奥马珠单抗治疗2例高水平IgE过敏性哮喘患儿的用药监护

目的 探讨奥马珠单抗对高水平IgE过敏性哮喘患儿的临床疗效和安全性。方法 回顾性分析2020年8月至2021年5月期间,上海市儿童医院呼吸科收治的应用奥马珠单抗治疗的2例过敏性哮喘患儿的临床资料,并在结束治疗后进行定期药学随访,分析奥马珠单抗治疗剂量和疗程、治疗效果及药物不良反应情况。结果 2例患儿在接受奥马珠单抗治疗后哮喘症状控制满意,减少哮喘治疗过程中吸入激素使用剂量,鼻部症状减轻。2例患儿共接受奥马珠单抗皮下注射20次,未见不良反应,在结束治疗后定期药学随访,结果显示,患儿身体状况良好。结论 奥马珠单抗用于高水平IgE过敏性哮喘患儿的治疗,可以改善哮喘控制症状,长期安全性良好,但其合适的用药剂量和疗程尚需进一步经验积累。     

重度哮喘使用奥马珠单抗治疗无效的患者特征

目的了解重度哮喘使用奥马珠单抗治疗无效的患者特征。方法选择2018年3月至2021年2月接受奥马珠单抗治疗的118例重度哮喘患者作为研究对象,比较奥马珠单抗治疗有效组和无效组的临床特征,评估与奥马珠单抗治疗失败相关的因素,并分析奥马珠单抗治疗失败后接受替代治疗患者的临床结局。结果奥马珠单抗治疗有效组和无效组的治疗时间、使用糖皮质激素、合并嗜酸性粒细胞性慢性鼻-鼻窦炎(ECRS)以及合并嗜酸粒细胞性中耳炎(EOM)情况比较,差异有统计学意义(P<0.05);Logistic回归分析发现,合并ECRS、合并EOM为奥马珠单抗治疗失败的独立影响因素(P<0.05)。结论合并ECRS、EOM可能会导致重度哮喘患者使用奥马珠单抗治疗无效,建议此类患者考虑采用抗白介素(IL)-5抗体或抗IL-5Rα抗体治疗。     

舌下含服粉尘螨滴剂治疗86例变应性鼻炎疗效观察

目的评价舌下含服粉尘螨滴剂变应原疫苗治疗变应性鼻炎的疗效。方法将粉尘螨过敏为主的变应性鼻炎患者156例,分为实验组和对照组,实验组进行舌下含服粉尘螨滴剂治疗2年,观察治疗前及治疗后1年的各项临床症状评分,并进行综合评价。结果两组在治疗后1年在鼻部症状、体征、视觉模拟量表评分(VAS评分)及药物评分几方面有差异,均有统计学意义(P值均<0.01)。治疗期间无严重不良反应病例发生。结论经舌下含服粉尘螨滴剂治疗变应性鼻炎是一种安全有效的方法。     

孟鲁司特钠治疗学龄前儿童变应性鼻炎的疗效观察

目的观察孟鲁司特钠片剂口服治疗学龄前儿童变应性鼻炎的疗效。方法将2010年1月—2012年6月在本院耳鼻咽喉科门诊治疗的89例变应性鼻炎学龄前儿童随机分为两组。对照组（42例）给予糠酸莫米松鼻喷剂常规治疗;实验组（47例）在此基础上加用孟鲁司特钠口服。比较两组治疗后鼻部症状好转的差异,并于治疗结束12周后比较两组的复发情况。结果实验组在急性期鼻部症状控制及中期复发率情况两方面均优于对照组,差异有统计学意义（P〈0.05）;且无明显不良反应。结论口服孟鲁司特钠治疗学龄前儿童变应性鼻炎对急性期鼻部症状控制有一定意义,且能减少中期复发,对其远期疗效值得进一步研究。     

