中国中药杂志

2021, v.46(19) 5103-5109

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坤泰胶囊治疗围绝经期综合征的系统评价再评价
Overview of systematic reviews on Kuntai Capsules in treatment of perimenopausal syndrome

门晓亮;赵丽萍;杨杰;李博;
MEN Xiao-liang;ZHAO Li-ping;YANG Jie;LI Bo;Beijing Daxing District Maternal and Children Health Care Hospital;Beijing Hospital of Traditional Chinese Medicine, Capital Medical University;

摘要(Abstract):

该文对坤泰胶囊治疗围绝经期综合征的有效性和安全性的系统评价进行了再评价。检索中、英文数据库中有关坤泰胶囊治疗围绝经期综合征的系统评价,检索时间自建库至2020年8月31日,对最终纳入的系统评价使用AMSTER-2量表、GRADE量表及ROBIS工具分别进行方法学质量评价、证据质量等级及偏倚风险评价。共纳入6篇系统评价,28个结局指标。AMSTER-2方法学质量评估结果显示6篇系统评价中1篇为低质量,其余5篇均为极低质量。GRADE量表对28个临床结局指标进行质量评价,3个为中级证据,其余为低级或极低级证据,3个中级证据中1个采用Kupperman评分,2个采用总有效率。ROBIS偏倚风险评价纳入文献的系统评价均为高风险。结果表明坤泰胶囊治疗围绝经期综合征潮热出汗等症状临床是有效的,对雌二醇(E_2)水平的改善不如激素替代组,不良反应较激素替代组低,但证据质量有待提高,方法学质量较低,偏倚风险较高,建议今后规范和合理的设计系统评价,重视研究方案的注册,并按照PRISMA声明书写研究报告。
To evaluate the efficacy and safety of Kuntai Capsules in the treatment of perimenopausal syndrome. Systematic reviews on Kuntai Capsules in the treatment of perimenopausal syndrome were retrieved from Chinese and English databases from database establishment to August 31, 2020. AMSTER-2 scale, GRADE scale and ROBIS tools were used respectively to evaluate the methodological quality, evidence quality level and bias risk of the finally included systematic reviews. A total of 6 systematic reviews with 28 outcome indicators were included. The results of AMSTER-2 methodological quality assessment showed that one of the six systematic reviews was of low quality, and the other five were of extremely low quality. GRADE scale showed that 28 clinical outcome indicators were evaluated, three of which were intermediate-level ones, and the rest were low-level or very low-level ones. Two evidences of the three intermediate evidences were total efficiency, and the other intermediate evidence was Kupperman score. ROBIS bias risk assessment showed all the included studies were of high risk. The results showed that, Kuntai Capsules were effective in the treatment of perimenopausal symptoms, such as hot flashes and sweating. The improvement of E_2 level was not as good as that in the menopause hormone therapy group, but the incidence of adverse reactions was lower than that in the menopause hormone therapy group. However, the quality of evidence needs to be improved due to the low quality of methodology and high risk of bias. It is suggested that systematic review and reasonable design should be carried out in the future, and attention should be paid to the registration of research schemes. In addition, the research reports shall be prepared according to PRISMA statement.

关键词(KeyWords): 坤泰胶囊;围绝经期综合征;系统评价再评价;AMSTER-2;GRADE;ROBIS
Kuntai Capsules;perimenopausal syndrome;overview of systematic reviews;AMSTER-2;GRADE;ROBIS

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基金项目(Foundation): 北京市大兴区妇幼保健院院级项目(2020001)

作者(Author): 门晓亮;赵丽萍;杨杰;李博;
MEN Xiao-liang;ZHAO Li-ping;YANG Jie;LI Bo;Beijing Daxing District Maternal and Children Health Care Hospital;Beijing Hospital of Traditional Chinese Medicine, Capital Medical University;

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