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.

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.

Simultaneous and interference-free determination of eleven nonsteroidal anti-inflammatory drugs illegally added into Chinese patent drugs using chemometrics-assisted HPLC-DAD strategy

In this work, a smart strategy that combines three-way high performance liquid chromatography-diode array detection(HPLCDAD) data with second-order calibration method based on alternating trilinear decomposition(ATLD) algorithm was proposed for simultaneous determination of eleven non-steroidal anti-inflammatory drugs(NSAIDs) illegally added into Chinese patent drugs and health products. All target analytes were rapidly eluted out within 14.5 min under a simple gradient elution. With the aid of the prominent "second-order advantage" of the ATLD algorithm, three HPLC problems, i.e. peak overlaps, unknown interferences and baseline drift, could be mathematically calibrated, and pure signals of target analytes could be extracted out from heavy-interference but information-rich HPLC-DAD data. The average spiked recoveries for all target analytes were in the range of 95.9%–106.4% with standard deviations lower than 7.5%. Validation parameters including sensitivity(SEN), selectivity(SEL), limit of detection(LOD), limit of quantitation(LOQ) and precisions of intra-day and inter-day were calculated to validate the accuracy of the proposed method, quantitative results were further confirmed by the classic HPLC method, which proved that chemometrics-assisted HPLC-DAD analytical strategy was highly efficient, accurate and green for drug-abuse monitoring of NSAIDs in Chinese patent drugs and health products.

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.

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.

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。

基于2020年版《中国药典》一部含毒性动物饮片中成药梳理分析与药学监护要点建立

目的分析含毒性动物饮片中成药,并建立其临床使用监护要点。方法根据2020年版《中国药典》收载的8味含毒性动物饮片,筛选药典中收载的含毒性动物饮片的中成药目录,梳理其药品说明书各项内容并整理其用药监护等内容。结果共纳入94种含毒性动物饮片中成药,按功能分类多集中于理血剂、开窍剂、补益剂等方面,其中含1种毒性动物饮片的有65种,含2种毒性动物饮片的有19种,含3种毒性动物饮片的有7种,含4种毒性动物饮片的有3种。多数含毒性动物饮片的中成药说明书标注了妊娠、哺乳、经期、儿童、肝肾功能异常等用药禁忌,且部分说明书标注了用药疗程等信息,需加强用药监护。结论含毒性动物饮片中成药是需加强用药监护的一类药品,需关注药品说明书标注的特殊人群、患者基础疾病、用药疗程、药物相互作用等方面,同时,还应注意长期使用此类药品可能导致毒性动物饮片的毒性成分蓄积和不良反应等情况,从而保证临床用药安全。

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。

我院2018—2022年补益类中成药的应用分析

目的 分析2018年1月—2022年12月我院补益类中成药的应用现状及趋势,为此类药的合理使用提供参考。方法 统计2018年1月—2022年12月药品数据库中补益类中成药年销售金额和用量进行统计,分析补益类中成药的销售金额、用药频度(DDDs)、日用药金额(DDC)、总金额排序号/DDDs排序号(DUI)值。结果 补益类中药口服剂型用药金额呈逐年上升趋势,注射剂构成比呈逐年下降趋势。口服剂型得到越来越广泛的应用,但是价格偏高。结论 我院补益药中成药品种结构基本合理,常用的补益药DDC值偏高,患者经济负担过重。补益药的不良反应发生率逐年增加,应注重合理用药。

中成药治疗复发性流产的临床研究概况性综述

目的系统梳理中成药治疗复发性流产(RSA)的药品信息和临床研究现状,为临床合理用药提供参考证据,为临床实践和医疗卫生决策提供依据。方法检索中英文数据库中对中成药治疗RSA的临床文献进行系统回顾,利用相关软件进行文献管理,并对药品及研究的基本信息进行提取,以文字描述和图表的形式开展可视化对比分析。结果共纳入95篇文献,包括系统评价和Meta分析2篇,临床研究93篇;涉及11种中成药,包括1种中药注射剂。临床研究数量较多的药品是滋肾育胎丸、固肾安胎丸和保胎灵制剂;2005年起相关研究数量整体呈升高趋势,已在全国24个地区开展;样本量为51~100例的研究最多,包括67项(72.04%);研究数量最多的比较类型是中成药联合西药与西药比较,研究总量达75项(80.65%)。目前临床无统一的治疗方案及疗效判断标准,部分研究(43.01%)记录了患者用药过程中不良反应发生情况。结论临床上中成药治疗RSA具有较好的适宜性,其与西药联用的效果明确。但存在药品说明书内容缺乏、用药时机疗程和结局评价指标未标准化、用药安全的重视程度不够、中医特色体现度不足等问题有待未来改善。

