唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究

Objective To evaluate the clinical efficacy and safety of zolpidem in treatment of primary insomnia in elderly patients.Methods An open, perspective, fixed-dose, multicentre and selfcontrolled clinical trial was conducted.Total of 115 elderly patients who met with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria for primary insomnia were administered 3 week nightly treatment with zolpidem 5 mg.The primary efficacy measurement was the change of Pittsburg Sleep Quality Index(PSQI) score after 1 week treatment in comparison with the baseline.The secondary efficacy measurement included the changes from baseline in total score of the PSQI, Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) and self-reported sleeping parameters ( latency of falling asleep, total sleeping time and sleeping quality) after 3 week treatment.Results The mean reduction score 17 items of PSQI were 2.8 after 1 week treatment and 3.2 at the end of 3 week ( P ＜ 0.01 ).The selfreported sleeping parameters were much improved from the baseline (P ＜0.01 ).The total scores of HAMD and HAMA were reduced significantly ( P ＜ 0.01 ) after 3 week treatment.The overall incidence of adverse events was 19.1%, with the frequent adverse events of dizziness, headache, sleepiness, nausea and fatigue, and the severity was mild or moderate.Conclusion It is effective and safe of zolpidem 5 mg nightly in treatment of elderly insomnia patients.     

Comparison of Treatment Effect of Resperidone on First-Episode Schizophrenia Patients at Different Ages and its Influencing Factor Analysis

Objectives To explore the treatment effect of risperidone on patients with firstepisode schizophrenia at different ages and analyze its influencing factors.Methods fifty cases of adult patients with the first-episode schizophrenia(adult group)and forty cases of juvenile patients with the firstepisode schizophrenia(juvenile group)treated in our hospital from March 2013 to March 2015 were selected for oral administration of risperidone.The clinical efficacy,adverse effect,brief psychiatric rating scale(BPRS)score before and after the therapy,brain-derived neurotrophic factor(BDNF)and blood lipid level were compared between the two groups after eight weeks’treatment with risperidone,and meanwhile,the multivariable linear regression analysis was performed to the related factors possibly influencing the efficacy of risperidone.Results The difference of total effective rate between the adult group(86%)and the juvenile group(82.5%)was not significant(P0.05).The total score of BPRS,TC,TG,and LDL-C levels in the two groups after the treatment were significantly decreased compared with that before the treatment,while BDNF was significantly increased.The difference of inter-group comparison was significant before and after the treatment(P0.05).However,the comparison difference between two groups was not significant before and after the treatment(P0.05).The multivariable linear regression equation was used to analyze the longer duration of untreated psychosis(DUP),BPRS total score before treatment and BDNF levels that influence the efficacy of risperidone on patients with schizophrenia.Conclusion the treatment efficacy of risperidone on adult patients and juvenile patients with first-episode schizophrenia was similar and it was safe and effective.The DUP,BPRS total score before treatment and BDNF levels were associated with the efficacy of risperidone.     

利培酮口服液合用氯硝西泮与氟哌啶醇针剂肌内注射治疗精神分裂症急性激越症状疗效和安全性的研究

Objective To compare the efficacy and safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia or schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of 6 week acute treatment from switching IM injection to oral.Method Altogether 205 patients exhibiting agitation were randomly assigned to receive either oral treatment with risperidone oral solution puls clonazepam ( n = 104) or intramuscular injection treatment with haloperidol ( n = 101 ).The primary efficacy outcome measure was the change in scores based on PANSS-EC in session Ⅰ ( the first five days), and the response rate based on the PANSS score in session Ⅱ ( the following 6 weeks).Safety was evaluated using the Simpson-Angus Scale (ASA), Barnes Akathisia Scale (BAS), adverse events and lab test.Result Mean acute-agitation score improvement was significant after 5 day treatment in both groups (P ＜0.01 ) and were similar in both groups ( P ＞ 0.05).While the cooperation was better and the advert events, especially extrapyramidal symptoms was lower in risperidone oral solution groups than that in haloperidol IM injection group(P ＜0.05).The mean PANSS-EC and PANSS scores remained stable after switching from IM injection to oral.The efficacy was not differenct in both groups after 6 week treatment (P ＞ 0.05).There was no significant difference at the rate of total advert events ( P ＞ 0.05 ) while there were yet significantly higher rates of extrapyramidal symptoms in switching drug group than that in oral group ( P ＜ 0.05 ).Conclusion Risperidone oral solution plus oral clonazepam has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation, but risperidone oral solution plus clonazepam has better compliance and tolerability.The illness is stable after switching from haloperidol IM injection to risperidone oral solution, in the following 6 week treatment.     

