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联合卡泊三醇软膏序贯治疗寻常型银屑病疗效评价

目的：评价钙泊三醇倍他米松软膏联合卡泊三醇软膏治疗寻常型银屑病的临床疗效。方法：30例银屑病患者全身左右侧皮损随机分为治疗组或对照组。治疗组外用钙泊三醇倍他米松软膏和卡泊三醇软膏;对照组外用卡泊三醇软膏。治疗第2、4、8周末进行疗效评价。结果：治疗2、4、8周后治疗组有效率（53.33%、70%和86.67%）均明显高于对照组（30%、46.67%和66.67%）,组间差异均有统计学意义（P〈0.05）。结论：钙泊三醇倍他米松软膏联合卡泊三醇软膏治疗寻常型银屑病疗效较单独使用卡泊三醇好。     

中药方剂浸浴联合外用钙泊三醇倍他米松软膏治疗寻常性银屑病57例临床观察

目的探讨中药方剂浸浴疗法联合外用钙泊三醇倍他米松软膏对寻常性银屑病患者的疗效。方法将114例寻常性银屑病患者随机等分为实验组(57例)和对照组(57例),实验组采用中药方剂浸浴联合外用钙泊三醇倍他米松软膏;对照组采用婴幼儿沐浴露浸浴联合外用钙泊三醇倍他米松软膏,两组疗程均为4周。结果治疗结束后,实验组有效率为82.46%,对照组为63.16%,差异具有统计学意义(P=0.04)。实验组治疗第2,4周的PASI分别为7.46±1.03和1.26±0.94与对照组的8.03±0.98和3.07±1.11比较差异具有统计学意义(P均0.01)。结论中药方剂浸浴联合外用钙泊三醇倍他米松软膏对寻常性银屑病患者的皮损症状起到很好地缓解作用,疗效显著。     

钙泊三醇倍他米松乳膏与卡泊三醇软膏序贯治疗银屑病

目的:观察钙泊三醇倍他米松乳膏与卡泊三醇软膏序贯治疗银屑病患者的疗效及安全性。方法:将90例斑块状寻常性银屑病患者随机分为3组,第一组:外用钙泊三醇倍他米松乳膏4周(每日1次)+钙泊三醇倍他米松乳膏与卡泊三醇软膏交替使用2周(均每日1次,2种交替)+卡泊三醇软膏6周(每日1次);第二组:外用钙泊三醇倍他米松软膏6周+卡泊三醇软膏6周(均每日1次);第三组:外用卡泊三醇软膏12周(每日2次)。结果:3组患者治疗4、6、12周后银屑病皮损面积和严重程度指数(PASI)评分分别与各组治疗前比较,差异均有统计学意义(P均0.05)。第一组与第二组疗效均优于第三组,差异均有统计学意义(P均0.05),但第一组与第二组疗效比较,差异无统计学意义(P0.05)。结论:序贯疗法起效快且疗效优,为患者节省医疗开支并减少糖皮质激素的不良反应。     

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。     

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。     

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。     

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。     

钙泊三醇倍他米松软膏治疗神经性皮炎临床疗效观察

目的观察分析钙泊三醇倍他米松软膏治疗神经性皮炎的临床疗效。方法将73例神经性皮炎患者根据治疗方案分为2组。治疗组37例,外用钙泊三醇倍他米松软膏;对照组36例,外用复方氟米松软膏,疗程均为4周。在治疗4周末比较2组的疗效。结果治疗组有效率明显高于对照组,差异有统计学意义(P0.05)。结论钙泊三醇倍他米松乳膏的临床疗效可靠,未见明显不良反应。     

308nm准分子激光联合卡泊三醇软膏治疗斑块状银屑病疗效评价

目的：评价308 nm准分子激光联合卡泊三醇软膏治疗斑块状银屑病的临床疗效.方法：将93例稳定期斑块状银屑病随机分为3组,治疗组（33例） 予308 nm准分子激光照射,每周2次联合外搽卡泊三醇软膏,每日2次;对照1组（30例）外搽卡泊三醇软膏;对照2组（30例）,予308 nm准分子激光照射,方法同治疗组,2个月后判断疗效.结果：治疗组、对照1组和对照2组的有效率分别为90.91%、73.33%、63.33%.3组间疗效比较差异有统计学意义（均P〈0.05）.结论：308 nm准分子激光联合卡泊三醇软膏治疗斑块状银屑病能更好地提高疗效.     

