Zimeldine to geriatric patients in once daily dosage. A pharmacokinetic and clinical study

The therapeutic efficacy, tolerability and pharmacokinetics of zimeldine in elderly depressed patients were evaluated after administration of different doses of the drug in once daily evening doses. The doses of zimeldine were 100 mg during the first 2 weeks, 150 mg during the next 2 weeks and 200 mg during the last 2 weeks. Nine of the 11 patients (mean age 78 years) included in the study completed the 6-week treatment period, and all nine improved according to the Hamilton depression rating scale. The drug was well tolerated and the side effects were few and mild. No influence of clinical importance was noted in haematology, liver and kidney functions, EEG, blood pressure or pulse rate. Steady-state plasma concentrations of zimeldine, and its active metabolite norzimeldine, were achieved in most cases after 1 week of treatment in each dose regimen. The plasma concentrations increased linearly with the increase in dose. The maximal interindividual variations in plasma concentrations were 8-fold for zimeldine and 3-fold for norzimeldine . The plasma levels of both zimeldine and norzimeldine were higher in the elderly than reported earlier in younger patients. The ratio of norzimeldine/zimeldine concentrations was reduced in the elderly, indicating a reduction of the metabolic capacity. The results suggest that zimeldine can be administered in a once daily dosage regimen to elderly patients, but they should be given a lower dose than younger patients.     

氟西汀和曲唑酮的抗焦虑作用

目的　观察氟西汀 (fluoxetine)和曲唑酮 (trazodone)对焦虑症状的改善作用。方法　选择符合CCMD II R抑郁症诊断标准、伴有焦虑或单纯广泛性焦虑的病例共 148例 ,按就诊顺序随机分为 4组。一组单用氟西汀2 0mg/d ,一组用氟西汀 2 0mg/d加曲唑酮 50～ 10 0mg/d ,一组用氟西汀 2 0mg/d加罗拉 1 5mg/d ,一组用安慰剂加少量安定或 10g/dL水化氯醛。观察 8周。结果　氟西汀能有效的改善焦虑症状 ,但疗效出现较晚 ,第 6周才显示抗焦虑效果。加用曲唑酮或罗拉能加强氟西汀的抗焦虑作用 ,同时能缓解氟西汀在用药早期加重焦虑和影响睡眠的副作用。结论　氟西汀有抗焦虑疗效。用氟西汀抗焦虑的早期加用曲唑酮或罗拉有利于病情的缓解和提高患者的治疗依从性。     

Efficacy and tolerability of trazodone retard monotherapy: results of the Serbian non-interventional study

Objective: Trazodone is an effective antidepressant. The present study was designed as a non-interventional open-label, multi-centre, post-marketing study. The aim of the study was to evaluate the therapeutic effectiveness and tolerability of trazodone retard formulation (Trittico^® retard) in everyday clinical practice.

Methods: Two hundred and forty-two patients with depressive disorder from 19 different centres were included in the study. The antidepressant and anxyolitic effects were assessed using Hamilton anxiety rating scale 14 items version, Hamilton depression rating scale 14 items version and Clinical Global Impression Severity scale.

Results: After only two weeks of therapy, a statistically significant improvement in the HAM-D score, was observed. This observation was maintained over the whole study period, up to the day 56.

Conclusions: Our study points toward clinical effectiveness of the prolonged-release formulation of trazodone in the treatment of unselected depressed patients in real-world practice.     

Gender differences in efficacy and sexual function in long-term trazodone treatment (preliminary results)

Objects. To evaluate the effect of trazodone on depressive or anxiety symptoms and sexual function depending on patient gender. Method. A total of 111 patients (59 men, 52 women) subjected to long-term treatment with trazodone were studied. The effect of the therapy was recorded according to the Clinical Global Impression – Severity of Illness (CGI-S) scale. The incidence of sexual dysfunction was assessed on the Utvalg for Kliniske Undersogelser (UKU) scale. Results. The effect of the therapy was similar in both genders. The incidence of diminished sexual desire was low and comparable in both genders; orgasmic dysfunctions were present only in women at the level of statistical significance. A positive correlation between the severity of the illness and the occurrence of diminished sexual desire and orgasmic dysfunction was found in women but not in men. Conclusion. The occurrence of sexual dysfunctions in trazodone therapy was lower than in population. It seems that trazodone is an effective therapy of depressive and anxiety symptoms in both genders and it is convenient for sexually active patients, because the occurrence of sexual dysfunctions was present the general to a low degree.     

