摘要
目的 观察参芪膏治疗脾肾亏虚型老年肌少症的临床疗效和安全性。方法 选取社区老年肌少症患者150例,随机分为治疗组和对照组各75例,治疗组口服参芪膏,对照组口服参芪膏模拟剂,两组疗程均为12周。比较两组患者治疗前后肌少症的改善情况[包括骨骼肌质量指数(SMI)、握力和五次起坐时间],比较两组治疗前后中医证候评分及健康状况[包括身体质量指数(BMI)、衰弱量表(FRAIL)、营养状况简表(MNA-SF)、国际体力活动量表(IPAQ)、日常生活能力评分量表(ADL)、匹兹堡睡眠质量指数评价量表(PSQI)和简易老年抑郁量表(GDS-15)]。比较两组治疗前后血清肌肉生长抑制素(MSTN),鸢尾素(irisin)、肿瘤坏死因子α(TNF-α)、白细胞介素1β(IL-1β)、白细胞介素6(IL-6)和白细胞介素10(IL-10)水平,并通过液相色谱-质谱法(LC-MS)分析治疗后两组患者血清代谢物的变化。结果 与本组治疗前比较,治疗后治疗组SMI和握力值均提升(P<0.01),两组患者的五次起坐时间均缩短(P<0.01),除对照组夜尿频多症状差异无统计学意义(P>0.05)外,两组其余各症状评分及中医证候评分均明显降低(P<0.01),治疗组BMI与MNA-SF、IPAQ评分及血清IL-10水平均升高,FRAIL、ADL、PSQI、GDS-15评分和血清MSTN、irisin、TNF-α、IL-1β水平均降低,对照组ADL评分与血清MSTN、irisin水平均降低,IPAQ评分升高(P<0.05或P<0.01);两组患者治疗后比较,治疗组SMI、握力均高于对照组,而五次起坐时间均低于对照组(P<0.05或P<0.01),治疗组倦怠乏力、畏寒肢冷、腰膝酸软、失眠症状评分和中医证候评分均低于对照组(P<0.01),BMI及MNA-SF、IPAQ评分均高于对照组,ADL、PSQI、GDS-15评分均低于对照组(P<0.05或P<0.01)。治疗后治疗组血清MSTN、irisin、TNF-α、IL-1β水平均降低,IL-10水平升高(P<0.05或P<0.01);对照组血清MSTN和irisin均降低(P<0.01)。血清代谢组学结果提示,治疗后治疗组和对照组之间血清代谢产物存在差异,治疗后两组间筛选出排名前10的差异代谢物涉及17个相关通路。结论 参芪膏可以有效改善老年肌少症患者的肌肉质量和肌肉力量,降低患者的炎症状态,调节代谢紊乱,增加营养水平,提高生活质量,且安全性较好。
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 treatment 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,Ambulation,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-1βdecreased;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 treatment,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 weakness,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-1βdecreased 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 treatment,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.
作者
王蓉芸
华丽江山
李小燕
凡颖
罗琦
王云超
杨莉莉
孙秋华
WANG Rongyun;HUA Lijiangshan;LI Xiaoyan;FAN Ying;LUO Qi;WANG Yunchao;YANG Lili;SUN Qiuhua(Zhejiang Chinese Medical University,Hangzhou,310053;Qingbo Subdistrict Community Health Service Center,Shangcheng District,Hangzhou;Puyan Subdistrict Community Health Service Center,Binjiang District,Hangzhou)
出处
《中医杂志》
北大核心
2025年第24期2553-2563,共11页
Journal of Traditional Chinese Medicine
基金
浙江省自然科学基金(LZ25H270001)
浙江省中医药科技计划项目(2025ZL031)。
关键词
肌少症
老年
脾肾亏虚
参芪膏
随机对照试验
sarcopenia
elderly
spleen-kidney deficiency
Shenqi Paste(参芪膏)
randomized controlled trial