屋尘螨免疫治疗儿童变应性鼻炎—哮喘综合征的临床疗效观察

目的 评价屋尘螨特异性免疫治疗对儿童变应性鼻炎—哮喘综合征的临床疗效和安全性.方法 将2010年6月—2012年6月年该院哮喘门诊44例变应性鼻炎—哮喘综合征患儿分为随机观察组（24例）和对照组（20例）,两组均采用哮喘和变应性鼻炎常规治疗,观察组联合屋尘螨特异性免疫治疗,所有患儿在治疗开始和治疗3、6、9及12个月进行呼气峰流速测定、哮喘症状及鼻部症状评分.结果 （1）治疗3个月,两组患儿的呼气峰流速值有所升高,哮喘症状及鼻部症状评分有所下降,但差异无统计学意义（P＞0.05）.（2）治疗6、9、12个月,观察组患儿的呼气峰流速值较对照组均明显升高,哮喘症状及鼻部症状评分均明显下降,差异均有统计学意义（P＜0.05）.（3）观察组少数患儿出现轻微不良反应,无严重不良反应发生.结论 屋尘螨特异性免疫治疗在维持治疗阶段能明显改善儿童变应性鼻炎—哮喘综合征的症状及肺功能,不良反应少.     

奥马珠单抗治疗过敏性疾病及其相关进展

目的:归纳IgE单克隆抗体——奥马珠单抗在过敏性疾病治疗中的应用进展,同时介绍阻断IgE信号转导以治疗过敏性疾病的研究新进展。方法:查阅美国国立生物技术信息中心(NCBI)和相关专业学术期刊全文数据库1993-2013年有关奥马珠单抗以及阻断IgE信号转导以治疗过敏性疾病的研究文献,对相关研究进展作一整理归纳。结果与结论:奥马珠单抗抑制IgE和相关变应原介导的免疫反应,在哮喘、变应性鼻炎、过敏性皮肤疾病等过敏性疾病治疗中发挥了良好作用,具有良好的应用前景。通过阻断IgE信号转导以治疗过敏性疾病的策略也值得期待。     

粉尘螨滴剂对3～14岁支气管哮喘和过敏性鼻炎的疗效及安全性分析

目的评估舌下特异性免疫治疗药物＂粉尘螨滴剂＂治疗3～14岁过敏性哮喘及变应性鼻炎患儿的疗效和安全性。方法对78例3～14岁由粉尘螨过敏引起的过敏性哮喘和（或）变应性鼻炎患儿进行为期25周的脱敏治疗,记录治疗前后患儿的哮喘症状评分和鼻炎症状评分,统计分析疗效及安全性。结果治疗后患儿的哮喘症状评分和鼻炎症状评分较治疗前均显著下降,差异具有统计学意义（P〈0.01）。治疗期间出现7例次局部不良反应,1例次全身不良反应,未出现严重全身不良反应。结论舌下特异性免疫治疗粉尘螨滴剂是治疗儿童过敏性哮喘和变应性鼻炎的一种安全、有效的治疗方法。     

医药互动模式下注射用奥马珠单抗的合理用药分析

目的 分析注射用奥马珠单抗的使用情况,并提出改进和防范举措,促进合理用药。方法 通过医院信息系统收集2020年12月至2022年3月首都医科大学附属北京朝阳医院门诊使用注射用奥马珠单抗的处方记录,依据医药互动模式制订奥马珠单抗合理用药点评路径,从用药指征、用法用量和其他不适宜3个维度开展处方点评。结果 共收集2818条使用注射用奥马珠单抗的处方记录,涉及355例患者的就诊信息,主要诊断均为支气管哮喘。通过处方点评发现,注射用奥马珠单抗存在不合理用药17例（4.79%）,均为无适应证用药,即不符合将奥马珠单抗用于大剂量吸入性糖皮质激素,并联合长效β2受体激动剂等其他控制药物治疗后症状仍未得到控制,且血清总IgE水平升高的重度过敏性哮喘患者;注射用奥马珠单抗起始用药剂量和使用频次均按药品说明书要求,且给药途径及其他均未见不合理。结论 医药互动模式下的合理用药点评可以更好地促进注射用奥马珠单抗在哮喘患者中的合理使用。     

