Matsuno Yuichi, Hirano Atsushi, Torisu Takehiro, Okamoto Yasuharu, Fuyuno Yuta, Fujioka Shin, Umeno Junji, Moriyama Tomohiko, Nagai Shuntaro, Hori Yoshifumi, Fujiwara Minako, Kitazono Takanari, Esaki Motohiro
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
J Gastroenterol Hepatol. 2020 Mar;35(3):412-417. doi: 10.1111/jgh.14823. Epub 2019 Aug 26.
Indigo naturalis (IN) is a traditional Chinese herbal medicine reported to be effective in inducing remission in ulcerative colitis (UC). We conducted a retrospective observational study to investigate the efficacy and safety of IN for induction and maintenance therapy in patients with inflammatory bowel disease.
Data were collected from the electric medical records of patients with inflammatory bowel disease who had started IN treatment between March 2015 and April 2017 at Kyushu University Hospital. Clinical response and remission rates were assessed based on the clinical activity index determined by Rachmilewitz index or Crohn's disease (CD) activity index. Cumulative IN continuation rates were estimated using the Kaplan-Meier method. Overall adverse events (AEs) during follow-up were also analyzed.
Seventeen UC patients and eight CD patients were enrolled. Clinical response and remission rates at week 8 were 94.1% and 88.2% in UC patients and 37.5% and 25.0% in CD patients, respectively. Clinical remission rates, as assessed through non-responders imputation analyses at weeks 52 and 104, were 76.4% and 70.4% in UC patients and 25.0% and 25.0% in CD patients, respectively. Ten patients (40%) experienced AEs during follow-up. Three patients (12%) experienced severe AEs, including acute colitis requiring hospitalization in two patients and acute colitis with intussusception requiring surgery in one patient.
Indigo naturalis showed favorable therapeutic efficacy in UC, whereas its therapeutic efficacy in CD appeared to be modest. The risk of severe AEs should be recognized for IN treatment.
青黛是一种传统中药，据报道对诱导溃疡性结肠炎（UC）缓解有效。我们进行了一项回顾性观察研究，以调查青黛在炎症性肠病患者诱导和维持治疗中的疗效及安全性。
收集2015年3月至2017年4月在九州大学医院开始接受青黛治疗的炎症性肠病患者的电子病历数据。根据Rachmilewitz指数或克罗恩病（CD）活动指数确定的临床活动指数评估临床反应和缓解率。采用Kaplan-Meier法估计青黛累积持续使用率。还分析了随访期间的总体不良事件（AE）。
纳入17例UC患者和8例CD患者。UC患者第8周的临床反应率和缓解率分别为94.1%和88.2%，CD患者分别为37.5%和25.0%。通过对无反应者进行插补分析评估，UC患者第52周和104周的临床缓解率分别为76.4%和70.4%，CD患者分别为25.0%和25.0%。10例患者（40%）在随访期间出现AE。3例患者（12%）出现严重AE，包括2例需要住院治疗的急性结肠炎和1例需要手术治疗的伴有肠套叠的急性结肠炎。
青黛在UC中显示出良好的治疗效果，而其在CD中的治疗效果似乎一般。应认识到青黛治疗存在严重AE的风险。
