补肾调肝法治疗老年期抑郁的临床疗效观察
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摘要
目的：老年期抑郁症患者常合并有多种躯体疾病,临床症状复杂且不典型,给临床诊断带来了一定的难度。在治疗方面,西医学常用的几类药物副作用大,且老年期抑郁症患者多伴有其他疾病,难以长期服用,疗效尚不满意。中医药在治疗老年期抑郁症的研究中已显示了良好的前景,本研究采用补肾调肝法治疗老年期抑郁症患者,通过观察治疗前后证候群、神经心理学量表分值、睡眠量表分值、MoCA量表分值等指标的变化及患者治疗前后的病情改善情况进行分析比较,初步揭示补肾调肝法对老年期抑郁症的中医证候群的改善规律,并对病机演变、病位的转化规律有一定提示作用。
方法：将2009年3月-2010年1月在北京中医药大学东方医院就诊并经门诊医师确诊的60例老年期抑郁症患者随机分为2组。
给药：分别给予补肾调肝汤、盐酸舍曲林口服；其中,西药组给予盐酸舍曲林(左洛复)片,50mg／日／次口服；补肾调肝汤组予补肾调肝汤水煎剂,日2次分服；观察指标：抑郁症核心症状改善情况、肾虚肝郁证候改善情况、HAMD分值、HAMA分值、PSQI分值；
观察周期与时点：分别在给药的0、1、2、4、8、12周对患者进行评价,观察周期为0-12周；
结果：1.治疗周期满12周后对患者各项量表分值进行比较发现,补肾调肝汤与盐酸舍曲林相比,对于汉密顿焦虑量表(Hamilton Anxiety scale, HAMD),汉密顿抑郁量表(Hamilton Depression scale, HAMA)的减分率没有明显差异；对于匹兹堡睡眠指数(Pittsburgh sleep quality index,PSQI)及肾虚肝郁量表的减分率有明显差异,在睡眠质量及肾虚肝郁证候改善方面,补肾调肝汤组优于盐酸舍曲林组；
2.补肾调肝汤与盐酸舍曲林对HAMA量表分值均有影响,但无明显统计学差异。补肾调肝汤起效时间为1周,即明显改善患者躯体症状；盐酸舍曲林起效时间约为2周,4-8周为一个平台期,患者病情无明显变化；12周时,盐酸舍曲林组略好于补肾调肝汤组。
3.补肾调肝汤与盐酸舍曲林对HAMD量表分值均有影响,但无明显统计学差异。补肾调肝汤起效时间为1周,即明显改善患者躯体症状；盐酸舍曲林起效时间约为2周,4-12周补肾调肝汤作用持续,无反复波动。
4.本次研究就诊患者的中医证候群具有明显的肾虚肝郁证型特点,其症状表现涵盖多个方面,在全部病例中,出现频率超过50%的症状如下：情绪低落、神思不聚、腰酸背痛、情绪不宁、周身乏力。补肾调肝汤对于改善患者的神思不聚、周身乏力症状,显著优于盐酸舍曲林；
5.西药组患者主要中医症状在前4周呈逐渐改善状态,但从4-12周,中医主要症状改善下降,考虑与药物副作用有关；
6.补肾调肝汤对于失眠的改善明显好于盐酸舍曲林,而对认知功能的改善,两者相似,考虑与观察周期较短有关。
结论：
1.补肾调肝汤能够有效改善老年期抑郁症的情绪低落、兴趣索然等核心症状；同时,通过补益肝肾而达到改善周身乏力、腰酸背痛等躯体症状；
2.补肾调肝汤起效时间约为1周,作用稳定,本次研究未见其有明显副作用。补肾调肝汤的有效性、安全性得到了验证；
3.补肾调肝法能够改善失眠、善忘等症状,因失眠、善忘与抑郁症有一定内在联系,所以此类症状得到改善的同时,抑郁症病情也得到了缓解,这也说明,补肾调肝法虽然没有特定的靶向性,但却通过改善机体整体状态而改善疾病,充分考虑到了老年期抑郁患者的生理特点,明显降低毒副作用及联合用药的风险,对老年期抑郁患者的非抑郁症相关躯体症状也有一定的改善作用。
Object:Senile patients with depression is often associated with a variety of physical diseases, atypical clinical symptoms makes it hard to diagnosis. Regarding the treatment of several types commonly used in Western medicine side effects of drugs, the long-term use and efficacy is still not satisfied. Chinese medicine in the treatment of senile depression studies have shown good prospects, this study reinforce Kidney&Liver treatment of elderly patients with depression can be applied in clinical use. Compared with the syndromes, neuropsychological scale scores, PSQI scores, MoCA Scale scores and other indicators of changes and the condition of patients before and after treatment, to explore the role of kidney &liver adjustment mechanism.
