This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate （AA） and enzalutamide （Enz） for metastatic castration-resistant prostate cancer （mCRPC）. A lit...This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate （AA） and enzalutamide （Enz） for metastatic castration-resistant prostate cancer （mCRPC）. A literature search was performed with PubMed, Embase, and Web of Science databases to identify relevant studies. Reviewed literature included published phase III trials of AA or Enz in mCRPC and studies regarding their sequential administration. Given the difference in control arms in AA （active comparator） and Enz （true placebo） randomized phase III studies, indirect comparisons between AA and Enz in mCRPC showed no statistically significant difference in overall survival in prechemotherapy and postchemotherapy settings （HR. 0.90, 95% CI, 0.73-1.11; HR： 0.85, 95% CI, 0.68-1.07）. Compared with AA, Enz may better outperform control arms in treating mCRPC both before and after chemotherapy regarding secondary endpoints based on indirect comparisons： time to prostate-specific antigen （PSA） progression （HR. 0.34, 95% CI, 0.28-0.42; HR： 0.40, 95% CI, 0.30-0.53）, radiographic progression-free survival （HR： 0.37, 95% CI, 0.28-0.48; HR： 0.61, 95% CI, 0.50-0.74）, and PSA response rate （OR： 18.29, 95% CI, 11.20-29.88; OR： 10.69, 95% CI, 3.92-29.20）. With regard to the effectiveness of Enz following AA or AA following Enz, recent retrospective case series reported overall survival and secondary endpoints for patients with mCRPC progression after chemotherapy. However, confirmatory head-to-head trials are necessary to determine the optimal sequencing of these agents.展开更多
BACKGROUND Gastritis is one of the most frequently diagnosed diseases requiring medical treatment in South Korea.Fexuprazan,a novel potassium-competitive acid blocker,has been approved for treating gastritis and erosi...BACKGROUND Gastritis is one of the most frequently diagnosed diseases requiring medical treatment in South Korea.Fexuprazan,a novel potassium-competitive acid blocker,has been approved for treating gastritis and erosive esophagitis.Meanwhile,rebamipide is the most commonly used mucoprotective agent for acute and chronic gastritis in real-world settings in South Korea.However,there have been no studies comparing the efficacy of these two drugs yet.AIM To compare the efficacy of fexuprazan with that of rebamipide for acute and chronic gastritis.METHODS This was a matching-adjusted indirect comparison.Individual patient data from a phase III study of fexuprazan(10 mg BID)were compared with cumulative data from two matching studies of rebamipide(100 mg TID).Erosion improvement and healing rates were compared between two weeks of fexurapan,two weeks of rebamipide,and four weeks of rebamipide.The two main outcome variables were presented as percentages,and the risk differences(RD)and 95%confidence intervals(CI)were calculated for the relative treatment effects.RESULTS In the primary analysis,the erosion improvement and healing rates after a twoweek treatment with fexuprazan were 64.5%and 53.2%,respectively,while a twoweek treatment with rebamipide resulted in erosion improvement and healing rates of 43.6%(RD:21.0%;95%CI:9.6-32.3;P<0.01)and 35.6%(RD:17.6%;95%CI:6.1-29.2;P=0.003),respectively.In the additional analysis,the erosion improvement and healing rates for the two-week fexuprazan treatment(64.2%and 51.2%,respectively)were similar to those obtained during a four-week treatment with rebamipide(60.6%;RD:3.6%;95%CI:-9.8,17.0;P=0.600 and 53.5%;RD:-2.3%;95%CI:-16.1,11.5;P=0.744,respectively).CONCLUSION The two-week fexuprazan treatment was superior to the two-week rebamipide treatment and similar to the fourweek rebamipide treatment for patients with gastritis.展开更多
