Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas

Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical safe medication.Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed,Web of Science,Springer Link,CNKI,Wanfang and VIP database were retrieved from December 2019 to May 2021.Then we extracted and analyzed the effective information included in the literature.Results and Conclusion According to the pre-developed retrieval plan,a total of 136 documents were obtained,and a total of 6 documents met the inclusion criteria finally.553 patients used three Chinese patent medicines and three herbal formulas,and there were 133 cases of adverse reactions.The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine,and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine.

Clinical evidence and potential mechanisms of Chinese medicines for the treatment of diabetic retinopathy

Diabetic retinopathy is one of the main causes of visual impairment and blindness on a global scale. At present, thelimitations of anti-vascular endothelial growth factor agents, steroids, laser photocoagulation, and vitreous surgery haveled to a growing awareness of the role of Chinese medicines in the treatment of diabetic retinopathy. This review firstdescribes the ingredients and characteristics of the formulae including Chinese herbal formulaes, Chinese patent drugsand ancient processed drugs and summarizes the application of Chinese medicines and their mechanisms of action in thetreatment of diabetic retinopathy. Due to the complexity of Chinese medicines, in-depth mechanisms, side effects of herb,and drug interactions need to be elaborated in future research. Chinese medicines have the potencial to protect theresidual eyesight and delay the progression of disease, thereby offering a beneficial, exploitable option in thetreatment/prevention of diabetic retinopathy.

Comparative Evaluation of Antitumor Chinese Patent Medicine Injections Based on Evidence-Based Medicine and Markov Model

Objective: The objective of this study was to explore the safety, efficacy, economy, and other aspects of frequently-used antitumor Chinese patent medicine injections through a comprehensive evaluation of evidence-based medical research to provide scientific information and decision-making basis for drug selection, rational drug use, public awareness of safe drug use, and medical insurance. Materials and Methods: The names of five frequently used antitumor Chinese patent medicine injections were used as search terms, including the compound Sophora flavescens injection, Kangai injection, Aidi injection, Kanglaite injection, and Brucea javanica oil emulsion injection. Relevant evidence-based medical research was extracted from the databases. A descriptive evaluation was conducted, and the Markov model was used for the cost-benefit analysis. Finally, the above injections are ranked by comprehensive scores using the multi-criteria decision analysis and Delphi method. Results: The five injections had their own advantages in enhancing the effectiveness of anti-tumor treatments, improving the quality of life for cancer patients, and reducing the incidence of adverse reactions. From the perspective of economy and other attributes, compound S. flavescens was superior to B. javanica oil, Aidi, Kangai, and Kanglaite. After a comprehensive evaluation of the above five injections, the compound S. flavescens injection received the highest score. Conclusions: Compound S. flavescens, Kangai, Aidi, B. javanica oil, and Kanglaite have their own advantages in effectiveness and no significant difference in safety. Compound S. flavescens injection has the highest comprehensive score. Clinical attention should be paid to monitoring the initial stage of medication and special groups.

Developing new drugs from annals of Chinese medicine

Developing new pharmaceuticals requires massive amounts of time,money and efforts.The key step is how to find a safe and effective entity for a disease condition and how to develop it as new drug effectively.Unfortunately,the FDA’s rate of approving new entities has declined dramatically in the last three decades.There is a strong need to review the current strategy and to optimize process in developing new drugs,both to shorten the process and increase the success rate.Chinese medicine has used natural products to treat patients for thousands of years,and Chinese medicine practitioners have chronicled the patients and treatment methods for thousands of years.There is much information that has not yet been used.The success stories of artimisinin and arsentic trioxide are wonderful examples of how the annals of Chinese medicine can provide leads for discovering new drugs.This paper argues that the annals of Chinese medicine are valuable and describes how they can be used in modern drug discovery.The major topics addressed are:(i)why Chinese medicine is a rich resource for finding new drugs;(ii)how to identify a potential valuable record from Chinese medicine annals;(iii)when a potential valuable record is identified from annals,how to proceed;and(iv)both why and how the approach used for chemical drugs should be revised for drugs based on the historical documents related to herbal medicine.In conclusion,we argue here that the annals of Chinese medicine offer not only a rich resource for new drugs,but also several centuries of patient data with regard to safety and efficacy,that in effect represent pilot studies.Acknowledging and using these data can shorten new drug discovery time and improve efficiency of the drug development process,bringing more effective,safe drugs to market much more quickly and cheaply.

