糖尿病无症状菌尿症女性患者的抗菌治疗。

Antimicrobial treatment in diabetic women with asymptomatic bacteriuria.

作者信息

Harding Godfrey K M, Zhanel George G, Nicolle Lindsay E, Cheang Mary

机构信息

Department of Internal Medicine, University of Manitoba, Winnipeg, Man., Canada.

出版信息

N Engl J Med. 2002 Nov 14;347(20):1576-83. doi: 10.1056/NEJMoa021042.

DOI:10.1056/NEJMoa021042

PMID:12432044

Abstract

BACKGROUND

Asymptomatic bacteriuria is common among women with diabetes, and the treatment of such infections has been recommended to prevent complications related to symptomatic urinary tract infection.

METHODS

We enrolled women (>16 years of age) with diabetes, bacteriuria (> or =105 colony-forming units of an organism per milliliter in cultures of two consecutive urine specimens), and no urinary symptoms; 50 were randomly assigned to receive placebo and 55 to receive antimicrobial therapy. For the first six weeks, which included the initial course of treatment, the study was placebo-controlled and double-blind. Subsequently, the women were screened for bacteriuria every three months for up to three years; antimicrobial therapy was provided to women in the antimicrobial-therapy group who had asymptomatic bacteriuria.

RESULTS

Four weeks after the end of the initial course of therapy, 78 percent of placebo recipients had bacteriuria, as compared with 20 percent of women who received antimicrobial agents (P<0.001). During a mean follow-up of 27 months, 20 of 50 women in the placebo group (40 percent) and 23 of 55 women in the antimicrobial-therapy group (42 percent) had at least one episode of symptomatic urinary tract infection. The time to a first symptomatic episode was similar in the placebo group and the antimicrobial-therapy group (P=0.67 by the log-rank test), as were the (+/-SD) rates of any symptomatic urinary tract infection (1.10+/-0.17 and 0.93+/-0.14 per 1000 days of follow-up, respectively; relative risk, 1.19; 95 percent confidence interval, 0.28 to 1.81), pyelonephritis (0.28+/-0.08 and 0.13+/-0.05 per 1000 days of follow-up; relative risk, 2.13; 95 percent confidence interval, 0.81 to 5.62), and hospitalization for urinary tract infection (0.10+/-0.36 and 0.06+/-0.22 per 1000 days of follow-up; relative risk, 1.93; 95 percent confidence interval, 0.47 to 7.89). The women in the antimicrobial-therapy group had almost five times as many days of antibiotic use for urinary tract infection as did the women in the placebo group (158.2+/-1.7 vs. 33.7+/-0.91 per 1000 days of follow-up; relative risk, 0.21; 95 percent confidence interval, 0.20 to 0.22).

CONCLUSIONS

Treatment of asymptomatic bacteriuria in women with diabetes does not appear to reduce complications. Diabetes itself should not be an indication for screening for or treatment of asymptomatic bacteriuria.

摘要

背景

无症状菌尿在糖尿病女性中很常见，已建议治疗此类感染以预防与有症状的尿路感染相关的并发症。

方法

我们纳入了年龄大于16岁、患有糖尿病、菌尿（连续两次尿液标本培养中每毫升尿液中某种微生物的菌落形成单位≥10⁵）且无泌尿系统症状的女性；50名女性被随机分配接受安慰剂，55名女性接受抗菌治疗。在最初六周，包括初始治疗疗程，该研究为安慰剂对照、双盲研究。随后，每三个月对这些女性进行菌尿筛查，最长持续三年；抗菌治疗组中有无症状菌尿的女性接受抗菌治疗。

结果

初始治疗疗程结束四周后，78%接受安慰剂的女性有菌尿，而接受抗菌药物治疗的女性中这一比例为20%（P<0.001）。在平均27个月的随访期间，安慰剂组50名女性中有20名（40%），抗菌治疗组55名女性中有23名（42%）至少有一次有症状的尿路感染发作。安慰剂组和抗菌治疗组首次出现有症状发作的时间相似（对数秩检验P=0.67），有症状的尿路感染（分别为每1000天随访1.10±0.17次和0.93±0.14次；相对风险，1.19；95%置信区间，0.28至1.81）、肾盂肾炎（每1000天随访0.28±0.08次和0.13±0.05次；相对风险，2.13；95%置信区间，0.81至5.62）以及因尿路感染住院（每1000天随访0.10±0.36次和0.06±0.22次；相对风险，1.93；95%置信区间，0.47至7.89）的发生率也相似。抗菌治疗组女性因尿路感染使用抗生素的天数几乎是安慰剂组女性的五倍（每1000天随访分别为158.2±1.7天和33.7±0.91天；相对风险为0.21；95%置信区间为0.20至0.22）。