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糖尿病伴发抑郁症的证候学研究及益肾解郁方干预的临床疗效评价
【作者】 卢伟；
【导师】 高彦彬；
【作者基本信息】 北京中医药大学 ， 中医内科学， 2012， 博士
【摘要】 糖尿病伴发抑郁症是在糖尿病的基础上出现抑郁症状,临床表现主要为情绪低落、兴趣减退、内心痛苦、沮丧、忧伤、苦闷、悲观、失望和精神不振,乏力,睡眠障碍(入睡困难或早醒),还会出现认知功能障碍,严重者有自杀倾向。目前对于该病的治疗多应用西药抗抑郁剂进行治疗,因其副作用大,起效较慢,患者依从性较差。中医药辨证论治,副作用小,具有一定的优势。但是目前对该病的中医辨证分型尚无统一的标准；因此,开展该病的中医症候学研究,探索有效的方药,对于提高糖尿病伴发抑郁症的临床疗效具有重要的意义。目的通过证候学研究,探讨糖尿病伴发抑郁症的证型特点；采用随机对照的试验方法客观评价益肾解郁方治疗糖尿病伴发抑郁症肾虚肝郁证的临床疗效及部分机制探讨。方法1.以2008年中华中医药学会发布的《中医内科常见病诊疗指南·郁病》为基础制定糖尿病伴发抑郁症的中医证候学量表,根据患者的临床表现及临床资料,建立数据库,统计糖尿病伴发抑郁症患者中医辨证分型及证候规律。2.采用随机、对照、盲法原则,共选取符合糖尿病伴发抑郁症及中医学肾虚肝郁证诊断标准的132例患者,随机分为治疗组和对照组。治疗组在基础治疗的同时给予口服益肾解郁方,每日1剂,分两次服。对照组在常规治疗的基础上予口服氟西汀胶囊,每日服用20mg。疗程3个月。结果一糖尿病伴发抑郁症的证候学研究1在209例糖尿病伴发抑郁症的患者中中医辨证分型肾虚肝郁证最多,占28.23%,其次是肝郁脾虚证,占20.11%,肝气郁结证18.66%,血行郁滞证16.75%,肝胆湿热证占14.35%,忧郁伤神型最少,1.91%。2.糖尿病伴发抑郁症患者肝郁脾虚证的焦虑／躯体化因子分高于肾虚肝郁证(p<0.05)；肝郁脾虚证的迟滞,绝望感和体重减轻因子分低于肾虚肝郁证,差异显著(p<0.05)。二益肾解郁方治疗糖尿病伴发抑郁症的临床疗效1两组HAMD量表评分比较两组治疗后HAMD评分较治疗前均明显降低,差异显著(p<0.05)；治疗组总有效率85.24%,对照组总有效率为77.42%,两组疗效比较,差异显著(p<0.05)。表明治疗组在HAMD评分改善方面优于对照组。治疗组疗后的焦虑／躯体化因子分,迟滞因子分,睡眠障碍因子分均明显降低(p<0.05或p<0.01)。组间比较,治疗组的睡眠障碍因子得分低于对照组(p<0.05)。2两组SDS量表评分比较两组治疗后SDS量表得分均有所下降,与治疗前相比,差异显著(p<0.05)；治疗组起效时间为治疗2周,对照组起效时间为治疗4周。治疗组总有效率90.16%,对照组总有效率为79.03%,差异显著(p<0.05)。说明治疗组在治疗糖尿病伴发抑郁症方面,起效时间早于对照组,主观评价疗效优于对照组。3两组中医证候疗效比较中医疗效指数统计,治疗组的总有效率93.44%,对照组总有效率为82.26%,组间对照差异显著(p<0.05)。治疗组的中医症状情绪抑郁,兴趣索然,腰酸乏力,胸胁胀痛和睡眠状况均显著改善(p<0.05或p<0.01)。组间比较结果显示,治疗组的睡眠状况改善优于对照组(p<0.05)。4两组糖尿病特异生存质量量表评分比较疗后治疗组的生理维度,心理精神维度和总分低于治疗前,差异显著(p<0.05)。疗后对照组心理精神维度和总分低于治疗前,差异显著(p<0.05)。组间比较结果显示,疗后治疗组的在生理维度,心理精神维度和总分均低于对照组,差异显著(p<0.05)。说明治疗组患者的生存质量优于对照组。5两组HPA轴功能指标比较疗后治疗组和对照组8：00皮质醇数值和16：00皮质醇数值均有所下降,差异显著,(p<0.05)；疗后治疗组和对照组皮质醇节律消失患者比例均有所下降,与疗前相比,差异显著(p<0.05)。6两组血清血糖,糖化血红蛋白,血脂,血压指标比较疗后治疗组空腹血糖,餐后2h血糖,HBAIC均较治疗前下降,差异显著(p<0.01或p<0.05)；对照组仅空腹血糖较疗前下降(p<0.05),其余指标无显著改变。组间比较结果显示,治疗后治疗组空腹血糖和餐后2h血糖均低于对照组,差异显著(p<0.05)。治疗组血脂,血压较治疗前无明显改变。结论12型糖尿病伴发抑郁症具有不同于单纯抑郁症的证候学特点,即肾虚肝郁证所占比例高于其他证型。22型糖尿病伴发抑郁症的不同证型的抑郁表现的维度不同。3益肾解郁方可以改善2型糖尿病伴发抑郁症肾虚肝郁证患者的抑郁症状,提高糖尿病患者的生存质量。4益肾解郁方通过改善下丘脑-垂体-肾上腺轴的功能紊乱缓解2型糖尿病伴发抑郁症肾虚肝郁证患者的症状。5益肾解郁方可以协助改善2型糖尿病伴发抑郁症肾虚肝郁证患者的血糖水平。
【Abstract】 Type2diabetes with depression is a kind of depression combined with diabetes. The main clinical manifestation of Type2diabetes with depression is low in spirits, loss of interest and pleasure, sad, dejected, empty, hopeless, depressed, exhausted both in body and mind, sleep disorders,cognitive symptoms and suicide thoughts and behaviours. There is no standards of pattern identification of Traditional Chinese Medicine now. The treatment for Type2diabetes with depression is antidepressant, which has serious side effects and slow onset, thus the patients have poor compliance. Treatment based on pattern identification of traditional Chinese medicine has small side-effects and have certain advantages. It is important to study Type2diabetes with depression from the point of traditional Chinese medicine, and on this basis to improve the clinical curative effect of the disease.ObjectiveTo understand the characteristics of traditional Chinese medicine patterns of Type2diabetes with depression, and to study different patterns with the HAMD scale; observation on the Yishen Jieyu Decoction in treating Type2diabetes with depression of syndrome of kidney deficiency and liver qi stagnation and study on its mechanism.Method1. We developed survey questionnaires, collected information of209cases with survey method, identified the pattern of traditional Chinese medicine diagnosis according to the case information. Then we made a census of the data of the disease.2According to the randomized, placebo-controlled and blinded principles,132patients of Type2diabetes with depression with TCM syndrome diagnostic of kidney deficiency and liver qi stagnation were selected and divided into the treatment and control group. The therapy group was given the Yishen Jieyu Decoction. The control group was given oral fluoxetine capsules,20mg a day. Each group were treated by oral medication for3months. After treatment both group were given the observation of curative effect.Results1. In209cases of Type2diabetes with depression,the highest rate of traditional Chinese medicine is the pattern of kidney deficiency and liver qi stagnation,28.23%, followed by liver qi stagnation and spleen deficiency syndrome,20.11%, pattern of liver qi stagnation syndrome18.66%, pattern of dampness-heat of liver and gallbladder14.35%, blood stasis pattern16.75%, pattern of melancholy and depression impairing the spirit is at least,1,91%.2The anxiety/somatization score of patients with liver qi stagnation and spleen deficiency syndrome is higher than the score of patients with kidney deficiency and liver qi stagnation syndrome.The difference is significant (p<0.05).The weight reduce score, retardation score and despair score of patients with kidney deficiency and liver qi stagnation syndrome is higher than the score of patients with liver qi stagnation and spleen deficiency syndrome. The difference is significant (p<0.01or p<0.05). 