利培酮口服液合用氯硝西泮与氟哌啶醇针剂肌内注射治疗精神分裂症急性激越症状疗效和安全性的研究

Objective To compare the efficacy and safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia or schizophrenic-affective disorder and to explore the possibility of decreasing efficacy of 6 week acute treatment from switching IM injection to oral.Method Altogether 205 patients exhibiting agitation were randomly assigned to receive either oral treatment with risperidone oral solution puls clonazepam ( n = 104) or intramuscular injection treatment with haloperidol ( n = 101 ).The primary efficacy outcome measure was the change in scores based on PANSS-EC in session Ⅰ ( the first five days), and the response rate based on the PANSS score in session Ⅱ ( the following 6 weeks).Safety was evaluated using the Simpson-Angus Scale (ASA), Barnes Akathisia Scale (BAS), adverse events and lab test.Result Mean acute-agitation score improvement was significant after 5 day treatment in both groups (P ＜0.01 ) and were similar in both groups ( P ＞ 0.05).While the cooperation was better and the advert events, especially extrapyramidal symptoms was lower in risperidone oral solution groups than that in haloperidol IM injection group(P ＜0.05).The mean PANSS-EC and PANSS scores remained stable after switching from IM injection to oral.The efficacy was not differenct in both groups after 6 week treatment (P ＞ 0.05).There was no significant difference at the rate of total advert events ( P ＞ 0.05 ) while there were yet significantly higher rates of extrapyramidal symptoms in switching drug group than that in oral group ( P ＜ 0.05 ).Conclusion Risperidone oral solution plus oral clonazepam has similar therapeutic effect to haloperidol IM injection in the treatment of acute agitation, but risperidone oral solution plus clonazepam has better compliance and tolerability.The illness is stable after switching from haloperidol IM injection to risperidone oral solution, in the following 6 week treatment.     

帕利哌酮缓释片治疗急性精神分裂症疗效及安全性的对照研究

Objective The study was designed to evaluate the efficacy and safety of flexible doses of paliperidone extended-release tablets (paliperidone ER) (3 -12) mg/d comparing with olanzapine (5 -15)mg/d in acute hospitalized patients with schizophrenia. Methods All 288 hospitalized patients with DSM-Ⅳ schizophrenia were randomized into paliperidone ER ( n = 143 ) or olanzapine ( n=145 ) treatment in a 6-week, multicenter, double-blind, parallel-group study. The primary efficacy measure was the total score changes of the Positive and Negative Syndrome Scale (PANSS). Clinical Global Impression (CGI),response rate and Visual Analogue Scale (VAS) were adopted as secondary efficacy measures. Results Both paliperidone ER and olanzapine groups demonstrated a significant improvement in total PANSS score (P<0.001). The PANSS total score in paliperidone ER group was reduced (32.3 ± 17.1) at end point,and olanzapine group (34.1 ± 17.4). There was no statistically significant difference between the two groups (P =0.369) after 6-week treatment. There were no statistical differences between two groups in CGI,response rate and VAS sleep quality assessments by the end of the treatment. The common adverse events were extrapyramidal symptoms, insomnia, constipation and prolactin increasing in paliperidone ER group,and somnolenee, EPS, abnormal liver function and abnormal lipid metabolism in olanzapine group.Conclusion Paliperidone ER and olanzapine are similarly effective in significantly improving the symptoms of inpatient with acute schizophrenia. Paliperidone ER demonstrates a favorable safety profile with fewer somnolence, abnormal liver function and abnormal lipid metabolism comparing with olanzapine.     

抑郁症患者治疗前后血浆孤啡肽的研究

Objective To explore the changes of plasma orphanin FQ (OFQ) level in depressive patients before and after treatment. Methods The plasma OFQ levels of 38 depressive patients were determined with radioimmunoassay at baseline and after 8 week antidepressant treatment, and 32 healthy persons were examined once as controls. Results The concentrations of OFQ in patients were significantly higher at baseline than after treatent and in controls [(21.9 ± 2. 3 ) ng/L vs. ( 10. 9 ± 2. 1 ) ng/L; (21.9±2. 3) ng/L vs. (10. 2 ± 1.8 )ng/L; all P < 0. 01]. There were no significant differences in OFQ between patients after treatment and in controls. The OFQ concentration in patients at baseline was positively correlated to the scores of 24-items Hamilton Depression Scale (HAMD) (r =0. 857,P <0. 01 ), the change of OFQ concentration between baseline and after treatment was also positively correlated to the alteration of HAMD scores (r = 0. 342, P < 0. 05 ). Conclusions The results suggest that the alteration of OFQ may be involved in depression.     