Tricyclic antidepressants in the treatment of depressions. A double-blind clinical comparison of clomipramine (Anafranil) and amitriptyline.

The clinical efficacy of oral clomipramine and amitriptyline treatment (50--125 mg/day) was compared over a period of 2 months in 72 depressive patients visiting a psychiatric out-patient clinic. Both drugs were equally effective as measured by the Hamilton Rating Scale for Depression. According to a nurse's independent evaluation of 13 items the two drugs were equipotent in relieving depressive symptoms and no statistically significant differences between the treatment groups were found in the global evaluation by the investigator and the patient. A trend in favour of clomipramine was, however, seen in several parameters. The declines in the Hamilton Rating Scale scores and the nurse's evaluation scores were highly significant during the first 2 weeks of treatment (P less than 0.001) in both groups and the scores continued to decrease during the 2nd month of the study. The most common unwanted effects were dryness of the mouth and fatigue. The frequency of side effects was 51% in the clomipramine group and 43% in the amitriptyline group. The side effects were generally mild and transient and called for discontinuation of treatment in only one case in each group.     

曲唑酮治疗抑郁症患者睡眠障碍的交叉试验研究

目的：验证曲唑酮对抑郁症患者的睡眠改善作用。方法：以艾司唑仑为对照药，采用交叉试验。结果；随着治疗的进行，曲唑酮与艾司唑一样，明显改善了抑郁症患者的睡眠指标，且两药对大多数观察指标的影响无明显差异。结论：曲唑酮能较好地改善抑郁症患者的睡眠障碍，具有较好的应用前景。     

帕罗西汀合并丁螺环酮治疗抑郁症的对照研究

目的观察帕罗西汀合并丁螺环酮治疗抑郁症的临床疗效及可行性。方法对符合中国精神障碍分类与诊断标准第3版(CCMD-3)抑郁症诊断标准的80例患者随机分为帕罗西汀合并丁螺环酮组和单用帕罗西汀组,每组各40例。采用汉密顿抑郁量表(HAMD)、汉密顿焦虑量表(HAMA)、副反应量表(TESS)于治疗前及治疗后1、2、4周末分别评定临床疗效及副作用。结果研究组HAMD减分率于2、4周末均明显高于对照组(P<0.05),研究组HAMA减分率自第1周末起即明显高于对照组。两组副反应评分无显著差异,均无严重副反应。结论帕罗西汀合并丁螺环酮治疗抑郁症疗效确切,起效快,副作用较轻,特别适于伴有明显焦虑的抑郁症患者。     

舍曲林与麦普替林治疗抑郁症临床对照研究

目标：比较舍曲林与麦普替林治疗抑郁症和副反应。方法：将64例符合CCMD－2－R抑制症诊断标准的患者随机分两组,分别给予舍曲林与麦普 替林治疗,于治疗前和治疗后1、2、4、6周末分别用Hamiton抑郁量表（HAMD）,及副反应量表（TESS）评定。结果：舍曲林组显效率75％,麦普替林组显效率78．1％。HAMD总分及各因子分6周末的减分率两组间无显著差异（P＞0．05）。舍曲林组主要副反应为口干、震颤、消化系症状,未发现心血管反应,麦普替林主要为抗胆碱能症状。结论：舍曲林与麦普替林对抑郁症疗效相当,两药间无靶症状特异性,舍曲林无心血管重要副作用,值得临床首先选用。     

