钙泊三醇倍他米松软膏与卡泊三醇软膏联合NB-UVB治疗稳定期寻常性银屑病疗效比较

目的观察钙泊三醇倍他米松软膏和卡泊三醇软膏分别联合窄谱中波紫外线(NB-UVB)照射治疗寻常性银屑病的疗效与安全性。方法将入选的60例患者随机分为2组,各30例。治疗组每晚用钙泊三醇倍他米松软膏外搽皮损1次,对照组每日早、晚分别予卡泊三醇软膏外搽皮损1次,且两组同时予NB-UVB照射治疗,3次/周。两组患者的疗程均为4周。分别于治疗过程中每周观察1次疗效。结果治疗2周时,治疗组有效率(33.33%)高于对照组(10.00%),差异有统计学意义(P<0.05)。治疗4周时,治疗组有效率和对照组差异不显著(P>0.05)。主要不良反应为瘙痒和毛囊炎。结论钙泊三醇倍他米松软膏或卡泊三醇软膏联合NB-UVB治疗寻常性银屑病均安全有效,但钙泊三醇倍他米松软膏起效快于卡泊三醇软膏。     

钙泊三醇倍他米松软膏治疗斑块状银屑病疗效评价

目的:评价钙泊三醇倍他米松软膏治疗斑块状银屑病的临床疗效。方法:治疗组(70例)给予钙泊三醇倍他米松软膏外用,对照组(56例)给予钙泊三醇软膏外用和5%松馏油软膏封包。结果:6周后治疗组有效率为88.57%,对照组有效率为75.00%,不良反应发生率分别为10.00%和23.75%,差异均有统计学意义(均P0.05)。结论:钙泊三醇倍他米松软膏外用治疗斑块状银屑病有效且相对安全。     

中药联合钙泊三醇倍他米松软膏及钙泊三醇软膏序贯治疗寻常型银屑病(血热证)的疗效观察

目的观察中药内服及药浴联合钙泊三醇倍他米松软膏及钙泊三醇软膏序贯外用治疗寻常型银屑病(血热证)的临床疗效及安全性。方法通过随机方法将156例寻常型银屑病(血热证)患者分为试验组和对照组:2组均予中药汤药(半枝莲方)口服,1剂/d,中药药浴(生地榆方)隔日1次,试验组同时予钙泊三醇倍他米松软膏及钙泊三醇软膏序贯外用;共治疗10周,分别于4周、6周、10周时观察疗效,计算2组治疗前后皮疹PASI评分情况及总有效率,并监测生化指标(血常规、尿常规、肝肾功能)变化情况。结果治疗结束后试验组PASI评分为2.80±1.43,总有效率为96.1%,均高于对照组的4.23±2.76、87.5%,比较差异有统计学意义(P0.05);在治疗的不同阶段试验组的PASI评分均低于对照组,差异有统计学意义(P0.05);2组治疗前后血清生化的各项指标均大致正常。结论中药内服及药浴联合钙泊三醇倍他米松软膏及钙泊三醇软膏序贯治疗寻常型银屑病(血热证)有较好的临床疗效,安全性高。     

中医汗蒸疗法联合卡泊三醇倍他米松软膏治疗寻常型银屑病的临床观察

目的 观察中医汗蒸疗法联合卡泊三醇倍他米松软膏治疗寻常型银屑病的临床疗效和安全性.方法 73例于寒冷季节就诊的静止期寻常型银屑病患者,随机分为观察组(38例)和对照组(35例);观察组给与中医汗蒸疗法联合卡泊三醇倍他米松软膏治疗,对照组仅给与卡泊三醇倍他米松软膏治疗;观察治疗前、治疗第2周、治疗第4周时的银屑病皮损面积...     

卡泊三醇软膏联合口服中药治疗寻常性斑块状银屑病的临床疗效观察

目的 评价单纯外用卡泊三醇软膏和外用卡泊三醇软膏联合口服中药治疗对寻常性斑块状银屑病的疗效.方法 60例患者随即分成单纯外用卡泊三醇软膏组和外用卡泊三醇软膏联合口服中药组.疗程为12周.两组患者分别于治疗后进行临床疗效评估.结果 两组于第8周以后皮损PASI评分差异有统计学意义(P<0.05).治疗结束时,单纯西药组的有效率为73.3%,中西药联合组的有效率为93.3%,两组比较差异有统计学意义(P<0.05).结论 外用卡泊三醇软膏联合口服中药治疗寻常性斑块状银屑病优于单纯外用卡泊三醇软膏治疗.     

