Rui Yang, Cheng Hu, Yuxin Zhuo, Wen Wang, Qingyuan Tan, Yuxin Shen, Kun Jiang, Xin Sun, Qing Xia, Lihui Deng
{"title":"中药补益治疗脓毒症或感染性休克的疗效和安全性：随机对照试验的系统评价和贝叶斯网络荟萃分析方案。","authors":"Rui Yang, Cheng Hu, Yuxin Zhuo, Wen Wang, Qingyuan Tan, Yuxin Shen, Kun Jiang, Xin Sun, Qing Xia, Lihui Deng","doi":"10.1186/s13643-024-02736-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Sepsis is a life-threatening organ dysfunction with high morbidity and mortality. Various studies have demonstrated the effectiveness of Chinese tonic medicines (CTMs) in treating sepsis or septic shock. However, trials directly comparing the efficacy and safety of different CTMs for sepsis or septic shock are still lacking. To identify the most optimal CTM for treating sepsis or septic shock, we plan to perform a systematic review and network meta-analysis of various CTMs used for sepsis or septic shock patients.</p><p><strong>Methods: </strong>Randomized controlled trials (RCTs) that investigated the efficacy and safety of CTMs for patients with sepsis or septic shock will be systematically searched in Pubmed, Embase, Cochrane Central Register of Controlled Trials, Scopus, Web Of Science, CBM, CNKI, Wanfang, and VIP databases from inception to November 2023. The quality of the included studies will be assessed using the Cochrane Risk of Bias V.2.0. tool. The confidence of evidence will be evaluated through the CINeMA (Confidence in Network Meta-Analysis) web application. Primary outcomes include the delta Sequential Organ Failure Assessment (△SOFA) score at day 7 after interventions and 28-day mortality. Secondary outcomes comprise delta serum lactate levels (△Lac) and delta mean arterial pressure (△MAP) at day 7 after interventions as well as total dose and duration of vasoactive drugs. Safety outcome includes adverse drug reactions or adverse drug events (ADRs/ADEs). The Bayesian network meta-analysis will be conducted using the \"BUGSnet\" package in R version 4.2.2. The surface under the cumulative ranking curve (SUCRA) values will be used to rank each treatment. Statistical inconsistency assessment, publication bias assessment, heterogeneity analysis, sensitivity analysis, and subgroup analysis will be performed.</p><p><strong>Discussion: </strong>This study will provide new insights into the efficacy and safety of various CTMs used in sepsis or septic shock patients, providing help for future clinical practice and research.</p><p><strong>Systematic review registration: </strong>CRD42023482572.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"314"},"PeriodicalIF":6.3000,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11670501/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of Chinese tonic medicines for treating sepsis or septic shock: a protocol for a systematic review and Bayesian network meta-analysis of randomized controlled trials.\",\"authors\":\"Rui Yang, Cheng Hu, Yuxin Zhuo, Wen Wang, Qingyuan Tan, Yuxin Shen, Kun Jiang, Xin Sun, Qing Xia, Lihui Deng\",\"doi\":\"10.1186/s13643-024-02736-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Sepsis is a life-threatening organ dysfunction with high morbidity and mortality. Various studies have demonstrated the effectiveness of Chinese tonic medicines (CTMs) in treating sepsis or septic shock. However, trials directly comparing the efficacy and safety of different CTMs for sepsis or septic shock are still lacking. To identify the most optimal CTM for treating sepsis or septic shock, we plan to perform a systematic review and network meta-analysis of various CTMs used for sepsis or septic shock patients.</p><p><strong>Methods: </strong>Randomized controlled trials (RCTs) that investigated the efficacy and safety of CTMs for patients with sepsis or septic shock will be systematically searched in Pubmed, Embase, Cochrane Central Register of Controlled Trials, Scopus, Web Of Science, CBM, CNKI, Wanfang, and VIP databases from inception to November 2023. The quality of the included studies will be assessed using the Cochrane Risk of Bias V.2.0. tool. The confidence of evidence will be evaluated through the CINeMA (Confidence in Network Meta-Analysis) web application. Primary outcomes include the delta Sequential Organ Failure Assessment (△SOFA) score at day 7 after interventions and 28-day mortality. Secondary outcomes comprise delta serum lactate levels (△Lac) and delta mean arterial pressure (△MAP) at day 7 after interventions as well as total dose and duration of vasoactive drugs. Safety outcome includes adverse drug reactions or adverse drug events (ADRs/ADEs). The Bayesian network meta-analysis will be conducted using the \\\"BUGSnet\\\" package in R version 4.2.2. The surface under the cumulative ranking curve (SUCRA) values will be used to rank each treatment. Statistical inconsistency assessment, publication bias assessment, heterogeneity analysis, sensitivity analysis, and subgroup analysis will be performed.