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
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
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
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
目的介绍基于共识选择健康测量工具的标准(consensus-based standards for the selection of health measurement instruments,COSMIN)而改良的定量系统评价证据分级(the grading of recommendations assessment,development and evalua...目的介绍基于共识选择健康测量工具的标准(consensus-based standards for the selection of health measurement instruments,COSMIN)而改良的定量系统评价证据分级(the grading of recommendations assessment,development and evaluation,GRADE)方法,以帮助国内研究者更全面地认识与应用COSMIN评价体系。方法翻译COSMIN用户手册与阅读文献,将COSMIN改良版GRADE方法与传统GRADE法相比较分析。结果COSMIN基于传统GRADE法对其进行个性化改良,针对患者报告结局测量工具的特点更好地调整与说明了评价流程与方法。结论研究者应遵循COSMIN评价体系,规范患者报告结局测量工具系统评价的制作过程,提高研究质量。展开更多
[目的]系统评价电针夹脊穴疗法与单纯西药治疗带状疱疹的疗效及安全性,为带状疱疹治疗提供准确的临床决策。[方法]在中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(CBM)、Web of Science、EMbase、PubMed、Cochran...[目的]系统评价电针夹脊穴疗法与单纯西药治疗带状疱疹的疗效及安全性,为带状疱疹治疗提供准确的临床决策。[方法]在中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(CBM)、Web of Science、EMbase、PubMed、Cochrane Library及相关注册平台检索有关电针夹脊穴治疗带状疱疹的随机对照实验研究(RCT)文献,并使用RevMan 5.3进行Meta分析,以GRADE系统对证据质量进行分级。[结果]研究涉及1 758例病人参与的23个RCTs。Meta分析显示,电针夹脊穴疗法在有效率[RR=1.22,95%CI(1.15,1.30)]、视觉模拟评分(VAS)[MD=1.93,95%CI(1.64,2.23)]、临床症状评分[MD=1.21,95%CI(1.03,1.38)]方面与西药组比较总体差异均有统计学意义(P<0.001)。GRADE系统证据质量分级显示质量较低。[结论]现有证据表明,电针夹脊穴及其联合其他疗法治疗带状疱疹疗效优于单纯西药治疗,但证据质量级别仍属较低水平,故需要更严格的设计、大规模的RCT确认电针夹脊穴疗法治疗带状疱疹的疗效。展开更多
目的对国内上市的水痘减毒活疫苗（Varicella Attenuated Live Vaccine,Var V）的保护效果和证据质量进行评价和分析。方法电子检索科克伦对照试验中心注册库（The Cochrane Central Register of Controlled Trials）、医疗文献分析及...目的对国内上市的水痘减毒活疫苗（Varicella Attenuated Live Vaccine,Var V）的保护效果和证据质量进行评价和分析。方法电子检索科克伦对照试验中心注册库（The Cochrane Central Register of Controlled Trials）、医疗文献分析及在线检索系统（Medline）、中国全文期刊数据库（1915年~）、万方数据库（1988年~）,将国产Var V针对1~13岁儿童保护效果的随机对照试验纳入分析,由两名评价员共同提取资料,用Meta分析软件（Review Manager,Rev Man）5.2版本进行研究质量和统计分析,利用证据推荐分级的评估、制订与评价（The Grading of Recommendations Assessment,Development and Evaluation;GRADE）方法对整合证据的质量进行评级。结果共纳入6篇原始研究,无异质性,其干预措施为A公司和B研究所生产的冻干（Freeze-dried）Var V,对照措施为麻疹-流行性腮腺炎减毒活疫苗,干预对象多为3~6岁儿童,研究地点分别为山东、湖南和湖北省。