探讨中西医结合治疗肾阴虚型2型糖尿病的临床疗效

目的：探讨中西医结合治疗肾阴虚型2型糖尿病的临床疗效。方法70例肾阴虚型2型糖尿病患者作为观察对象,随机分为观察组和对照组,各35例。观察组予以中西医治疗,对照组仅予以西医治疗。结果观察组治疗效果优于对照组,两组高密度脂蛋白胆固醇（HDL-C）与低密度脂蛋白胆固醇（LDL-C）治疗后比较,差异无统计学意义（P〉0.05）,而空腹血糖（FPG）、服糖后2 h血糖（P2hPG）、总胆固醇（TC）以及糖化血红蛋白（HbA1c）、甘油三脂（TG）在治疗后观察组改善优于对照组,两组比较差异有统计学意义（P〈0.05）。结论针对肾阴虚型2型糖尿病患者采用中西医结合方式进行治疗,可有效改善患者的临床症状,提高治疗效果及生活质量。     

纠正低蛋白血症减少抗结核药物性肝损伤发生临床研究*

目的 探讨纠正低蛋白血症对减少抗结核药物性肝损伤(DILI)发生的作用。方法 2019 年3月～2021 年3 月汕头市中心医院感染病科收治的56例肺结核合并低蛋白血症患者被分为两组,每组28例。给予两组2HRZE/4HR抗结核治疗,另给予观察组输注人血白蛋白纠正低蛋白血症,对照组仅接受抗结核治疗,两组治疗时间均为6个月。使用全自动生化分析仪检测血清白蛋白(ALB)、天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、碱性磷酸酶(ALP)和总胆红素(TBIL)水平,采用化学发光法检测血清总胆汁酸(TBA)水平。在DILI发生时,给予护肝治疗。在治疗结束时,评定临床转归,进行痰培养和肺部CT检查。结果 观察组结核治愈有效率为92.9%,显著高于对照组的71.4%(P<0.05);观察组痰菌转阴率为91.3%,显著高于对照组的(66.7%,P<0.05),肺部病变吸收率为89.3%,显著高于对照组的64.3%(P<0.05);在治疗期间,观察组DILI发生率为25.0%,显著低于对照组的53.6%(P<0.05);在DILI发生时,7例观察组血清ALB水平为(35.2±4.9)g/L,显著高,15例对照组【(29.6±4.9)g/L g/L,P<0.05】,而血清TBIL水平为(33.6±5.2)μmol/L,显著低于对照组【(45.7±16.6)μmol/L,P<0.05】;在护肝治疗后,观察组血清AST、ALT、ALP、TBIL和TBA水平分别为(39.4±9.8)U/L、(35.1±10.8)U/L、(98.6±16.2)U/L、(17.4±4.6)μmol/L和(81.3±13.7)μmol/L,均显著低于对照组【分别为(64.8±9.9)U/L、(78.0±13.8)U/L、(133.7±22.9)U/L、(26.5±6.8)μmol/L和(96.9±16.4)μmol/L,P<0.05】。结论 补充人血白蛋白及时纠正低蛋白血症,对于肺结核合并低蛋白血症患者能够提高结核治愈率,降低药物性肝损害发生率,值得进一步研究。     

超声酶水解提取/高效液相色谱-原子荧光光谱联用法测定动物源性中药中的砷形态

目的 采用液相色谱-原子荧光光谱（HPLC-AFS）联用技术对动物源性中药中一甲基砷酸（monomethylarsine,MMA）、二甲基砷酸（dimethyarsine,DMA）、三价砷[As（Ⅲ）]、五价砷[As（V）]的形态进行研究。方法 样品中加入pH 2.5的胃蛋白酶液,于55℃超声20 min,6 000 r·min^-1离心3 min,取其上清液,过滤进样。采用Hamilton PPRP-X100阴离子交换色谱柱（150 mm×4.6mm,5 μm）分离,1 mmol·L^-1磷酸二氢铵溶液（pH 8.5）,20 mmol·L^-1磷酸二氢铵溶液（pH 7.0）体系组成的流动相按一定比例进行梯度洗脱,流速为1.0 mL·min^-1,进样量为100 μL。结果 4种砷形态在13 min内完成分离。MMA、DMA、As（Ⅲ）、As（V）的检出限分别为0.01,0.01,0.01和0.02 mg·kg^-1,样品中加标量为0.03~0.1 mg·kg^-1时,4种砷化合物的回收率为93.4%~105.4%,精密度RSD为0.8%~4.4%。结论 本研究建立的超声酶水解提取/HPLC-AFS测定动物源性中药中砷形态的分析方法样品提取简便,提取率高,测定方法精密度好,准确度高。     

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.