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Use and Safety of Anthroposophic Medications for Acute Respiratory and Ear Infections: A Prospective Cohort Study

机译:急性呼吸道和耳部感染的人类营养药物的使用和安全性:一项前瞻性队列研究

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Objective: Anthroposophic medications (AMED) are widely used, but safety data on AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of adverse drug reactions (ADR) to AMED in outpatients using AMED for acute respiratory and ear infections.Methods: A prospective four-week observational cohort study was conducted in 21 primary care practices in Europe and the U.S.A. The cohort comprised 715 consecutive outpatients aged 1 month, treated by anthroposophic physicians for acute otitis and respiratory infections. Physicians’ prescription data and patient reports of adverse events were analyzed. Main outcome measures were use of AMED and ADR to AMED.Results: Two patients had confirmed ADR to AMED: 1) swelling and redness at the injection site after subcutaneous injections of Prunus spinosa 5%, 2) sleeplessness after intake of Pneumodoron? 2 liquid. These ADR lasted one and two days respectively; both subsided after dose reduction; none were unexpected; none were serious. The frequency of confirmed ADR to AMED was 0.61% (2/327) of all different AMED used, 0.28% (2/715) of patients, and 0.004% (3/73,443) of applications.Conclusion: In this prospective study, anthroposophic medications used by primary care patients with acute respiratory or ear infections were well tolerated.Abbreviations: A-: anthroposophy; ADR: adverse drug reactions; AE: adverse events; AM: anthroposophic medicine; AMED: AM medication; C-: conventional; ENE-patients: eligible, not enrolled patients; IIPCOS: International Primary Care Outcomes Study
机译:目的:嗜人药物(AMED)被广泛使用,但是来自大型前瞻性研究的关于AMED的安全性数据稀疏。该分析的目的是确定使用AMED进行急性呼吸道和耳部感染的门诊患者对AMED的药物不良反应(ADR)的发生频率。美国该队列包括715名1个月大的连续门诊病人,这些病人均由人类医学医师治疗了急性中耳炎和呼吸道感染。分析了医生的处方数据和不良事件的患者报告。结果:两名患者已确认ADR为AMED:1)皮下注射刺李5%皮下注射后,注射部位出现肿胀和发红; 2)摄入气胸后失眠? 2液体。这些ADR分别持续了1天和2天;减量后均消退;没有一个是意料之外的。没有一个是认真的。确诊为AMED的ADR发生率为使用的所有不同AMED的0.61%(2/327),0.28%(2/715)的患者和0.004%(3 / 73,443)的应用。结论:在这项前瞻性研究中,人为初级呼吸道感染或耳部感染的初级保健患者对药物的耐受性良好。 ADR:药物不良反应; AE:不良事件; AM:人类营养医学; AMED:AM药物; C-:常规; ENE患者:符合条件但未入组的患者; IIPCOS:国际初级保健成果研究

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