Re: Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis
Re: Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis
复制标题
回复：2018 年东京指南：急性胆管炎和胆囊炎的抗菌治疗
DOI：
10.1002/jhbp.556
复制
发表时间：
2018
期刊：
影响因子：
--
通讯作者：
J. Regimbeau
中科院分区：
文献类型：
--
作者：
O. Guérin;J. Regimbeau
我们怀着一定的兴趣阅读了关于急性胆管炎和结石性胆囊炎治疗管理的新东京指南2018，特别是Gomi等人撰写并发表在贵刊上的文章“东京指南2018：急性胆管炎和胆囊炎的抗菌治疗”[1]。回答问题4：“急性胆囊炎患者抗菌治疗的最佳持续时间”，作者报告了两项随机临床试验，一项由Loozen等人发表，另一项由我们自己的小组发表[2，3]。他们的结论是“尽管在两项随机对照试验中均未证明非劣效性，但无临床显著差异。”Loozen等人的研究确实未证明非劣效性。根据意向治疗分析的结果显示，两组的术后并发症发生率均为4%，95% CI = [ 8.2%; 8.9%]（P = 0.2%）。本研究的非劣效性界值为5% [2]。然而，在我们的研究中已经证明了非劣效性。这项法国多中心研究始于2010年，旨在证明在急性低度和中重度结石性胆囊炎（I级和II级）中，胆囊切除术后不使用抗生素治疗并不劣于抗生素治疗处方：主要评价标准是术后感染（POI）。为了确定非劣效性，95%置信区间的上限必须低于非劣效性界值（11%）。在我们的研究中，两组之间没有显著差异（无抗生素组的POI率为17%，抗生素组为15%），95% CI = [ 8.98%; 5.12%]在意向治疗分析中（P = 1.93%），两组比较差异无统计学意义（两组的POI发生率均为13%），符合方案分析的95% CI = [ 5.0%; 6.3%]（P = 0.3%）[3]。然后，证明了不使用抗生素治疗和POI的非劣效性。我科致力于简化急性结石性胆囊炎（ACC）患者的护理，除早期胆囊切除术外，我们的方向与您的指南相同：轻度或中度ACC患者术后无需抗生素治疗[1，3]，无需引流[4]，住院时间短[5]。目前，我们正在评估这些准则在法国的执行情况。由于TG 13对抗生素治疗仍不清楚，欢迎这些官方新东京指南2018支持我们的方法。
It is with a certain interest that we read the new Tokyo Guidelines 2018 about the therapeutic management of acute cholangitis and calculous cholecystitis, especially the article “Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis”, written by Gomi et al. and published in your journal [1]. To answer question 4: “What is the optimal duration of antimicrobial therapy for patients with acute cholecystitis”, the authors reported two randomized clinical trials, one published by Loozen et al. and the other one by our own group [2, 3]. Their conclusion was “Although non-inferiority was not proven in either RCT, there was no clinically significant difference.” It is true that non-inferiority has not been proven in the study by Loozen et al. The results according to the intention-to-treat analysis showed a postoperative complication rate of 4% in both groups with a 95% CI = [ 8.2%; 8.9%] (P = 0.2%). The noninferiority margin of this study was 5% [2]. However, non-inferiority has been proven in our study. Started in 2010, this French multicenter study aimed to show that the absence of antibiotic therapy was not inferior to the antibiotic therapy prescription after cholecystectomy for acute low and moderately severe lithiasic cholecystitis (grade I and grade II): the main evaluation criteria was Post-Operative Infections (POI). To establish the non-inferiority, the upper limit of the 95% confidence interval had to be lower than the non-inferiority margin (11%). In our study, there was no significant difference between the two groups (POI rate of 17% in the antibiotic-free group vs. 15% in the antibiotic group) with a 95% CI = [ 8.98%; 5.12%] in the intention-to-treat analysis (P = 1.93%) and there was no significant difference between the two groups (POI rate of 13% in both groups) with a 95% CI = [ 5.0%; 6.3%] in the per protocol analysis (P = 0.3%) [3]. Then, the non-inferiority of the absence of antibiotic therapy and the POI has been proven. Our department is involved in the approach of simplification of care of patients with acute calculous cholecystitis (ACC) and we are going in the same direction as your guidelines in addition to early cholecystectomy: no postoperative antibiotic therapy in patients with mild or moderate ACC [1, 3], no drainage [4] and short length of hospital stay [5]. Currently, we are in the process of evaluating the implementation of these guidelines in France. Due to the TG13 that remained unclear on the antibiotic treatment, these official new Tokyo Guidelines 2018 are welcome to support our approach.