Studies on the Degranulation of RBL-2H3 Cells Induced by Traditional Chinese Medicine Injections

Aims: To study RBL-2H3 cell degranulation phenomena induced by some TCMIs through cell morphological and ultra-structural observation, released enzyme activity and establish RBL-2H3 cell degranulation test indicated by β- hexosaminidase activity as a method to evaluate TCMIs at nonclinical stage. Methods: RBL-2H3 cells were used to study the degranulation by co-culture with positive control C48/80 and some TCMIs through morphological and ultra-structure observation, β-hexosaminidase activity detection. RBL-2H3 cell degranulation test was established to detect β-hexosaminidase activity caused by 17 kinds of TCMIs and their ingredients. The cytotoxicity effect of some TCMIs on both RBL 2H3 and BRL cells was measured by CCK-8 assay. Results: Toluidine blue staining and ultra-structure of electronic microscope observation of treated RBL-2H3 cells showed degranulation morphologically. Detection of β-hexosaminidase activity in the supernatant of treated cells showed some TCMIs had elevated enzyme release rates. Further analysis of the ingredients and compound in Tanreqing Injection and Shengmai Injection showed Scutellaria baicalensis Georgi in Tanreqing Injection, Red ginseng and Fructus Schisandrae Chinensis in Shengmai Injection were responsible to the degranulation of RBL-2H3 cells. Osmotic pressures and pH influenced RBL-2H3 degranulation. High Osmotic pressure of Tanreqing Injection and low pH of chlorogenic acid at 2.5 and 5.0 mmol/L congcentration might be responsible to high β-hexosaminidase activity. Most of the TCMIs inducing degranulation had cytotoxicity effect for both RBL-2H3 and BRL cells, but some TCMIs inducing degranulation had no cytotoxicity effect. Conclusion: Some TCMIs can induce degranulation of RBL-2H3 cells;RBL-2H3 cell degranulation test can be used in non-clinical stage to detect the risk causing anaphylactoid reactions. Osmotic pressures and pH influenced RBL-2H3 degranulation, and they should be measured before testing. The mechanism of degranulation caused by some TCMIs is cytotoxic, and some are non-cytotoxic and may be through exicytosis.

An analysis of the national TCM master Lu Zhizheng’s academic thought

Lu Zhizheng as one of the first national TCM masters in China, has gradually formed an academic thought of his own after longterm clinical practice of TCM. Such as development of spleen and stomach theory,18-character guideline——holding central area, operating also, taking good care of emotional activities, soothing liver, moistening dryness, improving digestion, and while his conclusions have been used for clinical practice flexibly. He suggested that the key of pathogenesis may be excessive fluid together with phlegm dampness and proposed the treatment rules of diseases caused by dampness. And he attempted to expound the methods and results of the research of rheumatism diseases. If conditions of diseases change,Professor Lu Zhizheng would be agile and adjust according to the conditions. The method of herbs is principled,and King Way therapy used by TCM treatment should be promoted.

Rapid and sensitive liquid chromatography–tandem mass spectrometric method for the quantitative determination of potentially harmful substance 5,5′-oxydimethylenebis (2-furfural) in traditional Chinese medicine injections

With the rapid development and wide application of traditional Chinese medicine injection(TCMI), a number of adverse events of some TCMIs have incessantly been reported and have drawn broad attention in recent years. Establishing effective and practical analytical methods for safety evaluation and quality control of TCMI can help to improve the safety of TCMIs in clinical applications. In this study, a sensitive and rapid high-performance liquid chromatography–tandem mass spectrometry(HPLC–MS/MS)method has been developed and validated for the quantitative determination of potentially harmful substance5,5′-oxydimethylenebis(2-furfural, OMBF) in TCMI samples. Chromatographic separation was performed on a C18 reversed-phase column(150 mm × 2.1 mm, 5 μm) by gradient elution, using methanol–water containing 0.1% formic acid as mobile phase at the flow rate of 0.3 m L/min. MS/MS detection was performed on a triple quadrupole mass spectrometer with positive electrospray ionization in the multiple reaction-monitoring mode. The method was sensitive with a limit of quantification of 0.3 ng/m L and linear over the range of 0.3–30 ng/m L(r = 0.9998). Intra-and inter-day precision for analyte was o9.52% RSD withrecoveries in the range 88.0–109.67% at three concentration levels. The validated method was successfully applied to quantitatively determine the compound OMBF in TCMIs and glucose injections. Our study indicates that this method is simple, sensitive, practicable and reliable, and could be applied for safety evaluation and quality control of TCMIs and glucose injections.

