复方石斛消渴颗粒联合二甲双胍西格列汀治疗气阴两虚型2型糖尿病回顾性临床分析

目的:回顾性分析院内制剂复方石斛消渴颗粒联合二甲双胍西格列汀治疗气阴两虚型2型糖尿病(T2DM)的临床效果。方法:收集2020年11月至2024年4月于福建中医药大学附属第二人民医院治疗,诊断为气阴两虚证,T2DM的患者80例,对照组和观察组各40例,对照组给予二甲双胍西格列汀,观察组给予复方石斛消渴颗粒联合二甲双胍西格列汀联合治疗,比较两组患者治疗30 d后中医证候、空腹血糖水平(FBG)指标的改善情况;部分患者佩戴血糖监测传感器连续动态监测血糖,记录24 h葡萄糖目标范围内时间、葡萄糖高于目标范围时间、葡萄糖低于目标范围内时间和平均血糖,比较治疗前和治疗三个月两组上述指标的差异。结果:治疗后,观察组患者各项中医证候积分均低于对照组,差异具有统计学意义(P Objective: To retrospectively analyze the clinical effect of compound Dendrobium thirst elimination granules combined with metformin and sitagliptin composite preparation in the treatment of type 2 diabetes mellitus (T2DM) patients with Qi Yin Deficiency. Methods: Treatment at the Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine from November 2020 to April 2024, The diagnosis of qi and Yin two deficiency syndrome, In 80 patients with T2DM, 40 cases each in the control and observation group. The control group was given metformin sitagliptin, the observation group received a combination of compound Dendrobium dequenching granules with metformin sitagliptin. Compare the improvement of TCM syndrome and fasting blood glucose level (FBG) after 30 d of treatment;some patients wear blood glucose monitoring sensors to continuously and dynamically monitor blood glucose, record time in 24 h glucose target range, glucose above target range time, glucose below target range time and mean blood glucose, compare the above indicators before and three months of treatment. Results: After treatment, the TCM syndrome scores of the patients in the observation group were lower than those of the control group, and the difference was statistically significant (P < 0.05);FBG was lower in the observation group, the difference was statistically significant (P < 0.05);the baseline was consistent of two samples before the treatment, After three months of treatment, patients in the observation group had greater glucose reduction and no lower glucose values than the target range, and the glucose volatility was less and more stable. Conclusion: T2DM patients treated with compound Dendrobium granules and metformin sitagliptin could hypoglycemic action and regulate the imbalance of body between Yin and Yang to improve the TCM syndrome.

复方石斛消渴颗粒特征图谱及2个成分定量方法的建立

目的 建立复方石斛消渴颗粒特征图谱并测定其主要成分葛根素、丹酚酸B的含量。方法 采用HPLC法,资生堂C_(18)反相色谱柱(250 mm×4.6 mm, 5μm),流动相乙腈(A)-0.1%磷酸溶液(B),梯度洗脱,二极管阵列检测器检测,检测波长分别为250 nm、286 nm,流速1.0 mL·min^(-1),柱温35℃。结果 特征图谱试验中,通过与对照药材色谱图的对比,10批供试品色谱图中有7个共有峰。以葛根素为参比峰,测定方法的精密度、重复性、稳定性试验中的各共有峰的相对保留时间的RSD均小于1%,相对峰面积的RSD均小于2%;含量测定方法中,葛根素、丹酚酸B分别在21.83~218.28μg·mL^(-1)、20.36~203.56μg·mL^(-1)内线性关系良好,平均加样回收率分别为98.4%、97.8%,RSD分别为1.23%、1.02%。结论 该方法稳定可靠,可用做复方石斛消渴颗粒的质量控制。