活血化瘀类中成药辅助治疗神经根型颈椎病有效性的网状Meta分析

目的:系统评价不同活血化瘀类中成药辅助治疗神经根型颈椎病(cervical spondylotic radiculopathy,CSR)的临床疗效。方法:应用计算机检索中国知网、维普网、万方数据库、PubMed、Web of Science和Cochrane Library中关于活血化瘀类中成药辅助治疗CSR的随机对照试验,检索时限均为建库至2023年9月20日。对照组单纯采用常规非手术方法治疗,试验组在对照组的基础上联合活血化瘀类中成药口服治疗。依据文献检索及筛选方案筛选出符合要求的文献后,由2名研究人员分别独立进行数据提取和质量评价。采用Stata18.0软件绘制网状关系图,对治疗有效率、颈部疼痛视觉模拟量表(visual analogue scale,VAS)评分、颈椎功能障碍指数(neck disability index,NDI)进行网状Meta分析,并根据累计概率排名曲线下面积(the surface under the cumulative ranking curve,SUCRA)对治疗方法的疗效进行排序。采用比较-校正漏斗图进行发表偏倚检验。结果:共检索到6768篇文献,通过逐层筛选最终纳入28篇文献,涉及颈痛颗粒、颈舒颗粒、脊痛消胶囊、痹祺胶囊、舒筋通络颗粒、颈复康颗粒共6种活血化瘀类中成药。网状Meta分析结果显示,在治疗有效率方面,不同活血化瘀类中成药辅助治疗CSR的疗效排序为颈痛颗粒联合常规治疗(SUCRA=78.4%)>痹祺胶囊联合常规治疗(SUCRA=71.6%)>颈舒颗粒联合常规治疗(SUCRA=62.1%)>舒筋通络颗粒联合常规治疗(SUCRA=53.7%)>脊痛消胶囊联合常规治疗(SUCRA=43.3%)>颈复康颗粒联合常规治疗(SUCRA=40.5%)>常规治疗(SUCRA=0.4%);在颈部疼痛VAS评分方面,不同活血化瘀类中成药辅助治疗CSR的疗效排序为舒筋通络颗粒联合常规治疗(SUCRA=96.3%)>痹祺胶囊联合常规治疗(SUCRA=86.2%)>颈复康颗粒联合常规治疗(SUCRA=51.6%)>颈痛颗粒联合常规治疗(SUCRA=50.8%)>颈舒颗粒联合常规治疗(SUCRA=37.4%)>脊痛消胶囊联合常规治疗(SUCRA=27.4%)>常规治疗(SUCRA=0.4%);在NDI方面,不同活血化瘀类中成药辅助治疗CSR的疗效排序为痹祺胶囊联合常规治疗(SUCRA=95%)>颈复康颗粒联合常规治疗(SUCRA=71.3%)>颈痛颗粒联合常规治疗(SUCRA=69.2%)>脊痛消胶囊联合常规治疗(SUCRA=38.7%)>颈舒颗粒联合常规治疗(SUCRA=20.8%)>常规治疗(SUCRA=5.0%)。结论:现有的证据表明,颈痛颗粒辅助治疗CSR的综合疗效最佳,舒筋通络颗粒在缓解颈部疼痛方面效果最佳,痹祺颗粒在改善颈椎功能方面效果最佳。但由于对照组采用的非手术疗法不尽相同及文献数量、质量等的限制,本研究的结论尚需进一步验证。

某院中成药说明书的儿科用药风险分析与管理思考

目的调查我院儿科用中成药种类、药品说明书和使用现状,分析临床用药风险,为儿童安全合理用药提供参考。方法调查我院使用的128种中成药药品情况,统计分析其说明书中用法用量、不良反应、禁忌、注意事项、药物相互作用、临床试验或药理毒理等内容标注情况。随机抽取2021年6月和10月门急诊中成药处方进行点评,判断处方规范性和合理性,挖掘潜在的儿科用药风险。结果128种中成药中,儿童专用品种54种,占42.19%。含有毒性饮片的中成药共计47种,涉及毒性中药材21种。说明书标注内容调查显示,明确儿童用法用量的药品占52.35%,标注不良反应、禁忌、注意事项的药品分别占32.03%、32.81%、82.03%,药物相互作用、临床试验或药理毒理标注率不高。我院门急诊中成药处方不合理问题集中于缺少中医诊断和用法用量不适宜,存在一定的用药风险。结论中成药儿童品种少、说明书中儿童用药信息缺失增加了临床用药风险,建议加强儿童专用药物研发,开展多维度研究以补充中成药儿童用药相关信息。药师应针对儿童机体、患病及用药特点,形成针对化、精细化、个性化的药学服务路径,加强对儿童用药的监督和指导,保障儿童合理安全用药。

