基于“肾虚致衰”理论的“杞鹿健肾颗粒”对老年衰弱综合征肾气虚证的二阶段交叉对照研究

“Qilu Jianshen granules”based on the theory of“kidney-qi deficiency causing weakness”on senile debilitating syndrome of kidney-qi deficiency type:A two-stage cross-over controlled study

目的观察杞鹿健肾颗粒治疗老年衰弱综合征肾气虚证的临床疗效,为中医药有效防治老年衰弱综合征提供依据。方法选取2018年6月-2019年6月就诊于上海中医药大学附属岳阳医院老年病科门诊的年龄≥65岁的老年衰弱综合征患者80例,随机分为A、B 2组,每组40例。采用随机、二阶段交叉对照的临床研究设计。第一阶段干预3个月,A组40例给予杞鹿健肾颗粒联合常规治疗,B组40例只给予常规治疗。经过1个月药物洗脱期,将2组的干预措施互相交换,继续第二阶段3个月治疗。从肌力评价指标(握力)、躯体活动能力评价指标(步速、重复坐站)、肾气虚证症状评分方面,评估杞鹿健肾颗粒改善老年衰弱综合征的临床疗效。结果所有受试者均完成研究。通过对疗效观察指标的分析,不同受试者及试验阶段对观察指标无影响;杞鹿健肾颗粒对握力、步速、肾气虚证评分的影响差异均有统计学意义(P均<0.05),对重复坐站的影响差异无统计学意义(P>0.05)。结论杞鹿健肾颗粒可以改善老年衰弱患者的衰弱状态及肌力,提高躯体活动能力。

Objective It is to observe the clinical efficacy of Qilu Jianshen granules on senile debilitating syndrome of kidney-qi deficiency type,and to provide clinical evidences for the effective prevention and treatment of senile debilitating syndrome with traditional Chinese medicine.Methods Eighty patients with senile debilitating syndrome aged≥65 years who attended the outpatient clinic of the Department of Geriatrics of Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2018 to June 2019 were selected and randomly divided into group A and group B,with 40 cases in each group.A randomized,two-stage crossover controlled clinical study design was used.In the first phase of the 3-month intervention,40 cases in group A were given Qilu Jianshen granules combined with conventional therapy,and 40 cases in group B were given conventional therapy only.After a one month drug elution period,the interventions of the two groups were exchanged with each other,and the second phase of the 3-month treatment course was continued.The clinical efficacy of Qilu Jianshen granules in improving senile debility syndrome was evaluated in terms of muscle strength evaluation index(grip strength),somatic mobility evaluation index(gait speed,five times sit to stand),and scors of kidney-qi deficiency symptom.Results All the subjects completed the study.By analyzing the observed indicators of efficacy,there was no effect of different subjects and test phases on the observed indicators;the differences of the effects of Qilu Jianshen granules on grip strength,gait speed,and scores of kidney-qi deficiency syndrome were all statistically significant(all P<0.05),and the difference of the effect on five times sit to stand was not statistically significant(P>0.05).Conclusion Qilu Jianshen granules can improve the debilitating state,improve muscle strength,and enhance somatic mobility in patients with senile debilitating syndrome.