标准免疫治疗方案用于188例变应性鼻炎患者的疗效评价

目的探讨标准化尘螨变应原免疫治疗方案用于变应性鼻炎的临床疗效及安全性。方法选取2014年1月~2015年1月之间我院收治的188例变应性鼻炎患者作为研究对象,采用数字表法随机分为观察组和对照组各94例,对照组采用常规药物治疗,包括抗组胺药物、鼻用皮质类固醇等,观察组患者采用标准化尘螨变应原免疫治疗方案,两组患者均维持治疗1年,治疗结束后进行疗效评估及不良反应统计,并采用鼻结膜炎生活质量调查问卷(RQLQ)调查对比两组患者治疗前后的生活质量。结果观察组患者总有效率为88.3%,显著高于对照组的54.3%,差异具有统计学意义(χ2=7.451,P0.05);观察组患者共进行治疗期间共3例出现I级全身性反应,不良反应发生率为6.4%,但所有不良反应病例均经药物治疗后迅速缓解,对照组未发生明显全身性反应,两组对比无显著差异(χ2=1.947,P0.05);治疗前两组患者的各项RQLQ评分对比均无显著差异,治疗后观察组患者的活动、睡眠、行为、鼻部症状、眼部症状、情感、总体生活质量评分均显著低于对照组,差异具有统计学意义(P0.05)。结论标准免疫治疗方案用于变应性鼻炎患者的疗效确切,能够有效改善患者的临床症状,提高患者的生活质量,且安全性较好,值得在临床上推广和应用。     

斯奇康在常年性变应性鼻炎治疗中的效果分析

目的：探讨斯奇康注射液治疗常年性变应性鼻炎的疗效。方法：收集本院2008年10月～2010年10月收治的变应性鼻炎患者80例,随机分为2组,治疗组局部鼻腔应用鼻用类固醇（辅舒良）联合应用斯奇康注射液;对照组单纯局部鼻腔应用鼻用类固醇（辅舒良）,比较两组症状变化及血清IgE变化。结果：停止治疗1个月,两组有效率差异无统计学意义（P〉0.05）;停止治疗2、3个月后两组对比,有效率差异有统计学意义（P〈0.05）,治疗前血清IgE比较差异无统计学意义。治疗后差异有统计学意义（P〈0.05）。在整个治疗过程中,部分患者除有鼻部不适外,均无不良反应。结论：斯奇康注射液佐治常年性变应性鼻炎的疗效是肯定的。     

舌下含服标准化粉尘螨滴剂治疗儿童变应性鼻炎的临床评价

目的评价舌下含服标准化粉尘螨变应原滴剂治疗儿童变应性鼻炎的疗效及安全性。方法采用前后对照,比较125例粉尘螨变应性鼻炎儿童患者在接受1年免疫治疗前、后的症状评分、药物评分,评价舌下免疫治疗的疗效;计算不良反应发生率,评价其安全性。结果免疫治疗1年后,125例患儿症状评分和药物评分较治疗前均明显减少（P〈0．01）,有效率81．6％;其中6例（4．8％）出现局部不良反应,未出现严重全身不良反应。结论舌下含服标准化粉尘螨变应原滴剂是治疗尘螨引起的儿童变应性鼻炎的一种有效治疗方法,并具有较好的安全性。     

Second generation antihistamines in the treatment of seasonal allergic rhinitis due to parietaria and cypress pollen

Second generation antihistamines have been employed in the treatment of seasonal allergic rhinitis for many years. However, their effects on two distinctive Mediterranean allergic conditions, viz. Parietaria pollinosis and cypress pollinosis, have been scarcely investigated, so far. A comparative efficacy and side effect trial of astemizole and terfenadine in the treatment of seasonal allergic rhinitis due to either Parietaria or cypress pollen was carried out in 27 adult patients, according to a double-blind, double-dummy parallel-group design. Airborne pollen monitoring allowed comparison of symptom scores with pollen counts. Seven patients (26%) withdrew, due to poor symptom control. In contrast, in a subset of 15 patients who completed the trial, treatment led to a substantial and statistically significant decline in symptom severity in both the astemizole and the terfenadine study group. However, no statistically significant inter-group differences could be detected.     