某三级甲等综合医院门诊药房中成药药品说明书信息标注情况分析

目的完善医院门诊药房中成药药品说明书的信息标注,促进临床合理用药。方法通过医院信息系统收集某三级甲等(简称三甲)综合医院门诊药房83种中成药的药品说明书,参照相关法规、指南等分析各项目信息标注情况。结果83份药品说明书中,非处方药中除11份未标注警示语外,其余各项目均标注完整;处方药药品说明书【药品名称】【成分】【性状】【功能主治】【规格】等17项内容均标注完整,【药代动力学】【老年患者用药】【儿童用药】【孕妇及哺乳期妇女用药】【药物相互作用】等7项有缺项。结论该院门诊药房使用的中成药药品说明书信息标注存在缺项严重、表述模糊、界定不清的情况,建议相关部门加强对中成药药品说明书的管理,督促药品上市许可持有人进行修改和完善,以保障临床用药安全。

基于专家意见及数据挖掘分析继发性痛经中成药用药规律

目的:基于专家意见,通过数据挖掘的方式,分析疗效确切的中成药治疗继发性痛经的用药规律。方法:筛选2017版医保目录、2015版《中华人民共和国药典》中治疗痛经的药物,合并同一方剂不同剂型中成药,运用德尔菲法,对妇科专家以问卷调查的形式筛选出最常用、最推荐的治疗继发性痛经的中成药,并通过中医传承辅助平台探究治疗继发性痛经的中成药处方的用药规律、核心组合及关联规则,基于无监督的熵层次聚类推演出新方。结果:共筛选出中成药处方25个,涉及中药75味,常用药物为延胡索、当归、香附、川芎、白芍、丹参、五灵脂、红花、肉桂、熟地黄;主要归肝、脾经;通过关联规则得出常用药对以延胡索、当归、川芎相互组合为主;进一步聚类分析得到潜在核心组合8个,新处方4首。结论:临床常用治疗继发性痛经中成药处方用药以活血化瘀药为主,兼补血、温阳、益气,标本兼治,聚类分析得出的潜在药物组合和新方具有一定理论价值及代表性,可为临床探索及实验研究提供参考。

我国省级药品带量采购趋势研究

目的:总结省级药品带量采购的趋势,为完善政策设计提出建议。方法:采用文献分析、实地调研和专家咨询法,分析药品带量采购政策设计、执行和优化情况。结果:省级药品带量采购持续提速扩面,各地积极探索中成药和生物药带量采购,普遍按竞争充分性分组评审,采取价格联动并公开中选价。结论:省级药品带量采购呈现新的趋势,应总结各地的实践经验,形成药品带量采购规范与标准,合理开展价格联动,探索完善特殊药品带量采购规则,充分发挥省际联盟优势,引导零售药店规范参与。

基于国家专利的中药复方治疗癫痫的数据挖掘研究

目的基于数据挖掘研究中药复方专利治疗癫痫的用药及配伍规律。方法通过查询国家知识产权局专利公布网站中治疗癫痫的中药复方专利数据,运用Excel、Origin 2021、R 4.3.1、Cytoscape 3.9.1等软件进行描述性分析、关联规则分析、聚类分析和计算相关拓扑学属性值进行构建核心复杂网络。结果纳入治疗癫痫的中药复方专利共346项,涉及中药738味,用药频次前5味的中药分别是石菖蒲、天麻、全蝎、僵蚕、钩藤。药物类别以平肝息风药为主,聚类分析共得到2大类药物组合,共现网络得到核心组合石菖蒲-全蝎-天麻-僵蚕-钩藤;关联规则得到数据23条。结论本研究揭示了治疗癫痫的主要特点,即以平肝熄风、息风止痉、宁心安神为主的治疗方向结合与活血化瘀、健脾化痰等个体化的辩证诊治策略。这一发现旨在为中医药临床治疗癫痫提供了参考和借鉴价值。