Gallelli Luca, Siniscalchi Antonio, Palleria Caterina, Mumoli Laura, Staltari Orietta, Squillace Aida, Maida Francesca, Russo Emilio, Gratteri Santo, De Sarro Giovambattista
Department of Health Science, School of Medicine, University of Catanzaro, Clinical Pharmacology and Pharmacovigilance Unit, MaterDomini Hospital, Catanzaro. Italy.
Department of Neurology, Annunziata Hospital, Via F. Migliori, 1 - 87100 Cosenza. Italy.
Curr Drug Saf. 2017;12(3):171-177. doi: 10.2174/1574886312666170616090640.
Drug treatment may be related to the development of adverse drug reactions (ADRs).
In this paper, we evaluated the ADRs in patients admitted to Catanzaro Hospital.
After we obtained the approval by local Ethical Committee, we performed a retrospective study on clinical records from March 01, 2013 to April 30, 2015. The association between drug and ADR or between drug and drug-drug-interactions (DDIs) was evaluated using the Naranjo's probability scale and Drug Interaction Probability Scale (DIPS), respectively.
During the study period, we analyzed 2870 clinical records containing a total of 11,138 prescriptions, and we documented the development of 770 ADRs. The time of hospitalization was significantly higher (P<0.05) in women with ADRs (12.6 ± 1.2 days) with respect to men (11.8± 0.83 days). Using the Naranjo score, we documented a probable association in 78% of these reactions, while DIPS revealed that about 22% of ADRs were related to DDIs. Patients with ADRs received 3052 prescriptions on 11,138 (27.4%) having a mean of 6.1±0.29 drugs that was significantly higher (P<0.01) with respect to patients not experiencing ADRs (mean of 3.4±0.13 drugs). About 19% of ADRs were not diagnosed and were treated as new diseases.
Our results indicate that drug administration induces the development of ADRs also during the hospitalization, particularly in elderly women. Moreover, we also documented that ADRs in some patients are under-diagnosed, therefore, it is important to motivate healthcare to report the ADRs in order to optimize the patients' safety.
药物治疗可能与药物不良反应(ADR)的发生有关。
在本文中,我们评估了卡坦扎罗医院收治患者的药物不良反应情况。
在获得当地伦理委员会批准后,我们对2013年3月1日至2015年4月30日的临床记录进行了回顾性研究。分别使用纳伦霍概率量表和药物相互作用概率量表(DIPS)评估药物与ADR之间或药物与药物相互作用(DDI)之间的关联。
在研究期间,我们分析了2870份临床记录,其中包含总共11138张处方,并记录了770例ADR的发生情况。发生ADR的女性患者住院时间(12.6±1.2天)显著高于男性患者(11.8±0.83天)(P<0.05)。使用纳伦霍评分,我们记录了这些反应中78%可能存在关联,而DIPS显示约22%的ADR与DDI有关。发生ADR的患者在11138张处方中接受了3052张(27.4%),平均用药6.1±0.29种,这显著高于未发生ADR的患者(平均用药3.4±0.13种)(P<0.01)。约19%的ADR未被诊断出来,而是被当作新疾病进行治疗。
我们的结果表明,住院期间给药也会引发ADR,尤其是在老年女性中。此外,我们还记录到一些患者的ADR未得到充分诊断,因此,促使医护人员报告ADR以优化患者安全非常重要。