盐酸安非他酮治疗抑郁症的疗效观察

目的评价盐酸安非他酮片治疗抑郁症的临床疗效和不良反应。方法将符合CCMD-3诊断标准的单相抑郁发作和双相情感障碍抑郁发作的患者65例,给予盐酸安非他酮片75～300mg/d,疗程均为42d。采用汉密尔顿抑郁量表(HAMD)和不良反应量表(TESS)评定疗效和药物不良反应,实验室检查包括血常规、尿常规、生化和心电图。结果,临床有效率78.5%(51/65).不良反应率为12.3%(8/65).未见严重不良反应。结论安非他酮能有效治疗抑郁症,不良反应轻微。     

安非他酮与帕罗西汀治疗抑郁症的治疗依从性对照研究

目的评价安非他酮与帕罗西汀治疗抑郁症的药物疗效。方法将60例符合CCMD-3抑郁症诊断标准的患者随机分为2组,分别给予安非他酮和帕罗西汀,治疗后1,2,4,6周后评价疗效和观察不良反应。结果 2组改善抑郁症状的起效时间相似,治疗6周末汉密顿抑郁量表(HAMD)评分分值下降无统计学意义,但安非他酮组药物不良反应较帕罗西汀组少。结论安非他酮治疗抑郁症患者更可以提高病人的治疗依从性。     

安非他酮缓释片治疗抑郁症的随机双盲多中心临床试验

目的评价安非他酮缓释片治疗抑郁症的疗效和安全性。方法采用随机、双盲双模拟、多中心、平行对照(氟西汀),为期6 wk。共入组237例,完成232例,其中安非他酮组117例,氟西汀组115例。2组分别服用安非他酮缓释片300 mg.d-1和氟西汀20 mg.d-1治疗。结果治疗6 wk后,安非他酮组和氟西汀组的汉密尔顿抑郁量表(HAMD)总分减分值分别为(12.45±6.85)与(12.63±6.10)分,有效率分别为69.23%与67.83%,临床痊愈率分别为35.04%和45.22%,2组相比差异均无统计学意义(P>0.05)。非劣效性检验显示,安非他酮组疗效非劣于氟西汀组。2组的不良反应发生率分别为52.14%和52.17%,差异无统计学意义(P>0.05)。结论安非他酮缓释片是一种安全有效的抗抑郁药。     

本刊“医药专论”专题预告

本刊2012年第7期"医药专论"将聚焦抗抑郁药物的临床应用。抗抑郁药物的种类繁多,临床应用广泛,目前新型抗抑郁药物的研发和临床应用研究已取得很大进展。如何选择抗抑郁药物并同时客观评价药物的疗效以指导临床实践尤为重要,由复旦大学附属中山医院心理医学科季建林教授撰写的抗抑郁药物治疗的起效与疗效评价从循证医学的角度评估不同抗抑郁药物治疗急性期抑郁症的疗效,并探讨难治性抑郁症的治疗策略及疗效评估。妊娠期焦虑和抑郁的治疗需权衡抗抑郁药物     

安非他酮与舍曲林治疗抑郁症疗效比较

目的比较安非他酮与舍曲林对抑郁症的疗效及其安全性。方法125例抑郁症分为2组。安非他酮组63例[男性30例,女性33例,年龄(36±s 13)岁,本次抑郁病期(3±5)mo]予安非他酮300～450 mg·d~(-1),po,bid;舍曲林组62例[男性28例,女性34例,年龄(40±11)岁,本次抑郁病期(3±4)mo]予舍曲林50～100 mg,po,qd;均6 wk为一个疗程。结果对抑郁症状的治疗,安非他酮组显效率71%,舍曲林组显效率74%,2组疗效比较差异无显著意义(P>0.05);对伴随焦虑症状的治疗,安非他酮组显效率48%,舍曲林组显效率45%,2组疗效比较差异无显著意义(P>0.05)。整体药物不良反应发生率2组相当。结论安非他酮与舍曲林疗效相当,能有效治疗抑郁症及伴随焦虑症状,不良反应轻微。     

