糠酸莫米松联合氯雷他定片对非变应性鼻炎的疗效观察

目的分析糠酸莫米松联合氯雷他定片治疗NAR的疗效。方法选择34例NAR患者应用糠酸莫米松联合氯雷他定片治疗。分别对患者治疗前、治疗后1个月、治疗后3个月的临床症状进行评估。结果患者治疗前主要症状的评分为(2.71±0.53)分,治疗后1个月为(1.81±0.53)分,治疗后3个月为(0.89±0.43)分;对患者治疗前后分类症状视觉模拟量表评分比较,9个症状评分均呈下降趋势,差异有统计学意义(P<0.05);在治疗过程中头痛发生率3.0%(1/33),鼻腔干燥发生率3.0%(1/33)。结论糠酸莫米松联合氯雷他定片可以有效改善NAR患者的临床症状。     

0.05%卤米松乳膏治疗皮炎湿疹类皮肤病多中心、随机对照、开放研究

目的观察0.05%卤米松乳膏治疗皮炎湿疹类皮肤病的疗效和安全性,并与0.1%糠酸莫米松乳膏进行比较。方法采用多中心、随机、开放试验,对92例亚急性湿疹和神经性皮炎患者外用0.05%卤米松乳膏或0.1%糠酸莫米松乳膏进行治疗,观察记录患者的临床表现和治疗反应。结果0.05%卤米松乳膏临床疗效优于0.1%糠酸莫米松乳膏,有效率分别为91.3%和71.7%(P<0.05),治疗指数分别为86.79%和74.37%(P<0.05)。结论0.05%卤米松乳膏治疗亚急性湿疹和神经性皮炎效果好,不良反应轻。     

防风通圣颗粒联合西替利嗪片治疗慢性湿疹的疗效观察

目的:评价防风通圣颗粒联合西替利嗪片治疗慢性湿疹的临床疗效和安全性。方法:150例慢性湿疹患者分为A组、B组和C组各50例,A组患者口服防风通圣颗粒,2次/d,3 g/次,西替利嗪片,1次/d,10 mg/次;B组口服西替利嗪片,1次/d,10 mg/次;C组患者口服防风通圣颗粒,2次/d,3 g/次;三组患者均外用曲安奈德乳膏,2次/d,连续治疗2周为1个疗程。结果:A组患者治疗后基愈率为66%,显效率为24%,进步率为10%,无效率为0%,有效率为90%;B组患者治疗后基愈率为50%,显效率为22%,进步率为24%、无效率为4%,有效率为72%;C组患者治疗后基愈率为48%,显效率为20%,进步率为28%,无效率为4%,有效率为68%。A组与B、C组疗效比较差异均有显著的统计学意义(χ2=5.263 2,P=0.021 8;χ2=7.293 6,P=0.006 9);B与C组疗效比较差异无显著的统计学意义(χ2=0.190 5,P=0.662 5)。三组患者均无明显不良反应。结论:防风通圣颗粒联合西替利嗪片治疗慢性湿疹是安全的、有效的。     

Once-daily fluticasone furoate/vilanterol versus twice-daily fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA

Objective: We aimed to demonstrate non-inferiority of once-daily fluticasone furoate/vilanterol 100/25 µg (FF/VI) to twice-daily fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adults/adolescents with asthma well controlled on inhaled corticosteroid/long-acting β₂ agonist (ICS/LABA). Methods: This was a randomized, double-blind, double-dummy, parallel-group, 24-week study (NCT02301975/GSK study 201378). Patients whose asthma met study-defined criteria for control were randomized 1:1:1 to receive FF/VI, FP/SAL or twice-daily FP 250 µg for 24 weeks. Primary endpoint was change from baseline in evening trough forced expiratory volume in 1 second (FEV₁). Secondary endpoints included rescue-/symptom-free 24-hour periods. Safety was also assessed. Results: The intent-to-treat (ITT) population included 1504 randomized and treated patients (504 FF/VI; 501 FP/SAL; 499 FP); mean age 43.5 years, 64% female. FF/VI demonstrated non-inferiority (using a margin of ?100 mL) to FP/SAL for evening trough FEV₁ at Week 24 (ITT: 19 mL [95% confidence interval (CI) ?11 to 49]; per protocol population [N = 1336]: 6 mL [95% CI ?27 to 40]). Improvement in evening trough FEV₁ at Week 24 for both FF/VI (123 mL; p < 0.001) and FP/SAL (104 mL; p < 0.001) was greater than FP. FF/VI increased rescue-/symptom-free 24-hour periods by 1.2%/1.2% compared with FP/SAL. All treatments were well tolerated. On-treatment adverse event (AE) rates were 43% to 45% across arms; there were no drug-related serious AEs. Conclusions: FF/VI was non-inferior to FP/SAL for evening trough FEV₁ at 24 weeks. These data suggest that patients well controlled on FP/SAL could step across to FF/VI without loss of control.     

