复苏合剂联合西医常规治疗急性呼吸窘迫综合征的多中心前瞻性随机对照研究

A Multi-center,Prospective,Randomized Controlled Trial of Fusu Agent Combined with Conventional Western Medicine in the Treatment of Acute Respiratory Distress Syndrome

目的观察复苏合剂联合西医常规治疗急性呼吸窘迫综合征(ARDS)的临床疗效。方法采用多中心、前瞻性、随机对照研究方法,将105例ARDS患者按随机数字表法分为治疗组(53例)和对照组(52例)。两组均给予西医常规治疗,治疗组在此基础上加用复苏合剂,对照组给予等量的安慰剂。两组疗程均为14天。收集两组患者28、90天病死率,中医证候评分、中医疗效评价、呼吸末正压(PEEP)、氧分压/吸入氧浓度(PaO_(2)/FiO_(2))、急性生理学及慢性健康状况(APACHE)Ⅱ评分、ICU住院时间、呼吸机使用时间和不良反应发生情况。结果治疗组28、90天全因病死率明显低于对照组(26.42%vs.46.15%,32.08%vs.55.77%,P<0.05),中医总有效率优于对照组(79.25%vs.61.54%,P<0.05)。与对照组比较,治疗组治疗1周后APACHEⅡ评分和PEEP值明显下降(Z分别为0.021、0.030,均P<0.05)、PaO_(2)/FiO_(2)改善(Z=0.033,P<0.05);治疗组治疗2周后中医证候评分和APACHEⅡ评分明显下降(Z分别为0.041、0.029,均P<0.05)、PaO_(2)/FiO_(2)持续升高(Z=0.043,P<0.05);治疗组机械通气时间和ICU住院时间明显缩短(Z分别为2.138、2.096,均P<0.05)。结论中西医结合综合方案能降低ARDS患者28天和90天病死率,且能改善PaO_(2)/FiO_(2),减少呼吸机使用时间和ICU住院时间。

Objective To observe the clinical effect of Fusu Agent combined with Western medicine on acute respiratory distress syndrome(ARDS).Methods Using a multi-center,prospective,randomized controlled trial method,105 patients with ARDS were randomly assigned to the treatment group(53 cases)and the control group(52 cases)according to the random digit table.All patients received conventional Western medical treatment,patients in the treatment group additionally took Fusu Agent,and patients in control group additionally took same amount of placebo.The course of treatment in both groups was 14 days.Collect the 28-day mortality,90-day mortality,Chinese medicine(CM)syndrome score,CM efficacy evaluation,positive endexpiratory pressure(PEEP),ratio of partial pressure of oxygen to inspired fraction of oxygen(PaO_(2)/FiO_(2)),Acute Physiology and Chronic Health Evaluation(APACHE)Ⅱscore,ICU hospital stay,ventilator use time and adverse reactions happening.Results The 28-day and 90-day all-cause mortality in the treatment group was significantly lower than that in the control group(26.42%vs.46.15%,32.08%vs.55.77%,P<0.05),and the total effective rate of CM was better than that in the control group(79.25%vs.61.54%,P<0.05).Compared with the control group,the APACHEⅡscore and PEEP value of the treatment group decreased significantly after 1 week of treatment(Z=0.021,0.030,P<0.05),PaO_(2)/FiO_(2) improved(Z=0.033,P<0.05).After 2 weeks of treatment,the CM syndrome score and ApacheⅡscore in the treatment group decreased significantly(Z=0.041,0.029,P<0.05),and PaO_(2)/FiO_(2) increased continuously(Z=0.043,P<0.05);the treatment group’s mechanical ventilation time and ICU hospital stay significantly shortened(Z=2.138,2.096,P<0.05).Conclusion The integrated program of integrated Chinese and Western medicine can reduce the 28-day and 90-day mortality of ARDS patients,and can improve PaO_(2)/FiO_(2),reduce ventilator use time and ICU hospital stay.