A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris

In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.     

Retrospective assessment of PASI 50 and PASI 75 attainment with a calcipotriol/betamethasone dipropionate ointment

BACKGROUND: The US National Psoriasis Foundation recently recommended that PASI 50 and PASI 75 response rates be used in clinical trials to enable comparisons across studies of different psoriasis therapies. To date, these response rates have not been reported for the two-compound ointment containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark). Further, in order to compare Daivobet with other therapeutics recently presented to the European regulatory authorities and the FDA, comparison with the biologicals, efalizumab, etanercept and alefacept, were also made. OBJECTIVES: To present the PASI 50 and PASI 75 results for the two-compound ointment containing calcipotriol and betamethasone dipropionate. METHODS: Data from six phase III studies conducted with the two-compound ointment were pooled and the PASI 50 and PASI 75 response rates calculated for patients with severe (PASI>or=17) or less severe disease (PASI<17) at treatment commencement. Results for the biological therapies, efalizumab, etanercept and alefacept, were obtained from relevant published phase III studies. RESULTS: PASI 50 and PASI 75 were achieved by more patients treated with the two-compound ointment than with the individual components. In patients with severe disease, the PASI 50 response rate after 4 weeks' treatment was 88.8% with the two-compound ointment, 69.2% with betamethasone dipropionate, 53.8% with calcipotriol, and 30.0% with ointment vehicle. In comparison, 12 weeks' treatment with the biologicals resulted in PASI 50 response rates of 59% with efalizumab, 74% with etanercept, and 56% with alefacept. CONCLUSIONS: The two-compound ointment is effective, producing a PASI 50 and PASI 75 response in greater than 80% and 50% of patients, respectively, regardless of psoriasis severity.     

A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris

BACKGROUND: Topical corticosteroids and calcipotriol have been used separately for many years to treat psoriasis. A new combination ointment has been formulated, which contains both calcipotriol and the corticosteroid betamethasone dipropionate. OBJECTIVE: To compare the combination ointment with betamethasone dipropionate ointment, calcipotriol ointment and ointment vehicle in patients with psoriasis vulgaris. METHODS: 1,603 patients were randomised to one of the 4 double-blind treatments used once daily for 4 weeks. RESULTS: The mean percentage change in the PASI at the end of treatment was -71.3 (combination), -57.2 (betamethasone), -46.1 (calcipotriol) and -22.7 (vehicle). The mean difference of combination minus betamethasone was -14.2 (95% CI: -17.6 to -10.8, p < 0.001), of combination minus calcipotriol -25.3 (95% CI: -28.7 to -21.9, p < 0.001) and of combination minus vehicle -48.3 (95% CI: -53.2 to -43.4, p < 0.001). 6.0% of patients (combination) reported local adverse reactions compared to 4.9% (betamethasone), 11.4% (calcipotriol) and 13.6% (vehicle). CONCLUSION: Calcipotriol/betamethasone dipropionate combination ointment used once daily is well tolerated and more effective than either active constituent used alone.     

A comparison of twice-daily calcipotriol ointment with once-daily short-contact dithranol cream therapy: a randomized controlled trial of supervised treatment of psoriasis vulgaris in a day-care setting

