未洗脱二甲亚砜冰冻复融血小板的功能及其临床应用研究

Functions and clinical applications of frozen-thawed platelet without dimethyl suifoxide elution

目的探讨未洗脱二甲亚砜（DMSO）冰冻复融血小板的功能及其临床应用的可行性。方法采用简单抽样法选择2015年1月至12月山东省东营市中心血站制备和保存的60份（每份为200 mL）未洗脱DMSO冰冻复融血小板作为研究对象，纳入复融后血小板原液组（n＝60）。取复融后血小板原液组血小板10 mL与复融后的新鲜冰冻血浆30 mL，按照体积比为1∶3的比例混匀后，纳入血小板混合液组（n＝60）。并随机选择同期本血站采集的60份新鲜液态血小板原液，纳入对照组（n＝60）。采用简单随机抽样法选择同期于东营市第二人民医院接受未洗脱DMSO冰冻复融血小板输注的150例患者作为输血反应的观察对象。3组血小板均进行血栓弹力图及复钙后凝血时间检测，比较各组血小板凝血功能。回顾性分析150例患者输注未洗脱DMSO冰冻复融血小板后输血反应发生情况；并比较150例输注未洗脱DMSO冰冻复融血小板患者输注前及输注后1、24、48和72 h的外周血血小板计数，分析输注未洗脱DMSO冰冻复融血小板的临床应用效果。本研究临床试验遵循的程序符合东营市第二人民医院人体试验委员会所制定的伦理学标准，得到该伦理会批准，征得受试对象本人的知情同意，并与之签订临床研究知情同意书。结果①血小板混合液组血栓弹力图凝血指数（CI）为2.5±0.2，高于对照组的1.0±0.1和复融后血小板原液组的0.9±0.2，并且差异均有统计学意义（t＝16.69、23.02，P〈0.05）。②血小板混合液组、复融后血小板原液组及对照组血小板复钙后凝血时间分别为（6.3±0.5）、（9.0±0.8）、（11.7±1.1）min，3者比较，差异有统计学意义（F＝27.38，P〈0.05）。复融后血小板原液组血小板复钙后凝血时间较对照组显著缩短，并且差异有统计学意义（q＝－7.38，P〈0.05）。血小板混合液组血小板复钙后凝血时间较对照组及复融后血小板原液组亦显著缩短，并且差异均有统计学意义（q＝－3.36、－2.29，P〈0.05）。③本组150例患者共计输注未洗脱DMSO冰冻复融血小板319个治疗量，无1例发生输血不良反应。血小板输注48 h后血小板计数较输注前增加（7.6±1.1）×109/L，较输注1、24 h后的增加值[（16.3±2.5）×109/L和（13.5±2.5）×109/L]低，并且差异有统计学意义（t＝－24.87、－25.92，P〈0.05）。结论未洗脱DMSO冰冻复融血小板与新鲜冰冻复融血浆（体积比为1︰3）混合物凝血功能明显提高，快速止血效果好，未洗脱DMSO冰冻复融血小板临床输注无输血不良反应，可满足急性止血需求。

Objective To investigate the functions and feasibility of clinical applications of frozen- thawed platelet without dimethyl sulfoxide （DMSO） elution. Methods From January to December 2015, a total of 60 bags （200 mL/bag） of cryopreserved platelets which were prepared and saved by Dongying Central Blood Station of Shangdong Province were included into this study, by simple random sampling method. These 60 bags of cryopreserved platelets were thawed and included in thawed original platelet group （n：60）. After mixing 10 mL platelet of thawed original platelet group with 30 mL fresh frozen-thawed plasma according to the volume ratio of 1 ： 3, the new gained ones were included into the mixed platelet group （n=60）. And a total of fresh platelet which were collected by our blood station in the same period were included into control group （n = 60）. The quality of above-mentioned frozen-thawed platelets, freshliquid platelets, and fresh frozen-thawed plasma met the relevant regulations in Quality Requirements for Whole Blood and Blood Components （GB18469-2012）. A total of 150 patients who received frozen-thawed platelets without DMSO elution transfusion in the Second People＇s Hospital of Dongying at the same period were randomly selected as blood transfusions reaction observation objects, by using simple random sampling method. Three groups of platelets were detected with thrombelastogram and coagulation time after recalcification, so as to compare the platelet coagulation function in each group. A retrospective analysis was carried out on the transfusion reactions of 150 patients after transfusion with frozen-thawed platelets without DMSO elution, and the platelet counts in peripheral blood were compared before and 1, 24, 48 and 72 h after transfusion, so as to analyze the clinical application of frozen-thawed platelets without DMSO elution. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of the Second People＇ s Hospital of Dongying. Informed consent was obtained from all participants. Results （1） Thrombelastography coagulation index （CI） of mixed platelet group was 2.5-0.2, which was higher than that of 1.0＋0.1 in control group, and that of 0.94-0.2 in thawed original platelet group, and the differences were statistical significant （t= 16. 69, 23. 02; P〈O. 05）. （2） The coagulation time after recalcification of mixed platelet group, thawed original platelet group and control group were （6.5 ± 0.5）, （9.0±0.75）, （11.0 ± 1.08） min, respectively. There was significant different of coagulation time after recalcification among these three groups （F= 27. 38, P〈0. 05）. Compared with control group, the coagulation time after reealcification of platelet in thawed original platelet group was obviously shortened, and the difference was statistically significant （q=- 7.38, P〈0.05）. Compared with control group and original platelet group, the coagulation time after recalcification of platelet in mixed platelet group was also obviously shortened, and the differences were statistically significant （q=- 3.36, --2.29,P〈0.05）. （3） In this study, 150 patients were transfused with a total of 319 therapeutic dose of frozen-thawed platelet without DMSO elution, and no adverse transfusion reaction were found in them. Compared with pre- transfusion, the platelet count was increased by （7.6±1.1）〉 I＆/L of 48 h after transfusion, the increase value was lower than those of （16.3±2.5）X 109/L and （13.5±2.5）〉（ 109/L at 1 and 24 h after the transfusion, and the differences were statistically significant （t = -- 24. 87, -- 25. 92, P 〈 0. 05）. Conclusions The coagulation function of the mixture of frozen-thawed platelet without DMSO elution and fresh frozen-thawed plasma （the volume ratio of 1 ： 3） was significantly increased, its quick hemostasis effect was good. No adverse transfusion reaction was found of clinical transfusion of frozen-thawed platelet without DMSO elution, which could meet the need of acute hemostasis.