钙泊三醇倍他米松乳膏联合窄谱中波紫外线治疗稳定期寻常型银屑病的疗效分析

目的:观察钙泊三醇倍他米松软膏、卡泊三醇软膏和糠酸莫米松乳膏分别与窄谱中波紫外线(NB-UVB)照射联合治疗寻常型银屑病的效果与不良反应。方法:将90例稳定期寻常型银屑病患者随机分为3组,每组30例。治疗组予钙泊三醇倍他米松软膏,对照组A予卡泊三醇软膏,对照组B予糠酸莫米松乳膏。3组均将药物涂擦于皮肤损伤部位,每日1次;均在治疗过程中接受NB-UVB照射,3次/周;3组患者的疗程均为4周。治疗过程中每周观察1次疗效。结果:治疗2周时,治疗组的有效率(36.67%)高于对照组A(13.33%)和对照组B(13.33%),差异有统计学意义(P0.05);治疗4周时,治疗组有效率(93.33%)高于对照组A(73.33%)与对照组B(66.67%),差异有统计学意义(P0.05)。钙泊三醇倍他米松的主要不良反应为灼热和红斑,但患者可耐受。结论:钙泊三醇倍他米松软膏、卡泊三醇软膏和糠酸莫米松乳膏与NB-UVB联合应用治疗寻常型银屑病均安全有效,其中以钙泊三醇倍他米松软膏的起效最快、疗效最好、不良反应最少。     

Validated high-performance thin-layer chromatographic (HPTLC) method for simultaneous determination of nadifloxacin,mometasone furoate,and miconazole nitrate cream using fractional factorial design

A high-performance thin-layer chromatographic method for simultaneous determination of nadifloxacin, mometasone furoate, and miconazole nitrate was developed and validated as per International Conference on Harmonization guidelines. High-performance thin-layer chromatographic separation was performed on aluminum plates precoated with silica gel 60F₂₅₄ and methanol:ethyl acetate:toluene: acetonitrile:3M ammonium formate in water (1:2.5:6.0:0.3:0.2, % v/v) as optimized mobile phase at detection wavelength of 224 nm. The retardation factor (R_f) values for nadifloxacin, mometasone furoate, and miconazole nitrate were 0.23, 0.70, and 0.59, respectively. Percent recoveries in terms of accuracy for the marketed formulation were found to be 98.35–99.76%, 99.36–99.65%, and 99.16–100.25% for nadifloxacin, mometasone furoate, and miconazole nitrate, respectively. The pooled percent relative standard deviation for repeatability and intermediate precision studies was found to be < 2% for three target analytes. The effect of four independent variables, methanol content in total mobile phase, wavelength, chamber saturation time, and solvent front, was evaluated by fractional factorial design for robustness testing. Amongst all four factors, volume of methanol in mobile phase appeared to have a possibly significant effect on retention factor of miconazole nitrate compared with the other two drugs nadifloxacin and mometasone furoate, and therefore it was important to be carefully controlled. In summary, a novel, simple, accurate, reproducible, and robust high-performance thin-layer chromatographic method was developed, which would be of use in quality control of these cream formulations.     

糠酸莫米松鼻喷雾剂治疗药物性鼻炎22例

目的观察糠酸莫米松鼻喷雾剂治疗萘甲唑啉滴鼻剂所致药物性鼻炎的临床疗效与不良反应。方法采用前瞻性、非随机、自身对照研究,22例药物性鼻炎患者停用萘甲唑啉滴鼻剂,接受糠酸莫米松鼻喷雾剂治疗,第1周每天早晨和睡前各使用1次,每个鼻孔各喷2揿,每揿50 μg。从第2周开始,每天早晨使用1 次,每个鼻孔各喷两揿,每揿50 μg。共治疗4周。鼻塞程度采用视觉模拟量表（VAS）,记录患者治疗前后VAS评分。鼻镜观察有无鼻出血、鼻中隔穿孔等药物不良反应。结果治疗前后VAS评分分别为（8.7±1.5）和（1.6±1.6）分,差异有统计学意义（P＜0.01）。治疗后显效17例,有效5例,总有效22例。治疗结束行鼻镜检查,患者未出现鼻出血、鼻中隔穿孔等不良反应。结论糠酸莫米松鼻喷雾剂能有效治疗因滥用萘甲唑啉滴鼻剂所致药物性鼻炎,治疗期间未见药品不良反应。     

