Wu Hong Mei, Sun Hong Juan, Wang Feng, Yang Ming, Dong Bi Rong, Liu Guan J
Center of Geriatrics and Gerontology, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, Sichuan, China, 610041.
Cochrane Database Syst Rev. 2014 Oct 15;2014(10):CD007861. doi: 10.1002/14651858.CD007861.pub2.
Chronic kidney disease (CKD) is a worldwide public health problem which is at high increased risk of cardiovascular disease (CVD) and renal failure. Deterioration of kidney function causes an increase in circulating toxins, which, in turn promotes the progression of CKD. Oral adsorbents with capacity to adsorb and remove substances including uraemic toxins from the intestine could be effective in minimising kidney injury.
To investigate the benefits and harms of oral adsorbents for preventing or delaying the progression of CKD.
We searched the Cochrane Renal Group's Specialised Register (to 22 September 2014) through contact with the Trials' Search Co-ordinator using search terms relevant to this review. The following four Chinese medical databases were also searched: China Biological Medicine Database (1979 to May 2012); Chinese Science and Technique Journals Database (to May 2012); China National Infrastructure (to May 2012); Wan Fang database (to May 2012).
Randomised controlled trials (RCTs) and quasi-RCTs comparing any oral adsorbents for preventing or delaying the progression of CKD.
Two authors independently assessed and extracted information. Information was collected on methods, participants, interventions and outcomes (incidence of end-stage kidney disease (ESKD), mortality, quality of life and adverse events). Results were expressed as risk ratios (RR) for dichotomous outcomes or as mean differences (MD) for continuous data with 95% confidence intervals (CI). Adverse events were expressed as risk differences (RD).
Fifteen studies (1590 patients) conducted in Japan, China, and the USA were identified. The risk of bias of the included studies was moderate or high and the sample sizes were small.Three studies compared oral AST-120 plus routine treatment with placebo plus routine treatment; however data on our outcome measures of interest were not reported in two studies. These studies did not assess or did not provide data for our primary outcomes of interest (incidence of ESKD; time to ESKD; all-cause mortality). There was no significant difference in the changes of serum creatinine (SCr), slope of 1/SCr over time and creatinine clearance (CrCl) between AST-120 and placebo for patients with CKD.Eight studies compared oral AST-120 plus routine treatment with routine treatment alone; data on our outcome measures of interest were not reported in one study. There was no significant difference in incidence of ESKD, all-cause mortality and the change in health-related quality of life between AST-120 and routine treatment for patients with CKD. AST-120 showed beneficial effects on delaying the decline of kidney function measured by using the slope of change in estimated CrCl (SMD 0.39, 95% CI 0.21 to 0.5) and the mean changes of glomerular filtration rate (GFR) (MD -0.76 mL/min/mo, 95% CI -0.82 to -0.70) for patients with CKD; AST-120 was not superior to routine treatment in retarding the decline of kidney function measured by using the 1/SCr slope over time, occurrence of increase in SCr concentration, doubling of SCr concentration, changes in GFR from baseline (mL/min/1.73 m²) and slope of the eGFR curve (mL/min/mo) for patients with CKD.Three studies compared oral Ai Xi Te plus routine treatment with routine treatment alone. These studies did not assess our primary outcomes of interest. Compared with routine treatment, Ai Xi Te had positive effects on reducing SCr (MD -113.40 (µmol/L), 95% CI -188.69 to -38.10) and retarding the decline of CrCl (MD 9.74 (mL/min), 95% CI 4.28 to 15.21) for patients with CKD.One study compared oral Niaoduqing granules plus routine treatment with routine treatment alone, but did not assess our primary outcomes of interest. Compared with routine treatment, Niaoduqing granules had positive effects on reducing SCr (MD -135.60 (µmol/L), 95% CI -198.03 to -73.17) and CrCl (MD 13.30 (mL/min), 95% CI 5.69 to 20.91).The most commonly reported adverse events associated with AST-120 and Ai Xi Te were gastrointestinal symptoms however no serious adverse events were reported.
