西格列汀联合二甲双胍治疗2.谢、肝功能、脂肪因子的影响_丁红霞.pdf

目的观察西格列汀联合二甲双胍治疗2型糖尿病(T2DM)合并非酒精性脂肪肝(NAFLD)患者的疗效，并探讨其对患者糖脂代谢、肝功能、脂肪因子的影响。方法选取2020年5月至2022年6月平顶山市第一人民医院收治的116例T2DM合并NAFLD患者作为研究对象，按随机数表法分为二甲双胍组和西格列汀联合组各58例。二甲双胍组患者予以二甲双胍治疗，西格列汀联合组患者在二甲双胍组治疗的基础上联合西格列汀治疗。治疗6个月后，比较两组患者的临床效果，以及治疗前后的糖脂代谢相关指标空腹血糖(FPG)、糖化血红蛋白(HbA1c)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)、肝功能相关指标谷氨酰基转移酶(GGT)、天冬氨酸转氨酶(AST)、丙氨酸氨基转移酶(ALT)水平、脂肪因子血清趋化素(chemerin)、摄食抑制因子-1(nesfatin-1)水平、体质量指数(BMI)、肝脏脂肪含量、CT肝脾密度比值、非酒精性脂肪性肝纤维化评分(NAFLDFS)，并比较两组患者治疗期间的不良反应发生情况。结果治疗6个月后，西格列汀联合组患者的治疗总有效率为77.59%，明显高于二甲双胍组的60.34%，差异有统计学意义(P0.05)；治疗6个月后，西格列汀联合组患者的HbA1c、FPG、LDL-C水平、血清GGT、AST、ALT、chemerin、nesfatin-1水平、BMI、肝脏脂肪含量、NAFLDFS评分分别为(6.690.64)%、(6.870.76)mmol/L、(2.490.30)mmol/L、(41.782.71)U/L、(34.092.38)U/L、(35.752.09)U/L、(72.4910.73)ng/mL、(5.701.85)ng/mL、(25.370.95)kg/m2、(8.271.28)%、(0.320.06)分，明显低于二甲双胍组的(7.240.78)%、(7.460.82)mmol/L、(2.840.41)mmol/L、(46.473.35)U/L、(38.123.26)U/L、(39.522.63)U/L、(80.5112.09)ng/mL、(6.622.09)ng/mL、(26.181.02)kg/m2、(9.411.56)%、(0.470.08)分，HDL-C水平、CT肝脾密度比值分别为(1.920.68)mmol/L、0.930.08，明显高于二甲双胍组的(1.570.59)mmol/L、0.810.12，差异均有统计学意义(P0.05)。结论西格列汀联合二甲双胍治疗T2DM合并NAFLD患者临床疗效较好，可有效改善糖脂代谢和肝功能指标，降低BMI、肝脏脂肪含量、脂肪肝与肝纤维化程度，并下调血清chemerin、nesfatin-1水平，具有较高的安全性。【关键词】2型糖尿病；非酒精性脂肪肝；西格列汀；二甲双胍；疗效；糖脂代谢；肝功能；脂肪因子【中图分类号】R587.1【文献标识码】A【文章编号】10036350（2023）13184606Efficacy of sitagliptin combined with metformin in the treatment of type 2 diabetes mellitus patients withnonalcoholic fatty liver disease and its effect on glucose and lipid metabolism,liver function,and adipokines.DING Hong-xia1,TIAN Yong1,YU Yuan-yuan1,CUI Xiao-lei1,LI Jin1,WANG Jun-hong1,XIE He-nan2.1.Departmentof Endocrinology,Pingdingshan First Peoples Hospital,Pingdingshan 467000,Henan,CHINA;2.Department of Geriatrics,Henan Provincial Peoples Hospital,Zhengzhou 450000,Henan,CHINA【Abstract】ObjectiveTo observe the efficacy of sitagliptin combined with metformin in treatment of type 2 di-abetes mellitus(T2DM)patients with nonalcoholic fatty liver disease(NAFLD),and to explore its effects on glucose andlipid metabolism,liver function,and adipokines.MethodsA total of 116 patients with T2DM and NAFLD admitted toPingdingshan