RRLC-Q-TOF-MS法测定安神类中成药、保健食品中14种非法添加的催眠类药物

目的建立安神类中成药、保健食品中非法添加14种催眠类药物的定性和定量测定方法。方法使用RRLC-Q-TOF-MS作为检测方法，化合物准分子离子峰的保留时间、一级质谱和二级质谱作为定性依据；一级质谱准分子离子峰面积作为定量依据。结果建立安神类中成药、保健食品中非法添加14种催眠类药物的定性和定量检验测定方法，14种成分线性相关系数（r）均〉0．99，回收率80％～120％。结论RRLC-Q-TOF-MS法定性准确，干扰少，定量线性及回收率良好，适用于安神类中成药、保健食品非法添加催眠类药品的定性和定量检验。

以现实为导向:抗战时期新四军对中医药的运用

医药短缺是影响新四军生存、发展和壮大的重要难题。抗战初期,新四军积极筹建西医人才队伍,拓宽西药获取渠道,使医药困难得以暂时缓解。皖南事变后,由于日伪实行医药管制,新四军西医西药获取渠道严重受阻,致使医药困境再度加剧。基于此,新四军遵循中共中央方针,结合自身实践经验,破除中西医门户之见,形成独具特色的中医药政策。中医药政策的制定,是新四军在极端困境下采取的应急之策。新四军通过筛选与培养中医人才扩充医疗队伍,甄别与利用中草药缓解西药短缺,使处于弱势地位的中医药为抗战事业提供了不可或缺的医疗保障。对中医药的改造与运用,是新四军华中抗日根据地在医药卫生领域践行“自力更生”策略的重要体现。新四军的中医药实践展现了军部与其所属部队在医疗卫生工作中的多维互动,体现了各部队医疗卫生实践的同一性与特殊性。

Analysis on Composition Rules of Chinese Patent Drugs Treating Pain-Related Diseases Based on Data Mining Method

Objective: To analyze the composition rules of oral prescriptions in the treatment of headache, stomachache and dysmenorrhea recorded in National Standard for Chinese Patent Drugs(NSCPD) enacted by Ministry of Public Health of China and then make comparison between them to better understand pain treatment in different regions of human body. Methods: Constructed NSCPD database had been constructed in 2014. Prescriptions treating the three pain-related diseases were searched and screened from the database. Then data mining method such as association rules analysis and complex system entropy method integrated in the data mining software Traditional Chinese Medicine Inheritance Support System(TCMISS) were applied to process the data. Results: Top 25 drugs with high frequency in the treatment of each disease were selected, and 51, 33 and 22 core combinations treating headache, stomachache and dysmenorrhea respectively were mined out as well. Conclusions: The composition rules of the oral prescriptions for treating headache, stomachache and dysmenorrhea recorded in NSCPD has been summarized. Although there were similarities between them, formula varied according to different locations of pain. It can serve as an evidence and reference for clinical treatment and new drug development.

Function and application of Traditional Chinese Medicine Inheritance Calculate System

Traditional Chinese Medicine Inheritance Calculate System(TCMICS)is a computational tool designed to facilitate the analysis of diseases,symptoms,syndromes,prescriptions,and acupoints based on databases of existing prescriptions,medical cases,or compound formulas.The software,currently updated to version 3.5,comprehensively presents the relationships between diseases,symptoms,syndromes,prescriptions,herbalmedicines,and acupoints.TCMICS integrates the functions of importing,retrieving,and analyzing diseases,syndromes,symptoms,tonguemanifestations,pulsemanifestations,herbal medicines,prescriptions,medical cases,and related information.It includes 7 functional modules:statistical analysis,prescription analysis,symptom analysis,tongue manifestation analysis,pulse manifestation analysis,acupoint analysis,and comprehensive analysis.TCMICS has been recognized by academicians,national TCM veterans,and renowned TCM clinics in Beijing,Shanghai,Guizhou,Shandong,Tianjin,and so on.It is regarded as an important tool for inheriting the academic thoughts and clinical experience of renowned TCM veterans and has been applied to the inheritance of Chinese medical expertise and analysis of TCM literature,as well as the development of TCM products.

Network Meta-analysis of Four Chinese Patent Medicines Combined with Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blockers in Early Diabetic Nephropathy Treatment

The objective of the study is to systematically evaluate the efficacy of four Chinese patent medicines in combination with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB) in the treatment of early diabetic nephropathy (DN). Retrospectively, previously published randomized controlled trials (RCTs) of four different Chinese patent medicines combined with ACEI or ARB in the treatment of patients with early DN were searched overall from databases. The data were analyzed by R, Generate Mixed Treatment Comparisons and STATA softwares. A total of 78 RCTs were finally included. Network meta-analysis showed that the total effective rate of the Jinshuibao capsule-ACEI/ARB combination group and Huangkui capsule-ACEI/ARB combination groups were better than the others;Jinshuibao capsule-ACEI/ARB combination group reduced the 24-h urinary protein excretion (24-h UTP), urine microalbumin excretion rate (UAER), serum creatinine (Scr), and glycosylated hemoglobin (HbAlc) values. The Huangkui capsule-ACEI/ARB combination demonstrated a better reduction of (blood urea nitrogen [BUN]). Reduced incidences of adverse effects were only observed on treatment with Bailing capsule-ACEI/ARB combination. In early DN, combination of Jinshuibao capsule-ACEI/ARB provided the highest effective rate;moreover, it could reduce the24-h values of UTP, UAER, Scr, and HbAlc;Huangkuai capsule-ACI/ARB combination group showed a good effect on reducing BUN. Bailing capsule-ACEI/ARB combination group had reduced the incidences of adverse reactions.