吡硫翁锌气雾剂联合钙泊三醇倍他米松软膏序贯治疗斑块型银屑病的观察

目的观察吡硫翁锌气雾剂联合钙泊三醇倍他米松软膏序贯治疗斑块型银屑病的疗效以及安全性。方法 182例斑块状银屑病患者随机分为观察组和对照组,观察组90例应用吡硫翁锌气雾剂联合钙泊三醇倍他米松软膏外用治疗,对照组92例单用钙泊三醇倍他米松软膏外用治疗;两组疗程均为4周。结果观察组有效率为83.3%;对照组有效率为52.2%;两组比较差异均有统计学意义(P0.05)。结论应用吡硫翁锌气雾剂联合钙泊三醇倍他米松软膏序贯治疗银屑病起效快、副作用小。     

钙泊三醇倍他米松软膏联合窄谱中波紫外线治疗寻常性银屑病疗效观察

目的观察钙泊三醇倍他米松软膏联合窄谱中波紫外线治疗寻常性银屑病的疗效和安全性。方法将56例寻常性银屑病患者随机纳入对照组或试验组。试验组采用钙泊三醇倍他米松软膏联合窄谱中波紫外线照射治疗,对照组仅用窄谱中波紫外线照射治疗。结果治疗8周后,试验组有效率为60.6%,对照组有效率为21.3%,两组有效率比较差异有统计学意义(P0.05)。结论钙泊三醇倍他米松软膏联合窄谱中波紫外线治疗寻常性银屑病起效快,安全性高,患者依从性较好。     

钙泊三醇倍他米松软膏联合中药浴治疗寻常性斑块状银屑病疗效观察

目的观察钙泊三醇倍他米松软膏联合中药浴治疗寻常性斑块状银屑病的临床疗效及不良反应。方法将93例寻常性斑块状银屑病患者随机分为试验组和对照组,均外用钙泊三醇倍他米松软膏每日1次;试验组同时给予中药方剂洗浴每日1次,对照组使用婴儿沐浴液洗浴每日1次,两组均4周为1个疗程,分别于2、4周时观察疗效。结果治疗结束后,试验组有效率为86.96%,对照组有效率为70.21%,两组比较差异有统计学意义(χ2=3.86,P0.05)。两组患者均无严重不良反应。结论钙泊三醇倍他米松软膏联合中药浴治疗寻常性斑块状银屑病疗效好,能很快缓解皮损症状,是一种安全有效的治疗方法。     

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。     

中药泡洗联合钙泊三醇倍他米松软膏治疗肢端型白癜风的疗效观察

目的:评价中药泡洗联合钙泊三醇倍他米松软膏治疗肢端型白癜风的疗效和安全性。方法:将120例肢端白癜风患者随机分为3组:联合治疗组40例,采用中药泡洗后外用钙泊三醇倍他米松软膏治疗,每天1次;对照组1 40例,单纯外用钙泊三醇倍他米松软膏治疗;对照组2 40例,单纯采用中药泡洗治疗。对照组药物使用方法及疗程同治疗组。均治疗8周为1个疗程,连续治疗2个疗程,2个疗程结束后评价临床疗效和不良反应。结果:联合治疗组有效率为57.5%,对照组1有效率为35.0%,对照组2有效率为30.0%,联合治疗组有效率与对照组1、2相比,差异均有统计学意义(P值均<0.05)。三组患者均未见严重不良反应。结论:中药泡洗联合钙泊三醇倍他米松软膏治疗肢端型白癜风疗效确切,安全性好。     

Efficacy of treatment with calcipotriol/betamethasone dipropionate followed by calcipotriol alone compared with tacalcitol for the treatment of psoriasis vulgaris: a randomised, double-blind trial

BACKGROUND: A two-compound product containing calcipotriol 50 microg/g and betamethasone dipropionate 0.5 mg/g (Daivobet, Dovobet) has been demonstrated to be an effective, once daily, treatment for psoriasis vulgaris. OBJECTIVE: To compare the efficacy and safety of treatment with the two-compound product for 4 weeks followed by calcipotriol for 4 weeks, with that of tacalcitol for 8 weeks in patients with stable psoriasis vulgaris. METHODS: 501 patients were randomised to double-blind treatment with the two-compound product followed by calcipotriol 50 microg/g once daily, or to tacalcitol 4 microg/g once daily. RESULTS: Treatment with the two-compound product/calcipotriol was significantly more effective than tacalcitol in terms of mean percentage PASI reduction (65.0 vs. 33.3% at week 4 and 59.0 vs. 38.4% at week 8; p < 0.001 for both). CONCLUSION: A treatment regimen comprising calcipotriol/betamethasone ointment (Daivobet) for 4 weeks followed by calcipotriol for 4 weeks is superior to tacalcitol ointment for 8 weeks in patients with psoriasis vulgaris.     

