目的 评价茯苓泽泻汤联合生活方式干预对湿证代谢综合征（MetS）人群的临床疗效。方法 采用随机双盲对照设计，将40例湿证MetS患者按1∶1随机分为试验组及对照组，每组20例。试验组予茯苓泽泻汤口服，对照组予安慰剂口服，每次 150 mL，1日2次；两组均同时配合健康生活方式宣教（健康饮食模式及运动方式），干预周期为16周。分别于治疗前后评价中医湿证量表评分，以及MetS诊断相关指标：腰围（WC）、收缩压（SBP）、舒张压（DBP）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）、空腹血糖（FBG）；其他代谢指标：身体质量指数（BMI）、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、胰岛素抵抗指数（HOMA-IR）、尿酸（UA） ；炎症相关指标：C-反应蛋白（CRP）、肿瘤坏死因子α（TNF-α）、白细胞介素6（IL-6）。结果 共有33例完成试验，其中试验组17例，对照组16例。与基线期比较，试验组的FBG、BMI、LDL-C水平及湿证量表评分在干预第8、16周时均明显下降 （P＜0.05），WC 水平在干预第8周时明显下降（P＜0.05），CRP 水平在干预第16周时明显下降（P＜0.05）；而对照组的SBP、IL-6水平在干预第8、16周时明显下降（P＜0.05），WC、DBP、HOMA-IR水平在干预第8周时明显下降（P＜0.05）。但两组组间所有结局指标在干预第8、16周时的差异无统计学意义（P＞0.05）。试验过程未发生严重不良事件。结论 初步表明茯苓泽泻汤联合生活方式干预对湿证 MetS 人群代谢及炎症相关指标具有积极调控作用，有助于改善湿证水平，可为下一步研究提供依据。

Objective To explore the clinical efficacy of Fuling Zexie Decoction combined with lifestyle intervention in patients with metabolic syndrome （MetS） of dampness syndrome. Methods A total of 40 patients with MetS of dampness syndrome were randomly divided into experimental group （n=20） and control group （n=20） according to a randomized double-blind placebo-controlled design. The experimental group was given oral administration of Fuling Zexie Decoction，the control group was given placebo，150 mL each time，twice a day. Both groups were given healthy lifestyle（healthy eating habits and exercise mode） education. The intervention period was 16 weeks. Traditional Chinese medicine dampness syndrome scale score and the diagnostic indexes of MetS，including waist circumference （WC），systolic blood pressure （SBP），diastolic blood pressure （DBP），triglyceride （TG），high density lipoprotein cholesterol （HDL-C） and fasting blood glucose （FBG）， were evaluated before and after treatment. Other metabolic indexes such as body mass index（BMI），total cholesterol（TC），low density lipoprotein cholesterol（LDL-C），homeostasis model assessment of insulin resistance（HOMA-IR），uric acid（UC），as well as inflammation related indexes including C-reactive protein （CRP），interleukin-6 （IL-6） and tumor necrosis factor（TNF-α） were also evaluated. Results A total of 33 people completed the trial，including 17 people in the experimental group and 16 people in the control group. Compared to the baseline period，FBG，BMI，LDL-C and dampness syndrome scale score in the experimental group were significantly decreased at the 8th and 16th week of intervention（P＜0.05）. WC was significantly decreased at the 8th week of intervention （P＜0.05）. CRP showed a downward trend at the 16th week of intervention（P＜0.05）. Moreover，SBP and IL-6 in control group decreased significantly at the 8th and 16th week of intervention 0.05 . WC DBP and HOMA-IR decreased significantly at the 8th week of intervention （P＜0.05）. There was no significant difference in other outcome indexes between the two groups at the 8th and 16th week of intervention （P＞0.05）. The safety indexes of all patients before and after intervention were not significantly abnormal，and no serious adverse events occurred. Conclusion This study initially shows the positive regulatory effect of Fuling Zexie Decoction combined with lifestyle on metabolism and inflammation-related indexes in people with MetS of dampness syndrome，which helps to improve the level of dampness syndrome and provides a basis for further research.

R285.6；R259

省部共建中医湿证国家重点实验室课题 （SZ2020ZZ10，SZ2020ZZ11，SZ2021ZZ3201，SZ2021ZZ3202）；广东省中医药管理局项目（201507003）；广州市基础研究计划项目 （2060206）。