A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary c...A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary comparisons included superiority,inferiority and no significance difference;hence,they did not differentiate between no proof of difference vs proof of no difference.We updated the criteria employed in the original“simplified”figure in order to include this differentiation.A revised version of the simplified figure is proposed and described herein.An example of application is also presented.The example is focused on first-line treatments for paroxysmal atrial fibrillation.Three treatments(medical therapy,cryoballoon ablation,radiofrequency ablation)are compared with one another through direct and indirect comparisons.展开更多
Objective:An increasing number of studies indicate that autophagy plays an important role in the pathogenesis of spinal cord injury,and that regulating autophagy can enhance recovery from spinal cord injury.However,th...Objective:An increasing number of studies indicate that autophagy plays an important role in the pathogenesis of spinal cord injury,and that regulating autophagy can enhance recovery from spinal cord injury.However,the effect of regulating autophagy and whether autophagy is detrimental or beneficial after spinal cord injury remain unclear.Therefore,in this study we evaluated the effects of autophagy regulation on spinal cord injury in rats by direct and indirect comparison,in an effort to provide a basis for further research.Data source:Relevant literature published from inception to February 1,2018 were included by searching Wanfang,CNKI,Web of Science,MEDLINE(OvidSP),PubMed and Google Scholar in English and Chinese.The keywords included"autophagy","spinal cord injury",and"rat".Data selection:The literature included in vivo experimental studies on autophagy regulation in the treatment of spinal cord injury(including intervention pre-and post-spinal cord injury).Meta-analyses were conducted at different time points to compare the therapeutic effects of promoting or inhibiting autophagy,and subgroup analyses were also conducted.Outcome measure:Basso,Beattie,and Bresnahan scores.Results:Of the 622 studies,33 studies of median quality were included in the analyses.Basso,Beattie,and Bresnahan scores were higher at 1 day(MD=1.80,95%CI:0.81-2.79,P=0.0004),3 days(MD=0.92,95%CI:0.72-1.13,P<0.00001),1 week(MD=2.39,95%CI:1.85-2.92,P<0.00001),2 weeks(MD=3.26,95%CI:2.40-4.13,P<0.00001),3 weeks(MD=3.13,95%CI:2.51-3.75,P<0.00001)and 4 weeks(MD=3.18,95%CI:2.43-3.92,P<0.00001)after spinal cord injury with upregulation of autophagy compared with the control group(drug solvent control,such as saline group).Basso,Beattie,and Bresnahan scores were higher at 1 day(MD=6.48,95%CI:5.83-7.13,P<0.00001),2 weeks(MD=2.43,95%CI:0.79-4.07,P=0.004),3 weeks(MD=2.96,95%CI:0.09-5.84,P=0.04)and 4 weeks(MD=4.41,95%CI:1.08-7.75,P=0.01)after spinal cord injury with downregulation of autophagy compared with the control group.Indirect comparison of upregulation and downregulation of autophagy showed no differences in Basso,Beattie,and Bresnahan scores at 1 day(MD=-4.68,95%CI:-5.840 to-3.496,P=0.94644),3 days(MD=-0.28,95%CI:-2.231-1.671,P=0.99448),1 week(MD=1.83,95%CI:0.0076-3.584,P=0.94588),2 weeks(MD=0.81,95%CI:-0.850-2.470,P=0.93055),3 weeks(MD=0.17,95%Cl:-2.771-3.111,P=0.99546)or 4 weeks(MD=-1.23,95%Cl:-4.647-2.187,P=0.98264)compared with the control group.Conclusion:Regulation of autophagy improves neurological function,whether it is upregulated or downregulated.There was no difference between upregulation and downregulation of autophagy in the treatment of spinal cord injury.The variability in results among the studies may be associated with differences in research methods,the lack of clearly defined autophagy characteristics after spinal cord injury,and the limited autophagy monitoring techniques.Thus,methods should be standardized,and the dynamic regulation of autophagy should be examined in future studies.展开更多
