目的 观察金芪降糖片对使用预混胰岛素2型糖尿病（气虚内热证）患者降糖疗效及血糖波动的影响。方法 采用随机、双盲、安慰剂对照、多中心临床试验设计，选取预混胰岛素治疗的2型糖尿病（气虚内热证）患者60例，随机分成试验组和对照组，试验组在常规治疗基础上给予金芪降糖片（0.56 g/片，每天3次，每次3片，餐前0.5 h口服）治疗，对照组在常规治疗基础上给予金芪降糖片模拟片（每天3次，每次3片，餐前0.5 h口服）治疗。疗程均为12周。比较两组的临床疗效。观察治疗前后两组葡萄糖目标范围内时间（time in range，TIR）、平均血糖波动幅度（mean amplitude of glycemic excursion，MAGE）、糖化血红蛋白（glycosylated hemoglobin，HbA1c）、空腹血糖（fasting blood glucose，FBG）、餐后2 h血糖（2-hour postprandial blood glucose，2hPG）的变化。结果 治疗后，试验组TIR、MAGE明显改善（P<0.05），对照组TIR、MAGE未见明显改善（P>0.05），两组治疗后比较差异有统计学意义（P<0.05）。治疗后，试验组HbA1c明显下降（P<0.05），对照组HbA1c略有下降，但差异不显著（P>0.05），且试验组HbA1c达标率明显高于对照组（P<0.05）。治疗后，两组FBG略低于治疗前，且两组比较差异均无统计学意义（P>0.05）。治疗后，试验组2hPG明显降低（P<0.01），对照组2hPG略有降低，但差异无统计学意义（P>0.05），且试验组明显低于对照组（P<0.05）。治疗后，试验组中医证候改善总有效率（40.0%）明显高于对照组（6.7%），且差异有统计学意义（P<0.05）。两组不良反应发生率差异无统计学意义（P>0.05）。结论 金芪降糖片可进一步降低使用预混胰岛素的2型糖尿病（气虚内热证）患者的血糖，并减少其血糖波动，达到良好的血糖控制目标，改善患者的临床症状，值得临床推广使用。

Objective To observe the effect of Jinqi Jiangtang Tablets (金芪降糖片) on glucose-lowering efficacy and blood glucose fluctuation in patients with type 2 diabetes mellitus (qi deficiency and internal heat) treated with premixed insulin. Methods Using a randomized, double-blind, placebo-controlled, multicenter clinical trial design, 60 patients with type 2 diabetes mellitus (qi deficiency and internal heat) treated with premixed insulin were randomly divided into the experimental group and the control group, and the experimental group was treated with Jinqi Jiangtang Tablets (0.56 g/tablet, three tablets three times daily, taken orally half an hour before meal) on the basis of conventional treatment, while the control group was treated with Jinqi Jiangtang Tablets Mock (0.56 g/tablet, three times a day, taken orally half an hour before meal) the basis of conventional treatment, and the duration of treatment was 12 weeks. The changes of glucose time in range (TIR), mean amplitude of glycemic excursion (MAGE), glycated hemoglobin (HbA1c), fasting blood glucose (FBG), 2 h postprandial blood glucose (2hPG) were observed before and after treatment. Results After treatment, the TIR and MAGE of the test group increased significantly, and the difference was statistically significant compared with the control group (P < 0.05); There was no significant improvement in TIR and MAGE in the control group (P > 0.05), and the difference between the two groups after treatment was statistically significant (P < 0.05). After treatment, the HbA1c of the test group decreased significantly (P < 0.05) and decreased slightly in control group without significant difference (P > 0.05), and the HbA1c compliance rate was higher than that of the control group (P < 0.05). After treatment, the FBG of the two group was lower than that before treatment, but the difference was not statistically significant (P > 0.05). After treatment, the 2hPG decreased significantly in the experimental group (P < 0.01) and decreased slightly in control group without significant difference (P > 0.05), and the experimental group was significantly lower than the control group (P < 0.05). After treatment, the total effective rate of traditional Chinese medicine syndromes experimental group (40.0%) was significantly higher than that of control group (6.7%), and the difference was statistically significant (P < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion Jinqi Jiangtang Tablets can further reduce blood glucose in patients with type 2 diabetes mellitus (qi deficiency and internal heat) using premixed insulin, and reduce their blood glucose fluctuations, achieve good blood glucose control goals and improve patients' clinical symptoms, which is worthy of clinical promotion.

R285.64

上海市临床重点专科项目（shslczdzk05401）；上海市中医临床重点实验室项目（20DZ2272200）；长三角中医内分泌代谢病专科联盟项目（ZY（2021-2023）-0302）；四明青年基金（SGKJ-202108）