自制复方酮康唑软膏的药效学和安全性研究

目的 评价自制复方酮康唑软膏的药效学和安全性。方法 采用纸片扩散法,选取6种真菌和2种细菌,考察自制软膏及3种市售制剂对抑菌圈直径的影响。另外,采用单次和多次给药的皮肤刺激性,及皮肤变态反应,评价自制软膏的安全性。结果 自制软膏与含酮康唑的市售制剂类似,均对6种真菌产生了显著的抑菌圈。对铜绿假单胞菌,各制剂均未产生抑菌圈;对金黄色葡萄球菌,自制软膏与市售莫匹罗星软膏的抑菌圈相似,且显著大于其他市售制剂。给予自制软膏后,皮肤刺激反应评分均小于0.5,致敏率为0,组织结构与正常皮肤无差异。结论 自制的复方酮康唑软膏的抑菌性能优于多数市售制剂,且具有良好的皮肤安全性,有望用于皮肤浅部真菌感染的治疗。     

皮敏消胶囊联合糠酸莫米松治疗寻常型银屑病的疗效观察

目的：观察皮敏消胶囊联合糠酸莫米松软膏治疗寻常型银屑病的临床疗效和安全性。方法123例寻常型银屑病患者分为治疗组、对照1组和对照2组各41例,治疗组患者口服皮敏消胶囊,每天3次,每次4片,外用糠酸莫米松软膏,每天2次,每次1遍,连续治疗8周;对照1组患者口服复方氨肽素片,每天3次,每次5片,外用糠酸莫米松软膏,每天2次,每次1遍,连续治疗8周;对照2组患者外用糠酸莫米松软膏,每天2次,每次1遍,连续治疗8周。结果治疗组患者治疗后有效率为80．49％;对照1组患者治疗后有效率为78．05％;对照2组患者治疗后总有效率为63．41％。治疗组、对照1组与对照2组疗效比较差异均有统计学意义（Z＝-2．359,P＝0．018;Z＝-2．102,P＝0．036）;治疗组与对照1组疗效比较差异无统计学意义（Z＝-0．271,P＝0．787）。三组患者均无明显不良反应。结论皮敏消胶囊联合糠酸莫米松软膏治疗寻常型银屑病是安全的、有效的。     

玉屏风颗粒联合糠酸莫米松鼻喷雾剂治疗慢性鼻炎的临床研究

目的探讨玉屏风颗粒联合糠酸莫米松鼻喷雾剂治疗慢性鼻炎的临床疗效。方法选取2016年1月—2017年1月开封市祥符区第一人民医院收治的慢性鼻炎患者70例为研究对象,依照入组时间编号并采用随机信封法将其分为对照组和治疗组,每组各35例。对照组吸入糠酸莫米松鼻喷雾剂,2揿/次,1次/d,病情得到控制后剂量减半。治疗组在对照组治疗的基础上温水冲服玉屏风颗粒,1袋/次,3次/d。两组患者均连续治疗4周。观察两组的临床疗效,比较两组的鼻窦CT评分、鼻内镜评分、临床症状评分、免疫功能水平和复发率。结果治疗后,对照组和治疗组的总有效率分别为77.14%、94.29%,两组比较差异有统计学意义(P0.05)。治疗后,两组鼻窦CT评分和鼻内镜评分显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组评分指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组鼻塞、鼻涕、嗅觉减退、头痛评分均显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组评分指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组CD3+、CD4+水平显著升高,而CD8+水平显著下降,同组治疗前后比较差异有统计学意义(P0.05);且治疗组免疫功能指标水平明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,对照组和治疗组的复发率分别为17.14%、2.86%,两组比较差异有统计学意义(P0.05)。结论玉屏风颗粒联合糠酸莫米松鼻喷雾剂治疗慢性鼻炎具有较好的临床疗效,可提高细胞免疫功能,改善临床症状,减少复发率,安全性较好,具有一定临床推广应用价值。     

Efficacy,safety, and tolerability of mometasone furoate in adult Japanese patients with mild asthma: open-label clinical trial findings

Abstract

Objective:

To evaluate the clinical efficacy and safety of mometasone furoate administered via a dry powder inhaler (MF-DPI) in Japanese patients with intermittent or mild persistent asthma who were not previously receiving inhaled corticosteroids.     

Use of mometasone furoate administered via a dry powder inhaler in the treatment of asthma

Abstract

Background:

Inhaled corticosteroids (ICSs) are effective controller medications that treat the chronic inflammation of asthma. The goal of asthma treatment is to improve lung function, symptoms, and the ability to perform daily activities, while decreasing the risk of exacerbations. Mometasone furoate delivered via a dry powder inhaler (MF-DPI) is indicated for once-daily maintenance treatment of asthma in patients as young as 4 years old.     