3The HAMD scores after treatment are significantly reduced than that before treatment. The difference is significant (p<0.05); The total effective rate of treatment group is85.24%, the total effective rate of the control group is77.42%. The difference is significant (p<0.05). The treatment group is better in improvement of HAMD score than controlled group.4After treatment,anxiety/somatization score in the treatment group is significantly lower than that before the treatment (p<0.05); The retardation score in the treatment group is significantly lower than that before treatment (p<0.05), sleep disturbance score in the treatment group is significantly lower than before treatment (p<0.01). Comparison between the two groups showed that the sleep disturbance score in the treatment group is less than that of the control groups. The difference is significant (p<0.05).5After treatment,SDS scale scores of the two groups declined, compared with that before treatment. The difference is significant (p<0.05). The onset time of the treatment group is2weeks after the treatment. The onset time of the control group is4weeks after the treatment. The total effective rate in the treatment group is90,16%, the total effective rate of the control group is79.03%. The difference is significant (p<0.05). The result proved that the subjective evaluation of the therapeutic effect in the treatment group is better than the control group and the onset time is earlier than the control group.6Curative effect of traditional Chinese medicine index showed that the total effective rate of treatment group is93.44%, the total effective rate of control group is82.26%.Group comparison difference is significant(p<0.05).7Diabetes-specific quality of life scale statistics showed that the physical dimension score, psycho-spiritual dimension score and total score in the treatment group after the treatment is lower than that before treatment. The difference is significant (p<0.05). Psycho-spiritual dimension score and total score in the control group after the treatment is lower than that before treatment. The difference is significant (p<0.05). Comparison between the two groups showed that, after treatment, physical dimension score, psycho-spiritual dimension score and total score in treatment group are lower than the control group. The difference is significant (p<0.05).This proved that the quality of life of treatment group is better than that of the control group.8HPA-axis function index statistics showed that the cortisol level in8:00AM and16:00PM declined after the treatment. The difference is significant (p<0.05); The rate of cortisol rhythm disappears in treatment group decreased after treatment. The difference is significant (p<0.05).9Serum glucose, HbAIC, serum lipids, blood pressure index statistics showed that fasting blood glucose,2H after a meal blood glucose, HbAIC declined after the treatment. The difference is significant (p<0.01, p<0.05); comparison of the two groups showed that fasting blood glucose and2H after a meal blood glucose are lower than the control group, The difference is significant (p<0.05). There is no obvious change in lipids and blood pressure. Conclusion1The syndrome differentiation typing in Type2diabetes with depression is different from a simple depression, high incidence of kidney deficiency and liver qi stagnation are its characteristics.2The dimension on the performance of different patterns of Traditional Chinese Medicine in Type2diabetes with depression is different.3The Yishen Jieyu Decoction can reduce the depression level of patients with Type2diabetes with depression, and improve the quality of life in patients with diabetes.4TheYishen Jieyu decoction can improve dysfunction of the hypothalamus-pituitary-adrenal axis in patients of kidney deficiency and liver qi stagnation of Type2diabetes with depression.5The Yishen Jieyu decoction can help to reduce the serum glucose level of patients of kidney deficiency and liver qi stagnation of Type2diabetes with depression.