Differences in psychosocial factors among novice, experienced, and veteran health promotion volunteers in Japan

ABSTRACT Objective: To examine differences in psychosocial factors among health promotion volunteers (HPVs) according to years of experience.
Design: Cross-sectional survey.
Sample: A total of 604 HPVs in Koka and Konan cities in Japan in 2005.
Measurements: Demographic data, extent of HPV activity (such as years of HPV experience), and psychosocial factors such as overall activity satisfaction, burden of HPV activities, and social support.
Results: Compared with HPVs with 1–3 years of experience, those with 4–8 years of experience indicated that the head of the neighborhood association failed to recognize their role and lacked knowledge of HPV activity content, but that they felt greater support from community members. Those with 9 or more years of experience had more managerial experience, were more highly motivated at the end of the HPV training course, and indicated greater support from community members than those with 1–3 years of experience.
Conclusions: When considering the constellation of HPV activities; the ways in which these activities are performed; and the strategies to recruit, train, support, and retain HPVs; it may be important to take into account the differences among HPVs by years of experience.     

A translational,caffeine-induced model of onset insomnia in rats and healthy volunteers

Rationale Insomnia is a common and disabling complaint for which there is a need for improved treatments. Successful drug discovery relies on the use of appropriate animal models to assess likely outcome in the clinic. Objectives The purpose of this study was to develop a translational, caffeine-induced model of insomnia in rats and healthy volunteers. We used sleep onset latency (SOL) as a comparable sleep measure between the two species. The model was validated by two effective sleep-promoting agents with different pharmacology, zolpidem and trazodone, which have GABA-ergic and serotonergic mechanisms, respectively. Materials and methods In rats, radiotelemetry transmitters with electroencephalogram and electromyogram electrodes were implanted for sleep recording. Animals were administered with caffeine alone (10 mg/kg) or in combination with zolpidem (10 mg/kg) or trazodone (20 mg/kg), or vehicle, in crossover experiments. Home polysomnography was performed in 12 healthy male volunteers in a randomised, placebo-controlled, 4-week crossover study. Subjects received placebo, caffeine (150 mg) or caffeine in combination with zolpidem (10 mg) or trazodone (100 mg). Subjective sleep effects in volunteers were assessed using the Leeds Sleep Evaluation Questionnaire. Results Caffeine caused a significant prolongation in objective SOL in rats and humans. This effect was sensitive to zolpidem and trazodone, both of which attenuated the caffeine-induced increase in SOL. Furthermore, both hypnotics restored the disruption in subjective measures of sleep onset caused by caffeine in volunteers. Conclusions This model therefore provides a promising paradigm in which we can study novel treatments for sleep disorders and an opportunity for direct comparison of results between rodents and humans.     

Lack of sex differences to the subjective effects of nitrous oxide in healthy volunteers

Background

Although numerous studies have assessed subjective effects of nitrous oxide, few studies have analyzed for sex differences. Since sex differences have been reported in subjective effects of several drugs such as opioids, nicotine and alcohol, we sought to determine if sex modulates the subjective effects of the inhalant, nitrous oxide, in healthy volunteers.

Methods

Thirty-eight females and seventy-two males from nine studies that were conducted in our laboratory were included in this retrospective analysis. All experimental studies utilized randomized, placebo-controlled, repeated measures designs in which subjects inhaled 30% nitrous oxide in oxygen and 100% oxygen (placebo). Dependent measures in this analysis were subjective effects measured at baseline and 15 min into the inhalation period.

Results

Nitrous oxide produced a number of subjective effects, including those that could be considered abuse liability-related (“elated,” “having pleasant thoughts,” drug liking), but sex did not modulate these effects.

Conclusions

Females and males showed similar subjective responses to 30% nitrous oxide. Future prospective studies might assess other concentrations, other measures (choice, analgesic response), and other inhaled general anesthetics to more comprehensively characterize the role of sex in response to inhalants.     

Laughter therapy as an intervention to promote psychological well-being of volunteer community care workers working with HIV-affected families

The study explores the experiences of volunteer community care workers working with HIV-affected families, participating in laughter therapy. Laughter therapy is being used as an intervention to positively influence individuals experiencing various forms of emotional distress. Community care workers play a vital role in the support of the HIV/AIDS-infected and -affected members in communities. The nature of this type of work and their limited training contributes to high levels of secondary trauma and emotional exhaustion. The purpose of the study was firstly, to explore the effects of working with orphans and vulnerable children (OVC) on the community care workers and secondly, to establish the impact that laughter therapy has to positively combat stresses of working within the care workers’ environment. All the community care workers from a community-based organisation that provides care for HIV/AIDS-infected and -affected OVC and their families in the greater region of Soweto, South Africa, took part in daily laughter therapy sessions for one month. To assess the experiences of participants of laughter therapy, seven community care workers agreed to participate in a mixed method assessment. Interviews were conducted before and after the intervention using the Interpretative Phenomenological Analysis as framework. As supportive data, a stress and anxiety and depression scale were added in the interview. Participants reported more positive emotions, positive coping, improved interpersonal relationships and improvement in their care work after exposure to laughter therapy. Quantitative results on stress, anxiety and depression for each participant confirmed observed changes. Laughter therapy as a self-care technique has potential as a low-cost intervention strategy to reduce stress and counteract negative emotions among people working in highly emotional environments.     

