龟龄集胶囊治疗老年衰弱综合征临床研究

Clinical Study on Guilingji Capsules for Senile Frailty Syndrome

目的:观察龟龄集胶囊治疗老年衰弱综合征的临床疗效及安全性。方法:随机选取伴有老年衰弱综合征的患者24例,所有患者均予龟龄集胶囊治疗,每次2粒(每粒0.3 g),每天1次,连续治疗12周,于第6周、第12周时进行随访,记录治疗前后受试者的生命体征、衰弱症状、睡眠质量、日常生活能力(ADL)等评分,检测血清转铁蛋白、维生素B12、维生素D、促甲状腺素、超氧化物歧化酶、白细胞介素-6、性激素6项等相关治疗指标,并观察不良反应情况。结果:与治疗前比较,治疗12周后临床衰弱量表评分(CFS)、匹兹堡睡眠质量指数(PSQI)、ADL均下降,差异均有统计学意义(P<0.05,P<0.01);简易精神状态(MMSE)评分明显上升,差异均有统计学意义(P<0.01)。与治疗前比较,治疗6周后及治疗12周后,脆弱易损伤(等级4)由16.67%上升为37.50%及66.67%,差异均有统计学意义(P<0.05);与治疗前比较,治疗6周后及治疗12周后,轻度衰弱(等级5)由83.33%下降为62.5%及33.33%,差异均有统计学意义(P<0.05)。治疗12周后,孕酮及维生素D均明显上升,差异均有统计学意义(P<0.05,P<0.01);白细胞介素-6明显下降,差异有统计学意义(P<0.05)。其余指标血清转铁蛋白、维生素B12、促甲状腺素、超氧化物歧化酶、睾酮、雌二醇、促黄体生成素、催乳素、促卵泡生成激素治疗前后比较,差异均无统计学意义(P>0.05)。治疗期间,龟龄集胶囊的治疗效果相对保持稳定,严重不良事件发生率4.17%。结论:龟龄集胶囊能够有效改善老年衰弱综合征患者的衰弱症状,具有良好的临床有效性和安全性。

Objective:To observe the clinical effect and safety of the therapy of Guilingji capsules for senile frailty syndrome.Methods:A total of 24 patients with senile frailty syndrome were randomly selected.All patients were treated with Guilingji capsules,two capsules each time,0.6 g per capsule,once a day for 12 weeks.The patients were followed up after6 and 12 weeks of treatment.Before and after treatment,the scores of vital signs,frailty symptoms,sleep quality and ability of daily living(ADL)of the participants were recorded.The related indexes,such as serum transferrin,vitamin B12,vitamin D,thyrotropin,superoxide dismutase,interleukin-6,and six sex hormones,were detected,and the adverse reactions were observed.Results:After 12 weeks of treatment,the scores of Clinical Frailty Scale(CFS),Pittsburgh Sleep Quality Index(PSQI)and ADL were decreased when compared with those before treatment,differences being significant(P<0.05,P<0.01);the scores of Mini Mental State Examination(MMSE)were significantly increased,differences being significant(P<0.01).After 6 and 12 weeks of treatment,the proportion of very mild frailty(Grade Four)was increased from16.67%to 37.50%and 66.67%when compared with those before treatment,differences being significant(P<0.05);after6 and 12 weeks of treatment,the proportion of mild frailty(Grade Five)was decreased from 83.33%to 62.5%and 33.33%when compared with those before treatment,differences being significant(P<0.05).After 12 weeks of treatment,progesterone and vitamin D were significantly increased,differences being significant(P<0.05,P<0.01);the IL-6 was significantly decreased,the difference being significant(P<0.05).There was no significant difference being found in the comparisons of serum transferrin,vitamin B12,thyrotropin,superoxide dismutase,testosterone,estradiol,luteinizing hormone,prolactin and follicle stimulating hormone before and after treatment(P>0.05).During treatment,the curative effect of Guilingji capsules was relatively stable,and the incidence of serious adverse reactions was 4.17%.Conclusion:The therapy of Guilingji capsules can effectively improve the symptoms of patients with senile frailty syndrome,with good clinical effects and safety.