基于国家专利的中药复方治疗化学性肝损伤用药规律研究

目的分析国家专利治疗化学性肝损伤的组方用药规律,为新药研发及相关专利的申请提供参考。方法以国家知识产权局中国专利公布公告网站收录的授权专利为资料来源,使用Microsoft Excel 2018建立数据库,对中药频次与分类进行统计分析;采用SPSS Statistic 21.0和SPSS Modeler 15.0对高频中药(频次≥10)进行性味归经分析、系统聚类分析、关联度与网络分析。结果纳入专利100项,涉及中药186味,以葛根最为常见;高频中药15味,药味以甘为主,药性以温、平为主,多归脾、肝经;聚类分析得到7组中药组合;二项、三项和四项关联规则分别为6、24、2项,各项组合分别为6、16、2项;核心药物为葛根、五味子、丹参、甘草、山楂、枸杞子、黄芪、柴胡、姜黄和枳椇子。结论中药复方治疗化学性肝损伤常用补虚、解表、化瘀、活血、渗湿及利水药;临证多采用疏肝理气之剂,适当伍以柔润之品。     

蒙药治疗肝损伤的实验研究进展

随着蒙医药临床与实验科学的快速发展，关于肝损伤的实验研究也逐渐增多，其研究内容从最初的药物对实验动物生化指标的影响发展到组织病理形态学改变以及分子生物，免疫蛋白测定等。本文章通过查阅与总结从1992年至今关于蒙药治疗肝损伤实验研究，总结多种蒙药复方、单药及其提取物对不同模型导致肝损伤的作用及影响，为蒙药治疗肝损伤的进一步研究发展提供最初的信息资源。     

被动吸烟与神经管缺陷关系的病例对照研究

目的 探讨妇女怀孕前后被动吸烟与神经管缺陷（NTDs）的相关性。方法 采用1[DK]∶1配对病例对照研究，选取2010-2014年山西省“削峰工程”监测医院登记的生育NTDs患儿的妇女411例作为病例组，同时选择怀孕前后居住在同一个县（或区）、民族相同、末次月经与病例妇女相差3个月以内的生育健康儿童的妇女411例作为对照组进行问卷调查。用单因素和多因素条件logistic回归模型探究妇女怀孕前后被动吸烟与NTDs的关系。结果 妇女怀孕前后被动吸烟增加生育NTDs患儿的风险（aOR=1.209，95%CI:1.043～1.401，P=0.012）。且随着被动吸烟的频次增加，生育NTDs患儿的风险增加，与未被动吸烟的妇女相比，每周被动吸烟4～6次的妇女和每周被动吸烟大于6次的妇女生育NTDs患儿的OR值分别为2.113和2.903（趋势〖XC小五号.EPS;P〗=13.381，P＜0.001）。妇女被动吸烟的主要场所是家中（71.6%），且妇女被动吸烟程度与丈夫吸烟情况相关（r=0.405）。结论 妇女怀孕前后被动吸烟会增加生育NTDs患儿的风险，且随着被动吸烟频次的增加，生育NTDs患儿的风险增加。     

Effects of socioeconomic status on mortality after Parkinson's disease: A nationwide population-based matched cohort study in Korean populations

IntroductionTo evaluate the mortality rate and impact of SES on mortality in PD using a nationwide cohort in Korea.MethodsWe selected patients diagnosed with PD (ICD-10 code: G20) and registration code for PD (V124) in the program for rare intractable diseases between 2004 and 2015. After that, atypical parkinsonism was excluded. A matched cohort of individuals without PD were enrolled by randomly matching patients by sex, age, and year of diagnosis to the PD group with a ratio of 1:9. Cox proportional hazard models were used to identify the effects of SES on mortality using Hazard Ratios and 95% confidence intervals.ResultsIn total, 26,570 participants were enrolled. The mortality rate was 30.37% in PD cohort and 16.69% in the comparison cohort. According to income level, PD patients in low-middle group revealed significantly decreased HRs of 0.704 (95% CI, 0.533–0.930) compared to those in the lowest group. The medical aid group showed an increased mortality rate (HR = 1.552, 95% CI, 1.191–2.021) compared to the national health insurance group. In the subgroup analyses, medical aid was associated with mortality only in PD with female (HR = 1.740, 95% CI, 1.242–2.438) or aged 60–79 years (HR = 1.434, 95% CI 1.005–2.045). There was no significant difference in mortality rate according to residential area in PD.ConclusionsIn Korea, individual level low SES including income level and insurance type were significantly associated with increased mortality, whereas regional level SES (residential area) was not related with mortality on PD.     

Analysis of Interventional Clinical Research Protocols Related to Coronavirus Disease 2019 and Future Expectations

Coronavirus disease 2019 (COVID?19) is a newly emerging infectious disease.After its outbreak, researchersstarted a large number of clinical interventional studies, using a variety of interventions to study the different types of COVID?19 cases. In this article, we searched the websites of Chinese Clinical Trial Registry, ClinicalTrials.gov, etc., to study the publicly registered research information. Through the classification and summary of interventional methods, evaluation indicators, research design, etc., this article provided readers with the outline of clinical research about COVID?19, and looked forward to the scientificity, feasibility, and future evidence of the clinical researches.     

Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study

Abstract

Objective: To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice.

Methods: This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.

Results: The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulin-naive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was –1.2 (p?=?.066) and 0.0 (p?=?.915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was –0.5% (p?<?.001) and –0.9% (p?<?.001), respectively, and –1.5% (p?<?.001) in insulin-naive T2DM.

Conclusions: This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice.     

基于医院信息系统的乳腺癌临床特征及中西医用药特征分析

目的 解析真实世界中乳腺恶性肿瘤患者的人群特征、诊断特征、中西医用药特征，为乳腺癌的临床防治提供参考。方法 采集2002年2月至2015年5月全国60家三级甲等医 院信息系统（Hospital Information System，HIS）中，出院诊断为“乳腺癌”的患者用药信息，采用SAS9.3统计软件，对人口学信息、诊断信息、医嘱用药信息等进行描述性分析。结果 39798例乳腺癌患者，平均年龄（50.93者，平均年龄）岁；多以门诊入院，入院病情以“一般”为主;合并疾病主要为高血压，骨肿瘤，联用西药以抑制肿瘤细胞增殖、治疗并发症、缓解放化疗不良反应为主；中医辨证以痰瘀互结证，气阴两虚证，肝气淤滞证，脾气亏虚证型最为常见，临床清热解毒剂、益气扶正剂，活血化瘀剂应用较多。结论 乳腺癌中西医结合治疗，联用药物广泛，临床治疗基本符合临床指南。