帕罗西汀与阿米替林治疗抑郁症的对照研究

目的验证帕罗西汀治疗抑郁症的疗效及安全性.方法对60例抑郁症患者分别以帕罗西汀与阿米替林治疗,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,采用副反应量表(TESS)评定副反应.结果帕罗西汀组与阿米替林组治疗前后HLAMD、HAMA、CGI-SI评分及减分比较均无显著性差异(P＞0.05).帕罗西汀组的副反应较阿米替林组少而轻,帕罗西汀常见的副反应有恶心、头晕、口干等.结论帕罗西汀治疗抑郁症的疗效同阿米替林相当,副反应少而轻.     

万拉法新与马普替林治疗抑郁症对照研究

目的 研究万拉法新的抗抑郁疗效及副作用。方法 采用随机对照方法,以马普替林为对照组,应用HAMD、HAMA、TESS量表,在疗前、疗后1、2、4、6周进行疗效及副反应评定。结果 万拉法新的痊愈率(63.6％)高于马普替林(45.5％),但无显著性差异(X~2=0.825,P>0.05);其显效率(81.8％)与马普替林(77.3％)相近。万拉法新见效快,副作用发生率低而轻微。结论 万拉法新抗抑郁疗效肯定、副作用少。     

氟西汀与丙咪嗪治疗抑郁症的临床对照研究

目的：研究氟西汀与丙咪嗪治疗抑郁症的临床疗效和副反应。方法：对42例符合CCMD－2－R诊断标准的重性抑郁症住院患者，随机分组，分别用氟西汀和丙咪嗪治疗6周，用汉密尔顿抑郁量表（HAMD）和临床疗效总评量表（CGI）评定临床疗效，用副反应量表（TESS）评定副反应。结果：氟西汀组显效率85．7％，丙咪嗪组显效率为76．2％，两得无明显差异（P＞0．05），氟西汀组副作用较丙咪嗪组少而轻。结论：氟西汀治疗抑郁症疗效好，副反应少而轻。     

万拉法新与阿米替林治疗抑制症对照研究

目的研究万拉法新的抗抑郁疗效及副作用.方法采用随机对照方法,以阿米替林为对照组,应用HAMD、HAMA、TESS量表,在疗前、疗后1、2、6周进行疗效及副反应评定.结果万拉法新的痊愈率(70%)高于阿米替林(45%),但无显著差异(x2=2.56,P＞0.05);显效率(85%)与阿米替林(80%)相近.万拉法新见效快,副作用发生率低而轻微.结论万拉法新抗抑郁疗效肯定、副作用轻微.     

帕罗西汀与阿米替林治疗抑郁症的对照研究

目的 探讨帕罗西汀治疗抑郁症的疗效和安全性。方法 61例抑郁症病人随机分为阿米替林组31例。帕罗西汀组30例。共治疗6周，采用汉密尔顿抑郁量表（HAMD）和临床总体评定量表（CGI）评定临床疗效，采用副反应量表（TESS）评定副反应。结果 帕罗西汀组与阿米替林组治疗前后HAMD和CGI-SI分值比较均有显著性差异。而两组减分相比治疗前后无显著性差异。帕罗西汀组副作用明显比阿米替林组轻，在植物神经，心血管以及神经系统方面二者有显著性差异。结论 帕罗西汀治疗抑郁症疗效好，副反应小，服用方便，依从性好，是治疗抑郁症的理想药物。     

Zimeldine versus amitriptyline in endogenous depression. A double-blind study with special reference to effects on liver function

In a double-blind comparison of 21 inpatients with endogenous depression 225 mg zimeldine demonstrated the same degree of antidepressive efficacy as 150 mg amitriptyline after 4 weeks of treatment. Only "sleep disturbances" on the Hamilton Rating Scale for Depression (HRS) showed significant (P less than 0.05) improvement with amitriptyline. Only small differences in the frequency of side effects were seen. In the zimeldine group, increased sweating and headache were more pronounced, while the amitriptyline patients more often reported dry mouth and constipation. Body weight was not significantly changed by either treatment. In the zimeldine group, treatment had to be interrupted in three patients due to hypersensitivity reactions in the form of drug fever. Three other patients in the zimeldine group showed clinically significant elevation of liver enzymes. Hypersensitivity reactions and abnormal blood chemistry were both reversible. The adverse reactions are discussed, the cause of the occurrence remaining unknown.     