Specific inhibition of the endothelin A receptor with ZD4054: clinical and pre-clinical evidence

Activation of the endothelin A receptor (ET(A)) by endothelin-1 (ET-1) mediates events that regulate mitogenesis, apoptosis, angiogenesis and metastasis in tumours. Specific blockade of ET(A) may have anticancer effects, while retaining beneficial endothelin B receptor (ET(B))-mediated effects such as apoptosis and clearance of ET-1. ZD4054 is an orally active, specific ET(A) antagonist in clinical development. In receptor-binding studies, ZD4054 specifically bound to ET(A) with high affinity; no binding was detected at ET(B). In a randomised placebo-controlled trial in eight healthy volunteers, a single oral dose of ZD4054 reduced forearm vasoconstriction in response to brachial artery infusion of ET-1, thus providing clinical evidence of ET(A) blockade. ET(B) blockade was assessed in an ascending, single-dose, placebo-controlled trial in 28 volunteers. For all doses of ZD4054, mean plasma ET-1 concentrations measured at 4 and 24 h were within the placebo reference range (a rise in ET-1 would indicate ET(B) blockade) and there was no evidence of dose-related changes. These data confirm the specificity of ZD4054 for ET(A), with no activity at ET(B) in a clinical or preclinical setting. As a result of this specificity, ZD4054 has the potential to block multiple ET(A)-induced pathological processes, while allowing beneficial ET(B)-mediated processes to continue, which may, in turn, lead to an effective cancer therapy.     

甲磺酸加替沙星片健康人单剂口服药代动力学

目的研究健康人口服单剂甲磺酸加替沙星片后药代动力学特征,为该药II期临床试验提供依据。方法采用3剂量3周期拉丁方实验设计。9名健康受试者单剂口服甲磺酸加替沙星片100、200、300mg,HPLC法测其血清、尿药物浓度。结果受试者口服甲磺酸加替沙星片后,人体耐受良好,体内过程符合二室开放模型。主要药代动力学参数与给药剂量呈线性关系,tmax为0.5～0.7h,Cmax分别为1.42、2.42、3.25μg/ml,AUC0-∞分别为11.33、21.85、32.32μg·h/ml,V/Fc值为50～80L,t1/2β为8～9h,72h尿药累积回收率约为63.5%。结论甲磺酸加替沙星片口服吸收良好,血峰浓度高,组织分布广,消除半衰期长。200mg每日一次口服用于治疗敏感菌感染。     

连续口服甲磺酸加替沙星片的人体耐受性研究

目的 :在中国健康成年志愿者中 ,评估连续口服甲磺酸加替沙星片的耐受性。方法 :根据GCP原则设计试验方案 ,选择 10名 18～ 4 0岁健康男性受试者参加连续口服甲磺酸加替沙星片耐受性试验 ,口服甲磺酸加替沙星片每次 4 0 0mg ,每日 1次 ,连续10d。观察临床症状、体征 ,包括体温、脉搏、呼吸频率、血压等指标 ;实验室指标包括心电图、脑电图、血常规、凝血功能、尿常规、肝功能、肾功能、电解质等。结果 :入选受试者给药后及给药期间症状、体征及实验室检查均未见有临床意义的改变。试验中未见严重的临床不良反应 ,有 2例受试者出现GPT、GOT轻度升高 ,可能与药物有关 ,停药 1wk后恢复正常。结论 :10名健康受试者连续口服甲磺酸加替沙星片10d ,每日 4 0 0mg ,可安全耐受     

丹酚酸胶囊Ⅰ期临床耐受性研究

目的 :观察和评价丹酚酸胶囊单次及连续给药对人体的安全性 ,推荐临床安全、有效的用药剂量。方法 :将 32名健康志愿者随机分为 4 0 0、6 0 0、80 0和 10 0 0mg单次给药组 (n =6 )及连续给药组 (2 0 0mg ,tid× 7d ,n =8)。各组观察指标为一般情况、生命体征 (心率、呼吸、血压 ) ;血尿常规、肝肾功能等实验室检查 ;监测心电图 ;试验过程中观察不良反应。结果 :单次给药后 1、2 4、72h ,受试者的生命体征及实验室结果与给药前相比均未发现异常变化。连续给药耐受性试验结果显示 ,服药后第 4及第 8天 (停药后 1天 )受试者的生命体征和实验室检查结果与给药前相比均在正常值范围内。结论 :健康志愿者对丹酚酸胶囊单次及连续给药均有很好的耐受性。本次耐受性试验最大给药剂量为 10 0 0mg,安全性好 ,临床推荐剂量为2 0 0mg ,tid。