通心络胶囊治疗糖尿病心肌病的临床疗效观察

摘要

目的：观察通心络胶囊对糖尿病心肌病的治疗效果及其对左心室射血分数（ LVEF）、氧化应激、炎性因子的影响。方法收集2011年2月—2013年2月黄石市中心医院老年病科诊治的糖尿病心肌病患者48例，采用随机数字表法随机分为治疗组和对照组各24例。对照组予以常规治疗，而治疗组在对照组的基础上联合通心络胶囊治疗。治疗8周后，观察2组临床疗效，比较血清过氧化氢酶（CAT）、谷胱甘肽过氧化物酶（GSH-Px）、超氧化物歧化酶（SOD）、丙二醛（MDA）、白介素-1（IL-1）、白介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）的变化；并观察不良反应。结果（1）治疗8周后，2组患者临床症状均得到不同程度的改善，治疗组的总有效率为91弿．67％，明显高于对照组的75．00％（χ2＝6．34， P ＝0．043）；（2）2组LVEF较治疗前均增加（ t ＝12．54， P ＝0．032；t ＝9．12， P ＝0．041），且治疗组明显高于对照组（ t ＝8．13， P ＝0．02）；（3）2组患者GSH-Px、 SOD、CAT等氧化应激指标治疗后较治疗前均升高，而MDA均降低，且治疗组较对照组改善更明显（ t ＝29．21， P ＝0．01；t ＝26．12， P ＝0．03；t ＝31．12， P ＝0．00；t ＝21．88， P ＝0．04）；（4）治疗后2组患者血清IL -1、TNF-α、IL-6等炎性因子水平均降低，且治疗组较对照组降低更明显（ t ＝25．44， P ＝0．00；t ＝28．11， P ＝0．00；t ＝27．23， P ＝0．00）；（5）2组患者均无严重不良反应发生。结论通心络胶囊可有效改善糖尿病心肌病患者的心功能，降低体内炎性介质水平以及氧化应激水平。%Objective To investigate therapeutic effect of Tongxinluo on diabetic cardiomyopathy ,and explore its in-fluence on cardiac function , oxidative stress and inflammation in patients with diabetic cardiomyopathy .Methods 48 patients with diabetic cardiomyopathy in Huangshi city center hospital were randomly divided into treatment group and control group . Patients in control group and treatment group received general treatment ; besides, patients in treatment group also received Tongxinluo .Indicators of oxidative stress and inflammatory cytokines were detected by enzyme linked immunosorbent assay (ELISA method).Malondialdehyde (MDA) was detected by thiobarbituric acid method and superoxide dismutase (SOD) was detected by hydroxylamine method .The variable between cases and controls were compared using independent t test varia-bles or Mann-Whitney U test.Results (1) After 8 weeks treatment, clinical symptoms of two groups of patients were im-proved, and improved cardiac function in different degree , the treatment group total effective rate was 91.67%;(2) The con-trol group total effective rate was 75%.The difference of total effective rate between two groups was statistical significantly (P <0.01).After eight weeks treatment, LVEF of patient from both treatment group and control group significantly in-creased ( P <0.05);LVEF of patient from treatment group was more significantly high than in control group;(3) After eight weeks treatment , the GSH-Px, SOD, CAT level of patient from both treatment group and control group was significantly in-creased, and MDA, inflammatory cytokines from both groups was significantly reduced;the GSH-Px, SOD, CAT level of pa-tient from treatment group was more significantly high than that in control group , and MDA, inflammatory cytokines was more significantly lower than that in control group .Conclusion Tongxinluo can improve clinical symptoms and cardiac function . Besides , oxidative stress and inflammation in patients with diabetic cardiomyopathy were well regulated .