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MBEFT治疗未服药的首发抑郁的疗效评定及电生理机制研究
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摘要
【背景】抑郁症是当今在全球严重影响人类健康的重大疾病,其发病率、复发率、自杀率、犯罪率高。大量研究显示,抑郁症患者对传统治疗(包括药物治疗、ECT、CBT等)的依从性较低,其主要原因是传统治疗的疗程长、费用高、副作用大、治疗过程中患者面临多种障碍等。开发和验证新的安全、经济、快捷、易行的治疗技术既是满足抑郁症临床治疗的迫切需要,更成为现代医学研究的热点和难点。
     文献报道用MB和EFT分别治疗抑郁症后均能一定程度缓解患者症状,但整合两种技术治疗抑郁症是否有效抑或疗效更佳却极少报道。本研究希望通过观察MBEFT治疗不同类型的抑郁症的疗效和安全性,并初步探讨其治疗抑郁症的电生理机制,为尝试研发抑郁症治疗的新技术奠定基础。
     【目的】(1)评价MBEFT干预不同类型的门诊首发抑郁症患者的临床效果。(2)验证MB治疗抑郁症的疗效。(3)比较MBEFT、MB对抑郁症不同临床症候群的改善效果,为今后在临床个性化运用提供指导。(4)通过对抑郁症患者心理干预前后HRV的变化,探讨MBEFT、MB对抑郁症患者自主神经系统的作用规律。
     【方法】
     第一部分为临床试验研究。研究对象为按照DSM-Ⅳ标准诊断为首次发作的抑郁症患者,年龄在18~60岁共51例,以病人就诊顺序随机入组的原则,分为MBEFT治疗组25例和MB治疗组26例;选取正常对照组(即HAMD-17项总分<7,其他条件与治疗组完全匹配)25人,随机分为MBEFT对照组14例和MB对照组11例。对所有被试在履行知情同意程序后采集临床资料,并使用HAMD、SDS、SAS临床量表评定,作为治疗前(基线期)病情的严重程度和临床症侯群的评定。MBEFT治疗组和对照组接受每天1次,每次40分钟的MBEFT干预,连续7天。MB治疗组和对照组的接受每天1次,每次30分钟的MB干预,连续7天。每次心理干预都在神经科学中心心理治疗室由作者本人完成。于治疗结束、随访1周、2周、1月、3月、6月,对所有被试分别使用HAMD、SDS、SAS临床量表评定,评价近期、中期疗效。
     第二部分为电生理试验部分。参加第一部分实验的所有被试于第1天(治疗前),使用RM6240多道生理信号记录仪记录静息态下5min的ECT,作为HRV的基线值。分别于第3、5、8天(治疗结束)、第15天(随访第1周)、第35天(随访1月)时采集静息态下的心电记录5min。使用RM6240多道生理信号采集处理系统做HRV频域分析。根据各受试组不同时点的HRV指标(LF、HF、LF/HF)的变化规律,反映交感-副交感神经系统的功能状态及平衡性,探讨MBEFT、MB影响抑郁症患者自主神经活动的作用规律。
     【结果】第一部分临床评定结果
     (1)抑郁症患者中女性显著多于男性,共病焦虑者高达70%,共病组的HAMD均分显著高于单纯抑郁症组。与MB治疗抑郁症相比,MBEFT治疗依从性高,但失访率也高,其中男性失访率远远高于女性。
     (2)两种技术治疗抑郁症均有效,两种方法在改善临床症状方面无统计学差异。治疗结束时MBEFT组52%的患者可达临床痊愈,36%的患者可达显著水平,12%的患者有改善;MB组60%可达到临床痊愈水平,40%为临床显著改善。
     (3)MBEFT治疗结束后疗效稳定,随访至3月、6月疗效进一步显现,HAMD评分可达正常对照组水平。MB治疗结束至随访3月,疗效进一步显著;随访至6月,疗效有所减弱;随访过程中, HAMD评分始终不能降至正常对照组水平,病人有部分症状残存,预示随着时间推移,部分病例有复然的趋势。
     (4)MBEFT适用于不同严重程度的抑郁症的治疗。1个疗程治疗结束时显示中度组症状改善情况优于轻度、重度两组;但随访1月比较,重度组疗效优于轻、中度组;随访6月比较,三组组间无差异。
     (5)MB适用于不同严重程度的抑郁症的治疗。1个疗程治疗结束时显示,中度组症状改善情况可达显效水平,轻度、重度两组均可达到临床痊愈水平。随访至6月,中组、重度组疗效稳定,而轻度组疗效有所下降,提示有复燃的可能。
