Multicenter Clinical Randomized Controlled Trial and Network Pharmacology Analysis of Zhenzhu Qingyuan Granules for the Treatment of Gastroesophageal Reflux Disease

Objective To evaluate the clinical efficacy and safety of Zhenzhu Qingyuan Granules through a clinical randomized controlled trial and to analyze the potential action targets and pathways of this formula using network pharmacology.Methods Patients with gastroesophageal reflux disease(GERD)of liver–stomach stagnant heat pattern who met the inclusion and exclusion criteria were randomly divided into the control group and the observation group.The control group received oral rabeprazole,whereas the observation group were given Zhenzhu Qingyuan Granules in addition to the rabeprazole.The treatment duration was 8 weeks.Clinical efficacy was observed in both groups after 8 weeks.Network pharmacology was used to analyze the action targets of ZhenzhuQingyuanGranules and the genes related to GERD,and core targets were inferred.Gene Ontology and Kyoto Encyclopedia of Genes and Genomes enrichment analyses were conducted to explore the potential mechanisms of this formula.Results The clinical research results showed that the total effective rate in the treatment group was 92.68%,compared with 70.00%in the control group,with a statistically significant difference(p<0.05).After treatment,both Chinese medicine syndrome score and endoscopic score improved in both groups compared with before treatment(p<0.05),and the treatment group showed greater improvement than the control group(p<0.05).Network pharmacology identified effective components of Zhenzhu Qingyuan Granules for treating GERD,including quercetin,luteolin,andβ-sitosterol,with potential action targets such as tumor protein 53(TP53),protein kinase B(AKT1),and tumor necrosis factor.Conclusion Zhenzhu Qingyuan Granules can significantly improve clinical symptoms in patients with GERD of liver–stomach stagnated heat pattern,enhance clinical efficacy,and have high safety.This formula may exert therapeutic effects through multiple targets and pathways.

Active components of Bupleuri Radix in the treatment of schizophrenia analyzed by network pharmacology and clinical verification

Background:Bupleuri Radix is a common Chinese medicinal material in traditional Chinese medicine.Currently,the therapeutic effect of treating schizophrenia is relatively well understood.However,there are fewer studies examining the underlying mechanisms of its treatment.The objective of the study was to investigate the primary mechanisms of Bupleuri Radix in treating schizophrenia through network pharmacology and clinical validation.Method:Network pharmacology revealed possible molecular mechanisms,followed by clinical verification.Sixty-seven schizophrenia patients undergoing treatment at the Hunan Brain Hospital between October and November 2022 were recruited and randomly divided into the olanzapine group and the olanzapine+Bupleuri Radix group.Additionally,32 healthy people undergoing physical examinations during the same period were included as the control group.The patient’s positive and negative symptom scale scores were compared.qPCR was used to detect the mRNA expression levels of ESR1,mTOR,EIF4E,and SMAD4 in peripheral blood.Results:Through network pharmacological analysis,it was concluded in this study that Bupleuri Radix might regulate the mTOR,PI3K-Akt,and HIF-1 signaling pathways.Clinical experiments indicated that compared with before treatment,the positive and negative symptom scale scores and total scores of the two treatment groups were significantly decreased after treatment(P<0.01).In addition,the positive and negative symptom scale scores and total scores in the olanzapine+Bupleuri Radix group were significantly decreased(P<0.01)compared to the olanzapine group after treatment.Before treatment,ESR1 mRNA expression levels in peripheral blood were significantly higher in the two treatment groups than in the control group,whereas the mRNA expression levels of mTOR,EIF4E,and SMAD4 in peripheral blood were significantly lower(P<0.01).The mRNA expression levels of mTOR,EIF4E,and SMAD4 in peripheral blood were significantly higher after therapy than before treatment,whereas the mRNA expression levels of ESR1 in peripheral blood were significantly lower(P<0.01).After therapy,the olanzapine+Bupleuri Radix group’s mRNA expression levels of mTOR,EIF4E,and SMAD4 were significantly higher than those of the olanzapine group,whereas the mRNA expression levels of ESR1 were significantly lower(P<0.01).Conclusion:The mechanism of Bupleuri Radix’s therapeutic efficacy in schizophrenia may involve the up-regulation of mTOR,EIF4E,and SMAD4 mRNA expression and the down-regulation of ESR1 mRNA expression in peripheral blood.

