治疗银屑病的主要作用机制是调节角质形成细胞(KC)的分化异常,改善KC的过度增殖,促进炎症消退犤2犦。为进一步验证他扎罗汀凝胶治疗寻常型银屑病的疗效及安全性,笔者用他扎罗汀凝胶(重庆华邦制药有限公司)治疗了115例寻常型银屑病患者,并进行了临床观察,疗效满意,现报告如下。1对象与方法1.1观察对象为2001年10月～2002年1月在上海市12家医院就诊的寻常型银屑病患者,共115例。病人平均年龄45岁(18～65岁),病程6个月～20年。皮损面积占整个体表的2%～30%。靶皮损基线评分:斑块肥厚程度…     

他扎罗汀倍他米松乳膏多次局部外用后人体系统吸收和安全性研究

【摘要】 目的 评价他扎罗汀倍他米松乳膏多次局部外用后在健康受试者和银屑病患者中的系统吸收和安全性。方法 2008年9月至2009年4月,在中国医学科学院皮肤病医院入组12例健康受试者,分别进入0.15%/0.15%和0.2%/0.2%他扎罗汀倍他米松乳膏组,每组6例,于两侧前臂屈侧及腰背部共4处,每处每天涂抹0.03 g试验药物,连续用药7 d,于给药前和开始用药后1、3、5、7 d采集静脉血样。2010年10月至2011年3月在中国医学科学院皮肤病医院收集60例非头部银屑病患者,按照3∶1∶1比例随机分配进入0.05%/0.05%他扎罗汀倍他米松乳膏组（36例）、0.05%二丙酸倍他米松乳膏组（12例）和0.05%他扎罗汀凝胶组（12例）,他扎罗汀倍他米松乳膏组和他扎罗汀凝胶组早上用空白基质乳膏、晚上用试验药物;二丙酸倍他米松乳膏组早晚各使用1次试验药物;各组均在患病部位连续用药6周,分别于用药前和开始用药后2、4、6周采集静脉血样。液相色谱串联质谱法测定血浆中他扎罗汀酸和倍他米松的浓度。记录受试者不良事件,用药前后检查受试者血尿常规和肝肾功能。结果 12例健康受试者在开始给药1、3、5和7 d后体内他扎罗汀酸和倍他米松的浓度均低于定量下限浓度（0.04 μg/L）。银屑病患者连续用药2、4和6周后,他扎罗汀倍他米松乳膏组2例（5.56%）检出他扎罗汀酸,最高浓度为0.112 μg/L,4例（11.11%）检出倍他米松,最高浓度为0.201 μg/L;二丙酸倍他米松乳膏组12例中2例检出倍他米松,最高浓度为0.112 μg/L。在所有健康受试者及患者中均未观察到与试验药物相关的系统不良反应或实验室指标异常。结论 他扎罗汀倍他米松乳膏多次局部外用系统吸收少,无蓄积,具有良好的系统安全性。     

他扎罗汀凝胶与糠酸莫米松乳膏联合治疗寻常型银屑病

2004年2月～2005年3月我科应用0．05％他扎罗汀凝胶（商品名：炔维，重庆华邦制药股份有限公司）与糠酸莫米松乳膏（商品名：艾洛松，上海先灵葆雅制药有限公司）联合治疗寻常型银屑病，取得满意疗效，现将结果报道如下。     

他扎罗汀联合莫米松乳膏及UVB治疗寻常性银屑病

寻常性银屑病在临床上常见,以往的局部治疗以单独使用糖皮质激素药物为主,疗效欠佳,且停药后容易出现皮损反跳现象。我们采用第三代维A酸类药物他扎罗汀,联合莫米松乳膏(商品名艾洛松)、UVB治疗寻常性银屑病取得良好疗效,现报道如下。一、病例选择入选标准：年龄在18～60岁之间的寻常性银屑病患者,男女不限;皮损面积占整个体表面积的2％～30％;4周内无     

他扎罗汀倍他米松乳膏人体皮肤耐受性研究

目的 探讨健康志愿者单次或多次局部外用不同浓度的他扎罗汀倍他米松乳膏后,健康皮肤对受试药物的耐受性,预测受试药物对人体皮肤潜在的不良反应及其强度.方法 34例单次给药受试者分为6组,分别进行他扎罗汀与倍他米松浓度均为0.025％、0.05％、0.1％、0.15％、0.2％、0.25％的单次给药耐受性试验.12例多次给药受试者分为2组,分别进行他扎罗汀与倍他米松浓度均为0.2％、0.15％每天给药1次、连续给药7d的多次给药耐受性试验.观察受试者给药前后体征、实验室检查、给药部位皮肤反应及主观感觉、内源性皮质醇水平的变化,以及经皮吸收进入系统循环的药物量.结果 试验中未发生严重不良事件.单次给药34例受试者用药后均未出现与受试药物有关的不良反应,各项观察指标均未发现与受试药物有关的异常改变.多次给药12例受试者在开始给药后0～7d给药部位无任何异常皮肤反应及自觉不适症状,给药后14 d(停药后7 d)0.2％组6例受试者中5例、0.15％组6例受试者中2例,给药部位皮肤出现轻度刺激反应症状;其他各项观察指标均未发现与受试药物有关的异常改变.结论 他扎罗汀与倍他米松乳膏单次给药的最大耐受剂量为0.25％他扎罗汀和0.25％倍他米松.0.15％他扎罗汀和0.15％倍他米松连续给药7d是比较安全的.     

