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作 者:张李博 王瑶 马嘉 吴金鸿 郭婷婷 刘光珍[3] 鞠宝兆[1] ZHANG Li-Bo;WANG Yao;MA Jia;WU Jin-hong;GUO Ting-ting;LIU Guang-zhen;JU Bao-zhao(Liaoning University of Traditional Chinese Medine,Shenyang 110847,China;Shanxi University of Traditional Chinese Medicine,Taiyuan 030024,China;Shanxi Academy of Chinese Medicine,Taiyuan 030012,China)
机构地区:[1]辽宁中医药大学,辽宁沈阳110847 [2]山西中医药大学,山西太原030024 [3]山西省中医药研究院,山西太原030012
出 处:《海南医学院学报》2023年第4期302-310,共9页Journal of Hainan Medical University
基 金:山西省科技攻关项目(2016ZD0307);晋药综合开发利用协同创新中心项目(2017-JYXT-32);山西省重点研发计划重点项目计划(201603D3113023);山西省重点研发计划(指南)项目(201703D421024);山西中医药大学研究生教育创新计划项目(2020JG001)。
摘 要:目的:运用循证医学方法评价益肾活血法治疗难治性肾病综合征(refractorynephrotic syndrome,RNS)的疗效及安全性。方法:检索CNKI、WanFang、VIP、CBM、PubMed、EMbase、Cochrane Library等数据库关于益肾活血法治疗RNS的随机对照试验(randomized controlled trial,RCT),检索时间为2008年6月~2020年7月,根据Cochrane系统评价方法对文献进行质量评价,采用ReviewManager5.3软件进行Meta分析。结果:本次研究共纳入18篇文献和1432例患者,结果显示:益肾活血法在提高总有效率[OR=4.15,(95%CI:3.03,5.68),P<0.05]和血浆白蛋白[MD=5.08,(95%CI:3.42,6.74),P<0.05],降低24 h尿蛋白定量[MD=-0.99,(95%CI:-1.30,-0,69),P<0.05]、复发率[OR=0.21,95%CI(0.11,0.40),P<0.05]、不良反应发生率[OR=0.33,95%CI(0.21,0.52),P<0.05]方面均优于对照组;而在提高完全缓解率方面受疗程的影响,疗程≤9周[OR=1.52,(95%CI:0.74,3.13),P=0.25]2组疗效相当,疗程12~24周[OR=2.47,(95%CI:1.63,3.74),P<0.05]和疗程≥26周[OR=2.04,(95%CI:1.43,2.91),P<0.05]试验组优于对照组。结论:益肾活血法治疗难治性肾病综合征的疗效及安全性优于西医组,但确切疗效仍需要更高质量的前瞻性研究加以证实。Objective:To evaluate the efficacy and safety of Yishen-Huoxue Formula in the treatment of refractory nephrotic syndrome(RNS)using evidence-based medicine.Methods:Databases CNKI,WanFang,VIP,CBM,PubMed,EMbase,and Cochrane Library were searched for randomized controlled trials(RCTs)on the treatment of RNS with the YishenHuoxue Formula from June 2008 to July 2020.The quality of the literature was evaluated by the Cochrane.Meta-analysis was performed using Review Manager 5.3 software.Results:A total of 18 articles and 1432 patients were included in this study.The results showed compared to the control group,Yishen-Huoxue Formula was much better in improving total effectiverate[OR=4.15,(95%CI:3.03,5.68),P<0.05],plasma albumin[MD=5.08,(95%CI:3.42,6.74),P<0.05]and decreasing 24-hour urine protein quantitation[MD=-0.99,(95%CI:-1.30,-0,69),P<0.05],recurrence rate[OR=0.21,95%CI(0.11,0.40),P<0.05],and adverse reaction rate[OR=0.33,95%CI(0.21,0.52),P<0.05].However,the improvement of complete remission rate was affected by the course of treatment.The effects were similar in less than or equal to nine weeks[OR=1.52,(95%CI:0.74,3.13),P=0.25],whereas the experimental group was superior to the control group in 12~24 weeks[OR=2.47,(95%CI:1.63,3.74),P<0.05]and more than or equal to 26 weeks[OR=2.04,(95%CI:1.43,2.91),P<0.05].Conclusion:The efficacy and safety of Yishen-Huoxue Formula for refractory nephrotic syndrome is better than that of the Western medicine group,but the exact efficacy still needs to be confirmed by prospective studies of higher quality.
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