桃花汤对ICU患者抗菌药物相关性腹泻的影响：一项多中心随机对照研究

Effect of Taohua decoction on antibiotic associated diarrhea in intenive care unit： a multi-central randomizedcontrolled study

目的 评价桃花汤治疗抗菌药物相关性腹泻（AAD）的临床疗效.方法 选取2015年4月至2016年11月嘉兴市中医医院、嘉兴市第一医院、嘉兴市第二医院、海宁市中医院等4家医院重症加强治疗病房（ICU）收治的诊断为AAD患者62例.按随机数字表法将患者分为试验组（32例）和对照组（30例）.两组均给予西药常规治疗,试验组在常规治疗基础上同时服用桃花汤（组成：赤石脂30 g、干姜15 g、粳米30 g）,对照组仅给予西医常规治疗,两组疗程均为14 d.观察两组治疗前后中医证候积分、腹泻持续时间、腹痛缓解时间、抗菌药物使用时间、急性生理学与慢性健康状况评分系统Ⅱ（APACHEⅡ）评分、白蛋白水平、内镜下及光镜下病理改变等情况.结果 两组治疗后中医证候积分和APACHEⅡ评分均较治疗前降低,白蛋白较治疗前升高,且试验组治疗后上述指标的变化较对照组更显著〔中医证候积分：（分）：9.32±8.86比13.50±6.52, APACHEⅡ评分（分）：11.08±4.37比14.06±5.42,白蛋白（g/L）：33.89±5.02比30.85±6.44,均P〈0.05〕;试验组腹泻持续时间（d：12.28±2.28比15.36±8.68）、腹痛缓解时间（d：10.09±6.41比14.27±7.52）、抗菌药物使用时间（d：11.77±4.72比15.08±6.98）均较对照组明显缩短（均P〈0.05）.内镜和光镜下显示,试验组治疗后肠黏膜轻度改变患者数均较对照组增加（内镜：18例比8例,光镜：19例比9例）,但中度（内镜：14例比20例,光镜：13例比19例）、重度（内镜：0比2例,光镜：0比2例）改变患者数较对照组减少.结论 桃花汤可以提高轻度AAD患者的临床疗效.

Objective To evaluate the clinical efficacy of Taohua decoction in treating antibiotic-associated diarrhea （AAD）. Methods Sixty-two patients diagnosed with AAD admitted to the department of intenive care unit （ICU） of Jiaxing Hospital of Traditional Chinese Medicine （TCM）, Jiaxing First Hospital, Jiaxing Second Hospital and Haining Hospital of TCM from April 2015 to November 2016 were enrolled, and they were divided into an experimental group （32 cases） and a control group （30 cases） according to the random number table method. The two groups were given routine treatment of western medicine, the patients in experimental group were additionally given Taohua decoction （ingreients： red halloysite 30 g, zingiberis 15 g, japonica rice 30 g）, while in the control group, the patients only received the routine treatment of western medicine. The therapeutic course in the two groups was 14 days. The TCM syndrome score, the duration of diarrhea, the time of abdominal pain relief and the time using antibiotics, besides acute physiology and chronic health evaluation Ⅱ （APACHEⅡ） score, albumin level, endoscopic and pathological changes were observed before and after treatment in the two groups. Results After treatment, the scores of TCM syndrome and APACHE Ⅱin the two groups were all lower than those before treatment, the level of albumin was higher than that before treatment, and the changes of above indexes in the experimental group were more significant than those in the control group [the scores of TCM syndrome： 9.32±8.86 vs. 13.50±6.52, APACHE Ⅱ score： 11.08±4.37 vs. 14.06±5.42, albumin （g/L）： 33.89±5.02 vs. 30.85±6.44, all P 〈 0.05]; in experimental group, the time of diarrhea duration （days：12.28±2.28 vs. 15.36±8.68）, time of abdominal pain relief （days： 10.09±6.41 vs. 14.27±7.52）, time of using antibiotics （days： 11.77±4.72 vs. 15.08±6.98） were significantly shorter than those of the control group （all P 〈 0.05）. The examinations of endoscopy and light microscopy showed that after treatment the numbers of patients with mild intestinal mucosal changes in the experimental group were increased compared with those in the control group （endoscope：18 cases vs. 8 cases, light microscopy： 19 cases vs. 9 cases）, but the numbers of patients with moderate （endoscope：14 cases vs. 20 cases, light microscopy： 13 cases vs. 19 cases） and severe （endoscope： 0 vs. 2 cases, light microscopy：0 vs.2 cases） changes were less than those in the control group. Conclusions Taohua decoction can improve the clinical efficacy of mild AAD patients.