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[PMID]:28574526
[Au] Autor:Hollander-Rodriguez JC; Montjoy HL; Smedra B; Prouty JP
[Ad] Endereço:Cascades East Family Medicine Residency, Oregon Health & Science University, Portland, OR, USA.
[Ti] Título:Clinical Inquiry: Do oral decongestants have a clinically significant effect on BP in patients with hypertension?
[So] Source:J Fam Pract;66(6):E1-E2, 2017 Jun.
[Is] ISSN:1533-7294
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:It is unclear. Pseudoephedrine causes an average increase of 1.2 mm Hg in systolic blood pressure (BP) in patients with controlled hypertension. However, the studies are not adequately powered to provide evidence about whether this rise in systolic BP is linked to patient-oriented outcomes (strength of recommendation: C, multiple randomized controlled trials supporting disease-oriented evidence). Significant variations in BP are defined differently among studies. In addition, we do not have data on chronic use of oral decongestants; the longest time on medication in these trials was 4 weeks.
[Mh] Termos MeSH primário: Pressão Sanguínea/efeitos dos fármacos
Hipertensão/fisiopatologia
Descongestionantes Nasais/uso terapêutico
Pseudoefedrina/uso terapêutico
[Mh] Termos MeSH secundário: Seres Humanos
Descongestionantes Nasais/efeitos adversos
Pseudoefedrina/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Nasal Decongestants); 7CUC9DDI9F (Pseudoephedrine)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170815
[Lr] Data última revisão:
170815
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170603
[St] Status:MEDLINE


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[PMID]:28347584
[Au] Autor:Meoli EM; Goldsweig AM; Malm BJ
[Ad] Endereço:Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
[Ti] Título:Acute Myocardial Infarction from Coronary Vasospasm Precipitated by Pseudoephedrine and Metoprolol Use.
[So] Source:Can J Cardiol;33(5):688.e1-688.e3, 2017 May.
[Is] ISSN:1916-7075
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Pseudoephedrine is a sympathomimetic α- and ß-adrenergic receptor agonist that causes vasoconstriction and reduction in edema throughout the nasal passages. Coronary vasospasm associated with pseudoephedrine has been reported in the literature. We discuss the case of a patient with new-onset atrial fibrillation receiving metoprolol for rate control on a background of pseudoephedrine use for allergic rhinitis leading to acute myocardial infarction from multivessel coronary vasospasm. This case illustrates the importance of understanding the pharmacology of potential drug-drug interactions when managing patients with acute cardiovascular syndromes.
[Mh] Termos MeSH primário: Asma/tratamento farmacológico
Fibrilação Atrial/tratamento farmacológico
Vasoespasmo Coronário
Metoprolol
Infarto do Miocárdio
Nitroglicerina/administração & dosagem
Pseudoefedrina
[Mh] Termos MeSH secundário: Antiarrítmicos/administração & dosagem
Antiarrítmicos/efeitos adversos
Asma/complicações
Fibrilação Atrial/complicações
Fibrilação Atrial/diagnóstico
Broncodilatadores/administração & dosagem
Broncodilatadores/efeitos adversos
Angiografia Coronária/métodos
Vasoespasmo Coronário/induzido quimicamente
Vasoespasmo Coronário/diagnóstico por imagem
Eletrocardiografia/métodos
Feminino
Seres Humanos
Metoprolol/administração & dosagem
Metoprolol/efeitos adversos
Meia-Idade
Infarto do Miocárdio/diagnóstico
Infarto do Miocárdio/etiologia
Infarto do Miocárdio/fisiopatologia
Infarto do Miocárdio/terapia
Pseudoefedrina/administração & dosagem
Pseudoefedrina/efeitos adversos
Resultado do Tratamento
Vasodilatadores/administração & dosagem
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Arrhythmia Agents); 0 (Bronchodilator Agents); 0 (Vasodilator Agents); 7CUC9DDI9F (Pseudoephedrine); G59M7S0WS3 (Nitroglycerin); GEB06NHM23 (Metoprolol)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170802
[Lr] Data última revisão:
170802
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170329
[St] Status:MEDLINE


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[PMID]:28122105
[Au] Autor:Bahtouee M; Monavarsadegh G; Ahmadipour M; Motieilangroodi M; Motamed N; Saberifard J; Eghbali S; Adibi H; Maneshi H; Malekizadeh H
[Ad] Endereço:Department of Internal Medicine, Persian Gulf Martyr's Hospital, Azadi Square, Bushehr, Bushehr Province, Iran 7517933755. bahtoueem@bpums.ac.ir.
