Tanreqing Injection Research Articles

The Pharmacokinetic Study of Tanreqing Injections in Pneumonia Model Rats and the Effect of Cefixime on Tanreqing Injections During Combined Administration by UPLC–MS/MS

Combining traditional Chinese medicine and chemical drugs with antimicrobial activities has become more popular, but there is insufficient relevant research on such combinations. The Tanreqing injection ( TRQI ), a Chinese compound medicine, exhibits therapeutic effects in treating upper respiratory tract infections, severe influenza, and pneumonia. This research investigates the pharmacokinetics of TRQI in pneumonia model rats and explores the effect of the antibiotic cefixime on its metabolism. The pneumonia model rats were randomly divided into four groups: low, medium, and high (3, 6, and 12 mL·kg −1 ) dose TRQI group, and a medium dose TRQI combined with cefixime (48 mL·kg −1 ) group. Blood samples were collected from the tail vein at different time points between 0–24 h after injection. A sensitive and quick method based on ultra-performance liquid chromatography-tandem mass spectrometry (UPLC–MS/MS) was established for the simultaneous determination of the 13 TRQI components in the blood samples. The analytes were separated on an XBridge TM C 18 column (2.1 mm × 150 mm, 5 um), with the flow phase consisting of methanol and 0.1% formic acid water at a flow rate of 0.3 mL/min. The assay method met the biological sample determination requirements, demonstrating good adaptability and practicability for application in the pharmacokinetic study of TRQI in pneumonia model rats. Moreover, the method was used successfully in the interaction study of TRQI with cefixime. The results indicated that co-administration results in a significant change in the pharmacokinetic parameters of the main TRQI components. However, the changes in the pharmacokinetic characteristics of multiple TRQI components were inconsistent. Thus, the results of this drug combination under different pathological conditions in clinical applications were unpredictable. Therefore, more attention should be paid to the combined use of cefixime and TRQI in clinical applications to avoid the risk of adverse drug reactions in future studies.

Effects and safety of tanreqing injection on viral pneumonia: A protocol for systematic review and meta-analysis: Retraction.

Effects and safety of tanreqing injection on viral pneumonia: A protocol for systematic review and meta-analysis: Retraction.

The effectiveness and safety of Tanreqing Injection combined with ganciclovir on the treatment of respiratory syncytial virus pneumonia in children: A protocol for systematic review and meta-analysis of randomized controlled trials.

Background:Based on the Theory of Traditional Chinese Medicine, this study systematically evaluated the effectiveness and safety of Chinese medicine preparation Tanreqing injection combined with ganciclovir on the treatment of respiratory syncytial virus pneumonia in children, and provided new ideas and methods for the treatment of respiratory syncytial virus pneumonia (RSVP) in children. At the same time, it also studies the effectiveness and safety of the combination of Chinese and Western medicine on the treatment of related diseases from the direction of evidence-based medicine.Methods:The relevant literature was searched by the computer in the electronic network databases, the retrieved databases include Chinese database and English database, English database includes PubMed, Cochrane Library, Embase and Web of Science. Chinese database includes: CNKI, SinoMed, WangFang Date, VIP and other networks electronic full-text database, conducting a randomized controlled trial of Tanreqing Injection combined with ganciclovir (study group) and ganciclovir alone (control group) on the treatment of RSVP in children and the retrieval time limit is set from the establishment of each database to July 1, 2020. According to the inclusion and exclusion criteria, the literature is independently searched and screened by 2 researchers, and conducting the full-text retrieval and evaluation of the research to be included, and extracting the information and checking it after reading the full-text; In case of disagreement, a third researcher will be invited to participate, and the decision is made after discussion by the 3 researchers. They were using the bias risk assessment tool provided by the Cochrane Handbook for Systematic Reviews of Interventions 3.0.2 to evaluate the selected literature. They were using RevMan 5.3 statistical software to conduct statistical analysis.Results:This study will be carried out in full accordance with the steps of systematic review as required in the Cochrane Handbook for Systematic Reviews of Interventions. All research results will be published publicly in international academic journals with peer review.Conclusion:After the meta-analysis of Tanreqing injection combined with ganciclovir on the treatment of RSVP in children, this paper will give a scientific and objective judgment on the effectiveness and safety of the combined use of Chinese and Western medicine on the treatment of RSVP in children, to provide evidence-based medical evidence for the clinical application, effectiveness and safety of Chinese and Western medicine combined on the treatment of RSVP in children.PROSPERO registration number:OSF platform, registration number: j2bz5.

Effects and safety of Tanreqing injection on viral pneumonia: A protocol for systematic review and meta-analysis.

