ABSTRACT
OBJECTIVE@#To explore the efficacy and action mechanism of penetrating moxibustion at governor vessel for persistent allergic rhinitis of deficiency-cold syndrome.@*METHODS@#Ninety patients with persistent allergic rhinitis of deficiency-cold syndrome were randomly divided into an observation group (@*RESULTS@#Compared before treatment, the TCM symptom scores, VAS scores, RQLQ scores, serum levels of IgE and complete blood count of EOS in the two groups were all reduced after treatment (@*CONCLUSION@#Based on the momethasone furoate nasal spray, the adjuvant treatment of penetrating moxibustion at governor vessel could significantly improve the clinical symptoms in patients with persistent allergic rhinitis of deficiency-cold syndrome, and its mechanism may be related to the regulation of immune disorder.
Subject(s)
Humans , Acupuncture Points , Moxibustion , Quality of Life , Rhinitis, Allergic/drug therapy , Syndrome , Treatment OutcomeABSTRACT
ABSTRACT INTRODUCTION: Allergic rhinitis is considered the most prevalent respiratory disease in Brazil and worldwide, with great impact on quality of life, affecting social life, sleep, and also performance at school and at work. OBJECTIVE: To compare the efficacy and safety of two formulations containing mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis after four weeks of treatment. METHODS: Phase III, randomized, non-inferiority, national, open study comparing mometasone furoate in two presentations (control drug and investigational drug). The primary endpoint was the percentage of patients with reduction of at least 0.55 in nasal index score (NIS) after four weeks of treatment. Secondary outcomes included total nasal index score score after four and 12 weeks of treatment; individual scores for symptoms of nasal obstruction, rhinorrhea, sneezing, and nasal pruritus; as well as score for pruritus, lacrimation, and ocular redness after four and 12 weeks of treatment. The study was registered at clinicaltrials.gov with the reference number NCT01372865. RESULTS: The efficacy primary analysis demonstrated non-inferiority of the investigational drug in relation to the control drug, since the upper limit of the confidence interval (CI) of 95% for the difference between the success rates after four weeks of treatment (12.6%) was below the non-inferiority margin provided during the determination of the sample size (13.7%). Adverse events were infrequent and with mild intensity in most cases. CONCLUSION: The efficacy and safety of investigational drug in the treatment of persistent allergic rhinitis were similar to the reference product, demonstrating its non-inferiority.
Resumo Introdução: A rinite alérgica é considerada a doença respiratória mais prevalente no Brasil e em todo o mundo, com grande impacto na qualidade de vida; além de, afetar a vida social, o sono e também o desempenho na escola e no trabalho. Objetivo: Comparar a eficácia e segurança de duas formulações contendo furoato de mometasona no tratamento da rinite alérgica persistente leve, moderada ou grave por um período de quatro semanas. Método: Trata-se de um estudo nacional aberto de fase III, randomizado, de não inferioridade de comparação do furoato de mometasona em duas apresentações (medicação de controle e fármaco sob investigação). O ponto final primário foi o percentual de pacientes com redução mínima de 0,55 no escore de índice nasal (EIN) após quatro semanas de tratamento. Os desfechos secundários foram: escore NIS total após 4 e 12 semanas de tratamento; escores individuais para sintomas de obstrução nasal, rinorréia, espirros e prurido nasal, bem como escores para prurido, lacrimejamento e hiperemia conjuntival após 4 e 12 semanas de tratamento. O estudo foi registrado em clinicaltrials.gov com o número de referência NCT01372865. Resultados: A análise de eficácia primária demonstrou não inferioridade do fármaco sob investigação em relação à medicação de controle, visto que o limite superior do intervalo de confiança (IC) de 95% para a diferença entre os percentuais de sucesso após quatro semanas de tratamento (12,6%) situava-se abaixo da margem de não inferioridade proporcionada durante a determinação do tamanho da amostra (13,7%). Eventos adversos foram pouco frequentes e de leve intensidade na maioria dos casos. Conclusão: A eficácia e a segurança de um fármaco experimental no tratamento da rinite alérgica persistente foram similares às do produto de referência, o que demonstrou sua não inferioridade.
Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Anti-Allergic Agents/therapeutic use , Rhinitis, Allergic/drug therapy , Mometasone Furoate/therapeutic use , Severity of Illness Index , Treatment OutcomeABSTRACT
Allergic rhinitis (AR),with an increasing uptrend of the prevalence in many developed and developing countries,is a global health problem that affects people of all ages and ethnic groups.However,data on the prevalence of self-reported AR in western China are rare.This study investigated the epidemiological features of self-reported AR in western China.In the cross-sectional,population-based study,a validated questionnaire survey on self-reported AR was carried out in 4 major cities in western China by multistage,stratified and cluster sampling,from January to December 2008.The total prevalence rate was 34.3％,with 32.3％ (Chongqing),34.3％ (Chengdu),37.9％ (Urumqi),30.3％ (Nanning),respectively.The prevalence presented to increase with age before 30 years old while decrease with age after 30 years old,and the highest prevalence was in 19-30 years group in Chongqing,Chengdu and Nanning which significantly showed “persistent and moderate-severe” type (P＜0.0001); In Urumqi,there wasn't a significant increasing or decreasing trend of prevalence rate with age but with an “intermittent and mild”predominance (P＜0.0001).There were no distinct sexual differences in prevalence rates in the 4 cities.The morbidity was positively related to monthly average temperature and sunshine (r=0.76645,P=0.0036; r=0.67303,P=0.0165),but negatively associated with relative humidity (r=-0.64391,P=0.0238) in Urumqi.Interestingly,the monthly morbidity was negatively associate with average temperature,sunshine and precipitation in Nanning (r=-0.81997,P=0.0011; r=-0.60787,P=0.0360; r=-0.59443,P=0.0415).Self-reported AR is becoming common in western China with a rapid development in recent years,affecting about three persons out of ten.The climatic factors may have an indirect impact on the prevalence rate through the effects on the local allergens.
ABSTRACT
BACKGROUND AND OBJECTIVES: Allergic rhinitis (AR) is commonly sub-classified into seasonal and perennial rhinitis. The recent "Allergic Rhinitis and its impact on Asthma (ARIA) Workshop" proposed to replace these terms by intermittent vs persistent AR. But the validity of this new classification is still largely unknown. SUBJECTS AND METHOD: Three hundred-eleven allergic rhinitis patients were included in this study. Patients were categorized into seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) groups, according to sensitized allergens. Twenty-eight items questionnaire filled out by patients were designed for this study. Based on the questionnaire, patients were classified into either intermittent or persistent AR. Patients' information and associated factors were analysed between the groups. RESULTS: Within the population with AR, 58% of the subjects had persistent AR. About 41% of the patients were classified as moderate-severe persistent AR. There was no association between the intermittent/persistent and the SAR/PAR classifications. Subjects with persistent AR had more severe symptoms, higher rate of self-awareness and had been previously diagnosed with AR. There were no significant difference in sensitization to allergens. However, grass, tree, house dust mite allergy is more common in persistent AR than in intermittent AR. More patients in "Blockers" and "Mixed" groups had persistent AR. CONCLUSION: A statistical comparison of the two classifications showed that they cannot be used interchangeably, as they do not represent the same stratum of disease. There is also an evidence that the persistent type describes a distinct group with characteristics that differentiates them from intermittent AR. These results support the validity of the new ARIA classification as shown in other studies.