Long-Term Maintenance Effect of Qing Dai for Ulcerative Colitis.
Long-Term Maintenance Effect of Qing Dai for Ulcerative Colitis.
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DOI：
10.1089/acm.2018.0057
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发表时间：
2018-04
影响因子：
2.6
通讯作者：
Hideo Suzuki;Y. Mizokami;M. Gosho;T. Kaneko;H. Matsui;A. Yanaka
中科院分区：
文献类型：
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作者：
Hideo Suzuki;Y. Mizokami;M. Gosho;T. Kaneko;H. Matsui;A. Yanaka
方法回顾性分析2010年至2017年间对常规治疗（包括5-氨基水杨酸、泼尼松龙或硫唑嘌呤）耐药且临床活动指数（CAI）评分> 5的患者。患者从 Seishinshoyakudo（日本东京）购买青黛自用，初始口服剂量为 1 g，每天两次，粉末形式。在青黛给药前以及给药后 2、12 和 24 个月时监测 CAI 评分。缓解定义为 CAI 评分在 2 个月内下降 > 50%，缓解定义为 CAI 评分维持在 < 4。2 还监测不良事件和内镜 Matts 3 级的发生情况。该研究得到了筑波大学医院机构审查委员会 (H28-76) 的审查和批准。使用Statcel 4 (OMS Publishing Co., Saitama, Japan)和SAS 9.4 (SAS Institute, NC)软件进行统计分析。结果平均年龄为38岁，范围为16-71岁，有效率为90%(18/20)。在有反应者和无反应者之间没有发现患者特征的有意义的差异。服用青黛后，18 名应答者的连续 CAI 评分在 2 个月内从 6.9±1.5 降至 0.8±1.1，12 个月内降至 0.6±0.8，24 个月内降至 0.5±0.5 (p<0.001)。在初始 CAI 评分高 (p= 0.03) 和内镜 Matts 分级高 (p= 0.04) 的患者中观察到快速反应。观察期间所有应答者均维持缓解。代表性2例内镜检查结果变化见图1。青黛给药前已发现粘膜糜烂、红肿、炎性息肉或深度溃疡（图1A、D）。 3～6个月后，观察到粘膜愈合，溃疡变为疤痕（图1B、E）。粘膜愈合可持续长达 30 个月（图 1C、F）。
MethodsPatients who are refractory to conventional therapy, including 5-aminosalicylic acid, prednisolone, or azathioprine, and who have a clinical activity index (CAI) score of> 5 at the initiation of the Qing Dai therapy between 2010 and 2017 were retrospectively analyzed. The patients purchased Qing Dai from Seishinshoyakudo (Tokyo, Japan) for their own use and took an initial oral dose of 1 g twice a day in powder form. The CAI scores were monitored before and at 2, 12, and 24 months after Qing Dai administration. Response was defined as a decrease in CAI score of> 50% within 2 months, and remission was defined as a CAI score maintained at< 4. 2 The occurrence of adverse events and endoscopic Matts grade 3 was also monitored. The study was reviewed and approved by the University of Tsukuba Hospital Institutional Review Board (H28-76). Statistical analyses were performed with Statcel 4 (OMS Publishing Co., Saitama, Japan) and SAS 9.4 (SAS Institute, NC) software.ResultsThe mean age was 38 years with a range of 16–71 years, and the response rate was 90%(18/20). No meaningful differences in patient characteristics were found between the responders and nonresponders. The sequential CAI scores in 18 responders decreased from 6.9±1.5 to 0.8±1.1 in 2 months, to 0.6±0.8 in 12 months, and to 0.5±0.5 in 24 months (p< 0.001) after Qing Dai administration. Rapid response was observed in the patients with high initial CAI scores (p= 0.03) and high endoscopic Matts grade (p= 0.04). Remission was maintained in all the responders during observation. The changes in endoscopic findings in the representative two cases are shown in Figure 1. Mucosal erosion, redness, inflammatory polyps, or deep ulcerations were found before Qing Dai administration (Fig. 1A, D). After 3 to 6 months, mucosal healing was observed, and the ulcer changed to a scar (Fig. 1B, E). Mucosal healing persisted for up to 30 months (Fig. 1C, F).