AUTHORS' CONCLUSIONS: Few studies reported our primary outcomes of interest. For our secondary outcomes, there is evidence of limited quality that AST-120, Ai Xi Te and Niaoduqing granules may have positive effects on delaying the decline of kidney function. There were no serious adverse events for any of the interventions in patients with CKD. Given the lack of information for our primary outcomes, the low methodological quality of most studies, and the small sample sizes, there is no strong evidence on the effectiveness of these oral adsorbents.
慢性肾脏病(CKD)是一个全球性的公共卫生问题,其患心血管疾病(CVD)和肾衰竭的风险大幅增加。肾功能恶化会导致循环毒素增加,进而促进CKD的进展。具有从肠道吸附和清除包括尿毒症毒素在内的物质能力的口服吸附剂可能对减轻肾损伤有效。
探讨口服吸附剂预防或延缓CKD进展的益处和危害。
我们通过与试验检索协调员联系,使用与本综述相关的检索词,检索了Cochrane肾脏组专业注册库(截至2014年9月22日)。还检索了以下四个中国医学数据库:中国生物医学数据库(1979年至2012年5月);中国科技期刊数据库(截至2012年5月);中国国家知识基础设施(截至2012年5月);万方数据库(截至2012年5月)。
比较任何口服吸附剂预防或延缓CKD进展的随机对照试验(RCT)和半随机对照试验。
两位作者独立评估并提取信息。收集了关于方法、参与者、干预措施和结局(终末期肾病(ESKD)发病率、死亡率、生活质量和不良事件)的信息。结果以二分结局的风险比(RR)或连续数据的均值差(MD)表示,并带有95%置信区间(CI)。不良事件以风险差(RD)表示。
共纳入在日本、中国和美国开展的15项研究(1590例患者)。纳入研究的偏倚风险为中度或高度,样本量较小。三项研究比较了口服AST - 120加常规治疗与安慰剂加常规治疗;然而,两项研究未报告我们感兴趣的结局指标数据。这些研究未评估或未提供我们感兴趣的主要结局(ESKD发病率;至ESKD的时间;全因死亡率)的数据。对于CKD患者,AST - 120与安慰剂在血清肌酐(SCr)变化、1/SCr随时间的斜率以及肌酐清除率(CrCl)方面无显著差异。八项研究比较了口服AST - 120加常规治疗与单纯常规治疗;一项研究未报告我们感兴趣的结局指标数据。对于CKD患者,AST - 120与常规治疗在ESKD发病率、全因死亡率以及健康相关生活质量变化方面无显著差异。AST - 120在延缓CKD患者肾功能下降方面显示出有益作用,以估计CrCl变化斜率衡量(标准化均数差0.39,95%CI 0.21至0.5)以及肾小球滤过率(GFR)的平均变化(MD - 0.76 mL/min/月,95%CI - 0.82至 - 0.70);在延缓CKD患者肾功能下降方面,AST - 120在以1/SCr随时间斜率、SCr浓度升高发生率、SCr浓度翻倍、GFR从基线的变化(mL/min/1.73 m²)以及估算肾小球滤过率(eGFR)曲线斜率(mL/min/月)衡量时并不优于常规治疗。三项研究比较了口服爱西特加常规治疗与单纯常规治疗。这些研究未评估我们感兴趣的主要结局。与常规治疗相比,爱西特对降低CKD患者的SCr(MD - 113.40(µmol/L),95%CI - 188.69至 - 38.10)和延缓CrCl下降(MD 9.74(mL/min),95%CI 4.28至15.21)有积极作用。一项研究比较了口服尿毒清颗粒加常规治疗与单纯常规治疗,但未评估我们感兴趣的主要结局。与常规治疗相比,尿毒清颗粒对降低SCr(MD - 135.60(µmol/L),95%CI - 198.03至 - 73.17)和CrCl(MD 13.30(mL/min),95%CI 5.69至20.91)有积极作用。与AST - 120和爱西特相关的最常报告的不良事件是胃肠道症状,但未报告严重不良事件。
很少有研究报告我们感兴趣的主要结局。对于我们的次要结局,有质量有限的证据表明AST - 120、爱西特和尿毒清颗粒可能对延缓肾功能下降有积极作用。CKD患者中任何干预措施均未出现严重不良事件。鉴于缺乏我们主要结局的信息、大多数研究方法学质量较低以及样本量较小,没有有力证据证明这些口服吸附剂的有效性。