First Peoples Hospital from May 2020 to June 2022 were collected as research objects and randomly di-vided into metformin group and sitagliptin combined with metformin group by random number table,with 58 patients ineach group.The metformin group was treated with metformin,while the sitagliptin combined with metformin group wastreated with sitagliptin on the basis of the metformin group.After 6 months of treatment,the clinical effects,glucose andlipid metabolism indicators glycosylated hemoglobin A1c(HbA1c),fasting plasma glucose(FPG),low density lipopro-tein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),and liver function indicators-glutamyltrans-ferase(GGT),aspartate aminotransferase(AST),alanine aminotransferase(ALT),adipose factors serum levels of chemo-kine,dietary inhibitor-1(nesfatin-1),body mass index(BMI),liver fat content,CT liver spleen density ratio,and nonalco-holic fatty liver fibrosis score(NAFLDFS)before and after treatment were compared between the two groups.The inci-dence of adverse reactions was compared between the two groups during the treatment.ResultsAfter 6 months of treat-ment,the total effective rate in the sitagliptin combined with metformin group was 77.59%,which was significantly higherthan 60.34%in the metformin group(P3 个月但血糖控制仍不理想，HbA1c水平7.5%，空腹血糖(FPG)水平7.0 mmol/L；(3)经超声检查提示脂肪肝；(4)近期未应用他汀类、糖皮质激素等影响脂质代谢、炎症指标水平药物；(5)同意本研究采用的药物治疗方案，签署同意书。排除标准：(1)伴有肿瘤、重症感染者；(2)处于慢性疾病活动期者；(3)有严重的脏器功能性或器质性病变者；(4)合并有炎症性肠病、胰腺炎、风湿免疫、血液系统相关病变者；(5)伴有精神障碍性疾病者；(6)药物性肝病、酒精性肝炎等其他类型肝病；(7)酒精摄入量女性70 g/周，男性140 g/周。按随机数表法将患者分为二甲双胍组和西格列汀联合组，每组58例。两组患者的基线资料比较差异均无统计学意义(P0.05)，具有可比性，见表1。本研究经我院医学伦理委员会批准。els of GGT,AST,ALT,chemerin,nesfatin-1,BMI,liver fat content,and NAFLDFS in sitagliptin combined with metfor-min group were(6.690.64)%,(6.870.76)mmol/L,(2.490.30)mmol/L,(41.782.71)U/L,(34.092.38)U/L,(35.752.09)U/L,(72.4910.73)ng/mL,(5.701.85)ng/mL,(25.370.95)kg/m2,(8.271.28)%,and(0.320.06)points,respec-tively,which were significantly lower than(7.240.78)%,(7.460.82)mmol/L,(2.840.41)mmol/L,(46.473.35)U/L,(38.123.26)U/L,(39.522.63)U/L,(80.5112.09)ng/mL,(6.622.09)ng/mL,(26.181.02)kg/m2,(9.411.56)%,and(0.470.08)points in the