</p><p><strong>Discussion: </strong>This study will provide new insights into the efficacy and safety of various CTMs used in sepsis or septic shock patients, providing help for future clinical practice and research.</p><p><strong>Systematic review registration: </strong>CRD42023482572.</p>\",\"PeriodicalId\":22162,\"journal\":{\"name\":\"Systematic Reviews\",\"volume\":\"13 1\",\"pages\":\"314\"},\"PeriodicalIF\":6.3000,\"publicationDate\":\"2024-12-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11670501/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Systematic Reviews\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13643-024-02736-5\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Systematic Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13643-024-02736-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
背景：败血症是一种危及生命的器官功能障碍，具有很高的发病率和死亡率。各种研究已经证明了中药在治疗败血症或感染性休克方面的有效性。然而，直接比较不同中药对脓毒症或感染性休克的疗效和安全性的试验仍然缺乏。为了确定治疗脓毒症或感染性休克的最佳中药，我们计划对用于脓毒症或感染性休克患者的各种中药进行系统回顾和网络荟萃分析。方法：系统检索Pubmed、Embase、Cochrane Central Register of controlled trials、Scopus、Web of Science、CBM、中国知网、万方、VIP等数据库，检索从成立至2023年11月期间研究中药治疗脓毒症或感染性休克疗效和安全性的随机对照试验（RCTs）。纳入研究的质量将采用Cochrane风险偏倚v2.0进行评估。工具。证据的置信度将通过CINeMA（网络元分析置信度）网络应用程序进行评估。主要结局包括干预后第7天delta序贯器官衰竭评估（△SOFA）评分和28天死亡率。次要结局包括干预后第7天的δ血清乳酸水平（△Lac）和δ平均动脉压（△MAP）以及血管活性药物的总剂量和持续时间。安全性结局包括药物不良反应或药物不良事件（adr /ADEs）。贝叶斯网络元分析将使用R 4.2.2版本中的“BUGSnet”包进行。累积排序曲线（SUCRA）值下的表面将用于对每个处理进行排序。进行统计不一致评估、发表偏倚评估、异质性分析、敏感性分析和亚组分析。讨论：本研究将对各种中药在脓毒症或感染性休克患者中的疗效和安全性提供新的认识，为今后的临床实践和研究提供帮助。系统评价注册：CRD42023482572。
Efficacy and safety of Chinese tonic medicines for treating sepsis or septic shock: a protocol for a systematic review and Bayesian network meta-analysis of randomized controlled trials.
Background: Sepsis is a life-threatening organ dysfunction with high morbidity and mortality. Various studies have demonstrated the effectiveness of Chinese tonic medicines (CTMs) in treating sepsis or septic shock. However, trials directly comparing the efficacy and safety of different CTMs for sepsis or septic shock are still lacking. To identify the most optimal CTM for treating sepsis or septic shock, we plan to perform a systematic review and network meta-analysis of various CTMs used for sepsis or septic shock patients.
Methods: Randomized controlled trials (RCTs) that investigated the efficacy and safety of CTMs for patients with sepsis or septic shock will be systematically searched in Pubmed, Embase, Cochrane Central Register of Controlled Trials, Scopus, Web Of Science, CBM, CNKI, Wanfang, and VIP databases from inception to November 2023. The quality of the included studies will be assessed using the Cochrane Risk of Bias V.2.0. tool. The confidence of evidence will be evaluated through the CINeMA (Confidence in Network Meta-Analysis) web application. Primary outcomes include the delta Sequential Organ Failure Assessment (△SOFA) score at day 7 after interventions and 28-day mortality. Secondary outcomes comprise delta serum lactate levels (△Lac) and delta mean arterial pressure (△MAP) at day 7 after interventions as well as total dose and duration of vasoactive drugs. Safety outcome includes adverse drug reactions or adverse drug events (ADRs/ADEs). The Bayesian network meta-analysis will be conducted using the "BUGSnet" package in R version 4.2.2. The surface under the cumulative ranking curve (SUCRA) values will be used to rank each treatment. Statistical inconsistency assessment, publication bias assessment, heterogeneity analysis, sensitivity analysis, and subgroup analysis will be performed.
Discussion: This study will provide new insights into the efficacy and safety of various CTMs used in sepsis or septic shock patients, providing help for future clinical practice and research.
期刊介绍：
Systematic Reviews encompasses all aspects of the design, conduct and reporting of systematic reviews. The journal publishes high quality systematic review products including systematic review protocols, systematic reviews related to a very broad definition of health, rapid reviews, updates of already completed systematic reviews, and methods research related to the science of systematic reviews, such as decision modelling. At this time Systematic Reviews does not accept reviews of in vitro studies. The journal also aims to ensure that the results of all well-conducted systematic reviews are published, regardless of their outcome.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
