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一项双盲随机对照试验,以确定汉方柴胡汤对心血管手术患者误吸性肺炎的预防作用。

A Double-Blind Randomized Controlled Trial to Determine the Preventive Effect of Hangekobokuto on Aspiration Pneumonia in Patients Undergoing Cardiovascular Surgery.

作者信息

Kawago Koji, Nishibe Toshiya, Shindo Shunya, Inoue Hidenori, Motohashi Shinya, Akasaka Junetsu, Ogino Hitoshi

机构信息

Department of Cardiovascular Surgery, Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan.

Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.

出版信息

Ann Thorac Cardiovasc Surg. 2019 Dec 20;25(6):318-325. doi: 10.5761/atcs.oa.19-00128. Epub 2019 Jul 18.

DOI:10.5761/atcs.oa.19-00128
PMID:31316037
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6923725/
Abstract

PURPOSE

This study aimed to assess whether hangekobokuto (HKT) can prevent aspiration pneumonia in patients undergoing cardiovascular surgery.

METHODS

We performed a single-center, double-blinded, randomized, placebo-controlled study of HKT in patients undergoing cardiovascular surgery. JPS HKT extract granule (JPS-16) was used as HKT. The primary endpoint was defined as the prevention of postoperative aspiration pneumonia. The secondary endpoints included complete recovery from swallowing and coughing disorders.

RESULTS

Between August 2014 and August 2015, a total of 34 patients were registered in this study. The rate of subjects with postoperative aspiration pneumonia was significantly lower in the HKT group than in the placebo group (p = 0.017). In high-risk patients for aspiration pneumonia, the rate was significantly lower in the HKT group than in the placebo group (p = 0.015). The rate of subjects with swallowing disorders tended to be lower in the HKT group than in the placebo group (p = 0.091), and in high-risk patients, the rate was significantly lower in the HKT group than in the placebo group (p = 0.038).

CONCLUSIONS

HKT can prevent aspiration pneumonia in patients undergoing cardiovascular surgery. In high-risk patients for aspiration pneumonia, HKT can prevent aspiration pneumonia and improve swallowing disorders.

摘要

目的

本研究旨在评估半夏厚朴汤(HKT)能否预防心血管手术患者发生吸入性肺炎。

方法

我们对心血管手术患者进行了一项关于HKT的单中心、双盲、随机、安慰剂对照研究。采用日本汉方制剂半夏厚朴汤提取物颗粒(JPS - 16)作为HKT。主要终点定义为预防术后吸入性肺炎。次要终点包括吞咽和咳嗽障碍完全恢复。

结果

2014年8月至2015年8月,本研究共纳入34例患者。HKT组术后吸入性肺炎患者的发生率显著低于安慰剂组(p = 0.017)。在吸入性肺炎高危患者中,HKT组的发生率显著低于安慰剂组(p = 0.015)。HKT组吞咽障碍患者的发生率倾向于低于安慰剂组(p = 0.091),在高危患者中,HKT组的发生率显著低于安慰剂组(p = 0.038)。

结论

HKT可预防心血管手术患者发生吸入性肺炎。在吸入性肺炎高危患者中,HKT可预防吸入性肺炎并改善吞咽障碍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/c3dc5072244f/atcs-25-318-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/d3e5de0ce9df/atcs-25-318-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/a35e08649ef6/atcs-25-318-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/c3dc5072244f/atcs-25-318-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/d3e5de0ce9df/atcs-25-318-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/a35e08649ef6/atcs-25-318-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46fa/6923725/c3dc5072244f/atcs-25-318-g003.jpg

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