四逆散合甘麦大枣汤治疗2型糖尿病合并抑郁焦虑状态临床观察

Clinical Observation on Sini Powder Combined with Gan Mai Dazao Decoction in the Treatment of Type 2 Diabetes Mellitus Complicated with Depression and Anxiety

【目的】观察四逆散合甘麦大枣汤治疗肝郁脾虚型2型糖尿病合并抑郁焦虑状态患者的临床疗效。【方法】将60例肝郁脾虚型2型糖尿病合并抑郁焦虑状态患者随机分为治疗组和对照组,每组各30例。2组患者均给予糖尿病基础治疗,在此基础上,对照组给予氟哌噻吨美利曲辛片口服治疗,观察组在对照组基础上加用四逆散合甘麦大枣汤治疗,4周为1个疗程,连续治疗2个疗程。观察2组患者治疗前后糖代谢指标及汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分和世界卫生组织生存质量测定量表(WHOQOL-BREF)评分的变化情况,并评价2组患者的中医证候疗效、抑郁焦虑改善疗效和安全性。【结果】(1)疗效方面,治疗8周后,治疗组中医证候疗效和抑郁焦虑改善疗效的总有效率分别为93.3%(28/30)、93.3%(28/30),对照组分别为70.0%(21/30)、73.3%(22/30),组间比较,治疗组的中医证候疗效和抑郁焦虑改善疗效均明显优于对照组(P<0.05)。(2)糖代谢指标方面,治疗后,2组患者血清空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA1c)水平均较治疗前明显改善(P<0.05),且治疗组对血清FPG、2hPG、HbA1c水平的改善作用均明显优于对照组(P<0.05)。(3)抑郁焦虑方面,治疗后,2组患者的HAMD和HAMA评分均较治疗前明显降低(P<0.05),且治疗组对HAMD和HAMA评分的降低作用均明显优于对照组(P<0.05)。(4)生活质量方面,治疗后,2组患者WHOQOL-BREF量表的生理领域、心理领域、环境领域以及社会关系领域评分均较治疗前明显改善(P<0.05),且治疗组对WHOQOL-BREF量表各领域评分的改善作用均明显优于对照组(P<0.05)。(5)试验过程中,2组患者的血、尿、大便常规和肝肾功能、心电图等安全性指标均无异常改变,亦均未出现与本次治疗有关的过敏现象及其他严重不适症状。【结论】四逆散合甘麦大枣汤治疗肝郁脾虚型2型糖尿病合并抑郁焦虑状态患者疗效确切,可有效改善患者抑郁焦虑症状,提高患者的生活质量。

Objective To observe the clinical efficacy of Sini Powder combined with Gan Mai Dazao Decoction in the treatment of patients with type 2 diabetes mellitus(T2DM)complicated with anxiety and depression and differentiated as liver stagnation and spleen deficiency type.Methods Sixty T2DM patients complicated with depression and anxiety and differentiated as liver stagnation and spleen deficiency type were randomly divided into treatment group and control group,with 30 cases in each group.Both groups were given basic treatment for diabetes,and additionally,the control group was given oral administration of Flupentixol melitoxin tablets,while the observation group was given Sini Powder combined with Gan Mai Dazao Decoction based on the treatment of the control group.Four weeks constituted a course and the treatment lasted for 2 courses.The glucose metabolism indexes,Hamilton Depression Scale(HAMD)scores,Hamilton Anxiety Scale(HAMA)scores,and World Health Organization Quality of Life Scale brief version(WHOQOL-BREF)scores of the two groups were observed before and after treatment.Meanwhile,traditional Chinese medicine(TCM)syndrome efficacy,and the curative effect on improving depression and anxiety and safety in the two groups were evaluated.Results(1)In terms of efficacy:after 8 weeks of treatment,the total effective rates of TCM syndrome efficacy and depression and anxiety improvement efficacy in the treatment group were 93.3%(28/30)and 93.3%(28/30),and were 70.0%(21/30)and73.3%(22/30)in the control group,respectively.The intergroup comparison showed that the TCM syndrome efficacy and depression and anxiety improvement efficacy in the treatment group were significantly superior to those in the control group(P<0.05).(2)In terms of glucose metabolism indexes,the levels of serum fasting blood glucose(FPG),2-hour postprandial blood glucose(2hPG)and HbA1c in the two groups after treatment were significantly improved compared with those before treatment(P<0.05).The effect on improving the serum FPG,2hPG and HbA1c levels in the treatment group was significantly superior to that in the control group(P<0.05).(3)In terms of depression and anxiety,HAMD scores and HAMA scores in the two groups after treatment were significantly decreased compared with those before treatment(P<0.05),and the effect on lowering HAMD scores and HAMA scores in the treatment group was significantly superior to that in the control group(P<0.05).(4)In terms of quality of life,the scores of physiological,psychological,environmental and social relation domains of WHOQOL-BREF in the two groups after treatment were significantly improved compared with those before treatment(P<0.05),and the effect on improving the scores of various domains of WHOQOL-BREF in the treatment group was significantly superior to that in the control group(P<0.05).(5)During the trial,there were no abnormal changes occurring in the routine test of blood,urine,and stool,and in the examination of liver function,kidney function,electrocardiogram and other safety indicators in the two groups.No allergic phenomenon or other serious disorders related to the treatment occurred in the two groups either.Conclusion Sini Powder combined with Gan Mai Dazao Decoction exerts certain effect for the treatment of T2DM patients complicated with anxiety and depression and differentiated as liver stagnation and spleen deficiency type.The combined therapy is effective on relieving depression and anxiety,and on improving the quality of life of the patients.