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
摘要
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 multicenter, 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 (1144±s 1609), (1078±1487) and (1388±1958)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.