冰冻健康人血浆(S／D法)防治烧创伤休克的多中心随机对照试验  

Frozen human plasma,solvent/detergent-treated for burn resuscitation and traumatic shock:a multicenter,randomized,and blind controlled clinical trial

作　　者：王志勇[1] 吴敏洁[1] 廖镇江[1] 夏照帆[2] 蒋耀光[3] 彭毅志[4] 

机构地区：[1]上海交通大学医学院附属瑞金医院烧伤科,上海200025 [2]中国人民解放军第二军医大学附属长海医院,上海200433 [3]中国人民解放军第三军医大学重庆大坪医院,重庆400042 [4]中国人民解放军第三军医大学重庆西南医院,重庆400038

出　　处：《中国新药与临床杂志》2007年第7期490-493,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:评价冰冻健康人血浆(S/D法)对烧伤复苏及创伤性休克治疗的有效性及安全性。方法:多中心、随机、阳性对照研究。共408例需输血病人,随机分为试验组(予单血型或通用型S/D血浆)和对照组(予新鲜冰冻人血浆),均按烧伤面积及创伤或手术失血量应用血浆进行抗休克复苏,监测生命体征,直至病情稳定无需再补充血浆为止。比较2组抗休克的有效率、血浆用量及安全性。结果:试验组272例,其中单血型组133例,通用型组139例;对照组136例。治疗期间所有病人生命体征平稳,3组血浆防治烧创伤休克的有效率均为100％,血浆用量分别为(1144±s1609)、(1078±1487)和(1388±1958)mL,差异无显著意义(P>0.05)。单血型组发生1例过敏反应(0.8％),余无其他不良反应。无由药物引起的肝炎及其他病毒感染。结论:冰冻健康人血浆(S/D法)是安全、有效的防治烧创伤休克的药物。AIM： To evaluate the efficacy and safety of frozen human plasma, solvent/detergent-treated （S/D plasma） for burn resuscitation and traumatic shock. METHODS： A muhicenter, randomized, and blind controlled clinical trial was conducted in 408 patients requiring blood transfusion. They were divided into two groups randomly. The patients in experiment group were treated with S/D plasma （single blood type and universal blood type） and the patients in control group were treated with fresh frozen plasma. The anti-shock resuscitation processes were carried out by calculating and recording the burn areas and plasma volume used for replenishment of blood lose during trauma or surgery, together with monitoring the vital signs of body temperature, heart and respiratory rate, blood pressure until the patients＇ condition became stable and under controlled with no more need of plasma transfusion. The efficacy rates, plasma dosages and safeties were studied and compared for these two groups. RESULTS： Two hundred and seventy-two patients in experiment group including 133 in single blood type group and 139 universal blood type group, and 136 patients in control group, showed efficacy rates of all three groups were 100 % and plasma dosages used were （1 144 ± s 1 609）, （1 078 ± 1 487） and （1 388 ± 1 958） mL respectively, with no significant differences among them （P〉 0.05）. One patient suffered from hypersensitive reaction in single blood type group （0.8 % ）, with no virus infection, drug induced hepatitis and other adverse reactions. CONCLUSION： S/D plasma is an effective and safe agent for burn resuscitation and traumatic shock.

关 键 词：烧伤 创伤和损伤 休克 随机对照试验 多中心研究 冰冻健康人血浆(S/D法) 

分 类 号：R644[医药卫生—外科学] R641[医药卫生—临床医学]