Baseline CD4 T Cell Level Predicts Recovery Rate after Initiation of ART in HIV Infected Nigerians

The most characteristic immunologic disorder in HIV infection is the progressive loss of CD4 T lymphocytes, thus, it remains the most important and commonly used marker for monitoring of immune status of HIV-infected individuals. This study monitored CD4 T lymphocyte cell dynamics among HIV patients on ART, and consequently defined an optimal baseline level required for enhanced ARV treatment. Ninety-eight (M = 33; F = 65) out of 106 consenting HIV-infected ARV-naïve patients enrolled and monitored for 24 months were considered in the analysis. The patients were classified into four groups based on baseline CD4 T lymphocyte cell levels, and specific parameters were evaluated at interval. Median CD4 T lymphocyte increased from 114 (Range: 6–330) at baseline to highest 357 (Range: 15–1036) cells/μL at 18 months of therapy. Fifty (51.0%), 58(59.2%), 75(76.5%), 69(70.4%), 63(64.3%), and 69(70.4%) doubled their preceding CD4 levels during the 3^rd, 6^th, 9^th, 12^th, 18^th, and 24^th months of ART, respectively. Maximum 337, 302, 360, and 475 cells/μL of blood were attained by groups commenced on ART with baseline CD4 ≤ 50, 51–100, 101–200, and 201–350 cells/μL of blood, respectively. The results show that higher baseline CD4 T lymphocyte cell level correlates with enhanced restoration and plateau after commencement of ART.     

Determinants for a low health-related quality of life in asthmatics

People with asthma suffer from impaired health-related quality of life (HRQL), but the determinants of HRQL among asthmatics are not completely understood. The aim of this investigation was to study determinants of low HRQL in asthmatics and to study whether the determinants of HRQL differ between sexes and age groups. A cohort of three age groups in Sweden was investigated in 1990 using a questionnaire with focus on respiratory symptoms. To study quality of life, the generic instrument Gothenburg Quality of Life was used. The participants were also investigated with interviews, spirometry, and allergy testing. Asthma was diagnosed in 616 subjects. Fifty-eight per cent (n = 359) of the subjects were women; and 24% were smokers, 22% ex-smokers, and 54% were non-smokers. Women were more likely than men to report poor health-related quality of life. Respiratory symptoms severity was another independent determinant of a lower quality of life as well as airway responsiveness to irritants. Current and former smokers also reported lower quality of life. Finally, absenteeism from school and work was associated with lower quality of life. Factors such as sex, smoking habits, airway responsiveness to irritants, respiratory symptom severity, allergy, and absenteeism from school and work were associated with low HRQL in asthmatics.     

临床常用头孢菌素类抗菌药物药品说明书评价

摘要：目的：将临床常用的头孢菌素类抗菌药物说明书进行对比分析,为药品说明书的完善和合理使用提供参考。方法：收集整理临床常用的14种头孢菌素类原研药和仿制药共计28份药品说明书,依据相关法律法规和参考资料为评价标准对其进行对比分析。结果：28份药品说明书中,主要在注意事项、药物相互作用、特殊人群用药、贮藏条件、修订日期等方面存在差异。此外,亦存在适应证范围不一、同一说明书对应多种规格、用法用量存在差异、不良反应存在差异、药物过量描述不一、药代动力学描述不一等问题。结论：头孢菌素类抗菌药物,尤其是仿制药药品说明书的内容完整度有待提高,说明书修订有待加强,建议不断完善头孢菌素类抗菌药物药品说明书,以保证患者用药安全。     

Public knowledge,perception, and experience with generic medications in Saudi Arabia

Objectives:To assess the public knowledge and perception about generic medications in Saudi Arabia, and their willingness to use generic medications.Methods:This cross-sectional, online-questionnaire-based study was conducted between May and July 2019, including participants who can read and complete an Arabic online survey. Chi-square test and contingency coefficient were used to investigate differences in different segments of participants and assess the association between knowledge and perception.Results:A total of 397 participants have completed the survey. One-half of them were female, the majority were of young age (<35 years), and 40% of them were buying their medications independently. Only 40.5% of participants had adequate knowledge and 60% of them had positive perception on generics. Participants with higher level of education were more likely to have adequate knowledge (p=0.002) and positive perception (p=0.006). The study found a moderate relationship between knowledge and perception about generics (standardized C=0.35, p<0.001). The country of origin for medications was a significant indicator of quality for two-thirds of participants, and one-half of them believed that local generics can compete with imported ones. About one-half of participants used generics and the majority of them were satisfied with their experience.Conclusion:There is a general lack of knowledge, while having a positive perception on generic medications among the general public in Saudi Arabia. Future studies should focus on strategies to improve it and assess its cost-savings consequences while maintaining quality of care.     

