鼻腔冲洗联合糠酸莫米松鼻喷雾剂治疗变应性鼻炎的疗效观察

目的 观察糠酸莫米松鼻喷雾剂联合鼻腔冲洗治疗变应性鼻炎(AR)的临床疗效.方法 将70例AR患者分为观察组和对照组,每组35例.对照组给予糠酸莫米松鼻喷雾剂治疗,观察组在对照组基础上加用鼻腔冲洗.治疗4周后,比较两组治疗前后的临床疗效和不良反应.结果 治疗后,对照组总有效率为71.43％,观察组为94.29％,两组比较差异有统计学意义(P＜0.05).两组患者鼻塞、打喷嚏、流清涕等症状明显改善,鼻内镜下体征评分有所下降,两组比较差异有统计学意义(P＜0.05).结论 鼻腔冲洗联合糠酸莫米松鼻喷雾剂治疗AR,临床效果明显,不良反应小,值得临床推广应用.     

The use of quantitative analysis and Hansen solubility parameter predictions for the selection of excipients for lipid nanocarriers to be loaded with water soluble and insoluble compounds

The aim of these studies was to determine the miscibility of different API with lipid excipients to predict drug loading and encapsulation properties for the production of solid lipid nanoparticles and nanostructured lipid carriers. Five API exhibiting different physicochemical characteristics, viz., clarithromycin, efavirenz, minocycline hydrochloride, mometasone furoate, and didanosine were used and six solid lipids in addition to four liquid lipids were investigated. Determination of solid and liquid lipids with the best solubilization potential for each API were performed using a traditional shake-flask method and/or a modification thereof. Hansen solubility parameters of the API and different solid and liquid lipids were estimated from their chemical structure using Hiroshi Yamamoto’s molecular breaking method of Hansen Solubility Parameters in Practice software. Experimental results were in close agreement with solubility parameter predictions for systems with ΔδT < 4.0 MPa^1/2. A combination of Hansen solubility parameters with experimental drug-lipid miscibility tests can be successfully applied to predict lipids with the best solubilizing potential for different API prior to manufacture of solid lipid nanoparticles and nanostructured lipid carriers.     

辛芩颗粒联合糠酸莫米松鼻喷雾剂治疗儿童变应性鼻炎的临床研究

目的观察辛芩颗粒联合糠酸莫米松鼻喷雾剂治疗儿童变应性鼻炎的临床疗效。方法选取2015年3月—2016年12月在成都市妇女儿童中心医院就诊的变应性鼻炎患儿238例,随机分成对照组和治疗组,每组各119例。对照组患儿清晨鼻喷糠酸莫米松鼻喷剂,2喷/次,1次/d;治疗组患儿在对照组的基础上口服辛芩颗粒,5 g/次,2次/d。两组患儿均治疗30 d。评价治疗后两组患者临床疗效,同时比较治疗前后两组症状评分和体征评分以及IL-10和IgE水平改变。结果治疗后,对照组和治疗组的总有效率分别为78.15%、90.76%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患儿临床症状和体征评分均明显降低,同组比较差异具有统计学意义(P0.05);且治疗后治疗组患儿上述评分显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患儿IL-10水平显著升高,IgE水平显著降低,同组比较差异具有统计学意义(P0.05);且治疗组患儿IL-10和IgE水平明显优于对照组,两组比较差异具有统计学意义(P0.05)。结论辛芩颗粒联合糠酸莫米松鼻喷雾剂治疗儿童变应性鼻炎效果良好,能够有效的改善患儿的临床症状,且安全性较高,具有一定的临床推广应用价值。     

The role of patient training in the management of seasonal rhinitis and asthma: clinical implications