Effects of intranasal corticosteroid on nasal adenosine monophosphate challenge in persistent allergic rhinitis

BACKGROUND: Response to a single dose nasal adenosine monophosphate challenge has been used as a surrogate inflammatory marker for allergic rhinitis. Attenuation of response following intranasal corticosteroid would further validate the challenge. OBJECTIVE: To assess the effect of 4 weeks of 200 mcg once daily mometasone furoate nasal spray on a simplified (single 160 mg dose) nasal adenosine monophosphate challenge. METHODS: Twenty participants with persistent allergic rhinitis completed a double blind placebo-controlled crossover study. Outcome measures were the peak nasal inspiratory flow and total nasal symptoms score responses to nasal adenosine monophosphate challenge, as well as domiciliary peak nasal inspiratory flow and patient symptom diary cards. RESULTS: Mometasone significantly (P < 0.05) attenuated response time profiles vs. placebo for peak nasal inspiratory flow but not total nasal symptom scores. For the maximum percentage fall this amounted to a mean difference of 9.6% (95% confidence interval 1.3-17.9%). The coefficient of variation for repeatability was 48.7%. Improvements were seen in prechallenge and domiciliary measurements of peak nasal inspiratory flow (both P < 0.05) and total nasal symptom scores (both P < 0.01). CONCLUSIONS: Mometasone attenuates the peak nasal inspiratory flow response to a single 160 mg nasal adenosine monophosphate challenge. Such challenges have been shown to be sensitive to the effects of antihistamines, antileukotrienes and now nasal steroids. This further supports their application as surrogate inflammatory markers for therapeutic trials in allergic rhinitis, potentially as 20 min challenges which can be conducted in a non-hospital setting.     

Efficacy and safety of mometasone furoate nasal spray in nasal polyposis

BACKGROUND: Studies have suggested that topical corticosteroids are effective in the treatment of nasal polyps; however, this has yet to be confirmed in a large, robust clinical trial. OBJECTIVE: To evaluate the efficacy and safety of mometasone furoate nasal spray (MFNS) for nasal polyposis. METHODS: A total of 354 subjects with bilateral nasal polyps and clinically significant congestion/obstruction participated in this multinational, randomized, double-blind, placebo-controlled study. Subjects received MFNS 200 microg once or twice daily or placebo for 4 months. Coprimary endpoints were (1) change from baseline to last assessment in physician-evaluated bilateral polyp grade score and (2) change from baseline averaged over month 1 in subject-assessed nasal congestion/obstruction. ANOVA was used for all efficacy endpoints, except for change in bilateral polyp grade score, for which baseline polyp grade was added as a covariate. RESULTS: Compared with placebo, MFNS 200 microg administered once or twice daily produced significantly greater reductions in bilateral polyp grade score (P < .001, P = .010, respectively) and congestion/obstruction (P = .001, P < .001), as well as improvement in loss of smell (P < .001, P = .036), anterior rhinorrhea (P < .001 for both), and postnasal drip (P < .001, P = .001) over month 1. MFNS 200 microg twice daily was superior to MFNS 200 microg once daily in reducing congestion/obstruction (P = .039), and there were more improvers in the MFNS 200 microg twice daily group (P = .035). MFNS was well tolerated in both groups. CONCLUSION: MFNS 200 mug, once or twice daily, was safe and significantly superior to placebo in reducing polyp grade (size and extent) and improving congestion/obstruction and return of sense of smell. MFNS is an effective medical treatment for nasal polyposis and may reduce or delay the need for surgery.     

用反相高效液相色谱法同时测定复方酮康唑软膏中三组分的含量

目的建立同时测定复方酮康唑软膏中酮康唑、莫匹罗星和糠酸莫米松含量的方法。方法采用反相高效液相色谱法,色谱柱为Intersil ODS-3(250 mm×4.6 mm,5μm),流动相为甲醇-pH5.5磷酸盐缓冲液(65∶35),柱温45℃,流速1.0 ml/min,检测波长248 nm。结果方法学验证表明,酮康唑、莫匹罗星和糠酸莫米松3种成分线性关系良好(r≥0.9995),日内日间精密度均小于3.0%,回收率在90%~108%之间,稳定性和重复性的RSD均小于3.0%,符合方法学要求。按照新建立的方法测定了3个批次样品中三组分的含量,结果符合要求。结论该方法简便可靠,可为复方酮康唑软膏的质量控制提供依据,也为其质量标准研究奠定了基础。     

复方酮康唑软膏的制备与稳定性考察

目的 制备复方酮康唑软膏并考察其稳定性。方法 以酮康唑、莫匹罗星和糠酸莫米松为主药,以聚乙二醇（PEG）为基质制备软膏;利用影响因素试验考察软膏中药物的稳定性。结果 PEG400和PEG3350的比例为2：1时,软膏的黏度最佳,易于涂展。制成软膏后,高温下糠酸莫米松和莫匹罗星稳定性良好;酮康唑有少许分解,加入0.5%的抗坏血酸棕榈酸酯（L-A）后,酮康唑的含量明显提高。加速试验发现,放置6个月后软膏的颜色无变化,3种药物的含量均在98%以上。结论 本实验成功制备了新型复方酮康唑软膏,药物稳定性良好。     

Systemic bioactivity of intranasal triamcinolone and mometasone in perennial allergic rhinitis

AIMS: To evaluate the systemic bioactivity of triamcinolone acetonide (TA) 220 micro g or mometasone furoate (MF) 200 micro g over 3 weeks in perennial allergic rhinitis. METHODS: Twenty-seven patients received TA 220 micro g or MF 200 micro g once daily for 3 weeks with a 2 week placebo washout period prior to each randomized treatment. Measurements were made at baseline after each washout and after each randomized treatment, comprising overnight 10-h urinary cortisol corrected for creatinine (OUCC), 08.00 h plasma cortisol and 08.00 h serum osteocalcin. RESULTS: There were no significant differences between baseline values prior to TA or MF, and for any outcome measures comparing randomized treatments to respective baseline values or comparing TA with MF. For OUCC compared with baseline, the geometric mean fold suppression (95% CI) was 1.02 (0.78, 1.33) for TA (2% decrease), 1.07 (0.80, 1.42) for MF (7% decrease), and 1.05 (0.79, 1.39) for TA vs MF (5% decrease). CONCLUSIONS: Standard doses of TA or MF over 3 weeks showed no differences in systemic bioactivity markers compared with respective baseline values after placebo washout, and there were no differences between TA vs MF.