中医药治疗老年单纯收缩期高血压的临床研究结局指标分析

Analysis of clinical trials of traditional Chinese medicine in elderly patients with simple systolic hypertension

关键词:  核心指标集  老年单纯收缩期高血压  中医药  随机对照试验

Key words:  core index set  simple systolic hypertension in the elderly  traditional Chinese medicine  randomized controlled trial

摘要:

[目的] 梳理中医药治疗老年单纯收缩期高血压（ISH）的随机对照试验（RCT）的评价指标，构建中医药治疗老年ISH临床试验核心指标集。[方法] 检索PubMed、CoChrane library、Embase、中国知网数据库、万方数据库、维普数据库中应用中药联合长效钙拮抗剂（CCB）或肾素-血管紧张素-醛固酮系统阻断剂（ACEI或ARB）干预老年ISH的随机对照临床研究，检索时限均为建库至2019年12月31日。[结果] 纳入38篇RCT，共计2 848例患者，涉及396个指标，频次排列前16位的指标依次为：诊室收缩压（7.04%）、降压有效率（6.31%）、中医证候疗效（6.31%）、诊室舒张压（5.56%）、肝功能（4.29%）、肾功能（4.29%）、血常规（4.04%）、尿常规（3.79%）、不良反应发生率（3.54%）、夜间平均收缩压（3.28%）、24小时平均收缩压（3.03%）、日间平均收缩压（3.03%）、中医证候积分（3.03%）、诊室脉压差（2.78%）、日间平均舒张压（2.78%）及夜间平均舒张压（2.78%）。[结论] 中医药治疗老年ISH的指标选择存在较多的问题，如差异性较大、指标测量时点差异大、缺乏中医药特色等，需加快研制老年ISH；核心指标集。

Abstract:

[Objective] To sort out the evaluation indexes of randomized controlled trials （RCT） of traditional Chinese medicine（TCM） in the treatment of isolated systolic hypertension（ISH） in the elderly，and to construct the core index set of clinical trials of TCM in the treatment of ISH in the elderly. [Methods] PubMed，CoChrane library， Embase，CNKI database，Wanfang database，VIP database were searched for randomized controlled clinical trials of TCM combined with long-acting calcium antagonist（CCB） or renin-angiotensin-aldosterone system blocker（ACEI or ARB） in the intervention of ISH in the elderly. The retrieval time limit was from the establishment of the database to December 31，2019. [Results] 38 RCTS were included，with a total of 2848 patients，involving 396 indicators. The top 16 indicators in frequency rank were as follows：Office systolic blood pressure（7.04%），antihypertensive effective rate（6.31%），TCM syndrome efficacy（6.31%），office diastolic blood pressure（5.56%），liver function（4.29%）， renal function（4.29%），blood routine（4.04%），urine routine（3.79%），incidence of adverse reactions（3.54%），night average systolic blood pressure（3.28%），24-hour mean systolic blood pressure（3.03%），daytime mean systolic blood pressure（3.03%），TCM syndrome score（3.03%），office pulse pressure difference（2.78%），daytime mean diastolic blood pressure（2.78%） and night mean diastolic blood pressure（2.78%）. [Conclusion] There are many problems in the selection of indicators for the treatment of ISH in the elderly with TCM，such as large differences， large differences in measurement time points of indicators，and lack of characteristics of TCM. It is necessary to accelerate the development of ISH in the elderly. Set of core metrics.