Methods:60 cases of senile depression were randomly divided into 2 groups, who came from Beijing University of Chinese Medicine, Dongfang Hospital.
Delivery:western medicine group were given sertraline hydrochloride (Zoloft) Tablets,50mg/day/oral dose; Bushen-tiaogan tang Group were given decoction twice a day;
SCALES:The core symptoms of depression to improve the situation, kidney deficiency syndrome Liver depression and to improve the situation, HAMD score, HAMA scores, PSQI score;
Period:0,1,2,4,8,12 weeks respectively in drug delivery to evaluate the patients;
Results:
1. Bushen-tiaogan tang, compared with sertraline hydrochloride for the HAMD, HAMA reduction fraction was no significant difference; for PSQI and kidney liver Yu Scale significantly reduced rate of differences in sleep quality and improvement of kidney Liver depression syndromes, Bushen-tiaogan tang decoction is superior to sertraline hydrochloride group;
2. Compared with sertraline hydrochloride on the HAMA scale scores there was no significant statistical difference in the two groups, but the onset time of the role of Bushen Tiaogan Tang 1 week, and significantly improves the physical symptoms; the onset time of sertraline hydrochloride 2 week,no significant fluctuations in 4-8 weeks as a platform for period, no significant change in patient's condition.sertraline hydrochloride, slightly better than Bushen-tiaogan tang 12 week;
3. Compared with sertraline hydrochloride on the HAMD scale scores were there was no statistically significant difference, but the onset time of the role of Bushen Tiaogan Tang 1 week, and significantly improves the physical symptoms; the onset time of sertraline hydrochloride 2 week, Bushen-tiaogan tang acted a little slow but smoothly in 4-12-week, without any fluctuations;
4. Visits the patients in this study group of syndromes with distinct characteristics of kidney liver stagnation syndrome, its symptoms include a number of aspects, in all cases, the frequency of more than 50% of the following symptoms:depression, Meditation does not gather, back pain, fidget, whole body fatigue. Bushen Tiaogan Tang for improving patient Meditation is not poly, whole body fatigue symptoms, significantly better than sertraline hydrochloride;
5. Patients with sertraline hydrochloride showed gradual improvement in the first 4 weeks of the clinical symptoms, from 4-12 weeks, the medicine down the main symptoms, drug side effects to consider;
6. The improvement of insomnia was also compared, Bushen-tiaogan tang significantly better than sertraline hydrochloride, while the improvement of cognitive function, both similar to and considering the relatively short observation period;
Conclusion:
1. Bushen-tiaogan tang can be effective in improving depression in old age depression, interest dull core symptoms; the same time, through the liver and kidney tonic to achieve the improvement of whole body fatigue, back pain or other symptoms of somatization;
2. The stable effecite time is about 1 weeks, this study showed that no obvious siae effects. The safety has been verified;
3. In term of insomnia, forgetfulness and other symptoms due to insomnia, forgetfulness and depression have a certain intrinsically linked, so these symptoms improved, depression can also been eased, which also shows that the reinforcement of liver & kidney is effective to improve the overall state of the body in elderly patients with physiological characteristics significantly reduced toxicity and the risks of combination therapy for patients with senile depression non-somatic symptoms of depression related to a certain degree of improvement.
