Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

Five‐year efficacy of finasteride in 801 Japanese men with androgenetic alopecia

Finasteride is standard medical treatment for androgenetic alopecia; however, no large studies with 5 years or more of follow up have been performed in Japan. The authors followed Japanese men with androgenetic alopecia treated with finasteride for 5 years to evaluate long‐term treatment efficacy. Of 903 men treated with finasteride (1 mg/day), 801 patients were evaluated over 5 years by modified global photographic assessment. Although the proportion of improvement was high (99.4%), modified global photographic assessment scores after 5 years of treatment were lower in patients with more advanced disease as measured by the modified Norwood–Hamilton scale. After separating patients into “sufficient” and “insufficient” efficacy groups according to the modified global photographic assessment score after 5 years (scores ≥6 and <6, respectively), multivariate analysis showed that independent risk factors of insufficient efficacy were age at start of treatment of 40 years or more (P = 0.021) and classification on the modified Norwood–Hamilton scale (P < 0.001), whereas presence of stress at start of treatment was a negative predictor (P = 0.025). In conclusion, continuous finasteride treatment for 5 years improved androgenetic alopecia with sustained effect among Japanese. Younger age and less advanced disease at start of treatment were the key predictors of higher finasteride efficacy.     

Identification and evaluation of antioxidants in Japanese parsley

Two cultivars of Japanese parsley were harvested in different seasons; their antioxidant capacities were evaluated by oxygen radical absorbance capacity (ORAC) methods, and the contents of hydrophilic and lipophilic antioxidants were compared. Japanese parsley possessed potent antioxidant capacities both in hydrophilic and lipophilic extracts when evaluated by ORAC methods. LC/MS/MS analyses revealed that chlorogenic acid and four kinds of quercetin glycosides were major antioxidants in the hydrophilic extract. Lutein was the main contributor to the antioxidant capacity of the lipophilic extract. Antioxidant capacities of the hydrophilic extracts of both cultivars tended to be higher in winter because of the increase in the contents of chlorogenic acid and quercetin glycosides. An obvious trend in the lipophilic antioxidant capacities or lutein contents was not observed irrespective of the cultivar.     

Psychometric properties of the Repetitive Behavior Scale-Revised for individuals with autism spectrum disorder in Japan

Restricted and repetitive behaviors (RRBs) constitute a core symptom of autism spectrum disorder (ASD). The Repetitive Behavior Scale-Revised (RBS-R) is a widely used questionnaire administered by parents or caregivers to assess RRBs in individuals with ASD. This study evaluated the psychometric properties of the RBS-R Japanese Version (RBS-R-J). The ASD and non-ASD groups comprised 274 and 36 participants, respectively. We examined corrected item-total correlation, Cronbach's alpha, and RBS-R-J scores of different diagnostic groups, as well as correlations between RBS-R-J scores and intelligence quotient (IQ), autistic symptoms, adaptive/maladaptive functioning, aberrant behaviors, and sensory processing. All items showed moderate corrected item-total correlations. Cronbach's alpha coefficient was .93. We found significant differences in the mean RBS-R-J scores of the low-functioning ASD group and the intellectual disabilities group, and of low-functioning and high-functioning ASD groups. RBS-R-J scores negatively correlated with IQ and scores on the Sensory Profile (Japanese version) and Adaptive Behavior Composite of the Maladaptive Behavior Index of the Vineland Adaptive Behavior Scales-Second Edition (VABS-II; Japanese version), but positively correlated with scores on the peak and current symptoms subscales of the Pervasive Developmental Disorders Autism Society Japan Rating Scale, the VABS-II, and the Aberrant Behavior Checklist-Community (Japanese version). From these results, we conclude that RBS-R-J showed good reliability, diagnostic validity, and convergent validity, indicating that it is a reliable, valid instrument for use among ASD individuals in clinical and research settings.     

Infective Endocarditis Due to Treponema pallidum: A Case Diagnosed Using Polymerase Chain Reaction Analysis of Aortic Valve

Syphilis is a sexually transmitted disease caused by Treponema pallidum. Syphilitic aortitis might coexist in a dysfunctional aortic valve, but the etiology remains unclear, because microbiological diagnosis is difficult. A 62-year-old man with low-grade fever was diagnosed with aortitis and infective endocarditis, due to Treponema pallidum infection, using polymerase chain reaction analysis. This case suggests that syphilis might cause infective endocarditis.     