国产安非他酮缓释片治疗抑郁症的Ⅱ期临床研究

目的:评价安非他酮治疗抑郁症的疗效和安全性。方法:采用随机、双盲、多中心、平行对照研究。共入组抑郁症患者237例,其中试验组119例,对照组118例,分别口服安非他酮150～450 mg·d-1,氟西汀10～30 mg·d-1。疗程均为6周。用汉密尔顿抑郁量表(HAMD)和临床总体印象量表(CGI)评定疗效,药物不良反应量表(TESS)评定安全性。结果:治疗6周后两组患者HAMD评分较基线均显著降低(P<0．05),总有效率安非他酮组70．69％,氟西汀组74．14％。组间差异无显著性(P>0．05)。不良反应发生率安非他酮组41．4％,氟西汀组44．8％,组间差异无显著性(P>0．05)。结论:安非他酮治疗抑郁症安全有效。     

盐酸安非他酮缓释片治疗焦虑症的临床观察

目的观察盐酸安非他酮缓释片用于焦虑症临床治疗的疗效及不良反应,探讨安非他酮作为新型抗焦虑药物的应用价值。方法选取59例焦虑症患者,按照分段随机法分为安非他酮组(治疗组)30例及氟西汀组(对照组)29例,两组患者分别口服安非他酮片300mg/d及氟西汀片20mg/d,疗程均为6周。分别于治疗前后采用汉密尔顿焦虑量表(HAMA)及临床总体印象量表(CGI)评价两组疗效,并进行统计学分析及安全性分析。结果疗程结束后,治疗组及对照组的临床有效率分别为66.7%、65.6%(P>0.05),HAMA减分值分别为(8.80±5.59)、(8.79±5.31)(P>0.05),临床总体印象降低值分别为(2.60±0.86)、(2.93±1.03)(P>0.05),不良事件发生率分别为63.3%,48.3%(P>0.05),未发生严重不良事件,各项指标差异均无统计学意义。结论盐酸安非他酮用于焦虑症的治疗具有与氟西汀相近的疗效及安全性,可作为一种新型抗焦虑药物用于临床治疗。     

盐酸安非他酮与盐酸氟西汀治疗抑郁症的临床研究

目的比较安非他酮与氟西汀对抑郁症的疗效和安全性。方法将125例抑郁症患者随机分为两组,研究组口服安非他酮治疗,对照组口服氟西汀治疗,均6周一个疗程。研究组63例,男30例,女33例;平均年龄(38.8±12.4)岁,平均病程(15.5±4.9)个月,予安非他酮300～450mg/d,po,tid。对照组62例,男28例,女34例;平均年龄(35.9±11.1)岁,平均病程(14.9±8.6)个月,予氟西汀20～40mg/d,po,qd。结果对抑郁症的治疗,安非他酮组显效率71%,氟西汀组为74%,两组间疗效比较无显著性差异(P>0.05);对伴随焦虑症状的治疗,安非他酮组显效率48%,氟西汀组显效率45%,两组比较无显著性差异(P>0.05)。两组不良反应发生率均较低,且程度较轻微。结论安非他酮与帕罗西汀治疗抑郁症总体疗效相当,能有效治疗抑郁及伴随焦虑症状,且安全性高。     