方法：将2009年3月-2010年1月在北京中医药大学东方医院就诊并经门诊医师确诊的60例老年期抑郁症患者随机分为2组。
给药：分别给予补肾调肝汤、盐酸舍曲林口服；其中,西药组给予盐酸舍曲林(左洛复)片,50mg／日／次口服；补肾调肝汤组予补肾调肝汤水煎剂,日2次分服；观察指标：抑郁症核心症状改善情况、肾虚肝郁证候改善情况、HAMD分值、HAMA分值、PSQI分值；
观察周期与时点：分别在给药的0、1、2、4、8、12周对患者进行评价,观察周期为0-12周；
结果：1.治疗周期满12周后对患者各项量表分值进行比较发现,补肾调肝汤与盐酸舍曲林相比,对于汉密顿焦虑量表(Hamilton Anxiety scale, HAMD),汉密顿抑郁量表(Hamilton Depression scale, HAMA)的减分率没有明显差异；对于匹兹堡睡眠指数(Pittsburgh sleep quality index,PSQI)及肾虚肝郁量表的减分率有明显差异,在睡眠质量及肾虚肝郁证候改善方面,补肾调肝汤组优于盐酸舍曲林组；
2.补肾调肝汤与盐酸舍曲林对HAMA量表分值均有影响,但无明显统计学差异。补肾调肝汤起效时间为1周,即明显改善患者躯体症状；盐酸舍曲林起效时间约为2周,4-8周为一个平台期,患者病情无明显变化；12周时,盐酸舍曲林组略好于补肾调肝汤组。
3.补肾调肝汤与盐酸舍曲林对HAMD量表分值均有影响,但无明显统计学差异。补肾调肝汤起效时间为1周,即明显改善患者躯体症状；盐酸舍曲林起效时间约为2周,4-12周补肾调肝汤作用持续,无反复波动。
4.本次研究就诊患者的中医证候群具有明显的肾虚肝郁证型特点,其症状表现涵盖多个方面,在全部病例中,出现频率超过50%的症状如下：情绪低落、神思不聚、腰酸背痛、情绪不宁、周身乏力。补肾调肝汤对于改善患者的神思不聚、周身乏力症状,显著优于盐酸舍曲林；
5.西药组患者主要中医症状在前4周呈逐渐改善状态,但从4-12周,中医主要症状改善下降,考虑与药物副作用有关；
6.补肾调肝汤对于失眠的改善明显好于盐酸舍曲林,而对认知功能的改善,两者相似,考虑与观察周期较短有关。
结论：
1.补肾调肝汤能够有效改善老年期抑郁症的情绪低落、兴趣索然等核心症状；同时,通过补益肝肾而达到改善周身乏力、腰酸背痛等躯体症状；
2.补肾调肝汤起效时间约为1周,作用稳定,本次研究未见其有明显副作用。补肾调肝汤的有效性、安全性得到了验证；
3.补肾调肝法能够改善失眠、善忘等症状,因失眠、善忘与抑郁症有一定内在联系,所以此类症状得到改善的同时,抑郁症病情也得到了缓解,这也说明,补肾调肝法虽然没有特定的靶向性,但却通过改善机体整体状态而改善疾病,充分考虑到了老年期抑郁患者的生理特点,明显降低毒副作用及联合用药的风险,对老年期抑郁患者的非抑郁症相关躯体症状也有一定的改善作用。
Object:Senile patients with depression is often associated with a variety of physical diseases, atypical clinical symptoms makes it hard to diagnosis. Regarding the treatment of several types commonly used in Western medicine side effects of drugs, the long-term use and efficacy is still not satisfied. Chinese medicine in the treatment of senile depression studies have shown good prospects, this study reinforce Kidney&Liver treatment of elderly patients with depression can be applied in clinical use. Compared with the syndromes, neuropsychological scale scores, PSQI scores, MoCA Scale scores and other indicators of changes and the condition of patients before and after treatment, to explore the role of kidney &liver adjustment mechanism.