[Ti] Título:Acetylcysteine in the treatment of subacute sinusitis: A double-blind placebo-controlled clinical trial.
[So] Source:Ear Nose Throat J;96(1):E7-E11, 2017 Jan.
[Is] ISSN:1942-7522
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Sinusitis is a common disease with harmful effects on the health and finances of patients and the economy of the community. It is easily treated in most of its acute stages but is associated with some management difficulties as it goes toward chronicity. Therefore, we tried to improve the treatment of subacute sinusitis by using acetylcysteine, which is a safe mucolytic and antioxidant agent. Thirty-nine adult patients with subacute sinusitis proved by computed tomography (CT) were enrolled in a double-blind, placebo-controlled trial. They received oral amoxicillin-clavulanic acid and normal saline nasal drops for 10 days and oral pseudoephedrine for 7 days. In addition, the patients received acetylcysteine (600 mg orally, once daily) in the intervention group or placebo in the control group for 10 days. A paranasal CT scan was taken at baseline and 30 days after patients finished the treatment and was evaluated quantitatively by Lund-Mackay (LM) score. Symptoms and some aspects of quality of life also were assessed at baseline and 14 days after initiation and 30 days after termination of the treatment via the Sino-Nasal Outcome Test questionnaire. The groups showed no significant difference in LM score after treatment. A positive correlation was observed between the LM and SNOT-20 scores. We concluded that adding oral acetylcysteine to amoxicillin-clavulanic acid, pseudoephedrine, and intranasal normal saline has no benefit for the treatment of subacute sinusitis.
[Mh] Termos MeSH primário: Acetilcisteína/uso terapêutico
Depuradores de Radicais Livres/uso terapêutico
Sinusite/tratamento farmacológico
[Mh] Termos MeSH secundário: Doença Aguda
Adulto
Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico
Antibacterianos/uso terapêutico
Doença Crônica
Método Duplo-Cego
Quimioterapia Combinada
Feminino
Seres Humanos
Masculino
Descongestionantes Nasais/uso terapêutico
Seios Paranasais/diagnóstico por imagem
Pseudoefedrina/uso terapêutico
Sinusite/diagnóstico por imagem
Cloreto de Sódio/uso terapêutico
Inquéritos e Questionários
Tomografia Computadorizada por Raios X
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Free Radical Scavengers); 0 (Nasal Decongestants); 451W47IQ8X (Sodium Chloride); 74469-00-4 (Amoxicillin-Potassium Clavulanate Combination); 7CUC9DDI9F (Pseudoephedrine); WYQ7N0BPYC (Acetylcysteine)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170614
[Lr] Data última revisão:
170614
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170126
[St] Status:MEDLINE


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[PMID]:28049947
[Au] Autor:Hiyama H; Ozawa A; Kumazawa H; Takeda O
[Ad] Endereço:Botanical Raw Materials Research Laboratories, Tsumura & Co.
[Ti] Título:Stabilization of Ephedrine Alkaloid Content in Ephedra sinica by Selective Breeding and Stolon Propagation.
[So] Source:Biol Pharm Bull;40(1):43-48, 2017.