Background:Influenza-related viral pneumonia is a severe threat to human health, which has caused high morbidity and mortality each year. The objective of this study was to assess the efficacy and safety of Tanreqing Injection therapy in patients with viral pneumonia.Materials and methods:This protocol established in this study has been reported following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Web of Science, PubMed, EMBASE and the Cochrane Library were searched for clinical randomized trials in cases with viral pneumonia until 1st of July 2020. We will use a combination of Medical Subject Heading and free-text terms with various synonyms to search based on the Eligibility criteria. Two investigators independently reviewed the included studies and extracted relevant data. The relative risk (RR) and 95% confidence intervals (CIs) of were used as effect estimate. I-square (I2) test, substantial heterogeneity, sensitivity analysis and publication bias assessment will be performed accordingly. Stata 14.0 and Review Manger 5.3 are used for meta-analysis and systematic review.Results:The results will be published in a peer-reviewed journal.Conclusion:The results of this review will be widely disseminated through peer-reviewed publications and conference presentations. This evidence may also provide helpful evidence of whether Tanreqing Injection therapy was efficient and safe in patients with viral pneumonia.PROSPERO registration number:CRD42020164164.

The efficacy and safety of Tanreqing injection combined with western medicine for severe pneumonia: A protocol for systematic review and meta-analysis.

Background:Tanreqing injection, as a kind of traditional Chinese medicine injection widely used in clinic, has the effects of clearing heat, reducing phlegm and detoxifying, and avoids the problems of slow effect and complicated decocting of traditional Chinese medicine. Severe pneumonia is a critical disease of the respiratory system, with symptoms such as dyspnea, shortness of breath, high fever, and coma. Clinical studies have found that Tanreqing injection combined with Western medicine has a good effect in the treatment of severe pneumonia. In order to explore the efficacy and safety of Tanreqing injection combined with antibiotics in the treatment of severe pneumonia, we plan to conduct a systematic evaluation and meta-analysis.Methods:Randomized controlled trials (RCTs) on the treatment of severe pneumonia with Tanreqing injection combined with western medicine were collected by searching PubMed, The Cochrane Library, Embase, Web of Science, CNKI, Wanfang Database, Weipu Database, and China Biomedical Literature Service System (CBM) by computer with the retrieval time from establishment of database to July 2020. Two researchers independently screened and extracted the literature, and finally evaluated the bias risk of the included study, and meta-analysis was conducted using RevMan5.3 software.Results:The study evaluated the efficacy and safety of Tanreqing injection combined with Western medicine in the treatment of severe pneumonia in terms of total response rate, CURB-65 score, white blood cell count (WBC), antipyretic time (AT), adverse reaction incidence, etc.Conclusions:This study will provide a reliable evidence-based basis for the clinical application of Tanreqing injection in the treatment of severe pneumonia.Ethics and dissemination:The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.OSF Registration number:DOI 10.17605/OSF.IO/SQDMG.

Effects and safety of tanreqing injection on viral pneumonia: A protocol for systematic review and meta-analysis.

Background:Viral pneumonia is a common respiratory disease that leads to high mortality around the world. Tanreqing (TRQ) injection has been widely used to treat viral pneumonia in China. However, the efficiency and safety of TRQ injection for viral pneumonia have not been scientifically and methodically evaluated up to now. Thus, this protocol describes a plan of performing a systematic review and meta-analysis to evaluate the efficacy and safety of TRQ injection on patients with viral pneumonia.Methods:Only randomized controlled trials will be enrolled in our study, and we will search eligible studies in the following electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials, Clinical Trials, China National Knowledge Infrastructure, the Wanfang database, the Chinese Scientific Journal Database, and the Sinomed. The total effective rate of clinical efficacy will be used as primary outcome. Time to relieve symptoms, incidence of adverse reactions, and the laboratory parameters will be used as secondary outcomes. Any side effects and adverse events will be recorded and assessed as safety outcomes. Study inclusion, data extraction, and quality assessment will be performed independently by 2 reviewers, and any disagreement will be resolved by a third reviewer. After that, data synthesis and subgroup analysis will be conducted with the Review Manager V.5.3.3 software.Results:This review will provide a high-quality synthesis to assess the effectiveness and safety of TRQ injection for viral pneumonia patients.Conclusion:Our study will provide comprehensive evidence to decide whether TRQ injection is effective and safe for viral pneumonia patients.Prospero registration number:PROSPERO CRD42020164164

Clinical efficacy and safety of Tanreqing injection combined with antibiotics versus antibiotics alone in the treatment of pulmonary infection patients after chemotherapy with lung cancer: A systematic review and meta-analysis.

