菲米司酮与排石颗粒对比用于预防经尿道中段吊带术后泌尿道感染的非劣效性研究。
Femistina versus Canephron as a prevention of urinary tract infections after midurethral sling surgery - Non-inferiority study.
机构信息
2(nd) Department of Gynecology, Medical University of Lublin, ul. Jaczewskiego 8, 20-954 Lublin, Poland.
Department of Paediatric Propedeutics, Medical University of Lublin, ul. A. Gebali 9, 20-091, Lublin, Poland.
出版信息
Eur J Obstet Gynecol Reprod Biol. 2022 Oct;277:71-76. doi: 10.1016/j.ejogrb.2022.08.009. Epub 2022 Aug 13.
OBJECTIVE
Urinary tract infection (UTI) is relatively common post-operative complication following midurethral sling placement (MUS), even in cases where intraoperative antibiotic prophylaxis was given. The primary aim of this study was to investigate the non-inferiority of Femistina as compared with Canephron in reducing symptomatic UTI in first six months following surgery.
STUDY DESIGN
A sample size of 144 patients per group was established, to provide at least 90% power to demonstrate the non-inferiority of phytodrug Femistina versus Canephron as a prevention of post-MUS urinary tract infection.
RESULTS
Women suffering from stress urinary incontinence and mixed urinary incontinence (MUI) with predominant SUI symptoms as confirmed by urodymamics (n = 320) were randomized in a 1:1 ratio to Femistina (40 mg, oral, twice daily for 20 days) or Canephron (3 × 5 ml taken orally-three times daily for 4 weeks). Both groups were homogenous for age, type of operation (only TOT outside-in) and severity of illness as indicated by ICIQ-SF questionnaire. We found that symptoms of UTI were significantly lower in patients receiving Femistina. During first 6 months after surgery UTI was confirmed in only 10 patients receiving Femistina (6,25%) when compared to 25 (15,63%) subjects receiving Canephron, p < 0.007.
CONCLUSION
Femistina is not inferior to Canephron in preventing lower urinary tract infection after midurethral sling surgery.
目的
即使在术中给予抗生素预防的情况下，尿道中段吊带（MUS）放置后尿路感染（UTI）也是一种相对常见的术后并发症。本研究的主要目的是研究 Femistina 与 Canephron 相比在减少术后 6 个月内症状性 UTI 方面的非劣效性。
设计
为每组建立了 144 例患者的样本量，以提供至少 90%的效力来证明植物药 Femistina 与 Canephron 作为预防 MUS 后尿路感染的非劣效性。
结果
患有压力性尿失禁和混合性尿失禁（MUI）且以尿动力学证实为主的 SUI 症状的女性（n=320）按 1:1 的比例随机分为 Femistina（40mg，口服，每天两次，共 20 天）或 Canephron（3×5ml，口服，每天三次，共 4 周）组。两组在年龄、手术类型（仅 TOT 从外向内）和 ICIQ-SF 问卷所示疾病严重程度方面均具有同质性。我们发现，接受 Femistina 治疗的患者 UTI 症状明显较低。在手术后的前 6 个月内，仅接受 Femistina 的 10 例患者（6.25%）证实患有 UTI，而接受 Canephron 的 25 例患者（15.63%），p<0.007。
结论
Femistina 在预防尿道中段吊带手术后下尿路感染方面并不逊于 Canephron。
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