目的:间接比较含冰片和不含冰片的中成药联合常规治疗对急性心肌梗死(AMI)经皮冠状动脉介入治疗(PCI)后心室重构和心功能的影响。方法:检索自建库至2024年3月PubMed、Web of Science、EMbase、Cochrane Library、中国知网(CNKI)、万方(W...目的:间接比较含冰片和不含冰片的中成药联合常规治疗对急性心肌梗死(AMI)经皮冠状动脉介入治疗(PCI)后心室重构和心功能的影响。方法:检索自建库至2024年3月PubMed、Web of Science、EMbase、Cochrane Library、中国知网(CNKI)、万方(WanFang Data)、维普(VIP)和中国生物医学文献服务系统(SinoMed),纳入中成药(含冰片或不含冰片)联合常规治疗治疗AMI并行PCI病人的随机对照试验(RCT)。使用ITC软件间接比较含冰片与不含冰片中成药的疗效。结果:与单纯常规治疗(CT)相比,含冰片和不含冰片中成药均可显著改善心室重构和心功能。间接比较,尽管含冰片中成药在改善左室舒张末期内径(LVEDD)[MD=-1.17,95%CI(-1.78,-0.56),P=0.36]、左室收缩末期内径(LVESD)[MD=-0.93,95%CI(-2.30,0.44),P=0.94]和左室射血分数(LVEF)[MD=-0.88,95%CI(-2.04,0.28),P=0.82]方面的效果差异均无统计学意义,但含冰片中成药在LVEDD改善方面表现出一定的优势趋势。结论:含冰片和不含冰片中成药联合常规治疗均可显著改善AMI病人PCI术后的心室重构和心功能。虽然未发现差异有统计学意义,但含冰片中成药在LVEDD改善方面可能具有优势。未来需更多直接比较试验以验证两种中成药配方的疗效差异及冰片的潜在协同增效作用。展开更多
探讨扶正化瘀胶囊和安络化纤丸治疗慢性乙型肝炎肝纤维化的有效性和安全性。采用Jadad评分法进行文献质量评价,运用Rev Man 5.3软件进行Meta分析,利用ITC软件进行间接比较,以单用恩替卡韦片（ETV）为共同对照,查找相关随机对照试验（RCT...探讨扶正化瘀胶囊和安络化纤丸治疗慢性乙型肝炎肝纤维化的有效性和安全性。采用Jadad评分法进行文献质量评价,运用Rev Man 5.3软件进行Meta分析,利用ITC软件进行间接比较,以单用恩替卡韦片（ETV）为共同对照,查找相关随机对照试验（RCT）,纳入扶正化瘀胶囊（FZ）或安络化纤丸（AL）联合ETV对比单用ETV治疗慢性乙型肝炎肝纤维化的RCTs进行间接Meta分析。最终纳入文献15篇（FZ 10篇,AL 5篇）,包括1 316个病例。Meta分析显示FZ联合ETV在治疗慢性乙型肝炎肝纤维化时透明质酸（HA）、层黏连蛋白（LN）、Ⅲ型前胶原（PCⅢ）和Ⅳ型胶原（Ⅳ-C）均显著改善;AL联合ETV在治疗慢性乙型肝炎肝纤维化时LN,PCⅢ,Ⅳ-C均显著改善,但HA没有显著改善。间接Meta分析显示FZ与AL在降低HA,LN,PCⅢ,Ⅳ-C方面没有显著性差异,不具有统计学意义。安全性方面,所纳入的研究中FZ试验组的不良反应发生率为5.33%,主要不良反应为胃部不适、头晕等;对照组的不良反应发生率为4.17%,主要不良反应为腹胀、头痛等。AL试验组和对照组均未发现明显不良反应。目前有限的证据表明FZ和AL治疗慢性乙型肝炎肝纤维化在疗效方面无显著性差异,不具有统计学意义。AL的安全性高于FZ。但所纳入的研究整体质量不高,数量有限且存在异质性,二者的评估有待高质量大样本的临床试验加以证实。展开更多
文摘This study was designed to evaluate the efficacy, tolerability, and sequential administration of abiraterone acetate （AA） and enzalutamide （Enz） for metastatic castration-resistant prostate cancer （mCRPC）. A literature search was performed with PubMed, Embase, and Web of Science databases to identify relevant studies. Reviewed literature included published phase III trials of AA or Enz in mCRPC and studies regarding their sequential administration. Given the difference in control arms in AA （active comparator） and Enz （true placebo） randomized phase III studies, indirect comparisons between AA and Enz in mCRPC showed no statistically significant difference in overall survival in prechemotherapy and postchemotherapy settings （HR. 0.90, 95% CI, 0.73-1.11; HR： 0.85, 95% CI, 0.68-1.07）. Compared with AA, Enz may better outperform control arms in treating mCRPC both before and after chemotherapy regarding secondary endpoints based on indirect comparisons： time to prostate-specific antigen （PSA） progression （HR. 0.34, 95% CI, 0.28-0.42; HR： 0.40, 95% CI, 0.30-0.53）, radiographic progression-free survival （HR： 0.37, 95% CI, 0.28-0.48; HR： 0.61, 95% CI, 0.50-0.74）, and PSA response rate （OR： 18.29, 95% CI, 11.20-29.88; OR： 10.69, 95% CI, 3.92-29.20）. With regard to the effectiveness of Enz following AA or AA following Enz, recent retrospective case series reported overall survival and secondary endpoints for patients with mCRPC progression after chemotherapy. However, confirmatory head-to-head trials are necessary to determine the optimal sequencing of these agents.
