软坚通脉汤在PCI术后Ⅲ期心脏康复中的应用

The application of Ruanjian Tongmai decoction on post-PCI patients participating in cardiac rehabilitation (phase Ⅲ)

目的初步观察软坚通脉汤应用于经皮冠状动脉支架植入术(PCI术)Ⅲ期心脏康复的效果。方法纳入2015年1月-2016年1月在东直门医院门诊治疗的PCI术后Ⅲ期康复患者,随机分为治疗组和对照组,对照组给予有充分循证证据的冠心病二级预防用药,治疗组在对照组的基础上加用软坚通脉汤,2组均给予家庭康复,疗程8周。观察软坚通脉汤对PCI术后Ⅲ期心脏康复患者中医症状、生活质量的改善。结果试验共有62例接受随机分组,随访期间服用其他中药1例,主动退出试验2例,失访3例,最后纳入分析56例。治疗组中医症状改善总有效率为78.6%,明显高于对照组的46.4%。治疗前后CQQC问卷得分比较,2组均可以从病情、医疗状况、一般生活和社会心理状况4个维度上提高患者的生活质量,但治疗组对于患者体力状况的改善优于对照组(P<0.01),更能有效提高患者的生活质量(P<0.01)。结论在康复教育、规范的循证用药及生活方式调整等强化管理措施的基础上,加用中药软坚通脉汤后,患者的症状和生活质量改善更为明显,提示在PCI术后Ⅲ期康复方案中加用中药软坚通脉汤可以提高康复疗效。

Objective To observe the effect of Ruanjian Tongmai decoction on post-PCI patients participating in phase Ⅲ of home-based cardiac rehabilitation（CR）. Methods The outpatients following PCI（phase Ⅲ of CR） in our hospital during Jan 2015 to Jan 2016 were recruited to participate in the Randomized Controlled Trial（RCT）. The patients were assigned into the control group or Ruanjian Tongmai decoction group（RJTMD）. Both groups received home-base CR and western medicines following the guideline; the RJTMD group also received Ruanjian Tongmai decoction. The CQQC and the rate of traditional chinese medicine（TCM） symptoms were evaluated at the baseline and at 8 weeks. Results In total, 62 outpatients following PCI（phase Ⅲ of CR） were enrolled. During the intervention period, 3 were lost to follow-up, 1 took prohibited, and 2 take the initiative to quit. After 8 weeks, 56 participants remained with 28 in the RJTMD group and 28 in the control group. The total effective rate was 78.6% in the RJTMD group, significantly higher than 46.4% in the control group. Changes in scores of CQQC before and after the treatment show that both the RJTMD and the control can improve the patient＇s quality of life（QOL） from the four dimensions of illness, medical condition, general life and social psychological status; According to the changes in the scores of CQQC between the two groups, the improvement of the physical condition in the RJTMD group was superior to control group（P〈0.01）, and thus can more effectively improve the QOL of the patients（P〈0.01）. Conclusion After comprehensive CR, the RJTMD group had better effective rate and QOL than the control group, suggesting that Chinese herbal Ruanjian Tongmai Decoction can help to increase the effect of CR in phase Ⅲ.