metformin group;the HDL-C level and CT liver spleen density ratio were(1.920.68)mmol/Land 0.930.08,respectively,which were significantly higher than(1.570.59)mmol/L and 0.810.12 in the metformingroup;the differences were statistically significant(P0.05).ConclusionSitagliptin combined with metformin in the treatment of patients with T2DM andNAFLD can effectively improve glucose and lipid metabolism and liver function,reduce BMI,liver fat content,fatty liv-er,and liver fibrosis,and down-regulate serum levels of chemerin and nesfatin-1,with high safety.【Key words】Type 2 diabetes mellitus;Nonalcoholic fatty liver disease;Sitagliptin;Metformin;Efficacy;Glu-cose and lipid metabolism;Liver function;Adipokines表1两组患者的一般资料比较x-s，例(%)Table 1Comparison of general information between the two groups x-s,n(%)组别西格列汀联合组二甲双胍组2/t值P值例数5858男/女33(56.9)/25(43.1)37(63.8)/21(36.2)0.5760.448年龄(岁)54.728.0956.317.481.0990.274糖尿病病程(年)4.961.845.242.060.7720.442BMI(kg/m2)28.791.6829.151.911.0750.285二甲双胍54(93.10)51(87.93)0.9040.342阿卡波糖15(25.86)19(32.76)0.6660.415磺脲类45(77.59)42(72.41)0.4140.520城镇37(63.79)33(56.90)农村21(36.21)25(43.10)药物使用情况居住地0.5760.4481.2治疗方法所有患者均进行饮食调控、合理运动等基础管理。二甲双胍组患者在此基础上予以盐酸二甲双胍片(生产厂家：中美上海施贵宝制药有限公司，国药准字：H20023370，药品规格：0.5 g10片6板/盒)治疗，初始剂量0.5 g/次，1次/d，若血糖指标依然偏高，可遵医嘱适当增加剂量，每日最大剂量不超过2 g，最高剂量1 g/次，2次/d。血糖降至正常后，遵医嘱下调剂量至0.5 g/次维持治疗。西格列汀联合组在二甲双胍组治疗的基础上联合西格列汀治疗。盐酸二甲双胍的服用剂量和频次与二甲双胍组相同；磷酸西格列汀(生产厂家：杭州默沙东制药有限公司，国药准字：J20140095，药品规格：0.1 g7片/盒)，0.1 g/次，1次/d，餐前口服。两组均持续治疗6个月后评估疗效。1.3观察指标与评价(检测)方法(1)临床效果：治疗6个月后评价疗效。疗效评价标准8：临床症状与体征未见改善，CT肝脏密度较治疗前提高，但仍较1847海南医学2023年7月第34卷第13期Hainan Med J,Jul.2023,Vol.34,No.13脾脏低5 HU以上，肝功能指标较治疗前降低0.676判定为肝纤维化。(4)不良反应：治疗期间，记录两组患者的胃肠道反应、泌尿系统感染、低血糖等不良反应发生情况。1.4统计学方法应用SPSS22.0统计软件分析数据。计量资料符合正态分布且方差齐，以均数标准差(x-s)表示，两组间比较行独立样本t检验，组内比较行配对样本t检验；计数资料比较行2检验，若理论频数1，Fishers精确检验，理论频数1且5，用校正检验。以P0.05为差异有统计学意义。2结果2.1两组患者的治疗效果比较治疗期间，两组患者均无中途退出者。治疗6个月后，西格列汀联合组患者的治疗总有效率为77.59%，明显高于二甲双胍组的60.34%，差异有统计学意义(2=4.028，P=0.0450.05)；治疗6个月后，两组患者的HbA1c、FPG、LDL-C水平明显低于治疗前，HDL-C水平明显高于治疗前，且西格列汀联合组患者的 HbA1c、FPG、LDL-C 水平明显低于二甲双胍组，HDL-C水平明显高于二甲双胍组，差异均有统计学意义(P0.05)，见表3。