     (6)两种疗法对于抑郁症临床各症侯群均有改善作用。治疗结束及随访中,两治疗组的认知障碍因子、迟缓因子的分值相对稳定,组间差异不显著(p>0.05)。治疗焦虑∕躯体化因子、睡眠障碍因子方面,MBEFT中期疗效明显优于MB组。MB中期随访结果预示病人的躯体化和睡眠障碍方面有复燃趋势。
     (7)两种疗法对于改善单纯抑郁者、共病焦虑者的抑郁情绪均有效。 MBEFT治疗抑郁共病焦虑的早期疗效较好,但随访中HAMD分值有波动,而对单纯抑郁组疗效于随访1周有波动,随访1月、3月、6月都很稳定。MB对于抑郁共病焦虑和单纯抑郁的患者同样有效。两组间HAMD在随访1周、1月差异显著。MBEFT治疗抑郁共病焦虑者的焦虑情绪与MB效果无差异。
     (8)医患双方在抑郁严重程度的评定上具有较好的一致性。也表明HAMD和SDS工具评定抑郁的有效。
     (9)从自评(SDS、SAS)结果显示,MBEFT、MB对于改善抑郁患者的抑郁、焦虑情绪均有效,且疗效比较稳定。随访至3月,两种疗法对缓解焦虑的疗效更加显著;但MBEFT的疗效略优于MB。MBEFT对抑郁症(特别是共病焦虑的抑郁)疗效优于MB。
     第二部分电生理实验结果
     (1)1个疗程的MBEFT、MB干预均能显著降低抑郁症患者的LF值,达到正常人的水平;随访1周、1月LF值基本稳定。实验过程中两个正常对照的LF值无显著变化(p>0.05)。
     (2)1个疗程的MBEFT、MB的干预均能显著提升抑郁症患者的HF值,使之达到正常人水平;两种干预在随访中虽都有波动,但幅度不太大,差异不显著。MB干预提高抑郁症患者的HF值更明显,但差异无统计学意义。与MBEFT组,MB组治疗结束到随访1周,临床痊愈率、显效率均高于MBEFT组。两组间HF的变化幅度与临床疗效的判断结果比较一致。实验过程中两个正常对照的HF值无显著变化(p>0.05)。
     (3)1个疗程的MBEFT、MB干预显著降低抑郁症患者的LF/HF值,使之达到正常人水平;随访1周、1月LF/HF值比较稳定。随访中这种差异逐渐消失。实验过程中两个正常对照的LF值无显著变化(p>0.05)。【结论】
     1. MBEFT、MB对不同严重程度的抑郁症的抑郁、焦虑情绪改善均有效,但MBEFT对重度抑郁及抑郁共病焦虑者疗效更佳,疗效稳定且持久。MB治疗抑郁后仍有部分残存症状(特别是焦虑/躯体化和睡眠障碍方面),预示有复燃的可能。
     2. MBEFT、MB影响HF的变化幅度与临床疗效的判断比较一致,提示HF可以作为临床疗效评价的一个灵敏的、客观的、量化的指标。MBEFT通过提高副交感神经的兴奋性,调节交感-副交感神经系统的平衡而缓解抑郁症状。
【Background】As a global major disease, depression affects humanhealth seriously with a high incidence rate, recurrence rate, crime rate andSuicide rate. Numerous studies have shown that, the compliance of patientswith depression to the traditional therapy (including medication, ECT, CBTet al.) is low and the main reason is the traditional treatment is facing variousobstacles such as the long course, high cost and considerable side effects. Todevelop and validate a new treatment technology which is more secure,economic, fast, and easy, it is not only to meet the urgent need of clinicaltreatment of depression, but also to become a modern medical researchhotspot and difficulty.
