Kiguba Ronald, Karamagi Charles, Bird Sheila M
Department of Pharmacology and Therapeutics Makerere University College of Health Sciences Kampala Uganda.
Clinical Epidemiology Unit Makerere University College of Health Sciences Kampala Uganda.
Pharmacol Res Perspect. 2017 Feb 17;5(2):e00298. doi: 10.1002/prp2.298. eCollection 2017 Apr.
We sought to determine the prevalence at admission and incidence during hospitalization of antibiotic-associated suspected adverse drug reactions (aa-ADRs) among Ugandan inpatients; and to characterize these aa-ADRs. We conducted a prospective cohort study of 762 consented adults admitted on medical and gynecological wards of the 1790-bed Mulago National Referral Hospital. Thirty percent were known HIV-seropositive (232/762). Nineteen percent (148/762; 95% CI: 17-22%) of inpatients experienced at least one aa-ADR. At hospital admission, 6% (45/762; 95% CI: 4-8%) of patients had at least one aa-ADR; and 15% (45/300; 11-20%) of those who had received antibiotics in the 4-weeks preadmission. Twenty-four (53%) of these 45 patients had serious aa-ADRs. The incidence of aa-ADRs was 19% (117/629; 95% CI: 16-22%) of patients who received antibiotics [community-acquired: 9% (27/300; 95% CI: 6-13%); hospital-acquired: 16% (94/603; 95% CI: 13-19%)]: 39 (33%) of 117 patients had serious aa-ADRs. Of 269 aa-ADRs, 115 (43%) were community-acquired, 66 (25%) probable/definite, 171 (64%) preventable, 86 (32%) serious, and 24 (9%) rare. Ceftriaxone was the most frequently implicated for serious hospital-acquired aa-ADRs. Cotrimoxazole, isoniazid, rifampicin, ethambutol, and pyrazinamide were the most frequently linked to serious community-acquired aa-ADRs. Fatal jaundice (isoniazid), life-threatening difficulty in breathing with shortness of breath (rifampicin) and disabling itchy skin rash with numbness of lower swollen legs (ethambutol, isoniazid) were observed. Pharmaceutical quality testing of implicated antibiotics could be worthwhile. Periodic on-ward collection and analysis of antibiotic-safety-data standardized by consumption is an efficient method of tracking antibiotics with 1%-risk for serious aa-ADRs.
我们试图确定乌干达住院患者入院时抗生素相关疑似药物不良反应（aa-ADRs）的患病率以及住院期间的发病率；并对这些aa-ADRs进行特征描述。我们在拥有1790张床位的穆拉戈国家转诊医院的内科和妇科病房对762名同意参与研究的成年人进行了一项前瞻性队列研究。30%的患者已知HIV血清学阳性（232/762）。19%（148/762；95%CI：17 - 22%）的住院患者经历了至少一次aa-ADR。入院时，6%（45/762；95%CI：4 - 8%）的患者至少有一次aa-ADR；在入院前4周内接受过抗生素治疗的患者中，这一比例为15%（45/300；11 - 20%）。这45名患者中有24名（53%）发生了严重的aa-ADR。接受抗生素治疗的患者中aa-ADR的发病率为19%（117/629；95%CI：16 - 22%）[社区获得性：9%（27/300；95%CI：6 - 13%）；医院获得性：16%（94/603；95%CI：13 - 19%）]：117名患者中有39名（33%）发生了严重的aa-ADR。在269例aa-ADR中，115例（43%）为社区获得性，66例（25%）可能/确定，171例（64%）可预防，86例（32%）严重，24例（9%）罕见。头孢曲松是导致严重医院获得性aa-ADR最常见的药物。复方新诺明、异烟肼、利福平、乙胺丁醇和吡嗪酰胺是与严重社区获得性aa-ADR最常相关的药物。观察到致命性黄疸（异烟肼）、危及生命的呼吸困难伴气短（利福平）以及导致下肢肿胀伴麻木的致残性瘙痒皮疹（乙胺丁醇、异烟肼）。对相关抗生素进行药品质量检测可能是值得的。定期在病房收集并分析按消耗量标准化的抗生素安全数据是追踪具有1%严重aa-ADR风险的抗生素的有效方法。
