{"title":"熊去氧胆酸用于新生儿高胆红素血症的依据、完整性和证据质量","authors":"O.V. Zakharova","doi":"10.15690/pf.v21i2.2739","DOIUrl":null,"url":null,"abstract":"Background. Systematic reviews are considered the highest evidence of the effectiveness and safety of treatment methods used in clinical practice. The veracity of a results and conclusions of systematic reviews is directly related to their quality. The aim of the study is an assessment of the currency, completeness and methodological quality of published systematic reviews on the evaluation of the effectiveness of ursodeoxycholic acid (UDCA) for the treatment of neonatal hyperbilirubinemia. Materials and methods. A meta-epidemiological methodological study was conducted. The search for evidence sources was performed in November 2023 in the specialized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), LILACS, CNKI, LENS.ORG, еLibrary.Ru, in registers ClinicalTrials.gov, ICTRP, ISRCTN, PROSPERO, as well as in the Google Academy and Google search engines. Additionally, the lists of references and citations of selected publications have been reviewed. Only systematic reviews and randomized clinical trials are included in the study. The search was carried out to assess the currency and completeness of systematic reviews. A systematic review is considered currency if the most recent studies are included in its analysis. A systematic review is considered complete if its analysis includes all identified studies that meet the inclusion criteria set by the review authors and are published no later than the date of the last search conducted by the review authors. The methodological quality of the systematic reviews was assessed using the AMSTAR-2 tool. Results. As a result of the search, 4 systematic reviews and 23 randomized trials were identified. All reviews evaluated the effect of UDCA in combination with phototherapy on the level of total serum bilirubin, the duration of phototherapy and the frequency of adverse events (for example, loose stools, vomiting, rash) compared with phototherapy alone and/or placebo. All systematic reviews have been published over the past two years, but have already lost their currency. There are missing studies and/or outcomes in each review. The methodological quality of the reviews was found to be extremely low. Conclusion. Given the listed shortcomings of systematic reviews, their results and conclusions should be treated with caution. In order to obtain the most accurate and reliable evidence, a new systematic review is needed.","PeriodicalId":19997,"journal":{"name":"Pediatric pharmacology","volume":" 1286","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rationale, completeness and quality of evidence for the use of ursodeoxycholic acid in neonatal hyperbilirubinemia\",\"authors\":\"O.V. Zakharova\",\"doi\":\"10.15690/pf.v21i2.2739\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background. Systematic reviews are considered the highest evidence of the effectiveness and safety of treatment methods used in clinical practice. The veracity of a results and conclusions of systematic reviews is directly related to their quality. The aim of the study is an assessment of the currency, completeness and methodological quality of published systematic reviews on the evaluation of the effectiveness of ursodeoxycholic acid (UDCA) for the treatment of neonatal hyperbilirubinemia. Materials and methods. A meta-epidemiological methodological study was conducted. The search for evidence sources was performed in November 2023 in the specialized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), LILACS, CNKI, LENS.ORG, еLibrary.Ru, in registers ClinicalTrials.gov, ICTRP, ISRCTN, PROSPERO, as well as in the Google Academy and Google search engines. Additionally, the lists of references and citations of selected publications have been reviewed. Only systematic reviews and randomized clinical trials are included in the study. The search was carried out to assess the currency and completeness of systematic reviews. A systematic review is considered currency if the most recent studies are included in its analysis. A systematic review is considered complete if its analysis includes all identified studies that meet the inclusion criteria set by the review authors and are published no later than the date of the last search conducted by the review authors. The methodological quality of the systematic reviews was assessed using the AMSTAR-2 tool. Results. As a