Meta分析发现接种这种Vra V可明显降低水痘发病的概率[相对危险度（Relative Risk,RR）=0.11,95%可信区间（Confidence Interval,CI）=0.07~0.16],此结果与国内其他类型研究及国际研究结果一致。6篇研究报告存在明显缺陷,根据GRADE评价方法,整合的证据质量级别为＂极低＂。结论本研究结果基于现有发表文献得到的,国内上市Var V的保护效果可能与此估计值存在差异,提示国内Var V及其他此领域评价研究应提高研究质量,并提高文章报告的质量和完整性。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。
文摘目的介绍基于共识选择健康测量工具的标准(consensus-based standards for the selection of health measurement instruments,COSMIN)而改良的定量系统评价证据分级(the grading of recommendations assessment,development and evaluation,GRADE)方法,以帮助国内研究者更全面地认识与应用COSMIN评价体系。方法翻译COSMIN用户手册与阅读文献,将COSMIN改良版GRADE方法与传统GRADE法相比较分析。结果COSMIN基于传统GRADE法对其进行个性化改良,针对患者报告结局测量工具的特点更好地调整与说明了评价流程与方法。结论研究者应遵循COSMIN评价体系,规范患者报告结局测量工具系统评价的制作过程,提高研究质量。
文摘目的系统评价脉血康胶囊治疗急性脑梗死(acute cerebral infarction,ACI)的临床疗效和安全性,以期为ACI的临床治疗提供参考。方法计算机检索国内外7大数据库,收集脉血康胶囊治疗ACI随机对照试验(randomized controlled trial,RCT),采用Cochrane5.1.0偏倚风险评估工具进行方法学质量评价,采用RevMan5.3软件对临床有效率、神经功能评分、血浆纤维蛋白原(fibrinogen,FIB)及不良反应等结局指标进行Meta分析,运用GRADE(grading of recommendations,assessment,development and evaluation)系统对关键结局指标的证据质量和推荐等级进行分级。结果纳入文献19篇,Meta分析结果显示:(1)脉血康胶囊+西医常规治疗提高临床总有效率[RRNIHSS=1.17,95%CI(1.07,1.28),P=0.0008;RRNDS=1.24,95%CI(1.14,1.34),P<0.00001;RR临床症状=1.55,95%CI(1.20,2.00),P=0.0007]、改善神经功能[MD重度卒中=−6.24,95%CI(−6.86,−5.62),P<0.00001;MD中度卒中=−1.97,95%CI(−2.91,−1.03),P<0.0001;MDNDS=−5.11,95%CI(−7.36,−2.85),P<0.00001]、降低FIB[MD=−0.86,95%CI(−1.13,−0.59),P<0.00001]均优于单独西医常规治疗,两组不良反应发生率[RR=0.58,95%CI(0.29,1.18),P=0.13]差异无统计学意义。(2)脉血康胶囊+动脉溶栓术+西医常规治疗以临床神经功能缺损程度评分标准(clinical nerve deficiency scale,NDS)为疗效评定标准的临床总有效率[RRNDS=1.30,95%CI(1.14,1.47),P<0.0001]、改善神经功能评分优于动脉溶栓术+西医常规治疗,且差异具有统计学意义(P<0.05),两组比较在以美国国立卫生研究院卒中量表(national institutes of health stroke scale,NIHSS)为疗效评定标准的临床总有效率[RRNIHSS=1.15,95%CI(0.97,1.37),P=0.11]、降低FIB[MD=−0.16,95%CI(−0.33,−0.00),P=0.05]、不良反应发生率(P=0.50)方面差异无统计学意义。(3)脉血康胶囊+重组人组织型纤溶酶原激活剂(rt-PA)静脉溶栓+西医常规治疗降低FIB、改善神经功能缺损优于rt-PA静脉溶栓+西医常规治疗,差异具有统计学意义(P<0.05)。结论脉血康胶囊联合西医常规治疗可改善ACI的临床总有效率、神经功能,降低FIB,且不良反应发生率较低;脉血康胶囊+动脉溶栓术+西医常规治疗可改善以NDS为疗效评定标准的临床总有效率和神经功能;脉血康胶囊+rt-PA静脉溶栓+西医常规治疗可改善ACI的神经功能并降低FIB,但考虑到纳入研究的文献质量有限,证据等级较低,有待更多设计严谨、高质量、大样本的研究进一步验证。
