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.

Stability and compatibility of common traditional Chinese medicine injections matching with fructose injection

In recent years,China has attached great importance to the work of traditional Chinese medicine(TCM),more and more Chinese patent medicines are included in the national medical insurance catalogue,and the clinical application of TCM injections is also increasing.This article reviews a total of 20 literature reports on the compatibility of fructose injections with TCM injections from 2005 to the present,and evaluates the stability based on the appearance,pH,insoluble particles and content changes after compatibility,and provides for the rational use of fructose injections.Theoretical evidence provides options for special patients with special solvent limit.

Clinical Observation on the Improved Short-Term Effects of Anti-Tumor Purified Chinese Medicine Injection Ai-Jing for 138 Cases with Malignant Tumors

The subjects of this study were to observe the improved short-term effects of anti-tumor purified Chinese medicine injection Ai-Jing for 138 cases with malignant tumors. This was a multi-center clinical study, and a total of 138 patients included 96 males and 42 females, with the age from 60 to 76 years. Ai-Jing has obtained the Chinese invention patent since 2008 (ZL991-03528.3). A novel technique acupoint injection method was adopted. Except for lung cancer, patients with other malignant tumors were injected once every other day, 2 ml each time. A course of treatment needs 6 Ai-Jing injections, lung cancer patients need 10 - 20 Ai-Jing injections. At the same time, patients were treated with traditional medicine decoction. Due to the limited number of cases, cure rate, recovery rate and remission rate were calculated as a whole, respectively 18.12%, 44.20% and 32.15%. All the invalid patients were lung cancer, accounting for 16.67% of the patients treated with lung cancer, and the total treatment inefficiency was 6.52%. Conclusion: Chinese Medicine Injection Ai-Jing extracts the effective components of anti-cancer and tumorigenesis, and has the effects of anti-cancer and tumorigenesis, anti-inflam-matory and analgesic, and repairing body damage, with small toxic and side effects and low cost.

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.

The effect of foot bath of Chinese medicine combined with acupoint injection for diabetic peripheral neuropathy:a meta analysis

Objective:The aim of this systematic review was to assess the effect of foot bath of Chinese medicine combined with acupoint injection(FBCMCAI)on patients with diabetic peripheral neuropathy(DPN).Methods:Databases such as Cochrane Library,Pubmed,Web Of Science,China Biology Medicine(CBM),CNKI,VIP and WANFANG DATA were electronically searched to collect the randomized controlled trials(RCTs)(up to October 2016).According to the inclusion and exclusion criteria,literature about effects of FBCMCAI in the treatment of DPN were screened and data were extracted.Literature quality evaluation was appliced by Cochrane Reviewer Handbook 5.1.0.A random or a fixed effects model was used to analyze outcomes by RevMan 5.3 software.Subgroup analysis,sensitivity analysis,and orientation description were performed if necessary.Results:11 randomized controlled trials with a total of 927 patients were included.Meta analysis results revealed that the efficacy of FBCMCAI for DPN was significantly superior to the control treatment(OR=5.07,95%CI:3.23-7.94,Z=7.08,P<0.00001).Besides,there was an increase in motor conduction velocity of peroneal nerve(SMD=1.08,95%CI:0.66-1.48,Z=5.30,P<0.00001),motor conduction velocity of tibial nerve(SMD=1.08,95%CI:0.58-1.58,Z=4.22,P<0.0001)and motor conduction velocity of median nerve(SMD=0.46,95%CI:0.23-0.68,Z=3.96,P<0.0001)in FBCMCAI groups.For another,there was also an increase in sensory motor conduction velocity of the motor nerve(SMD=0.80,95%CI:0.54-1.05,Z=6.06,P<0.00001)and sensory motor conduction velocity of median nerve(SMD=0.66,95%CI:0.38-0.93,Z=4.73,P<0.00001)in the FBCMCAI groups.Symptoms score was significantly reduced after FBCMCAI treatment(WMD=-4.21,95%CI[-4.95,-3.48],Z=11.25,P<0.00001).Conclusion:FBCMCAI may have significant therapeutic efficacy for the treatment of DPN.Diabetic neurologic symptoms and nerve conduction velocities can be improved under FBCMCAI treatment.In-depth research and high quality randomized controlled trials on the efficacy of FBCMCAI are necessary.