[Is] ISSN:1347-5215
[Cp] País de publicação:Japan
[La] Idioma:eng
[Ab] Resumo:The Ephedra herb, which has been used in Kampo medicines, originates from terrestrial stems of Ephedra species. It is important to establish cultivation methods and cultivars to secure a stable supply of the Ephedra herb that would meet the quality standards for the ephedrine alkaloids content. In this study, we first grew Ephedra sinica plants derived from seeds in the field for 5 years. Then, for selective breeding of cultivars that could meet the quality standards for the ephedrine alkaloids content, we measured the content of total alkaloids (TAs), ephedrine (Eph), and pseudoephedrine (PEph) in individual plants derived from seedlings and grown for 4 years in the field. The range of the TA content in each individual plant was narrower than that among individual plants grown in the field. Therefore, individual plants were selected according to their TA content, Eph/PEph ratio, and stolon-formation capability. The selected individuals were propagated using stolons, and their TA content was studied for 2 years. In the second year, the TA content in terrestrial stems derived from stolons of the selected individuals was as high as that of their parents. Therefore, it was confirmed that the selected individuals that were propagated using stolons could produce TA reproducibly. This study suggested that selective breeding using stolon propagation is effective for stabilizing Ephedra herb TA content.
[Mh] Termos MeSH primário: Alcaloides/metabolismo
Ephedra sinica/metabolismo
Efedrina/metabolismo
Pseudoefedrina/metabolismo
[Mh] Termos MeSH secundário: Alcaloides/análise
Efedrina/análise
Melhoramento Vegetal
Pseudoefedrina/análise
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Alkaloids); 7CUC9DDI9F (Pseudoephedrine); GN83C131XS (Ephedrine)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170203
[Lr] Data última revisão:
170203
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170105
[St] Status:MEDLINE
[do] DOI:10.1248/bpb.b16-00531


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[PMID]:27925348
[Au] Autor:Klimek L; Schumacher H; Schütt T; Gräter H; Mueck T; Michel MC
[Ad] Endereço:Center for Rhinology and Allergology, Wiesbaden, Germany.
[Ti] Título:Factors associated with efficacy of an ibuprofen/pseudoephedrine combination drug in pharmacy customers with common cold symptoms.
[So] Source:Int J Clin Pract;71(2), 2017 Feb.
[Is] ISSN:1742-1241
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:AIM: The aim of this study was to explore factors affecting efficacy of treatment of common cold symptoms with an over-the-counter ibuprofen/pseudoephedrine combination product. METHODS: Data from an anonymous survey among 1770 pharmacy customers purchasing the combination product for treatment of own common cold symptoms underwent post-hoc descriptive analysis. Scores of symptoms typically responsive to ibuprofen (headache, pharyngeal pain, joint pain and fever), typically responsive to pseudoephedrine (congested nose, congested sinus and runny nose), considered non-specific (sneezing, fatigue, dry cough, cough with expectoration) and comprising all 11 symptoms were analysed. Multiple regression analysis was applied to explore factors associated with greater reduction in symptom intensity or greater probability of experiencing a symptom reduction of at least 50%. RESULTS: After intake of first dose of medication, typically ibuprofen-sensitive, pseudoephedrine-responsive, non-specific and total symptoms were reduced by 60.0%, 46.3%, 45.4% and 52.8%, respectively. A symptom reduction of at least 50% was reported by 73.6%, 55.1%, 50.9% and 61.6% of participants, respectively. A high baseline score was associated with greater reductions in symptom scores but smaller probability of achieving an improvement of at least 50%. Across both multiple regression approaches, two tablets at first dosing were more effective than one and (except for ibuprofen-sensitive symptoms) starting treatment later than day 2 of the cold was generally less effective. DISCUSSION AND CONCLUSIONS: Efficacy of an ibuprofen/pseudoephedrine combination in the treatment of common cold symptoms was dose-dependent and greatest when treatment started within the first 2 days after onset of symptoms.
