腹膜透析(PD)和血液透析(HD)是肾衰竭患者开始透析的两种可能方式。只有少数随机对照试验(RCT)评估了PD与HD。这两种模式的利弊仍然不确定。本综述包括RCT和非随机干预研究(NRSIs)。
为了评估PD的益处和危害,与HD相比,肾衰竭患者开始透析。
我们检索了2000年至2024年6月的Cochrane肾脏和移植研究注册,使用与这篇综述相关的搜索词。登记册中的研究是通过对CENTRAL的搜索确定的,MEDLINE,和EMBASE,会议记录,国际临床试验注册平台(ICTRP)搜索门户,和ClinicalTrials.gov.从2000年至2023年3月28日,在MEDLINE和EMBASE中搜索了NRSIs。
RCTs和NRSIs在开始透析的人群中评估PD与HD相比是合格的。
两名研究者独立评估这些研究是否合格,然后提取数据。使用标准Cochrane方法评估偏倚风险,并提取每份报告的相关结果.主要结果是残余肾功能(RKF)。次要结果包括全因,心血管和感染相关死亡,感染,心血管疾病,住院治疗,技术生存,生活参与和疲劳。
84项研究共153份报告(2项RCT,82个NRSIs)被包括在内。研究在设计(小型单中心研究到国际注册分析)和纳入人群(广泛的纳入标准与仅限于更具体的参与者)方面差异很大。此外,治疗递送(例如自动与连续门诊PD,采用导管的HD与动静脉瘘或移植物相比,中心与家庭HD)和随访时间差异很大。就致盲参与者和人员以及与生活质量有关的致盲结果评估而言,这两个纳入的RCT被认为具有高偏倚风险。然而,在两项研究中,大多数其他标准被评估为低偏倚风险.尽管大多数NRSIs的偏倚风险(纽卡斯尔-渥太华量表)普遍较低,由于观察性研究设计的限制,研究存在选择偏倚和残余混杂因素的风险.在儿童中,HD和PD在全因死亡方面可能几乎没有差异(6项研究,5752名参与者:RR0.81,95%CI0.62至1.07;I2=28%;低确定性)和心血管死亡(3项研究,7073名参与者:RR1.23,95%CI0.58至2.59;I2=29%;低确定性),并且不清楚与感染相关的死亡(4项研究,7451名参与者:RR0.98,95%CI0.39至2.46;I2=56%;非常低的确定性)。在成年人中,与HD相比,PD在六个月时对RKF(mL/min/1.73m2)有不确定的影响(2项研究,146名参与者:MD0.90,95%CI0.23至3.60;I2=82%;非常低的确定性),12个月(3项研究,参与者606:MD1.21,95%CI-0.01至2.43;I2=81%;确定性非常低)和24个月(3项研究,334名参与者:MD0.71,95%CI-0.02至1.48;I2=72%;非常低的确定性)。PD对12个月时的残余尿量有不确定的影响(3项研究,253名参与者:MD344.10毫升/天,95%CI168.70至519.49;I2=69%;非常低的确定性)。PD可能降低RKF丢失的风险(3项研究,2834名参与者:RR0.55,95%CI0.44至0.68;I2=17%;低确定性)。与HD相比,PD对全因死亡有不确定的影响(42项研究,700,093名参与者:RR0.87,95%CI0.77至0.98;I2=99%;非常低的确定性)。在仅限于RCT的分析中,PD可以降低全因死亡的风险(2项研究,1120名参与者:RR0.53,95%CI0.32至0.86;I2=0%;中等确定性)。PD对两种心血管疾病都有不确定的影响(21项研究,68,492名参与者:RR0.96,95%CI0.78至1.19;I2=92%)和感染相关死亡(17项研究,116,333名参与者:RR0.90,95%CI0.57至1.42;I2=98%(两者的确定性都很低)。与HD相比,PD对经历菌血症/血流感染的患者数量有不确定的影响(2项研究,2582名参与者:RR0.34,95%CI0.10至1.18;I2=68%)和经历感染发作的患者人数(3项研究,277名参与者:RR1.23,95%CI0.93至1.62;I2=20%(均非常低的确定性)。PD可能会减少菌血症/血流感染发作的次数(2项研究,2637名参与者:RR0.44,95%CI0.27至0.71;I2=24%;低确定性)。