Kauf Teresa L, McKinnon Peggy, Corey G Ralph, Bedolla John, Riska Paul F, Sims Matthew, Jauregui-Peredo Luis, Friedman Bruce, Hoehns James D, Mercier Renée-Claude, Garcia-Diaz Julia, Brenneman Susan K, Ng David, Lodise Thomas
Health Economics and Outcomes Research, Merck & Co., Inc., 2000 Galloping Road, Kenilworth, NJ, 07033, USA.
Global Center for Scientific Affairs, Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.
BMC Infect Dis. 2015 Nov 7;15:503. doi: 10.1186/s12879-015-1261-9.
Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers.
The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge.
No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95% confidence interval [CI], 0.249-0.997; P < 0.05).
This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.
ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).
复杂皮肤及皮肤结构感染（cSSSI）的治疗给医疗保健系统带来了巨大负担。了解与不同抗菌药物相关的相对资源利用情况，对于患者、医疗保健提供者和支付方的决策至关重要。
作者进行了一项开放标签、实用、随机（1:1）的临床研究（N = 250），以比较达托霉素与万古霉素治疗因疑似或确诊耐甲氧西林金黄色葡萄球菌感染而住院的cSSSI患者的有效性。主要研究终点为感染相关住院时间（IRLOS）。次要终点包括医疗保健资源利用、成本、临床反应和患者报告的结局。在抗生素治疗结束前或出院前，以及出院后14天和30天，每天对患者进行评估。
两组在IRLOS、总住院时间和总住院费用方面未发现差异。住院时间占总住院费用的85.9%，而药物费用占6.4%。在治疗第2天和第3天，与万古霉素相比，达托霉素的临床成功率有升高趋势，但无统计学意义。在多变量分析中，万古霉素与第2天临床成功的可能性较低相关（优势比[OR] = 0.498，95%置信区间[CI]，0.249 - 0.997；P < 0.05）。
本研究未提供一种治疗方法在临床、经济或患者结局方面优于另一种治疗方法的确凿证据。数据表明，对于住院的cSSSI患者，医生和患者的偏好而非药物采购成本，应是初始抗生素选择的主要驱动因素。
ClinicalTrials.gov：NCT01419184（日期：2011年8月16日）。