This study aimed to evaluate the efficacy and safety of Tanreqing injection (TRQi) in the treatment of pulmonary infection after chemotherapy in patients with lung cancer. Cochrane Library, PubMed, Web of Science, EMbase, CNKI, VMIS, Wan-Fang, and CBM databases were comprehensively searched from established to March 2020. randomized controlled trials (RCTs) of TRQi were selected. The evaluation manual of Cochrane RCT was used to evaluate the methodological quality of all included studies, Stata 13.0 and Review Manager 5.3 software was used for meta-analysis. This study is registered with PROSPERO (CRD42020175533). Eighteen RCTs with a total of 1,438 patients were met the inclusion criteria. Meta-analysis showed that compared with antibiotics alone, TRQi plus antibiotics could significantly improve the clinical efficacy, defervescence time, lung rale disappearance time, cough disappearance time, and average hospitalization time, reduce white blood cell, C-reactive protein, and procalcitonin levels, and adverse reactions. However, due to the small sample size and low quality of the study, more rigorous and more RCTs are needed for further verification. In conclusion, this study provides useful evidence for the efficacy and safety of TRQi combined with antibiotics in the treatment of pulmonary infection after chemotherapy with lung cancer.

Chinese Patent Medicines in the Treatment of Coronavirus Disease 2019 (COVID-19) in China.

BackgroundCoronavirus Disease 2019 (COVID-19) is an emerging and rapidly evolving disease, with no recommended effective anti-coronavirus drug treatment. Traditional Chinese Patent Medicines (CPMs) have, however, been widely used to treat COVID-19 in China, and a number of clinical practice results have shown them to have a significant role in its treatment. Consequently, numerous guidelines and expert consensus have recommended the use of CPMs to treat COVID-19.Aim of the StudyThe objectives of this review are to provide up-to-date information on the pharmacology and clinical research on CPMs in the treatment of COVID-19, discuss the research findings, and to better guide clinical application and scientific research on CPMs in the treatment of COVID-19.MethodsThe frequencies of CPM recommendations by guidelines and expert consensus for treatment of COVID-19 in China were ranked. This report identifies the top 10 CPMs, which include Huoxiang Zhengqi capsule (HXZQC), Lianhua Qingwen capsule (LHQWC), Jinhua Qinggan granule (JHQGG), Shufeng Jiedu capsule (SFJDC), Tanreqing injection (TRQI), Xiyanping injection (XYPI), Xuebijing injection (XBJI), Shenfu injection (SFI), Shengmai injection (SMI), and Angong Niuhuang pill (AGNHP). Relevant studies from 2000 to 2020 on these top 10 CPMs, covering usage, dosage, mechanism, curative effect, and precautions, were collected from pharmacopoeia, reports, and theses via library and digital databases (including PubMed, CNKI, Google Scholar, Web of Science, and Elsevier).ResultsThe properties of the top 10 CPMs included antiviral, antibacterial, anti-inflammatory, antipyretic and analgesic, anti-acute lung injury, anti-shock, immune regulation, and enhancement of pulmonary function. In addition, clinical research results and Chinese treatment data showed that the CPMs had good therapeutic efficacy in the treatment of COVID-19, and adverse reactions were minimal.ConclusionsKnowledge of the characteristics of the top 10 CPMs and precautions that should be taken may help clinicians to rationally improve therapeutic efficacy, and promote the role of Chinese Medicine in the control of the COVID-19 global epidemic.

Tabu search algorithm analysis on effect of Xingnaojing Injection in treatment of craniocerebral injury and complications in real world

In this study, Tabu search algorithm was used to analyze the drug combination of Xingnaojing Injection in the treatment of brain injury and complications in the real world, and the clinical drug combination of Xingnaojing Injection in the treatment of brain injury and complications was selected and summarized. The combination of Xingnaojing Injection, Namefen and Citicoline were recommended in the treatment of brain injury and complications. For brain edema and nerve injury, Mannitol/Glycerol Fructose/Furosemide+Tetrahexose Monosialate Ganglioside Sodium should be recommended. For those with pulmonary infection, Xingnaojing Injection+Xiyanping+Ambroxol Hydrochloride+Tanreqing Injection should be recommended. For those with shock, Hydroxyethyl Starch+Dopamine Hydrochloride/Dobutamine Hydrochloride+Sodium Bicarbonate should be recommended. The combination reflected the characteristics of Chinese and Western medicine. The above medication regimen was only for clinicians' reference. The clinical application should be based on patients' specific conditions, clinical benefits and risks, as well as the incompatibility. On the basis of the findings, further studies can be carried out for prospective clinical efficacy evaluation and safety evaluation for a specific subgroup module.