Relationship of nocturnal concentrations of melatonin,gamma-aminobutyric acid and total antioxidants in peripheral blood with insomnia after stroke: study protocol for a prospective non-randomized controlled trial

Melatonin and gamma-aminobutyric acid (GABA) have been shown to regulate sleep. The nocturnal concentrations of melatonin, GABA and total antioxidants may relate to insomnia in stroke patients. In this prospective single-center non-randomized controlled clinical trial performed in the China Rehabilitation Research Center, we analyzed the relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke. Patients during rehabilitation of stroke were recruited and assigned to the insomnia group or non-insomnia group. Simultaneously, persons without stroke or insomnia served as normal controls. Each group contained 25 cases. The primary outcome was nocturnal concentrations of melatonin, GABA and total antioxidants in peripheral blood. The secondary outcomes were Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, Fatigue Severity Scale, Morningness-Eveningness Questionnaire (Chinese version), and National Institute of Health Stroke Scale. The relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke was analyzed and showed that they were lower in the insomnia group than in the non-insomnia group. The severity of stroke was higher in the insomnia group than in the non-insomnia group. Correlation analysis demonstrated that the nocturnal concentrations of melatonin and GABA were associated with insomnia after stroke. This trial was regis-tered at ClinicalTrials.gov, identifier: NCT03202121.     

膨体聚四氟乙烯软组织补片在鼻外伤一期整复术中的应用

BACKGROUND： Several studies have reported the use of zolpidem for induced arousal after permanent vegetative states. However, changes in brain function and EMG after zolpidem treatment requires further investigation. OBJECTIVE： To investigate the effect of zolpidem, an unconventional drug, on inducing arousal in patients in a permanent vegetative state after brain injury using visual single photon emission computerized tomography and digitized cerebral state monitor. DESIGN： A self-controlled observation. SETTING： Shenzhen People＇s Hospital. PARTICIPANTS： Seven patients in a permanent vegetative state were selected from the Department of Neurosurgery, Shenzhen People＇s Hospital from March 2005 to May 2007. The group included 5 males and 2 females, 24-55 years of age, with a mean age of 38.5 years. All seven patients had been in a permanent vegetative statement for at least six months. The patient group included three comatose patients, who had sustained injuries to the cerebral cortex, basal ganglia, or thalamus in motor vehicle accidents, and four patients, who had suffered primary/secondary brain stem injury. Informed consents were obtained from the patients＇ relatives. METHODS： The patients brains were imaged by ^99Tc^m ECD single photon emission computerized tomography prior to treatment with zolpidem [Sanofi Winthrop Industrie, France, code number approved by the State Food ＆ Drug Administration （SFDA） J20040033, specification 10 mg per tablet. At 8：00 p.m., 10 mg zolpidem was dissolved with distilled water and administered through a nasogastric tube at 1 hour before and after treatment and 1 week following treatment, respectively. Visual analysis of cerebral perfusion changes in the injured brain regions before and after treatment was performed. Simultaneously, three monitoring parameters were obtained though a cerebral state monitor, which included cerebral state index, electromyographic index, and burst suppression index. MAIN OUTCOME MEASURES： Comparison of the three brain fun     

Transplantation of autologous peripheral blood mononuclear cells in the subarachnoid space for amyotrophic lateral sclerosis: a safety analysis of 14 patients

There is a small amount of clinical data regarding the safety and feasibility of autologous peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis.The objectives of this retrospective study were to assess the safety and efficacy of peripheral blood mononuclear cell transplantation in 14 amyotrophic lateral sclerosis patients to provide more objective data for future clinical trials.After stem cell mobilization and collection,autologous peripheral blood mononuclear cells(1 × 109) were isolated and directly transplanted into the subarachnoid space of amyotrophic lateral sclerosis patients.The primary outcome measure was incidence of adverse events.Secondary outcome measures were electromyography 1 week before operation and 4 weeks after operation,Functional Independence Measurement,Berg Balance Scale,and Dysarthria Assessment Scale 1 week preoperatively and 1,2,4 and 12 weeks postoperatively.There was no immediate or delayed transplant-related cytotoxicity.The number of leukocytes,serum alanine aminotransferase and creatinine levels,and body temperature were within the normal ranges.Radiographic evaluation showed no serious transplant-related adverse events.Muscle strength grade,results of Functional Independence Measurement,Berg Balance Scale,and Dysarthria Assessment Scale were not significantly different before and after treatment.These findings suggest that peripheral blood mononuclear cell transplantation into the subarachnoid space for the treatment of amyotrophic lateral sclerosis is safe,but its therapeutic effect is not remarkable.Thus,a large-sample investigation is needed to assess its efficacy further.     

