Milstone Aaron, Patsimas John, Farzan David, Castaldo Richard, Singh Harmeet, Feurer Irene, Harnett James, Luke David R
Pulmonary Division, Vanderbilt University Medical Center, Nashville, TN 37232, USA.
Clin Ther. 2005 Jun;27(6):926-39. doi: 10.1016/j.clinthera.2005.06.001.
The 3-day course of azithromycin (AZM) 500 mg/d was introduced to the US market in June 2002.
The objective of this study was to evaluate changes in health-related quality of life (HRQOL) as measured by the St. George's Respiratory Questionnaire (SGRQ) over a 1-month period in patients receiving a 3-day course of AZM for bacterial acute exacerbation of chronic bronchitis (AECB).
This was a prospective, multicenter, observational study evaluating outpatient adults with AECB who received either 3 days of AZM 500 mg/d or 5- to 14-day courses of other antibiotics (usual care [UC]) as directed by the clinician. Patients completed 2 HRQOL instruments-the SGRQ and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)-at baseline, day 14, and end of study (EOS) at days 24 to 28. In addition, patients kept a diary for the first 14 days after initiating antibiotic therapy.
One hundred twenty-eight patients (57 AZM, 71 UC) were clinically evaluable. There were no significant differences between treatment groups in clinical presentation or baseline demographics, with the exception of a higher percentage of patients with diabetes mellitus in the UC group compared with the AZM group (16.9% vs 3.5%; P = 0.02). Both groups reported similar improvements in signs and symptoms, absenteeism, concomitant respiratory medication use, resource utilization, compliance, and treatment satisfaction as reported in the patient diary. The AZM group reported statistically significant improvement (simple contrasts for end of study vs baseline) in SGRQ measures (total score, P < 0.001; symptoms, P = 0.031; activity, P < 0.001; impacts, P < 0.001) and the SF-36 mental and physical summary components, compared with baseline (both, P < 0.001). Similarly, the UC group reported significant improvement in all SGRQ measures and in the SF-36 physical component score (P < 0.01), but not in the SF-36 mental component score, compared with baseline. At EOS, 80.0% of AZM patients and 59.0% of UC patients had a > or =4-point improvement on the SGRQ total score; however, this difference was not statistically significant in the multivariate analysis. In addition, 89.5% of AZM patients and 89.9% of UC patients were satisfied or very satisfied with their treatment (P = NS). Resource utilization was similar between the groups.
In this observational study, patients with AECB treated with a 3-day course of AZM experienced significant improvements in HRQOL as measured by a change of > or =4 points on the SGRQ and SF-36 physical and mental component scores versus baseline.
阿奇霉素（AZM）500毫克/天的三日疗程于2002年6月进入美国市场。
本研究的目的是评估接受三日疗程AZM治疗慢性支气管炎细菌性急性加重（AECB）的患者在1个月期间，通过圣乔治呼吸问卷（SGRQ）测量的健康相关生活质量（HRQOL）的变化。
这是一项前瞻性、多中心、观察性研究，评估门诊患有AECB的成年人，他们按照临床医生的指示接受3天的500毫克/天AZM治疗或5至14天疗程的其他抗生素（常规治疗[UC]）。患者在基线、第14天以及研究结束时（EOS，第24至28天）完成2项HRQOL工具——SGRQ和医学结局研究36项简短健康调查（SF - 36）。此外，患者在开始抗生素治疗后的前14天记录日记。
128例患者（57例AZM组，71例UC组）可进行临床评估。治疗组之间在临床表现或基线人口统计学方面无显著差异，但UC组糖尿病患者的百分比高于AZM组（16.9%对3.5%；P = 0.02）。两组在患者日记中报告的体征和症状、缺勤情况、伴随呼吸药物使用、资源利用、依从性和治疗满意度方面均有类似改善。与基线相比，AZM组在SGRQ测量（总分，P < 0.001；症状，P = 0.031；活动，P < 0.001；影响，P < 0.001）以及SF - 36心理和身体综合成分方面报告有统计学显著改善（两者，P < 0.001）。同样，与基线相比，UC组在所有SGRQ测量以及SF - 36身体成分得分方面有显著改善（P < 0.01），但在SF - 36心理成分得分方面无改善。在EOS时，80.0%的AZM患者和59.0%的UC患者SGRQ总分改善≥4分；然而，在多变量分析中，这种差异无统计学意义。此外，89.5%的AZM患者和89.9%的UC患者对其治疗感到满意或非常满意（P = 无显著差异）。两组之间的资源利用情况相似。
在这项观察性研究中，接受三日疗程AZM治疗的AECB患者，通过SGRQ以及SF - 36身体和心理成分得分较基线变化≥4分来衡量，其HRQOL有显著改善。