Methods:60 cases of senile depression were randomly divided into 2 groups, who came from Beijing University of Chinese Medicine, Dongfang Hospital.
Delivery:western medicine group were given sertraline hydrochloride (Zoloft) Tablets,50mg/day/oral dose; Bushen-tiaogan tang Group were given decoction twice a day;
SCALES:The core symptoms of depression to improve the situation, kidney deficiency syndrome Liver depression and to improve the situation, HAMD score, HAMA scores, PSQI score;
Period:0,1,2,4,8,12 weeks respectively in drug delivery to evaluate the patients;
Results:
1. Bushen-tiaogan tang, compared with sertraline hydrochloride for the HAMD, HAMA reduction fraction was no significant difference; for PSQI and kidney liver Yu Scale significantly reduced rate of differences in sleep quality and improvement of kidney Liver depression syndromes, Bushen-tiaogan tang decoction is superior to sertraline hydrochloride group;
2. Compared with sertraline hydrochloride on the HAMA scale scores there was no significant statistical difference in the two groups, but the onset time of the role of Bushen Tiaogan Tang 1 week, and significantly improves the physical symptoms; the onset time of sertraline hydrochloride 2 week,no significant fluctuations in 4-8 weeks as a platform for period, no significant change in patient's condition.sertraline hydrochloride, slightly better than Bushen-tiaogan tang 12 week;
3. Compared with sertraline hydrochloride on the HAMD scale scores were there was no statistically significant difference, but the onset time of the role of Bushen Tiaogan Tang 1 week, and significantly improves the physical symptoms; the onset time of sertraline hydrochloride 2 week, Bushen-tiaogan tang acted a little slow but smoothly in 4-12-week, without any fluctuations;
4. Visits the patients in this study group of syndromes with distinct characteristics of kidney liver stagnation syndrome, its symptoms include a number of aspects, in all cases, the frequency of more than 50% of the following symptoms:depression, Meditation does not gather, back pain, fidget, whole body fatigue. Bushen Tiaogan Tang for improving patient Meditation is not poly, whole body fatigue symptoms, significantly better than sertraline hydrochloride;
5. Patients with sertraline hydrochloride showed gradual improvement in the first 4 weeks of the clinical symptoms, from 4-12 weeks, the medicine down the main symptoms, drug side effects to consider;
6. The improvement of insomnia was also compared, Bushen-tiaogan tang significantly better than sertraline hydrochloride, while the improvement of cognitive function, both similar to and considering the relatively short observation period;
Conclusion:
1. Bushen-tiaogan tang can be effective in improving depression in old age depression, interest dull core symptoms; the same time, through the liver and kidney tonic to achieve the improvement of whole body fatigue, back pain or other symptoms of somatization;
2. The stable effecite time is about 1 weeks, this study showed that no obvious siae effects. The safety has been verified;
3. In term of insomnia, forgetfulness and other symptoms due to insomnia, forgetfulness and depression have a certain intrinsically linked, so these symptoms improved, depression can also been eased, which also shows that the reinforcement of liver & kidney is effective to improve the overall state of the body in elderly patients with physiological characteristics significantly reduced toxicity and the risks of combination therapy for patients with senile depression non-somatic symptoms of depression related to a certain degree of improvement.
引文
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[1]曲淼,唐启盛,裴清华.益肾疏肝法治疗抑郁症肾虚肝郁型的随机对照临床研究[J].中华中医药学刊.2007,11(25)：2343-2346.
[2]中华医学会精神科分会.CCMD-3中国精神障碍分类与诊断标准[S].济南：山东科学技术出版社,2001.
[3]American psychiatric association. Diagnostic and StatisticalMan-ual ofMental Disorders[M]. Fourth Edition (DSM-Ⅳ).Washington DC,1994.
[4]郑筱萸.中药新药临床研究指导原则(试行)[M].中国医药科技出版社,2005：146-148.