Clinical Observation and Network Pharmacology Study on Analgesic Effect of Qianghuo Chushi Decoction on Fasciitis

[Objectives]To observe the clinical analgesic effect of Qianghuo Chushi Decoction(QHCSD)on patients with fasciitis,and explore its possible molecular mechanism based on network pharmacology.[Methods]120 enrolled patients were randomly divided into experimental group and control group,and were separately treated with QHCSD formula granules and Diclofenac Sodium Enteric-coated Tablets for 4 weeks.The patient’s pain visual analogue scale(VAS)was used as the curative effect indicator.The molecular action mechanism of QHCSD was predicted based on network pharmacology,the active components of QHCSD were screened using TCMSP database,potential targets were predicted by PharmMapper server,compound-target network and protein interaction network were constructed,and GO-based enrichment analysis and KEGG-based biological pathway enrichment analysis were performed.[Results]After treatment,the pain scores in each group were significantly lower than those before treatment(P<0.01),the score of the experimental group was significantly lower than that of the control group(P<0.01),and the total effective rate of the experimental group was 83.33%,which was significantly higher than that of the control group(78.33%,P<0.05).Based on 108 active components in QHCSD,a compound-target network was constructed.The PPI network contained 155 nodes and 527 interaction relationships,and key nodes included FOS,ESR1,NCOA1,RELA,EGFR,MAPK8,IL-6,etc.The GO pathway mainly involved steroid hormone and its receptor activity,RNA polymerase II transcriptional regulator binding,nuclear receptor activity,protein heterodimerization activity and other pathways.KEGG metabolic pathways included PI3 K-Akt signaling pathway,Kaposi’s sarcoma-associated herpesvirus(KSHV)infection and other pathways.[Conclusions]QHCSD has a significant analgesic effect on fasciitis,and the PI3 K-Akt signaling pathway may be the key pathway for its analgesic effect.

PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF NEW DRUGS FROM CLINICAL PHARMACOLOGY STUDIES

The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-

Pediatric Clinical Pharmacology and Child Health:A Canadian Perspective

Introduction Canadian academic centres and children’s hospitals have had a longstanding interest in the improvement of drug therapy for children through research conducted across the four pillars of activity identified as being of

Systems pharmacology modeling in neuroscience: Prediction and outcome of PF-04995274, a 5-HT4 partial agonist, in a clinical scopolamine impairment trial

Background: 5-HT4receptors in cortex and hippocampus area are considered as a possible target for modulation of cognitive functions in Alzheimer’s disease (AD). A systems pharmacology approach was adopted to evaluate the potential of the 5-HT4 modulation in providing beneficialeffects on cognition in AD. Methods: A serotonergic synaptic cleft model was developed by integrating serotonin firing, release, synaptic half-life, drug/tracer properties (affinity and agonism) as inputs and5-HT4 activity as output. The serotonergic model was calibrated using bothinvivo data on free 5-HT levels in preclinical models and human imaging data. The model was further expanded to other neurontransmitter systems and incorporated into a computer-based cortical network model which implemented the physiology of 12 different membrane CNS targets. A biophysically realistic, multi-compartment model of 80 pyramidal cells and 40 interneurons was further calibrated usingdata reported for working memory tasks in healthyhumans and schizophrenia patients. Model output was the duration of the network firing activity in response to an external stimulus. Alzheimer’s disease (AD) pathology, in particular synapse and neuronal cell loss in addition to cholinergic deficits, was calibrated to align with the natural clinical disease progression. The model was used to provide insights into the effect of 5-HT4 activation on working memory and to prospectively simulate the response of PF- 04995274, a 5-HT4partial agonist, in a scopolamine-reversal trial in healthy human subjects. Results: The model output suggested a beneficial effect of 5-HT4 agonism on working memory. The model also projected no effect or an exacerbation of scopolamine impairment for low in- trinsic activity 5-HT4agonists, which was supported by the subsequent human trial outcome. The clinical prediction of the disease model strongly suggests that 5-HT4 agonists with high intrinsic activity may have a beneficial effect on cognition in AD patients.

Teaching Clinical Pharmacology to Undergraduate Nursing Students: Barriers and Strategies

This study examined perceived learning barriers to and strategies for teaching clinical pharmacology to undergraduate nursing students. The purposes of this study were to discuss barriers and strategies for teaching clinical pharmacology to undergraduate nursing students and compare those findings to student evaluation responses. This study used a comparative, cross-sectional design and examined data from nursing faculty who had taught pharmacology and from student evaluations over the past five years to compare perceived barriers and strategies. Several barriers were identified, including content saturation, course placement, English as a second language, and resources. Effective teaching strategies identified were lectures, teaching by drug class, reviewing pathophysiology, and case studies. Students’ evaluations revealed that students found that the course content was substantial and felt that the textbook did not fully demonstrate nursing considerations. Other answers were nonspecific. Using these strategies is critical to effectively deliver pharmacological material and to foster understanding among undergraduate students. Faculty members agree that having pharmacological concepts threaded throughout the curriculum increases students’ knowledge of medications and medication management. Additional creative approaches to teaching clinical pharmacology to undergraduate nursing students are needed.