Effect of Xingnaojing Injection in treatment of cerebral hemorrhage based on Tabu search algorithm:a real world study

In this study, Tabu search algorithm was used to analyze the effect of Xingnaojing Injection in the treatment of cerebral hemorrhage in the real world. Through the analysis of the results, the therapies based on the pathogeny of cerebral hemorrhage were screened out: Xingnaojing Injection+hemostatic drugs for promoting blood circulation and removing stasis. Cerebral hemorrhage complicated with brain edema: combined with mannitol or mannitol+aescin. The patients with relevant complications in the acute stage of cerebral hemorrhage could select according to the indications: ①Aminocycline+Oxiracetam+Piperacillin Sodium Sulbactam Sodium+Sodium Lactate Ringer; ②Aminocycline+Oxiracetam+Nifedipine+Captopril+Metoclopramide+Cimetidine; ③Insulin+Pantoprazole+So-dium Nitroprusside. The combined therapies for patients of the stable stage with complicating diseases could select according to the indications: ① Monosialotetrahexosyl Ganglioside Sodium+Deproteinized Calf Blood Serum+Nitroglycerin+Compound Potassium Dihydrogn Phosphate; ② Edaravone+Gangliosides+Captopril+Levofloxacin+Tanreqing Injection+Aminophylline. The analysis of subgroup module of drugs for promoting blood circulation and removing blood stasis suggested that the safety of traditional Chinese medicine should be paid attention to in the treatment of cerebral hemorrhage. This study was based on the data of the real world, but with some problems, such as lack of data and confounding factors. The summarized medication plan is only for the reference of clinicians. The clinical application shall be based on the specific situation of patients and the clinical benefits and risks, and pay attention to the incompatibility.

Study on treatment of "cytokine storm" by anti-2019-nCoV prescriptions based on arachidonic acid metabolic pathway

Since the outbreak of 2019-nCoV, the epidemic has developed rapidly and the situation is grim. LANCET figured out that the 2019-nCoV is closely related to "cytokine storm". "Cytokine storm" is an excessive immune response of the body to external stimuli such as viruses and bacteria. As the virus attacking the body, it stimulates the secretion of a large number of inflammatory factors: interleukin(IL), interferon(IFN), C-X-C motif chemokine(CXCL) and so on, which lead to cytokine cascade reaction. With the exudation of inflammatory factors, cytokines increase abnormally in tissues and organs, interfering with the immune system, causing excessive immune response of the body, resulting in diffuse damage of lung cells, pulmonary fibrosis, and multiple organ damage, even death. Arachidonic acid(AA) metabolic pathway is principally used to synthesize inflammatory cytokines, such as monocyte chemotactic protein 1(MCP-1), tumor necrosis factor(TNF), IL, IFN, etc., which is closely related to the occurrence, development and regression of inflammation. Therefore, the inhibition of AA metabolism pathway is benefit for inhibiting the release of inflammatory factors in the body and alleviating the "cytokine storm". Based on the pharmacophore models of the targets on AA metabolic pathway, the traditional Chinese medicine database 2009(TCMD 2009) was screened. The potential herbs were ranked by the number of hit molecules, which were scored by pharmacophore fit value. In the end, we obtained the potential active prescriptions on "cytokine storm" according to the potential herbs in the "National novel coronavirus pneumonia diagnosis and treatment plan(trial version sixth)". The results showed that the hit components with the inhibitory effect on AA were magnolignan Ⅰ, lonicerin and physcion-8-O-β-D-glucopy-ranoside, which mostly extracted from Magnoliae Officinalis Cortex, Zingiberis Rhizoma Recens, Lonicerae Japonicae Flos, Rhei Radix et Rhizoma, Salviae Miltiorrhizae Radix et Rhizoma, Scutellariae Radix, Gardeniae Fructus, Ginseng Radix et Rhizoma, Arctii Fructus, Dryopteridis Crassirhizomatis Rhizoma, Paeoniaeradix Rubra, Dioscoreae Rhizoma. Finally the anti-2019-nCoV prescriptions were analyzed to obtain the potential active prescriptions on AA metabolic pathway, Huoxiang Zhengqi Capsules, Jinhua Qinggan Granules, Lianhua Qingwen Capsules, Qingfei Paidu Decoction, Xuebijing Injection, Reduning Injection and Tanreqing Injection were found that may prevent 2019-nCoV via regulate cytokines. This study intends to provide reference for clinical use of traditional Chinese medicine to resist new coronavirus.

