妊娠期妇女使用中成药的疗效及子代安全性评价

目的：通过评价妊娠期妇女使用中成药的疗效及子代安全性,探讨建立中成药妊娠期循证医学证据体系的必要性。方法：选取2016年某院门诊使用中成药的妊娠期妇女纳入研究,随访周期为1年,从药品、患者年龄、妊娠情况、生产方式、新生儿情况等方面进行统计分析,与课题研究期间某院全部出生新生儿的数据为对照,统计两组之间是否存在显著性差异。结果：研究组入组患者720人,随访结果204人,分析结果显示研究组和研究亚组新生儿体质量、性别比例和流产情况与对照组无统计学差异。结论：本研究所涉及的10种中成药对妊娠期妇女使用总体上是安全的,个别品种出现的异常情况还需进一步研究。     

Exploration and Preparation of a Dose-Flexible Regulation System for Levetiracetam Tablets via Novel Semi-Solid Extrusion Three-Dimensional Printing

Levetiracetam therapy is often associated with high levels of individual variation in the recommended dose required to achieve preferential treatment. Thus, a reliable and dynamic regulation system to accurately tailor dose is necessary. The main objective of this study is to explore and prepare a dose-flexible control system suitable for rapid release tablets equipped with high drug loading and a cylindrical model design. Semi-solid extrusion 3-dimensional printing was utilized to fabricate a series of tablets of increased volume. This method was compatible with 3 patterns to regulate the volumes to manipulate the tablet mass and achieve tailored personalized precision dosing. All tablets from each pattern exhibited a smooth surface and regular shape, as well as sufficient mechanical strength. A good linear correlation between the mass and theoretical volume of the tablets was maintained, regardless of the pattern used. The range of dose accuracy was between 103.3% and 96.2%, with an acceptable variation coefficient in the range of 0.6%-3.2%. Faster release behavior for levetiracetam can be achieved from the small-sized tablets due to their larger surface area/mass ratio. All the results demonstrated the potential and capability of semi-solid extrusion 3-dimensional printing as a novel pharmaceutical manufacturing technique to provide a dynamic and highly accurate controllable system for preparing patient-tailored medicines.     

Perspectives of physicians practicing in low and middle income countries towards generic medicines: A narrative review

Objectives

This review was conducted to document published literature related to physicians’ knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries.

Methods

A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists.

Results

Sixteen articles were included in this review. The majority (n = 11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians’ knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians’ concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing.

Conclusion

The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels.     

WHO's role in the global health system: what can be learned from global R&D debates?

Recent global debates on the research and development (R&D) of health technologies, such as drugs, diagnostics and vaccines, can be seen as a microcosm of discussions on the role of the World Health Organization (WHO) in the global health system more broadly. The global R&D system has come under heightened scrutiny with the publication of a 2012 report by the WHO Consultative Expert Working Group on Research and Development (CEWG), which made a number of recommendations to more equitably meet global health needs. The CEWG report followed a decade-long process of debate at the WHO on the weaknesses of the global R&D system, which include problems of affordability, limited research where market returns are small or uncertain (such as the ‘neglected diseases’ that predominantly affect the world's poorest), inefficient overlap of research efforts, and overuse of medicines such as antibiotics. The CEWG report called on WHO Member States to develop a global framework to improve monitoring, coordination and financing of R&D efforts through the establishment of a Global Health R&D Observatory and the negotiation of a binding treaty on R&D. While the treaty option has been put on the back-burner for several years, Member States nevertheless agreed at the 2013 World Health Assembly (WHA) on concrete steps towards a global framework. Progress at the 2013 WHA reaffirmed the central role of WHO as a convener, and the WHA's decision to create the Observatory within the WHO Secretariat underscored the organization's role as a source of strategic knowledge in the global health system. However, despite WHO's constitutional mandate as the ‘directing and coordinating authority on international health work’, in reality it faces major challenges in coordinating autonomous R&D actors such as states, firms and foundations in the global system. Strengthening its ability to do so requires, at a minimum, reforming its financing arrangements to provide it with a greater degree of independence from its largest donors. In addition, WHO may seem to be the natural arena for negotiating a binding R&D treaty, but negotiating new global agreements in other arenas such as the WTO, WIPO, or plurilateral fora offer the possibility of more enforceable and stronger public health norms. Nevertheless, no single arena in the existing system of global governance is perfectly suitable for the negotiation of progressive, inclusive, binding, enforceable, global health rules. While tradeoffs are inherent in the choice of any particular arena, leadership from either the multilateral institutions or influential governments can make a key difference in how beneficial any R&D treaty may be for health. In the coming years, global R&D debates will remain a critical issue to watch. The evolution of the global R&D system will be a harbinger not only of WHO's place in a rapidly-changing global health system, but also of our collective capacity to strengthen institutions of global governance for health.     