Thoughts on the Construction of Evidence-based Nursing Standard Plan for Dominant Diseases in Traditional Chinese Medicine

The evidence-based Traditional Chinese Medicine(TCM) nursing in standard plan is to be constructed by a combination of evidence-based thinking and expert consensus.(1) The symptoms of diseases with better curative effect in TCM and the nursing techniques of TCM based on scientific evidence can be preliminarily presented through bibliometric analysis.(2) Expert consultation letters can be developed based on bibliometric results, and symptoms of dominant diseases in TCM and TCM nursing techniques can be selected through those letters.(3) Based on the selected symptoms and TCM nursing techniques, the PICO can be determined, and then evidence search, evidence extraction, evidence analysis can be conducted and synthesized, and recommendations would be chosen.(4) The recommendation grade of each recommendation can be determined by applying the Delphi method and referring to GRADE.(5) The plan will be determined through discussions of experts. The construction of TCM nursing plan would make sure that TCM nursing is scientific, and internationalize TCM nursing.

Traditional Chinese medicine compounds for the treatment of functional dyspepsia:an updated meta-analysis of randomized,double-blind,placebo-controlled trials

Objective To evaluate the efficacy and safety of traditional Chinese medicine(TCM)compounds for the treatment of functional dyspepsia(FD).Methods The Pub Med,Embase,Cochrane Library,Web of Science,Chinese Biomedical Database(CBM),Wanfang Data,China National Knowledge Infrastructure(CNKI),and China Science and Technology Journal Database(VIP)were searched to collect randomized,double-blind,and placebo-controlled trials of FD treated with TCM compounds.The search duration was from the establishment of the database to March 2,2021.After two researchers independently screened the literature,extracted the data,and evaluated the bias risk included in the study,they used Rev Man 5.4 software for meta-analysis.Results A total of 23 clinical trials were included,including 2898 patients.Meta-analysis showed that the overall remission rate of FD treated with TCM compounds was significantly higher than that of placebo(73.8%vs.46.2%)[RR=1.50,95%CI(1.29,1.76),P<0.00001].Among the single symptoms,TCM compounds were superior to the placebo in improving epigastric pain[MD=﹣0.99,95%CI(﹣1.37,﹣0.61),P<0.00001],epigastric burning sensation[MD=﹣0.32,95%CI(﹣0.59,﹣0.05),P=0.02],postprandial fullness discomfort[MD=﹣1.59,95%CI(﹣1.96,﹣1.21),P<0.00001],and early satiety symptoms[MD=﹣0.93,95%CI(﹣1.32,﹣0.54),P<0.00001].Compared with the placebo,TCM compounds treatment can obviously improve TCM syndrome in patients with FD[MD=﹣5.58,95%CI(﹣7.55,﹣3.61),P<0.00001],gastric emptying rate[MD=12.22,95%CI(8.90,15.55),P<0.00001],and helped to improve patients’quality of life[MD=11.27,95%CI(0.10,22.43),P=0.05].No severe adverse events were reported between the two groups[RR=1.34,95%CI(0.91,1.96),P=0.14].Conclusion Our results showed that TCM compounds treatment could significantly alleviate FD symptoms,improve gastric emptying in FD patients,and help to improve their quality of life.No severe adverse reactions have been reported in clinical applications.Due to the limitation of the quantity and quality of the included studies,the above conclusions need to be verified by more high-quality studies.