     Reported in the literature, with MB and EFT respectively in treatmentof depression, to some extent, can alleviate the symptoms, but there is rarelyreport regarding the integration of the two techniques in the treatment ofdepression is effective or even better. This study explores theelectrophysiological mechanism of the treatment through observation the efficacy and safety of MBEFT in the treatment of different types ofdepression, so as to lay a foundation for trying to develop new technology tothe treatment of depression.
     【Purpose】(1) To valuate the clinical effect of MBEFT interventionin different types of outpatients with first-episode depression.(2) To test andverify the MB treatment’s curative effect of depression.(3) To compare theimprovements of MBEFT and MB on depression of different clinicalsyndrome, and to provide guidance for the clinical individualization use inthe future.(4) To explore the law that MBEFT and MB act on the patients’autonomic nervous system through their HRV change before and afterpsychological intervention.
     【Methods】The first part is clinical trials. According to the DSM-Ⅳcriteria,51patients at the age of18to60as the research objects havediagnosis of depression of the first attack, with the principle of randomdivide into two groups in accordance with their clinical order: the MBEFTtreatment group25cases and the MB treatment group26cases. Selectnormal control group (namely the total score of HAMD-17<7, otherconditions match with the treatment group)25people, randomly divided intoMBEFT control group14cases and MB control group11cases. After theperformance of the informed consent procedures, collect all the subjects’clinical data, and assess it with HAMD, SDS, SAS clinical scale, as theseverity of the illness and clinical syndrome evaluation before treatment (baseline period). MBEFT treatment group and control group to acceptMBEFT intervention once a day, each time40minutes, for seven days. MBtreatment group and control group to accept MB intervention once a day,each time30minutes, for seven days. Every time the psychologicalintervention was completed by the author in the neuroscience centerpsychological treatment room. In the end of therapy, follow-up after oneweek, two weeks,1month,3months,6months, all subjects were evaluatedrespectively by HAMD, SDS and SAS clinical scale for their short, mediumcurative effect.
     The second part is the electrophysiological test. In the first day (beforetreatment), all subjects that had joined in the first part of the experiment, wasrecorded resting state5min ECT by using RM6240multi-channelphysiological signal recorder, as HRV baseline values. On the third, fifth,eighth day (the end of treatment), the fifteenth day (follow-up first week),and the thirty-fifth day (follow-up a month) collected their ECG records for5min under resting state. Using RM6240multi-channel physiological signalacquisition and processing system for HRV frequency domain analysis.According to the law of change of the HRV index (LF, HF, LF/HF) of eachtested group at different time points, reflects the function and balance of thesympathetic-parasympathetic nerve system, and explore the law MBEFT,MB affecting the autonomic nervous activity of patients with depression.
     【Results】The first part Results of clinical evaluation
     Among patients with depression, the number of women is significantlymore than that of men, and comorbidity anxiety amounts as high as70%, andthe HAMD equipartition of the comorbidity group is significantly higherthan that of pure depression group. Compared with MB treatment ofdepression, MBEFT treatment compliance is higher, but the rate of loss tofollow-up is also higher, of which the men’s is much higher than thefemale’s.
     The two kinds of techniques in the treatment of depression are botheffective, and they have no statistical difference in improving the clinicalsymptoms. At the end of treatment,52%patients of the MBEFT groupreached clinical recovery;36%can up to significant level;12%haveimproved; while60%of the MB group can achieve clinical recovery leveland40%have significant clinically improvement.
     After the end of MBEFT treatment, its curative effect is stable, whichwas shown further in the follow-up to3months and6months, HAMD scorecould up to a normal control group level. The significant effect of MBtreatment showed further from the end of treatment to3months’ follow-up;to the6th month’s follow-up, it was weakened; during the follow-up, theHAMD score still could not down to the normal control group level, patientshad some residual symptoms, signaling that over time, some cases wouldhave the tendency of recurrence.