The clinical research on the efficacy of Tanreiqing injection combined with routine western medicine in treating chronic obstructive pulmonary disease at acute and aggravating period with syndrome of phlegm-heat obstructing lung

Objective To evaluate effect of Tanreqing injection combined conventional western medicine therapy on acute exacerbation of chronic obstructive pulmonary disease (AECOPD) of Phlegm heat obstructing Lung. Methods A total of 112 patients with AECOPD were randomly divided into two groups with digital table method from February 2015 to February 2018, 56 cases in each group. The control group was treated byconventional western medicine therapy, and treatment group was treated by Tanreqing injection based on control group. Both groups' treatment lasted for 2 weeks. The modified version of British Medical Reseach Council respiratory questionnaire (mMRC) was used for severity evaluation in breath difficulty. The COPD assessment test (CAT) was used for the assessment of symptoms, activity ability, psychological, social impact and sleep. The FEV1% and FEV1/FVC were recorded. The SaO2, PaO2 and PaCO2 were recorded. The phlegm heat obstructing lung symptom scores were detected. The adverse reactions were recorded. Results The total effective rate of treatment group was 94.4% (51/54), and the control group was 77.3% (41/53). There was statistically significant difference between two groups (χ2=5.138, P=0.023). After treatment, the mMRC and CAT scores in the treatment group were significantly lower than those in the control group (t value were 17.233, 17.111, respectively, all Ps<0.01); the cough, wheezing, shortness of breath, fever, dry mouth, constipation scores were significantly lower than the control group (t value were 27.717, 29.387, 27.227, 30.268, 28.430, 29.738, respectively, all Ps<0.01). After treatment, the FEV1% (52.34% ± 5.79% vs. 46.98% ± 5.72%, t=4.817), FEV1/FVC (61.36 ± 6.52 vs. 56.93 ± 5.94, t=3.675) in the treatment group were significantly higher than the control group (P<0.01); SaO2 (90.11% ± 9.53% vs. 83.56% ± 8.84%, t=3.684); the PaO2 (91.22 ± 9.79 mmHg vs. 85.18 ± 8.80 mmHg, t=3.354) significantly higher than the control group (P<0.01), and PaCO2 (44.75 ± 4.94 mmHg vs. 51.05 ± 5.46 mmHg, t=6.261) significantly lower than the control group (P<0.01). The incidence of adverse reactions in the treatment group was 11.1% (6/54), and the control group was 7.5% (4/53). There was no statistically significant difference between two groups (χ2=0.091, P=0.763). Conclusions Tanreiqing injection combined with conventional western medicine therapy can take effectsimprove levels of SaO2 and PaO2, reduce PaCO2 level of the AECOPD patients. Key words: Pulmonary disease, chronic obstructive; Acute disease; Phlegm heat obstructing Lung; Tan Re Qing Zhu She Ye; Integrated Chinese traditional and western medicine therapy; Drug-related side effects and adverse reactions

Chemical profiling and quantification of Tanreqing injection, a systematic quality control strategy equipped with UPLC-Q-Orbitrap fusion MS

Tanreqing injection is a Chinese medical formula used to treatment of respiratory diseases. In our study, we developed a feasible and accurate strategy applying an ultra-high-performance liquid chromatography coupled with Q Exactive™ Plus-Orbitrap Fusion mass spectrometers (UPLC-Q-Orbitrap Fusion MS/MS) to clarify and quantify the chemical profiling of Tanreqing injection rapidly. A total of 80 ingredients were identified by comparing the accurate mass, fragment ions, and cleavage pathways, including flavonoids, phenyl propionic acid, coumarins, amino acids, cholesterol, etc. And 18 characteristic components among them were definitely identified by comparison with reference substance. Meanwhile, the 18 representative constituents were simultaneously measured in eight batches Tanreqing injection utilizing UPLC-Q-Orbitrap Fusion MS/MS in negative ion mode. Among the 18 components, beta-d-glucopyranosiduronic acid, baicalin, ursodeoxycholic acid, and chenodeoxycholic acid were the predominant constituents. In principal components analysis results, five dominating components were extracted, and the variant contribution rates were ranked as: 37.86, 22.86, 16.42, 9.80, 7.32%, with the accumulated value 94.26%. 5-caffeoylquinic acid, isochlorogenic acid C, and baicalin possessed larger loads on the first factor. Our research carried out qualitative and quantitative analysis on Tanreqing injection, provided a certain reference for the research on pharmacodynamic material basis and the selection of quality markers.

The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China.

