Incidence, risk factors and risk prediction of hospital-acquired suspected adverse drug reactions: a prospective cohort of Ugandan inpatients
Incidence, risk factors and risk prediction of hospital-acquired suspected adverse drug reactions: a prospective cohort of Ugandan inpatients
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DOI：
10.1136/bmjopen-2015-010568
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发表时间：
2017-01-01
期刊：
影响因子：
2.9
通讯作者：
Bird, Sheila M.
中科院分区：
文献类型：
--
作者：
Kiguba, Ronald;Karamagi, Charles;Bird, Sheila M.
目的了解乌干达住院患者医院获得性疑似药物不良反应(ADR)发生率及危险因素。我们还构建了风险评分来预测和定性评估低风险和高风险ADR患者之间的特殊性。方法在拥有1790张床位的穆拉戈国家转诊医院的内科和妇科病房接受同意的成年人的前瞻性队列。使用Naranjo分级法，将医院获得性可疑ADR分为可能(可能/可能/确定)或不可能(可能/确定)和可能(可能/确定)。结果医院获得性可疑ADR发生率为25%(194/762，95%CI：22%~29%)：44%(85/194)发生严重ADR。可能发生不良反应的风险为11%(87/762，95%可信区间为9%~14%)：46%(40/87)出现严重的可能不良反应。仅抗菌药物(51/194)、子宫强直性药物(21/194)、心血管药物(16/194)、抗疟药(12/194)和止痛药(10/194)是最常见的药物。住院期间使用6种或6种以上常规药物(OR=2.31，95%CI 1.29~4.15)和入院前4周自行报告使用中药(OR=1.96，95%CI 1.22~3.13)是可能发生医院获得性ADR的危险因素。可能发生院内获得性不良反应的危险因素有：使用6种或6种以上常规药物(OR=2.72，95%CI 1.79~4.13)、入院前4周内使用中药(OR=1.68，95%CI 1.16~2.43)、住院3个月(OR=1.57，95%CI 1.09~2.26)和住妇科病房(OR=2.16，95%CI 1.36~3.44)。高危ADR患者涉及的药物种类较多，其中心血管类药物与可能的ADR关联最多。结论院前使用中草药、住院期间使用6种或6种以上常规药物的患者发生疑似ADR的风险较高。我们的风险评分应该在大规模研究中得到验证，并在常规临床护理中进行测试。
Objectives To determine the incidence and risk factors of hospital-acquired suspected adverse drug reactions (ADRs) among Ugandan inpatients. We also constructed risk scores to predict and qualitatively assess for peculiarities between low-risk and high-risk ADR patients.Methods Prospective cohort of consented adults admitted on medical and gynaecological wards of the 1790-bed Mulago National Referral Hospital. Hospital-acquired suspected ADRs were dichotomised as possible (possible/probable/definite) or not and probable (probable/definite) or not, using the Naranjo scale. Risk scores were generated from coefficients of ADR risk-factor logistic regression models.Results The incidence of possible hospital-acquired suspected ADRs was 25% (194/762, 95% CI: 22% to 29%): 44% (85/194) experienced serious possible ADRs. The risk of probable ADRs was 11% (87/762, 95% CI 9% to 14%): 46% (40/87) had serious probable ADRs. Antibacterials-only (51/194), uterotonics-only (21/194), cardiovascular drugs-only (16/194), antimalarials-only (12/194) and analgesics-only (10/194) were the most frequently implicated. Treatment with six or more conventional medicines during hospitalisation (OR=2.31, 95% CI 1.29 to 4.15) and self-reported herbal medicine use during the 4weeks preadmission (OR=1.96, 95% CI 1.22 to 3.13) were the risk factors for probable hospital-acquired ADRs. Risk factors for possible hospital-acquired ADRs were: treatment with six or more conventional medicines (OR=2.72, 95% CI 1.79 to 4.13), herbal medicine use during the 4weeks preadmission (OR=1.68, 95% CI 1.16 to 2.43), prior 3months hospitalisation (OR=1.57, 95% CI 1.09 to 2.26) and being on gynaecological ward (OR=2.16, 95% CI 1.36 to 3.44). More drug classes were implicated among high-risk ADR-patients, with cardiovascular drugs being the most frequently linked to possible ADRs.Conclusions The risk of hospital-acquired suspected ADRs was higher with preadmission herbal medicine use and treatment with six or more conventional medicines during hospitalisation. Our risk scores should be validated in large-scale studies and tested in routine clinical care.