三黄清幽汤治疗2型糖尿病(脾虚胃热证)合并口疮临床疗效及安全性观察

Clinical Efficacy and Safety of Sanhuang Qingyou Decoction in the Treatment of Type 2 DM with Oral Ulcers(Syndrome of Spleen Deficiency and Stomach Heat)

目的:观察三黄清幽汤治疗2型糖尿病(脾虚胃热证)合并口疮临床疗效及安全性。方法:研究合计纳入135例脾虚胃热证2型糖尿病合并口疮患者,均由北京中医医院顺义医院2017年1月—2019年12月收治,采取随机数字表法将其分为两组,对照组患者(67例)常规治疗,观察组患者(68例)在对照组治疗基础上联合三黄清幽汤治疗,比较两组患者临床疗效、治疗前后患者中医症状(口干口渴、倦怠乏力、心下痞满、胀闷呕恶、食后饱满、口疮等)积分变化、治疗前后患者糖代谢因子水平变化、血脂水平变化、口疮愈合时间、不良反应。结果:观察组患者治疗总有效率(98.53%,67/68)高于对照组(89.55%,60/67),有统计学意义(P<0.05);治疗前,两组患者口干口渴、倦怠乏力、心下痞满、胀闷呕恶、食后饱满、口疮等中医症状积分、空腹血糖(FPG)及糖化血白蛋白(GA)、空腹胰岛素(FINS)、糖化血红蛋白(HbAlc)水平、低密度脂蛋白(LDL-C)及总胆固醇(TC)水平比较,差异无统计学意义(P>0.05);治疗后各组患者口干口渴、倦怠乏力、心下痞满、胀闷呕恶、食后饱满、口疮等中医症状积分、FPG、GA、FINS、LDL-C水平均改善,观察组患者治疗后口干口渴、倦怠乏力、心下痞满、胀闷呕恶、食后饱满、口疮等中医症状积分、FPG、GA、FINS、LDL-C水平均优于对照组(P<0.05),治疗后两组患者HbAlc及TC水平均无明显改变(P>0.05);观察组患者口疮愈合时间短于对照组,有统计学意义(P<0.05);两组均未见严重不良反应,对照组出现1例腹泻(P>0.05)。结论:三黄清幽汤治疗脾虚胃热证2型糖尿病合并口疮临床疗效显著,患者症状改善,血糖水平恢复良好,患者血脂水平一定程度改善,无不良反应,安全可靠,值得应用。

Objective:To explore the clinical efficacy and safety of Sanhuang Qingyou Decoction in the treatment of type 2 diabetes mellitus(DM)with oral ulcers(DM)of syndrome of Spleen deficiency and Stomach heat.Methods:135 cases of type 2 DM with oral ulcers met the inclusion criteria were randomly divided into the control group(n=67)and the observation group(n=68).The control group was treated with conventional medication;on which basis,the observation group was also treated with Sanhuang Qingyou Decoction.The clinical curative effect,the scores of TCM symptoms(dry mouth,thirst,fatigue,epigastric fullness sensation,bloating and nausea,oral ulcers),the levels of sugar metabolic factors and blood lipid,the healing time of oral ulcer and the adverse reactions were observed and compared between the two groups.Results:The total effective rate of the observation group was 98.53%(67/68),which was significantly higher than 89.55%(60/67)of the control group(P<0.05).There were no statistical differences in the scores of TCM symptoms,fasting plasma glucose(FPG),glycated albumin(GA),fasting insulin(FINS),glycosylated hemoglobin(HbAlc),low density lipoprotein cholesterol(LDL-C)and total cholesterol(TC)between the two groups before the treatment(P>0.05).The scores of TCM symptoms and the levels of FPG,GA,FINS and LDL-C were all significantly improved after the treatment in the two groups(P<0.05),of which the improvements in the observation group were more significant(P<0.05).There were no statistical differences in the levels of HbAlc and TC between before and after the treatment in the two groups(P>0.05).The healing time of oral ulcers was shorter in the observation group than that in the control group(P<0.05).No serious adverse reactions were observed in the two groups,only one case of diarrhea occurred in the control group and there was no statistical difference between the two groups(P>0.05).Conclusion:Sanhuang Qingyou Decoction has a significant clinical effect on the treatment of type 2 DM with oral ulcers of Spleen deficiency and Stomach heat.The therapy can significantly improve the clinical symptoms and the levels of blood glucose and blood lipid of the patients with no adverse reactions,which is safe and reliable and is worthy of clinical application.