鱼腥草鼻用喷雾剂急性毒性、局部刺激性及过敏性的实验研究

目的观察鱼腥草鼻用喷雾剂的急性毒性、黏膜刺激性以及皮肤过敏反应。方法参照中药新药研究指导原则,采用最大给药量试验观察鼻腔给药后动物短期内出现的急性毒性反应及其程度;结合一般情况观察与组织病理学检查综合判断呼吸道黏膜发生的局部刺激性反应;对豚鼠皮肤多次局部涂抹致敏,观察其过敏反应。结果药物鼻腔给药后对大鼠的最大给药量为8.0 g.kg-1,腹腔给药对小鼠的最大给药量为50.0 g.kg-1,短期内均未见毒性反应及死亡情况;局部刺激性实验中动物一般状况良好,未发生全身反应甚至死亡情况,给药局部鼻黏膜未见红斑、水肿等刺激反应,组织病理学检查发现鼻、喉、气管、支气管等呼吸道黏膜未见损伤性变化及大量炎细胞浸润;对豚鼠皮肤的多次刺激致敏试验显示药物具有轻度致敏性。结论鱼腥草鼻用喷雾剂鼻腔局部用药无明显毒性及刺激性,其临床使用安全可靠。     

曲安奈德鼻喷雾剂治疗过敏性鼻炎的临床研究

目的评价曲安奈德鼻喷雾剂治疗过敏性鼻炎的临床疗效及安全性,方法以丙酸倍氯米松鼻喷雾剂(商品名伯克纳)为对照药,采用开放性、随机对照、多中心临床试验的方法治疗过敏性鼻炎160例.剂量用法曲安奈德鼻喷雾剂,鼻腔喷入,每次每鼻孔2揿,每日1次,每揿55μg;丙酸倍氯米松鼻喷雾剂,鼻腔喷入,每次每鼻孔2揿,每日2次,每揿50μg.疗程均为2周.结果曲安奈德鼻喷雾剂与丙酸倍氯米松鼻喷雾剂临床疗效评价例数分别为100例和60例,两药临床有效率分别为8 8%和90%,药物不良反应发生率分别为13%和10%.以上结果经统计学处理均无显著差异(P＞0.05).结论曲安奈德鼻喷雾剂治疗过敏性鼻炎安全有效.     

抗组胺鼻喷雾剂与糖皮质激素鼻喷雾剂对于常年性变应性鼻炎的疗效

目的比较抗组胺鼻喷雾剂和糖皮质激素鼻喷雾剂对于常年性变应性鼻炎的疗效。方法本实验将92例常年性变应性鼻炎患者随机分为两组,采取双盲、安慰剂干预及交叉设计的方法比较抗组胺鼻喷雾剂与安慰剂和糖皮质激素鼻喷雾剂与安慰剂的疗效。两个实验组都采用Balaam设计随机分为4个亚组,即AA组(药物-药物),PA组(安慰剂-药物),AP组(药物-安慰剂)和PP组(安慰剂-安慰剂)。利用调查日志记录症状变化情况。应用SAS中的PROC MIXED程序对数据进行分析。结果与安慰剂相比较糖皮质激素鼻喷雾剂较抗组胺鼻喷雾剂在缓解除流涕以外的所有症状方面疗效更显著。在调查日志中,与安慰剂相比较糖皮质激素鼻喷雾剂较抗组胺鼻喷雾剂在缓解除白天嗜睡以外的所有症状方面疗效更显著。基于调查日志中的数据,糖皮质激素鼻喷雾剂和抗组胺鼻喷雾剂在改善睡眠如同白天嗜睡和鼻塞方面一样疗效更优。结论糖皮质激素鼻喷雾剂在睡眠、白天嗜睡、打喷嚏、眼部及鼻部搔痒、以及鼻塞等症状上效果优于抗组胺鼻喷雾剂。因此,对于缓解变应性鼻炎症状糖皮质激素鼻喷雾剂比抗组胺鼻喷雾剂等有效。糖皮质激素鼻喷雾剂可以作为常年性变应性鼻炎的一线用药。     

