艾灸干预亚健康阳虚质随机对照试验的系统综述

A systematic review of randomized controlled trials on the intervention of moxibustion on subhealth yang deficiency

关键词:  艾灸  阳虚质  亚健康  Meta分析  系统综述

Key words:  moxibustion  yang deficiency  subhealthy  Meta analysis  system review

摘要:

[目的] 应用循证医学方法评价艾灸干预亚健康阳虚质临床疗效与安全性，为艾灸干预亚健康阳虚质提供循证证据。[方法] 检索中国知网（CNKI）、维普数据库（VIP）、万方数据库（WANFANG DATA）、中国生物医学文献服务系统（SinoMed）4个中文数据库2011年1月1日-2019年12月31刊载的文献，纳入干预措施为艾灸和金匮肾气丸治疗亚健康阳虚质临床随机对照试验（RCT），通过阅读全文对文献进行筛选并提取相关数据，合并效应量进行Meta分析。[结果] 共纳入11项RCT，根据Cochrane协作网评价手册偏倚风险评估工具对纳入研究进行文献质量评价。经过文献质量评价，9篇低度偏倚为A级，2篇中度偏倚为B级。Meta分析结果显示，艾灸干预亚健康阳虚质临床总有效率相对危险度（RR）=1.37，95%置信区间（CI）（1.21，1.54），P<0.001；阳虚体质转化分数均数差（MD）=-0.72，95% CI（-1.00，-0.45），P<0.001；总体健康评分标准均数差（SMD）=1.23，95% CI（0.17，2.29），P<0.05；活力评分MD=9.37，95% CI（6.87，11.87），P<0.001；生理机能评分SMD=0.90，95% CI（0.45，1.34），P<0.001；躯体疼痛评分SMD=0.75，95% CI（0.06，1.44），P<0.005；阳虚证评分SMD=0.55，95% CI（0.18，0.92），P<0.05。[结论] 研究结果显示，与金匮肾气丸相比，艾灸干预亚健康阳虚质总有效率更高，但由于纳入文献数量较少，质量较低，研究结论仍需高质量RCT进一步证实。

Abstract:

[Objective] To systematically evaluate the effect of moxibustion on the intervention of subhealthy yang deficiency.[Methods] The four Chinese databases of China National Knowledge Infrastructure (CNKI), CQVIP database(VIP), Wanfang database(WANFANG DATA), and the Chinese biomedical literature database service system (SignoMed) were searched for literatures published from in January 2011-December 2019, and the included interventions were randomized controlled trials(RCTs) of moxibustion and Jingui Shenqi Pills treatment for the treatment of yang deficiency. The literature was screened and relevant data were extracted by reading the full text, and the effect sizes were combined for Meta analysis.[Results] A total of 11 RCTs were included to assess the quality of the literature using the Cochrane collaboration's risk of bias assessment tool. Nine articles were rated A(low bias) and two articles were rated B(moderate bias). Meta-analysis showed that the relative risk (RR) of moxibustion in the treatment of subhealthy yang deficiency was 1.37, 95% confidence interval(CI)(1.21, 1.54), P<0.001. The mean difference of yang deficiency constitution transformation score was-0.72, 95% CI(-1.00, -0.45), P<0.001. The standardized mean difference (SMD) for overall health score SMD=1.23, 95% CI(0.17, 2.29), P<0.05. Mean difference of vitality score was 9.37, 95% CI (6.87, 11.87), P<0.001. SMD of physiological function score was 0.90, 95% CI(0.45, 1.34), P<0.001. SMD of somatic pain score was 0.75, 95% CI(0.06, 1.44), P<0.005. The standard mean difference of yang deficiency syndrome score was 0.55, 95%CI(0.18, 0.92), P<0.05). Most of the included studies did not report recurrence rate, quality of life and adverse reactions, and these indicators could not be further analyzed.[Conclusion] Compared with the traditional Chinese medicine Jingui Shenqi Pills for treating yang deficiency, the moxibustion was more efficient in the treatment of subhealthy yang deficiency. However, due to the small quantity and low quality of the included literature, we still need to design a large sample, multi-center and high-quality randomized controlled clinical trial to verify it in the future.