目的:评估与安慰剂相比,StroVac疫苗在复发性尿路感染(rUTI)患者中的有效性和安全性。
方法:我们进行了前瞻性,双盲,无并发症rUTI患者的安慰剂对照研究。患者每两周接受三次单次肌内注射StroVac。主要终点是随机分组后13.5个月的细菌性尿路感染(UTI)数量,并在比较verum和安慰剂组时根据各自的“基线”值进行调整。次要终点是未复发的患者人数,第一次复发的时间,复发的频率,和患者使用经过验证的问卷对生活质量进行自我评估。
结果:在2012年1月至2015年3月期间,将376例患者随机分为两组。平均年龄为44.4岁。患者主要为女性(98.4%)。在StroVac组(n=188)中,UTI的数量从5.5降至1.2,安慰剂组(n=188)从5.4降至1.3(p=0.63).在纳入研究前患有≥7个UTI的患者中,StroVac在统计学上显著优于安慰剂(p=0.048)。然而,在所有其他次要端点中,两组间无统计学差异(均P>0.3)。
结论:StroVac像以前的研究一样减少了临床相关尿路感染的数量,但没有显示出比选择的安慰剂更好的统计学结果。最有可能的是,那是因为,自确认以来,所选择的安慰剂本身的预防作用。因此,需要使用不同无效安慰剂制剂的安慰剂对照和双盲研究,以确定StroVac在预防rUTI中的重要性.
OBJECTIVE: To evaluate efficacy and safety of vaccination with StroVac compared to placebo in patients with recurrent urinary tract infections (rUTI).
METHODS: We performed a prospective, double-blinded, placebo-controlled study in patients with uncomplicated rUTI. Patients received three single intramuscular injections with StroVac every two weeks. Primary endpoint was the number of bacterial urinary tract infections (UTI) over 13.5 months after randomization and adjusted by the respective \"baseline\" value when comparing verum and placebo group. Secondary endpoints were the number of patients with non-recurrence, time to first recurrence, frequency of recurrences, and patients\' self-assessment of quality of life using a validated questionnaire.
RESULTS: 376 patients were randomized to both groups between January 2012 and March 2015. Mean age was 44.4 years. Patients were mainly female (98.4%). In the StroVac group (n = 188), the number of UTIs was reduced from 5.5 to 1.2, in the placebo group (n = 188) from 5.4 to 1.3 (p = 0.63). In patients with ≥ 7 UTIs prior to study inclusion, StroVac was statistically significantly superior to placebo (p = 0.048). However, in all other secondary endpoints, no statistical differences between the two groups could be seen (all p > 0.3).
CONCLUSIONS: StroVac reduced the number of clinically relevant UTIs like in former studies but did not show statistically significant better results than the chosen placebo. Most likely, that was due to a, since confirmed, prophylactic effect of the chosen placebo itself. Therefore, placebo-controlled and double-blinded studies using a different ineffective placebo preparation are needed to determine the importance of StroVac in prophylaxis of rUTI.