Department of Nephrology, Centre hospitalier de l'Université de Montréal, Montréal, Canada.
Health innovation and evaluation hub, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Canada.
Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.
BACKGROUND: 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). OBJECTIVES: To evaluate the benefits and harms of PD, compared to HD, in people with kidney failure initiating dialysis. SEARCH METHODS: 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. SELECTION CRITERIA: RCTs and NRSIs evaluating PD compared to HD in people initiating dialysis were eligible. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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; I = 28%; low certainty) and cardiovascular death (3 studies, 7073 participants: RR 1.23, 95% CI 0.58 to 2.59; I = 29%; low certainty), and was unclear for infection-related death (4 studies, 7451 participants: RR 0.98, 95% CI 0.39 to 2.46; I = 56%; very low certainty). In adults, compared with HD, PD had an uncertain effect on RKF (mL/min/1.73 m) at six months (2 studies, 146 participants: MD 0.90, 95% CI 0.23 to 3.60; I = 82%; very low certainty), 12 months (3 studies, 606 participants: MD 1.21, 95% CI -0.01 to 2.43; I = 81%; very low certainty) and 24 months (3 studies, 334 participants: MD 0.71, 95% CI -0.02 to 1.48; I = 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; I = 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; I = 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; I = 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; I = 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; I = 92%) and infection-related death (17 studies, 116,333 participants: RR 0.90, 95% CI 0.57 to 1.42; I = 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; I = 68%) and the number of patients experiencing infection episodes (3 studies, 277 participants: RR 1.23, 95% CI 0.93 to 1.62; I = 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; I = 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; I = 55%), coronary artery disease (3 studies, 5826 participants: RR 0.95, 95% CI 0.46 to 1.97; I = 62%); ischaemic heart disease (2 studies, 58,374 participants: RR 0.86, 95% CI 0.57 to 1.28; I = 95%), congestive heart failure (3 studies, 49,511 participants: RR 1.10, 95% CI 0.54 to 2.21; I = 89%) and stroke (4 studies, 102,542 participants: RR 0.94, 95% CI 0.90 to 0.99; I = 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; I = 97%) and all-cause hospitalisation events (4 studies, 42,582 participants: RR 1.02, 95% CI 0.81 to 1.29; I = 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; I = 97%; very low certainty). AUTHORS' CONCLUSIONS: 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.