Hyperbaric oxygen therapy for cerebral blood flow and electroencephalogram in patients with acute cerebral infarction Choice for therapeutic occasion

BACKGROUND: Hyperbaric oxygen (HBO) therapy increases blood oxygen content, changes cerebral blood flow (CBF) and cerebral metabolism. Its therapeutic effects on cerebrovascular disease have been fully confirmed, but the occasion for HBO therapy is still unclear. OBJECTIVE: To observe the therapeutic effects of HBO therapy at different time on CBF and electroencephalogram (EEG) in patients with acute cerebral infarction (CI). DESIGN: Randomized controlled trial. SETTING: Department of Neurology, Shidong Hospital, Yangpu District of Shanghai. PARTICIPANTS: Ninety-six inpatients with acute CI, admitted to Department of Neurology, Shidong Hospital, Yangpu District of Shanghai from January 2001 to December 2006, were involved in this experiment. The involved participants met the diagnosis criteria of acute CI and confirmed by skull CT or MRI. They all were patients with moderate CI (16–30 points) according to neurologic deficit score formulated by Chinese Medical Association. Informed consents of detected items and therapeutic regimen were obtained from all the involved participants. They were randomized into two groups with 48 in each: early-stage treatment group and advanced-stage treatment group. Among the 48 patients in the early-stage treatment group, 21 male and 27 female, aged 53–68 years, 22 patients were found with basal ganglia infarction, 10 with brain lobe infarction, 16 with multiple infarction, 27 accompanied with hypertension and 2 accompanied with diabetes mellitus. Among the 48 patients in the advanced-stage treatment group, 23 male and 25 female, aged 52–71 years, 25 patients were found with basal ganglia infarction, 10 with brain lobe infarction, 12 with multiple infarction, 1 with brain stem infarction, 28 accompanied with hypertension and 1 accompanied with diabetes mellitus. METHODS: After admission, patients of two groups received routine drug treatment. ① Patients in the early-stage treatment group and advanced-stage treatment group began to receive HBO therapy within one week of CI and 4 weeks after CI, respectively. The total course of treatment both was 2 weeks. EEG examination was carried out before and after therapy, and CBF was determined with 133Xe inhalation. ② Assessment criteria of curative effects: Basically cured: neurologic symptoms and body signs disappeared, could work and do housework; Markedly effective: score of neurologic deficit was decreased by over 21 points, could manage himself/herself partially; Effective: score of neurologic deficit was decreased by 8 to 12 points; Non-effective: Score was increased or decreased less than 8 points, neurologic deficit was worsened, even died. Total effective rate = (number of cured+number of markedly effective+number of effective)/ number of total cases×100%. ③ t test and Chi-square test were used for comparing the difference of measurement data and enumeration data respectively, and Ridit analysis was used for comparing the difference of clinical curative effects. MAIN OUTCOME MEASURES: ① Comparison of EEG and CBF of patients from two groups before and after treatment. ② Comparison of post-treatment neurologic deficit of patients between two groups. RESULTS: All the involved 96 patients with CI participated in the final analysis. ① Clinical symptoms of patients from two groups after therapy were significantly improved as compared with those before therapy, and curative effects of early treatment group were better than those of advanced treatment group （U =1.99，P < 0.05）. ②After treatment, CBF in each region of brains, except for that in parietal lobe of patients in the advanced-stage treatment group, was significantly improved (P < 0.05–0.01); The improvement of CBF of patients in the early-stage treatment group was more obvious than that in the early-stage treatment group (P < 0.05–0.01). ③ The abnormal rate of EEF of patients from early-stage treatment group and advanced-stage treatment group before treatment was 94% and 96%, respectively. After treatment, improvement rate of EEG of patients in the early-stage treatment group was 95%, which was significantly different from that in the advanced-stage treatment group （82%，χ2 =4.32，P < 0.05） CONCLUSION: HBO therapy both at early and advanced stages of CI (within 1 week and 4 weeks after CI attack) can improve CBF and EEG of patients with early CI, especially.     