与HD相比;不确定PD是否降低急性心肌梗死的风险(4项研究,110,850名参与者:RR0.90,95%CI0.74至1.10;I2=55%),冠状动脉疾病(3项研究,5826名参与者:RR0.95,95%CI0.46至1.97;I2=62%);缺血性心脏病(2项研究,58,374名参与者:RR0.86,95%CI0.57至1.28;I2=95%),充血性心力衰竭(3项研究,49,511名参与者:RR1.10,95%CI0.54至2.21;I2=89%)和卒中(4项研究,102,542名参与者:RR0.94,95%CI0.90至0.99;I2=0%),因为确定性证据低至非常低。与HD相比,PD对住院患者数量的影响不确定(4项研究,3282名参与者:RR0.90,95%CI0.62至1.30;I2=97%)和全因住院事件(4项研究,42,582名参与者:RR1.02,95%CI0.81至1.29;I2=91%(非常低的确定性)。纳入的研究均未具体报道生活参与或疲劳。然而,两项研究评估了就业。与HD相比,PD对一年的就业有不确定的影响(2项研究,593名参与者:RR0.83,95%CI0.20至3.43;I2=97%;非常低的确定性)。
PD和HD对RKF的保存效果比较,全因和特定原因的死亡风险,菌血症的发病率,其他血管并发症(如中风,心血管事件)和患者报告的结果(例如生活参与和疲劳)是不确定的,基于主要从NRSIs获得的数据,因为只包括两个RCT。
Peritoneal dialysis (PD) and haemodialysis (HD) are two possible modalities for people with kidney failure commencing dialysis. Only a few randomised controlled trials (RCTs) have evaluated PD versus HD. The benefits and harms of the two modalities remain uncertain. This review includes both RCTs and non-randomised studies of interventions (NRSIs).
To evaluate the benefits and harms of PD, compared to HD, in people with kidney failure initiating dialysis.
We searched the Cochrane Kidney and Transplant Register of Studies from 2000 to June 2024 using search terms relevant to this review. Studies in the Register were identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov. MEDLINE and EMBASE were searched for NRSIs from 2000 until 28 March 2023.
RCTs and NRSIs evaluating PD compared to HD in people initiating dialysis were eligible.
Two investigators independently assessed if the studies were eligible and then extracted data. Risk of
bias was assessed using standard Cochrane methods, and relevant outcomes were extracted for each report. The primary outcome was residual kidney function (RKF). Secondary outcomes included all-cause, cardiovascular and infection-related death, infection, cardiovascular disease, hospitalisation, technique survival, life participation and fatigue.
