Early onset vulvar Lichen Sclerosus in premenopausal women and oral contraceptives

OBJECTIVE: For vulvar Lichen sclerosus (LS) immunological factors, genetic predisposition, and decreased 5 alpha-reductase activity have been discussed as aetiological factors. During the last decade an increase of LS in young women has been suspected. Aim of this study was to evaluate data of premenopausal women with early onset LS to find potential risk factors focussing on the use of oral contraceptives. STUDY DESIGN: We retrospectively analyzed the data of 40 premenopausal patients with early onset LS regarding use of oral contraceptives (OCPs), and first occurrence of LS. To compare these data in a case-control study we analyzed a matched control group of 110 healthy women. RESULTS: All our LS patients were using OCPs compared to 73 women (66.4%) in the control group. OCPs with anti-androgenic activity (chlormadinone acetate, cyproterone acetate, dienogest, and drospirenone) were used by 28 (70%) of the LS patients and by 35 (47.9%) of the 73 women using OCPs in the control group. Thus, the odds ratio for early onset LS for women using anti-androgenic OCPs was 2.53 (95% CI: 1.12-5.75). CONCLUSION: Our data suggest that disturbance of the androgen dependent growth of the vulvar skin by OCPs and especially by OCPs with anti-androgenic properties might trigger the early onset of LS in a subgroup of susceptible young women.     

大鼠外涂丙酸氯倍他索乳膏引起全身性感染

０．２％丙酸氯倍他索（ＣＰ）乳膏１ｇ单次用于大鼠完整及破损皮肤、０．０５％ＣＰ乳膏１ｇ连续２周和０．１％ＣＰ乳膏１ｇ连续３周（该组无菌饲养）用于大鼠完整皮肤，４组分别有４／１０、２／１０、３／１０、２／１０的大鼠在用药后发生肝、肺、肾、心等多器官杆状杆菌属全身性感染、消化道出血并死亡。无感染的动物血清ＡＬＴ升高，ＡＳＴ降低。停药后无动物死亡，ＡＬＴ和ＡＳＴ恢复正常。结果表明，单次或多次大剂量、大面积用ＣＰ乳膏期间可出现继发性感染的副作用，消化道出血、ＡＬＴ升高和ＡＳＴ降低等不良反应     

Clobetasol propionate followed by calcipotriol is superior to calcipotriol alone in topical treatment of psoriasis

Background Although potent, topical corticosteroids offer effective and rapid healing of psoriatic lesions. Their long term use is limited because of the risk of side effects. Calcipotriol is safe for long-term treatment, but its initial efficacy is lower than with topical corticosteroids.
Objectives To investigate whether 2 weeks of treatment with clobetasol propionate 0.05% ointment bd followed by 4 weeks of treatment with calcipotriol 50 /μg/g bd would offer therapeutic advantages over 6 weeks of continuous treatment with calcipotriol.
Methods Forty-nine patients with moderate to severe plaque psoriasis were recruited from five centres in Norway. In a randomised, double-blind, right- versus left-side comparison, ointments were applied to two symmetrically-located areas.
Results Two weeks of treatment with clobetasol propionate produced a significantly greater decrease in total symptom score (combined scores of erythema, induration and scaling) than calcipotriol treatment ( P < 0.0001). This improvement on the clobetasol.propionate-treated side of the body was maintained throughout a subsequent 4-week treatment period when calcipotriol was applied to both sides of the body ( P < 0.0001). The superiority of the clobetasol propionate followed by calcipotriol treatment was maintained during a 4-week, treatment-free, observation period. Treatments were well tolerated with no rebound effect.
Conclusions Clobetasol propionate ointment bd for 2 weeks followed by treatment with calcipotriol ointment bd for 4 weeks was superior to calcipotriol ointment alone in the treatment of plaque psoriasis.     