表2 两组患者的治疗效果比较(例)Table 2Comparison of clinical effects between the two groups(n)组别西格列汀联合组二甲双胍组例数5858无效1323有效3631显效94总有效率(%)77.5960.34表3两组患者治疗前后的糖脂代谢指标比较(x-s)Table 3Comparison of glucose and lipid metabolism indexes between the two groups before and after treatment(x-s)时间治疗前治疗6个月后组别西格列汀联合组二甲双胍组t值P值西格列汀联合组二甲双胍组t值P值例数58585858HbA1c(%)8.821.148.581.021.1950.2356.690.64a7.240.78a4.1520.001FPG(mmol/L)9.761.659.391.411.2980.1976.870.76a7.460.82a4.0190.001LDL-C(mmol/L)3.940.723.760.631.4330.1552.490.30a2.840.41a5.2470.001HDL-C(mmol/L)0.980.390.900.441.0360.3021.920.68a1.570.59a2.9610.004注：与本组治疗前比较，aP0.05。Note:Compared with that in the same group before treatment,aP0.05)；治疗6个月后，两组患者的血清血清GGT、AST、ALT 水平明显低于治疗前，且西格列汀联合组的血清GGT、AST、ALT水平明显低于二甲双胍组，差异均具有统计学意义(P0.05)；治疗6个月后，两组患者的血清chemerin、nesfatin-1水平明显低于治疗前，且西格列汀联合组患者的血清chemerin、nesfatin-1水平明显低于二甲双胍组，差异均有统计学意义(P0.05)；治疗 6 个月 后，两 组 患 者的 BMI、肝 脏 脂 肪含 量、NAFLDFS评分明显低于治疗前，CT肝脾密度比值明显高于治疗前，且西格列汀联合组患者的BMI、肝脏脂肪含量、NAFLDFS评分明显低于二甲双胍组，CT肝脾密度比值明显高于二甲双胍组，差异均有统计学意义(P0.05)，见表7。表4两组患者治疗前后的肝功能指标比较(x-s，U/L)Table 4Comparison of liver function indicators between the twogroups before and after treatment(x-s,U/L)时间治疗前治疗 6 个月后组别西格列汀联合组二甲双胍组t值P值西格列汀联合组二甲双胍组t值P值例数58585858GGT57.365.4155.826.051.4450.15141.782.71a46.473.35a8.2890.001AST49.244.6048.075.281.2720.20634.092.38a38.123.26a7.6040.001ALT47.853.9646.934.521.1660.24635.752.09a39.522.63a8.5470.001注：与本组治疗前比较，aP0.05。Note:Compared with that in the same group before treatment,aP0.05.表5两组患者治疗前后的血清chemerin、nesfatin-1水平比较(x-s，ng/mL)Table 5Comparison on serum levels of chemerin and nesfatin-1 between the two groups before and after treatment(x-s,ng/mL)组别西格列汀联合组二甲双胍组t值P值例数5858治疗前104.2616.43101.1515.391.0520.295治疗6个月后72.4910.73a80.5112.09a3.7790.001治疗前10.163.689.572.940.9540.342治疗6个月后5.701.85a6.622.09a2.5100.014chemerinnesfatin-1注：与本组治疗前比较，aP0.05。Note:Compared with that in the same group before treatment,aP0.05.表6两组患者治疗前后的BMI、肝脏脂肪含量、CT肝脾密度比值、NAFLDFS评分比较(x-s)Table 6Comparison of BMI,liver fat content,CT liver spleen density ratio,and NAFLDFS between the two groups before and after treatment(x-s)时间治疗前治疗6个月后组别西格列汀联合组二甲双胍组t值P值西格列汀联合组二甲双胍组t值P值例数58585858BMI(kg/m2)28.791.6829.151.911.0750.28525.370.95a26.181.02a4.4260.001肝脏脂肪含量(%)16.912.6716.362.251.2000.2338.271.28a9.411.56a4.3020.001CT肝脾密度比值0.630.160.690.191.8400.0680.930.08a0.810.12a6.3370.001NAFLDFS评分(分)0.910.090.880.121.5230.1310.320.06a0.470.08a11.4240.001注：与本组治疗前比较，aP0.05。