BACKGROUND: Calcipotriol has become a first-line treatment for psoriasis. Its efficacy and safety have been shown in many comparative clinical trials carried out in outpatients. In a comparative study in patients visiting the outpatient department once every 14 days, it was shown that calcipotriol was more effective and better tolerated compared with dithranol. OBJECTIVES: To compare the clinical efficacy of calcipotriol ointment with that of dithranol cream in a supervised treatment regimen. METHODS: In a multicentre randomized controlled trial in six centres in the Netherlands, 106 patients with chronic plaque psoriasis were included, 54 receiving calcipotriol ointment twice daily and 52 dithranol cream once daily. Patients were treated at the day-care centre, using the care instruction principle of daily visits during the first week and twice-weekly visits subsequently for up to 12 weeks. RESULTS: This study failed to prove that calcipotriol is as efficacious as dithranol when used in a day-care setting (noninferiority test). The mean percentage reduction in Psoriasis Area and Severity Index from baseline to end of treatment was 57.0% in the calcipotriol group vs. 63.6% in the dithranol group. However, the two-sided test for superiority indicated no statistically significant difference between the treatment groups (P = 0.39). At the end of treatment, 15% of the patients treated with calcipotriol ointment and 25% of those treated with dithranol cream did not require any further treatment. Although calcipotriol ointment appeared to be more effective during the first 8 weeks, a difference was no longer apparent at 12 weeks. In comparison with the high number of drop-outs due to cutaneous side-effects in the calcipotriol group, the frequency of a tolerable degree of irritation appeared to be higher in patients treated with dithranol. However, concomitant corticosteroid treatment of dithranol irritation in seven patients may have contributed to this difference between both treatments. Moreover, patients receiving therapy with calcipotriol ointment experienced fewer application-related skin and subcutaneous tissue disorders than patients treated with dithranol cream: 21 of 53 (40%) and 37 of 52 (71%), respectively. This difference is statistically significant (P = 0.001). CONCLUSIONS: The hypothesis that calcipotriol ointment might be at least as effective as dithranol cream in the day-care setting could not be proven in the present study. Whereas calcipotriol has become a mainstay in the routine outpatient treatment of psoriasis not requiring a day-care setting, dithranol treatment, being difficult as a routine outpatient therapy, has increased efficacy and improved tolerability if the treatment is carried out in a day-care setting.     

Calcipotriol cream with or without concurrent topical corticosteroid in psoriasis: tolerability and efficacy

The objectives of the study were to determine whether concurrent treatment with calcipotriol (50 μg/g) and either clobetasone 17-butyrate cream (0.5 mg/g) (moderate potency) or betamethasone 17-valerate cream (1 mg/g) (potent) or placebo (vehicle of calcipotriol) was more effective and/or caused less skin irritation than calcipotriol cream (50 μg/g) used twice daily. It was a multicentre, double-blind, parallel group study. Patients applied calcipotriol cream in the morning and either vehicle (n = 174), calcipotriol (n = 174), clobetasone (n = 175) or betamethasone creams (n = 176) in the evening for up to 8 weeks. Adverse events led to withdrawal in 20 patients (2.9%). The mean percentage change in PASI (psoriasis area and severity index) was ?40.6 in the calcipotriol/vehicle group, ?48.3 in the calcipotriol/calcipotriol group, ?53.7 in the calcipotriol/clobetasone 17-butyrate group and ?57.5 in the calcipotriol/betamethasone 17-valerate group. A statistically significant difference was seen between the four treatment groups (P = 0.006) with calcipotriol/vehicle being less effective than the other treatments. A statistically significant difference in favour of calcipotriol/betamethasone 17-valerate was seen between the calcipotriol/calcipotriol group and the calcipotriol/betamethasone 17-valerate group. The majority of adverse events were skin irritations, which were reported for 31.2% of patients treated with calcipotriol/vehicle, 34.3% of patients treated with calcipotriol twice daily and 23.8% vs. 17.1% of patients treated with calcipotriol/clobetasone 17-butyrate and calcipotriol/betamethasone 17-valerate, respectively. Skin irritation was seen statistically significantly less frequently in patients treated with calcipotriol/ clobetasone 17-butyrate or calcipotriol/betamethasone 17-valerate (P = 0.001), whereas no difference was seen between the other groups. In conclusion, calcipotriol applied twice daily was as effective as calcipotriol/clobetasone 17-butyrate, but slightly less effective than calcipotriol/betamethasone 17-valerate. The incidence of skin irritation was less for patients using concurrent corticosteroids, whereas treatment with calcipotriol/vehicle did not reduce the incidence of skin irritation when compared with calcipotriol twice daily.     

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.     

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.