A total of 153 reports of 84 studies (2 RCTs, 82 NRSIs) were included. Studies varied widely in design (small single-centre studies to international registry analyses) and in the included populations (broad inclusion criteria versus restricted to more specific participants). Additionally, treatment delivery (e.g. automated versus continuous ambulatory PD, HD with catheter versus arteriovenous fistula or graft, in-centre versus home HD) and duration of follow-up varied widely. The two included RCTs were deemed to be at high risk of
bias in terms of blinding participants and personnel and blinding outcome assessment for outcomes pertaining to quality of life. However, most other criteria were assessed as low risk of
bias for both studies. Although the risk of
bias (Newcastle-Ottawa Scale) was generally low for most NRSIs, studies were at risk of selection
bias and residual confounding due to the constraints of the observational study design. In children, there may be little or no difference between HD and PD on all-cause death (6 studies, 5752 participants: RR 0.81, 95% CI 0.62 to 1.07; I2 = 28%; low certainty) and cardiovascular death (3 studies, 7073 participants: RR 1.23, 95% CI 0.58 to 2.59; I2 = 29%; low certainty), and was unclear for infection-related death (4 studies, 7451 participants: RR 0.98, 95% CI 0.39 to 2.46; I2 = 56%; very low certainty). In adults, compared with HD, PD had an uncertain effect on RKF (mL/min/1.73 m2) at six months (2 studies, 146 participants: MD 0.90, 95% CI 0.23 to 3.60; I2 = 82%; very low certainty), 12 months (3 studies, 606 participants: MD 1.21, 95% CI -0.01 to 2.43; I2 = 81%; very low certainty) and 24 months (3 studies, 334 participants: MD 0.71, 95% CI -0.02 to 1.48; I2 = 72%; very low certainty). PD had uncertain effects on residual urine volume at 12 months (3 studies, 253 participants: MD 344.10 mL/day, 95% CI 168.70 to 519.49; I2 = 69%; very low certainty). PD may reduce the risk of RKF loss (3 studies, 2834 participants: RR 0.55, 95% CI 0.44 to 0.68; I2 = 17%; low certainty). Compared with HD, PD had uncertain effects on all-cause death (42 studies, 700,093 participants: RR 0.87, 95% CI 0.77 to 0.98; I2 = 99%; very low certainty). In an analysis restricted to RCTs, PD may reduce the risk of all-cause death (2 studies, 1120 participants: RR 0.53, 95% CI 0.32 to 0.86; I2 = 0%; moderate certainty). PD had uncertain effects on both cardiovascular (21 studies, 68,492 participants: RR 0.96, 95% CI 0.78 to 1.19; I2 = 92%) and infection-related death (17 studies, 116,333 participants: RR 0.90, 95% CI 0.57 to 1.42; I2 = 98%) (both very low certainty). Compared with HD, PD had uncertain effects on the number of patients experiencing bacteraemia/bloodstream infection (2 studies, 2582 participants: RR 0.34, 95% CI 0.10 to 1.18; I2 = 68%) and the number of patients experiencing infection episodes (3 studies, 277 participants: RR 1.23, 95% CI 0.93 to 1.62; I2 = 20%) (both very low certainty). PD may reduce the number of bacteraemia/bloodstream infection episodes (2 studies, 2637 participants: RR 0.44, 95% CI 0.27 to 0.71; I2 = 24%; low certainty). Compared with HD; It is uncertain whether PD reduces the risk of acute myocardial infarction (4 studies, 110,850 participants: RR 0.90, 95% CI 0.74 to 1.10; I2 = 55%), coronary artery disease (3 studies, 5826 participants: RR 0.95, 95% CI 0.46 to 1.97; I2 = 62%); ischaemic heart disease (2 studies, 58,374 participants: RR 0.86, 95% CI 0.57 to 1.28; I2 = 95%), congestive heart failure (3 studies, 49,511 participants: RR 1.10, 95% CI 0.54 to 2.21; I2 = 89%) and stroke (4 studies, 102,542 participants: RR 0.94, 95% CI 0.90 to 0.99; I2 = 0%) because of low to very low certainty evidence. Compared with HD, PD had uncertain effects on the number of patients experiencing hospitalisation (4 studies, 3282 participants: RR 0.90, 95% CI 0.62 to 1.30; I2 = 97%) and all-cause hospitalisation events (4 studies, 42,582 participants: RR 1.02, 95% CI 0.81 to 1.29; I2 = 91%) (very low certainty). None of the included studies reported specifically on life participation or fatigue. However, two studies evaluated employment. Compared with HD, PD had uncertain effects on employment at one year (2 studies, 593 participants: RR 0.83, 95% CI 0.20 to 3.43; I2 = 97%; very low certainty).
The comparative effectiveness of PD and HD on the preservation of RKF, all-cause and cause-specific death risk, the incidence of bacteraemia, other vascular complications (e.g. stroke, cardiovascular events) and patient-reported outcomes (e.g. life participation and fatigue) are uncertain, based on data obtained mostly from NRSIs, as only two RCTs were included.