Research on the mechanism of Chaihu Huangqin medicine based on integrated pharmacology to improve the clinical symptoms of COVID-19

Objective:Novel coronavirus(COVID-19)was used to improve the clinical symptoms of the new type coronavirus(LV),based on integrated pharmacology.Methods:TCMIP v2.0 was used to predict the key target and action pathway of Bupleurum baicalensis Georgi in improving the clinical symptoms of covid-19.The multi-dimensional network diagram of"drug pair active component key target action pathway"was drawn to explore its action mechanism from the molecular level.Results:Bupleurum and Scutellaria baicalensis could regulate IL signaling pathway and clec7a(a member of C-type lectin domain 7 family)/Inflammatory pathway,immune stress and other related signaling pathways can inhibit activated cytokines,alleviate excessive immune response,eliminate inflammation,and resist virus.In addition,the core targets of Bupleurum baicalensis baicalensis Georgi:nuclear factor kB(NFKB2,NFKB1),interleukin(IL-6,IL-1B),toll like receptor 4(TLR4),tumor necrosis factor(TNF)and so on are mostly induced by inflammation It is related to body damage.Bupleurum and scutellaria have the clinical effects of anti-inflammatory,antiviral,strengthening immunity,inhibiting pulmonary fibrosis and so on.Conclusion:Radix Bupleuri Scutellariae can be used to treat covid-19 by multi-channel,multi-target and multi ring.The results of this study provide a theoretical basis for Bupleurum Scutellaria to improve the use of COVID-19.

Mechanism of Liangxue Huayu decoction in treatment of age-related macular degeneration based on network pharmacology and clinical validation

Background:This paper investigates the mechanism of Liangxue Huayu decoction treating age-related macular degeneration through network pharmacology and clinical verification.Methods:The potential targets of Liangxue Huayu decoction were retrieved by the BATMAN-TCM database,and age-related macular degeneration-related disease targets were collected using the OMIM,GeneCards,and CTD databases.The intersection of targets for Liangxue Huayu decoction for age-related macular degeneration was performed using the online tool Venny2.1.0.Protein-protein interaction network was drawn using the String database.And core targets were obtained with the CytoNCA plugin.The gene ontology and Kyoto Encyclopedia of Genes and Genomes enrichment analyses were performed using the Metascape database.Finally,targets of Liangxue Huayu decoction for age-related macular degeneration were identified in clinical research.Results:In this study,832 potential action targets and 9,475 age-related macular degeneration-related disease targets were screened,and 575 intersection targets of Liangxue Huayu decoction and age-related macular degeneration were obtained.Protein-protein interaction network analysis showed that 15 core targets include chemokine 8,interleukin 1,histone deacetylase 2,estrogen receptor 2,and glutamate ionotropic receptor NMDA type subunit 1,et al.Gene ontology enrichment analysis included 2,727 biological processes,434 molecular functions,and 206 cellular components.Kyoto Encyclopedia of Genes and Genomes enrichment analysis selected 107 signaling pathways.Clinical validation showed that peripheral blood chemokine 8 and interleukin 1 levels were significantly lower after age-related macular degeneration patients compared with before treatment,and the difference was statistically significant(t chemokine 8=12.684,t interleukin 1=11.405,all P<0.001).Conclusion:By treating age-related macular degeneration with multiple targets and multiple pathways,Liangxue Huayu decoction can down-regulate the expression of inflammatory factors and treat age-related macular degeneration,which provides a basis for further studying the action mechanism of regulating age-related macular degeneration.

