便携式四诊合参辅助诊疗仪的临床试验和临床评价研究

Clinical trial and assessment of a portable apparatus for auxiliary diagnosis and treatment based on four TCM diagnostic methods

目的通过临床试验验证并评价便携式四诊合参辅助诊疗仪(简称四诊合参辅助诊疗仪)的重复稳定性、有效性和安全性。方法采用分段均衡随机法,随机选择受试者进入试验组。应用四诊合参辅助诊疗仪,采集30例受试者的四诊信息,通过医师判断与仪器辅助判断对比做出四诊合参辅助诊疗仪的诊疗建议。间隔一段时间2次采集受试者信息自身对照,做出四诊合参辅助诊疗仪的重复稳定性、有效性评价;对四诊合参辅助诊疗仪的临床疗效和安全性做出评价。结果四诊合参辅助诊疗仪对30例受试者脉诊结果、舌图的采集分析、闻诊信息采集分析及受试者体质五行分类指标与医师人工诊断结果一致性很好,重复稳定性和四诊辨证及治疗建议结果符合率高,其辅助诊断和治疗建议结果得到临床医师的认可。整个研究过程受试者未发现不良反应。结论四诊合参辅助诊疗仪具有很好的重复稳定性、有效性和安全性,可实现标准所列的四诊合参辅助临床诊断,提出临床干预措施。

Objective To validate and assess the reproducibility,stability,reliability,effectiveness and safety of the portable apparatus for auxiliary diagnosis and treatment based on four TCM diagnostic methods through a clinical trial.Method Balanced random segmentation method was used to randomly choose patients or volunteers for the trial group.TCM diagnostic information of 30 voluntary subjects was collected by using the portable apparatus.Suggestions for diagnosis and treatment from the portable apparatus were obtained by operating the apparatus by TCM physicians.The reproducibility,stability and reliability of the portable apparatus were assessed with a self-control method through collecting the TCM diagnostic information of the voluntary subjects for 2 times at an interval period of time.The clinical effectiveness and safety of the portable apparatus were also assessed in the clinical trial.Result It was found the judgment of the portable apparatus on the indexes of TCM pulse diagnosis,TCM tongue diagnosis,TCM auscultation and TCM constitution classification according to the five elements theory in the 30 voluntary subjects were very well conformable to that made by TCM physicians,and that the work of the portable BD-SZ apparatus showed high reproducibility and stability.Suggestions for diagnosis and treatment from the portable BD-SZ apparatus were recognized by clinical TCM physicians.No untoward reactions were found in the voluntary subjects in the trial.Conclusion The portable BD-SZ apparatus for auxiliary diagnosis and treatment based on four TCM diagnostic methods shows desirable reproducibility,stability,reliability,effectiveness and safety;it can basically realize the auxiliary diagnosis and treatment based on four TCM diagnostic methods as described in the relevant document.