Intellectual Property Protection and High Quality Development of Radix Glycyrrhizae for Treatment of COVID-19

Radix Glycyrrhizae is the dominant native medicinal material variety in the north and northwestern medicinal materials producing areas.It is a main Chinese medicine of effective TCM drugs and formulas for the treatment of new coronavirus disease(COVID-19).This paper introduces the medicinal value of Radix Glycyrrhizae,involving the labeling,cultural heritage,and creative intellectual property rights of the Chinese medicinal materials,analyzes the poverty-stricken areas that are ecologically suitable for Radix Glycyrrhizae cultivation,and the superior counties and production bases of the Chinese medicinal materials.Besides,mainly from the aspects of perfect intellectual property rights,the establishment of authentic medicinal material production bases,and the construction of quality control systems,etc.,it discusses the rural revitalization strategy and the development strategy of traditional Chinese medicine(TCM),agricultural intellectual property protection and high-quality development strategy of Radix Glycyrrhizae.

Analyzing the risk of drug abuse for morphine-containing Chinese patent medicines in China

Chinese patent medicines（CPMs） are widely used across China, and they are differently administrated from chemical drugs. For traditional reasons, CPMs may contain opium-derived compounds, such as morphine, which may pose the issues of drug abuse and addiction. In the present study, we aimed to evaluate the present risk of morphine-containing CPMs in causing drug abuse and addiction, based on a questionnaire-based approach and from a medicinal administrative perspective. We chose 76 CPMs containing morphine from government document and set them as the study group, and 10 chemical drugs containing morphine were set as the control group. Because there is no ready-made method, we created an evaluation sheet consisting of five questions to evaluate each drug and generate a risk-value score. Crosstabs analysis using SPSS 15.0 was conducted to obtain the influencing factors. We found that the study group obtained a mean score of 2.04 for the risk value, which was five times of that of the control group. Specifically, no maximum limit of morphine or codeine was set in product quality standards for more than four-fifth of the drugs. Moreover, 46.0% of package inserts failed to show any warning about addiction or prohibition over the long-term use of the drugs. The number of ingredients, as well as the functions of the drugs, was found to correlate with the risk value. Our findings suggested that CPMs were more risky in causing drug abuse and addiction than chemical drugs. Approaches, such as i） controlling the number of ingredients, ii） setting up maximum limit of morphine or codeine in quality standard, iii） providing more information on the package insert of drugs and iv） monitoring the drug containing both morphine and ephedrine, will be effective in reducing the risk of drug abuse and addiction.

New Progress in Modern Research on Chinese Herbal Medicines Published in Chinese Traditional and Herbal Drugs in 2010:Annual Highlights and Comments

As a series of and continuous publication,the papers published on Chinese Traditional and Herbal Drugs in 2010 were selectively and briefly highlighted to reflect the new progress on modern research of Chinese herbal medicines.Within 617 articles,chemical constituents(127),pharmaceutics and technology(149),pharmacological studies and clinical observation,and medicinal materials are still major categories.Some comments have also been personally provided.

医疗机构基于“三结合”中药新药研发及管理体系的构建

目的:在中药审评审批制度改革的政策背景下,围绕医疗机构,探索中医药理论、人用经验和临床试验相结合(简称“三结合”)的审评证据体系落地举措,为医疗机构中药制剂及中药新药研发提供参考。方法:根据“三结合”审评证据体系下中药新药研发的相关要求,从机构层面加强人用经验研究相关配套建设,从管理层面搭建中药研发、成果转化服务平台,从临床层面规范开展人用经验研究,构建医疗机构中药新药研发及管理体系。结果:医疗机构中药新药研发及管理体系的构建,有助于将临床诊疗数据转变为支持中药新药注册的人用经验证据,通过提高中药研发水平促进中药新药转化。结论:在医疗机构构建基于“三结合”的中药新药研发及管理体系,是“三结合”审评证据体系落地、政策引导研发实践的路径之一。

