中医及中西医结合治疗老年单纯收缩期高血压的多中心随机双盲对照临床试验(英文)

Traditional Chinese versus integrative treatment in elderly patients with isolated systolic hypertension:a multicenter,randomized,double-blind controlled trial

背景:单纯收缩期高血压(isolated systolic hypertension,ISH)是老年人的常见病,严重危害老年人的健康。中医及中西医结合治疗模式在改善老年ISH患者生活质量以及保护靶器官等方面具有一定优势,但需要进一步的循证医学研究。目的:观察中医(降压胶囊)及中西医结合(降压胶囊联合尼莫地平)治疗模式对老年ISH患者血压、血管活性物质的影响及其安全性。设计、场所、受试者和干预措施:采用多中心、随机双盲、阳性对照的试验设计。按标准入选中国中医科学院西苑医院、北京延庆县中医院及延庆社区卫生服务中心的老年ISH患者270例,采用随机区组法分为中医组(降压胶囊联合尼莫地平模拟药)、中西医结合组(降压胶囊联合尼莫地平)和西医组(尼莫地平联合降压胶囊模拟药),每组各90例。疗程为4周。主要结局指标:观察各组治疗后诊室血压和动态血压水平,血管活性物质如内皮素-1(endothelin-1,ET-1)、一氧化氮(nitric oxide,NO)、血栓素B_2(thromboxane B_2,TXB_2)和6-酮-前列腺素1α(6-ketoprostaglandin1α,6-keto-PGF1α)水平的变化,并评价其安全性。结果:治疗结束后,中医组脱落10例(80例完成试验),中西医结合组脱落14例(76例完成试验),西医组脱落5例(85例完成试验)。治疗后各组收缩期血压值低于治疗前,差异均有统计学意义(P<0.05),中西医结合组收缩期血压明显低于中医组或西医组(P<0.05)。治疗后各组24 h平均收缩压及昼间平均收缩压明显降低,中西医结合组夜间平均收缩压亦明显降低,与治疗前比较,差异有统计学意义(P<0.05);中西医结合组24 h平均收缩压和昼间平均收缩压低于中医组和西医组(P<0.05)。治疗后各组患者血清NO、血浆6-keto-PGF1α水平均升高,而血浆ET-1和TXB_2水平降低(P<0.05),且中西医结合疗法对降低血浆TXB_2含量的作用明显优于中医或西医疗法(P<0.05)。结论:中医及中西医结合治疗模式应用于老年ISH患者的疗效肯定,安全性高,且中西医结合治疗模式在降压及相关指标改善等方面具有明显协同增效的优势,值得进一步研究。

Background：Isolated systolic hypertension（ISH） is a common disease in elderly people,threatening the r health.Traditional Chinese medicine（TCM） treatment or integrative treatment had advantages in improving quality of life and protecting target organs,but need to be proved by large evidence-based researches. Objective：To observe the effects of TCM treatment（Jiangya Capsule） or integrative treatment（combination of Jiangya Capsule and nimodipine） on blood pressure and vasoactive agents,and their safety in elderly ISH patients. Design,setting,participants and interventions：A multicenter.randomized,double-blind controlled trial was adopted.A total of 270 elderly ISH patients recruited from Xiyuan Hospital,and TCM Hospital and Community Health Service Centers of Yanqing County of Beijing were randomly divided into 3 groups：TCM group （Jiangya Capsule plus nimodipine simulation.90 cases）,integrative group（Jiangya Capsule plus nimodipine,90 cases） and Western medicine（WM） group（nimodipine plus Jiangya Capsule simulation, 90 cases）.They were all treated for 4 weeks. Main outcome measures：Before and after 4-week treatment,office blood pressure,24-hour ambulatory blood pressure,serum nitric oxide（NO）,and plasma endothelin-1（ET-1）,thromboxane B_2（TXB_2） and 6-keto-prostaglandin 1α（6-keto-PGF1α） were detected,and safety evaluation was conducted. Results：After 4-week treatment,5 patients in TCM group were lost to follow-up and another 5 patients were excluded,and 80 patients finished the trial;7 patients in integrative group were lost to follow-up and another 7 patients were excluded,and 76 patients finished the trial;2 patients in WM group were lost to follow-up and another 3 patients were excluded,and 85 patients finished the trial.After treatment,systolic blood pressure （SBP） decreased in each group（P〈0.05）,and integrative treatment was superior to TCM or WM treatment in decreasing SBP（P〈0.05）.Twenty-four hour average SBP and day average SBP decreased significantly in each group,and night average SBP decreased in integrative group,and integrative treatment was superior to TCM or WM treatment in decreasing day average SBP.Serum NO and plasma 6-keto-PGF 1αlevels were elevated and plasma ET-1 and TXB2 levels were reduced after treatment,and integrative treatment was superior to TCM or WM treatment in reducing plasma TXB2 level. Conclusion：TCM treatment or integrative treatment has affirmative effects and safety in treating elderly ISH patients,and integrative treatment has superiority in improving some indexes,and deserves further study.