1、中国中医急症 2023年2月第32卷第2期JETCM.Feb.2023，Vol.32，No.2保元汤联合达格列净治疗2型糖尿病合并急性亚急性心衰临床观察谢益朱春磊陈曦徐珑嫣（江苏省海安市中医院，江苏 海安 226602）中图分类号：R587.1文献标志码：B文章编号：1004-745X（2023）02-0278-05doi：10.3969/j.issn.1004-745X.2023.02.023【摘要】目的 观察保元汤联合达格列净对2型糖尿病合并急性亚急性心衰患者的临床疗效。方法 将80例2型糖尿病合并急性心衰患者随机分为观察组与对照组各40例。对照组予常规治疗，观察组在对照组基础上口服达格列
2、净联合保元汤，对比两组临床疗效。比较两种临床疗效；观察两组治疗前后中医证候积分、空腹血糖（FBG）、餐后2h血糖（2hPBG）及糖化血红蛋白（HbA1c）的变化；观察两组患者治疗前、治疗后第3天、第7天心功能分级；观察两组治疗前后6 min步行试验（6WMT）及NT-proBNP的变化。结果 两组患者中医证候积分较治疗前显著降低（P0.05），两组比较，观察组显著低于对照组（P0.05）；两组FBG、2hPBG及HbA1c均较治疗前显著下降（P0.05），观察组治疗后FBG、2hPBG及HbA1c显著低于对照组（P0.05）；两组6WMT均较治疗前显著上升（P0.05），而NT-proBNP均
3、较治疗前显著下降（P0.05），两组比较，观察组6WMT显著高于对照组（P0.05），NT-proBNP显著低于对照组（P0.05）。观察组心功能分级为级及级总人数显著多于治疗前（P 0.05），也显著多于对照组（P 0.05）。观察组总有效率为 90.00%，显著高于对照组的 72.50%（P 0.05）。结论 保元汤联合达格列净能显著改善2型糖尿病合并急性亚急性心衰患者临床症状，有效控制血糖，改善患者心脏功能及活动耐量，提高临床疗效。【关键词】2型糖尿病心力衰竭保元汤达格列净中西医结合Clinical Efficacy Observation on Baoyuan Decoction Co
4、mbined with Dapagliflozin on Patients with Type2 Diabetes Mellitus Complicated with Chronic Heart FailureXie Yi，Zhu Chunlei，Chen Xi，Xu Longyan.Haian Hospital of Traditional Chinese Medicine，Jiangsu，Haian 226602，China.【Abstract】Objective：To observe the clinical efficacy of Baoyuan Decoction combined
5、with dapagliflozin on patients with type 2 diabetes complicated with chronic heart failure.Methods：A total of 80 patients with type 2 diabetes mellitus complicated with heart failure were randomly divided into the observation group and control group，40 patients in each group.The control group was gi
6、ven routine treatment，and the observation group took dapagliflozin and Baoyuan Decoction orally on the basis of the control group.The efficacies of the two groups were compared.The change of TCM syndrome scores before and after treatment was observed.The changes of fasting bloodglucose（FBG），2 h post
7、prandial blood glucose（2h PBG）and glycated hemoglobin（HbA1c）before and after treatment were observed.The two groups were observed and compared with the grades of cardiac function before treatment，3rd day after treatment，and day 7 after treatment.The changes of 6 min walk test and NT-proBNP beforeand
8、 after treatment were observed.Results：Compared with before treatment，the scores of TCM syndrome weresignificantly lower after treatment（P0.05）；compared between groups，the observation group was significantly lower than that of the control group（P 0.05）.The level of FBG，2hPBG and HbA1c were significa