盐酸安非他酮缓释片治疗抑郁症的Ⅱ期临床研究

目的 评价盐酸安非他酮缓释片治疗轻中度抑郁症的临床疗效和安全性。方法 对符合《CCMD》勘抑郁症诊断标准的66例抑郁症患者进行盐酸安非他酮缓释片和氟西汀的对照研究，其中盐酸安非他酮缓释片组34例（300mg／d），氟西汀组32例（20mg／d），共治疗6周。采用汉密尔顿抑郁量表（HAMD），汉密尔顿焦虑量表（HAMA），临床总体评定量表（CGI）评定临床疗效，副反应量表（Tess）评定不良反应。结果经6w治疗后，盐酸安非他酮缓释片治疗总有效率为76．47％，氟西汀组为75．00％，两组比较。差异无显著性（P〉0．05）。两组的HAMD，HAMA评分治疗前后相比较差异有高度显著性（P〈0．01）。不良反应分析，两组药物不良反应的发生率无显著性差异（P〉0．05），常见的不良反应有恶心、口干、头昏、失眠、出汗、食欲减退、便秘等。结论 盐酸安非他酮缓释片治疗抑郁症安全有效。     

盐酸安非他酮缓释片治疗抑郁症的随机、双盲、平行对照的多中心临床研究

目的评价盐酸安非他酮缓释片治疗抑郁症的有效性和安全性,以及治疗该症伴随焦虑的疗效。方法共收集抑郁症患者211例,安非他酮组(治疗组)107例,氟西汀组(对比组)104例。采用多中心、随机、双盲双模拟、阳性药平行对照,剂量固定的研究。受试者分别口服安非他酮片300mg/d或氟西汀片20mg/d,疗程6周。结果治疗6周后,安非他酮组和氟西汀组的HAMD总分减分值分别为(11.75±6.66)、(11.91±5.43)(P=0.843);有效率分别为69.2%、74.0%(P=0.432);疾病严重度和总的进步评分(CGI)相比,P=0.295,0.245;治疗该症伴焦虑的HAMA总分减分评价疗效分别为(8.71±6.15)(、8.75±5.57),P=0.952。以上结果提示各项指标的对比均无统计学差异。不良反应为主要为口干、头昏、恶心。结论盐酸安非他酮缓释片治疗抑郁症和/(或)伴随焦虑的疗效和安全性与盐酸氟西汀相似,认为其可作为一种安全有效的新型抗抑郁药物。     

The effect of functional gastrointestinal disorders on psychological comorbidity and quality of life in patients with inflammatory bowel disease

Background  Symptoms of functional gastrointestinal disorders (FGIDs) are common in patients with inflammatory bowel disease (IBD). Psychological comorbidities of anxiety and depression are also highly prevalent in IBD.
Aim  To quantify the burden of FGIDs in a hospital-based cohort of patients with IBD and to determine whether there is any inter-relationship between the presence and number of FGIDs and patients' quality of life or psychological status.
Methods  A cross-sectional survey of 61 out-patients was performed. Data on psychological status, quality of life, disease activity and functional symptoms according to Rome III criteria were collected.
Results  Overall, 49 (80%) participants met Rome III criteria for a functional bowel disorder and 52% of participants met criteria for more than one FGID. Participants with no FGID had significantly better physical quality of life than those with more than two FGIDs ( P  = 0.025). However, there was no relationship among the number of FGIDs, mental quality of life, anxiety or depression.
Conclusions  Functional gastrointestinal disorders are highly prevalent in out-patients with IBD. Somewhat unexpectedly, the presence of anxiety and/or depression did not appear to correlate with either the presence or the number of FGIDs.     

