目的:评价尿毒清颗粒治疗慢性肾功能衰竭( CRF)的有效性及安全性。方法:计算机检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普期刊数据库、万方资源数据库、EMBASE、MEDLINE、PUBMED、Cochrane图书馆中关于尿毒清颗粒治疗CRF的随机和半随机对照试验,并手工检索相关杂志,由两位研究者独立进行筛选和资料提取后,并按照改良Jadad评分量表对纳入文献质量进行评价,应用Revman5.2软件进行Meta分析。结果:纳入21篇文献,共1738例患者,其中试验组930例,对照组808例。Meta分析结果显示,与对照组相比,尿毒清颗粒联合用药能降低CRF患者血肌酐(Scr)[MD=-69.45,95%CI(-84.05,-54.85)];降低尿素氮(BUN)[MD=-2.88,95%CI(-5.19,-0.57)];升高CRF患者内生肌酐清除率(Ccr)[MD=4.96,95%CI(2.71,7.21)];并且可以改善CRF患者症状和体征的总有效率[Peto OR=4.99,95%CI(3.94,6.32)];但对于升高血红蛋白(Hb)[MD=4.78,95%CI(-0.16,9.71)]与对照组相比差异无统计学意义。结论:与对照组相比,尿毒清颗粒联合用药能明显降低CRF患者Scr、BUN,升高Ccr以及改善患者症状和体征的总有效率,但对于升高Hb上无证据显示较对照组更为有效,表明尿毒清颗粒可能是一种相对安全和有效治疗CRF的药物。由于纳入的文献其研究方法学质量不高,有待进一步进行高质量的研究对其疗效及安全性进行研究。
Objective:To evaluate the efectiveness and safety of uremic clearance granule on treating chronic renal failure( CRF). Methods:All randomized or semi-randomized controlled trials( RCTs or semi-RCTs)of uremic clearance granule in treating CRF were collected from CBM,CNKI,VIP,WanFang,EMBASE,MEDLINE,PUBMED and Cochrane library clinical controlled trials database. After two researchers for screening and data extraction independently,the quality of the included literature research was evaluated according to the modified Jadad rating scale,then Revman 5. 2 was used to undertake meta analysis. Results:A total of 21 RCTs and semi-RCTs were obtained,including 1 738 patients,experimental group 930 patients vs control group 808 patients. Meta analysis indicated that uremic clearance granule treatment gave better results in lowering Serum creatinine(Scr)[MD=-69. 45,95%CI( -84. 05,-54. 85)],blood urea nitrogen(BUN)[MD= -2. 88,95%CI( -5. 19,-0. 57)];And also in-creasing endogenous creatinine clearance rate(Ccr)[MD=4. 96,95%CI(2. 71,7. 21)]. In addition,it can improve total efficien-cy of the symptoms and signs in patients with CRF[Peto OR=4. 99,95%CI(3. 94,6. 32)]. But there is no statistically significant for increasing the hemoglobin(Hb)[MD=4. 78,95%CI( -0. 16,9. 71)]compared with control therapy alone. Conclusion:Ure-mic clearance granule significantly reduced Scr,BUN,increased Ccr,and improve total efficiency of the symptoms and signs in pa-tients with CRF,subgroup analyzes found that combination therapy with uremic clearance granule is better than control therapy alone. However,there is no evidence for increasing the Hb is more effective than the control group in CRF treatment. Due to low quality of the methodological of included studies,pending further high-quality researches to study its efficacy and safety.