鼻渊通窍颗粒联合地氯雷他定治疗过敏性鼻炎的临床效果

目的 探讨鼻渊通窍颗粒联合地氯雷他定治疗过敏性鼻炎的临床效果.方法 选取2018年6月至2020年1月收治的130例过敏性鼻炎患者作为研究对象,根据随机数字表法将其分为对照组和研究组,各65例.对照组给予地氯雷他定治疗,研究组在对照组基础上给予鼻渊通窍颗粒治疗.比较两组的临床效果.结果 研究组的治疗总有效率为95.38％,高于对照组的81.54％(P<0.05).治疗1个月后,两组的SFAR、RQLQ评分均较治疗前降低,且研究组低于对照组(P<0.05).治疗1个月后,两组的两侧鼻腔总阻力及IL-4水平均较治疗前降低,IL-12水平均较治疗前升高,且研究组优于对照组(P<0.05).治疗1个月后,两组的不良反应总发生率无明显差异(P>0.05).结论 鼻渊通窍颗粒联合地氯雷他定治疗过敏性鼻炎的效果显著,能够减轻症状,提高患者生活质量,改善鼻腔生理功能和炎症反应,且不增加不良反应,值得临床推广和应用.     

How to prescribe antihistamines for chronic idiopathic urticaria: desloratadine daily vs PRN and quality of life

Background:  Chronic idiopathic urticaria (CIU) impairs quality of life (QoL). Currently, no consensus exists regarding how second-generation H₁-antihistamines (proven to control CIU symptoms) should be taken long-term: as daily treatment or only when symptoms return (PRN). We sought to determine which regimen improves or better maintains QoL in CIU: desloratadine (DL) daily or PRN.
Methods:  Subjects with CIU initially responding to DL 5 mg/day for 4 weeks were randomized for an additional 8 weeks, to DL 5 mg/day (arm 1: 'continuous', n  = 46) or to DL only on days when urticarial wheals were present (arm 2: "PRN", n  = 60). To ensure blinding, treatment was presented in both arms as a combination of daily treatment (arm 1: DL; arm 2: placebo), plus a "rescue" tablet (arm 1: placebo; arm 2: DL) to be taken only in case of symptoms. The main outcome measure was QoL assessed by the VQ-Dermato, a validated French QoL instrument, and the Dermatology Life Quality Index (DLQI).
Results:  At 4 and 8 weeks after randomization, subjects taking continuous DL showed statistically significant improvements in VQ-Dermato Global Index score ( P  = 0.001 and P  = 0.016, respectively) and dimension scores for daily living activity, mood state, and social functioning vs subjects taking DL PRN. Improvement in DLQI score at Week 4 was also significantly greater with continuous DL ( P  = 0.001).
Conclusion:  Continuous daily therapy with DL 5 mg is a better regimen than PRN treatment to maintain or improve QoL in subjects with CIU.     

H1‐antihistamines and urticaria: how can we predict the best drug for our patient?

Urticaria, and especially chronic spontaneous urticaria (CSU), is a difficult condition to treat. Consequently, clinicians need to use the best H₁‐antihistamines currently available and the pharmaceutical industries need to keep developing H₁‐antihistamines that are more effective than the ones we have today. To do this we need to be able to compare the clinical efficacy of both established and new drugs. Obviously, the ideal way to do this is to use head‐to‐head studies in CSU. However, such studies are extremely expensive and, in the case of novel molecules, have ethical and logistical problems. Consequently, we need to have predictive models. Although determination of Ki, an indicator of the in vitro potency of an H₁‐antihistamine, may help in the initial selection of candidate molecules, the large differences in volume of distribution and tissue accumulation in humans, precludes this from being a good predictor of clinical efficacy in CSU. From the data reviewed in this article, especially the direct comparative data of desloratadine and levocetirizine in weal and flare studies and CSU, weal and flare response would appear to be the best indicator we have of effectiveness of H₁‐antihistamines in clinical practice. However, it must be pointed out that the conclusion is, essentially, based on detailed comparisons of two drugs in studies sponsored by pharmaceutical companies. Consequently, to confirm the conclusions of this review, a multicentre study independent from the influence of pharmaceutical companies should be commissioned to compare the speed of onset and effectiveness of desloratadine, fexofenadine and levocetirizine in chronic spontaneous urticaria and against histamine‐induced weal and flare responses in the same patients so that we have a clear understanding of the predictive value of our models.     