文摘BACKGROUND Gastritis is one of the most frequently diagnosed diseases requiring medical treatment in South Korea.Fexuprazan,a novel potassium-competitive acid blocker,has been approved for treating gastritis and erosive esophagitis.Meanwhile,rebamipide is the most commonly used mucoprotective agent for acute and chronic gastritis in real-world settings in South Korea.However,there have been no studies comparing the efficacy of these two drugs yet.AIM To compare the efficacy of fexuprazan with that of rebamipide for acute and chronic gastritis.METHODS This was a matching-adjusted indirect comparison.Individual patient data from a phase III study of fexuprazan(10 mg BID)were compared with cumulative data from two matching studies of rebamipide(100 mg TID).Erosion improvement and healing rates were compared between two weeks of fexurapan,two weeks of rebamipide,and four weeks of rebamipide.The two main outcome variables were presented as percentages,and the risk differences(RD)and 95%confidence intervals(CI)were calculated for the relative treatment effects.RESULTS In the primary analysis,the erosion improvement and healing rates after a twoweek treatment with fexuprazan were 64.5%and 53.2%,respectively,while a twoweek treatment with rebamipide resulted in erosion improvement and healing rates of 43.6%(RD:21.0%;95%CI:9.6-32.3;P<0.01)and 35.6%(RD:17.6%;95%CI:6.1-29.2;P=0.003),respectively.In the additional analysis,the erosion improvement and healing rates for the two-week fexuprazan treatment(64.2%and 51.2%,respectively)were similar to those obtained during a four-week treatment with rebamipide(60.6%;RD:3.6%;95%CI:-9.8,17.0;P=0.600 and 53.5%;RD:-2.3%;95%CI:-16.1,11.5;P=0.744,respectively).CONCLUSION The two-week fexuprazan treatment was superior to the two-week rebamipide treatment and similar to the fourweek rebamipide treatment for patients with gastritis.
文摘A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary comparisons included superiority,inferiority and no significance difference;hence,they did not differentiate between no proof of difference vs proof of no difference.We updated the criteria employed in the original“simplified”figure in order to include this differentiation.A revised version of the simplified figure is proposed and described herein.An example of application is also presented.The example is focused on first-line treatments for paroxysmal atrial fibrillation.Three treatments(medical therapy,cryoballoon ablation,radiofrequency ablation)are compared with one another through direct and indirect comparisons.
