Ogawa Chikako, Sato Yoshiaki, Suzuki Chiyo, Mano Azusa, Tashiro Atsushi, Niwa Takafumi, Hamazaki Sayako, Tanahashi Yoshihiro, Suzumura Midori, Hayano Satoshi, Hayakawa Masahiro, Tsuji Takeshi, Hoshino Shin, Sugiyama Yuichiro, Kidokoro Hiroyuki, Kawada Jun-Ichi, Muramatsu Hideki, Hirakawa Akihiro, Ando Masahiko, Natsume Jun, Kojima Seiji
Department of Pediatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Division of Neonatology, Center for Maternal-Neonatal Care, Nagoya University Hospital, Nagoya, Japan.
PLoS One. 2018 Feb 13;13(2):e0192688. doi: 10.1371/journal.pone.0192688. eCollection 2018.
The aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma.
An open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The healing rate was evaluated until completion of 3 weeks of treatment.
Participants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104) or topical steroid ointment (n = 103). Healing rates after 2 weeks of treatment were 87.5% (91/104) in the silver nitrate cauterization and 82% (82/100) in the topical steroid ointment group group. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%), indicating that the non-inferiority criterion was not met. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 [90.4%] vs. 91/100 [91.0%]; 0.6% [-13.2 to 14.3]). No major complications occurred in either group.
This study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. To clarify non-inferiority, a larger study is needed.
本前瞻性多中心随机对照试验的目的是比较硝酸银烧灼术与局部用类固醇软膏治疗新生儿脐肉芽肿的疗效。
于2013年1月至2016年1月进行了一项开放标签、非劣效性随机对照试验。硝酸银烧灼术组和局部用类固醇软膏组的主要终点是治疗2周后的愈合率，非劣效性界值设定为10%。评估愈合率直至治疗满3周。
参与者包括207例新诊断为脐肉芽肿的新生儿，随机分为接受硝酸银烧灼术组（n = 104）或局部用类固醇软膏组（n = 103）。硝酸银烧灼术组治疗2周后的愈合率为87.5%（91/104），局部用类固醇软膏组为82%（82/100）。组间差异为-5.5%（95%置信区间，-19.1%，8.4%），表明未达到非劣效性标准。治疗3周后，局部用类固醇软膏治疗的愈合率与硝酸银烧灼术几乎相同（94/104 [90.4%] 对 91/100 [91.0%]；0.6% [-13.2至14.3]）。两组均未发生重大并发症。
本研究未证实局部用类固醇软膏治疗相对于硝酸银烧灼术的非劣效性，可能是由于愈合率低于预期导致试验效能不足。然而，考虑到硝酸银烧灼术有明显的化学烧伤风险，且局部用类固醇软膏治疗的总体疗效与硝酸银烧灼术相似，因其安全性和简便性，局部用类固醇软膏可被视为治疗新生儿脐肉芽肿的良好替代方法。为明确非劣效性，需要进行更大规模的研究。