康复期抑郁症患者心理干预对照分析

目的 探索心理干预对康复期抑郁症患者的疗效。方法 以HAMD和NOSIE为量化指标，对32例患者进行心理干预研究，并以30例患者做对照。结果 经t检验，研究组与对照组相比较，HAMD、中的总分及6个因子减分值和NOSIE中的总估计分及6个因子减分值均有显著差异。结论 心理干预对康复期抑郁症患者有较好的疗效。     

Nomifensine and amitriptyline in the treatment of depression. A multi-centre double-blind comparison

Nomifensine, an antidepressive agent acting like a dopamine agonist, was investigated in a randomized double-blind comparison with amitriptyline in 29 patients fulfilling the RDC criteria for major depression. The dosage was 150 mg daily in both treatment groups. Assessments were made at weekly intervals for 6 weeks with the Comprehensive Psychopathological Rating Scale. No significant difference could be demonstrated between the two drugs in overall therapeutic efficiency, and only one item, Fatiguability, differed significantly in favour of amitriptyline. Physical and laboratory variables showed no statistically significant differences. Neither drug elicited serious unwanted effects.     

童年丧亲对抑郁症患者个性及临床特征的影响

目的：了解童年丧亲的抑郁症患者个性和临床方面特征。方法：采用艾森克个性问卷测评52例童年丧亲的抑郁症患者（A组）及144例早年父母双全的抑郁症患者（B组）进行对照研究。结果：A组E分显著较低、N分显著较高,焦虑和自杀行为显著较多、临床显效率显著较低。病程迁延者显著多于B组。结论：童年丧亲患者个性更为内向且情绪更趋向不稳定,更易出现焦虑和自杀行为,临床疗效较差,预后不良。     

米氮平治疗抑郁症的临床疗效

目的　评价米氮平治疗抑郁症的临床疗效和安全性。方法　对符合CCMD 3抑郁症诊断标准的 5 3例抑郁症患者进行米氮平和丙咪嗪的对照研究 ,其中米氮平组 30例 (15～ 4 5mg/d) ,丙咪嗪组 2 3例 (10 0～ 2 0 0mg/d) ,共治疗 6周。采用汉密顿抑郁量表HAMD ,汉密顿焦虑量表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 ,米氮平组治疗总有效率为 87% ,显效率为 6 9% ,丙咪嗪组分别为 86 %和 6 7% ,两组相比较 ,差异无显著性 (P >0 0 5 )。米氮平组治疗第 1周就起效。两组的HAMD ,AHMA评分治疗前后相比较差异有高度显著性(P <0 0 1) ;两组之间比较差异无显著性 (P >0 0 5 )。米氮平组的不良反应相对于丙咪嗪组少而轻 ,常见的有头昏、口干、胃肠不适等。结论　米氮平治疗抑郁症疗效好 ,起效快 ,不良反应少而轻 ,适合临床应用。     

米氮平与氟西汀治疗抑郁症的疗效对比分析

目的　评价米氮平治疗抑郁症的临床疗效和安全性。方法　将符合CCMD - 3抑郁症诊断标准的 6 1例抑郁症患者随机分为米氮平组 (31例 )和氟西汀组 (30例 ) ,治疗 6周。用汉密顿抑郁量表 (HAMD)评定疗效 ,用副反应量表 (TESS)评定副反应。结果　米氮平组和氟西汀组的有效率分别为 78%和 77% ,二者比较差异无显著性 (P >0 0 5 ) ,但米氮平起效快 ,副反应轻。结论　米氮平是一种安全有效的新一代抗抑郁药。