盐酸氮（艹卓）斯汀与氯雷他定随机对照治疗变应性鼻炎的临床试验

目的 与对照药氯雷他定片比较,评价盐酸氮(?)斯汀片治疗变应性鼻炎的临床疗效及安全性。方法 用多中心、随机、双盲、平行对照的临床试验,试验组变应性鼻炎病人58例,每日服用盐酸氮(?)斯汀片2次,每次1 mg;对照组病人63例,每日口服氯雷他定片1 0 mg和安慰剂各1次。两组均连续服药14天。对治疗前后的喷嚏、流涕、鼻堵、鼻痒及鼻腔情况进行评分。结果 盐酸氮革斯汀片和氯雷他定片治疗变应性鼻炎的有效率分别为87.93％,82.54％;药物不良反应发生率分别为8.62％,14.06％。经统计学检验,两者差异均无显著性。 结论 盐酸氮(?)斯汀片治疗变应性鼻炎安全有效。     

盐酸氮斯汀与氯雷他定随机对照治疗变应性鼻炎的临床试验

目的与对照药氯雷他定片比较,评价盐酸氮     

Anti-IgE therapy with omalizumab in asthma and allergic rhinitis

The pharmacology, efficacy, dosage, adverse effects, and economics of anti IgE (omalizumab) are discussed. Omalizumab is the generic name for the human/murine chimeric (recombinant humanized) monoclonal IgG antibody. Anti-IgE prevents IgE from attaching to effector cells, and thereby blunts IgE-mediated inflammatory responses. After subcutaneous administration its absorption is slow, reaching peak concentration in serum after an average of 7-8 days. At recommended doses, serum free IgE levels decrease within 1 hour following the first dose and are maintained between doses. Dose and dosing frequency are adjusted according to body mass and serum total IgE concentration before the start of treatment. Omalizumab administered subcutaneously is an effective treatment for add-on therapy in patients with poorly controlled, moderate-to-severe allergic asthma and allergic rhinitis (adults and adolescents > 12 years). It reduces the requirement for inhaled corticosteroids while protecting against disease exacerbation. Omalizumab is well tolerated, but the safety profile requires long-term assessment in adults as well as in children.     

过敏性鼻炎68例临床观察

目的：评价富马酸卢帕他定治疗过敏性鼻炎的临床疗效。方法将2009年3月～2012年2月我院收治的68例过敏性鼻炎患者分为观察组和对照组各34例,其中观察组采用富马酸卢帕他定治疗,对照组采用氯雷他定分散片治疗,比较两组患者的临床疗效及不良反应发生情况。结果观察组总有效率为91.2%,对照组总有效率为61.8%,两组比较差异有统计学意义（P＜0.05）,观察组有1例,对照组有5例出现不良反应,差异有统计学意义。结论富马酸卢帕他定治疗过敏性鼻炎疗效好,安全性高,值得在临床上予以推广。     