[Mh] Termos MeSH primário: Anti-Inflamatórios não Esteroides/uso terapêutico
Resfriado Comum/tratamento farmacológico
Ibuprofeno/uso terapêutico
Descongestionantes Nasais/uso terapêutico
Pseudoefedrina/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Anti-Inflamatórios não Esteroides/administração & dosagem
Esquema de Medicação
Quimioterapia Combinada
Feminino
Seres Humanos
Ibuprofeno/administração & dosagem
Masculino
Descongestionantes Nasais/administração & dosagem
Medicamentos sem Prescrição
Medição da Dor
Pseudoefedrina/administração & dosagem
Inquéritos e Questionários
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Nasal Decongestants); 0 (Nonprescription Drugs); 7CUC9DDI9F (Pseudoephedrine); WK2XYI10QM (Ibuprofen)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161208
[St] Status:MEDLINE
[do] DOI:10.1111/ijcp.12907


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[PMID]:27662264
[Au] Autor:Deng S; Huang W; Ni X; Zhang M; Lu H; Wang Z; Hu J; Zhu X; Qiu C; Shang D; Zhang Y; Xiong L; Wen Y
[Ad] Endereço:a Institution of National Drug Clinical Trials, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital) , Guangzhou , China.
[Ti] Título:Pharmacokinetics of guaifenesin, pseudoephedrine and hydrocodone in a combination oral liquid formulation, administered as single and multiple doses in healthy Chinese volunteers, and comparison with data for individual compounds formulated as Antuss®.
[So] Source:Xenobiotica;47(10):870-878, 2017 Oct.
[Is] ISSN:1366-5928
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:1. A new oral liquid formulation combining guaifenesin, pseudoephedrine and hydrocodone is effective in improving the symptoms of common cold. The pharmacokinetic properties of the individual components were evaluated in a randomized, open-label, four-period study in 12 healthy Chinese volunteers following single and multiple doses. The data were compared with data for the individual ingredients in Antuss®. 2. In the single-dose period, exposure levels (AUC and C ) for guaifenesin, pseudoephedrine and hydrocodone increased directly as the dose of the oral liquid formulation increased from 5 to 15 mL. Only minor amounts of guaifenesin and hydrocodone were excreted in urine (∼0.10% and 4.66%, respectively). Pseudoephedrine was mainly excreted unchanged, with 44.95% of the dose excreted in urine within 24 h. After multiple dosing, there was no obvious accumulation of any drug, as assessed by AUC. When considering C , there was a trend toward accumulation of hydrocodone and pseudoephedrine. The pharmacokinetic profiles of guaifenesin and pseudoephedrine in the oral liquid formulation were similar to those in the branded preparation, Antuss®. 3. The newly developed oral liquid formulation combining guaifenesin, pseudoephedrine and hydrocodone was safe and well tolerated and might provide a reliable alternative to the branded formulation for patients with common colds.
[Mh] Termos MeSH primário: Guaifenesina/farmacocinética
Hidrocodona/farmacocinética
Pseudoefedrina/farmacocinética
[Mh] Termos MeSH secundário: Administração Oral
Adulto
Disponibilidade Biológica
Feminino
Voluntários Saudáveis
Seres Humanos
Masculino
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
495W7451VQ (Guaifenesin); 6YKS4Y3WQ7 (Hydrocodone); 7CUC9DDI9F (Pseudoephedrine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171018
[Lr] Data última revisão:
171018
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160924
[St] Status:MEDLINE
[do] DOI:10.1080/00498254.2016.1241451


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[PMID]:26888635
[Au] Autor:Miao L; Liu Y; Li H; Qi Y; Lu F
[Ad] Endereço:Department of Pharmaceutical Analysis, School of Pharmacy, Second Military Medical University, Shanghai, 200433, China.
[Ti] Título:Two-dimensional correlation infrared spectroscopy applied to the identification of ephedrine and pseudoephedrine in illegally adulterated slimming herbal products.
[So] Source:Drug Test Anal;9(2):221-229, 2017 Feb.