基金supported by the Beijing Excellent Talent Training Foundation of China,No.2017000021469G215(to DZhang)the Natural Science Foundation of Capital Medical University of China,No.PYZ2018081(to DZhang)the Youth Science Foundation of Beijing Tiantan Hospital of China,No.2016-YQN-14(to DZhang)
文摘Objective:An increasing number of studies indicate that autophagy plays an important role in the pathogenesis of spinal cord injury,and that regulating autophagy can enhance recovery from spinal cord injury.However,the effect of regulating autophagy and whether autophagy is detrimental or beneficial after spinal cord injury remain unclear.Therefore,in this study we evaluated the effects of autophagy regulation on spinal cord injury in rats by direct and indirect comparison,in an effort to provide a basis for further research.Data source:Relevant literature published from inception to February 1,2018 were included by searching Wanfang,CNKI,Web of Science,MEDLINE(OvidSP),PubMed and Google Scholar in English and Chinese.The keywords included"autophagy","spinal cord injury",and"rat".Data selection:The literature included in vivo experimental studies on autophagy regulation in the treatment of spinal cord injury(including intervention pre-and post-spinal cord injury).Meta-analyses were conducted at different time points to compare the therapeutic effects of promoting or inhibiting autophagy,and subgroup analyses were also conducted.Outcome measure:Basso,Beattie,and Bresnahan scores.Results:Of the 622 studies,33 studies of median quality were included in the analyses.Basso,Beattie,and Bresnahan scores were higher at 1 day(MD=1.80,95%CI:0.81-2.79,P=0.0004),3 days(MD=0.92,95%CI:0.72-1.13,P<0.00001),1 week(MD=2.39,95%CI:1.85-2.92,P<0.00001),2 weeks(MD=3.26,95%CI:2.40-4.13,P<0.00001),3 weeks(MD=3.13,95%CI:2.51-3.75,P<0.00001)and 4 weeks(MD=3.18,95%CI:2.43-3.92,P<0.00001)after spinal cord injury with upregulation of autophagy compared with the control group(drug solvent control,such as saline group).Basso,Beattie,and Bresnahan scores were higher at 1 day(MD=6.48,95%CI:5.83-7.13,P<0.00001),2 weeks(MD=2.43,95%CI:0.79-4.07,P=0.004),3 weeks(MD=2.96,95%CI:0.09-5.84,P=0.04)and 4 weeks(MD=4.41,95%CI:1.08-7.75,P=0.01)after spinal cord injury with downregulation of autophagy compared with the control group.Indirect comparison of upregulation and downregulation of autophagy showed no differences in Basso,Beattie,and Bresnahan scores at 1 day(MD=-4.68,95%CI:-5.840 to-3.496,P=0.94644),3 days(MD=-0.28,95%CI:-2.231-1.671,P=0.99448),1 week(MD=1.83,95%CI:0.0076-3.584,P=0.94588),2 weeks(MD=0.81,95%CI:-0.850-2.470,P=0.93055),3 weeks(MD=0.17,95%Cl:-2.771-3.111,P=0.99546)or 4 weeks(MD=-1.23,95%Cl:-4.647-2.187,P=0.98264)compared with the control group.Conclusion:Regulation of autophagy improves neurological function,whether it is upregulated or downregulated.There was no difference between upregulation and downregulation of autophagy in the treatment of spinal cord injury.The variability in results among the studies may be associated with differences in research methods,the lack of clearly defined autophagy characteristics after spinal cord injury,and the limited autophagy monitoring techniques.Thus,methods should be standardized,and the dynamic regulation of autophagy should be examined in future studies.
文摘目的:间接比较含冰片和不含冰片的中成药联合常规治疗对急性心肌梗死(AMI)经皮冠状动脉介入治疗(PCI)后心室重构和心功能的影响。方法:检索自建库至2024年3月PubMed、Web of Science、EMbase、Cochrane Library、中国知网(CNKI)、万方(WanFang Data)、维普(VIP)和中国生物医学文献服务系统(SinoMed),纳入中成药(含冰片或不含冰片)联合常规治疗治疗AMI并行PCI病人的随机对照试验(RCT)。使用ITC软件间接比较含冰片与不含冰片中成药的疗效。结果:与单纯常规治疗(CT)相比,含冰片和不含冰片中成药均可显著改善心室重构和心功能。间接比较,尽管含冰片中成药在改善左室舒张末期内径(LVEDD)[MD=-1.17,95%CI(-1.78,-0.56),P=0.36]、左室收缩末期内径(LVESD)[MD=-0.93,95%CI(-2.30,0.44),P=0.94]和左室射血分数(LVEF)[MD=-0.88,95%CI(-2.04,0.28),P=0.82]方面的效果差异均无统计学意义,但含冰片中成药在LVEDD改善方面表现出一定的优势趋势。结论:含冰片和不含冰片中成药联合常规治疗均可显著改善AMI病人PCI术后的心室重构和心功能。虽然未发现差异有统计学意义,但含冰片中成药在LVEDD改善方面可能具有优势。未来需更多直接比较试验以验证两种中成药配方的疗效差异及冰片的潜在协同增效作用。