Characterization of the sensory,affective, cognitive,biochemical, and neuronal alterations in a modified chronic constriction injury model of neuropathic pain in mice

The chronic constriction injury (CCI) of the sciatic nerve is a nerve injury-based model of neuropathic pain (NP). Comorbidities of NP such as depression, anxiety, and cognitive deficits are associated with a functional reorganization of the medial prefrontal cortex (mPFC). Here, we have employed an adapted model of CCI by placing one single loose ligature around the sciatic nerve in mice for investigating the alterations in sensory, motor, affective, and cognitive behavior and in electrophysiological and biochemical properties in the prelimbic division (PrL) of the mPFC. Our adapted model of CCI induced mechanical allodynia, motor, and cognitive impairments and anxiety- and depression-like behavior. In the PrL division of mPFC was observed an increase in GABA and a decrease in d -aspartate levels. Moreover an increase in the activity of neurons responding to mechanical stimulation with an excitation, mPFC (+), and a decrease in those responding with an inhibition, mPFC (−), was found. Altogether these findings demonstrate that a single ligature around the sciatic nerve was able to induce sensory, affective, cognitive, biochemical, and functional alterations already observed in other neuropathic pain models and it may be an appropriate and easily reproducible model for studying neuropathic pain mechanisms and treatments.     

精神分裂症患者头发铅、镉、铝、锌、铬及镍含量的性别和年龄差异

目的探讨精神分裂症患者头发铅、镉、铝、锌、铬及镍含量的性别和年龄差异.方法采用WFX-12型原子吸收分光光度计平行测定440例精神分裂症患者头发上述六种微量元素的含量进行性别比较,并按29岁之前、30～49岁之间、50岁之后三个年龄段进行分组比较.结果①上述六种微量元素含量存在性别差异,男患者头发镉、锌含量均高于女患者(P值分别为0.00、0.01);②患者三个年龄段的头发上述六种微量元素含量比较均无显著差异(P值均＞0.05).结论精神分裂症患者头发铅、镉、铝、锌、铬、镍含量存在性别差异,但无年龄差异.     

Expression of secreted semaphorins and their receptors in specific neuromeres, boundaries, and neuronal groups in the developing mouse and chick brain

Semaphorins constitute a family of signaling molecules with functions in axon pathfinding and neuronal migration. Neuropilins 1 and 2 have been identified as the ligand-binding component of semaphorin receptors. Both ligands and receptors are expressed in embryonic and adult organs in complementary and sometimes redundant patterns. In the present work, we compared the brain expression patterns of the class III semaphorins 3A, 3C, and 3F and neuropilins 1 and 2 between mouse and chick embryos at early developmental stages. Our studies revealed that expression of semaphorins is restricted in some cases to neuromeric transverse domains, to specific neuromeric boundaries, and to specific neuronal populations. Moreover, our studies also revealed coexpression of neuropilins and one or more semaphorins in some of the different expression sites. Comparison of the expression patterns between mouse and chick embryos showed large similarities, but important differences were also detected.     

Prevalence, knowledge, attitude, and practice of epilepsy in Kerala, South India

PURPOSE: To ascertain the prevalence and pattern of epilepsy and to characterize and quantify knowledge, attitude, and practice (KAP) toward epilepsy among the people of the state of Kerala, which is distinguished from the rest of India by a high level of literacy and health awareness of its population. METHODS: We conducted a door-to-door survey covering the entire population of 238,102 people residing in 43,681 households in a semiurban area of central Kerala. The screening questionnaire administered by medical social workers had a sensitivity of 100% for identifying persons with epilepsy. Neurologists examined all the individuals suspected of having epilepsy. We evaluated KAP toward epilepsy among 1,118 subjects (439 males and 679 females; mean age, 33.3 years; age range, 15-85 years) from households without epilepsy in the study area. RESULTS: Through a three-phased survey, we ascertained 1,175 cases (616 males and 559 females) with active epilepsy, providing a crude point prevalence ratio of 4.9 cases per 1,000 people and an age-adjusted prevalence ratio of 4.7 cases per 1,000 population. The highest age-specific prevalence rate of 6.5 per 1,000 occurred in the 10- to 19-year-old age group. Sex-specific prevalence rates did not significantly differ. The proportion of generalized and localization-related epilepsies was 58.8% and 30.6%, respectively. Ninety-nine percent of the KAP respondents had read or heard about epilepsy. Thirty-one percent and 27% thought epilepsy was a hereditary disorder and a form of insanity, respectively. About 40% of the respondents felt that individuals with epilepsy could not be properly educated or employed. Eleven percent would object to their children having contact with epileptic children. CONCLUSIONS: The prevalence and pattern of epilepsy in central Kerala, South India, do not differ from that of developed countries. Although the awareness of epilepsy among the people of Kerala was comparable to that of developed countries, the attitudes were much more negative. The need for educating the people of Kerala on epilepsy and for incorporating an adequate knowledge of epilepsy in the school curricula cannot be overemphasized.     

