Heldman A W, Hartert T V, Ray S C, Daoud E G, Kowalski T E, Pompili V J, Sisson S D, Tidmore W C, vom Eigen K A, Goodman S N, Lietman P S, Petty B G, Flexner C
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Am J Med. 1996 Jul;101(1):68-76. doi: 10.1016/s0002-9343(96)00070-8.
To compare the efficacy and safety of inpatient oral antibiotic treatment (oral) versus standard parenteral antibiotic treatment (intravenous) for right-sided staphylococcal endocarditis in injection drug users.
In a prospective, randomized, non-blinded trial, febrile injection drug users were assigned to begin oral or intravenous (IV) treatment on admission, before blood culture results were available. Oral therapy consisted of ciprofloxacin and rifampin. Parenteral therapy was oxacillin or vancomycin, plus gentamicin for the first 5 days. Antibiotic dosing was adjusted for renal dysfunction. Administration of other antibacterial drugs was not permitted during the treatment or follow-up periods. Bacteremic subjects having right-sided staphylococcal endocarditis received 28 days of inpatient therapy with the assigned antibiotics. Test-of-cure blood cultures were obtained during inpatient observation 6 and 7 days after the completion of antibiotic therapy, and again at outpatient follow-up 1 month later. Criteria for treatment failure and for drug toxicity were prospectively defined.
Of 573 injection drug users who were hospitalized because of a febrile illness and suspected right-sided staphylococcal endocarditis, 93 subjects (16.2%) had two or more sets of blood cultures positive for staphylococci; 85 of these bacteremic subjects (14.8%) satisfied diagnostic criteria for at least possible right-sided staphylococcal endocarditis (no other source of bacteremia was apparent) and entered the trial. Forty-four (oral, 19; IV, 25) of these 85 subjects completed inpatient treatment and evaluation including test-of-cure blood cultures. There were four treatment failures (oral, 1 [5.2%]; IV, 3 [12.0%]; not significant, Fisher's exact test). Drug toxicity was significantly more common in the parenterally treated group (oral, 3%; IV, 62%; P < 0.0001), consisting largely of oxacillin-associated increases in liver enzymes.
For selected patients with right-sided staphylococcal endocarditis, oral ciprofloxacin plus rifampin is effective and is associated with less drug toxicity than is intravenous therapy.
比较住院口服抗生素治疗(口服)与标准肠外抗生素治疗(静脉注射)对注射吸毒者右侧葡萄球菌性心内膜炎的疗效和安全性。
在一项前瞻性、随机、非盲试验中,发热的注射吸毒者在血培养结果出来之前入院时即开始口服或静脉注射治疗。口服治疗方案为环丙沙星和利福平。肠外治疗方案为苯唑西林或万古霉素,头5天加用庆大霉素。根据肾功能调整抗生素剂量。治疗期或随访期内不允许使用其他抗菌药物。患有右侧葡萄球菌性心内膜炎的菌血症患者接受指定抗生素的28天住院治疗。在抗生素治疗结束后第6和7天的住院观察期间以及1个月后的门诊随访时采集治愈检测血培养样本。前瞻性地定义了治疗失败和药物毒性的标准。
573例因发热性疾病和疑似右侧葡萄球菌性心内膜炎住院的注射吸毒者中,93例(16.2%)有多套血培养葡萄球菌阳性;其中85例菌血症患者(14.8%)符合至少可能的右侧葡萄球菌性心内膜炎诊断标准(无其他明显菌血症来源)并进入试验。这85例患者中有44例(口服组19例;静脉注射组25例)完成了住院治疗和评估,包括治愈检测血培养。有4例治疗失败(口服组1例[5.2%];静脉注射组3例[12.0%];差异无统计学意义,Fisher精确检验)。药物毒性在肠外治疗组更为常见(口服组3%;静脉注射组62%;P<0.0001),主要是苯唑西林相关的肝酶升高。
对于选定的右侧葡萄球菌性心内膜炎患者,口服环丙沙星加利福平有效,且与静脉注射治疗相比药物毒性较小。