BACKGROUND The standard management of autoimmune hepatitis(AIH)is based on corticosteroids,alone or in combination with azathioprine.Second-line treatments are needed for patients who have refractory disease.However,h...BACKGROUND The standard management of autoimmune hepatitis(AIH)is based on corticosteroids,alone or in combination with azathioprine.Second-line treatments are needed for patients who have refractory disease.However,high-quality data on the alternative management of AIH are scarce.AIM To evaluate the efficacy and safety of tacrolimus and mycophenolate mofetil(MMF)and the quality of evidence by using the Grading of Recommendations Assessment,Development and Evaluation approach(GRADE).METHODS A systematic review and meta-analysis of the available data were performed.We calculated pooled event rates for three outcome measures:Biochemical remission,adverse events,and mortality,with their corresponding 95%confidence intervals(CI).RESULTS The pooled biochemical remission rate was 68.9%(95%CI:60.4-76.2)for tacrolimus,and 59.6%(95%CI:54.8-64.2)for MMF,and rates of adverse events were 25.5%(95%CI:12.4-45.3)for tacrolimus and 24.1%(95%CI:15.4-35.7)for MMF.The pooled mortality rate was estimated at 11.5%(95%CI:7.1-18.1)for tacrolimus and 9.01%(95%CI:6.2-12.8)for MMF.Pooled biochemical remission rates for tacrolimus and MMF in patients with intolerance to standard therapy were 56.6%(CI:43.4-56.6)vs 73.5%(CI:58.1-84.7),and among non-responders were 59.1%(CI:48.7-68.8)vs 40.8%(CI:32.3-50.0),respectively.Moreover,the overall quality assessments using GRADE proved to be very low for all our outcomes in both treatment groups.CONCLUSION Tacrolimus and MMF are in practice considered effective for patients with AIH who are non-responders or intolerant to first-line treatment,but we found no high-quality evidence to support this statement.展开更多
目的系统评价补肾方剂改善高龄女性自然妊娠结局的临床疗效和安全性。方法检索中国知网、万方数据库、维普数据库、SinoMed、PubMed、Web of Science、Cochrane Library、Embase等数据库建库至2022年6月收录的补肾方剂改善高龄女性自然...目的系统评价补肾方剂改善高龄女性自然妊娠结局的临床疗效和安全性。方法检索中国知网、万方数据库、维普数据库、SinoMed、PubMed、Web of Science、Cochrane Library、Embase等数据库建库至2022年6月收录的补肾方剂改善高龄女性自然妊娠结局的随机对照研究(RCT)。运用偏倚风险工具进行质量评估,使用RevMan软件进行Meta分析。结果共纳入14篇RCT。Meta分析结果显示:补肾方剂联合西药治疗在提高妊娠率[RR=1.71,95%CI(1.45,2.01),P<0.00001]、降低卵泡刺激素(FSH)水平[SMD=-1.63,95%CI(-2.84,-0.43),P=0.008]、提高雌二醇(E_(2))水平[SMD=3.97,95%CI(1.76,6.17),P=0.0004]、增加排卵期子宫内膜厚度[SMD=2.12,95%CI(1.07,3.18),P<0.0001]方面均优于西药组;且补肾方剂单独使用在提高妊娠率[RR=1.94,95%CI(1.31,2.88),P=0.001]、降低FSH水平[SMD=-0.48,95%CI(-0.74,-0.22),P=0.0003]方面也具有显著疗效。结论与西医治疗比较,补肾方剂可以显著改善高龄女性自然妊娠结局,且不良反应较少,但仍需更多高质量、大样本、多中心的RCT予以验证。展开更多
BACKGROUND Nonalcoholic fatty liver disease(NAFLD)affects more than one-quarter of the global population.Due to the lack of approved chemical agents,many patients seek treatment from traditional Chinese medicine(TCM)f...BACKGROUND Nonalcoholic fatty liver disease(NAFLD)affects more than one-quarter of the global population.Due to the lack of approved chemical agents,many patients seek treatment from traditional Chinese medicine(TCM)formulas.A variety of systematic reviews have been published regarding the effectiveness and safety of TCM formulas for NAFLD.AIM To critically appraise available systematic reviews and sort out the high-quality evidence on TCM formulas for the management of NAFLD.METHODS Seven databases were systematically searched from their inception to 28 February 2020.The search terms included“non-alcoholic fatty liver disease,”“Chinese medicines,”“systematic review,”and their synonyms.Systematic reviews involving TCM formulas alone or in combination with conventional medications were included.The methodological quality and risk of bias of eligible systematic reviews were evaluated by using A Measure Tool to Assess Systematic Reviews 2(AMSTAR 2)and Risk of Bias in Systematic Review(ROBIS).The quality of outcomes was assessed by the Grading of Recommendations Assessment,Development and Evaluation(GRADE)system.RESULTS Seven systematic reviews were ultimately included.All systematic reviews were conducted based