氮卓斯汀鼻喷剂联合地氯雷他定治疗变应性鼻炎疗效的Meta分析

目的 应用Meta分析的方法分析氮卓斯汀鼻喷剂联合地氯雷他定治疗变应性鼻炎的疗效。方法 检索的数据库：中文数据库包括CNKI、万方、VIP、CBM等,英文数据库包括PubMed、Embase、Medline、Cochrane等。制定综合检索式,选用纽卡斯尔-渥太华量表（Newcastle-Ottawa Scale,NOS）进行质量评估,使用RevMan5.3软件对本次研究的数据进行处理,统计学效应指标选用RR值和95% CI,I²和P值为异质性检验的指标,然后进行敏感性分析、亚组分析、发表偏倚评估。其中发表偏倚评估使用Egger's法,如有必要使用剪补法进一步分析。结果 氮卓斯汀鼻喷剂联合地氯雷他定组与氮卓斯汀鼻喷剂组比较,Z=8.18（P<0.000 01）、RR（95% CI）：1.21（1.16,1.27）,差异有统计学意义（P<0.05）。亚组分析显示A组,Z=5.62（P<0.000 01）、RR（95% CI）：1.18（1.12,1.26）,差异有统计学意义（P<0.05）。B组Z=3.62（P=0.000 3）、RR（95% CI）：1.19（1.08,1.31）,差异有统计学意义（P<0.05）。C组Z=4.91（P<0.000 01）、RR（95% CI）：1.33（1.19,1.50）,差异有统计学意义（P<0.05）。敏感性分析示Z=6.27（P<0.000 01）、RR（95% CI）：1.19（1.13,1.26）,差异有统计学意义（P<0.05）。结论 氮卓斯汀鼻喷剂联合地氯雷他定比单一使用氮卓斯汀鼻喷剂治疗变应性鼻炎有更好的疗效。     

窄谱中波紫外线联合地氯雷他定治疗泛发性皮炎湿疹的临床疗效观察#br#

目的：评价窄谱中波紫外线联合地氯雷他定治疗泛发性皮炎湿疹的疗效和安全性。方法：采用非随机同期对照研究方法,将114例泛发性皮炎湿疹患者分为光疗组和激素治疗组,各57例。光疗组应用窄谱中波紫外线联合口服地氯雷他定片,激素治疗组外用糠酸莫米松软膏联合口服地氯雷他定片。光疗组在治 疗2、4及8周进行观察记录,激素治疗组在治疗2及4周进行观察记录。治疗结束后进行疗效评分和有效率评 价。结果：在治疗2周时,2组比较,激素治疗组疗效评分中位数（3）高于光疗组疗效评分中位数（2）（P＜0.05）;激素治疗组有效率（为38.6%）高于光疗组（为12.3%）（P＜0.05）。在治疗4周时,光疗组疗效评分为4,激素治疗组疗效评分中位数为5（P＞0.05）;光疗组有效率为59.6%,激素治疗组有效率为56.1%（P＞0.05）,2组比较差异无统计学意义（P＞0.05）。光疗组2周（2）、4周（4）及8周（6）的疗效评分两两比较差异有统计学意义（P＜0.05）;2周（12.3%）、4周（59.6%）及8周（84.2%）的有效率两两比较差异有统计学意义（P＜0.05）。 结论：窄谱中波紫外线联合地氯雷他定治疗泛发性皮炎湿疹安全有效。     

地氯雷他定的分子印迹聚合物的制备及其吸附性研究

目的:以地氯雷他定为模板分子,分别用甲基丙烯酸(MAA)、丙烯酰胺(AM)和两者(1:1)的混合物为功能单体制备了相应的聚合物。方法:将模板分子、功能单体、交联剂,按1:4:20比例制备相应的分子印迹聚合物,再将制得的棒状聚合物经过研磨、过筛后,采用平衡结合方法评价了该分子印迹聚合物的吸附结合特性。结果:研究表明,采用MAA为功能单体,以乙酸乙酯做溶剂合成的地氯雷他定MIP对模板分子的结合性最佳。结论:地氯雷他定MIP作为固相萃取填料,在临床体液样品中对地氯雷他定的富集和检测有应用前景。     

Combining desloratadine and pseudoephedrine in the treatment of seasonal allergic rhinitis

Nonsedating antihistamines are a first-line therapy in the management of allergic rhinitis. They relieve the majority of the histamine-mediated symptoms of the condition, including rhinorrhea, sneezing, and pruritus. The nonsedating antihistamine desloratadine is effective in alleviating the symptoms of both seasonal and perennial allergic rhinitis. It may also have some decongestant properties, and thus help to alleviate nasal congestion. Administering desloratadine in combination with the decongestant pseudoephedrine may offer allergic rhinitis patients with moderate-to-severe nasal congestion the benefits of desloratadine’s effectiveness for alleviating histamine-mediated symptoms plus pseudoephedrine’s relief from nasal congestion. This drug profile reviews a combination therapy containing desloratadine and pseudoephedrine, approved in the USA for the relief of the symptoms of seasonal allergic rhinitis, including nasal congestion.     

