Hamre Harald Johan, Glockmann Anja, Heckenbach Kirsten, Matthes Harald
Institute for Applied Epistemology and Medical Methodology, University of Witten/Herdecke, Zechenweg 6, 79111, Freiburg, Germany.
European Scientific Cooperative on Anthroposophic Medicinal Products, Zechenweg 6, 79111, Freiburg, Germany.
Drugs Real World Outcomes. 2017 Dec;4(4):199-213. doi: 10.1007/s40801-017-0118-5.
There is a need for data on the clinical safety of anthroposophic medicinal products (AMPs).
The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.
EvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. All physicians documented ADRs of Grades III-IV and serious ADRs, seven 'prescriber physicians' also documented non-serious ADRs of any intensity. Patients were eligible for this analysis if they had one or more AMP prescription in the years 2001-2010, followed by one or more physician visit.
A total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. Among patients of prescriber physicians, ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. In subgroup analyses according to age, specific AMPs or AMP groups, dosage forms, and concentrations (altogether 11 groups), the highest ADR frequency was 0.290% of prescriptions (for one specific AMP). Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.
In this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.
需要有关人智医学产品（AMPs）临床安全性的数据。
本分析的主要目的是确定相对于AMPs处方数量的药物不良反应（ADR）发生率。
EvaMed（人智医学评估）是一项针对德国38位门诊医生的患者进行的前瞻性药物警戒研究。诊断和处方从电子病历中提取。所有医生记录III-IV级ADR和严重ADR，7位“开处方医生”还记录了任何强度的非严重ADR。如果患者在2001年至2010年期间有一张或多张AMPs处方，随后有一次或多次医生就诊，则符合本分析条件。
共纳入44,662例患者，有311,731张AMPs处方，包括1722种不同的AMPs。发生了100例针对AMPs的ADR，由83种不同的AMPs引起。ADR强度分别为轻度、中度和重度的病例占50%（n = 50/100）、43%和7%；1例ADR为严重ADR。在开处方医生的患者中，任何强度的ADR发生在0.071%（n = 67/94,734）的AMPs处方中，以及0.502%（n = 65/12,956）的开具AMPs处方的患者中。在根据年龄、特定AMPs或AMPs组、剂型和浓度（共1l组）进行的亚组分析中，最高ADR发生率为0.290%的处方（针对一种特定AMPs）。在所有患者中，严重ADR发生在0.0003%（n = 1/311,731）的处方中以及0.0022%（n = 1/44,662）的患者中。
在这项来自大样本的分析中，门诊护理中AMPs治疗的ADR很少见；高强度ADR以及严重ADR非常罕见。