[Is] ISSN:1942-7611
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Two-dimensional correlation spectroscopy (2DCOS) was employed for the identification of ephedrine (Ep) and pseudoephedrine (Ps) present in illegally adulterated slimming herbal products (SHPs). Second derivative (SD) spectral pretreatment was used prior to 2DCOS analysis to highlight specific features not readily observable by Fourier transform infrared spectroscopy (FTIR), SD-FTIR, or original 2DCOS, leading to enhanced resolution and a reduced lower limit of detection (<1% in this study). After examining the power spectra of suspicious SHPs, bands containing characteristic peaks for Ep (701, 747, 1042, 1363, 1375, 1451, 1478 cm etc) and/or Ps (703, 767, 1037, 1375, 1428, 1455, 1590 cm 1, etc.) were selected to construct synchronous and asynchronous maps for further analysis, while the latter was applied to discriminate positive SHPs adulterated simultaneously with Ep and Ps. The proposed method is simple and economical and has the potential to identify other chemicals in illegally adulterated herbal products. Copyright © 2016 John Wiley & Sons, Ltd.
[Mh] Termos MeSH primário: Fármacos Antiobesidade/análise
Efedrina/análise
Descongestionantes Nasais/análise
Plantas Medicinais/química
Pseudoefedrina/análise
Espectroscopia de Infravermelho com Transformada de Fourier/métodos
Vasoconstritores/análise
[Mh] Termos MeSH secundário: Contaminação de Medicamentos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Obesity Agents); 0 (Nasal Decongestants); 0 (Vasoconstrictor Agents); 7CUC9DDI9F (Pseudoephedrine); GN83C131XS (Ephedrine)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170630
[Lr] Data última revisão:
170630
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160219
[St] Status:MEDLINE
[do] DOI:10.1002/dta.1963


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[PMID]:28068052
[Au] Autor:Drug Enforcement Administration, Department of Justice
[Ti] Título:Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments. Final rule.
[So] Source:Fed Regist;81(251):96992-7044, 2016 12 30.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.
[Mh] Termos MeSH primário: Comércio/legislação & jurisprudência
Substâncias Controladas
Controle de Medicamentos e Entorpecentes/legislação & jurisprudência
Desvio de Medicamentos sob Prescrição/legislação & jurisprudência
[Mh] Termos MeSH secundário: Processamento Automatizado de Dados/legislação & jurisprudência
Cápsulas
Composição de Medicamentos/instrumentação
Rotulagem de Medicamentos/legislação & jurisprudência
Embalagem de Medicamentos/legislação & jurisprudência
Efedrina
Seres Humanos
Hidroxibutiratos
Sistemas de Informação/legislação & jurisprudência
Fenilpropanolamina
Projetos Piloto
Desvio de Medicamentos sob Prescrição/prevenção & controle
Pseudoefedrina
Comprimidos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Capsules); 0 (Controlled Substances); 0 (Hydroxybutyrates); 0 (Tablets); 33RU150WUN (Phenylpropanolamine); 7CUC9DDI9F (Pseudoephedrine); GN83C131XS (Ephedrine)
[Em] Mês de entrada:1701
[Cu] Atualização por classe:170118
[Lr] Data última revisão:
170118
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:170110
[St] Status:MEDLINE


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[PMID]:27748955
[Au] Autor:Deckx L; De Sutter AI; Guo L; Mir NA; van Driel ML
[Ad] Endereço:Discipline of General Practice, School of Medicine, The University of Queensland, Building 16/910, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia, 4029.
[Ti] Título:Nasal decongestants in monotherapy for the common cold.