Fluoxetine treatment of depressed patients with comorbid anxiety disorders

Major depression with comorbid anxiety disorder is associated with poor antidepressant outcome compared to major depression without comorbid anxiety disorder. The purpose of our study was to assess changes in severity of both depressive and anxiety symptoms in outpatients with major depression with comorbid anxiety disorder following fluoxetine treatment. We enrolled 123 outpatients (mean age 38.9 +/- 10.8 years; 49% women) with major depressive disorder accompanied by one or more current comorbid anxiety disorders in our study. Patients were treated openly with fluoxetine 20 mg/day for 8 weeks. Efficacy assessments included the 17-item Hamilton Rating Scale for Depression (HAM-D) and the patient-rated Symptom Questionnaire (SQ) Scales for Depression and Anxiety. The mood and anxiety disorder modules of the Structured Clinical Interview for DSM-III-R were administered at screen and endpoint. We used 'intent-to-treat' analysis in examining all patients assigned to treatment and completing the baseline visit. The mean number of comorbid anxiety disorders per patient was 1.5 +/- 0.68. The mean HAM-D-17 score and mean Clinical Global Impressions-Severity scores decreased significantly from baseline to endpoint (week 8) following fluoxetine treatment (p < 0.0001). There were significant decreases in all four SQ scale scores, from baseline to endpoint: depression, anxiety, somatic symptoms and anger-hostility (p < 0.0001). Fifty-three percent of patients (n = 65) were depression responders (i.e. > or = 50% decrease in HAM-D-17 score at endpoint) and 46% (n = 57) were remitters (HAM-D-17 < or = 7 at endpoint). Patients with panic disorder had significantly higher baseline HAM-D-17 scores compared to those without panic disorder (p < 0.01). Patients with comorbid obsessive-compulsive disorder (OCD) were significantly less likely to be responders to fluoxetine at endpoint (> or = 50% decrease in HAM-D-17) and to be remitters (HAM-D-17 score of s 7 at endpoint) compared to patients without comorbid OCD (p < 0.01). Of the 41 patients on whom endpoint Structured Clinical Interview for DSM-III-R modules for anxiety disorders were available, 49% (n = 20) no longer met criteria for one or more of their anxiety disorder diagnoses at endpoint. Our preliminary findings suggest that fluoxetine is effective in treating outpatients with major depression with comorbid anxiety disorders, with a significant effect on both depression and anxiety symptoms. Further double-blind, placebo-controlled trials are required in larger samples to confirm our findings.     

Correlates and outcomes of depressed out-patients with greater and fewer anxious symptoms: a CO-MED report

The objective of this paper was to determine whether the presence of more vs. fewer anxious symptom features, at baseline, are associated with other clinical features and treatment outcomes in out-patients with major depressive disorder (MDD). This single-blind, randomized trial enrolled 665 MDD out-patients to compare the efficacy of two antidepressant medication combinations against escitalopram after 12-wk acute treatment and follow-up (total 28 wk). The sample was divided into those with greater (vs. fewer) anxiety features using the anxiety/somatization subscale of the baseline 17-item Hamilton Rating Scale for Depression. Baseline sociodemographic and clinical features, treatment features and outcomes compared these two groups. Overall, 74.7% of participants met the threshold for 'anxious features'. They were more likely to be female, have other concurrent anxiety disorders, more severe depression, more lethargic and melancholic features and poorer cognitive and physical functioning, quality of life and work and social adjustment. In acute treatment, participants with anxious features received comparatively higher doses of mirtazapine and venlafaxine and reported more side-effects. The groups with and without anxious features did not differ in treatment outcomes and side-effect burden. Despite being associated with a distinct clinical profile, baseline anxious features were not clinically useful in predicting acute treatment outcomes or differential treatment response.     

Influence of the dopamine D2 receptor (DRD2) exon 8 genotype on efficacy of tiapride and clinical outcome of alcohol withdrawal.

We tested the hypothesis that allelic variants of the human dopamine D2 receptor E8 genotype are associated with (i) dopamine D2 antagonist tiapride dose in treatment of alcohol withdrawal (n = 50) and (ii) with anxiety and depression in patients during alcoholism detoxification therapy (admission n = 87; discharge n = 50). DRD2 E8 A/A genotype was associated with increased dose of tiapride during a 9-day detoxification therapy and with increased anxiety and depression scores on admission and 2 weeks later. The findings suggest a pharmacogenetic influence of DRD2 E8 genotype on tiapride efficacy in alcohol withdrawal. In an earlier report, DRD2 E8 A/A genotype was associated with reduced responsiveness to the dopamine D2 agonist apomorphine; however, it is not clear whether both findings share the same biological basis. Earlier findings concerning association of DRD2 E8 A/A with increased anxiety and depression are replicated for the first time.     

