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[摘要]
目的 采用系統(tǒng)評價的方法研究雙膦酸鹽對患者腎毒性發(fā)生率、肌酐和尿素氮的影響。方法 計算機檢索Pubmed,Embase,Cochrane Library,中國學術期刊全文數(shù)據(jù)庫(CNKI)、中國生物醫(yī)學文獻數(shù)據(jù)庫(CBM)、維普數(shù)據(jù)庫(VIP)和萬方數(shù)據(jù)庫,從建庫起到2018年1月25日,限定語言為英語和漢語的隨機對照試驗(RCT)和前瞻性非隨機對照試驗。篩選文獻,提取數(shù)據(jù),運用Stata 12.0進行系統(tǒng)評價。結果 最終納入8個RCTs和8個前瞻性非隨機對照臨床試驗,共11 240名患者。Meta-分析結果顯示:與對照組相比,雙膦酸鹽顯著增加患者發(fā)生腎毒性的風險[OR=1.58,95%CI(1.28,1.95),P<0.000 1];而雙膦酸鹽治療組與對照組比較,在血清肌酐和尿素氮方面,無顯著性差異[MD=-1.06,95%CI(-5.43,3.30),P=0.63;MD=-0.07,95%CI(-0.32,0.19),P=0.61]。通過對患者使用的雙膦酸鹽種類、患者基礎疾病、患者的平均年齡、不同試驗類型以及給藥途徑進行亞組分析,雙膦酸鹽組肌酐值與對照組亦無統(tǒng)計學差異。結論 雙膦酸鹽明顯增加了患者發(fā)生腎毒性的風險,但血清肌酐和尿素氮兩種腎臟指標并無顯著性差異。建議在今后雙膦酸鹽的應用中納入更多腎毒性相關指標,以幫助臨床更早的發(fā)現(xiàn)患者的腎損害。
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[Abstract]
Objective The influences of bisphosphonates on the incidence rate of nephrotoxicity,creatinine (Cr) and blood urea nitrogen (BUN) of patients were studied by system evaluation method.Methods Randomized controlled trials (RCTs) and prospective non randomized controlled trials which were published in English or Chinese were systematically retrieved by computer in the Pubmed,Embase,Cochrane Library,China National Knowledge Infrastructure (CNKI),China Biology Medicine disc (CBM),VIP and Wanfang Datebase from the establishment of the datebase to January 25,2018.The literatures were screened and data were extracted,the system evaluation was performed by Stata 12.0.Results A total of 8 RCTs and 8 prospective non randomized controlled trials involving 11 240 patients were finally included in this study.The Meta-analysis results showed that bisphosphonates significantly increased the risk of nephrotoxicity of patients in comparison with control groups[OR=1.58,95%CI(1.28,1.95),P<0.000 1].However,there was no significant difference of Cr and BUN between bisphosphonates and control groups[MD=-1.06,95%CI(-5.43,3.30),P=0.63;MD=-0.07,95%CI(-0.32,0.19),P=0.61].According to the subgroup analysis of types of bisphosphonates,underlying diseases,average age of the patients,different types of trials and administration route,there were no statistical differences of creatinine value between bisphosphonates and control groups.Conclusion Bisphosphonates significantly increased the risk of nephrotoxicity,but there were no significant differences in Cr and BUN.It is suggested that more indicators of nephrotoxicity should be included in the future application of bisphosphonate to help early detection of renal damage of patients.
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