背景:腹膜透析 (PD) 和血液透析 (HD) 是两种可用于开始透析的肾功能衰竭患者的治疗方法。只有少数随机对照试验 (RCT) 评估了 PD 与 HD 的效果。两种治疗方法的获益和危害仍然不确定。本综述包括 RCT 和干预性非随机研究 (NRSI)。
目的:评估 PD 与 HD 在开始透析的肾功能衰竭患者中的效果。
检索方法:我们检索了 2000 年至 2024 年 6 月期间 Cochrane 肾脏病和移植注册中心的研究,使用了与本综述相关的检索词。在登记册中的研究通过对 CENTRAL、MEDLINE 和 EMBASE、会议论文集、国际临床试验注册平台 (ICTRP) 搜索门户和 ClinicalTrials.gov 的搜索确定。对 2000 年至 2023 年 3 月 28 日期间的 NRSI 进行了 MEDLINE 和 EMBASE 的检索。
选择标准:纳入了比较 PD 与 HD 在开始透析的患者中效果的 RCT 和 NRSI。
数据收集与分析:对 153 篇报告的 84 项研究(2 项 RCT,82 项 NRSI)进行了评估。研究在设计(从小型单中心研究到国际登记分析)和纳入人群(广泛的纳入标准与更具体的参与者限制)方面差异很大。此外,治疗方式(例如自动化与连续不卧床 PD、HD 用导管与动静脉瘘或移植物、中心与家庭 HD)和随访时间也差异很大。纳入的两项 RCT 在与生活质量相关的结局的结局评估方面被认为存在很高的偏倚风险,包括对参与者和人员的双盲以及偏倚。然而,对于大多数其他标准,这两项研究的偏倚评估均为低风险。尽管大多数 NRSI 的偏倚(纽卡斯尔-渥太华量表)通常较低,但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的风险。在儿童中,HD 和 PD 在全因死亡(6 项研究,5752 名参与者:RR 0.81,95% CI 0.62 至 1.07;I²=28%;低确定性)和心血管死亡(3 项研究,7073 名参与者:RR 1.23,95% CI 0.58 至 2.59;I²=29%;低确定性)方面可能没有差异,感染相关死亡(4 项研究,7451 名参与者:RR 0.98,95% CI 0.39 至 2.46;I²=56%;非常低确定性)的结局尚不清楚。在成人中,与 HD 相比,PD 在六个月时对 RKF(mL/min/1.73 m)的影响不确定(2 项研究,146 名参与者:MD 0.90,95% CI 0.23 至 3.60;I²=82%;非常低确定性),12 个月(3 项研究,606 名参与者:MD 1.21,95% CI -0.01 至 2.43;I²=81%;非常低确定性)和 24 个月(3 项研究,334 名参与者:MD 0.71,95% CI -0.02 至 1.48;I²=72%;非常低确定性)。PD 在 12 个月时对残余尿量的影响不确定(3 项研究,253 名参与者:MD 344.10 mL/天,95% CI 168.70 至 519.49;I²=69%;非常低确定性)。PD 可能降低 RKF 丧失的风险(3 项研究,2834 名参与者:RR 0.55,95% CI 0.44 至 0.68;I²=17%;低确定性)。与 HD 相比,PD 对全因死亡(42 项研究,700,093 名参与者:RR 0.87,95% CI 0.77 至 0.98;I²=99%;非常低确定性)的影响不确定。在仅包括 RCT 的分析中,PD 可能降低全因死亡的风险(2 项研究,1120 名参与者:RR 0.53,95% CI 0.32 至 0.86;I²=0%;中等确定性)。PD 对心血管(21 项研究,68,492 名参与者:RR 0.96,95% CI 0.78 至 1.19;I²=92%)和感染相关死亡(17 项研究,116,333 名参与者:RR 0.90,95% CI 0.57 至 1.42;I²=98%)的影响不确定(均为非常低确定性)。与 HD 相比,PD 对菌血症/血流感染(2 项研究,2582 名参与者:RR 0.34,95% CI 0.10 至 1.18;I²=68%)和感染发作(3 项研究,277 名参与者:RR 1.23,95% CI 0.93 至 1.62;I²=20%)的影响不确定(均为非常低确定性)。PD 可能减少菌血症/血流感染发作次数(2 项研究,2637 名参与者:RR 0.44,95% CI 0.27 至 0.71;I²=24%;低确定性)。与 HD 相比;尚不确定 PD 是否降低急性心肌梗死(4 项研究,110,850 名参与者:RR 0.90,95% CI 0.74 至 1.10;I²=55%)、冠状动脉疾病(3 项研究,5826 名参与者:RR 0.95,95% CI 0.46 至 1.97;I²=62%)、缺血性心脏病(2 项研究,58,374 名参与者:RR 0.86,95% CI 0.57 至 1.28;I²=95%)、充血性心力衰竭(3 项研究,49,511 名参与者:RR 1.10,95% CI 0.54 至 2.21;I²=89%)和中风(4 项研究,102,542 名参与者:RR 0.94,95% CI 0.90 至 0.99;I²=0%)的风险,因为证据质量为低至非常低。与 HD 相比,PD 在住院(4 项研究,3282 名参与者:RR 0.90,95% CI 0.62 至 1.30;I²=97%)和全因住院事件(4 项研究,42,582 名参与者:RR 1.02,95% CI 0.81 至 1.29;I²=91%)的影响不确定(非常低确定性)。纳入的研究均未专门报告生活参与度或疲劳。然而,有两项研究评估了就业。与 HD 相比,PD 在一年时的就业情况不确定(2 项研究,593 名参与者:RR 0.83,95% CI 0.20 至 3.43;I²=97%;非常低确定性)。
作者结论:基于主要来自 NRSI 的数据,PD 与 HD 在保留 RKF、全因和病因特异性死亡风险、菌血症发生率、其他血管并发症(如中风、心血管事件)以及患者报告的结局(如生活参与度和疲劳)方面的比较效果不确定。
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