St. John's wort versus placebo in social phobia: results from a placebo-controlled pilot study

Recognition of social anxiety disorder (social phobia) as a common and disabling condition has led to new advances in its pharmacotherapy. Limitations with selective seroton reuptake inhibitors (side effects) and behavior therapy (scarcity of trained therapists), coupled with the tendency for patients with the disorder to self-medicate with alternative treatments, have led to the interest in Saint John's wort (SJW) (Hypericum perforatum) for this disorder. Although the literature is mixed, SJW has demonstrated efficacy in several double-blind depression trials, and some open-label studies with anxiety disorders. There is pharmacokinetic evidence for the serotonergic, domaminergic, and GABAminergic activity of hypericum, all of which are implicated in social anxiety disorder. This study was designed to generate pilot data to examine the potential efficacy of SJW in generalized social anxiety disorder. Forty subjects were randomized to 12 weeks of treatment with a flexible dose (600-1800 mg) of SJW (n = 20) or placebo (n = 20). Subjects with comorbid depression (clinician HAMD > 16) were excluded. Results found no significant difference between mean change on the Liebowitz Social Anxiety Scale with SJW (11.4) and placebo (13.2), P = 0.27, effect size = -0.09. Post-hoc analyses found larger effects sizes associated with increased baseline severity, omitting patients with variable scores (+/-30%) during the first week, and use of self-report HAMD scores for exclusion. Results of the study fail to provide evidence for the efficacy of SJW in social phobia. The impact of methodologic improvements on signal detection, while suggestive of improvement, remains to be established.     

心理社会因素与脑卒中发生的关系进一步分析

目的探讨心理社会因素与脑卒中发生的关系。方法运用LES、TABPQ、TAS、SDS、SAS和自编资料调查表,对102例治疗组和98例对照组在不同行为类型、是否伴有焦虑和（或）抑郁情绪障碍、一年内发生重大生活事件多少进行分组对照分析。结果与对照组相比,治疗组A型行为人数多（P〈0.01）,负性生活事件分数高（P〈0.01）,有焦虑和抑郁情绪障碍者多见（P〈0.01）。结论A型行为、负性生活事件多发和情绪障碍是脑卒中发生的危险因素。     

Antidepressant use and salivary cortisol in depressive and anxiety disorders

Antidepressants are an effective treatment for depressive and anxiety disorders. Those disorders are frequently accompanied by heightened cortisol levels. Antidepressants may affect hypothalamic–pituitary–adrenal axis functioning, the alteration of which could be partially responsible for treatment efficacy. The association between antidepressants and cortisol was investigated in 1526 subjects of the Netherlands Study of Depression and Anxiety who were grouped into ‘serotonin reuptake inhibitor (SSRI) users’ (n = 309), ‘tricyclic antidepressant (TCA) users’ (n = 49), ‘other antidepressant users’ (n = 100), and ‘non-users’ (n = 1068). All subjects had a current or past diagnosis of anxiety and/or depression. Subjects provided 7 saliva samples from which 3 cortisol indicators were calculated: cortisol awakening response (CAR), evening cortisol, and cortisol suppression after ingestion of 0.5 mg dexamethasone. As compared to non-users, TCA users had a flattened CAR (effect size: Cohen's d = 0.34); SSRI users had higher evening cortisol levels (d = 0.04); and SSRI users showed decreased cortisol suppression after dexamethasone ingestion (d = 0.03). These findings suggest that antidepressant subtypes are associated with distinct alterations of the HPA axis. TCA users, who showed a flattened CAR, displayed the strongest alterations of salivary cortisol.     