Network meta-analysis of 3 kinds of Chinese medicine injection in the treatment of knee osteoarthritis

Objective:To compare the effect of three kinds of traditional Chinese medicine injection(zhengqing fengtongning injection,shenmai injection,cervus and cucumis polypeptide injection)on knee osteoarthritis with the method of Network meta-analysis.Methods:Two researchers independently used computers to search for randomized controlled clinical trials of zhengqing fengtongning injection,shenmai injection,or cervus and cucumis polypeptide injection for the treatment of knee osteoarthritis published in CNKI,VIP,WANFANG DATA,CBM and PubMed databases(since the date of database establishment to February 2020).After the methodological quality of included researches were evaluated,and the valid data were extracted,statistical analysis was performed With RevMan5.3 and R 3.53.Results:There were including 9 RCTs,which involving 720 patients.The results of network Meta-analysis showed that:All three traditional Chinese medicine injections effects are approximately equal.The probability ranking chart shows that Zhengqingfengtongning injection may have the best effect.Conclusions:Three commonly used traditional Chinese medicine injections can effectively treat knee osteoarthritis,of which Zhengqingfengtongning injection is probably the most effective.Due to the small number of literatures included in this study and the single outcome index,we still need to treat the results of this study with caution.It is suggested that more high-quality,long-term follow-up studies should be carried out for this kind of treatment in the future,so as to provide solid evidence support for the popularization of these treatment measures.

Benefit-Risk Assessment of Chinese Medicine Injections for Primary Liver Cancer Based on Multi-criteria Decision Analysis

ObjectiveTo evaluate the benefit-risk of 3 commonly used Chinese medicine injections, Aidi Injection (ADI), Cinobufagin Injection (CINI) and Compound Kushen Injection (CKI), in the treatment of primary liver cancer (PLC), so as to provide a reference for clinical decision-making.MethodsRandomized controlled trials (RCTs) of ADI, CINI and CKI in the treatment of PLC published in the databases of China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, SinoMed, PubMed, Cochrane Library, and Web of Science were retrieved from January 2020 to October 2022. The data of benefit and risk indicators were combined to obtain the effect value. The multi-criteria decision analysis (MCDA) model was applied to build the decision tree. The benefit value, risk value and benefit risk value of the 3 injections in PLC treatment were calculated. Monte Carlo simulation was carried out to calculate the 95% confidence interval and probability of differences among the 3 injections, so as to optimize the evaluation results.ResultsA total of 71 RCTs were included. The benefit values of ADI, CINI and CKI combined with transcatheter arterial chemoembolization (TACE) were 42, 38 and 36, respectively. The risk values were 42, 25 and 37, respectively. The benefit risk values were 42, 31 and 37, respectively. The benefit risk differences of ADI vs. CINI, ADI vs. CKI, and CKI vs. CINI were 11 (−0.86, 17.75), 5 (−5.01, 11.09), and 6 (−1.87, 12.63), respectively. The probability that ADI superior to CINI, ADI superior to CKI, and CKI superior to CINI was 96.26%, 77.27%, and 92.62%, respectively.ConclusionBased on the results of MCDA model, CINI combined with TACE has the greatest risk in the treatment of the PLC. Considering the efficacy and safety, the possible priority of the 3 Chinese medicine injections combined with TACE in the treatment of PLC is ADI, CKI and CINI.

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.

TREATMENT OF PRIMARY PALPEBRAL RETRACTION WITH ACUPOINT-INJECTION AND CHINESE MEDICINAL HERBS

In the present paper, the therapeutic effect of combined therapy of acupoint injection and Chinese medicinal herbs was observed in 59 cases of primary palpebral retraction patients. These 59 patients were divided into treatment group (n=38, treated with acupoint injection and Chinese medicinal herbs) and control group (n=21, treated with Chinese medicinal herbs alone). After 3 courses of treatment, of the 38 cases in treatment group, 25 (65.8%) were cured, 8 (21.1%) had marked improvement and 5 (13.2%) had improvement; of the 21 cases in control group, 8 (38.1%) were cured, 9 (42.9%) had marked improvement, 2 (9.5%) had improvement and 2 (9.5%) were ineffective. Statistical analysis showed a significant difference between the two groups in the therapeutic effect. The cure rate of experimental group was apparently higher than that of the control group, i.e. the therapeutic effect of the combined therapy of acupoint injection and Chinese medicinal herbs was superior to that of Chinese medicinal herbs alone.

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.