Evaluation on Common Hand, Foot and Mouth Disease Treated by Integrative Traditional Chinese Medicine and Western Medicine

Objective To evaluate the efifcacy and safety of traditional Chinese medicine (TCM) combined with Western medicine in the treatment of patients with common hand, foot and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods A total of 452 patients with common HFMD were randomly assigned to receive Western medicine alone (n=220) or combined with TCM (Reduning or Xiyanping injections) (n=232). The primary outcome was the incidence rate of rash/herpes disappearance within 5 days, while secondary outcomes included the incidence rate for fever, cough, lethargy, agitation, and vomiting clearance within 5 days. Results The rash/herpes disappearance rate was 45.5% (100/220) in Western medicine therapy group, and 67.2% (156/232) in TCM and Western medicine combined therapy group, with significant difference (P<0.001). Moreover, TCM remarkably increased the incidence rate of secondary disappearance, which was 56.4%in Western medicine therapy group and 71.4%in TCM and Western medicine combined therapy group (P=0.001). No drug-related adverse events were observed. Conclusions It’s suggested that the integrative TCM and Western medicine therapy achieved a better therapeutic efficacy. TCM may become an important complementary therapy on relieving the symptoms of HFMD.

Study on the Flow Injection Micro-Column Pre-Separation System Coupled With High Performance Liquid Chromatography for the Determination of Ecdysterone in Traditional Chinese Medicine

A flow injection (FI) micro-column system coupled with high performance liquid chromatography (HPLC) was proposed for the pre-separation and determination of active organic component (ecdysterone) in traditional Chinese medicine, Loulu. The factors influencing separation performance were investigated and optimized. Under the optimal conditions, the contents of ecdysterone in Loulu were determined by HPLC system using MeOH-H_2O (40: 60,V/V) as the mobile phase at a flow rate of 1. 0 mL/min. The calibration curve was linear in the range of 0. 5~ 100 mg/L of ecdysterone concentrations. The detection limit of the analyte was 0. 11mol/L(3) with a precision of 0. 38% RSD (n=7 f c= 10. 0 mg/L). The average recovery of the method was 98. 7%. The proposed method has been applied to determine ecdysterone in practical samples, and the determined values by both external standard method and standard addition method were in good agreement. Compared to the traditional solid extraction method, the system proposed has the advantages of simple procedure, good reproducibility, minimum volume requirement, reduction of matrix interference and low contamination risk.

基于多学科协作管理模式结合PDCA质量管理工具对中药注射剂的管控效果分析

目的:探讨多学科协作管理模式结合PDCA质量管理工具用于医院中药注射剂管理的成效,为促进中药注射剂的合理应用提供参考。方法:成立多学科协作管理小组,运用PDCA质量管理工具,采取综合干预措施管控河北省中医院(以下简称“该院”)中药注射剂的临床应用。以2020年为干预前、2021年为第1阶段干预后、2022年为第2阶段干预后,对比干预效果。结果:干预前,该院中药注射剂合理使用率为92.38%(3 008/3 256),第1阶段干预后、第2阶段干预后分别升高至94.64%(3 740/3 952)、97.34%(3 766/3 869),与干预前的差异有统计学意义(P<0.001),中药注射剂不合理使用情况得到明显改善。第2阶段干预后,在超疗程、未冲管方面较第1阶段干预后明显改善,差异均有统计学意义(P<0.001),且未发现中西药混合输注、溶剂剂量不适宜、给药途径不适宜、溶剂种类选择不当等问题。干预后,中药注射剂相关不良反应占药品总不良反应的比例呈逐年降低趋势,尤其是第2阶段干预后较干预前明显降低,差异有统计学意义(P=0.013)。结论:在医院中药注射剂管理中运用多学科协作管理模式结合PDCA质量管理工具,可使管理质量显著提高,该方法值得在医院药事管理中推广。

慢性萎缩性胃炎的中医辨治思路与对策

慢性萎缩性胃炎(CAG)是临床上公认的胃癌前疾病,中医药治疗CAG具有明显的优势及鲜明的特色。从CAG病因病机等方面的研究入手,对中医药治疗CAG提出治本独取阳明,补虚泻实,顾护脾胃,升降气机,调气和血,祛瘀通络,祛邪解毒,甘平凉润,和胃护络的辨治思路与对策,以期进一步提高中医药治疗CAG的临床疗效。