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.     

Spotlight on Calcipotriene/Betamethasone Dipropionate in Psoriasis Vulgaris of the Trunk, Limbs, and Scalp

Calcipotriene (calcipotriol)/betamethasone dipropionate (calcipotriene 50 mg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D₃ analog and a corticosteroid indicated for the oncedaily, topical treatment of psoriasis vulgaris of the trunk, limbs, and scalp in adults. Both the ointment (Daivobet®;Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriene/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriene/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacologic properties. Calcipotriene/betamethasone dipropionate has low systemic absorption and displays local antiinflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriene/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4–8 weeks, was more effective than placebo, calcipotriene, or tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriene/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriene/betamethasone dipropionate for 52 weeks was more effective than calcipotriene alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriene for 48 weeks after 4 weeks of calcipotriene/betamethasone dipropionate or alternating between calcipotriene/betamethasone dipropionate and calcipotriene every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriene/betamethasone dipropionate also improved health-related quality of life. Calcipotriene/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriene/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriene or tacalcitol and did not appear to be associated with a higher incidence of corticosteroid-related adverse events during long-term therapy. Pharmacoeconomic analyses predicted calcipotriene/betamethasone dipropionate to be more cost effective than other topical therapies. Thus, calcipotriene/betamethasone dipropionate is an important, effective, once-daily, topical therapy for the symptomatic treatment of psoriasis vulgaris of the trunk, limbs, and scalp.     

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.     

Consistency of data in six phase III clinical studies of a two-compound product containing calcipotriol and betamethasone dipropionate ointment for the treatment of psoriasis

BACKGROUND: Calcipotriol and betamethasone dipropionate are both proven products in the topical treatment of psoriasis. The efficacy and tolerability of a new ointment containing these two compounds has been assessed in six phase III clinical studies. OBJECTIVE: To compare the results obtained in the clinical studies of the new calcipotriol/betamethasone dipropionate ointment. METHODS: A total of 6050 patients with psoriasis took part in the six randomized, double-blind studies. The two-compound product was compared with each of the active constituents, either in the new ointment vehicle or in the marketed formulation. RESULTS: After 4 weeks of treatment the mean reduction in the Psoriasis Area and Severity Index (PASI) ranged from 65 to 74% with the two-compound product applied once or twice daily, from 46 to 59% with calcipotriol alone and from 57 to 63% with betamethasone dipropionate alone. The tolerability profile of the two-compound product was similar to betamethasone dipropionate monotherapy and better than calcipotriol alone. CONCLUSION: The new two-compound product containing calcipotriol and betamethasone dipropionate was found to consistently provide rapid, highly effective treatment of psoriasis vulgaris.     

卡泊三醇倍他米松软膏联合窄谱中波紫外线治疗斑块状银屑病的随机对照研究

【摘要】 目的 探讨卡泊三醇倍他米松软膏联合窄谱中波紫外线（NB-UVB）治疗斑块状银屑病的疗效及安全性。 方法 随机、单盲平行对照、多中心临床试验,108例斑块状银屑病患者随机纳入试验组或对照组,疗程4周。对照组单纯进行NB-UVB照射;试验组NB-UVB照射方法同对照组,卡泊三醇倍他米松软膏每晚外用。治疗前、治疗2周、4周时观察疗效及安全性,治疗结束后1、2、4周进行随访。 结果 两组患者治疗2周后,试验组有效率15.09%,对照组有效率2.04%,总体疗效分析差异有统计学意义。治疗4周后,试验组有效率77.36%,对照组26.53%,两组差异有统计学意义（P ＜ 0.01）。治疗前两组PASI评分比较,差异无统计学意义;治疗2周、4周以及随访1周、2周、4周时,两组PASI评分比较,差异均有统计学意义。试验组未发现不良反应,对照组有1例双小腿非皮疹部位出现疼痛性红斑。两组间不良反应发生率比较,差异无统计学意义。 结论卡泊三醇倍他米松软膏联合NB-UVB治疗斑块状银屑病是一种见效快、安全的治疗方法。     

Calcipotriol (Dovobet) ointment in combination with UVB therapy for psoriasis treatment

Dovobet is a compounded combination of calcipotriol [also calcipotriene] and betamethasone diproprionate, and is used for psoriasis vulgaris once daily. For this photo case presentation, Dovobet was used once daily in combination with UVB phototherapy 3 times a week. Light therapy was increased by 10% increments at each visit or as tolerated by the patient. Results show the combination of light therapy plus Dovobet may be an effective and convenient option in the treatment of psoriasis.