目的 探讨参芪降糖颗粒联合脯氨酸恒格列净治疗2型糖尿病的临床疗效。方法 纳入2022年2月—2025年1月福建医科大学附属第二医院收治的120例2型糖尿病患者，按随机数字表法平均分为对照组和治疗组。对照组晨起空腹口服脯氨酸恒格列净片，5 mg/次，1次/d。在此基础上，治疗组温水冲服参芪降糖颗粒，1袋/次，3次/d。两组均治疗12周。对比两组临床疗效，以及治疗前后典型症状（包括咽干口燥、少气懒言、乏力、倦怠等）积分，血糖水平[糖化血红蛋白（HbA1c）、空腹血糖（FPG）、餐后2 h血糖（2 h PG）]，糖尿病痛苦量表（DDS）和糖尿病患者生存质量特异性量表（DSQL）评分，以及血清淀粉样蛋白A（SAA）、脂蛋白相关磷脂酶A2（Lp-PLA2）、可溶性细胞间黏附分子-1（sICAM-1）、可溶性E-选择素（sE-selectin）水平。结果 治疗组总有效率（95.00%）高于对照组（83.33%）（P＜0.05）。治疗后，两组咽干口燥、少气懒言、乏力、倦、气短、腰膝酸软、自汗、形体消瘦等典型症状积分均降低（P＜0.05）；治疗组上述典型症状积分降低更明显（P＜0.05）。治疗后，两组HbA1c、FPG、2 h PG水平均降低（P＜0.05）；治疗组上述血糖水平降低更明显（P＜0.05）。治疗后，两组DDS和DSQL评分都减小（P＜0.05）；治疗组DDS和DSQL评分降低更明显（P＜0.05）。治疗后，两组血清SAA、Lp-PLA2、sICAM-1和sE-selectin水平均降低（P＜0.05）；治疗组上述血清细胞因子水平降低更明显（P＜0.05）。结论 参芪降糖颗粒联合脯氨酸恒格列净治疗2型糖尿病安全有效，可显著改善临床症状，降低血糖水平，通过抑制炎症反应、改善血管内皮功能，有利于控制病情发展。

Objective To investigate the clinical efficacy of Shenqi Jiangtang Granules combined with henagliflozin proline in treatment of type 2 diabetes mellitus. Methods A total of 120 patients with type 2 diabetes mellitus admitted to the Second Affiliated Hospital of Fujian Medical University from February 2022 to January 2025 were enrolled and equally randomized into a control group and a treatment group using a random number table method. The control group received oral Henagliflozin Proline Tablets (5 mg once daily) on an empty stomach in the morning. On this basis, the treatment group additionally received Shenqi Jiangtang Granules dissolved in warm water (one packet three times daily). Both groups were treated for 12 weeks. Clinical efficacy, typical symptom scores (including dry mouth and throat, lack of strength and reluctance to speak, fatigue, lassitude, shortness of breath, soreness and weakness of waist and knees, spontaneous sweating, and emaciation), blood glucose levels [glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 h PG)], diabetes distress scale (DDS) and diabetes specific quality of life scale (DSQL) scores, as well as serum levels of amyloid A (SAA), lipoprotein-associated phospholipase A2 (Lp-PLA2), soluble intercellular adhesion molecule-1 (sICAM-1), and soluble E-selectin (sE-selectin) were compared between the two groups before and after treatment. Results The total effective rate in the treatment group (95.00%) was higher than that in the control group (83.33%) (P < 0.05). After treatment, scores of all the above-mentioned typical symptoms decreased in both groups (P < 0.05). The decreases were more pronounced in the treatment group (P < 0.05). After treatment, levels of HbA1c, FPG, and 2h PG decreased in both groups (P < 0.05); the reductions were greater in the treatment group (P < 0.05). After treatment, DDS and DSQL scores decreased in both groups (P < 0.05). The treatment group showed significantly greater reductions (P < 0.05). After treatment, serum levels of SAA, Lp-PLA2, sICAM-1, and sE-selectin decreased in both groups (P < 0.05); the treatment group had more significant decreases in these serum cytokine levels (P < 0.05). Conclusion Shenqi Jiangtang Granules combined with henagliflozin proline is safe and effective in the treatment of type 2 diabetes mellitus. It significantly improves clinical symptoms and reduces blood glucose levels. By inhibiting inflammatory responses and improving vascular endothelial function, this combination therapy is beneficial for controlling disease progression.

R977

福建省自然科学基金项目(2023J01739)