Hamre Harald J, Glockmann Anja, Fischer Michael, Riley David S, Baars Erik, Kiene Helmut
Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany.
Drug Target Insights. 2007;2:209-19. Epub 2007 Sep 14.
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.
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.
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.
In this prospective study, anthroposophic medications used by primary care patients with acute respiratory or ear infections were well tolerated.
人智学药物（AMED）被广泛使用，但来自大型前瞻性研究的AMED安全性数据稀少。本分析的目的是确定使用AMED治疗急性呼吸道和耳部感染的门诊患者中药物不良反应（ADR）的发生率。
在欧洲和美国的21家初级保健机构进行了一项为期四周的前瞻性观察队列研究。该队列包括715名年龄≥1个月的连续门诊患者，由人智学医生治疗急性中耳炎和呼吸道感染。分析了医生的处方数据和患者的不良事件报告。主要结局指标是AMED的使用情况和AMED的ADR。
两名患者确诊对AMED有ADR：1）皮下注射5%刺李后注射部位肿胀和发红，2）服用Pneumodoron(®) 2液后失眠。这些ADR分别持续了一天和两天；剂量减少后均消退；均无意外情况；均不严重。确诊的AMED的ADR发生率在所有使用的不同AMED中为0.61%（2/327），在患者中为0.28%（2/715），在用药次数中为0.004%（3/73,443）。
在这项前瞻性研究中，初级保健患者使用人智学药物治疗急性呼吸道或耳部感染耐受性良好。