Effectiveness of fluticasone furoate 110 μg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen*

ABSTRACT

Background: Fluticasone furoate (FF) is a novel enhanced-affinity corticosteroid for the treatment of allergic rhinitis, delivered by a unique side-actuated device. This study was designed to investigate the efficacy and safety of FF nasal spray (FFNS) 110?μg once daily compared with placebo in adults and adolescents (aged ≥12?years) with seasonal allergic rhinitis (SAR) symptoms caused by mountain cedar (Juniperus ashei) pollen.

Methods: This was a randomized, double-blind, placebo-controlled, parallel-group, phase?III study conducted over a 2-week period (between 10 December 2004 and 19 January 2005) at seven study sites, in Austin, Texas, USA, and San Antonio, Texas, two metropolitan cities in the central Texas Hill Country located approximately 80 miles apart. Adult and adolescent patients (aged ≥12?years) with SAR, who were sensitized to mountain cedar (Juniperus ashei) pollen, were randomized to receive either FFNS 110?μg (n?=?152) or placebo (n?=?150) once daily. Patients rated the severity of each nasal symptom (rhinorrhea, nasal congestion, nasal itching, and sneezing) and ocular symptom (redness, watery eyes, itching and burning) on a 4-point categorical scale (0?=?none, 3?=?severe) in a reflective and instantaneous manner. Patients also rated their overall evaluation of response to therapy.

Results: FFNS significantly improved the nasal symptoms of SAR compared with placebo. The least square (LS) mean difference in the reflective total nasal symptom score (TNSS) was ?0.777 (p?=?0.003). A significant reduction in morning pre-dose instantaneous TNSS was also observed compared with placebo (LS mean difference ?0.902; p?<?0.001). Patients receiving FFNS had significantly greater improvements from baseline in reflective total ocular symptom scores (TOSS) than those receiving placebo (LS mean difference ?0.546; p?=?0.008). Significant improvements in ocular symptoms with FFNS versus placebo were also observed for morning pre-dose instantaneous TOSS (LS mean difference ?0.519; p?=?0.009). FFNS had a favorable safety and tolerability profile: fewer adverse events occurred with FFNS (22%) than with placebo (29%), and no serious adverse events were observed.

Conclusions: FFNS?110?μg once daily demonstrated efficacy in relieving both the nasal and ocular symptoms of SAR in adult and adolescent patients.

Trial registration: ClinicalTrials.gov identifier: NCT00115622.     

Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids

ABSTRACT

Background: Once-daily dosing with an inhaled corticosteroid (ICS) may simplify asthma management and improve patient compliance. Since asthma is frequently worse at night, evening dosing appears to be a more obvious choice to accommodate the chronobiology of asthma than morning dosing.

Objective: The primary study objective was to compare the efficacy and safety of mometasone furoate (MF) dry powder inhaler (MF-DPI) 400 µg qd PM (one 400 g inhalation) with placebo for the treatment of asthma in patients previously dependent on twice a day (bid, bis in die) ICS therapy. We also compared different regimens of MF-DPI with each other and with placebo.

Methods: This 12-week, multicenter, double-blind, placebo-controlled study evaluated lung function and asthma symptoms in 400 subjects with persistent asthma randomized to MF-DPI 200 µg qd (once a day, quaque die) PM, 400 µg qd PM as one inhalation from a 400 µg device, 400 µg qd PM as two inhalations from a 200 µg device, 200 µg twice daily (bid), or placebo. Evening doses were to be taken in the late afternoon or early evening, preferably before dinner time.

Results: Mean changes from baseline at endpoint in FEV₁ (forced expiratory volume in 1 s) were similar for MF-DPI 400 µg qd PM (one inhalation; 0.41 L), MF-DPI 400 g qd PM (2 inhalations; 0.49 L), MF-DPI 200 µg qd PM (0.41 L), and MF-DPI 200 µg bid (0.51 L); and all were significantly improved compared with placebo (0.16 L; p < 0.001). Secondary efficacy variables, including nocturnal awakenings and use of rescue albuterol, were also significantly improved with MF-DPI treatment compared with placebo. All treatments were generally safe and well tolerated, with adverse events of mild to moderate severity.

Conclusions: Once-daily evening dosing of MF-DPI at doses of 400 and 200 µg restored lung function and improved nocturnal and daytime symptom control in subjects with asthma previously dependent on bid ICS therapy. Comparable effectiveness of a total daily dose of 400 µg was demonstrated between once daily in the evening and twice-daily administration. The results also confirm the effectiveness of MF-DPI 200 µg qd PM, the lowest dose studied.