精细化管理法减少中药注射剂不合理配伍的效果分析

目的:评价精细化管理法减少中药注射剂不合理配伍的效果。方法:通过鱼骨图分析可能影响中药注射剂不合理配伍的因素,针对关键问题实施精细化管理,调查精细化管理干预前(2021年7—12月)、干预后(2022年7—12月)该院中药注射剂医嘱,对不合理配伍医嘱进行统计分析,对比干预前后中药注射剂医嘱配伍不合理率,探讨干预措施的有效性。结果:干预前,25453组中药注射剂医嘱中,不合理配伍医嘱2366组,中药注射剂医嘱配伍不合理率为9.30%;干预后,28466组中药注射剂医嘱中,不合理配伍医嘱855组,中药注射剂医嘱配伍不合理率为3.00%,不合理率较干预前降低67.74%。干预后,中药注射剂医嘱中溶剂剂量不适宜、违反“十九畏”原则和溶剂种类选择不当问题大幅减少,未冲管和中西药混合输注问题已基本不存在。表明精细化管理模式能够有效改善中药注射剂医嘱不合理配伍情况。结论:通过鱼骨图分析可能影响中药注射剂不合理配伍的因素,针对关键问题实施精细化管理,可有效减少中药注射剂的不合理配伍现象,为其他医院中药注射剂的合理应用提供了参考。

《泰山药物志》医学思想探析

《泰山药物志》是民国时期特色鲜明、影响较大的中医药学著作。全书共8卷(主干4卷),详载泰山药物500余味,附以单方验方及与泰山药物有关的轶事传闻,对研究民国时期医病特色、泰山药物的采集与使用具有较高的实用价值。结合书中所载处方及诊病记录,探析该书“治病先固本”“病理如事理”“天下物皆是药”“五海以和为贵”等医学药学思想,分析高宗岳医学思想的时代特征与思想渊源,对本书的历史价值与影响也作了初步探讨。

基于知识图谱的中药药物警戒研究

目的基于国内外公开发表的中药药物警戒为主题的期刊文献,构建中药药物警戒研究知识图谱,探讨其研究热点及发展方向。方法在中国知网、Web of science数据库检索近10年来国内外以“中药药物警戒”为主题的学术研究机构发表的相关文献,利用CiteSpace软件对其作者分布、关键词共现、关键词聚类、关键词突现等进行知识图谱分析。结果共纳入2785篇中文文献和229篇英文文献,主要突显出3个研究团队与研究机构。研究范畴主要集中于中药不良反应的识别、中药毒性机制的理解、中药风险防范与合理用药转化3个方面,研究内容不断深入、丰富。国内外发文热点各有侧重,对中药注射剂等安全问题关注持久。结合研究现状与未来发展思考,建立中药药物警戒发展与研究思维导图。结论中药药物警戒的建设应在传承中医药传统的同时,创新发挥现代技术优势,示范引领国际植物药药物警戒发展。

福州苍霞洲李氏中医儿科学术流派教育思想研究

中医药的传承发扬工作任重道远。在中医发展的历史长河中,中医学术流派从理论和实践方面丰富了中医药的内涵和实质,对于传承、弘扬、发展中医药事业至关重要。文章介绍了中医学术流派的概念及其教育模式,论述了福州苍霞洲李氏中医儿科学术流派的源流及教育思想,希望能够给提高中医教育质量,培养优秀的中医人才,助力中医药传承发展提供一些参考。

从“风火”论治变态反应性疾病思路

变态反应性疾病临床常见,其病位虽不同,但病机却有一定共性。总体而言,人体阴阳协调,则一气周流,如“春风”生养万物。一旦各种原因导致阳气郁而不升或逆而不降,疏布失常的“阳气”在人体内过度聚集,愈郁则愈欲疏泄,久积必终向外透解,如“风火”之邪侵及人体各处皮肤孔窍,则会出现相关部位的过敏症状。临床诊治中,根据变态反应性疾病发作的病机,常用熄风火以缓症状、透余热以防复发、养脉络以促复原、调五脏以兼标本等治法,并坚持以辨证为先、因势利导、急缓有异、清透兼施、整体局部辨证结合等为治疗原则,取得了良好疗效。文末列举一则验案加以说明,希望帮助读者更好理解和应用。