钙泊三醇倍他米松软膏外用治疗寻常性银屑病的随机、双盲、对照研究

目的 探讨钙泊三醇倍他米松软膏外用治疗稳定期寻常性银屑病患者的临床疗效和安全性。方法 随机、双盲、阳性药物平行对照、多中心临床试验,入组320例寻常性银屑病患者,随机纳入试验组或对照组,疗程4周。试验组早晨外用模拟剂软膏基质,晚间外用钙泊三醇倍他米松软膏;对照组早晚单用卡泊三醇软膏。于首次用药后第1、2、4周观察临床疗效及安全性。结果 治疗4周后试验组PASI评分较基线下降百分比（79.23%）大于对照组（70.43%）,两组比较,P < 0.01;且在治疗1周后的疗效优于对照组。治疗4周后,PASI评分较基线下降≥75%的患者频数百分比比较,试验组有效率为73.03%,对照组为48.32%,P < 0.01,两组差异有统计学意义。治疗1、2、4周后试验组靶皮损红斑、浸润、鳞屑单独积分以及皮损总面积百分比等指标改善方面均优于对照组。320例受试者中不良事件发生率为18.1%,不良反应发生率为13.1%,两组间差异无统计学意义。药物不良反应主要为与皮肤有关的轻中度反应如瘙痒、毛囊炎、红斑等。结论 钙泊三醇倍他米松软膏治疗稳定期寻常性银屑病患者具有起效快、疗效好和用药方便、相对安全的特点。     

A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet/Daivobet/Taclonex) in the treatment of psoriasis vulgaris

BACKGROUND: The calcipotriol/betamethasone dipropionate two-compound product Dovobet/Daivobet/Taclonex(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. OBJECTIVES: To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis. METHODS: Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required. RESULTS: Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively. CONCLUSIONS: Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment.     

Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vulgaris

BACKGROUND: A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis. OBJECTIVES: This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma). METHODS: In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment. RESULTS: The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3. CONCLUSIONS: Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.     

Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial

Background Current topical therapies for scalp psoriasis are difficult or unpleasant to apply, resulting in decreased adherence and efficacy. Objectives To compare the efficacy and safety of once‐daily treatment with a combination of calcipotriol 50 μg g^?1 plus betamethasone 0·5 mg g^?1 (as dipropionate) (Xamiol^®; LEO Pharma A/S, Ballerup, Denmark) and twice‐daily calcipotriol 50 μg mL^?1 scalp solution in patients with scalp psoriasis. Methods This 8‐week, multicentre, randomized, investigator‐blind, parallel‐group study compared two‐compound calcipotriol/betamethasone scalp formulation with calcipotriol scalp solution in patients with moderately severe scalp psoriasis. Primary efficacy outcome was the proportion of patients who achieved ‘clear’ or ‘minimal’ disease severity according to investigator’s global assessment of disease severity at week 8. Secondary efficacy outcomes and adverse events were also evaluated. Relapse and rebound were assessed in an 8‐week, post‐treatment observation phase. Results In total, 207 patients received the two‐compound scalp formulation and 105 patients received calcipotriol scalp solution. The proportion of patients with ‘clear’ or ‘minimal’ disease at week 8 was significantly greater in the two‐compound scalp formulation group (68·6%) than in the calcipotriol scalp solution group (31·4%; P < 0·001). Improvement was more rapid with the two‐compound scalp formulation than with calcipotriol scalp solution. Further evidence of the superiority of the two‐compound scalp formulation over the scalp solution was demonstrated through greater improvements in clinical signs and fewer adverse events. Conclusions A once‐daily combination of calcipotriol plus betamethasone dipropionate was significantly more effective and better tolerated than twice‐daily calcipotriol scalp solution in the treatment of scalp psoriasis.     

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.     

二丙酸倍他米松乳膏治疗湿疹和神经性皮炎的多中心、随机双盲对照研究

0.05%二丙酸倍他米松乳膏是一种超强效外用糖皮质激素类药物,可用于多种皮肤病的治疗。临床剂量下本品为一种安全的药物,患者耐受性好［１］。本研究旨在观察0.05%二丙酸倍他米松乳膏（重庆华邦制药有限公司）外用治疗亚急性或慢性湿疹和神经性皮炎的临床疗效和安全性,以0.05%醋酸氟轻松软膏（天津药业集团）作为阳性对照,进行多中心、随机、双盲、对照临床试验……     

The impact of a two-compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial

BACKGROUND: Psoriasis is a common disease and may have a significant impact on patients' quality of life (QoL). OBJECTIVES: To assess the impact on QoL of a new two-compound product (TCP) (Daivobet/Dovobet; LEO Pharma) which combines the topical vitamin D analogue calcipotriol (50 microg g(-1)) and the World Health Organization group III corticosteroid betamethasone dipropionate (0.5 mg g(-1)) in a single ointment vs. calcipotriol monotherapy using a placebo-controlled study design. METHODS: The Psoriasis Disability Index and the EuroQoL 5D questionnaire and visual analogue scale (VAS) were used in this study, which enrolled 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. These QoL instruments were completed by patients before and after treatment with the TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily. RESULTS: The TCP used once or twice daily and calcipotriol used twice daily were found to have statistically significant beneficial effects on patients' QoL over the course of treatment, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice daily in terms of reductions on the EuroQoL 5D questionnaire and VAS. CONCLUSIONS: The results suggest that calcipotriol twice daily and the new TCP applied twice daily have a substantial effect on QoL. Once-daily application of the TCP is superior to calcipotriol twice daily terms of QoL, which reflects the superior efficacy of this combination and the advantage of once-daily application when compared with twice-daily application.