基于医院与社区比较的中医非药物疗法治疗原发性高血压随机对照试验的现状与特征分析

Current situation and features of randomized controlled trials about Chinese medicine non-drug therapies on essential hypertension based on comparison between general hospitals and community health centers

目的比较医院与社区卫生机构开展的中医非药物疗法治疗原发性高血压随机对照试验(RCT)的现状与特征。方法系统检索中国知网(CNKI)、维普资讯中文期刊数据库(VIP)和万方数据库(WANFANG DATA),纳入2013—2018年发表的中医非药物疗法治疗原发性高血压的RCT期刊文献,分为医院组与社区组进行比较分析。结果共纳入85项RCT,其中医院组66项(77.6%),社区组19项(22.4%)。医院组RCT分布于22个省(自治区、直辖市),社区组RCT分布于8个省(自治区、直辖市)。2组样本量比较差异无统计学意义(P>0.05)。共涉及11类中医非药物疗法,其中医院组涉及10类,社区组涉及7类。社区组报告随访比例高于医院组(P<0.05)。社区组观测生存质量、其他指标的比例高于医院组(P<0.05);社区组仅用有效率作为血压控制结局指标的比例高于医院组(P<0.05)。2组核心期刊发表比例比较差异无统计学意义(P>0.05),社区组获得科研基金支持的比例高于医院组(P<0.05)。结论医院、社区卫生机构在RCT文献发表数量、地域分布、涉及的中医非药物疗法种类、随访、结局指标的选取及科研基金支持等方面有所不同,有待进一步研究。应进一步重视社区卫生机构开展RCT的作用,提升其科研水平。

Objective To analyze the situation and features of randomized controlled trials(RCTs) about the TCM non-drug therapies for essential hypertension(ESH) conducted in hospitals and community health centers. Methods CNKI, CQVIP and Wanfang databases were searched, and then we included RCTs about TCM non-drug therapies on ESH conducted in hospitals and community health centers from 2013 to 2018, and divided them into the hospital group and the community group. Results 85 RCTs were included, of which 66(77.6%) were conducted in hospitals and 19(22.4%) were carried out in communities. The RCTs of the hospital group were distributed in 22 provinces, autonomous regions and municipalities, and the RCTs of the community group were distributed in 8 provinces, autonomous regions and municipalities. The sample size had no statistically significant differences between the two groups(P>0.05). A total of 11 types of TCM non-drug therapies were involved in 2 groups. The hospital group involved 10 types and the community group involved 7 types. The RCTs’ ratio that reported follow-up was higher in the community group than in the hospital group(P< 0.05). The proportion of RCTs that reported quality of life and other outcomes was higher in the community group than in the hospital group(P<0.05). The proportion of RCTs with only effective rate as the outcome of blood pressure control was higher in the community group than in the hospital group(P<0.05). There was no significant difference in the ratio of RCTs published in core journals and non-core journals between the two groups(P>0.05). The proportion of RCTs supported by research funds was higher in the community group than in hospital group(P<0.05). Conclusions Hospitals and community differ in the number of RCTs published, geographical distribution, types of TCM non-drug therapies involved, follow-up, selection of outcomes and research funding support, etc. We should pay more attention to the role of RCTs conducted in community, so as to enhance its research.