Wu H M, Tang J L, Sha Z H, Cao L, Li Y P
Chinese Cochrane Center, Department of Gerontology, West China Hospital, Si Chuan University, Chengdu, Si Chuan, China, 610041.
Cochrane Database Syst Rev. 2004(2):CD003964. doi: 10.1002/14651858.CD003964.pub2.
Infection is one of the most common complications and still remains a significant cause of morbidity and occasionally mortality in patients, especially children with nephrotic syndrome. Many different prophylactic interventions have been used or recommended for reducing the risks of infection in nephrotic syndrome in clinical practice. Whether the existing evidence is scientifically rigorous and which prophylactic intervention can be recommended for routine use based on the current evidence is still unknown.
To assess the benefits and harms of any prophylactic interventions for reducing the risk of infection in children and adults with nephrotic syndrome.
We searched the Cochrane Renal Group Specialised Register (January 2003), The Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library Issue 1, 2003), MEDLINE and Pre-MEDLINE (1966 - February 2003), EMBASE (1980 - February 2003), China Biological Medicine Database (CBMdisc, 1979 - December 2002), reference lists of nephrology textbooks, review articles, relevant trials and abstracts from nephrology scientific meetings without language restriction.
Randomised controlled trials (RCTs) and quasi-RCTs comparing any prophylactic interventions (pharmacological or non-pharmacological) for preventing any infection in children and adults with nephrotic syndrome.
Two reviewers independently assessed and extracted information. Information was collected on method, participants, interventions and outcomes ( appearance of infection, mortality, quality of life and adverse events).
Five RCTs conducted in China, including 308 children with nephrotic syndrome were identified. No trials were identified in adults. All trials compared one kind of prophylactic pharmacotherapy (IVIG, thymosin or a compound of Chinese medicinal herbs - TIAOJINING) in addition to baseline treatment with baseline treatment alone. No RCTs were identified comparing antibiotic or non-pharmacological prophylaxis, or pneumococcal vaccination. Three trials showed a significantly better effect of IVIG on preventing nosocomial or unspecified infection in children with nephrotic syndrome (RR 0.39, 95% CI 0.18 to 0.82). Thymosin and TIAOJINING were also effective for reducing the risks of infection in children with nephrotic syndrome with RR 0.50 (95%CI 0.26 to 0.97) and 0.59 (95%CI 0.43 to 0.81) respectively. No serious adverse events were reported.
REVIEWERS' CONCLUSIONS: IVIG, thymosin and TIAOJINING may have positive effects on prevention of nosocomial or unspecified infection with no obvious serious adverse events in children with nephrotic syndrome. However the methodological quality of all trials was poor, the sample sizes small and all studies were from China, and thus there is no strong evidence on the effectiveness of these interventions.
感染是最常见的并发症之一,仍是患者(尤其是肾病综合征患儿)发病和偶尔死亡的重要原因。在临床实践中,已采用或推荐了许多不同的预防性干预措施来降低肾病综合征患者的感染风险。现有证据是否科学严谨,以及根据当前证据可推荐哪种预防性干预措施用于常规治疗,仍不清楚。
评估任何预防性干预措施对降低肾病综合征儿童和成人感染风险的利弊。
我们检索了Cochrane肾脏组专业注册库(2003年1月)、Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆2003年第1期)、MEDLINE和Pre-MEDLINE(1966年 - 2003年2月)、EMBASE(1980年 - 2003年2月)、中国生物医学数据库(CBMdisc,1979年 - 2002年12月)、肾脏病学教科书的参考文献列表、综述文章、相关试验以及肾脏病学科学会议的摘要,无语言限制。
比较任何预防性干预措施(药物或非药物)预防肾病综合征儿童和成人任何感染的随机对照试验(RCT)和半随机对照试验。
两名评价员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(感染出现情况、死亡率、生活质量和不良事件)的信息。
在中国进行了5项RCT,包括308例肾病综合征患儿。未发现成人相关试验。所有试验均比较了一种预防性药物治疗(静脉注射免疫球蛋白、胸腺素或中药复方 - 调机体宁)加基础治疗与单纯基础治疗。未发现比较抗生素或非药物预防或肺炎球菌疫苗接种的RCT。三项试验显示静脉注射免疫球蛋白对预防肾病综合征患儿医院感染或不明感染有显著更好的效果(相对危险度0.39,95%可信区间0.18至0.82)。胸腺素和调机体宁对降低肾病综合征患儿感染风险也有效,相对危险度分别为0.50(95%可信区间0.26至0.97)和0.59(95%可信区间0.43至0.81)。未报告严重不良事件。
静脉注射免疫球蛋白、胸腺素和调机体宁可能对预防肾病综合征患儿医院感染或不明感染有积极作用,且无明显严重不良事件。然而,所有试验的方法学质量较差,样本量小,且所有研究均来自中国,因此这些干预措施有效性的证据不足。