Note:Compared with that in the same group before treatment,aP0.05.表7 两组患者治疗期间的不良反应比较(例)Table 7Comparison of adverse reactions between the two groupsduring treatment(n)组别西格列汀联合组二甲双胍组例数5858胃肠道反应54泌尿系统感染10低血糖11总发生率(%)12.078.623讨论目前，在糖尿病治疗中，除常规降糖措施外，一般需对血脂、血压、体质量等多种危险因素采取综合干预10。积极治疗NAFLD可延缓NAFLD向终末期肝病进展，改善患者预后11-12。因此，在治疗T2DM合并NAFLD 患者时，应首选具有降糖作用，同时兼具减重、降脂、减轻胰岛素抵抗与脂肪肝作用的药物。本研究采用西格列汀联合二甲双胍联合治疗T2DM合并NAFLD患者，结果显示，治疗6个月后，西格列汀联合组治疗总有效率高于二甲双胍组，差异有统计学意义(P0.05)；西格列汀联合组 HbA1c、FPG、LDL-C水平、血清GGT、AST、ALT水平、BMI、肝脏脂肪含量、NAFLDFS评分均低于二甲双胍组，HDL-C水平、CT肝脾密度比值均高于二甲双胍组，差异有统计学意义(P0.05)，与田松明13、周玉等14研究结果相似，表明西格列汀联合二甲双胍治疗可有效改善糖脂代谢与肝功能，降低BMI、肝脏脂肪含量、脂肪肝与肝纤维化程度，提升疗效。分析原因在于，二甲双胍作为治疗T2DM的首选药物，在改善机体胰岛素抵抗的同时，可在一定程度上改善BMI。对合并NAFLD的T2DM患者，采取二甲双胍治疗，对部分患者的疗效一般，需与其他降糖、降脂药物联合使用，以提高疗效。且二甲双1849海南医学2023年7月第34卷第13期Hainan Med J,Jul.2023,Vol.34,No.13胍对改善肝脏脂肪变性的作用有限15。而西格列汀可有效抑制机体肾脏对葡萄糖的再吸收，下调肾葡萄糖阈值，加速尿糖排泄，起到降糖效应；且其能调节机体内源性葡萄糖的生成，空腹状态下胰高血糖素表达提升，胰岛素敏感性升高，可减轻胰岛素抵抗16；同时，西格列汀有一定的降脂、减重作用；另有研究指出，西格列汀还可提升锌-A2-糖蛋白、脂联素水平，减轻体重，抑制游离脂肪酸表达，抑制肝脏脂质生成，改善慢性炎症状态，减轻脂质过氧化反应，进而降低脂肪肝病变程度与纤维化程度，下调肝脏脂肪含量17。西格列汀联合二甲双胍可起到协同调节糖脂代谢、减重、改善机体对胰岛素抵抗与肝功能等作用，进而提升治疗效果。机体内脂肪组织的功能紊乱可导致脂肪因子的异常表达18。chemerin、nesfatin-1均为新型脂肪因子，其中chemerin参与糖脂代谢与胰岛素抵抗调节，且可促进炎症因子分泌，增加肝脏炎症反应，加剧胰岛素抵抗，促进T2DM、NAFLD发生、进展；nesfatin-1可调节血糖、抑制摄食、降低体重等，对机体能量代谢具有重要作用，且可参与胰岛素抵抗进程，在T2DM患者体内，其表达呈代偿性提高。本研究结果证实，治疗6个月后，西格列汀联合组血清chemerin、nesfatin-1水平低于二甲双胍组，差异有统计学意义(P0.05)，表明西格列汀联合二甲双胍治疗T2DM合并NAFLD不良作用少，具有较高的用药安全性。这可能是因为，西格列汀已经过临床验证，给药剂量在安全范围内，合理用药不会显著增加不良反应发生风险。综上所述，西格列汀联合二甲双胍治疗T2DM合并NAFLD患者临床疗效较好，可有效改善糖脂代谢与肝功能，降低BMI、肝脏脂肪含量、脂肪肝与肝纤维化程度，并下调血清chemerin、nesfatin-1水平，具有较高的安全性。参考文献1Lee CH,Lui DT,Lam KS.Non-alcoholic fatty liver disease and type2 diabetes:An update J.J Diabetes Investig,2022,13(6):930-940.2Zhu D.Study on the clinical effect of metformin vildagliptin tabletsin the treatment of 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XD,et al.The value of serum lp and slp inthe diagnosis of non-alcoholic fatty liver disease with liver fibrosisJ.Chinese Medical Innovations,2021,18(13):60-64.