Background: Tanreqing injection (TRQ) is a traditional Chinese medicine commonly used in China to treat pulmonary diseases presenting as phlegm-heat syndrome. Robust data on the safety of TRQ from real-world observational cohorts are currently lacking. Objective: To evaluate as the incidence, type, and predictors of adverse events (AEs) and adverse drug reactions (ADRs) of TRQ in clinical practice in China. Methods: We conducted a population-based cohort, multicenter study to evaluate the incidence, manifestation, outcomes, and risk factors of AEs and ADRs following TRQ use in China. Between April 2014 and May 2015 a total of 30,322 consecutive inpatients/emergency attendance patients from 90 hospitals across China administrated TRQ were followed-up for 7 days. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated using logistic regression to identify predictors of ADRs. Results: The incidence of AEs and ADRs was 1.4 and 0.3%, respectively. Skin and subcutaneous tissue disorders were the most common ADRs. All ADRs were mild or moderate in severity, except for one serious case of anaphylactic reaction. The majority of ADRs (72.8%) occurred in the first 2 h after TRQ administration. Two-thirds of patients (66.1%) in the study were prescribed TRQ off-label, including infants aged ≤24 months. A history of food allergy (OR 4.50, 95% CI: 1.35–15.00), drug allergy (OR 2.77, 95% CI: 1.56–4.94), and fast infusion speed (off-label use) (OR 2.10, 95% CI: 1.27–3.50) were associated with an increased risk of ADRs. Conclusion: TRQ is well tolerated in the general population, yet off-label use is prevalent. Efforts are required to educate prescribers to adhere to the drug label in order to minimize potential patient harm.

Systems pharmacology-based study of Tanreqing injection in airway mucus hypersecretion.

Mucus hypersecretion (MH) is recognized as a key pathophysiological and clinical feature of many airway inflammatory diseases. MUC5AC is a major component of airway mucus. Tanreqing injection (TRQ) is a widely used herbal formula for the treatment of respiratory inflammations for years in China. However, a holistic network pharmacology approach to understanding its therapeutic mechanisms against MH has not been pursued. This study aimed to explore the systems-level potential active compounds and therapeutic mechanisms of TRQ in the treatment of MH. We established systems pharmacology-based strategies comprising compound screenings, target predictions, and pathway identifications to speculate the potential active compounds and therapeutic targets of TRQ. We also applied compound-target and target-disease network analyses to evaluate the possible action mechanisms of TRQ. Then, lipopolysaccharide (LPS)-induced Sprague-Dawley (SD) rat model was constructed to assess the effect of TRQ in the treatment of MH and to validate the possible molecular mechanisms as predicted in systems pharmacology approach. The comprehensive compound collection successfully generated 55 compound candidates from TRQ. Among them, 11 compounds with high relevance to the potential targets were defined as representative and potential active ingredients in TRQ formula. Target identification revealed 172 potential targets, including pro-inflammatory cytokines of tumor necrosis factor α (TNF-α), interleukin (IL)-6, and IL-8. Pathway analyses uncovered the possible action of TRQ in the regulation of IL-17 signaling pathway and its downstream protein MUC5AC. Then in vivo experiment indicated that TRQ could significantly inhibit LPS stimulated MUC5AC over-production as well as the expression of TNF-α, IL-6, IL-8, and IL-17A, in both protein and mRNA levels. Based on the systems pharmacology method and in vivo experiment, our work provided a general knowledge on the potential active compounds and possible therapeutic targets of TRQ formula in its anti-MH process. This work might suggest directions for further research on TRQ and provide more insight into better understanding the chemical and pharmacological mechanisms of complex herbal prescriptions in a network perspective.

Rapid analysis of the Tanreqing injection by near-infrared spectroscopy combined with least squares support vector machine and Gaussian process modeling techniques.

Near-infrared spectroscopy (NIRS) combined with chemometrics was used to analyze the main active ingredients including chlorogenic acid, caffeic acid, luteoloside, baicalin, ursodesoxycholic acid, and chenodeoxycholic acid in the Tanreqing injection. In this paper, first, two hundred samples collected in the product line were divided into the calibration set and prediction set, and the reference values were determined by the High Performance Liquid Chromatography- Diode Array Detector/Evaporative Light Scattering Detector (HPLC-DAD/ELSD) method. Partial least squares (PLS) analysis was implemented as a linear method for models calibrated with different preprocessing means. Wavelet transformation (WT) was introduced as a variable selection technique by means of multiscale decomposition, and wavelet coefficients were employed as the input for modeling. Furthermore, two nonlinear approaches, least squares support vector machine (LS-SVM) and Gaussian process (GP), were applied to exploit the complicated relationship between the spectra and active ingredients. The optimal models for each ingredient were obtained by LS-SVM and GP methods. The performance of the final models was evaluated by the root mean square error of calibration (RMSEC), root mean square error of cross-validation (RMSECV), root mean square error of prediction (RMSEP) and correlation coefficient (R). All of the models in the paper give a good calibration ability with an R value above 0.92, and the prediction ability is also satisfactory, with an R value higher than 0.85. The overall results demonstrate that nonlinear models are more stable and predictable than linear ones, and they will be more suitable for the CHM system when high accuracy analysis is required. It can be concluded that NIRS with the LS-SVM and GP modeling methods is promising for the implementation of process analytical technology (PAT) in the pharmaceutical industry of Chinese herbal injections (CHIs).