on randomized controlled trials and published in the last decade.According to the AMSTAR 2 tool,one systematic review was judged as having a moderate confidence level,whereas the other studies were rated as having a low or extremely low level of confidence.The ROBIS tool showed that the included systematic reviews all had a high risk of bias due to insufficient consideration of identified concerns.According to the GRADE system,only two outcomes were determined as high quality;namely,TCM formulas with the HuoXueHuaYu principle were better than conventional medications in ultrasound improvement,and TCM formulas were superior to antioxidants in alanine aminotransferase normalization.Other outcomes were downgraded to lower levels,mainly because of heterogeneity among studies,not meeting optimal information sample size,and inclusion of excessive numbers of small sample studies.Nevertheless,the evidence quality of extracted outcomes should be further downgraded when applying to clinical practice due to indirectness.CONCLUSION The quality of available systematic reviews was not satisfactory.Researchers should avoid repeatedly conducting systematic reviews in this area and focus on designing rigorous randomized controlled trials to support TCM formula applications.展开更多
目的:对游戏疗法干预脑性瘫痪(脑瘫)病人的系统评价进行再评价,为改进脑瘫病人康复运动策略提供参考。方法:通过计算机检索the Cochrane Library、Embase、PubMed、Web of Science、中国知网、中国生物医学文献数据库、维普及万方等中...目的:对游戏疗法干预脑性瘫痪(脑瘫)病人的系统评价进行再评价,为改进脑瘫病人康复运动策略提供参考。方法:通过计算机检索the Cochrane Library、Embase、PubMed、Web of Science、中国知网、中国生物医学文献数据库、维普及万方等中英文数据库,收集有关对比不同游戏疗法对脑瘫病人康复效果的系统评价/Meta分析,采用系统评价方法学质量评价工具AMSTAR 2对纳入研究的方法学质量进行评价,采用证据质量分级系统GRADE进行证据分级。结果:最终纳入28项系统评价/Meta分析,方法学质量评价结果显示,11个条目报告较完整,1个条目未报告。结论:游戏疗法有利于脑瘫病人运动功能、平衡功能以及上肢功能的恢复,虽然所纳入文献的方法学质量整体较高,但基于结局指标的证据等级均较低。展开更多
This study aimed to develop a guideline for therapeutic drug monitoring（TDM） of vancomycin. We adopted the new guideline definition from the Institute of Medicine（IOM）, adhered closely to the six domains of the Ap...This study aimed to develop a guideline for therapeutic drug monitoring（TDM） of vancomycin. We adopted the new guideline definition from the Institute of Medicine（IOM）, adhered closely to the six domains of the Appraisal of Guidelines for Research ＆ Evaluation Ⅱ（AGREE Ⅱ）, and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome（PICO） and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation（GRADE）.展开更多
文摘BACKGROUND The standard management of autoimmune hepatitis(AIH)is based on corticosteroids,alone or in combination with azathioprine.Second-line treatments are needed for patients who have refractory disease.However,high-quality data on the alternative management of AIH are scarce.AIM To evaluate the efficacy and safety of tacrolimus and mycophenolate mofetil(MMF)and the quality of evidence by using the Grading of Recommendations Assessment,Development and Evaluation approach(GRADE).METHODS A systematic review and meta-analysis of the available data were performed.We calculated pooled event rates for three outcome measures:Biochemical remission,adverse events,and mortality,with their corresponding 95%confidence intervals(CI).RESULTS The pooled biochemical remission rate was 68.9%(95%CI:60.4-76.2)for tacrolimus,and 59.6%(95%CI:54.8-64.2)for MMF,and rates of adverse events were 25.5%(95%CI:12.4-45.3)for tacrolimus and 24.1%(95%CI:15.4-35.7)for MMF.The pooled mortality rate was estimated at 11.5%(95%CI:7.1-18.1)for tacrolimus and 9.01%(95%CI:6.2-12.8)for MMF.Pooled biochemical remission rates for tacrolimus and MMF in patients with intolerance to standard therapy were 56.6%(CI:43.4-56.6)vs 73.5%(CI:58.1-84.7),and among non-responders were 59.1%(CI:48.7-68.8)vs 40.8%(CI:32.3-50.0),respectively.Moreover,the overall quality assessments using GRADE proved to be very low for all our outcomes in both treatment groups.CONCLUSION Tacrolimus and MMF are in practice considered effective for patients with AIH who are non-responders or intolerant to first-line treatment,but we found no high-quality evidence to support this statement.