龚尚红,曹雨石,郑小蝶,等.血清瘦素及可溶性瘦素受体在诊断非酒精性脂肪肝合并肝纤维化中的价值J.中国医学创新,2021,18(13):60-64.10 Shah AS,Zeitler PS,Wong J,et al.ISPAD clinical practice consensusguidelines 2022:type 2 diabetes in children and adolescents J.Pedi-atr Diabetes,2022,23(7):872-902.11 Zhang H,Wang Y,Chen C,et al.Non-alcoholic fatty liver disease,sleep behaviors,and incident type 2 diabetes J.J Gastroenterol Hep-atol,2022,37(8):1633-1640.12 Yan HL,Zhang AH,Li HQ,et al.Related factors of patients withT2DM complicating NAFLD and the correlation of the complicationwith insulin resistance J.Hainan Medical Journal,2015,26(19):2831-2833.闫洪领,张爱华,李慧琼,等.2型糖尿病合并非酒精性脂肪肝的相关因素及其与胰岛素抵抗的关系J.海南医学,2015,26(19):2831-2833.13 Tian SM.Clinical study of cigliptin combined with metformin in thetreatment of type 2 diabetes with nonalcoholic fatty liver disease J.World Latest Medicne Information(Electronic Version),2020,20(54):137-138.田松明.西格列汀联合二甲双胍治疗2型糖尿病伴非酒精性脂肪1850Hainan Med J,Jul.2023,Vol.34,No.13海南医学2023年7月第34卷第13期心脏康健导引功对慢性心力衰竭易损期患者的干预效果沈瑞丽，林嘉文，张自秀，孟园园，赵心韵，陈军上海市杨浦区中医医院心病科，上海200000【摘要】目的观察心脏康健导引功对慢性心力衰竭易损期患者的干预效果。方法选取2020年10月至2022年5月期间上海市杨浦区中医医院心病科收治的66例慢性心力衰竭易损期患者以随机数表法分为观察组和对照组，每组33例。对照组患者给予常规干预，观察组患者采用心脏康健导引功干预。两组患者连续干预3个月，干预结束后比较两组患者的心肺功能、心率变异性，并采用6 min步行试验(6MWT)、明尼苏达心力衰竭生活质量评分量表(MLHF-Q)和中医证候积分评估两组患者的预后。结果 干预后，观察组患者的左心室射血分数(LVEF)和每搏输出量(SV)分别为(63.446.02)%、(74.938.02)mL，明显高于对照组的(57.036.06)%、(66.217.61)mL，差异均有统计学意义(P0.05)；左室舒张末径(LVEDD)和QT间期离散度(QTd)分别为(46.345.01)mm、(57.225.61)ms，明显低于对照组的(53.715.21)mm、(65.676.26)ms，差异均有统计学意义(P0.05)；干预后，观察组患者的用力肺活量(FVC)、肺泡通气量(VA)和最大呼气中段流量(MMEF)分别为(2.440.51)L、(5.310.80)L/min、(2.280.51)L/s，明显高于对照组的(2.010.47)L、(4.560.75)L/min、(1.900.46)L/s，差异均有统计学意义(P0.05)；干预后，观察组患者的心率变异性指标总标准差(SDNN)、两个相邻RR间期互差(PNN50)、差值均方根(RMSSD)分别为(132.8116.51)ms、(6.810.90)%、(43.285.51)ms，明显高于对照组的(121.4015.47)ms、(6.120.85)%、(36.895.46)ms，差异均有统计学意义(P0.05)；干预后，观察组患者的MLHF-Q评分、中医证候积分分别为(26.303.42)分、(15.002.53)分，明显低于对照组的(31.425.15)分、(17.553.17)分，6MWT距离为(356.4849.96)m，明显长于对照组的(293.4869.64)m，差异均有统计学意义(P0.05)。结论心脏康健导引功对慢性心力衰竭易损期患者的治疗干预能够改善其心肺功能、心率变异性，提高生活质量和运动耐量。【关键词】心脏康健导引功；慢性心力衰竭；易损期；心肺功能；心率变异性；生活质量【中图分类号】R541.6【文献标识码】A【文章编号】10036350（2023）13185105Intervention effect of he