参附注射液治疗心肾阳虚型慢性心力衰竭急性加重的临床研究

目的:观察参附注射液治疗心肾阳虚型慢性心力衰竭急性加重的临床疗效。方法:选取2023年10月—2024年1月在安徽中医药大学第一附属医院住院的慢性心力衰竭急性加重病人60例,按照随机数字表法分为观察组与对照组,各30例。观察组给予参附注射液加西医常规治疗,对照组仅给予西医常规治疗,比较两组治疗前后血浆氨基末端B型钠尿肽前体(NT-proBNP)、超敏肌钙蛋白I(hs-cTnI)、6 min步行试验(6MWT)、明尼苏达州心力衰竭生活质量问卷评分(MLHFQ)、中医证候积分及纽约心脏病协会(NYHA)心功能分级。结果:与治疗前比较,两组治疗后NT-proBNP、hs-cTnI水平降低(P<0.05),两组治疗后NT-proBNP、hs-cTnI水平比较差异均无统计学意义(P>0.05);与治疗前比较,两组治疗后6MWT、MLHFQ评分均明显改善(P<0.05),观察组改善程度优于对照组(P<0.05);两组治疗后各单项中医证候积分低于治疗前(P<0.05),观察组治疗后喘促气短、倦怠乏力、畏寒肢冷及言语声低评分低于对照组(P<0.05)。观察组总有效率为96.7%,对照组为80.0%,两组比较差异有统计学意义(P<0.05)。结论:参附注射液联合西药常规治疗可改善心肾阳虚型慢性心力衰竭急性加重病人心功能,提高病人运动耐量和生活质量。

蒋长庚主任治疗小儿咳嗽经验撷要

咳嗽是儿科常见的肺系疾病,是最常见的临床症状之一,本病一年四季均可发生,小儿各个年龄段均可发病,可对小儿身心健康造成较大的危害。西医通常予以抗感染、镇咳、平喘化痰等治疗,但存在疗效欠佳,病情反复、药物不良反应等问题。中医药治疗小儿咳嗽具有效果显著、不良反应少、整体调节的优势。蒋长庚主任从医、执教、科研近40年,治学严谨,对小儿肺系疾病颇有研究,在小儿咳嗽辨证论治方面经验丰富,疗效显著。文章分析蒋长庚主任对小儿咳嗽的病因病机、辨证要点、临床辨证治等的认识,总结蒋主任治疗儿童咳嗽的用药经验。蒋主任认为,咳嗽属肺家疾病,多由六淫外邪侵袭肺系,或脏腑功能失调,内伤及肺,肺气不清,失于宣发肃降所致。咳嗽与脾、肝、肾等脏腑功能失调关系密切。临床辨证时要详细询问病史,注重区分咳与嗽孰轻孰重;分辨新咳、暴咳或久咳,新咳、暴咳多实邪,久咳多虚损,常虚实夹杂;咳嗽多因痰作祟,着重辨别咳痰的性质;同时结合患儿体质因素、脏腑功能偏颇,灵活运用宣肺、肃肺、清肺、开肺、润肺、泻肺、补肺等常用治法,酌情予以益气温阳、补肾纳气、上病下治等变法,审证求因,灵活辨治。附案例1则,以资验证。