BACKGROUND: Allergic rhinitis is an inflammatory disease often associated with bronchial asthma. Intranasal corticosteroids and oral antihistamines are the first-choice drugs. Patient training is relevant to asthma management, but little is known about its impact on rhinitis. We evaluated the role of patient training in the treatment of allergic rhinitis and its effects on nasal and bronchial symptoms. METHODS: One hundred and one patients (M/F = 62/39, age range 12-62 years) with pollen-induced rhinitis (32 with concomitant mild asthma) were enrolled. They were randomized into three groups: A (n = 30) with drug therapy alone, B (n = 35) with drug therapy plus training on the use of nasal spray, and C (n = 36) the same as B plus a lesson on rhinitis and asthma. All patients received mometasone furoate nasal spray for 8 weeks as regular therapy, plus rescue medications on demand. Symptoms and drug consumption were evaluated during the pollen season. RESULTS: The rate of noncompliance/dropout was highest in the untrained patients (P = 0.001). No difference in nasal symptoms was seen among the three groups. On the other hand, group C had significantly fewer asthma symptoms (P = 0.02) and less albuterol use (P = 0.005) than group A. Moreover, the trained group globally used less rescue medication than the other groups (P = 0.02). CONCLUSIONS: Detailed training of patients seems to improve compliance with treatment, reduce concomitant asthma symptoms, and reduce the use of symptomatic drugs.     

Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo

BACKGROUND: Intranasal corticosteroids used with antibiotics are known to improve rhinosinusitis symptoms compared with antibiotic therapy alone. However, the efficacy of intranasal corticosteroid monotherapy for acute, uncomplicated rhinosinusitis is not established. OBJECTIVES: To evaluate efficacy and safety of mometasone furoate nasal spray (MFNS) versus amoxicillin and placebo in patients with acute, uncomplicated rhinosinusitis. METHODS: In this double-blind, double-dummy trial, subjects (> or =12 years; N = 981) were randomized to MFNS 200 microg once daily or twice daily for 15 days, amoxicillin 500 mg 3 times daily for 10 days, or respective placebo. Follow-up was 14 days. The primary efficacy endpoint was mean am/pm major symptom score over the treatment phase. Secondary efficacy endpoints included total symptom score. Safety assessments included disease recurrence during follow-up and adverse event monitoring. RESULTS: Mometasone furoate nasal spray 200 microg twice daily was significantly superior to placebo (P < .001) and amoxicillin (P = .002) at improving major symptom score. Starting on day 2, MFNS 200 microg twice daily improved total symptom score throughout treatment versus amoxicillin (P = .012) and placebo (P < .001). Global response to treatment was significantly greater with MFNS 200 microg twice daily versus amoxicillin (P = .013) and placebo (P = .001). Although significantly superior to placebo, MFNS 200 microg once daily was not superior to amoxicillin for the primary or secondary efficacy endpoints. All treatments were well tolerated with a similar incidence of adverse events. CONCLUSION: In patients with acute, uncomplicated rhinosinusitis, MFNS 200 microg twice daily produced significant symptom improvements versus amoxicillin and placebo, without predisposing the patient to disease recurrence or bacterial infection.     

抗菌功能性敷料联合糠酸莫米松乳膏治疗小儿湿疹的疗效观察

目的探讨抗菌功能性敷料联合糠酸莫米松乳膏治疗小儿湿疹的临床疗效。方法选取北京市海淀医院2016年1月—2017年7月接受治疗的92例小儿湿疹患者为研究对象,随机分为对照组和治疗组,每组各46例,对照组患儿涂抹糠酸莫米松乳膏,0.1 mg/次,每晚1次。治疗组患儿在对照组的基础上外敷抗菌功能性敷料,0.1 mg/次,1~3次/d。两组患者均连续治疗14 d。治疗后,观察两组的临床疗效,比较两组治疗前后临床症状、皮损程度评分和不良反应及复发情况。结果治疗后,对照组和治疗组的总有效率分别为84.78%、97.83%,两组总有效率比较差异有统计学意义(P0.05)。治疗后,两组临床症状和皮损程度评分均显著降低,同组治疗前后差异有统计学意义(P0.05);治疗后治疗组临床症状和皮损程度评分均显著低于对照组,两组比较差异有统计学意义(P0.05)。对照组和治疗组的复发率分别为19.57%、4.35%,两组复发率比较差异具有统计学意义(P0.05)。结论抗菌功能性敷料联合糠酸莫米松乳膏治疗小儿湿疹疗效显著,可明显改善患儿临床症状,安全性较高,具有一定的临床推广应用价值。     