文摘目的系统评价补肾方剂改善高龄女性自然妊娠结局的临床疗效和安全性。方法检索中国知网、万方数据库、维普数据库、SinoMed、PubMed、Web of Science、Cochrane Library、Embase等数据库建库至2022年6月收录的补肾方剂改善高龄女性自然妊娠结局的随机对照研究(RCT)。运用偏倚风险工具进行质量评估,使用RevMan软件进行Meta分析。结果共纳入14篇RCT。Meta分析结果显示:补肾方剂联合西药治疗在提高妊娠率[RR=1.71,95%CI(1.45,2.01),P<0.00001]、降低卵泡刺激素(FSH)水平[SMD=-1.63,95%CI(-2.84,-0.43),P=0.008]、提高雌二醇(E_(2))水平[SMD=3.97,95%CI(1.76,6.17),P=0.0004]、增加排卵期子宫内膜厚度[SMD=2.12,95%CI(1.07,3.18),P<0.0001]方面均优于西药组;且补肾方剂单独使用在提高妊娠率[RR=1.94,95%CI(1.31,2.88),P=0.001]、降低FSH水平[SMD=-0.48,95%CI(-0.74,-0.22),P=0.0003]方面也具有显著疗效。结论与西医治疗比较,补肾方剂可以显著改善高龄女性自然妊娠结局,且不良反应较少,但仍需更多高质量、大样本、多中心的RCT予以验证。
基金Evidence-based Capacity Building Project for Basic Traditional Chinese Medicine-Specialized Diseases,No.2019XZZX-XH012Shanghai Three-year Action Plan for Accelerating the Development of Traditional Chinese Medicine,No.ZY(2018-2020)-CCCX-2002-01.
文摘BACKGROUND Nonalcoholic fatty liver disease(NAFLD)affects more than one-quarter of the global population.Due to the lack of approved chemical agents,many patients seek treatment from traditional Chinese medicine(TCM)formulas.A variety of systematic reviews have been published regarding the effectiveness and safety of TCM formulas for NAFLD.AIM To critically appraise available systematic reviews and sort out the high-quality evidence on TCM formulas for the management of NAFLD.METHODS Seven databases were systematically searched from their inception to 28 February 2020.The search terms included“non-alcoholic fatty liver disease,”“Chinese medicines,”“systematic review,”and their synonyms.Systematic reviews involving TCM formulas alone or in combination with conventional medications were included.The methodological quality and risk of bias of eligible systematic reviews were evaluated by using A Measure Tool to Assess Systematic Reviews 2(AMSTAR 2)and Risk of Bias in Systematic Review(ROBIS).The quality of outcomes was assessed by the Grading of Recommendations Assessment,Development and Evaluation(GRADE)system.RESULTS Seven systematic reviews were ultimately included.All systematic reviews were conducted based on randomized controlled trials and published in the last decade.According to the AMSTAR 2 tool,one systematic review was judged as having a moderate confidence level,whereas the other studies were rated as having a low or extremely low level of confidence.The ROBIS tool showed that the included systematic reviews all had a high risk of bias due to insufficient consideration of identified concerns.According to the GRADE system,only two outcomes were determined as high quality;namely,TCM formulas with the HuoXueHuaYu principle were better than conventional medications in ultrasound improvement,and TCM formulas were superior to antioxidants in alanine aminotransferase normalization.Other outcomes were downgraded to lower levels,mainly because of heterogeneity among studies,not meeting optimal information sample size,and inclusion of excessive numbers of small sample studies.Nevertheless,the evidence quality of extracted outcomes should be further downgraded when applying to clinical practice due to indirectness.CONCLUSION The quality of available systematic reviews was not satisfactory.Researchers should avoid repeatedly conducting systematic reviews in this area and focus on designing rigorous randomized controlled trials to support TCM formula applications.
文摘This study aimed to develop a guideline for therapeutic drug monitoring（TDM） of vancomycin. We adopted the new guideline definition from the Institute of Medicine（IOM）, adhered closely to the six domains of the Appraisal of Guidelines for Research ＆ Evaluation Ⅱ（AGREE Ⅱ）, and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome（PICO） and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation（GRADE）.
文摘目的系统评价热毒宁注射液治疗毛细支气管炎的疗效与安全性。方法计算机检索Cochrane Library、Pub Med、Embase、中国学术期刊全文数据库、维普数据库、万方数据库,搜索热毒宁注射液治疗毛细支气管炎的随机对照试验,由2位研究者根据纳入排除标准独立进行文献筛选和资料提取。采用Rev Man 5.3软件对纳入文献进行质量评价和Meta分析,并采用"推荐分级的评价、制定与评估"系统对证据质量和等级推荐进行分级。结果共纳入9个随机双盲对照试验,均为在常规治疗基础上加用热毒宁注射液治疗婴幼儿毛细支气管炎。治疗组与对照组相比总有效率差异有统计学意义(风险率为1.19,95%置信区间1.06~1.35,P<0.05);治疗组与对照组相比,住院时长差异有统计学意义(平均差为-1.61,95%置信区间-2.70^-0.52,P<0.001);2组不良反应发生率差异无统计学意义(P>0.05)。经"推荐分级的评价、制定与评估"系统对证据质量评价显示,总有效率和住院时长2个结局指标的证据强度为低。结论热毒宁注射液能有效应用于毛细支气管炎的治疗,且无严重不良反应。由于纳入的研究普遍质量不高,尚需开展更多大样本、多中心和高质量的随机对照试验来进一步验证。
