论著

新型穿戴式气压治疗仪预防深静脉血栓的非劣效性临床研究

Evaluation of new type of wearable pneumatic compression pump in prevention of deep vein thrombosis:A non-inferiority study

:1663-1668
 
       目的   评价新型穿戴式气压治疗仪预防深静脉血栓的临床疗效及安全性。方法   将156例脑梗死患者随机分为对照组和试验组,各78例。试验组使用新型穿戴式气压治疗仪(邦普医疗/VW100)进行气压治疗。对照组使用韩国元金压力治疗仪进行气压治疗。两组疗程均为10 d,观察临床疗效及安全性,比较两组深静脉血栓形成率、医护人员和患者的使用满意度。结果   治疗10 d后,试验组与对照组深静脉血栓未发生率差值为1.2%,相应的95%置信区间为–5.3%~7.9%,下限高于–10%,医护人员和患者对试验组的评价优于对照组(P<0.001)。结论   新型穿戴式气压治疗仪预防深静脉血栓形成的临床疗效不劣于市面上已有的气压治疗仪,治疗过程中未见明显不良反应,临床使用安全有效。
        Objective  To  evaluate the  effectiveness  and  safety  of  new wearable  pneumatic  compression  pump in preventing deep vein thrombosis.Methods  One hundred and fifty-six patients with cerebral infarction were randomly divided into control and study group with 78 cases in each group.Study group was treated with the new wearable pneumatic compression pump(Bangpu Medical / VW100).Control group was treated with pneumatic compression pump(Wonjin-POWER).The course of both groups was 10 days,comparing the deep vein thrombosis  rate and useage satisfaction of patients and staffs between the two groups.Results  After 10 days of treatment,the difference between the incidence of deep venous thrombosis in the study and control group was 1.2%.The corresponding 95% confidence interval was(-5.3%,7.9%),and the lower limit was greater than -10%.The appraisal from medical staffs and the patients of study group was better than that of the control group(P<0.001).Conclusions  The clinical effect of the new wearable pneumatic compression pump to prevent deep vein thrombosis is not inferior to the existing pneumatic compression pump,which clinical practice experience is better.There is no obvious adverse reactions in the treatment process,and the clinical practice is also safe and effective.
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