盐酸替罗非班氯化钠注射液与丹红注射液等6种中药注射液配伍稳定性研究

目的:开展盐酸替罗非班氯化钠注射液与丹红注射液等6种中药注射液配伍稳定性研究。方法:采取室温(25℃)条件下考察盐酸替罗非班氯化钠注射液与丹红注射液、苦碟子注射液、银杏达莫注射液、注射用红花黄色素、参麦注射液、灯盏细辛注射液配伍后放置0、1、2、4、6 h的外观性状、p H值、可见异物、不溶性微粒数、吸收度变化等情况。结果:盐酸替罗非班氯化钠注射液与丹红注射液、苦碟子注射液、银杏达莫注射液、注射用红花黄色素、参麦注射液、灯盏细辛注射液配伍后,各配伍溶液在6 h内性状均无显著变化,无沉淀、无结晶、无明显可见异物、pH值无明显变化。与银杏达莫注射液、参麦注射配伍后6 h内的不溶性微粒均超出《中国药典》规定限度。结论:盐酸替罗非班氯化钠注射液与丹红注射液、苦碟子注射液、注射用红花黄色素、灯盏细辛注射液配伍稳定,与银杏达莫注射液、参麦注射液配伍不稳定。

红金消结胶囊联合醋酸亮丙瑞林治疗子宫内膜异位症临床研究

目的:观察红金消结胶囊联合醋酸亮丙瑞林治疗子宫内膜异位症的临床疗效。方法:选取82例子宫内膜异位症患者,按随机数字表法分为对照组与治疗组各41例。对照组给予注射用醋酸亮丙瑞林缓释微球治疗,治疗组在对照组基础上联合红金消结胶囊联合治疗。比较2组临床疗效与不良反应发生率,以及2组治疗前后中医证候评分、血清糖类抗原125 (CA125)、抗子宫内膜抗体(EMAb)、脂联素(APN)、肝细胞生长因子(HGF)水平、子宫体积、子宫内膜厚度、包块直径。结果:治疗组总有效率为95.12%,对照组为78.05%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组中医证候评分均较治疗前降低(P<0.05),且治疗组中医证候评分低于对照组(P<0.05)。治疗后,2组子宫内膜厚度、子宫体积、包块直径均较治疗前缩小(P<0.05),且治疗组上述3项指标均小于对照组(P<0.05)。治疗后,2组血清CA125、EMAb、HGF水平均较治疗前降低(P<0.05),APN水平较治疗前升高(P<0.05);且治疗组CA125、EMAb、HGF水平低于对照组(P<0.05),APN水平高于对照组(P<0.05)。对照组不良反应发生率为9.76%,治疗组为4.88%,2组比较,差异无统计学意义(P>0.05)。结论:红金消结胶囊联合注射用醋酸亮丙瑞林缓释微球治疗子宫内膜异位症疗效显著,能改善患者临床症状和体征,调节相关血清细胞因子水平,且没有增加药物治疗的不良反应。

关节腔靶向注射臭氧联合中药外敷治疗早期类风湿关节炎膝关节病变的临床研究

目的:探究关节腔靶向注射臭氧联合中药外敷治疗早期类风湿关节炎膝关节病变的临床效果。方法:回顾性选取九江市第一人民医院2022年6月—2023年9月收治的80例早期类风湿关节炎膝关节病变患者,根据治疗方案将其分为联合组(n=47)和对照组(n=33),对照组采用临床常规治疗方案,即采用曲安奈德进行关节腔注射治疗,联合组采用关节腔靶向注射臭氧联合中药外敷治疗。均治疗3周。比较两组疗效;比较两组治疗前后的C反应蛋白(CRP)、抗环瓜氨酸多肽抗体(ACCP)、类风湿因子(RF)和甘露聚糖结合凝集素(MBL)水平;比较两组治疗前后的视觉模拟评分法(VAS)评分及关节超声评估情况。结果:联合组总有效率为93.62%,高于对照组的72.73%,差异有统计学意义(P<0.05)。治疗后,两组血清RF、CRP、ACCP水平均低于治疗前,且联合组均低于对照组;两组血清MBL水平均高于治疗前,且联合组高于对照组,差异均有统计学意义(P<0.05)。治疗后,两组髌上囊积液深度、髌上囊滑膜厚度、VAS评分均低于治疗前,且联合组均低于对照组,差异均有统计学意义(P<0.05)。结论:关节腔靶向注射臭氧联合中药外敷治疗早期类风湿关节炎膝关节病变的效果较好,可以显著改善患者的血清学指标和疼痛程度,并减轻膝关节病变。