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。     

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。     

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。     

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。     

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。     

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.     

卡泊三醇软膏两种不同用法治疗轻中度斑块状银屑病的疗效观察

目的:观察卡泊三醇软膏分别按疗程和症状两种不同用药方法治疗轻中度斑块状银屑病的疗效及安全性.方法:斑块状银屑病患者60例,随机分为疗程治疗组及症状治疗组,每组30例,前者给予卡泊三醇软膏每日2次,共8周;后者给予卡泊三醇软膏每日2次,4周症状改善后改为每日1次,共8周,治疗前及治疗后第2、4、8周分别进行PASI评分,治疗前及治疗结束时测血钙浓度,判定疗效及记录不良反应.结果:经过8周观察,疗程治疗组治愈率和有效率分别为50.00%和76.67%,症状治疗组治愈率和有效率分别为23.33%和66.67%,两组治愈率有统计学差异,但有效率无统计学差异.疗程治疗组8例出现不良反应,对照组6例出现不良反应,均可耐受.结论:卡泊三醇治疗轻中度斑块状银屑病应足疗程用药.     

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.     

Calcitriol ointment and clobetasol propionate cream: a new regimen for the treatment of plaque psoriasis

For psoriasis therapy, topical derivatives of vitamin D3 represent a versatile option: they can be used either alone or in combination with other agents such as topical corticosteroids. In this two-phase parallel-group study, the naturally occurring vitamin D3 analogue, calcitriol, was compared with the vitamin D analogue calcipotriol in 125 patients with chronic plaque-type psoriasis. The proposed treatment regimen was an initial bitherapy for 2 or 4 weeks, with clobetasol propionate 0.05% cream, a super potent topical corticosteroid applied in the morning and either calcitriol 3 mug/g ointment or calcipotriol 50 mug/g ointment applied in the evening, followed by monotherapy with either calcitriol or calcipotriol applied twice daily until endpoint week 12. Efficacy evaluations (global assessment of improvement, PASI and body surface area (BSA) affected) showed no significant differences between the two regimen groups at the primary endpoints (week 2 and week 12) or at any interim points. At week 2 the investigator's global assessment showed clinical success (psoriasis markedly improved, almost clear or clear) for more than 50% of the patients in both groups and for 48 (79%) and 56 (88%) patients, respectively in the calcitriol and calcipotriol regimen group at week 12. Least-square means analysis of PASI indicated the calcitriol regimen to be equivalent to the calcipotriol regimen. There were no significant differences between the two groups with regards to cutaneous safety or to incidence of adverse events. The present study shows that for the treatment of mild to moderate plaque psoriasis calcitriol 3 mug/g ointment can provide a safe and effective alternative to calcipotriol 50 mug/g ointment while being administered within a regimen based on a bitherapy with corticosteroids followed by a vitamin D3 maintenance monotherapy.     

消银汤联合卡泊三醇软膏对血热型寻常性银屑病疗效及相关细胞因子水平的影响

目的 探讨消银汤联合卡泊三醇软膏治疗进展期血热型轻/中度（PASI评分 < 10）寻常性银屑病疗效和对IL-17、IL-22、TNF-α水平影响。方法 60例进展期血热型轻/中度寻常性银屑病患者分为治疗组及对照组,每组各30例。治疗组予消银汤口服;对照组予安慰剂口服,2组同时外用卡泊三醇软膏;另选志愿者30例作为健康对照组;疗程12周。记录治疗前、后PASI评分,检测治疗前、后Th17细胞、TNF-α、IL-22、IL-17水平。结果 治疗前,与健康对照组相比,治疗组及对照组在Th17细胞水平及血清IL-17、IL-22和TNF-α水平差异有统计学意义（P ＜ 0.05）,治疗组及对照组水平高于健康对照组;治疗后,上述指标与治疗前比较,差异有统计学意义（P ＜ 0.05）。治疗组治疗后PASI评分为（1.83 ± 1.28）,对照组为（2.91 ± 1.42）,差异有统计学意义（P ＜ 0.05）。治疗组总有效率为93.33%,与对照组总有效率73.33%比较差异有统计学意义（P ＜ 0.05）。治疗组在PASI评分,治疗总有效率及细胞因子水平改善方面优于对照组。结论 Th17细胞及血清IL-17、IL-22和TNF-α水平在轻/中度寻常性银屑病患者存在异常,消银汤联合卡泊三醇软膏对此有改善作用。     

An investigator-masked comparison of the efficacy and safety of twice daily applications of calcitriol 3 µg/g ointment vs. calcipotriol 50 µg/g ointment in subjects with mild to moderate chronic plaque-type psoriasis

BACKGROUND: Calcitriol and calcipotriol, two vitamin D derivatives, are available for topical treatment of psoriasis and have been shown to be effective. AIM: To compare the efficacy and safety of calcitriol 3 microg/g and calcipotriol 50 microg/g. METHODS: This was a multicentre, randomized, investigator-masked, and parallel comparison in subjects with mild to moderate chronic plaque-type psoriasis receiving either calcitriol or calcipotriol ointment twice daily for 12 weeks. Efficacy evaluations comprised global improvement (on a 4-point scale from 0: no change or worse, to 3: clear or almost clear) assessed by the investigator and by the subject. Efficacy further included the 'dermatological sum score' at each study visit. Safety evaluations included adverse event reporting, cutaneous safety assessed by the investigator and cutaneous discomfort assessment by the subject (both on a 5-point scale from 0: none, to 4: very severe). RESULTS: A total of 250 subjects of both gender were recruited. At week 12, the LSmean score of global improvement rated by the investigator was 2.27 for calcitriol and 2.22 for calcipotriol. This difference was not statistically significant, with calcitriol demonstrating to be non-inferior to calcipotriol for global improvement. This same parameter was scored by the subject, with a mean of 2.12 for calcitriol and 2.09 for calcipotriol. The percentage of patients with at least marked improvement tended to be in favour of calcitriol (95.7% vs. 85% for calcipotriol). However, differences were not statistically significant. The mean worst score for the cutaneous safety assessment was higher in the calcipotriol group (0.3 vs. 0.1 and 0.4 vs. 0.2, by the investigator and the patient, respectively). These differences were statistically significant in favour of a better safety profile for calcitriol (P=0.0035). Fourteen dermatological and treatment-related adverse events were reported with calcipotriol vs. only five with calcitriol for a total of 22 adverse events reported throughout the study. CONCLUSION: Calcitriol administered twice daily over a 12-week treatment period demonstrated similar efficacy to calcipotriol, while showing a significantly better safety profile.     

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.