Levin N W, Zasuwa G
Division of Nephrology, Henry Ford Hospital, Detroit, MI 48202.
Nephrol Dial Transplant. 1993;8 Suppl 2:30-9. doi: 10.1093/ndt/8.supp2.30.
A crossover study to compare the effects of seven different dialysers on intradialytic symptoms in 37 patients during dialysis with acetate-containing dialysate was performed at five centres in four countries. The same manufacturing lot of each dialyser and of blood line sets were used by all centres. The same clinical data (duration of dialysis, blood pressure, weights, temperature, drugs, symptoms, and treatments) and technical data (blood flow, dialyser clearance, and ultrafiltration rate) were collected. Kt/V for urea was used to determine dialysis prescribed. Intradialytic symptoms and signs were measured hourly or when observed by staff using the haemodialysis treatment form (see Introduction). After each week of treatment with a particular dialyser, patients completed a questionnaire relating to the presence and severity of symptoms. (Only presence or absence of symptoms are presented.) Wide differences in dialysis duration and blood flow between centres were noted. These may have contributed to the differences between centres in relationship to staff reported responses to different dialyser: Dialysers with the lowest incidence of both signs and symptoms and of chest pain, back pain, and itching (arbitrarily designated bioincompatibility symptoms) were the Duo-Flux and Filtral, with the G120 M, the CD 4000, and the T 150 having the highest incidence. By patient questionnaire the most biocompatible dialysers were the T 150, F 60, and the Filtral, with the most symptom producing being the G120 M and the G10-3N. Perceptions of symptoms between patients and staff differed substantially overall and between centres. Hypersensitivity reactions were noted in two patients, both occurring with cuprammonium cellulose hollow-fibre dialysis, despite adherence to manufacturers' instructions concerning saline priming and removal. Both patients showed antibody titres greater than 1:160 against ethylene oxide-HSA. Ethylene oxide was not detected (limit of detection 1 part per million) in dialysers, blood line sets, or fistula needles. The study suggests that dialysis symptom reporting is complicated by individual perceptions, staff reactions, and the efficiency of recording. In this study ethnic and cultural differences must be added to the haemodynamic differences and other prescription-related elements in influencing symptoms. Despite these problems a hierarchy of dialyser-related symptoms and signs could be discerned which largely paralleled laboratory findings of biocompatibility. Future comparative studies relating symptomatology to membrane and dialyser structure should consider the variables identified as influencing symptoms and their reporting.
在四个国家的五个中心进行了一项交叉研究,以比较七种不同透析器对37例使用含醋酸盐透析液进行透析的患者透析期间症状的影响。所有中心使用每个透析器和血路管的同一生产批次。收集相同的临床数据(透析时间、血压、体重、体温、药物、症状和治疗)和技术数据(血流量、透析器清除率和超滤率)。用尿素的Kt/V来确定规定的透析量。透析期间的症状和体征每小时测量一次,或由工作人员使用血液透析治疗表格观察记录(见引言)。在用特定透析器治疗的每周结束后,患者填写一份关于症状的存在和严重程度的问卷。(此处仅列出症状是否存在。)注意到各中心之间透析时间和血流量存在很大差异。这些差异可能是导致各中心在工作人员报告的对不同透析器的反应方面存在差异的原因:体征和症状以及胸痛、背痛和瘙痒(任意指定为生物不相容性症状)发生率最低的透析器是Duo-Flux和Filtral,而G120 M、CD 4000和T 150的发生率最高。根据患者问卷,生物相容性最好的透析器是T 150、F 60和Filtral,产生症状最多的是G120 M和G10 - 3N。患者和工作人员对症状的认知总体上以及各中心之间都存在很大差异。两名患者出现过敏反应,均发生在铜氨纤维素中空纤维透析过程中,尽管严格遵循了制造商关于生理盐水预充和清除的说明。两名患者针对环氧乙烷 - 人血清白蛋白的抗体滴度均大于1:160。在透析器、血路管或内瘘针中未检测到环氧乙烷(检测限为百万分之一)。该研究表明,透析症状报告因个体认知、工作人员反应和记录效率而变得复杂。在本研究中,种族和文化差异以及血流动力学差异和其他与处方相关的因素都会影响症状。尽管存在这些问题,但仍可辨别出与透析器相关的症状和体征的等级,这在很大程度上与生物相容性的实验室结果相符。未来将症状学与膜和透析器结构相关的比较研究应考虑已确定的影响症状及其报告的变量。