4种下尿路感染药物治疗方案的转化医学研究  

A translational medical study on four medication regimens to treat lower urinary tract infections

作　　者：刘晓玲[1] 韩蕾[2] 李文华 宋周烨[1] 王琛[1] 祁晓鸣[1] 赵本慧[1] 吕佳迪[1] 常晓雯[1] 周艺添[1] 许梦[1] 陈一新[1] 冯丹宇[1] 王娟[1] 王馨[1] 孙保玲[1] 陈丁丁[1] 周晓辉[1] 

机构地区：[1]中国药科大学临床药学教研室,江苏南京211198 [2]江苏建康职业学院,江苏南京210036 [3]航空总医院泌尿外科,北京100012

出　　处：《转化医学杂志》2013年第3期137-142,共6页Translational Medicine Journal

基　　金：国家基础科学人才培养基金(J0630858)

摘　　要：目的运用转化医学的研究方法进一步量化比较4种不同用药方案治疗下尿路感染的临床效果。方法临床研究:4种治疗方案(左氧氟沙星、阿奇霉素、左氧氟沙星+热淋清颗粒、阿奇霉素+热淋清颗粒)的临床观察由航空总医院泌尿外科完成;统计98例急性下尿路感染门诊病例的症状积分;采用疗效指数(efficacy index,EI)和成本(cost,C)/疗效指数(C/EI)对各方案进行药物经济学分析。实验室研究:将60只SD雌鼠随机分成6组(空白组、造模组、左氧氟沙星组、阿奇霉素组、左氧氟沙星+热淋清颗粒组、阿奇霉素+热淋清颗粒组),经尿道插管注入大肠杆菌液,建立下尿路感染大鼠模型。各组分别于给药前和给药后进行尿培养,末次取尿后采用血清药理学方法进行血清药敏试验,最后收集膀胱组织行苏木素和伊红(hematoxylinand eosin,HE)染色和免疫组化。结果临床EI结果显示,4种治疗方案的疗效差异无统计学意义(P>0.05)。左氧氟沙星方案药物经济学最好(C/EI=292.42±28.12,P<0.05),阿奇霉素+热淋清颗粒方案药物经济学最差(C/EI=585.80±129.36,P<0.05)。实验室结果表明,4种治疗方案的疗效顺序为:左氧氟沙星+热淋清颗粒>左氧氟沙星≥阿奇霉素=阿奇霉素+热淋清颗粒,且差异有统计学意义(P<0.05)。结论在临床上疗效差异无统计学意义的不同治疗方案,在实验室研究中差异却有统计学意义。提示转化医学的研究模式能把临床观察结果进一步定量化,从而具有更强的比较性,为临床常用治疗方案的选择提供更定量化的参考信息,具有单一的临床研究模式或单一的实验室研究模式所无法替代的作用。ObjectiveTo further quantify and compare the effects of four medication regimens in treatment of lower urinary tract infections by translational medical study. MethodsClinical research： the effects and pharmacoeconomics of four regimens [Lavofloxacin （L）, Azithromycin （A）, Lavofloxacin ＋ Relinqing （L＋R）, Azithromycin＋Relinqing （A＋R）] used for 98 patients with acute lower urinary tract infection were evaluated according to the value of effect index （EI） and cost effectiveness index （C/EI）. In laboratory research： sixty adult female Sprague Dawley rats were randomly divided into six groups （Lavofloxacin, Azithromycin, Lavofloxacin＋Relinqing, Azithromycin＋Relinqing, model, and blank group respectively）. Rat pathological models were established to investigate the effects of four regimens according to the results of colony count in rat′s urine, observation on HE （hematoxylin and eosin） and immunohistological staining of bladder tissue, and the results of antimicrobial susceptibility tests using the methods of serum pharmacology.ResultsThe clinical study showed no significant differences （P〉0.05） among four regimens in EI comparison, but in C/EI, regimen L had the lowest cost （C/EI=29242±2812, P〈0.05） and regimen A ＋ R had the highest cost （C/EI=58580±12936, P〈0.05）. The laboratory study concluded that the effect of regimen L＋R was better than other three regimens, and regimen L was superior to regimen A＋R whose effect was similar to regimen A. ConclusionThe effects of different regimens similar in clinical observation may be different in laboratory research. Translational medicine quantifies the results of clinical observations and thus provides the quantitative information in screening common therapeutic regimens, which implies that it won′t be replaced by single clinical or laboratory research.

关 键 词：下尿路感染 治疗方案 药物经济学 血清药理学 转化医学 

分 类 号：R691.3[医药卫生—泌尿科学]