卡介菌多糖核酸联合他扎罗汀等治疗寻常性银屑病疗效观察

目的观察卡介菌多糖核酸联合外用他扎罗汀及糠酸莫米松治疗寻常性银屑病临床疗效。方法患者随机分为两组。治疗组120例采用卡介菌多糖核酸2mL肌注,隔日1次,18次为1疗程;2mL肌注隔2日1次,18次为第2疗程;同时予他扎罗汀凝胶每晚外涂,糠酸莫米松乳膏隔日早晨外涂。对照A组80例仅肌注卡介菌多糖核酸,用法同治疗组;对照B组98例仅外涂他扎罗汀凝胶及糠酸莫米松乳膏,用法同治疗组。结果治疗组有效率91.66%,对照A,B组分别为86.25%,64.78%。治疗组与对照组比较差异有显著性(P1=0.0034,P2<0.0001)。结论卡介菌多糖核酸联合他扎罗汀凝胶及糠酸莫米松乳膏治疗寻常性银屑病疗效确切。     

Dose-ranging study of fluticasone furoate nasal spray for Japanese patients with perennial allergic rhinitis

ABSTRACT

Background: This study was designed to evaluate the efficacy and safety of fluticasone furoate nasal spray (FFNS), a novel enhanced-affinity intranasal corticosteroid, in Japanese patients with perennial allergic rhinitis (PAR), and to determine the optimal dose.

Methods: In this phase II, multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-ranging study, 240 patients (aged ≥ 16 years) received once-daily (od) treatment for 2 weeks with either FFNS 110 μg (n = 80), 220 μg (n = 81) or placebo (n = 79). Patients evaluated 3 nasal symptoms using a 4-point scale. Efficacy was assessed as the mean change from baseline in total nasal symptom score (TNSS).

Results: Treatment with FFNS resulted in a significantly greater decrease over the treatment period in the mean 3TNSS (sneezing, rhinorrhea, and nasal congestion; p < 0.001 each dose vs. placebo), compared with placebo. More patients receiving FFNS had a markedly or moderately improved impression of treatment than placebo recipients (48% and 49% for FFNS 110 μg and 220 μg, respectively, vs. 18% for placebo; p < 0.001). Nasal rhinoscopy findings revealed significant improvements in mucosal swelling of the inferior turbinate (110 μg: p = 0.004; 220 μg: p = 0.011) and amount of watery rhinorrhea (110 μg: p = 0.003; 220 μg: p < 0.001), compared with placebo. Both doses of FFNS were well tolerated.

Conclusions: Both FFNS 110 µg and 220 µg od were effective in alleviating nasal symptoms in Japanese patients with PAR over the 2-week duration of this study. FFNS 110 µg od was selected as the optimal dose for further evaluation in phase III clinical trials.     

复方布替萘芬乳膏在家兔体内的药动学研究

目的探索家兔外用复方布替萘芬乳膏的体内药动学评价方法。方法 6只家兔给予3 g复方布替萘芬乳膏,采用LC-MS/MS法同时测定家兔血浆中的布替萘芬和糠酸莫米松浓度。结果以LC-MS/MS法监测外用复方布替萘芬乳膏主要成分布替萘芬和糠酸莫米松通过皮肤吸收进入血液的药动学参数,布替萘芬Cmax为（16.16±7.15）ng/mL、Tmax为（10.5±7.3）h、AUC（0 T）为（131.1±51.07）ng h mL-1;糠酸莫米松Cmax为（0.707±0.439）ng/mL,Tmax为（6.7±8.7）h,AUC（0 T）为（2.891±1.368）ng h mL-1。结论外用乳膏同样可以药动学参数评估临床用药的安全性。本试验建立的LC-MS/MS同时测定血浆中布替萘芬和糠酸莫米松的方法,灵敏度高,符合透皮给药药动学研究要求。     

糠酸莫米松联合抗组胺药物对非变应性鼻炎的疗效观察

目的分析糠酸莫米松联合抗组胺药物治疗NAR的疗效。方法选择本院收治的NAR患者34例,应用糠酸莫米松联合抗组胺药物治疗。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语言评价量表评分比较,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为3.0%(1/33),鼻腔干燥发生率为3.0%(1/33)。结论糠酸莫米松联合抗组胺药物可以有效改善NAR患者的临床症状。