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1.湖南中医药大学 研究生院,长沙 410208
2.中国中医科学院 中医临床基础医学研究所 循证医学基础研究室,北京 100700
3.湖南省中医药研究院 附属医院,长沙 410006
4.湖南中医药大学 科技创新中心,长沙 410208
Published:20 March 2023,
Published Online:17 August 2022,
Received:06 June 2022,
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曾珊珊,谢乐,伍大华等.补益类中药注射液治疗缺血性脑卒中的系统评价再评价[J].中国实验方剂学杂志,2023,29(06):137-146.
ZENG Shanshan,XIE Le,WU Dahua,et al.Tonic Traditional Chinese Medicine Injections Against Cerebral Ischemic Stroke: An Overview of Systematic Reviews/Meta-analyses[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(06):137-146.
曾珊珊,谢乐,伍大华等.补益类中药注射液治疗缺血性脑卒中的系统评价再评价[J].中国实验方剂学杂志,2023,29(06):137-146. DOI: 10.13422/j.cnki.syfjx.20230693.
ZENG Shanshan,XIE Le,WU Dahua,et al.Tonic Traditional Chinese Medicine Injections Against Cerebral Ischemic Stroke: An Overview of Systematic Reviews/Meta-analyses[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(06):137-146. DOI: 10.13422/j.cnki.syfjx.20230693.
目的
2
对补益类中药注射液治疗缺血性脑卒中的系统评价/Meta分析进行再评价,为补益类中药注射液的临床实践和决策提供证据支持。
方法
2
查阅三大药品目录后获得补益类中药注射液品种,计算机检索7个中英文数据库,检索时限均从建库至2022年3月13日,纳入相关系统评价/Meta分析。使用AMSTAR-2评价工具、ROBIS工具、PRISMA 2020声明及GRADE系统对纳入文献的方法学质量、偏倚风险评估、报告质量及证据质量进行评价;另外通过建立文献重叠矩阵,计算校正后重叠面积(CCA)评价原始文献重复率。
结果
2
共计纳入5种补益类中药注射液及其18篇系统评价/Meta分析,AMSTAR-2评价显示18篇文献方法学质量均为极低级。ROBIS工具显示4项研究为低偏倚风险,14项研究为高偏倚风险。PRISMA 2020报告质量评价结果显示纳入研究得分为19.5~28.5,其中10篇为中等质量,8篇为低质量。GRADE系统结果显示1项证据级别为中级,15项为低质量,41项为极低质量。CCA为0.263,表示原始文献重复率较低。
结论
2
补益类中药注射液治疗缺血性脑卒中有效且安全性良好,但这一发现受到相关已发表系统评价/Meta分析方法学、报告质量和证据质量普遍较低的限制。建议完善研究设计,获得更高质量的临床证据,并严格按照程序进行系统评价,规范报告研究结果。
Objective
2
To re-evaluate the systematic reviews/Meta-analyses (SRs/MAs) of tonic traditional Chinese medicine (TCM) injections against cerebral ischemic stroke (CIS) and provide evidence support for clinical practice and decision-making.
Method
2
TCM injections of different varieties were obtained after searching the three major drug catalogues. Seven Chinese and English databases were searched from database inception to March 13,2022,for the relevant SRs/MAs. The methodological quality,risk of bias,reporting quality,and quality of evidence were assessed by Assessment of Multiple Systematic Reviews-2 (AMSTAR-2),the Risk of Bias in Systematic Review (ROBIS),the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 (PRISMA 2020),and the Grading of Recommendations Assessment,Development,and Evaluation (GRADE). In addition,the literature overlap matrix was established to calculate the corrected covered area (CCA) and evaluate the rate of overlaps of the original literature.
Result
2
Five types of TCM injections and 18 SRs/MAs were included. AMSTAR 2 evaluation showed that the methodological quality of 18 SRs/MAs was extremely low,and 14 SRs/MAs had a high risk of bias assessed by ROBIS. The quality evaluation results reported by the PRISMA 2020 showed that the scores of the studies included ranged from 19.5 to 28.5,with 10 being of medium quality and eight of low quality. The evaluation with the GRADE system demonstrated that one outcome was moderate-quality evidence,15 outcomes were low-quality evidence,and 41 outcomes were very low-quality evidence. The CCA of the included SRs/MAs was 0.263,indicating a low rate of overlaps of the original literature.
Conclusion
2
Tonic TCM injections are effective and safe in the treatment of CIS,but this conclusion should be treated with caution because of the low quality of methodology,reports,and evidence in published SRs/MAs. It is recommended to improve the study design,obtain clinical evidence of higher quality,and conduct systematic evaluations in strict accordance with procedures to standardize the reporting of research results.
补益类中药注射液缺血性脑卒中系统评价再评价
tonic traditional Chinese medicine injectioncerebral ischemic strokeoverview of systematic reviews
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