Treatment of depression with comorbid anxiety disorders: differential efficacy of paroxetine versus moclobemide

To compare the efficacy and tolerability of moclobemide versus paroxetine for the treatment of depression with comorbid anxiety disorders. Outpatients fulfilling DSM-III-R criteria for major depression or dysthymia and for a co-occurring comorbid anxiety disorder (panic disorder, generalized anxiety disorder or obsessive-compulsive disorder) after a 1-week run-in phase were randomly assigned to open-label moclobemide (300-600 mg/day) or paroxetine (20-40 mg/day) for 4 months. Primary criterion for response was a 50% score reduction from baseline on Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale scores. Mean changes in Clinical Global Impressions Severity of Illness and Improvement Scales (CGI-I) were also used to evaluate treatment response. Of the 123 patients included in the study, 65 were randomly assigned to moclobemide and 58 to paroxetine. At study end, the two treatment groups did not differ significantly in terms of proportion of responders. Treatment group differences emerged when comorbid anxiety diagnoses were considered. In patients with comorbid panic disorder, paroxetine was superior to moclobemide in improving both anxiety and depression (five patients out of 18 in the moclobemide group and nine out of 14 in the paroxetine group were rated as responders according to CGI-I, P = 0.04). Neither medication was superior in treating comorbid generalized anxiety disorder. These findings indicate that both moclobemide and paroxetine are effective for treatment of depression with comorbid anxiety disorders. However, in the subgroup with comorbid panic disorder, paroxetine is more effective than moclobemide in reducing both depressive and anxiety symptoms.     

利培酮对焦虑抑郁共病的疗效比较

目的观察利培酮联合氟西汀对焦虑抑郁共病的疗效和安全性。方法86例焦虑抑郁共病患者随机分为研究组(利培酮 氟西汀)44例、对照组(氟西汀)42例,治疗8周。于治疗前、治疗后每2周测评汉密尔顿抑郁量表(HAMD)24项、汉密尔顿焦虑量表(HAMA)、治疗中需处理的不良反应量表(TESS)。疗效评价以HAMD减分率为标准,不良反应以TESS评分为标准。结果两组HAMD、HAMA评分组间比较从第2周周末开始差异有显著性(P<0.05、P<0.01),两组疗效比较差异有显著性(P<0.05),各时期TESS评分比较差异无显著性(P>0.05)。结论利培酮联合氟西汀治疗焦虑抑郁共病的疗效和安全性较好。     

乌灵胶囊治疗伴轻中度抑郁焦虑症状的老年功能性消化不良的多中心随机对照临床试验

目的观察乌灵胶囊对伴轻、中度抑郁焦虑症状的功能性消化不良老年患者的疗效,并评估其临床应用的安全性。方法采用多中心、随机、阳性药物平行对照试验方法,以氟哌噻吨-美利曲辛为对照药物。266例功能性消化不良患者被随机分成试验组(145例)和对照组(121例)。试验组给予乌灵胶囊口服,3粒,每日3次;对照组给予氟哌噻吨-美利曲辛口服,1片,每日1次,疗程均为6wk。同时2组受试者均根据功能性消化不良分型及症状酌情给予抑酸、促动力、助消化药物。观察2组临床疗效、汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分及匹兹堡睡眠质量指数(PSQI)评分;根据副反应量表观察不良反应。结果试验组在治疗2、4及6 wk末的临床疗效与对照组相比均无显著差异(P>0.05);2组治疗6wk后与治疗前比较均有显著改善(P<0.01)。4、6wk末试验组的HAMD评分和HAMA评分的减分率均高于对照组。2组治疗6wk末PSQI评分与治疗前相比,均有显著改善(P<0.05),2组间PSQI评分的减分率无显著差异(P>0.05)。2组均无中、重度不良反应发生。结论乌灵胶囊治疗伴轻、中度抑郁焦虑症状的老年功能性消化不良患者的疗效较好,不良反应小,安全性好。