Ryu Hoyoung, Song Sang Hun, Lee Sang Eun, Song Kyoung-Ho, Lee Sangchul
Department of Urology.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Medicine (Baltimore). 2019 Mar;98(12):e14854. doi: 10.1097/MD.0000000000014854.
To investigate a way to reduce infectious complication after transrectal ultrasonography-guided prostate biopsy (TRUS-Bx), we planned a randomized trial to determine whether the use of the povidone-iodine suppository is effective in preventing infectious complications.
This study prospectively assessed 250 patients who underwent TRUS-Bx during December 2014 and May 2016. Clinical questionnaire responses and safety were evaluated. Povidone-iodine suppository after glycerin enema was performed 1 to 2 hours before TRUS-Bx. Both groups received the prophylactic antibiotics (ceftriaxone 2.0 g) 30 to 60 minutes before TRUS-Bx. No antibiotics were prescribed after TRUS-Bx.
The 120 were assigned in the treatment group using povidone-iodine suppository and 130 were assigned in the control group. There was no significant difference of clinicopathologic features including age, prostate-specific antigen and cancer detection rate in both groups (P > .05). No infectious and non-infectious complications were reported in both groups. Povidone-iodine suppository-related side effects were not reported. No significant differences in international prostate symptom score, sexual health inventory for men score, and European Organization for Research and Treatment of Cancer Quality of Life questionnaire scores were found between the 2 groups (P > .05). No changes in each questionnaire scores between before and after TRUS-Bx were observed.
Despite satisfying the predefined sample size, we could not prove the hypothesis that the use of povidone-iodine suppositories after TRUS-Bx would reduce infectious complications. A large-scale, multicenter, prospective study is needed to fully evaluate the clinical efficacy and safety of povidone-iodine suppository prior to TRUS-Bx.
为研究一种降低经直肠超声引导下前列腺穿刺活检（TRUS-Bx）术后感染性并发症的方法，我们计划开展一项随机试验，以确定聚维酮碘栓剂在预防感染性并发症方面是否有效。
本研究前瞻性评估了2014年12月至2016年5月期间接受TRUS-Bx的250例患者。对临床问卷回复和安全性进行了评估。在TRUS-Bx前1至2小时进行甘油灌肠后使用聚维酮碘栓剂。两组在TRUS-Bx前30至60分钟均接受预防性抗生素（头孢曲松2.0 g）治疗。TRUS-Bx术后未开抗生素。
120例被分配到使用聚维酮碘栓剂的治疗组，130例被分配到对照组。两组在年龄、前列腺特异性抗原和癌症检出率等临床病理特征方面无显著差异（P>0.05）。两组均未报告感染性和非感染性并发症。未报告聚维酮碘栓剂相关的副作用。两组在国际前列腺症状评分、男性性健康量表评分和欧洲癌症研究与治疗组织生活质量问卷评分方面无显著差异（P>0.05）。未观察到TRUS-Bx前后各问卷评分的变化。
尽管达到了预定的样本量，但我们无法证明TRUS-Bx后使用聚维酮碘栓剂会降低感染性并发症这一假设。需要进行大规模、多中心、前瞻性研究，以全面评估TRUS-Bx前聚维酮碘栓剂的临床疗效和安全性。