下鼻甲注射倍他米松与口服地氯雷他定治疗变应性鼻炎对照观察

目的：对比观察下鼻甲注射倍他米松与口服地氯雷他定治疗变应性鼻炎临床疗效及安全性。方法选择2013年1月至12月医院收治的变应性鼻炎患者150例,随机分为对照组和观察组,各75例。对照组给予口服地氯雷他定分散片,观察组患者下鼻甲注射复方倍他米松注射液,两组患者均治疗2周并随访3个月。对患者治疗前后的症状和体征等进行积分,并计算治疗指数,统计两组患者的临床疗效,观察起效时间,记录不良反应,随访复发次数。结果观察组患者的症状与体征积分低于对照组,治疗指数显著高于对照组,总有效率（96.00%）显著高于对照组（86.67%）,组间差异均有统计学意义（ P ﹤0.05）;观察组患者起效时间与对照组相当;治疗期间,观察组不良反应发生率为10.67%,低于对照组的16.00%（ P ﹤0.05）;随访3个月,观察组总复发率为26.67%,低于对照组的33.33%（ P ﹤0.05）。结论与口服地氯雷他定治疗变应性鼻炎比较,下鼻甲注射倍他米松的临床疗效更好、复发次数少,短期不良反应发生率更低,但长期用药的安全性尚需进一步研究,临床应根据患者具体情况权衡使用。     

Quality of life in adults with chronic idiopathic urticaria receiving desloratadine: a randomized, double-blind, multicentre, placebo-controlled study

Objective To assess the effect of desloratadine on quality of life (QoL) in chronic idiopathic urticaria (CIU). Study population Patients with a history of CIU (pruritus and weals lasting = 6 weeks) were included in this multicentre, randomized, double‐blind placebo‐controlled study that took place in dermatology centres throughout France. During the study, patients were randomized to receive desloratadine 5 mg daily or placebo for 42 days. Main outcome measures Variation of the scores of two QoL dermatology‐specific tools between baseline and day 42, the French translation version of the Dermatology Life Quality Index (DLQI) and the VQ‐Dermato (a French‐language scoring instrument). Results The intent‐to‐treat population comprised 137 patients [desloratadine (n = 65) or placebo (n = 72)]. Desloratadine treatment was associated with significantly greater improvements from baseline to day 42 compared with placebo in DLQI overall score (–6 vs. –2.2 points; P < 0.002) and VQ‐Dermato score (18.5 vs. 29.1 points; P = 0.009). Mean scores for sleep disruption and disruption of daily activities were significantly lower in the desloratadine group than in the placebo group from day 1 to the end of the study. Conclusions Desloratadine 5 mg/day was associated with significant improvements in two separate dermatology‐specific measures of QoL in patients with CIU. QoL proved to be a relevant primary outcome measure for therapeutic trials in CIU.     

Desloratadine and depression,a drug safety signal based on worldwide spontaneous reporting of side effects

Abstract

Objective: Desloratadine, a third-generation antihistamine, is claimed to cause fewer central nervous system (CNS) adverse drug reactions (ADRs) than antihistamines of the first- and second-generation. While literature is inconclusive regarding the possible CNS effects, symptoms like somnolence and hallucinations are acknowledged ADRs of desloratadine, indeed suggesting some passage of this drug across the blood–brain barrier. Depression is currently not described as an ADR in the approved desloratadine product labelling.

Materials and methods: In a joint signal detection workshop with the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb, case reports of suspected drug–ADR associations were analysed.

Results: Forty-nine unique case reports of desloratadine associated with depression or depressed mood were detected in the WHO global ADR database. In these reports, the median time to onset of depression was three days. Most patients recovered after withdrawal of desloratadine, and in five patients the symptoms of depression recurred after re-administration of desloratadine.

Conclusion: We hypothesize that desloratadine may enter the CNS and that it hence in rare cases may cause a clinically relevant state of depression, a relation that patients and their treating physicians should be made aware of.