9、ntly lower thanthose before treatment（P 0.05）；FBG，2hPBG and HbA1c in the observation group were significantly lower thanthose in the control group（P 0.05）.Compared with the pre-treatment period，6WMT increased significantly inthe two groups（P 0.05），while the NT-proBNP decreased significantly（P 0.05）；
10、compared between groups，the6WMT in the observation group was significantly higher than that of the control group（P0.05），and the NT-proBNP was significantly lower than that of the control group（P0.05）.The total number of cardiac function grades ofgrade and in the observation group was significantly h
11、igher than that before treatment（P0.05）and significantly higher than that of the control group（P 0.05）.The total effective rate of the observation group was90.00%，which was significantly higher than 72.50%of the control group（P0.05）。本研究已获医院伦理委员会批准，患者了解治疗方案并签署同意书。1.3治疗方法所有患者给予合理休息及低糖低钠饮食，使用盐酸二甲双胍（格华止
12、，中美上海施贵宝，国药准字H20023370，0.5 g，每日3次）控制血糖，并使用ACEI/ARB、受体阻滞剂、利尿剂、洋地黄类药物等常规抗心力衰竭治疗。观察组在常规治疗基础上联用保元汤和达格列净。保元汤组方：人参15 g，黄芪20 g，甘草6 g，肉桂5 g，独活10 g，威灵仙10 g，五加皮10 g，防己15 g，牛膝10 g。随症加减：瘀血症状严重者加三七；心悸、自汗症状重者加龙骨、牡蛎；咳喘、咯痰症状重者加葶苈子、法半夏；尿少下肢水肿无明显改善者加茯苓、泽泻、车前子。上方由本院中药制剂室煎制，加水煎至200 mL，分2袋各100 mL包装，每次1袋，每日2次，早晚分服。达格列净（安
13、达唐，阿斯利康生产，10 mg，国药准字J20170640）10 mg，每日1次。两组均连续治疗2周。1.4观察指标观察两组治疗前后采集两组患者空腹及早餐后 2 h 静脉血，观察空腹血糖（FBG）、餐后2h血糖（2hPBG）及HbA1c的变化。观察比较两组患者治疗前，治疗后第3天、第7天心功能分级（参照美国纽约心脏病学会心功能分级标准执行）。观察两组治疗前后6 min步行试验测定（6WMT）及NT-proBNP的变化。中医证候评分参照文献 6，包括气短、喘息、乏力、心悸、水肿、潴留等主症，倦怠懒言、自汗、语声低微、面色/口唇紫暗等次症，结合舌苔脉象，症状由轻到重分别记0分、2分、4分、6分。1
14、.5疗效标准8显效：心衰明显控制或心功能提高2级以上。有效：心衰有所缓解，心功能提高1级。无效：心衰未缓解，心功能提高不足1级，甚至恶化。1.6统计学处理应用SPSS22.0统计软件。计量资料以（xs）表示，用t检验，计数资料以n、%表示，用2检验。P0.05为差异有统计学意义。2结果2.1两组治疗前后中医证候积分比较见表1。经治tients with acute subacute heart failure，effectively control blood glucose，improve the patient s heart function andactivity tolerance，
15、and improve the clinical efficacy.【Key words】Type 2 diabetes mellitus；Chronic heart failure；Baoyuan Decoction；Dapagliflozin；Integration ofTCM and western medicine-279中国中医急症 2023年2月第32卷第2期JETCM.Feb.2023，Vol.32，No.2疗，两组患者中医证候积分较治疗前降低（P 0.05）；两组比较，观察组低于对照组（P0.05）。2.2两组治疗前后 FBG、2hPBG 及 HbA1c 水平比较见表2。治疗后
16、，两组FBG、2hPBG及HbA1c水平均较治疗前下降（P 0.05）；观察组治疗后FBG、2hPBG及HbA1c水平低于对照组（P0.05）。2.3两组治疗前后6WMT与NT-proBNP水平比较见表3。治疗后，两组6WMT较治疗前上升（P0.05），而NT-proBNP较治疗前下降（P 0.05）；两组比较，观察组6WMT高于对照组（P0.05），NT-proBNP低于对照组（P0.05）。2.4两组治疗前后心功能分级比较见表4。治疗后，观察组心功能分级为级及级总人数多于治疗前（P0.05），且多于对照组（P0.05）。2.5两组临床疗效比较见表5。观察组总有效率高于对照组（P0.05）。3讨论T2DM可显著增加心血管死亡、心肌梗死、脑卒中及心力衰竭发病风险，T2DM合并心力衰竭患病率呈现逐年上升趋势，心力衰竭在糖尿病心血管并发症中位居第二，且预后更差，已发展成为T2DM第一大死因，发展为日益严重的公共健康问题。糖尿病合并急性心衰的发病机制复杂，是多个因素综合作用的结果。研究发现，胰岛素抵抗可能是糖尿病与心衰的共同致病因素，T2DM患者多伴有胰岛素抵抗，当合并心衰时，IR可降低心肌