Efficacy of Tounongsan decoction(透脓散方)on pyogenic liver abscess:network pharmacology and clinical trial validation

OBJECTIVE:To elucidate the molecular mechanisms governing the effect of Tounongsan decoction(透脓散方,TNS)on the pyogenic liver abscess.METHODS:Based on oral bioavailability and druglikeness,the main active components of TNS were screened using the Traditional Chinese Medicine Systems Pharmacology platform.The Gene Card and Uni Prot databases were used to establish a database of pyogenic liver abscess targets.The interactive network map of drug-ingredients-target-disease was constructed using Cytoscape software(Version 3.7.2).A proteinprotein interaction network was constructed using the STRING database,and the related protein interaction relationships were analyzed.biological process of gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analyses were performed for the core targets.Finally,a clinical trial was performed to verify the reliability of the network pharmacology.RESULTS:Forty active components of TNS decoction were obtained,and 61 potential targets and 11 proteins were identified.Pathways involved in the treatment of pyogenic liver abscess include the phosphatidylinositide 3-kinases-protein kinase B(PI3K-AKT),advanced glycation end products-receptor for advanced glycation end products(AGE-RAGE),and tumor necrosis factor(TNF)signaling pathways.The results of network pharmacology analysis combined with clinical trials validated that TNS decoction could alleviate the inflammatory response of pyogenic liver abscesses by decreasing interleukin 6(IL-6)levels.CONCLUSIONS:TNS decoction has the characteristics of being multi-system,multi-component,and multi-target.Active ingredients in TNS,such as quercetin,kaempferol,fisetin,andβ-sitosterol,have strong potential to be candidate drugs for treating pyogenic liver abscesses.The possible mechanism of TSN decoction includes regulating immune and inflammatory responses and reducing IL-6 production to control inflammatory development.

Assessment of Appropriateness of Diagnostic Lymph Node Tissue Collection from the Operating Theater and by Interventional Radiologist. A Clinical Audit

Background: Appropriate sample requesting, collecting and timely dispatch to the appropriate laboratory is essential in establishing diagnosis of pathologies with lesions. Much time and effort may be wasted if this is not done according to certain standards. We conducted this study to assess the route of lymph node samples from requests to reaching the laboratories. Methods: We conducted an audit over a period from 4th June until 10th Aug 2023. Data for all the procedures performed over this period on lymph node samples (was entered into and analysed using Excel. Results: A total of eighteen samples for sixteen patients were obtained during this period. Median age of the patients was 34 years (19 - 73) with a M:F ratio of 5:11. Among the IR samples, nine samples were from the neck, three from inguinal area and one from axilla. Seven samples (53.8%) were tru-cut biopsies, six samples (46.15%) were FNA. All samples were sent to the pathology laboratory fixed in formalin. Samples for TB were sent only for five cases (31.25%) and for only two cases (12.5%) were samples sent for bacterial culture. For the OR samples, none were sent for either bacterial culture or TB. Overall, eight patients (50%) were not investigated for any infectious etiologies like brucella, toxoplasmosis, CMV, EBV plus other possible causes. Repeat sampling was required for 25% of patients (within and out of the audit period). Conclusions: to avoid delays in making diagnoses, it is paramount to consider infectious etiologies as possible diagnosis for lymphadenopathy and request appropriate investigations. This requires liaising with infectious diseases/clinical microbiology experts to guide regarding types of samples, types of media and timely dispatch to the correct laboratory.

Virtual reality:The bridge between medical education and clinical practice

After perusing the paper by Kim et al,I discovered that this is an interesting manuscript and a successful study.Virtual reality(VR)is an emerging and promising technology employed in the domain of medical practice and medical education over the past decade.In the era of big data,VR is constantly progressing in the fields of medical education and clinical diagnosis and treatment.As a novel scientific and technological tool,VR not only overcomes multiple limitations of the traditional medical teaching mode but also reduces the reliance on personnel and equipment.VR can simulate the real clinical situation,stimulate the enthusiasm of young doctors and nurses for clinical study,and simultaneously safeguard and promote medical safety and doctor-patient harmony.Favorable outcomes have been attained in clinical teaching and diagnosis and treatment activities.While enhancing the training conditions of medical cosmetics and elevating the level of clinical practice and teaching,the risks resulting from improper clinical diagnosis and treatment have been circumvented.All of this is evident and comprehensible.

Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia

Objectives:Rural patients have poor cancer outcomes and clinical trial(CT)enrollment compared to urban patients due to attitudinal,awareness,and healthcare access differential.Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers.The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients.Our hypotheses are that for both cancer types,urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties.Methods:We compared breast and lung cancer patients’survival rates and enrollment ratios in clinical trials between rural(RUCC 4-9)and urban counties in Georgia at a Comprehensive Cancer Center(CCC).To assess these differences,we carried out a series of independent samples t-tests and Chi-Square tests.Results:The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients,failing to substantiate our hypothesis.While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC,no significant variation was observed based on rural or urban classification.Conclusion:These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers.Further,the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities.

