藤菔降压片治疗1级高血压病肝阳上亢证随机对照试验

Tengfu Jiangya Tablet for Grade 1 Hypertension Patients with Gan-Yang Hyperactivity Syndrome:A Randomized Controlled Trial

目的 评价藤菔降压片治疗1级高血压病肝阳上亢证患者的疗效和安全性。方法 采用随机、单盲、安慰剂平行对照的方法,纳入1级高血压病肝阳上亢证患者130例,随机分为对照组65例,试验组65例。试验组予生活方式指导加藤菔降压片每日2次(1.5 g/次),对照组予生活方式指导加藤菔降压片安慰剂每日2次(1.5 g/次),共治疗4周。比较两组治疗前后主要疗效指标(中医证候积分、血压和血压达标率)及次要疗效指标(血脂、尿酸、花生四烯酸、血栓素B2、前列腺素E2以及尿微量白蛋白);进行安全性及依从性分析。结果 共129例患者完成试验,其中对照组65例,试验组64例。治疗组血压达标率优于对照组[65.63%(42/64)vs.43.08%(28/65),χ^(2)=6.606,P<0.05]。与本组治疗前比较,治疗后两组中医证候积分、收缩压、舒张压降低(P<0.05),且治疗组较对照组改善更为明显(P<0.05);治疗组花生四烯酸、血栓素B2下降(P<0.05),前列腺素E2升高(P<0.05)。与对照组比较,治疗组治疗后花生四烯酸水平下降(P<0.05)。两组患者均未出现不良反应,两组依从性比较,差异无统计学意义(P>0.05)。结论 藤菔降压片治疗1级高血压病肝阳上亢证安全、有效。(中国临床试验注册中心,No.ChiCTR-IIR-17011940)。

Objective To evaluate the efficacy and safety of Tengfu Jiangya Tablet(TJT)in the treatment of patients with grade 1 hypertension and Gan-Yang hyperactivity syndrome.Methods A total of 130 patients with grade 1 hypertension and Gan-Yang hyperactivity syndrome were included using a randomized,single-blind,placebo-controlled parallel design,with 65 patients in the control group and 65 patients in the experimental group.The experimental group received lifestyle guidance plus TJT twice daily(1.5 g per dose),while the control group received lifestyle guidance plus placebo TJT twice daily(1.5 g per dose).The treatment duration was 4 weeks.The main efficacy indicators[Chinese medicine(CM)syndrome score,blood pressure,and blood pressure control rate]and secondary efficacy indicators(blood lipids,uric acid,arachidonic acid,thromboxane B2,prostaglandin E2,and urinary microalbumin)before and after treatment between the two groups were compared.Safety and compliance analysis were conducted.Results A total of 129 patients completed the trial(65 in the control group and 64 in the experimental group).The blood pressure control rate in the experimental group was superior to the control group[65.63%(42/64)vs.43.08%(28/65),χ^(2)=6.606,P<0.05].Compared with baseline,both groups showed reductions in CM syndrome score,systolic blood pressure,and diastolic blood pressure after treatment(P<0.05),with the experimental group showing more significant improvement than the control group(P<0.05).Arachidonic acid and thromboxane B2 decreased in the experimental group(P<0.05),while prostaglandin E2 increased(P<0.05).Compared with the control group after treatment,arachidonic acid levels decreased in the experimental group(P<0.05).There were no adverse reactions in either group,and there was no statistically significant difference in compliance between the two groups(P>0.05).Conclusion TJT is safe and effective in treating grade 1 hypertension with Gan-Yang hyperactivity syndrome.(Chinese Clinical Trial Registry,No.ChiCTR-IIR-17011940).