The Effect of Tanreqing Injection on the Pharmacokinetics of Sirolimus in Rats.

To evaluate the effect of Tanreqing injection on the pharmacokinetics of sirolimus in rats, a high performance liquid chromatography tandem mass spectrometry method was developed for sirolimus assay in whole blood. Calibration curve of sirolimus was acquired over a concentration ranging from 2.5 to 100 ng/mL with r2= 0.9955. The matrix effects and extraction recoveries of sirolimus ranged from 144% to 152% and from 80% to 96%, respectively. The inter- and intraday relative standard deviations were both <10%. The stability investigation showed that the blood samples were stable for 30-day-storage at −20°C, for 8 h storage at room temperature, for 24 h storage in the auto-sampler at 4°C, and for three freeze-thaw cycle process. The pharmacokinetic results demonstrated that the Cmax, AUC, and AUMC of sirolimus in rats (7.5 mg/kg, i.g.) were increased after beincoadministration with Tanreqing Injection at 2.5, 5.0, and 7.5 mL/kg (i.v.), respectively, or at 5 min, 2 h, and 4 h (5.0 mL/kg, i.v.) after SRL dosing, respectively. For the first time, the results proved the herb-drug interaction between Tanreqing Injection and sirolimus and accordingly suggested avoiding concurrent reception of those two drugs for patients.

Tanreqing injection with ambroxol hydrochloride for heart failure and pulmonary infection in senile degenerative heart disease: a randomized controlled trial

Background and objective: Degenerative changes in the heart with age and decreased immune function mean that older adult patients with heart failure are vulnerable to infection by pathogenic bacteria. Tanreqing injection, a traditional Chinese compound medicine, has the functions of clearing heat, eliminating phlegm, and detoxifying, and can be used to treat pulmonary infection. We hypothesized that Tanreqing injection combined with ambroxol hydrochloride, a mucolytic drug, may effectively alleviate pulmonary infection and improve cardiac function in older adult patients with heart failure and pulmonary infection caused by degenerative heart disease. Participants and methods: This prospective, single-center, randomized, controlled clinical trial will include 320 patients with heart failure combined with pulmonary infection induced by senile degenerative heart disease from Sanya People’s Hospital, Sanya, China. All patients will receive conventional anti-heart failure treatment, and will be equally and randomly divided into a control group and a trial group. Patients in both groups will be treated with intravenous infusion of ambroxol hydrochloride, while patients in the trial group will additional receive Tanreqing injection. The treatment period will be 7 days. Patient recruitment and data collection will begin on July 1, 2019 and end on August 30, 2021. Analysis of the results will be performed from September 10–30, 2021. This study is scheduled to end on December 30, 2021. The study protocol was approved by the Medical Ethics Committee of Sanya People’s Hospital in October 2015 (approval No. S2015-065-03). Study protocol version is 1.0. This study will be performed in accordance with the principles of the Declaration of Helsinki. Written informed consent to participate will be obtained from participants or their family members. Results: The primary outcome measure is total effective rate after 7 days of treatment. Secondary outcome measures are change from baseline in left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular ejection fraction, left ventricular fractional shortening, number of pathogenic bacteria in the lung, serum procalcitonin level, and C-reactive protein level after 7 days of treatment, as well as incidence of adverse reactions after 7 days of treatment. In a pilot study among 120 patients with senile heart failure conducted from May 2016 to October 2017, patients were randomly assigned to trial and control groups (n = 60 per group). Gram-positive bacteria were found to be the main pathogens responsible for pulmonary infection in senile patients with heart failure, with a positive rate of 53.7% in both control and trial groups. After treatment, the number of pathogenic bacteria in the trial group was markedly lower than that in the control group (11 strains versus 17 strains). Furthermore, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and left ventricular ejection fraction were significantly lower (P Conclusion: The results of this planned study will confirm whether Tanreqing injection combined with ambroxol hydrochloride can markedly improve cardiac function in senile patients with heart failure and mitigate pulmonary infection caused by pathogenic bacteria. This study will also identify adverse drug reactions associated with the study treatment. Trial registration: This study was registered with the Chinese Clinical Trial Registry on April 29, 2019 (registration number: ChiCTR1900022879).

