贞术调脂胶囊联合西医常规疗法治疗老年2型糖尿病患者35例实效性真实世界研究

Zhenzhu Tiaozhi Capsule(贞术调脂胶囊)Combined with Conventional Western Medicine in the Treatment of35Elderly Patients with Type 2 Diabetes:A Real-world Pragmatic Study

目的观察贞术调脂胶囊联合西医常规疗法治疗老年2型糖尿病的有效性和安全性。方法基于真实世界采用实效性对照试验的设计方法,选择65例已确诊的老年2型糖尿病患者,根据患者意愿分为西医常规治疗组35例与贞术调脂胶囊组30例。西医常规治疗组根据诊疗指南给予饮食和运动指导、口服降糖药治疗,贞术调脂胶囊组在西医常规治疗的基础上加服贞术调脂胶囊,每次4粒(0.63 g/粒),每日3次。两组均连续治疗12周。治疗前后检测两组患者空腹静脉血浆葡萄糖(FBG)、糖化血红蛋白(HbA1c)水平,并判定FBG和HbA1c的达标情况;进行焦虑自评量表(SAS)、抑郁自评量表(SDS)、健康自评简表(SF-36)和糖脂代谢病中医证候量表评分。治疗期间记录低血糖事件及不良事件发生情况。结果贞术调脂胶囊组平均年龄大于西医常规治疗组,治疗前使用西药降糖药物种类少于西医常规治疗组(P<0.05)。两组治疗后FBG和HbA1c水平、FBG和HbA1c的达标情况与本组治疗前比较差异均无统计学意义(P>0.05);治疗后贞术调脂胶囊组FBG水平低于西医常规治疗组,FBG达标情况优于西医常规治疗组(P<0.05)。采用Logistic回归调整变量,结果显示,贞术调脂胶囊组的FBG达标率是西医常规治疗组的3.8倍[95%CI(1.0,14.2),P=0.046]。贞术调脂胶囊组治疗期间发生低血糖事件3例(8.6%),低于西医常规治疗组的9例(30.0%,P=0.026)。治疗后贞术调脂胶囊组患者SAS评分、SDS评分、SF-36评分和糖脂代谢病中医证候量表评分与本组治疗前比较差异有统计学意义(P<0.05);治疗后与西医常规治疗组比较,贞术调脂胶囊组患者SF-36评分和糖脂代谢病中医证候量表评分差异有统计学意义(P<0.05)。两组治疗期间均未发生不良事件。结论贞术调脂胶囊联合西医常规治疗在降低血糖、减少低血糖事件、改善抑郁及临床症状、提高整体健康状态方面优于单纯西医常规治疗,可获得多重获益,且安全性好。

Objective To explore the effectiveness and safety of Zhenzhu Tiaozhi Capsule(贞术调脂胶囊,ZTC)combined with conventional western medicine for elderly patients with type 2 diabetes(T2 D).Methods design of real-world pragmatic controlled trial design,65 elderly T2 D patients were divided into conventional western medicine(WM)group(35 cases)and ZTC group(30 cases)according to patients’willingness.The WM group was given diet and exercise guidance and oral hypoglycemic medications according to the guideline,while the ZTC group was additionally given ZTC,4 capsules each time(0.63 g each capsule),three times daily;the treatments in both groups lasted for 12 weeks.The levels of fasting blood glucose(FBG)and glycosylated hemoglobin(HbA1 c)were tested before and after treatment,and whether they were up to standards were assessed.The Zung self-rating anxiety scale(SAS),the Zung self-rating depression scale(SDS),the 36-item short form health survey(SF-36)and the traditional Chinese medicine(TCM)syndrome scale of glycolipid metabolism disease were assessed.The hypoglycemic events and adverse events were recorded during the treatment.ResultsThe mean age of the ZTC group was higher,and the use of hypoglycemic medications before treatment were less than that of the WM group(P<0.05).The levels of FBG and HbA1 c and the rates of these levels up to standards after treatment were not significantly different with those before treatment in both groups(P>0.05).The FBG level was lower,and the rate of the FBG level up to standard was higher in ZTC group than that in WM group after treatment(P<0.05).After adjusted with Logistic regression,the rate of the FBG level up to standard of ZTC group was 3.8 times that of WM group with 95%confidence interval(CI)1.0-14.2,P=0.046.There were 3(8.6%)cases of hypoglycemia in the ZTC group during treatment,which was lower than the 9 cases(30.0%)in the WM group(P=0.026).After treatment,the SAS score,SDS score,SF-36 score and the TCM syndrome scale score were significantly different with those before treatment in both groups(P<0.05);the SF-36 score and the TCM syndrome scale score of the ZTC group were significantly different with those of the WM group(P<0.05).There were no adverse events during treatment in both groups.Conclusion ZTC combined with conventional WM is superior to WM alone in lowering blood sugar,reducing hypoglycemia,improving depression and clinical symptoms,and increasing overall health condition,with multiple benefits and sound safety.