鼻炎通窍喷雾剂的主要药效学研究

目的:根据鼻炎通窍喷雾剂的功能与主治,通过动物实验,观察其主要药理作用,为临床使用提供依据。方法:选用小鼠耳廓肿胀模型和大鼠肉芽肿模型,观察鼻炎通窍喷雾剂对急、慢性炎症的影响;通过体内抗菌实验,观察鼻炎通窍喷雾剂的抗菌作用;建立豚鼠变应性鼻炎模型,观察致敏豚鼠的行为学改变。结果:鼻炎通窍喷雾剂能抑制大鼠塑料环肉芽肿形成;减轻二甲苯所致的小鼠耳廓肿胀度;能保护金黄色葡萄球菌感染的小鼠,降低其死亡率;能改善变应性鼻炎豚鼠的鼻部症状。结论:鼻炎通窍喷雾剂具有抗炎、抗菌和治疗变应性鼻炎的作用。     

曲安奈德鼻喷雾剂治疗变应性鼻炎疗效观察

目的：观察曲安奈德鼻喷雾剂治疗变应性鼻炎的临床疗效。方法：回顾性分析我院2011年11月～2013年12月收治的96例变应性鼻炎患者的临床资料,随机分为观察组和对照组,对照组给予氯雷他定片治疗,观察组在对照组的基础上给予曲安奈德鼻喷雾剂治疗,观察两组的疗效。结果：观察组总有效率（95.83%）高于对照组（79.17%）,差异有统计学意义（P<0.05）。结论：曲安奈德鼻喷雾剂治疗变应性鼻炎疗效显著,安全性好,值得临床推广。     

雷诺考特鼻喷雾剂治疗变应性鼻炎疗效分析

目的观察雷诺考特鼻喷雾剂治疗变应性鼻炎的临床疗效。方法把确诊为变应性鼻炎的160例患者随机分为2组,治疗组80例,以雷诺考特鼻喷雾剂鼻腔喷入,每次每侧鼻孔1喷(每喷64μg),两个鼻孔共2喷,早晚各1次,每天总量256μg,疗程为1个月。对照组丙酸倍氯米松鼻喷雾剂,鼻腔喷入,每次每鼻孔2喷,每日2次,每喷50μg。结果治疗组总有效率为97.5%,对照组总有效率为85%,两组比较差异有统计学意义(P<0.05)。结论雷诺考特鼻喷雾剂治疗变应性鼻炎安全有效。     

布地奈德鼻喷雾剂治疗过敏性鼻炎的临床疗效观察

目的探究布地奈德鼻喷雾剂对过敏性鼻炎的临床治疗效果并分析。方法选择本院2011年11月~2014年9月这近3年来收治的289例确诊为过敏性鼻炎的患者,给予每个过敏性鼻炎患者布地奈德鼻喷雾剂以进行治疗,观察并认真记录治疗前的鼻炎症状和严重程度和治疗后患者鼻炎症状消失的时间以及临床治疗效果。结果通过研究发现,患者鼻炎症状的消失时间一般为4~11d,而且我们还发现,症状消失时间和患者鼻炎症状的严重程度有关,鼻炎症状越严重,鼻炎症状消失的时间越长。临床治疗的总有效率达到了99%,在治疗过程中未发现严重不良反应,仅出现7例鼻干燥和3例鼻轻微出血等轻微的副反应,但是这些副反应症状随着治疗时间增加症状消失。结论布地奈德鼻喷雾剂对治疗过敏性鼻炎的临床治疗效果明显,而且在较短的治疗周期内就可以明显使患者临床症状好转,不良反应发生率也较低,在临床上值得广泛推广。     

雷诺考特鼻喷雾剂治疗变应性鼻炎的疗效观察

目的 观察雷诺考特鼻喷雾剂治疗变应性鼻炎的临床疗效.方法 根据诊断标准确诊为变应性鼻炎的患者随机分为两组,治疗组以雷诺考特鼻喷雾剂鼻腔喷入,每次每侧鼻孔1喷(每喷64ug),两个鼻孔共2喷,早晚各1次,每天总量25 6ug,疗程为1个月.对照组口服赛梗定2mg,每日2次或氯雷他定10mg,每日1次,疗程为1个月.结果 治疗组总有效率为90%,对照组总有效率为80%.结论 雷诺考特鼻喷雾剂治疗变应性鼻炎安全有效.     

