目的 探究参苓白术散联合吡格列酮治疗脾虚湿困型2型糖尿病的治疗效果与安全性。方法 选取2021年12月—2023年12月在武汉市中医医院治疗的脾虚湿困型2型糖尿病患者113例，根据治疗方案的差异将患者分成对照组（56例）和治疗组（57例）。对照组患者早餐前口服盐酸吡格列酮片，30 mg/d，1次/d；治疗组在对照组基础上口服参苓白术散，6 g/次，3次/d。两组患者均进行8周治疗。观察两组患者临床疗效，比较治疗前后两组患者中医证候评分和糖尿病生存质量特异性量表（DSQL）评分，及空腹血糖（FBG）、餐后2 h血糖（2 h PG）和糖化血红蛋白（HbA1c）、生长分化因子-15（GDF-15）、游离脂肪酸（FFA）和趋化素（chemerin）水平。结果 治疗后，对照组和治疗组临床总有效率分别为78.57%和94.74%，两组比较差异具有统计学意义（P＜0.05）。治疗后，两组患者中医证候评分和DSQL评分均显著下降（P＜0.05），且治疗组评分较对照组下降更显著（P＜0.05）。治疗后，两组患者FBG、2 h PG、HbA1c、GDF-15、FFA和chemerin水平均显著降低（P＜0.05），且治疗组这些指标水平较对照组下降更显著（P＜0.05）。结论 参苓白术散联合吡格列酮治疗脾虚湿困型2型糖尿病效果显著，不仅能够改善患者临床证候和生存质量，同时还能够促进血清学指标的恢复。

Objective To explore the therapeutic effect and safety of Shenling Baizhu Powder combined with pioglitazone in treatment of type 2 diabetes with spleen deficiency and dampness stagnation. Methods Patients (113 cases) with type 2 diabetes of spleen deficiency and dampness stagnation in Wuhan Hospital of Traditional Chinese Medicine from December 2021 to December 2023 were divided into control (56 cases) and treatment (57 cases) group based on different treatments. Patients in the control group were po administered with Pioglitazone Hydrochloride Tablets before breakfast, 30 mg/d, once daily. Patients in the treatment group were po administered with Shenling Baizhu Powder on the basis of the control group, 6 g/time, three time daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical evaluations were evaluated, the traditional Chinese medicine syndrome score and DSQL score, the levels of FBG, 2 h PG, HbA1c, GDF-15, FFA and chemerin in two groups before and after treatment were compared. Results After treatment, the total clinical effective rates in the control group and the treatment group were 78.57% and 94.74%, respectively, and the difference between the two groups was statistically significant (P < 0.05). After treatment, the TCM syndrome scores and DSQL scores of patients in two groups were decreased significantly (P < 0.05), and the score in the treatment group decreased more significantly than that in the control group (P < 0.05). After treatment, the levels of FBG, 2 h PG, HbA1c, GDF-15, FFA and chemerin were significantly reduced in two groups (P < 0.05), and the levels of these indicators in the treatment group decreased more significantly than in the control group (P < 0.05). Conclusion Shenling Baizhu Powder combined with pioglitazone produced notably effective results in treating spleen deficiency and dampness accumulation type 2 diabetes mellitus, improving patient symptoms and quality of life while promoting serum marker recovery.

R977

湖北省科学技术厅资助项目(2018CFB707)