result of the search, 4 systematic reviews and 23 randomized trials were identified. All reviews evaluated the effect of UDCA in combination with phototherapy on the level of total serum bilirubin, the duration of phototherapy and the frequency of adverse events (for example, loose stools, vomiting, rash) compared with phototherapy alone and/or placebo. All systematic reviews have been published over the past two years, but have already lost their currency. There are missing studies and/or outcomes in each review. The methodological quality of the reviews was found to be extremely low. Conclusion. Given the listed shortcomings of systematic reviews, their results and conclusions should be treated with caution. In order to obtain the most accurate and reliable evidence, a new systematic review is needed.\",\"PeriodicalId\":19997,\"journal\":{\"name\":\"Pediatric pharmacology\",\"volume\":\" 1286\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-05-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pediatric pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.15690/pf.v21i2.2739\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.15690/pf.v21i2.2739","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景。系统综述被认为是临床实践中治疗方法有效性和安全性的最高证据。系统综述结果和结论的真实性与其质量直接相关。本研究旨在评估已发表的关于熊去氧胆酸(UDCA)治疗新生儿高胆红素血症有效性评估的系统综述的时效性、完整性和方法学质量。材料与方法。进行了一项荟萃流行病学方法研究。2023 年 11 月,在专业数据库 MEDLINE、Cochrane 对照试验中央登记册 (CENTRAL)、Cochrane 系统性综述数据库 (CDSR)、LILACS、CNKI、LENS.ORG、еLibrary.Ru、ClinicalTrials.gov、ICTRP、ISRCTN、PROSPERO 登记册以及 Google Academy 和 Google 搜索引擎中进行了证据来源检索。此外,还查阅了部分出版物的参考文献和引文列表。本研究只包括系统综述和随机临床试验。搜索的目的是评估系统综述的时效性和完整性。如果一篇系统综述的分析中包含了最新的研究,则该综述被认为是最新的。如果一篇系统综述的分析包括了所有符合综述作者设定的纳入标准的已确定研究,且发表日期不晚于综述作者最后一次检索的日期,则该综述被认为是完整的。系统综述的方法学质量采用 AMSTAR-2 工具进行评估。结果。经过检索,共发现了 4 篇系统综述和 23 项随机试验。所有综述都评估了 UDCA 联合光疗与单独光疗和/或安慰剂相比对血清总胆红素水平、光疗持续时间和不良反应(如便稀、呕吐、皮疹)发生频率的影响。所有系统综述都是在过去两年中发表的,但已经失去了时效性。每篇综述都存在研究和/或结果缺失的情况。综述的方法学质量极低。结论鉴于系统综述存在上述缺点,应谨慎对待其结果和结论。为了获得最准确、最可靠的证据,需要进行新的系统综述。
Rationale, completeness and quality of evidence for the use of ursodeoxycholic acid in neonatal hyperbilirubinemia
Background. Systematic reviews are considered the highest evidence of the effectiveness and safety of treatment methods used in clinical practice. The veracity of a results and conclusions of systematic reviews is directly related to their quality. The aim of the study is an assessment of the currency, completeness and methodological quality of published systematic reviews on the evaluation of the effectiveness of ursodeoxycholic acid (UDCA) for the treatment of neonatal hyperbilirubinemia. Materials and methods. A meta-epidemiological methodological study was conducted. The search for evidence sources was performed in November 2023 in the specialized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), LILACS, CNKI, LENS.ORG, еLibrary.Ru, in registers ClinicalTrials.gov, ICTRP, ISRCTN, PROSPERO, as well as in the Google Academy and Google search engines. Additionally, the lists of references and citations of selected publications have been reviewed. Only systematic reviews and randomized clinical trials are included in the study. The search was carried out to assess the currency and completeness of systematic reviews. A systematic review is considered currency if the most recent studies are included in its analysis. A systematic review is considered complete if its analysis includes all identified studies that meet the inclusion criteria set by the review authors and are published no later than the date of the last search conducted by the review authors. The methodological quality of the systematic reviews was assessed using the AMSTAR-2 tool. Results. As a result of the search, 4 systematic reviews and 23 randomized trials were identified. All reviews evaluated the effect of UDCA in combination with phototherapy on the level of total serum bilirubin, the duration of phototherapy and the frequency of adverse events (for example, loose stools, vomiting, rash) compared with phototherapy alone and/or placebo. All systematic reviews have been published over the past two years, but have already lost their currency. There are missing studies and/or outcomes in each review. The methodological quality of the reviews was found to be extremely low. Conclusion. Given the listed shortcomings of systematic reviews, their results and conclusions should be treated with caution. In order to obtain the most accurate and reliable evidence, a new systematic review is needed.