Assessing the Levels of Clinical Reasoning Skills Using Self-Assessment of Clinical Reflection and Reasoning in Undergraduate Nursing Students: A Descriptive Comparative Study

Background: Clinical reasoning is a critical cognitive skill that enables undergraduate nursing students to make clinically sound decisions. A lapse in clinical reasoning can result in unintended harm to patients. The aim of the study was to assess and compare the levels of clinical reasoning skills between third year and fourth year undergraduate nursing students. Methods: The study utilized a descriptive comparative research design, based on the positivism paradigm. 410 undergraduate nursing students were systematically sampled and recruited into the study. The researchers used the Self-Assessment of Clinical Reflection and Reasoning questionnaire to collect data on clinical reasoning skills from third- and fourth-year nursing students while adhering to ethical principles of human dignity. Descriptive statistics were done to analyse the level of clinical reasoning and an independent sample t-test was performed to compare the clinical reasoning skills of the student. A p value of 0.05 was accepted. Results: The results of the study revealed that the mean clinical reasoning scores of the undergraduate nursing students were knowledge/theory application (M = 3.84;SD = 1.04);decision-making based on experience and evidence (M = 4.09;SD = 1.01);dealing with uncertainty (M = 3.93;SD = 0.87);reflection and reasoning (M = 3.77;SD = 3.88). The mean difference in clinical reasoning skills between third- and fourth-year undergraduate nursing students was not significantly different from an independent sample t-test scores (t = −1.08;p = 0.28);(t = −0.29;p = 0.73);(t = 1.19;p = 0.24);(t = −0.57;p = 0.57). Since the p-value is >0.05, the null hypothesis (H0) “there is no significantno significant difference in clinical reasoning between third year and fourth year undergraduate nursing students”, was accepted. Conclusion: This study has shown that the level of clinical reasoning skills of the undergraduate nursing students was moderate to low. This meant that the teaching methods have not been effective to improve the students clinical reasoning skills. Therefore, the training institutions should revise their curriculum by incorporating new teaching methods like simulation to enhance students’ clinical reasoning skills. In conclusion, evaluating clinical reasoning skills is crucial for addressing healthcare issues, validating teaching methods, and fostering continuous improvement in nursing education.

High rate of clinically relevant improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis

BACKGROUND The minimal clinically important difference(MCID)is defined as the smallest meaningful change in a health domain that a patient would identify as important.Thus,an improvement that exceeds the MCID can be used to define a successful treatment for the individual patient.AIM To quantify the rate of clinical improvement following anatomical total shoulder arthroplasty for glenohumeral osteoarthritis.METHODS Patients were treated with the Global Unite total shoulder platform arthroplasty between March 2017 and February 2019 at Herlev and Gentofte Hospital,Denmark.The patients were evaluated preoperatively and 3 months,6 months,12 months,and 24 months postoperatively using the Western Ontario Osteoarthritis of the Shoulder index(WOOS),Oxford Shoulder Score(OSS)and Constant-Murley Score(CMS).The rate of clinically relevant improvement was defined as the proportion of patients who had an improvement 24 months postoperatively that exceeded the MCID.Based on previous literature,MCID for WOOS,OSS,and CMS were defined as 12.3,4.3,and 12.8 respectively.RESULTS Forty-nine patients with a Global Unite total shoulder platform arthroplasty were included for the final analysis.Mean age at the time of surgery was 66 years(range 49.0-79.0,SD:8.3)and 65%were women.One patient was revised within the two years follow-up.The mean improvement from the preoperative assessment to the two-year follow-up was 46.1 points[95%confidence interval(95%CI):39.7-53.3,P<0.005]for WOOS,18.2 points(95%CI:15.5-21.0,P<0.005)for OSS and 37.8 points(95%CI:31.5-44.0,P<0.005)for CMS.Two years postoperatively,41 patients(87%)had an improvement in WOOS that exceeded the MCID,45 patients(94%)had an improvement in OSS that exceeded the MCID,and 42 patients(88%)had an improvement in CMS that exceeded the MCID.CONCLUSION Based on three shoulder-specific outcome measures we find that approximately 90%of patients has a clinically relevant improvement.This is a clear message when informing patients about their prognosis.