[So] Source:Cochrane Database Syst Rev;10:CD009612, 2016 Oct 17.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Many treatments for the common cold exist and are sold over-the-counter. Nevertheless, evidence on the effectiveness and safety of nasal decongestants is limited. OBJECTIVES: To assess the efficacy, and short- and long-term safety, of nasal decongestants used in monotherapy to alleviate symptoms of the common cold in adults and children. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 6, June 2016), which contains the Cochrane Acute Respiratory Infections (ARI) Specialised Register, MEDLINE (1946 to July 2016), Embase (2010 to 15 July 2016), CINAHL (1981 to 15 July 2016), LILACS (1982 to July 2016), Web of Science (1955 to July 2016) and clinical trials registers. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs investigating the effectiveness and adverse effects of nasal decongestants compared with placebo for treating the common cold in adults and children. We excluded quasi-RCTs. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted and summarised data on subjective measures of nasal congestion, overall patient well-being score, objective measures of nasal airway resistance, adverse effects and general recovery. One review author acted as arbiter in cases of disagreement. We categorised trials as single and multi-dose and analysed data both separately and together. We also analysed studies using an oral or topical nasal decongestant separately and together. MAIN RESULTS: We included 15 trials with 1838 participants. Fourteen studies included adult participants only (aged 18 years and over). In six studies the intervention was a single dose and in nine studies multiple doses were used. Nine studies used pseudoephedrine and three studies used oxymetazoline. Other decongestants included phenylpropanolamine, norephedrine and xylometazoline. Phenylpropanolamine (or norephedrine) is no longer available on the market therefore we did not include the results of these studies in the meta-analyses. Eleven studies used oral decongestants; four studies used topical decongestants.Participants were included after contracting the common cold. The duration of symptoms differed among studies; in 10 studies participants had symptoms for less than three days, in three studies symptoms were present for less than five days, one study counted the number of colds over one year, and one study experimentally induced the common cold. In the single-dose studies, the effectiveness of a nasal decongestant was measured on the same day, whereas the follow-up in multi-dose studies ranged between one and 10 days.Most studies were conducted in university settings (N = eight), six at a specific university common cold centre. Three studies were conducted at a university in collaboration with a hospital and two in a hospital only setting. In two studies the setting was unclear.There were large differences in the reporting of outcomes and the reporting of methods in most studies was limited. Therefore, we judged most studies to be at low or unclear risk of bias. Pooling was possible for a limited number of studies only; measures of effect are expressed as standardised mean differences (SMDs). A positive SMD represents an improvement in congestion. There is no defined minimal clinically important difference for measures of subjective improvement in nasal congestion, therefore we used the SMDs as a guide to assess whether an effect was small (0.2 to 0.49), moderate (0.5 to 0.79) or large (≥ 0.8).Single-dose decongestant versus placebo: 10 studies compared a single dose of nasal decongestant with placebo and their effectiveness was tested between 15 minutes and 10 hours after dosing. Seven of 10 studies reported subjective symptom scores for nasal congestion; none reported overall patient well-being. However, pooling was not possible due to the large diversity in the measurement and reporting of symptoms of congestion. Two studies recorded adverse events. Both studies used an oral decongestant and each of them showed that there was no statistical difference between the number of adverse events in the treatment group versus the placebo group.Multi-dose decongestant versus placebo: nine studies compared multiple doses of nasal decongestants with placebo, but only five reported on the primary outcome, subjective symptom scores for nasal congestion. Only one study used a topical decongestant; none reported overall patient well-being. Subjective measures of congestion were significantly better for the treatment group compared with placebo approximately three hours after the last dose (SMD 0.49, 95% confidence interval (CI) 0.07 to 0.92; P = 0.02; GRADE: low-quality evidence). However, the SMD of 0.49 only indicates a small clinical effect. Pooling was based on two studies, one oral and one topical, therefore we were unable to assess the effects of oral and topical decongestants separately. Seven studies reported adverse events (six oral and one topical decongestant); meta-analysis showed that there was no statistical difference between the number of adverse events in the treatment group (125 per 1000) compared to the placebo group (126 per 1000). The odds ratio (OR) for adverse events in the treatment group was 0.98 (95% CI 0.68 to 1.40; P = 0.90; GRADE: low-quality evidence). The results remained the same when we only considered studies using an oral decongestant (OR 0.95, 95% CI 0.65 to 1.39; P = 0.80; GRADE: low-quality evidence). AUTHORS' CONCLUSIONS: We were unable to draw conclusions on the effectiveness of single-dose nasal decongestants due to the limited evidence available. For multiple doses of nasal decongestants, the current evidence suggests that these may have a small positive effect on subjective measures of nasal congestion in adults with the common cold. However, the clinical relevance of this small effect is unknown and there is insufficient good-quality evidence to draw any firm conclusions. Due to the small number of studies that used a topical nasal decongestant, we were also unable to draw conclusions on the effectiveness of oral versus topical decongestants. Nasal decongestants do not seem to increase the risk of adverse events in adults in the short term. The effectiveness and safety of nasal decongestants in children and the clinical relevance of their small effect in adults is yet to be determined.