复方氟米松软膏与丙酸氯倍他索乳膏治疗慢性湿疹和神经性皮炎疗效对比研究

[摘要] 目的 观察奥深治疗慢性湿疹和神经性皮炎的临床疗效和不良反应。方法 151例慢性湿疹和神经性皮炎患者随机分为奥深治疗组76例（其中慢性湿疹45例，神经性皮炎31例），丙酸氯倍他索乳膏对照组75例（其中慢性湿疹43例，神经性皮炎32例），分别观察治疗后1、2、3周的临床疗效和不良反应。结果 治疗组和对照组治疗1周后的临床痊愈率分别为13.16 %和6.67%，两组比较无统计学差异（P>0.05），治疗组治疗后2、3周的临床痊愈率分别为53.95%和63.16%，对照组治疗后2、3周的临床痊愈率分别为28.00%和37.33 %，两组比较差异有统计学意义（P<0.05）；治疗组治疗后1、2、3周的临床有效率分别为43.42%，84.21%和92.11%，对照组治疗后1、2、3周的临床有效率分别为18.67 %，60.00%和69.33%，两组临床有效率比较差异均有统计学意义（P<0.05）。且未见有明显临床意义的不良反应。结论 奥深治疗慢性湿疹和神经性皮炎的疗效优于丙酸氯倍他索乳膏，无明显的不良反应，是治疗慢性湿疹和神经性皮炎较为理想药物。     

复方消银膏治疗轻中度寻常型银屑病临床观察

目的观察复方消银膏治疗轻中度寻常型银屑病的临床疗效及安全性。方法采取随机分组法,将符合入选标准的轻中度寻常型银屑病患者92例随机分为复方消银膏组、丙酸氯倍他索乳膏组、消银膏组。在治疗开始前及治疗开始后第1周、2周、4周、8周,对患者皮损进行评估和银屑病皮损面积和严重程度指数(PASI)评分,最终比较3者临床疗效指数、不良反应发生情况。结果 3种药物均在治疗第2周起效,且复方消银膏与激素药膏起效速度相当,均优于消银膏。结论复方消银膏治疗银屑病安全有效,与丙酸氯倍他索乳膏疗效相当,均优于消银膏。     

Accelerated Stability Testing of a Clobetasol Propionate-Loaded Nanoemulsion as per ICH Guidelines

The physical and chemical degradation of drugs may result in altered therapeutic efficacy and even toxic effects. Therefore, the objective of this work was to study the stability of clobetasol propionate (CP) in a nanoemulsion. The nanoemulsion formulation containing CP was prepared by the spontaneous emulsification method. For the formulation of the nanoemulsion, Safsol, Tween 20, ethanol, and distilled water were used. The drug was incorporated into an oil phase in 0.05% w/v. The lipophilic nature of the drug led to the O/W nanoemulsion formulation. This was characterized by droplet size, pH, viscosity, conductivity, and refractive index. Stability studies were performed as per ICH guidelines for a period of three months. The shelf life of the nanoemulsion formulation was also determined after performing accelerated stability testing (40°C ± 2°C and 75% ± 5% RH). We also performed an intermediate stability study (30°C ± 2°C/65% RH ± 5% RH). It was found that the droplet size, conductivity, and refractive index were slightly increased, while the viscosity and pH slightly decreased at all storage conditions during the 3-month period. However, the changes in these parameters were not statistically significant (p≥0.05). The degradation (%) of the optimized nanoemulsion of CP was determined and the shelf life was found to be 2.18 years at room temperature. These studies confirmed that the physical and chemical stability of CP were enhanced in the nanoemulsion formulation.     

中药泡洗联合丙酸氯倍他索乳膏外用治疗掌跖角化性湿疹疗效观察

目的观察中药泡洗联合丙酸氯倍他索乳膏外用治疗掌跖角化性湿疹临床疗效。方法将112例患者随机分为西药组36例,采用0.05%丙酸氯倍他索乳膏外涂患处,2次/d,中药组35例,采用燥湿润肤中药水煎后泡洗患处,30min/次,2次/d,治疗组41例,中药组泡洗后联合西药组治疗,疗程均4周。结果治疗组有效率95.12%高于西药组61.11%和中药组65.71%,差异有统计学意义(均P<0.05),复发率治疗组20.00%和中药组11.11%%均低于西药组50.00%,差异均有统计学意义(P<0.05)。治疗组未见明显不良反应。结论中西医结合治疗掌跖角化性湿疹临床效果好,不良反应小。