Beyond statistical significance:Embracing minimal clinically important difference for better patient care

The minimal clinically important difference(MCID)represents a pivotal metric in bridging the gap between statistical significance and clinical relevance,addressing the direct impact of medical interventions from the patient's perspective.This comprehensive review analyzes the evolution,applications,and challenges of MCID across medical specialties,emphasizing its necessity in ensuring that clinical outcomes not only demonstrate statistical significance but also offer genuine clinical utility that aligns with patient expectations and needs.We discuss the evolution of MCID since its inception in the 1980s,its current applications across various medical specialties,and the methodologies used in its calculation,highlighting both anchor-based and distribution-based approaches.Furthermore,the paper delves into the challenges associated with the application of MCID,such as methodological variability and the interpretation difficulties that arise in clinical settings.Recommendations for the future include standardizing MCID calculation methods,enhancing patient involvement in setting MCID thresholds,and extending research to incorporate diverse global perspectives.These steps are critical to refining the role of MCID in patient-centered healthcare,addressing existing gaps in methodology and interpretation,and ensuring that medical interventions lead to significant,patient-perceived improvements.

Clinical competency:perceptions of nursing interns and clinical mentors

Objective:To assess the clinical competency of nursing interns and the perception of clinical nurse mentors toward student nurses'clinical competency.Methods:A study was carried out among 104 nursing interns and 26 clinical nurse mentors using the purposive sampling technique.A self-repor ted perception scale was used to collect the data.Results:In general,most nursing interns perceived themselves as clinically competent during the internship.The clinical nurse mentors too repor ted that the current internship is helping the nursing interns in becoming competent.Conclusions:Frequent clinical evaluation,buddy system,provision of stipends,good leadership,and coordination between the academic institute and hospital are repor ted as the critical motivating factors for improving the clinical competency of student interns.

An Overview of Quality Management of Therapeutic Vaccines in Clinical Trials in China

Objective To provide suggestions and a reference for improving the quality management system of clinical trials of therapeutic vaccines and promoting the development of therapeutic vaccines in China.Methods Literature research,case study and comparative study were used to analyze the quality management system of clinical trials of therapeutic vaccines.Results and Conclusion From the perspective of the sponsor,investigators and the thirdparty technical service company,the problems such as the low efficiency of clinical trial sample preparation and the lax implementation of the protocol by hospital departments in the quality management of clinical trials of therapeutic vaccines in China were found.Then,the optimization plan for the quality management of clinical trials of therapeutic vaccines is proposed,including optimizing the preparation process of therapeutic vaccines and strengthening the training of hospital department personnel.

Patient Recruitment in Clinical Trials: Areas of Challenges and Success, a Practical Aspect at the Private Research Site

Enrolling in clinical trials could be time-sensitive and time-demanding tasks for the research site, especially if it is a private research organization compared to the research conducted at an academic or medical center. Every study differs in various aspects, such as phases, study indication, eligibility criteria, etc. In terms of meeting the enrollment deadline, typically, the study indication and availability of the patient’s population at the geographical area of the research site would decide if the trial could be time-consuming. Patient recruitment and retention are critical for the success of every clinical trial;however, worldwide, this area is facing tremendous pressure and challenges. Globally 55% of clinical trials terminated due to low recruitment, with an average enrollment success rate of 40% for Phase III and IV trials. Over 80% of clinical trial attempts fail to enroll, extending the study and adding new study sites. In the United States, more than 80% of clinical trials fail to achieve targeted patient enrollment, and 30% of study participants discontinue participation. This article reviewed various factors hindering clinical trial recruitment and retention and suggested strategies to make the research site successful.

Research progress of Sini decoction in pharmacy, pharmacology and clinical application

Sini decoction originated from Zhang Zhongjing's Treatise on Cold Pathogenic and Miscellaneous Diseases(200-210 C.E.)in the Eastern Han Dynasty.It is a traditional and famous prescription in China.Its preparations mainly include Sini decoction,Sini decoction drop pills and Sini decoction suppositories.The main chemical components are diterpenoid alkaloids,gingerol,volatile oil,coumarin,polysaccharide,triterpene saponins,flavonoids,amino acids,and alkaloids.This product has a cardiovascular function,anti-shock,anti-diabetes complications,anti-tumor,anti-atherosclerosis,and effects on the nervous system.Modern clinical practice is widely used in cardiovascular,respiratory,digestive,neurological and gynecological diseases.This paper reviews the pharmaceutical research,pharmacological effects,safety evaluation and clinical application of Sini decoction,including the source and composition of Sini decoction,the origin and resource status of authentic medicinal materials of Sini decoction,the research on preparation form reform,chemical composition and quality control,to provide a reference for further research and clinical promotion of Sini decoction.