Dogs, distemper, and multiple sclerosis in the United States

Geographic distribution of multiple sclerosis (MS) was defined by case/control ratios for state of pre-illness residence for US white male veterans "service-connected" for MS. The Veterinary Medical Data Program of the National Cancer Institute receives diagnostic information from most of the university veterinary medical centers in the US (and Canada). The Center for Disease Control had carried out a 2-year surveillance program for human bites by animals. State distributions for MS were compared with those for the proportion of admissions for canine distemper (CD), the ratio of CD cases to the human population, and human bites by dogs per unit of population. There was no evidence that any of the CD risk indices was positively correlated with that for MS. These results suggest that CD, exposure to dogs, or dog bites are unlikely to be involved in the etiology of MS.     

Beneficial effect of tibolone on mood, cognition, well-being, and sexuality in menopausal women

Tibolone is a synthetic molecule used extensively for the management of menopausal symptoms, with the proposed additional advantage of enhanced mood and libido. Tibolone, after oral administration, is rapidly converted into 3 major metabolites: 3α-hydroxytibolone and 3β-hydroxytibolone, which have estrogenic effects, and the Δ⁴-isomer, which has progestogenic and androgenic effects. The tissue-selective effects of tibolone are the result of metabolism, of enzyme regulation, and of receptor activation which vary in different tissues. Tibolone seems to be effective on estrogen-withdrawal symptoms such as hot flushes, sweating, insomnia, headache, and vaginal dryness, with results generally comparable to the effects exerted by estrogen-based treatments, and the additional property of a progestogenic activity on the endometrium. As well as relieving vasomotor symptoms, tibolone has positive effects on sexual well-being and mood, and improves dyspareunia and libido. These effects may depend on both estrogenic and androgenic actions exerted at the genital level and in the central nervous system, and on a reduction of sex-hormone-binding globulin and an increase of free testosterone, without affecting Δ-5 androgens levels. Based on the evidence available, tibolone is a valuable treatment option to relieve menopausal complaints, especially in women suffering persistent fatigue, blunted motivation, and loss of sexual desire despite an adequate estrogen replacement.     

唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究

目的 评价唑吡坦5 mg每日1次治疗老年原发性失眠的疗效和安全性.方法 采用开放性、前瞻性、固定剂量、多中心、自身对照的研究方法.115例符合美国精神障碍诊断和统计手册第4版原发性失眠诊断标准的老年门诊患者每日1次服用固定剂量唑吡坦5 mg,疗程3周.以治疗第1周末匹兹堡睡眠质量指数评分(PSQI)相对于基线的差值作为研究的主要疗效评价指标,次要疗效指标包括:治疗第3周末PSQI评分相对于基线的差值,治疗第1周末和第3周末主观睡眠有效参数评分(睡眠潜伏期、总的睡眠时间、睡眠质量)相对于基线的差值,治疗第3周末17项汉密尔顿抑郁量表(HAMD-17)评分和汉密尔顿焦虑量表(HAMA)评分相对于基线的差值.结果 治疗第1周末,PSQI量表总分较基线下降2.8分,差异有统计学意义(P＜0.01);治疗第3周末,PSQI评分较基线下降3.2分,差异有统计学意义(P＜0.01);治疗第1周末和第3周末主观睡眠有效参数均有明显改善:睡眠潜伏期缩短(P＜0.01),睡眠时间延长(P＜0.01),日间功能提高(P＜0.01);治疗第3周末,患者的HAMD-17和HAMA评分较基线均有降低(P＜0.01);不良事件的发生率为19.1%,主要为头晕、头痛、困倦、恶心、乏力等,程度为轻、中度.结论 每日1次服用固定剂量唑吡坦5 mg治疗老年原发性失眠安全有效.