鼻郎鼻腔喷雾器与布地奈德鼻喷雾剂联合治疗变应性鼻炎的临床观察

目的探讨鼻郎鼻腔喷雾器与布地奈德鼻喷雾剂联合治疗变应性鼻炎的临床疗效。方法选择2011年1月至2012年12月在我院治疗的变应性鼻炎患者153例,随机分为治疗组76例和对照组77例,对照组每日用布地奈德鼻喷雾剂喷鼻,治疗组在此基础上先用鼻郎鼻腔喷雾器喷鼻,二组患者均连用4周。结果治疗组一般用药当天起效,症状体征完全消失最短1周,对照组一般用药第2天起效,症状体征完全消失最短10d,二组均未见明显不良反应发生,治疗组总有效率为94.7%,高于对照组的84.4%,差异具有统计学意义(P<0.05)。结论鼻郎鼻腔喷雾器与布地奈德鼻喷雾剂联用治疗变应性鼻炎见效快,有效率明显高于单用布地奈德治疗,值得临床推广。     

盐酸纳洛酮鼻腔喷雾剂的药效学研究

目的:评价盐酸纳洛酮鼻腔喷雾剂的药效。方法:以新西兰大耳白兔为动物模型,通过给予中毒剂量的盐酸二氢埃托啡建立阿片类药物中毒模型,考察高、中、低三个浓度盐酸纳洛酮鼻腔喷雾剂的药效,并与肌内注射及静脉注射盐酸纳洛酮注射液的救治效果进行比较。结果:盐酸纳洛酮鼻腔喷雾剂治疗效果与肌注相当。结论:盐酸纳洛酮鼻腔喷雾剂起效迅速,救治效果显著,使用方便,特别适合危重症病人的自救与互救。     

敏停喷鼻剂对TDI致豚鼠过敏性鼻炎模型的影响

目的研究敏停喷鼻剂对豚鼠过敏性鼻炎模型的影响。方法用TDI致豚鼠过敏性鼻炎造模型，观察敏停喷鼻剂对过敏性鼻炎模型的鼻部过敏症状以及鼻黏膜病理组织形态学的影响。结果敏停喷鼻剂能明显减轻豚鼠过敏性鼻炎模型鼻部过敏症状以及鼻黏膜上皮炎细胞的浸润。结论敏停喷鼻剂对过敏性鼻炎可能具有较好的疗效。     

Fluticasone furoate nasal spray in allergic rhinitis

Fluticasone furoate is a novel glucocorticoid developed for the treatment of allergic rhinitis and other inflammatory diseases. Fluticasone furoate demonstrates high systemic clearance, low oral bioavailability and low absolute bioavailability after intranasal administration (<0.5%). The drug possesses a high receptor affinity. Fluticasone furoate is given once daily at a dose of 110 microg. Clinical studies tested the efficacy of fluticasone furoate in seasonal allergic rhinitis and perennial allergic rhinitis. Patients randomized to the drug experienced significant alleviation in their nasal and ocular symptoms as well as clinically relevant improvement in quality of life. The drug is well tolerated and has a good safety profile owing to reduced systemic exposure. Thus, fluticasone furoate might represent a single treatment option for nasal and ocular symptoms of allergic rhinitis.     

Ciclesonide nasal spray: in allergic rhinitis

Ciclesonide nasal spray delivers the corticosteroid ciclesonide as a hypotonic spray via a metered-dose manual pump. Systemic exposure to ciclesonide and its active metabolite desisobutyryl-ciclesonide is low after intranasal administration. High protein binding (approximately 99%) and rapid first-pass clearance further reduce systemic exposure to the drug. In well designed trials, intranasal ciclesonide 200 microg once daily for 2-4 weeks was more effective than placebo in terms of improving nasal symptoms in adolescents and adults with moderate to severe seasonal allergic rhinitis. Quality of life measures were statistically significantly improved in ciclesonide relative to placebo recipients during the first 2 weeks of therapy. Similarly, in adolescents and adults with moderately severe perennial allergic rhinitis, ciclesonide 200 microg once daily was more effective than placebo in terms of reducing nasal symptoms in well designed trials of 6 weeks' and 1 year's duration. Improvements relative to placebo in quality of life measures were not considered clinically relevant. Ciclesonide nasal spray was generally well tolerated in these clinical trials; most adverse events were mild to moderate in intensity.     

