Foon Richard, Toozs-Hobson Philip, Latthe Pallavi
Obstetrics and Gynaecology, Royal Shrewsbury hospital, Shrewsbury, UK.
Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD008224. doi: 10.1002/14651858.CD008224.pub2.
There is a risk that people who have invasive urodynamic studies (cystometry) will develop urinary tract infections or bacteria in the urine or blood. However, the use of prophylactic antibiotics before or immediately after invasive cystometry or urodynamic studies is not without risks of adverse effects and emergence of resistant microbes.
To assess the effectiveness and safety of administering prophylactic antibiotics in reducing the risk of urinary tract infections after urodynamic studies. The hypothesis was that administering prophylactic antibiotics reduces urinary tract infections after urodynamic studies.
We searched the Cochrane Incontinence Group Specialised Trial Register, MEDLINE (January 1966 to January 2009), CINAHL (January 1982 to January 2009), EMBASE (January 1966 to January 2009), PubMed (1 January 1980 to January 2009), LILACS (up to January 2009), TRIP database (up to January 2009), and the UK NHS Evidence Health Information Resources (searched 10 December 2009). We searched the reference lists of relevant articles, the primary trials and the proceedings of the International Urogynaecological Association International Continence Society and the American Urological Association for the years 1999 to 2009 to identify articles not captured by electronic searches. There were no language restrictions.
All randomized controlled trials and quasi-randomized trials comparing the use of prophylactic antibiotics versus a placebo or no treatment in patients having urodynamic studies were selected. Two authors (PL and RF) independently performed the selection of trials for inclusion and any disagreements were resolved by discussion.
All assessments of the quality of trials and data extraction were performed independently by two authors of the review (PL and RF) using forms designed according to Cochrane guidelines. We attempted to contact authors of the included trials for any missing data. Data were extracted on characteristics of the study participants including details of previously administered treatments, interventions used, the methods used to measure infection and adverse events.Statistical analyses were performed according to Cochrane Collaboration guidelines. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were expressed as a risk ratio (RR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method.The primary outcome was urinary tract infection. Heterogeneity was assessed by the P value and I(2) statistic.
Nine randomized controlled trials involving the prophylactic use of antibiotics in patients having urodynamic studies were identified and these included 973 patients in total; one study was an abstract. Two further trials were excluded from the review. The methods of the included trials were poorly described.The primary outcome in all trials was the rate of developing significant bacteriuria, defined as the presence of more than 100,000 bacteria per millilitre of a mid-stream urine sample on culture and sensitivity testing. The other outcomes included pyrexia, haematuria, dysuria and adverse reactions to antibiotics.The administration of prophylactic antibiotics when compared to a placebo reduced the risk of significant bacteriuria (4% with antibiotics versus 12% without, risk ratio (RR) 0.35, 95% CI 0.22 to 0.56) in both men and women. The administration of prophylactic antibiotics also reduced the risk of haematuria (RR 0.46, 95% CI 0.23 to 0.91). However, there was no statistically significant difference in the primary outcome, risk of symptomatic urinary tract infection (40/201, 20% versus 59/214, 28%; RR 0.73, 95% CI 0.52 to 1.03); or in the risk of fever (RR 5.16, 95% CI 0.94 to 28.16) or dysuria (RR 0.83, 95% CI 0.5 to 1.36). Only two of 135 people had an adverse reaction to the antibiotics. The number of patients needed to treat with antibiotics to prevent bacteriuria was 12.3. Amongst women, the number needed to treat to prevent bacteriuria was 13.4; while amongst men it was 9.1 (number needed to treat = 1/ absolute risk reduction).
AUTHORS' CONCLUSIONS: Prophylactic antibiotics did reduce the risk of bacteriuria after urodynamic studies but there was not enough evidence to suggest that this effect reduced symptomatic urinary tract infections. There was no statistically significant difference in the risk of fever, dysuria or adverse reactions. Potential benefits have to be weighed against clinical and financial implications, and the risk of adverse effects.
接受侵入性尿动力学检查(膀胱测压)的患者有发生尿路感染、尿液或血液中出现细菌的风险。然而,在侵入性膀胱测压或尿动力学检查之前或之后立即使用预防性抗生素并非没有不良反应风险以及耐药微生物出现的风险。
评估使用预防性抗生素降低尿动力学检查后尿路感染风险的有效性和安全性。假设是使用预防性抗生素可降低尿动力学检查后的尿路感染风险。
我们检索了Cochrane尿失禁组专业试验注册库、MEDLINE(1966年1月至2009年1月)、CINAHL(1982年1月至2009年1月)、EMBASE(1966年1月至2009年1月)、PubMed(1980年1月1日至2009年1月)、LILACS(截至2009年1月)、TRIP数据库(截至2009年1月)以及英国国民健康服务证据健康信息资源库(2009年12月10日检索)。我们检索了相关文章的参考文献列表、主要试验以及1999年至2009年国际 urogynecological协会国际尿失禁协会和美国泌尿外科学会的会议记录,以识别未被电子检索捕获的文章。无语言限制。
选择所有比较在接受尿动力学检查的患者中使用预防性抗生素与安慰剂或不治疗的随机对照试验和半随机试验。两位作者(PL和RF)独立进行纳入试验的选择,任何分歧通过讨论解决。
所有试验质量评估和数据提取均由该综述的两位作者(PL和RF)根据Cochrane指南设计的表格独立进行。我们试图联系纳入试验的作者获取任何缺失数据。提取了关于研究参与者特征的数据,包括先前给予治疗的细节、使用的干预措施、测量感染和不良事件的方法。根据Cochrane协作网指南进行统计分析。如有可用数据,则使用意向性分析的数据。对于二分数据,每项研究的结果以风险比(RR)及其95%置信区间(CI)表示,并使用Mantel-Haenszel方法合并进行荟萃分析。主要结局是尿路感染。通过P值和I²统计量评估异质性。
确定了9项关于在接受尿动力学检查的患者中预防性使用抗生素的随机对照试验,共包括973例患者;1项研究为摘要。另外2项试验被排除在综述之外。纳入试验的方法描述欠佳。所有试验的主要结局是发生显著菌尿的发生率,显著菌尿定义为在培养和药敏试验中,中段尿样本每毫升中细菌数超过100,000个。其他结局包括发热、血尿、排尿困难以及对抗生素的不良反应。与安慰剂相比,使用预防性抗生素降低了男性和女性显著菌尿的风险(抗生素组为4%,未使用组为12%,风险比(RR)0.35,95%CI 0.22至0.56)。使用预防性抗生素也降低了血尿风险(RR 0.46,95%CI 0.23至0.91)。然而,在主要结局即有症状尿路感染的风险方面无统计学显著差异(40/201,20% 对 59/214,28%;RR 0.73,95%CI 0.52至1.03);在发热风险(RR 5.16,95%CI 0.94至28.16)或排尿困难风险(RR 0.83,95%CI 0.5至1.36)方面也无统计学显著差异。135人中只有2人对抗生素有不良反应。预防菌尿所需使用抗生素治疗的患者数为12.3。在女性中,预防菌尿所需治疗数为13.4;而在男性中为9.1(所需治疗数 = 1/绝对风险降低)。
预防性抗生素确实降低了尿动力学检查后菌尿的风险,但没有足够证据表明这种效果降低了有症状的尿路感染。在发热、排尿困难或不良反应风险方面无统计学显著差异。必须权衡潜在益处与临床和经济影响以及不良反应风险。