Evaluation of omalizumab from a health plan perspective

OBJECTIVE: To review the pathophysiology of allergic asthma and information on the pharmacology, clinical efficacy, safety profile, and direct drug costs for omalizumab to provide a basis for a defined role of this agent in allergic asthma therapy in managed care organizations. SUMMARY: Omalizumab is a monoclonal antibody targeting the high-affinity receptor binding site on human immunoglobulin E (IgE). When bound by omalizumab, IgE does not bind to basophils. As a result, degranulation is attenuated and allergic asthma symptoms are reduced. In asthma trials, omalizumab reduced inhaled corticosteroid and rescue medication requirements and improved asthma control and asthma quality of life in moderate-to-severe allergic asthmatics with disease poorly controlled by inhaled corticosteroids. Omalizumab has generally been well tolerated. However, injection site reactions occur in nearly 1 of every 2 patients, a problem that generally becomes less with continued dose administration. Severe injection site reactions are reported in 12% of patients. Other adverse events commonly reported in clinical trials include viral infections (23%), upper respiratory infections (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). Because the acquisition cost of omalizumab is high (generally $15,000 to $44,000 per patient per year, before contractual discounts), its use is cost-prohibitive in all but the most severe, poorly controlled allergic asthmatic patients who are utilizing large amounts of emergency health care resources to manage exacerbations. Experience with use of this drug beyond 52 weeks is lacking. CONCLUSION: Although omalizumab has demonstrated efficacy and safety in adults and adolescents with uncontrolled moderate-to-severe allergic asthma, its use should be restricted to a narrowly defined population of allergic asthmatics who utilize large amounts of health care resources. If targeted only toward this population, cost-of-care studies suggest that the high cost of this product in these patients could be offset by savings resulting from the less frequent use of high-intensity medical services for asthma exacerbations. The use of omalizumab beyond 52 weeks needs evaluation.     

Meta-analysis of azelastine nasal spray for the treatment of allergic rhinitis

STUDY OBJECTIVE: To systematically review the efficacy of azelastine nasal spray for the treatment of allergic rhinitis. DESIGN: Meta-analysis of published randomized controlled trials reported in English. DATA SOURCE: Published literature from the PubMed-MEDLINE database. PATIENTS: Patients aged at least 12 (United States) or 16 years (Europe) with allergic rhinitis or nonallergic vasomotor rhinitis. MEASUREMENTS AND MAIN RESULTS: A global assessment of efficacy was used to estimate the number needed to treat for azelastine nasal spray compared with placebo or active comparators. The total symptom score was used to compare the effect size between azelastine and placebo. In five comparisons of azelastine and placebo, azelastine was most efficacious, with a summary number needed to treat of 5.0 (95% confidence interval [CI] 3.3-10.0). In reviewing 11 studies of azelastine versus active comparators, we found no significant difference between azelastine and active comparators (number needed to treat 66.7, 95% CI 14.3 to infinity to 25). Azelastine was more efficacious than placebo in terms of total symptom score (effect size of 0.36, 95% CI 0.26-0.46). CONCLUSION: Azelastine nasal spray was more efficacious than placebo in the treatment of allergic rhinitis. No significant differences were observed between azelastine and active comparators for the treatment of allergic rhinitis; however, when azelastine was compared with oral antihistamines as monotherapy, the trend favored azelastine. Because azelastine appears to be as efficacious as oral antihistamines, the choice of treatment for seasonal allergic rhinitis should depend on the patient's preference regarding the route of administration, adverse effects, and the cost of the drug.     

Omalizumab

* Omalizumab is a recombinant humanised monoclonal antibody which specifically binds to the C epsilon3 domain of immunoglobulin (Ig) E, the site of high-affinity IgE receptor binding. * Improvements in asthma symptoms and health-related quality-of-life, and a significant reduction in the frequency of asthma exacerbations were seen in allergic asthmatic patients treated with omalizumab. * Omalizumab was also effective in the treatment of children with allergic asthma demonstrating improvements in health-related quality-of-life and significant dosage reductions of inhaled corticosteroids. * Administration of omalizumab to patients with allergic rhinitis resulted in a rapid dose-dependent suppression of serum free IgE levels. * Omalizumab significantly improved health-related quality-of-life and nasal symptoms in patients with seasonal allergic rhinitis. Antihistamine requirements were also significantly reduced following treatment. * Adverse events were infrequent in clinical trials of omalizumab, and not significantly different from placebo. The most frequent drug-related event was mild to moderate urticaria.