     The MBEFT is applicable to the treatment of depression in different degrees. At the end of a course’s treatment, the symptoms of the moderategroup improved better than the mild group and the severe one; but comparedwith the1month’s follow-up, the severe group is better than that of mild,moderate ones; compared with the6th month’s follow-up, there was nodifference among them.
     The MB is applicable to the treatment of different depression degrees.At the end of a course’s treatment, the symptoms of the moderate groupimproves up to show level, the mild, severe two groups can achieve clinicalrecovery level. Follow up to the6th month, the curative effect on themoderate and severe group is stable, while the mild group efficacy hasdeclined, suggesting the possibility of recurrence.
     The two treatments both can improve the clinical syndrome ofdepression. At the end of treatment and during the follow-up, the scores ofthe two treatment groups’ cognitive impairment factor, retardation factorwere relatively stable and no significant differences between groups (P>0.05). On the treatment of anxiety/body factors and sleep disorder factors,the middle curative effect of MBEFT is obviously superior to the MB group.The midterm follow-up results of MB indicate the trend of patients’ bodyand sleep disorders recurrence.
     The two therapies both are valid to improve the depression of patients’with pure depression and comorbidity anxiety. In the treatment of depressioncomorbidity anxiety, MBEFT have a good early curative effect, but the scores of HAMD fluctuate in the follow-up; while its efficacy of the puredepression group fluctuates in the1week’s follow-up but stay stable in thefollowing follow-up of1month,3month and6month. MB is as effect fordepression comorbidity anxiety and pure depression patients. Between thetwo groups, HAMD is significantly different in follow-up for1week and1month. In the treatment for anxiety to patients’ with depression comorbidityanxiety, MBEFT and MB have no different effects.
     Both the doctors and patients in depression severity evaluation havegood consistency. It also shows that HAMD and SDS tools assessment ofdepression is effective.
     The self evaluation result (SDS, SAS) shows, MBEFT, MB areeffective for the improvement in depressive patients with depression andanxiety, and the curative effect is stable. Follow up to3months, the effect ofthe two kinds of therapy to relieve anxiety is more obvious; but the effect ofMBEFT is slightly better than that of MB. The curative effect of MBEFT ondepression (especially the depression comorbidity anxiety) is better than thatof MB.
     The second part Electrophysiological experiments
     (1) A course’s MBEFT and MB intervention both can significantlyreduce the LF value of patients with depression, reach the normal level; theLF value is basically stable in the follow-up1week and1month. During theexperimental process, the LF values of the two normal control groups had no significant change (P>0.05).
     (2) A course’s MBEFT and MB intervention can significantly improvethe HF value of patients with depression, so as to reach the normal level.Although the two interventions have fluctuated during the follow-up, but therange is not too big, the difference is not obvious. MB intervention improvethe HF value of patients with depression is more obvious, but the differenceshave no statistical significance. Compared with the MBEFT group, from theend of treatment to the1week follow-up, MB group’s clinical cure rate andeffective rate were higher than the MBEFT group. The HF value change ofthe two groups is consistency with the clinical judgment results. During theexperimental process, the HF values of the two normal control groups had nosignificant change (P>0.05).
     (3) A course’s MBEFT and MB intervention significantly reduced theLF/HF value of patients with depression, so as to reach the normal level; theLF/HF value is relatively stable in the follow-up1week and1month. Thisdifference gradually disappeared during the follow-up. During theexperimental process, the LF values of the two normal control groups had nosignificant change (P>0.05).
     【Conclusion】
     1. MBEFT and MB both are effective to improve the depression andanxiety of different levels severity of depression, but MBEFT has a bettereffect which is stable and lasting on severe depression and depression comorbidity anxiety. After the MB treatment of depression, there were stillsome residual symptoms (especially anxiety/body and sleep disorders),suggesting the possibility of recurrence.
     2. The range of the MBEFT and MB effect on HF is relativelyconsistent with the clinical judgment, suggesting HF can be used as asensitive, objective, quantified index on clinical curative effect evaluation.Through the enhancement of the excitability of the parasympathetic nerve,MBEFT regulates the balance of the sympathetic-parasympathetic nerve torelieve the symptoms of depression.
引文
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