中医杂志2025，Vol.66Issue(24)：2553-2563,11.DOI:10.13288/j.11-2166/r.2025.24.009
参芪膏治疗脾肾亏虚型老年肌少症的随机双盲对照试验
Shengqi Paste(参芪膏)for Senile Sarcopenia with Spleen-Kidney Deficiency Syndrome:A Randomized Double-Blind Controlled Trial
摘要
Abstract
Objective To evaluate the clinical effectiveness and safety of Shengqi Paste(参芪膏)for senile sarcopenia with spleen-kidney deficiency syndrome.Methods A total of 150 elderly patients with sarcopenia from the community were selected and randomly divided into a treatment group and a control group,with 75 participants in each group.The treatment group was given Shenqi Paste orally,while the control group was given a Shenqi Paste placebo orally.Both groups received treatment for a course of 12 weeks.The improvement of sarcopenia after treat-ment in the two groups was compared,including skeletal muscle mass index(SMI),grip strength,and time for five chair stands.The scores of traditional Chinese medicine(TCM)syndromes and health status indicators were also compared before and after treatment,including body mass index(BMI),FRAIL scale(Fatigue,Resistance,Ambu-lation,Illness,Loss of weight scale),Mini Nutritional Assessment-Short Form(MNA-SF),International Physical Activity Questionnaire(IPAQ),Activities of Daily Living(ADL)scale,Pittsburgh Sleep Quality Index(PSQI),and Geriatric Depression Scale-Short Form(GDS-15).Additionally,the serum levels of myostatin(MSTN),irisin,tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β),interleukin-6(IL-6),and interleukin-10(IL-10)were compared between groups before and after treatment.Changes in serum metabolites of patients in both groups after treatment were analyzed by liquid chromatography-mass spectrometry(LC-MS).Results Compared with the baseline(before treatment)within group,the SMI and grip strength in the treatment group significantly increased after treatment(P＜0.01);the time for five chair stands shortened in both groups(P＜0.01).Except for no significant difference in the symptom of more frequent nocturia in the control group(P＞0.05),the scores of other individual TCM symptoms and the total TCM syndrome score significantly decreased in both groups(P＜0.01).In the treatment group,BMI,MNA-SF score,IPAQ score,and serum IL-10 level all increased,while FRAIL scale score,ADL score,PSQI score,GDS-15 score,and serum levels of MSTN,irisin,TNF-α,and IL-1β decreased;in the control group,ADL score serum levels of MSTN and irisin decreased,IPAQ score increased(P＜0.05 or P＜0.01).Compared between groups after treat-ment,the SMI and grip strength in the treatment group were higher than those in the control group,while the time for five chair stands was shorter than that in the control group(P＜0.05 or P＜0.01);the scores of fatigue and weak-ness,fear of cold and cold limbs,soreness and weakness of waist and knees,insomnia,and the total TCM syndrome score in the treatment group were lower than those in the control group(P＜0.01).BMI,MNA-SF score,IPAQ score in the treatment group were higher than those in the control group,while the ADL score,PSQI score and GDS score-15 were lower than those in the control group(P＜0.05 or P＜0.01).Compared with the baseline within group,serum levels of MSTN,irisin,TNF-α,and IL-1β decreased in the treatment group after treatment,while IL-10 increased(P＜0.05 or P＜0.01);serum MSTN and irisin levels decreased in the control group(P＜0.01).Serum meta-bolomics results indicated differences in serum metabolites between the treatment and control groups after treat-ment,and the top 10 differential metabolites screened between groups after treatment were involved in 17 related metabolic pathways.Conclusion Shenqi Paste can effectively improve muscle mass and muscle strength in elderly patients with sarcopenia,reduce the inflammatory state of patients,regulate metabolic disorders,increase nutritional levels,improve quality of life,and show good safety.关键词
肌少症/老年/脾肾亏虚/参芪膏/随机对照试验Key words
sarcopenia/elderly/spleen-kidney deficiency/Shenqi Paste(参芪膏)/randomized controlled trial引用本文复制引用
王蓉芸,华丽江山,李小燕,凡颖,罗琦,王云超,杨莉莉,孙秋华..参芪膏治疗脾肾亏虚型老年肌少症的随机双盲对照试验[J].中医杂志,2025,66(24):2553-2563,11.基金项目
浙江省自然科学基金(LZ25H270001) （LZ25H270001）
浙江省中医药科技计划项目(2025ZL031) （2025ZL031）