Prevalence of use and reported side effects of herbal medicine among adults in Saudi Arabia

ObjectiveDespite the availability of well characterized and scientifically proven medicines, many people prefer the use of the less known herbal therapies that have no-scientific or evidence-based values as their first line of treatment. While this represents a growing worldwide issue, it is commonly practiced in developing countries including Saudi Arabia. Hence, the aim of the present study is to assess the prevalence of herbal medicine use, the most reported side effects and influencing factors in Saudi Arabia.DesignA community based cross sectional survey study.SettingsParticipants were recruited by convenience sampling method from local malls and family recreation sites.Main outcome measuresPrevalence of herbal medicine use and the associated risks.ResultsOut of the 1300 surveyed individuals, 1226 respondents (94 %) used herbal medicines for therapeutic purposes with the majority of the respondents using them based on traditional beliefs 699 (57 %) or family recommendations 417 (34 %). Young respondents <35 year olds who live in urban cities, showed a significantly better knowledge about herbal medicines use and the associated risks than their counterparts (p < 0.001). Despite the high percentage of reported side effects (46 %), more than half of the respondents 702 (54 %) use herbal medicines as their first line of therapy. However, the most reported reasons for the use of herbal medicine are the belief that they are safer, more effective and cheaper to buy than the standard medicines.ConclusionThere is a high prevalence use of non-scientifically proven herbal medicine and a low level of knowledge about their risks amongst participants.     

Simultaneous determination of glycyrrhizin and liquiritin in licorice roots and Kampo medicines by combination enzyme-linked immunosorbent assay using anti-glycyrrhizin and anti-liquiritin monoclonal antibodies

Immunoassay systems using monoclonal antibodies (mAbs) are one of the most useful techniques in the analytical, biochemical, and clinical fields. In this study, a combination enzyme-linked immunosorbent assay (ELISA) using both anti-glycyrrhizin and anti-liquiritin mAbs (anti-GL/Liq mixture mAbs) was developed for quality control of licorice and its products. The combination ELISA demonstrated high sensitivity, reproducibility, and specificity for the total content of GL and Liq by a single assay. The developed ELISA was effective and useful as the first screening method in the selection of high-quality licorice from the Glycyrrhiza species and in confirming the quality of licorice-containing Kampo medicines.     

Non-clinical efficacy-related studies for human medicines: An overview and retrospective analysis of data for a group of approved medicines

The lack of efficacy is a major cause of medicine's development failure at the clinical phase, which may lead to question, among other aspects, the translation of the non-clinical data into humans. The objectives of the work here presented were (i) to get an overview (based on public assessment reports) of the nature of the non-clinical efficacy-related studies presented to the regulatory authorities at the marketing authorization application's stage for a group of approved anticancer human medicines (15 in total) and (ii) to conduct a retrospective analysis of such studies in terms of any identified insufficiencies and consistency with the current regulatory non-clinical guidelines. Each medicine has been tested in a number of in vitro assays and animal studies, which, all together, are judged to be capable of providing information on the activity of the active substance and demonstrating an anti-tumour effect, as well as to be generally consistent with the available, although limited detailed, guidance. In spite of this, some aspects were identified which could have a potential impact on the translation on non-clinical data into humans, namely, apparent insufficiencies in terms of animal model/human bridging data/knowledge and in vivo data on pharmacokinetics/pharmacodynamics relationships.     

Economical impact of plasma fractionation project in Iran on affordability of plasma-derived medicines

In Iran all transfusion services are concentrated under authority of one public and centralized transfusion organization which has created the opportunity of using plasma produced in its blood centers for fractionation. In 2008 voluntary and non remunerated Iranian donors donated 1.8 million units of blood. This indicates a 25/1000 donation index. After responding to the needs for fresh plasma and cryoprecipitate each year about 150000 L of recovered plasma are reserved for fractionation. In an attempt to improve both blood safety profile and availability and affordability of plasma derived medicines, Iran's national transfusion service has entered into a contract fractionation agreement for surplus of plasma produced from donated blood by voluntary non remunerated donors. In order to ensure safety of product produced, Iran has chosen to collaborate with international fractionators based in highly regulated countries. The main objective of this study was to evaluate the impact of contract plasma fractionation on the affordability of the plasma derived medicines in Iran. During 2006–2008, Iran's contract fractionation project was able to produce 46%, 18% and 6% of IVIG, Albumin and FVIII consumed in Iran's market, respectively. In contrary to IVIG and Albumin, due to fairly high consumption of FVIII in Iran, the role of fractionation project in meeting the needs to FVIII was not substantial. However, Iran's experience has shown that contract plasma fractionation, through direct and indirect effects on price of plasma derived medicines, could substantially improve availability and affordability of such products in national health care system.