中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2012年
15期
1017-1022
,共6页
刘松桥%郑瑞强%李茂琴%严洁%陈华尧%穆心苇%常荣华%叶正龙%李小石%高永河%邱晓华%黄英姿%郭凤梅%杨毅%邱海波
劉鬆橋%鄭瑞彊%李茂琴%嚴潔%陳華堯%穆心葦%常榮華%葉正龍%李小石%高永河%邱曉華%黃英姿%郭鳳梅%楊毅%邱海波
류송교%정서강%리무금%엄길%진화요%목심위%상영화%협정룡%리소석%고영하%구효화%황영자%곽봉매%양의%구해파
呼吸窘迫综合征%死亡率%随机对照试验%血必净注射液
呼吸窘迫綜閤徵%死亡率%隨機對照試驗%血必淨註射液
호흡군박종합정%사망솔%수궤대조시험%혈필정주사액
Respiratory distress syndrome%Mortality%Randomized control trial%Xuebijing injection
目的 探讨血必净注射液对急性呼吸窘迫综合征( ARDS)患者预后的影响.方法 采用多中心前瞻性随机对照研究,纳入2008年1月至2010年7月10个研究中心预计病死率在20％～80％的早期ARDS患者,各分中心随机分为对照组和血必净治疗组.对照组采用常规治疗,治疗组为常规治疗加血必净注射液100 ml静脉滴注,12hl次疗程7d.观察患者28和90 d病死率,记录并比较治疗前后两组患者肺损伤评分(Murray评分)、急性生理和慢性健康评分Ⅱ(APACHEⅡ评分)、器官功能障碍评分(SOFA评分)、氧合指数、机械通气时问和28 d内无机械通气时间.结果 172例早期ARDS患者纳入研究,其中血必净治疗组91例,对照组81例,治疗后28、60、90 d病死率两组差异均无统计学意义；机械通气时间和28 d无机械通气时间差异无统计学意义；治疗后两组氧合指数均较入组前有明显改善,差异有统计学意义,治疗组氧合改善更为明显,但差异无统计学意义.治疗组Murray评分较对照组有下降趋势,但两组间差异无统计学意义；亚组分析显示不同病因ARDS患者(肺部感染、肺挫伤、肺外源性)各亚组血必净注射液治疗组和对照组28、60、90 d病死率,ICU住院时间和机械通气时问差异均无统计学意义,肺挫伤组治疗组住院时间长于对照组.总住院时间治疗组长于对照组,(38.48±34.4)d比(25.2±26.7)d,差异有统计学意义(P＜0.05).结论 血必净注射液未能降低ARDS患者病死率；但有改善ARDS患者肺损伤和氧合的趋势,有必要进行更大样本临床研究.
目的 探討血必淨註射液對急性呼吸窘迫綜閤徵( ARDS)患者預後的影響.方法 採用多中心前瞻性隨機對照研究,納入2008年1月至2010年7月10箇研究中心預計病死率在20％～80％的早期ARDS患者,各分中心隨機分為對照組和血必淨治療組.對照組採用常規治療,治療組為常規治療加血必淨註射液100 ml靜脈滴註,12hl次療程7d.觀察患者28和90 d病死率,記錄併比較治療前後兩組患者肺損傷評分(Murray評分)、急性生理和慢性健康評分Ⅱ(APACHEⅡ評分)、器官功能障礙評分(SOFA評分)、氧閤指數、機械通氣時問和28 d內無機械通氣時間.結果 172例早期ARDS患者納入研究,其中血必淨治療組91例,對照組81例,治療後28、60、90 d病死率兩組差異均無統計學意義；機械通氣時間和28 d無機械通氣時間差異無統計學意義；治療後兩組氧閤指數均較入組前有明顯改善,差異有統計學意義,治療組氧閤改善更為明顯,但差異無統計學意義.治療組Murray評分較對照組有下降趨勢,但兩組間差異無統計學意義；亞組分析顯示不同病因ARDS患者(肺部感染、肺挫傷、肺外源性)各亞組血必淨註射液治療組和對照組28、60、90 d病死率,ICU住院時間和機械通氣時問差異均無統計學意義,肺挫傷組治療組住院時間長于對照組.總住院時間治療組長于對照組,(38.48±34.4)d比(25.2±26.7)d,差異有統計學意義(P＜0.05).結論 血必淨註射液未能降低ARDS患者病死率；但有改善ARDS患者肺損傷和氧閤的趨勢,有必要進行更大樣本臨床研究.
목적 탐토혈필정주사액대급성호흡군박종합정( ARDS)환자예후적영향.방법 채용다중심전첨성수궤대조연구,납입2008년1월지2010년7월10개연구중심예계병사솔재20％～80％적조기ARDS환자,각분중심수궤분위대조조화혈필정치료조.대조조채용상규치료,치료조위상규치료가혈필정주사액100 ml정맥적주,12hl차료정7d.관찰환자28화90 d병사솔,기록병비교치료전후량조환자폐손상평분(Murray평분)、급성생리화만성건강평분Ⅱ(APACHEⅡ평분)、기관공능장애평분(SOFA평분)、양합지수、궤계통기시문화28 d내무궤계통기시간.결과 172례조기ARDS환자납입연구,기중혈필정치료조91례,대조조81례,치료후28、60、90 d병사솔량조차이균무통계학의의；궤계통기시간화28 d무궤계통기시간차이무통계학의의；치료후량조양합지수균교입조전유명현개선,차이유통계학의의,치료조양합개선경위명현,단차이무통계학의의.치료조Murray평분교대조조유하강추세,단량조간차이무통계학의의；아조분석현시불동병인ARDS환자(폐부감염、폐좌상、폐외원성)각아조혈필정주사액치료조화대조조28、60、90 d병사솔,ICU주원시간화궤계통기시문차이균무통계학의의,폐좌상조치료조주원시간장우대조조.총주원시간치료조장우대조조,(38.48±34.4)d비(25.2±26.7)d,차이유통계학의의(P＜0.05).결론 혈필정주사액미능강저ARDS환자병사솔；단유개선ARDS환자폐손상화양합적추세,유필요진행경대양본림상연구.
Objective To assess the therapeutic effect of Xuebijing injection on adult patients with acute respiratory distress syndrome (ARDS).Methods A multicenter prospective randomized control study was conducted at 10 intensive care units in Jiangsu province.A total of 172 early ARDS patients were randomly divided into Xuebijing treatment and control groups.All patients received routine therapy of ARDS while additional Xucbijing injcetion 100 ml was administered in the treatment group intravenously for 7 days.Lung injury score,acute physiology and chronic health evaluation Ⅱ ( APACHE Ⅱ ) score,multiple organ dysfunction score (MODS) and PaO2/FiO2 of the patients was recorded before and after treatment.Mortality at 28 days and the duration of mechanical ventilation were compared between two groups.Results Ninety-one patients were assigned to receive Xuebijing injection and 81 patients as control;Mortality at Days 28 and 90,the duration of mechanical ventilation and ventilation free days showed no difference between two groups (P ＞ 0.05 ).PaO2/FiO2 improved after randomization versus pre-treatment in all patients.There was no significant difference between two groups.Murray scores were not significantly different between two groups.In a subgroup analysis of patients with pulmonary infection, pulmonarycontusion and extra-pulmonary cause,two groups had no difference in mortality at Day 28,mortality at Day 90,the duration of mechanical ventilation,ventilation free days and days of ICU stay (P ＞0.05 ).Conclusion The treatment of Xuebijing injection early in course of ARDS does not improve the mortality of ARDS patients.But it may improve lung function and oxygenation.Further studies are warranted.