[Mh] Termos MeSH primário: Resfriado Comum/tratamento farmacológico
Descongestionantes Nasais/administração & dosagem
[Mh] Termos MeSH secundário: Administração Intranasal
Adulto
Criança
Seres Humanos
Imidazóis/administração & dosagem
Descongestionantes Nasais/efeitos adversos
Oximetazolina/administração & dosagem
Fenilpropanolamina/administração & dosagem
Pseudoefedrina/administração & dosagem
Ensaios Clínicos Controlados Aleatórios como Assunto
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Imidazoles); 0 (Nasal Decongestants); 33RU150WUN (Phenylpropanolamine); 7CUC9DDI9F (Pseudoephedrine); 8VLN5B44ZY (Oxymetazoline); WPY40FTH8K (xylometazoline)
[Em] Mês de entrada:1611
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161102
[St] Status:MEDLINE


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[PMID]:27577258
[Au] Autor:Hattingh HL; Varsani J; Kachouei LA; Parsons R
[Ad] Endereço:School of Pharmacy, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia. L.Hattingh@curtin.edu.au.
[Ti] Título:Evaluation of pseudoephedrine pharmacy sales before and after mandatory recording requirements in Western Australia: a case study.
[So] Source:Subst Abuse Treat Prev Policy;11(1):30, 2016 Aug 30.
[Is] ISSN:1747-597X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: A community pharmacy real-time electronic recording program, ProjectSTOP, enables Australian community pharmacists to verify pseudoephedrine requests. In Western Australia the program was available for voluntary use from April 2007 and became mandatory November 2010. This case study explores the effectiveness of the program by reviewing the total requests for pseudoephedrine products, and the proportion of requests which were classified as 'denied sales' before and after mandatory implementation. Seasonal and annual trends in these measures are also evaluated. METHODS: ProjectSTOP data recordings for Western Australia pharmacies between 1 December 2007 and 28 February 2014 were analysed. Data included a de-identified pharmacy number and date of each pseudoephedrine product request. The total number of requests and sale classification (allowed, denied, safety, or not recorded) were calculated for each month/pharmacy. The potential influence of mandatory reporting using ProjectSTOP was investigated using a Regression Discontinuity Design. Correlations between sales from the same pharmacy were taken into account by classifying the pharmacy number as a random effect. The main effects of year (continuous variable), and season (categorical variable) were also included in the model. RESULTS: There was a small but steady decline in the total requests for pseudoephedrine per month per 100,000 population (per pharmacy) from the time of mandatory reporting. The number of denied sales showed a steady increase up until mandatory reporting, after which it showed a significant decline over time. Total sales were heavily influenced by season, as expected (highest in winter, least in summer). The seasonal pattern was less pronounced for denied sales, which were highest in winter and similar across other seasons. The pattern over time for safety sales was similar to that for denied sales, with a clear change occurring around the time of mandatory reporting. CONCLUSION: Results indicate a decrease in pseudoephedrine product requests in Western Australia community pharmacies. Findings suggest ProjectSTOP has been successful in addressing suspicious sales and potential diversion however ongoing data review is recommended.
[Mh] Termos MeSH primário: Comércio/classificação
Comércio/tendências
Serviços Comunitários de Farmácia/estatística & dados numéricos
Uso de Medicamentos/tendências
Programas Obrigatórios
Pseudoefedrina/economia
[Mh] Termos MeSH secundário: Serviços Comunitários de Farmácia/legislação & jurisprudência
Seres Humanos
Austrália Ocidental
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
7CUC9DDI9F (Pseudoephedrine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160901
[St] Status:MEDLINE
[do] DOI:10.1186/s13011-016-0075-0



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