葛斛调脂方干预代谢综合征患者的随机对照研究

A Randomized Controlled Study on Gehu Tiaozhi Decoction Intervening Patients with Metabolic Syndrome

背景 全球约有1/4的人患有代谢综合征(Met S)。近年来我国Met S患病率也呈逐年上升趋势,对生命健康造成严重威胁。中医药治疗Met S有着多靶点、多环节的优势,但目前临床上缺乏高质量的随机对照研究和真实世界研究。目的 观察葛斛调脂方对Met S患者腰围(WC)、体质量、体脂率(BFP)及糖脂代谢的影响。方法2021年6月—2022年11月前瞻性选取上海中医药大学附属龙华医院门诊就诊及住院的84例Met S患者为研究对象。应用SPSS 25.0统计软件给定随机种子数,将受试者随机分为葛斛组(42例)和对照组(42例)。葛斛组应用葛斛调脂方颗粒治疗(葛根6 g,铁皮石斛6 g),患者空腹早晚各1次,1包/次,冲服,连续服用8周。对照组应用安慰剂颗粒干预,患者空腹早晚各1次,1包/次,冲服,连续服用8周。干预期间对两组患者进行相同的健康宣教(包括膳食方案和运动处方的指导)。干预8周后对比分析两组患者的WC、体质量、BMI、BFP、三酰甘油(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、空腹血糖(FBG)。结果 最终葛斛组41例、对照组41例完成8周的干预研究。治疗前两组患者WC、体质量、BMI、BFP比较,差异均无统计学意义(P>0.05)。两组治疗前后WC、体质量、BMI、BFP差值比较,差异均有统计学意义(P<0.05)。治疗前两组患者的TG、TC、HDL-C、LDL-C、FBG比较,差异均无统计学意义(P>0.05)。两组治疗前后TG、TC、FBG差值比较,差异均有统计学意义(P<0.05)。在治疗期间和随访结束后两组均未发生严重不良反应事件。结论 葛斛调脂方能较好地改善MetS患者的WC、体质量、BMI、BFP、TG、TC及FBG,且安全性较好。

Background About a quarter of the world's population suffers from metabolic syndrome(MetS).In recent years,the prevalence of MetS in China has also increased year by year,posing a serious threat to life and health.Traditional chinese medicine has the advantages of multi-target and multi-link in the treatment of MetS,but there is a lack of high-quality randomized controlled studies and real-world studies in clinical practice.Objective To observe the effects of Gehu Tiaozhi Decoction on waist circumference(WC),body weight,body fat percentage(BFP)and glucose and lipid metabolism in patients with MetS.Methods From June 2021 to November 2022,84 patients with MetS were prospectively selected from the outpatient department and inpatient department of LongHua Hospital Shanghai University of Traditional Chinese Medicine.The subjects were randomly divided into Gehu group(42 cases)and control group(42 cases).The patients in the Gehu group were treated with Gehu Tiaozhi Decoction(Pueraria lobamle radix 6 g,Dendrobium officinale 6 g).The patients were fasted once in the morning and once in the evening,1 bag each time,taken orally for 8 weeks.The control group was treated with placebo granules.The patients were fasted once in the morning and once in the evening,1 bag each time,taken orally for 8 weeks.During the intervention,the two groups of patients were given the same health education(including dietary regimen and exercise prescription guidance).After 8 weeks of intervention,the WC,body weight,BMI,BFP,triglyceride(TG),total cholesterol(TC),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C)and fasting blood glucose(FBG)were compared between the two groups.Results Finally,41 patients in the Gehu group and 41 patients in the control group completed the 8-week intervention study.No statistically significant differences of WC,body weight,BMI or BFP was found between the two groups before treatment(P>0.05).The differences of WC,body weight,BMI and BFP between the two groups before and after treatment were statistically significant(P<0.05).No statistically significant differences of TG,TC,HDL-C,LDL-C or FBG was found between the two groups before treatment(P>0.05).The differences of TG,TC and FBG between the two groups before and after treatment were statistically significant(P<0.05).During the treatment period and after the end of follow-up,there were no serious adverse reactions in either group.Conclusion Gehu Tiaozhi Decoction can better improve the WC,body weight,BMI,BFP,TG,TC and FBG of MetS patients,and has good safety.