Rapid determination of tannin in Danshen and Guanxinning injections using UV spectrophotometry for quality control

A technique for the determination of tannin content in traditional Chinese medicine injections(TCMI)was developed based on ultraviolet(UV)spectroscopy.Chemometrics were used to construct a mathematical model of absorption spectrum and tannin reference content of Danshen and Guanxinning injections,and the model was veried and applied.The results showed that the established UV-based spectral partial least squares regression(PLS)tannin content model performed well with a correlation coefficient(r)of 0.952,root mean square error of calibration(RMSEC)of 0.476
g/ml,root mean square error of validation(RMSEV)of 1.171
g/ml,and root mean square error of prediction(RMSEP)of 0.465
g/ml.Pattern recognition models using linear discriminant analysis(LDA)and k nearest neighbor(k-NN)classiers based on UV spectrum could successfully classify different types of injections and different manufacturers.The established method to measure tannin content based on UV spectroscopy is simple,rapid and reliable and provides technical support for quality control of tannin in Chinese medicine injections.

New insights for infection mechanism and potential targets of COVID-19:Three Chinese patent medicines and three Chinese medicine formulas as promising therapeutic approaches

The coronavirus disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)with high pathogenicity and infectiousness has become a sudden and lethal pandemic worldwide.Currently,there is no accepted specific drug for COVID-19 treatment.Therefore,it is extremely urgent to clarify the pathogenic mechanism and develop effective therapies for patients with COVID-19.According to several reliable reports from China,traditional Chinese medicine(TCM),especially for three Chinese patent medicines and three Chinese medicine formulas,has been demonstrated to effectively alleviate the symptoms of COVID-19 either used alone or in combination with Western medicines.In this review,we systematically summarized and analyzed the pathogenesis of COVID-19,the detailed clinical practice,active ingredients investigation,network pharmacology prediction and underlying mechanism verification of three Chinese patent medicines and three Chinese medicine formulas in the COVID-19 combat.Additionally,we summarized some promising and high-frequency drugs of these prescriptions and discussed their regulatory mechanism,which provides guidance for the development of new drugs against COVID-19.Collectively,by addressing critical challenges,for example,unclear targets and complicated active ingredients of these medicines and formulas,we believe that TCM will represent promising and efficient strategies for curing COVID-19 and related pandemics.

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。

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。

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。

Application of Traditional Chinese Medicine injection in treatment of primary liver cancer:a review

OBJECTIVE:To investigate the application of Traditional Chinese Medicine Injections(TCMIs) for treatment of primary liver cancer(PLC).METHODS:A literature review was conducted using PubMed/Medline,Cochrane Library Controlled Clinical Trials Database,China National Knowledge Infrastructure(CNKI),China Scientific Journal Database(CSJD) and China Biology Medicine(CBM).Online websites including journal websites and databases of ongoing trials,as well as some Traditional Chinese Medicine journals that are not indexed in the electronic databases were also searched.RESULTS:The literature review showed that TCMIs as adjunctive medication for the treatment of PLC could regulate patient immunity,reduce bone marrow suppression,relieve clinical symptoms,and improve quality of life,as well as control disease progression and prolong survival time.CONCLUSION:Within the limitations of this review,we conclude that application of TCMIs as adjunctive medication may provide benefits for patients with PLC.Further large,high-quality trials are warranted.

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。

紫癜1号方治疗儿童过敏性紫癜性肾炎临床观察

目的:观察紫癜1号方对紫癜性肾炎(HSPN)患儿外周血嗜酸性粒细胞及其凋亡因子Fas蛋白表达的影响。方法:选取2019年10月1日—2020年12月30日于深圳市中医院门诊和住院部诊治的HSPN患儿60例,随机分为观察组和对照组,各30例。观察组予紫癜1号方加减及中药针剂治疗,对照组给予西医常规治疗,2组疗程均为12周。观察治疗前、治疗第0、4、8、12周各时间段的尿N-乙酰氨基葡萄糖苷酶(NAG)、尿微量白蛋白(mALB)、β2-微球蛋白(β2-MG),以及血嗜酸性粒细胞(EOS)、死亡诱导因子(Fas)等变化情况和疗效变化。结果:治疗第4、8周时,观察组总有效率分别为83.33%、96.67%,明显高于对照组,组间比较有显著性差异(P<0.05);第4、8周时,观察组降低患儿NAG的效果显著优于对照组(P<0.01);各个观察时点观察组降低β2-MG的效果均优于对照组(P<0.05);第4、12周时,观察组降低m ALB的效果优于对照组(P<0.05)。治疗第4周时,促进Fas抗原表达、降低EOS的效果对照组优于观察组,差异有统计学意义(P<0.01)。结论:紫癜1号方在早期能改善HSPN患儿临床症状,对改善早期肾损害指标起效更快,作用更持久。