单抗N糖分析系统适用性对照品的建立

目的建立单抗N糖分析方法的系统适用性对照品,并设定相应的系统适用性要求。方法利用液质联用(LC-MS)仪对N糖系统适用性对照品进行N糖型的表征鉴别,并对对照品进行稳定性评价。结合方法特点和验证数据,对系统适用性要求进行设定。结果建立的系统适用性对照品具有良好的稳定性,其糖型涵盖了单抗主要的N糖型种类。针对3种药典拟收录的单抗N糖分析方法,设定了以下系统适用性要求,包括:图谱与典型图谱相似、G1F(1,6)和G1F(1,3)的分离度应满足具体要求、G0F%应在规定的范围内、G0F保留时间的RSD应≤4%。结论建立了单抗N糖系统适用性对照品,可配合3种2020年版《中国药典》拟收录的N糖分析方法使用。     

基于中药质量标志物和传统用法的中药饮片标准汤剂传承发展研究思路与建议

中药汤剂(也称煎剂)是中医师最常用的中药复方剂型,也是中药历史上应用最久和最广的制剂。药材是饮片的原料,饮片是制备提取物、构成中医处方和中药制剂的原料,更体现了传承发展中药的重要性。基于中药饮片标准汤剂,科学认识汤剂质量,提高药典饮片和中成药质量评价研究理论和方法是科学发展的重要策略。开展以中医药理论为指导、临床应用为基础的中药饮片标准汤剂研究,基于中药质量标志物理论和研究方法探讨饮片和煎煮工艺的影响,形成标准汤剂的质量评价体系,既有利于确保中医处方用药的安全和疗效,也有利于认识标准汤剂在"药材-饮片-中成药"的质量及其标准的差异和价值,提升国家对中药饮片监管水平,保障人民用药安全和有效;还有利于认识标准汤剂在中药饮片生产、中药配方颗粒及经典名方的传承研发中的重要意义。     

OTC drug advertising in Japan: the role of need for cognition and celebrity endorser credibility

Abstract

This research explores how the level of consumers’ need for cognition (NFC) is associated with celebrity endorser credibility and examines its effects on advertising-related attitudes. A 3 (endorser types: actor/actress, athlete, TV personality/talent) × 2 (endorser’s gender) factorial experiment with 435 Japanese consumers was conducted. Concerning Japanese OTC drug advertising, lower NFC individuals perceived celebrity endorsers as more credible in comparison to higher NFC individuals. The main effects of NFC and endorser type on endorser credibility existed; however, no interaction between the two variables was found. The endorser type had an influence on attitudes toward ads and the advertised brand.     

乙型脑炎、麻疹胎传母体抗体的调查

86对母婴血清标本用间接酶联免疫测定法(ELISA)测定了乙型脑炎抗体,118对用血凝抑制(血抑)试验测定了麻疹抗体。结果发现,脐血乙型脑炎抗体阳性率为79.1％,母血为74.4％,几何平均滴度在脐血显著高于母血(t=5.1857,P<0.01),比值为1.2∶1。脐血和母血的麻疹血抑抗体阳性率分别为86.4％及84.8％,几何均值也是前者高于后者(t=4.0349,P<0.01),比值为1.3∶1。 108份婴儿血清标本测定结果显示,0～3个月婴儿乙型脑炎抗体阳性率为35％,4～9个月仅为13％,10个月及以上的婴儿全部阴性。此结果与近年上海市小于1岁组乙型脑炎发病率最高相一致,提示应考虑提早乙型脑炎疫苗的接种年龄。     

Report from the 1st Japanese Urological Association-Japanese Society of Medical Oncology joint conference, 2006: ''A step towards better collaboration between urologists and medical oncologists''

The 1st Japanese Urological Association-Japanese Society of Medical Oncology Joint Conference, titled 'A step towards better collaboration between urologists and medical oncologists', was held to coincide with the 44th Meeting of the Japan Society of Clinical Oncology, Tokyo, in October 2006. The main theme of the conference addressed the need for a subspecialty of medical oncologist within urology to keep abreast of advances in medical oncology. Urologists should become more involved in the postoperative management of urologic cancer. Consensus on the optimal way to move forward in the treatment of urological cancer is needed. The conference featured eight lectures surveying the present status of uro-oncology in Europe, the USA, Korea, Singapore, and Japan; the relationship between surgical oncologists and medical oncologists; global trends and international clinical trials in uro-oncology; and the future of urologic oncology. These were followed by a general discussion titled 'Achieving better collaboration between the surgical oncologist and the medical oncologist.' This report presents a roundup of the 1st Japanese Urological Association-Japanese Society of Medical Oncology Joint Conference.