藿朴夏苓汤治疗超重/肥胖合并新诊断2型糖尿病（脾虚湿阻证）临床随机对照试验

Huo Po Xia Ling Decoction in the treatment of overweight/obesity with newly diagnosed type 2 diabetes mellitus（spleen deficiency and dampness obstruction syndrome）：randomized controlled trial

关键词:  藿朴夏苓汤  二甲双胍  超质量/肥胖  新诊断2型糖尿病  脾虚湿阻证

Key words:  Huo Pu Xia Ling Decoction  metformin  overweight/obese  newly diagnosed type 2 diabetes  syndrome of spleen deficiency and dampness obstruction

摘要:

[目的] 观察藿朴夏苓汤对超质量/肥胖合并新诊断2型糖尿病（脾虚湿阻证）患者胰岛功能及糖脂代谢的影响及安全性。[方法] 将超质量/肥胖合并新诊断2型糖尿病（脾虚湿阻证）患者依照随机数字表法分为对照组（盐酸二甲双胍组）和治疗组（藿朴夏苓汤联合盐酸二甲双胍组），比例为1∶1，疗程为12周。对比治疗前后两组胰岛素抵抗、血糖血脂、身体质量指数（BMI）及腰围、中医症状积分及安全性事件等指标变化，统计两组糖化血红蛋白（HbA1c）达标率差异。[结果] 2021年1月—2023年6月，初步纳入患者104例，脱落4例，最终参与并完成研究患者100例。治疗后，两组患者空腹血糖（FPG）、餐后2 h血糖（2 hPG）、HbA1c、胰岛素抵抗指数（HOMA-IR）、BMI、腰围、三酰甘油（TG）、胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、较治疗前均降低（P<0.05），高密度脂蛋白胆固醇（HDL-C）、空腹胰岛素（FINS）、空腹C-肽（FC-P）较治疗前升高（P<0.05），治疗组各指标疗效优于对照组（P<0.05）；治疗组HbA1c达标率为64.0%，优于对照组的44.0%（P<0.05）；治疗组中医证候积分更低，差异具有统计学意义（P<0.05）。[结论] 对于超质量/肥胖合并新诊断2型糖尿病（脾虚湿阻证）患者，藿朴夏苓汤可有效降低胰岛素抵抗，改善糖脂代谢，减轻体质量、提高HBA1c缓解率，缓解临床症状，且未出现不良事件，安全性较高。

Abstract:

[Objective] To observe the effects and safety of Huo Pu Xia Ling Decoction on islet function and glucose-lipid metabolism in overweight/obese patients with Newly Diagnosed Type 2 Diabetes（spleen deficiency and dampness obstruction syndrome）. [Methods] Overweight/obese patients with Newly Diagnosed Type 2 Diabetes（spleen deficiency and dampness obstruction syndrome） were randomly assigned to either the control group（metformin hydrochloride group） or the treatment group（Huo Pu Xia Ling Decoction combined with metformin hydrochloride group） in a 1∶1 ratio. The treatment duration was 12 weeks. Compare changes in insulin resistance，blood glucose and lipid levels，body mass index（BMI），waist circumference，traditional Chinese medicine（TCM） symptom scores，and safety events between the two groups before and after treatment. Calculate the differences in the rate of glycated hemoglobin（HbA1c） target achievement between the two groups. [Results] Between January 2021 and June 2023， a preliminary total of 104 patients were enrolled in the study，with 4 dropouts，resulting in 100 patients who completed the study. After treatment，both groups showed reductions in fasting blood glucose（FPG），2-hour postprandial glucose（2 hPG），glycated hemoglobin（HbA1c），insulin resistance index（HOMA-IR），body mass index（BMI），waist circumference，triglycerides（TG），cholesterol（TC），and low-density lipoprotein cholesterol（LDL-C） compared to pre-treatment levels（P<0.05）. High-density lipoprotein cholesterol（HDL-C），Fasting insulin（FINS） and fasting C-peptide（FC-P） levels increased compared to pre-treatment levels（P<0.05）. The treatment group showed better efficacy in all indicators compared to the control group（P<0.05）；the treatment group had an achievement rate of 64.0%，which was superior to the control group’s 44.0%（P<0.05）. It was found that the treatment group that received Huo Pu Xia Ling Decoction had lower TCM symptom scores post-treatment，with a statistically significant difference（P<0.05）. [Conclusion] In overweight/obese patients with Newly Diagnosed Type 2 Diabetes（spleen deficiency and dampness obstruction syndrome），Huo Pu Xia Ling Decoction effectively reduces insulin resistance，improves glucose and lipid metabolism，reduces body weight，increases the rate of achieving HbA1c targets，and alleviates clinical symptoms without any adverse events，It has a high safety profile.