新保元汤联合心脏康复干预经导管主动脉瓣置换术后患者随机对照研究

Effect of Xinbaoyuan Decotion Combined with Cardiac Rehabilitation Measures in Patients after Transcatheter Aortic Valve Replacement:A Randomized Controlled Trial

目的观察新保元汤联合心脏康复改善经导管主动脉瓣置换术(TAVR)术后患者整体功能的影响。方法本研究方案在中国临床试验注册中心注册(ChiCTR1900026403)。采用前瞻性、随机、对照的临床试验设计,60例成功行TAVR治疗的重度主动脉瓣狭窄患者(气血亏虚、瘀阻水停证),按照1:1比例随机分为治疗组和对照组,每组30例。两组均给予常规药物及心脏康复治疗,治疗组在此基础上加用新保元汤,干预4周,并随访24周。比较两组在4周时中医症状积分及有效率,4、24周时的6分钟步行试验(6MWT)距离、营养评分、明显虚弱比例及安全指标变化。结果最终完成观察57例,其中治疗组29例和对照组28例。干预4周后,治疗组中医症状积分降低(P<0.01),有效率(χ^(2)=8.265,P=0.004)及营养评分升高(P=0.037)且均优于对照组(P<0.05)。与本组治疗前比较,在4、24周时两组6MWT距离增加(P<0.001),虚弱比例下降(χ^(2)=85.444,P<0.001),且治疗组优于对照组,差异有统计学意义(P<0.05),肝、肾等安全性指标均未见异常变化。结论新保元汤联合康复措施可改善TAVR术后患者的中医症状、6MWT距离、营养及虚弱比例等整体功能水平。

Objective To explore the advantages of Xinbaoyuan Decotion(XBYD)combined with cardiac rehabilitation measures in improving the overall functioning of patients after transcatheter aortic valve replacement(TAVR).Methods A prospective,randomized,controlled clinical trial design was adopted.Totally 60 severe aortic stenosis patients with qi-blood deficiency and blood stasis and water stagnation syndrome who were successfully treated with TAVR were included in this study.Patients were randomly assigned to the treatment group and control group in the rate of 1:1,30 in each group.All patients received conventional Western medicine combined with cardiac rehabilitation measures treatment,while those in the treatment group additionally took XBYD.The patients were intervened for 4 weeks and followed up for 24weeks.Chinese medicine(CM)symptom score and effective rate were compared at 4 weeks.Six minutes walk test(6MWT)distance,nutrition score and proportion of apparent frailty were compared between the 2groups at 4 and 24 weeks.Results Fifty-seven cases completed the trial,including 29 cases in the treatment group and 28 cases in the control group.The decreasing of CM symptom score(P<0.01)and increasing of effective rate(χ^(2)=8.265,P=0.004)and nutrition score(P=0.037)in the treatment group were significantly better than those in the control group at 4 weeks(P<0.05).Compared with baseline in the same group,the 6MWT distance were significantly increased(P<0.001),and proportion of apparent frailty was also significantly decreased(χ^(2)=85.444,P<0.001)in the two groups.There were statistical difference at these items at 4 and 24 weeks between the treatment and control group(P<0.05).No abnormal changes were observed in liver,kidney and other safety indexes.Conclusion XBYD combined with rehabilitation measures can improve the overall functional level of patients after TAVR,such as CM symptoms,6MWT distance,nutrition and frailty ratio.(Registration No.ChiCTR1900026403)