从国家药品抽检角度分析已上市中成药需要关注的相关问题

药品抽检是药品监督和执法的重要技术支撑手段,通过分析抽检结果可有效发现上市后药品的质量风险,同时也可评价某类或一定区域内药品的质量。立足于历年国家药品抽检中发现的中成药品种质量问题和潜在安全风险,以与中成药质量相关的原料、生产工艺、辅料及包装材料等环节为切入点,分析已上市中成药需要关注的问题,以期为中成药质量的提升和监管工作的开展提供参考。

基于中医辨证论治理论探索中成药处方审核方法

目的:依据国家卫生健康委员会等3部门联合发布的《医疗机构处方审核规范》,探索符合该院中医类别医师医疗活动的中成药处方审核方法。方法:参考药品说明书及相关资料,建立有代表性的31种中成药的“应用要点”;回顾历史处方,与梳理的中成药“应用要点”对比,分为“一致诊断”“不规范诊断”“待讨论诊断”和“不适宜诊断”。采用多学科中医专家论证的方式,探索符合中医师思维模式及医疗行为的处方审核要素及审核方法。结果:建立了该院31种中成药处方审核方法,包括处方用药与诊断是否相符,处方剂量、用法是否正确,疗程是否适宜,联合用药是否适宜,是否有用药禁忌等方面。结论:以“药证相符”为核心,建立符合该院中医师临床诊疗思维的中成药处方审核要素及审核方法,规范化中成药审核,对保障患者合理使用中成药、减少中成药使用风险具有重要意义。

中成药治疗肾性贫血及其临床研究现状

目的分析并梳理中成药治疗肾性贫血的临床研究,以期为临床实践和未来研究方向提供参考。方法系统检索8个中英文数据库,收集中成药治疗肾性贫血的临床研究。采用描述性总结与图表结合的形式对结果进行展示。结果共纳入60篇研究,其中首篇关于中成药治疗肾性贫血的临床研究发表于2000年,绝大部分研究发表于近5年。研究类型最多的是随机对照试验,占比90%。关于透析依赖性肾性贫血的研究40篇,研究对象2916例;非透析依赖性肾性贫血研究2篇,研究对象174例;未提及透析或者非透析依赖的肾性贫血研究有18篇,研究对象1279例。临床研究中干预措施的对比形式主要是中成药联合西药与单用西药的对比。纳入的研究中有40篇将“血红蛋白的变化”设定为一项结局指标,其次是“总有效率”(35篇)。结论现阶段治疗肾性贫血的中成药种类繁多,其有效性和安全性尚待进一步研究。此外,临床研究的结局指标不一致,无法保证研究的科学性和严谨性。

4种治疗糖尿病周围神经病变补气活血类中成药的卫生技术评估

目的为临床选择糖尿病周围神经病变(DPN)治疗用补气活血类中成药提供参考。方法参考《医疗机构中成药遴选专家共识(第一版)》,结合临床实际,制订药物卫生技术评估细则,参考药品说明书、临床指南和文献,对4种中成药的安全性、有效性、经济性、适宜性、创新性、可及性、传承性进行评分,并计算总分。结果通心络胶囊、木丹颗粒、糖脉康颗粒、芪蛭降糖胶囊的评分分别为74.5分、72分、64.5分、57分。结论临床在选择治疗DPN的补气活血类中成药时,相对于糖脉康颗粒、芪蛭降糖胶囊,建议优先使用木丹颗粒、通心络胶囊。

某三甲医院2022年产科中成药不合理使用情况分析

目的:促进医院产科中成药的合理应用,保障孕产妇及婴儿用药安全。方法:利用临床用药决策支持软件对某三甲医院产科2022年度开具的中成药处方进行系统自动点评筛选,对筛选出的问题处方再次进行人工点评,对处方存在的问题类型进行归纳汇总,分析原因。结果:该院产科2022年开具中成药处方(含住院医嘱)共计14886张,系统智能筛选出问题处方3987张(26.78%),人工点评后确认存在用药不合理情况的处方199张(1.34%),其中不合理儿童药品处方19张(9.55%)。结论:该院产科2022年仍存在不合理使用中成药情况,医院需及时采取积极的干预措施,以保障产科用药规范合理,保障患者的安全。

基于专利视角的中药月见草发展分析

通过IncoPat专利数据库对全球月见草相关专利申请情况进行统计和分析,揭示相关专利的申请现状与发展趋势。结果表明,中国、韩国、日本是全球月见草最主要的技术来源地和专利布局地。使用月见草的中药制剂、化妆品、具有保健功能的食品和饮品、化学制剂以及动物饲料为目前的研发热点。中国月见草相关专利申请数量远超其他国家,但专利总体价值偏低。基于月见草产业发展趋势,建议我国专利申请人可依据自身优势和市场定位制定合理的发展策略。