Who is afraid of biosimilars? Openness to biosimilars in an Australian cohort of patients with rheumatoid arthritis

Biosimilars are increasingly adopted to improve affordability of biologics. An effective introduction of biosimilars requires an understanding of patient acceptance of these agents. We performed a cross‐sectional study of 132 patients with rheumatoid arthritis prior to the introduction of biosimilar switching or prescribing in this cohort. Despite being unfamiliar with biosimilars, most patients are willing to accept biosimilar medicines if recommended by their rheumatologist. Patient concerns about biosimilar uptake mainly focus on concerns about its efficacy. There is a significant correlation between patient attitudes towards biosimilar and generic medicines.     

国外仿制药参比制剂选择简介及对我国的启示

目的：为完善我国仿制药一致性评价中参比制剂选择机制和程序提供参考,为仿制药企业在应用选择参比制剂时提供思路。方法：详细介绍了美国FDA有关参比制剂选择指南草案的最新描述,以及欧盟、日本和WHO对于参比制剂的相关要求。结合我国现阶段仿制药一致性评价工作实际,为完善参比制剂选择程序提出建议。结果与结论：美国详细规定了仿制药参比制剂的选择思路和实际操作程序,为我国仿制药参比制剂的选择提供了新的思路。我国正处于仿制药一致性评价参比制剂遴选的关键时期,制定全面、完善的参比制剂遴选体系和机制,有助于规范参比制剂的选择程序,加快一致性评价工作进程,提升我国仿制药一致性评价参比制剂选择的科学性和完整性。     

日本蓝皮书的介绍及启示

目的：介绍日本仿制药上市后质量动态信息的最新查询途径,为建立我国相关橙皮书提供借鉴。方法：介绍日本蓝皮书的背景、结构和内容,并以熊去氧胆酸片为例,详细介绍日本蓝皮书的使用方法。结果与结论：仿制药质量再评价工作在日本开展了近20年,淘汰了约10%的不合格药品。对于仿制药质量再评价的跟踪和实施、市场抽验及药品质量研讨会有效保证了口服固体仿制药药品质量的一致性和有效性,日本蓝皮书是对该项工作成果的集中系统整理,对我国开展仿制药一致性评价工作具有积极的启示。     

A Rights-Based Approach for Service Providers to Measure the Quality of Life of Children with a Disability

Background

This paper identifies the best instruments for service providers to measure the quality of life (QoL) of children with a disability, with a focus on their alignment with the Convention on the Rights of Persons with a Disability (CRPD).

Considerations in establishing bioequivalence of inhaled compounds

Introduction: Generic inhalers are often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. The approach to assess bioequivalence (BE) in oral dosage form products is not sufficient to address the complexities of inhalational products (e.g., patient-device interface); hence, more considerations are needed and caution should be applied in determining BE of inhaled compounds.

Areas covered: This review outlines the evaluation process for generic inhalers, explores the regulatory approaches in BE assessment, and highlights the considerations and challenges in the current in vitro and in vivo approaches (lung deposition, pharmacokinetic, pharmacodynamic/clinical studies, and patient-device interface) for establishing BE of inhaled compounds.

Expert opinion: The ultimate goals in this field are to establish uniformity in the regulatory approaches to speed the drug submission process in different regions, clear physicians’ misconception of generic inhalers, and have meaningful clinical endpoints such as improvement in patient quality of life when compared to placebo and brand name drugs. As inhalational drugs become more common for other indications such as antibiotics, the technologies developed for inhaled compounds in the treatment of chronic pulmonary diseases may be extrapolated to these other agents.