地黄饮子治疗肾精亏虚型老年衰弱综合征的临床研究

Clinical study of Dihuang Yinzi in the treatment of frailty syndrome in elderly patients with kidney essence deficiency

目的针对肾精亏虚型老年衰弱患者选取经方“地黄饮子”治疗以期探究其临床的有效性和安全性。方法选择2021年1月—2023年4月复旦大学附属华东医院收治的78例经衰弱筛查量表(The“FRAIL”Scale)诊断为肾精亏虚型老年衰弱综合征的患者,使用随机数字表法随机入组对照组和观察组,每组各39例。2组均采取西医基础治疗及调护,观察组在其基础上加用汤剂地黄饮子。分别于治疗前、治疗8周后,比较2组的EFS衰弱量表评分、中医证候量表评分,以及相关血清营养指标水平[白蛋白(ALB)、总蛋白(TP)、25羟基维生素D[25(OH)D]]、骨代谢指标水平[β-胶原特殊序列(β-CROSSL)、血清N端骨钙素(N-MID)、超氧化物歧化酶(SOD)]。结果治疗8周后,观察组总有效率达94.87%,优于对照组总有效率74.35%(P<0.05);治疗后2组的EFS衰弱量表评分均下降,且观察组的EFS评分改善优于对照组(P<0.05);与本组治疗前比较,治疗后观察组ALB、TP、25(OH)D、N-MID、SOD水平上升,β-CROSSL水平下降(P<0.05);对照组25(OH)D、N-MID、SOD水平上升,β-CROSSL水平下降(P<0.05)。组间比较,治疗后观察组TP、25(OH)D、β-CROSSL、SOD水平改善优于对照组,差异有统计学意义(P<0.05)。2组均未出现严重不良事件及安全性指标异常。结论地黄饮子汤剂干预肾精亏虚型老年衰弱综合征患者安全有效,可以显著改善患者营养、骨代谢指标及生理功能状态。

Objective To explore the clinical effectiveness and safety of the herbal formula“Dihuang Yinzi”in the treatment of elderly frail patients with kidney essence deficiency.Methods 78 elderly patients diagnosed with frailty syndrome and kidney essence deficiency by the frailty screening scale(Edmonton Frail Scale,EFS)admitted to Huadong Hospital Affiliated to Fudan University from January 2021 to April 2023 were selected.They were randomly divided into treatment group and control group,with 39 cases in each group.Both groups received basic western medicine treatment and care,while the observation group was treated with Dihuang Yinzi decoction on the basis of the control group.Before treatment and 8 weeks after treatment,the EFS scores,traditional Chinese medicine(TCM)symptom scale scores,as well as the levels of serum nutritional indexes{albumin(ALB),total protein(TP),25 hydroxyvitamin D[25(OH)D]}and bone metabolism indexes[β-collagen special sequence(β-CROSSL),serum N-terminal osteocalcin(N-MID),superoxide dismutase(SOD)]were compared between the two groups.Results After 8 weeks of treatment,the total effective rate of the observation group reached 94.87%,which was better than that of the control group(74.35%)(P<0.05).After treatment,the EFS scores of both groups decreased,but the treatment group showed a greater improvement than the control group(P<0.05).Compared with before treatment,the levels of ALB,TP,25(OH)D,N-MID and SOD of the observation group increased after treatment,whileβ-CROSSL level decreased(P<0.05);the levels of 25(OH)D,N-MID and SOD of the control group increased after treatment,whileβ-CROSSL level decreased(P<0.05).The improvement of the levels of TP,25(OH)D,β-CROSSL and SOD in the observation group after treatment was better than that in the control group,with statistical significance(P<0.05).No serious adverse events or abnormal safety indicators were observed in both groups.Conclusion Dihuang Yinzi decoction is safe and effective in treating elderly patients with frailty syndrome and kidney essence deficiency,and can significantly improve their nutritional indexes,bone metabolism indexes and physiological function.