Efficacy and safety of traditional Chinese medicine combined with western medicine for early-phase treatment of acute ischemic stroke based on the primary syndrome elements: protocol for a randomized controlled trial

Background and objective: Acute ischemic stroke is a major cause of disability among adults. Although traditional Chinese medicine and western medicine have been widely used for the treatment of acute ischemic stroke, their efficacy when used in combination for the treatment of acute ischemic stroke during the early phase is poorly understood. According to traditional Chinese medicine theory, the primary syndrome elements of acute ischemic stroke during the early stage include three pathogens, “wind,” “fire,” and “phlegm,” and treatments that target these primary syndrome elements contribute to recovery from the condition. We have designed a randomized controlled trial to investigate the efficacy and safety of traditional Chinese medicine combined with western medicine in the treatment of acute ischemic stroke during the early phase based on the primary syndrome elements. Subjects and methods: This prospective, single-center, assessor-blinded, randomized controlled trial will enroll 120 eligible patients with acute ischemic stroke who will receive treatment in the Department of Emergency, Dongfang Hospital of Beijing University of Chinese Medicine, China. Participants will be randomly assigned to a combined treatment group or a control group. Both groups will undergo treatment with conventional western medicine, and patients in the combined treatment group will also receive traditional Chinese medicine (i.e., oral stroke initial state decoction, intravenous Gastrodin injection, and Tanreqing injection; Xingnaojing injection will be added for patients who are unconscious). Immediately after admission, patients will undergo 3-day treatment for early-phase ischemic stroke and subsequently undergo a 2-week follow up. This study was approved by Hospital Ethics Committee, Dongfang Hospital, Beijing University of Traditional Medicine, China (approval No. JDF-IRB-2016033602) on November 2, 2016. Written informed consent will be obtained from conscious patients or the legal guardians of unconscious patients. Outcome measures: The primary outcome measures of this study are the National Institute of Health Stroke Scale score and traditional Chinese medicine stroke scale score on days 1, 3, 7, and 14 after treatment. Secondary outcome measures include National Institute of Health Stroke Scale score, Barthel index, Modified Rankin scale score, Glasgow coma scale score on days 1, 3, 7, and 14 after treatment, serum matrix metalloproteinase-9 and vascular endothelial growth factor levels on days 1 and 3 after treatment. Safety outcomes on days 1 and 3 after treatment and adverse events on days 3, 7, and 14 after treatment are also evaluated. Discussion: The results of this study will provide evidence to support the rationale for using traditional Chinese medicine combined with western medicine for the treatment of acute ischemic stroke during the early phase, and may indicate the underlying mechanism in this treatment strategy. Trial registration: This study was registered with the Chinese Clinical Trial Registration (registration number: ChiCTR-INR-16010075) on December 4, 2016. Study protocol refers to 1.0. Patient recruitment began in December 2016 and will be ended in November 2019.

Retrospective analysis and discussion on 74 cases of adverse reactions of traditional Chinese medicine injection

As a modern dosage form drug with rapid effect, traditional Chinese medicine (TCM) injection has been more and more used in clinical practice. Meanwhile the safety of TCM injection has attracted more and more attention. The retrospective analysis on 74 cases of adverse reaction of TCM injections collected from 2007 to 2016 in the Third Affiliated Hospital of Beijing University of Chinese Medicine showed that the proportion of men and women with adverse reactions was 0.54:1; the average age was 62.5 years old; 21 kinds of TCM injections were involved. Among them, the most reported were blood-regulating agents. The top four kinds of TCM injections with highest adverse drug reactions (ADRs) were Tanreqing injection, Danhong Injection, Shuxuening Injection and Xuesaitong for injection. The top three clinical manifestations of adverse reactions were lesions of skin and its appendages, damage of circulatory system and damage of nervous system. The potential causes of the adverse reactions of TCM injections were analyzed, and it was believed that individual difference, medicine, pharmaceutical excipients, solvent and TCM syndrome differentiation may be the main five causes for the adverse reactions of TCM injections. In order to reduce the adverse reactions of TCM injections, it is suggested that the clinical pharmacists should participate in the application management of TCM injections in the hospital; the production enterprises shall strengthen the whole life cycle management of the drugs; and at the same time, the drug control and administration authorities should improve the drug management methods constantly and encourage the development of TCM injections to the high quality level.