目的通过前瞻性、多中心、随机、对照研究,评价杰瑞腹膜透析机用于维持性腹膜透析患者治疗的有效性与安全性。方法研究对象来自全国6家医院的腹膜透析中心,选择腹膜透析(以下简称腹膜透析)3个月以上、病情稳定的慢性肾衰竭患者。试验组...目的通过前瞻性、多中心、随机、对照研究,评价杰瑞腹膜透析机用于维持性腹膜透析患者治疗的有效性与安全性。方法研究对象来自全国6家医院的腹膜透析中心,选择腹膜透析(以下简称腹膜透析)3个月以上、病情稳定的慢性肾衰竭患者。试验组选用JARI-APD-1A自动腹膜透析机,对照组选用Baxter Home Choice腹膜透析机。采用多中心、随机、开放、二阶段交叉阳性对照设计,两个阶段的周期均为1日,主要有效性评价指标为单周期引流量的显示值与实测值之间的一致性以及单周期注入量的显示值与实测值之间的一致性,次要有效性评价指标为腹膜透析机设定温度的准确性以及毒素清除、电解质、酸碱紊乱的纠正效果,使用杰瑞腹膜透析机的研究结果均与Baxter Home Choice腹膜透析机的结果进行非劣效检验。安全性评价指标包括患者的临床症状、生命体征及机器故障发生情况等。结果 1共84名患者参加了本试验,其中男性47人,女性37人;平均年龄(45.33±11.34)岁,原发病以慢性肾小球肾炎为主,占50%,平均透析龄(37.70±27.67)月。2主要有效性评价指标:试验组与对照组单周期引流量的显示值与实测值之间的一致性,试验组97.62%、对照组98.81%达到了流量控制精度,通过非劣性检验显示,试验组不劣于对照组(Z=4.315,P<0.001);单周期注入量的显示值与实测值之间的一致性均达到了流量控制精度,通过非劣性检验显示,试验组不劣于对照组(Z=9.456,P<0.001)。3次要有效性评价指标:试验组与对照组腹膜透析机实测温度均达到了精度要求,试验组不劣于对照组;另外,试验组与对照组相比,治疗前、后的血尿素、肌酐及电解质(钾、钠、氯、钙、磷、二氧化碳结合力)均无统计学差异。4安全性评价指标:患者使用两种腹膜透析机治疗过程中均无不适症状,无不良事件,治疗前后的生命体征未见显著性差异。试验组与对照组均无故障发生。结论通过多中心、随机、开放、二阶段交叉临床试验,杰瑞腹膜透析机达到了主要、次要有效性评价指标及安全性评价指标的标准,其有效性、安全性不劣于Baxter腹膜透析机。展开更多
Objective： To explore the fundamental theory, methods and data of the quality of life （QOL） of soldiers and its influence factors in the first response army. Methods： Totally 215 soldiers in the first response arm...Objective： To explore the fundamental theory, methods and data of the quality of life （QOL） of soldiers and its influence factors in the first response army. Methods： Totally 215 soldiers in the first response army of a military area in China were inquired by using self-regulating questionnaire and WHOQOL-BREF （Chinese Edition）. Resalts： WHOQOL-BREF had good acceptability, reliability and validity in the first response army. QOL of soldiers in the first response army was middling. The influencing factors of QOL of the soldiers in first army includes self-report health, different areas where the army men come from, different arms of services, whether only child in family. And the difference was statistically significant. Conclusion： WHOQOL-BREF is fit for evaluating the quality of life of soldiers in the first response army. There are differences of the quality of life among the soldiers in the first response army. So we should take appropriate measures to improve the soldiers＇ quality of life.展开更多
文摘目的通过前瞻性、多中心、随机、对照研究,评价杰瑞腹膜透析机用于维持性腹膜透析患者治疗的有效性与安全性。方法研究对象来自全国6家医院的腹膜透析中心,选择腹膜透析(以下简称腹膜透析)3个月以上、病情稳定的慢性肾衰竭患者。试验组选用JARI-APD-1A自动腹膜透析机,对照组选用Baxter Home Choice腹膜透析机。采用多中心、随机、开放、二阶段交叉阳性对照设计,两个阶段的周期均为1日,主要有效性评价指标为单周期引流量的显示值与实测值之间的一致性以及单周期注入量的显示值与实测值之间的一致性,次要有效性评价指标为腹膜透析机设定温度的准确性以及毒素清除、电解质、酸碱紊乱的纠正效果,使用杰瑞腹膜透析机的研究结果均与Baxter Home Choice腹膜透析机的结果进行非劣效检验。安全性评价指标包括患者的临床症状、生命体征及机器故障发生情况等。结果 1共84名患者参加了本试验,其中男性47人,女性37人;平均年龄(45.33±11.34)岁,原发病以慢性肾小球肾炎为主,占50%,平均透析龄(37.70±27.67)月。2主要有效性评价指标:试验组与对照组单周期引流量的显示值与实测值之间的一致性,试验组97.62%、对照组98.81%达到了流量控制精度,通过非劣性检验显示,试验组不劣于对照组(Z=4.315,P<0.001);单周期注入量的显示值与实测值之间的一致性均达到了流量控制精度,通过非劣性检验显示,试验组不劣于对照组(Z=9.456,P<0.001)。3次要有效性评价指标:试验组与对照组腹膜透析机实测温度均达到了精度要求,试验组不劣于对照组;另外,试验组与对照组相比,治疗前、后的血尿素、肌酐及电解质(钾、钠、氯、钙、磷、二氧化碳结合力)均无统计学差异。4安全性评价指标:患者使用两种腹膜透析机治疗过程中均无不适症状,无不良事件,治疗前后的生命体征未见显著性差异。试验组与对照组均无故障发生。结论通过多中心、随机、开放、二阶段交叉临床试验,杰瑞腹膜透析机达到了主要、次要有效性评价指标及安全性评价指标的标准,其有效性、安全性不劣于Baxter腹膜透析机。
基金Supported by Youth Startup Fund of Second Military Medical University(05QN21)
文摘Objective： To explore the fundamental theory, methods and data of the quality of life （QOL） of soldiers and its influence factors in the first response army. Methods： Totally 215 soldiers in the first response army of a military area in China were inquired by using self-regulating questionnaire and WHOQOL-BREF （Chinese Edition）. Resalts： WHOQOL-BREF had good acceptability, reliability and validity in the first response army. QOL of soldiers in the first response army was middling. The influencing factors of QOL of the soldiers in first army includes self-report health, different areas where the army men come from, different arms of services, whether only child in family. And the difference was statistically significant. Conclusion： WHOQOL-BREF is fit for evaluating the quality of life of soldiers in the first response army. There are differences of the quality of life among the soldiers in the first response army. So we should take appropriate measures to improve the soldiers＇ quality of life.