曲安奈德喷雾剂对变应性鼻炎的作用

目的研究曲安奈德鼻腔局部给药对实验性变应性鼻炎动物模型的治疗作用及对组胺致大鼠鼻气道阻力增加的缓解作用。方法以实验性变应性鼻炎模型豚鼠和组胺致鼻气道阻力增加模型大鼠为试验对象 ,以豚鼠鼻腔分泌物量、喷嚏次数、搔鼻次数、鼻组织学及大鼠鼻气道阻力为指标 ,全面考察曲安奈德喷雾剂对变应性鼻炎的作用。结果曲安奈德鼻喷雾剂 (5 0、10 0、2 0 0 μg·kg-1,对卵蛋白致敏实验性变态反应性鼻炎豚鼠模型的各种变应性鼻炎的症状和体症均有明显改善作用 ;与模型对照组比较 ,各给药组动物鼻腔分泌物量、喷嚏次数、抓鼻次数明显减少 ,并可对抗组胺所致大鼠鼻气道阻力的增加。结论曲安奈德鼻喷雾剂鼻腔局部给药对实验性变应性鼻炎有显著改善作用     

Flunisolide nasal spray for perennial rhinitis in children.

Twenty-seven children with perennial rhinitis entered a double-blind cross-over study comparing nasal sprays of flunisolide---a new topical corticosteroid---and placebo. Symptoms were assessed over two consecutive monthly periods with each treatment. Weekly diary cards, monthly clinical assessments, and end-of-trial preferences all favoured the active drug. At the end of the trial 20 patients preferred the treatment month with flunisolide, four preferred the placebo month, and two rated the periods equally. Side effects were mild, the commonest being transient nasal stinging. Seventeen children who derived benefit from flunisolide continued with the treatment for a six-month open-study period. Many reduced the dosage from three times to twice or once daily without losing benefit. The effect of flunisolide on the pituitary-adrenal axis was assessed in seven children by measuring the 0900 blood cortisol concentrations at two-month intervals over the six months. No effect was observed. The results show that flunisolide is effective and safe for the treatment and prophylaxis of perennial rhinitis in children.     

辅舒良水溶性鼻喷雾剂治疗变应性鼻炎的疗效观察

目的　观察辅舒良 (丙酸氟替卡松 )水溶性鼻喷雾剂对常年性和季节性变应性鼻炎的临床疗效。方法　按随机抽样的方法对 36例 10～ 6 0岁常年性和季节性变应性鼻炎患者使用辅舒良水溶性鼻喷雾剂治疗 ,于治疗前、治疗后 2、4周各项指标观察记分。结果　 36例在治疗后 2、4周平均记分均明显降低 ,统计学分析差异均有显著性 (P均 <0 0 1) ;治疗 2周后总有效率高达 10 0 % ,无 1例发生明显的毒副反应。结论　辅舒良水溶性鼻喷雾剂使用方便 ,起效快 ,效果好 ,无明显毒副作用 ,是治疗变应性鼻炎的全新选择     

曲安奈德鼻喷雾剂治疗变应性鼻炎的疗效观察

目的观察曲安奈德鼻喷雾剂对变应性鼻炎的临床疗效。方法用曲安奈德鼻喷雾剂治疗42例12-60岁常年性变应性鼻炎患者,治疗时间1个月。在治疗前以及治疗后1周、1个月、6个月分别观察记录并评分。结果42例在治疗后1周、1个月、6个月各项观察指标记分均明显降低,分析差异有统计学意义（P均〈0.05）;治疗后1周、1个月、6个月的有效率有统计学差异（P〈0.05）。无1例发生明显的毒副反应。结论曲安奈德鼻喷雾剂是治疗过敏性鼻炎安全、有效的药物。     

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.     

右布地奈德鼻喷雾剂治疗过敏性鼻炎的临床对照研究

目的:对右布地奈德鼻喷雾剂治疗过敏性鼻炎的有效性和安全性进行评价,并与布地奈德鼻喷雾剂比较。方法:采用多中心、随机、开放、平行对照的临床试验,符合入选标准的过敏性鼻炎患者共222例,分成2组:右布地奈德组(试验组)110例,布地奈德组(对照组)112例。试验组给予右布地奈德鼻喷雾剂,25μg/喷,每次每个鼻孔2喷,早晚各1次;对照组给予布地奈德鼻喷雾剂,64μg/喷,每次每个鼻孔1喷,早晚各1次。2组均连续用药14d。疗效评价以症状积分下降指数作为主要指标,生活质量改善程度作为次要指标。结果:试验组和治疗组相比,症状积分下降指数、生活质量改善程度、不良反应发生率均相似,即0.78±0.24,0.76±0.23;96.4%,94.6%;以及13.6%,14.3%。结论:右布地奈德鼻喷雾剂治疗过敏性鼻炎与布地奈德鼻喷雾剂同样安全有效。