China Clinical Trial Registration Center Research Articles

The effect of a hybrid structured pulmonary rehabilitation education program for patients with lung cancer with a high risk of postoperative pulmonary complications: A quasi-experimental study

PurposeThe absence of standardized protocols and education are the main obstacles to perioperative pulmonary rehabilitation (PR), especially for patients with high-risk factors of postoperative pulmonary complications (PPCs). We aimed to explore the effect of a hybrid structured pulmonary rehabilitation education program (SPREP) on patients with lung cancer at high risk of PPCs. MethodsA quasi-experimental trial with a pre-post test design was conducted. The control group (n = 53) adopted routine perioperative pulmonary rehabilitation, while the intervention group (n = 53) received SPREP. Respiratory function, 6-min walk distance, Borg dyspnea scale, quality of life, anxiety–depression scores at admission, discharge, 2 weeks and 3 months post-discharge, and incidence of PPCs were compared between the two groups. ResultsThere were no significant differences on the 6-min walk distance and Borg Dyspnoea Scale at discharge between the two groups (P > 0.05), whereas the intervention group showed improved performance at the remaining time points (P < 0.05). In addition, the intervention group had improved exercise capacity, pulmonary function and quality of life, reduced levels of anxiety and depression at discharge, 2 weeks post-discharge and 3 months post-discharge (P < 0.05). In addition, incidence of PPCs was significantly reduced in the intervention group, especially postoperative pneumonia. ConclusionsThe SPREP could show significant benefits in enhancing exercise capacity, lung function, and quality of life, while diminishing the occurrence of PPCs and mitigating the levels of anxiety and depression, future large RCT need to further explore the efficacy. Trial registrationThis study was registered with the China Clinical Trial Registration Center (ChiCTR) under the Clinical Trial Registration Number [ChiCTR2200066698].

Preventing CXCL12 elevation helps to reduce acute exacerbation of COPD in individuals co-existing type-2 diabetes: A bioinformatics and clinical pharmacology study

AimsTo investigate the immunology shared mechanisms underlying chronic obstructive pulmonary disease (COPD) and type 2 diabetes mellitus (T2DM) and examine the impact of anti-diabetic drugs on acute exacerbation of COPD (AECOPD). MethodsWe analyzed GSE76925, GSE76894, GSE37768, and GSE25724 to identify differentially expressed genes. Hub-genes were identified through protein–protein interaction network analysis and evaluated by the receiver operating characteristic curve. CXCL12 emerged as a robust biomarker, and its correlation with lung function and CD8+ T cells were further quantified and validated. The activated signaling pathways were inferred through Gene set enrichment analysis (GSEA). The retrospective clinical analysis was executed to identify the influence of dipeptidyl peptidase-4 inhibitors (DPP-4i) on CXCL12 and evaluate the drug’s efficacy in AECOPD. ResultsThe significant up-regulation of CXCL12 expression in patients with two diseases were revealed. CXCL12 exhibited a negative correlation with pulmonary function (r = -0.551, p < 0.05). Consistent with analysis in GSE76925 and GSE76894, the positive correlation between the proportion of CD8+ T cells was demonstrated(r=0.469, p<0.05). GSEA identified “cytokines interaction” as an activated signaling pathway, and the clinical study revealed the correlation between CXCL12 and IL-6 (r=0.668, p<0.05). In patients with COPD and T2DM, DDP-4i treatment exhibited significantly higher serum CXCL12, compared to GLP-1RA. Analysis of 187 COPD patients with T2DM indicated that the DPP-4i group had a higher frequency of AECOPD compared to the GLP-1RA group (OR 1.287, 95%CI [1.018–2.136]). ConclusionsCXCL12 may represent a therapeutic target for COPD and T2DM. GLP-1RA treatment may be associated with lower CXCL12 levels and a lower risk of AECOPD compared to DPP-4i treatment.Clinical Trial Registration: China Clinical Trial Registration Center（ChiCTR2200055611）.

Status of outcome measures in randomized controlled trials of kidney-tonifying and blood-activating method in treatment of knee osteoarthritis

This study assesses the status of outcome measures in the randomized controlled trial(RCT) involving the kidney-tonif-ying and blood-activating method for treating knee osteoarthritis(KOA), aiming to establish a theoretical foundation for the development of a core set of outcome measures in traditional Chinese medicine(TCM) treatment of KOA. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, in addition to ClinicalTrials.gov and the China Clinical Trial Registration Center, with the time interval from inception to August 2023. The RCT of treating KOA with the kidney-tonifying and blood-activating method was included. Two assessors independently conducted literature screening, data collection, and qualitative analysis to compile the outcome measure results. A total of 350 RCTs were included, involving 165 outcome measures with the total frequency of 1 462. These outcome measures were categorized into six domains: symptom and sign measures(23) with the frequency of 718(49.1%), TCM symptom and syndrome measures(3) with the frequency of 53(3.6%), physical examination measures(130) with the frequency of 506(34.6%), quality of life measures(4) with the frequency of 20(1.3%), long-term efficacy measures(2) with the frequency of 6(0.4%), and safety measures(3) with the frequency of 159(10.9%). Additionally, 53 studies used TCM syndrome and symptom scores as indicators of efficacy, employing eight distinct measurement tools. The RCTs involving the kidney-tonifying and blood-activating method for treating KOA had a variety of problems, such as unclear prio-ritization of outcome measures, diversity in measurement tools, absence of standardized assessment criteria for specific measures, and non-standardized usage. These problems affected the research quality and reliability. Hence, it is advisable to draw upon international expertise, improve research design, and merge TCM efficacy characteristics with clinical research to establish a core set of KOA outcome measures aligned with TCM principles.

Zhuifeng Tougu capsules in the treatment of knee osteoarthritis (cold dampness obstruction syndrome): a randomized, double blind, multicenter clinical study

BackgroundIn Traditional Chinese Medicine (TCM) theory, cold dampness obstruction is one of the common syndromes of osteoarthritis. Therefore, in clinical practice, the main treatment methods are to dispel wind, remove dampness, and dissipate cold, used to treat knee osteoarthritis (KOA). This report describes a mulitercenter clinical study to assess Zhuifeng Tougu Capsule’s efficacy and safety in the treatment of patients who are cold dampness obstruction syndrome in KOA, and to provide evidence-based medical for the rational use of Zhuifeng Tougu Capsules in clinical practice.MethodsThis randomized, parallel group controlled, double-blind, double dummy trial will include a total of 215 KOA patients who meet the study criteria. 215 patients underwent 1:1 randomisation, with 107 cases assigned the experimental group (Zhuifeng Tougu Capsules + Glucosamine Sulfate Capsules Simulator) and 108 assigned the control group (Glucosamine Sulfate Capsules + Zhuifeng Tougu Capsules Simulator). After enrolment, patients received 12 weeks of treatment. The main efficacy measure is the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score. Visual analogue scale (VAS) pain score, Self-condition assessment VAS score, WOMAC KOA score, TCM syndrome score and TCM syndrome efficacy, ESR level, CRP level, suprapatellar bursa effusion depth, use of rescue drugs, and safety indicators are secondary efficacy indicators.ResultsCompared with before treatment, WOMAC pain score, VAS pain score, Self-condition assessment VAS score, WOMAC KOA score, and TCM syndrome score decreased significantly in both groups (P < 0.01). Also, the experimental group showed significant differences in the above indicators compared to control (P < 0.01). However, after treatment, no significant differences were showed in the ESR level, CRP level, and suprapatellar bursa effusion depth between the two groups (P > 0.05). No any serious adverse effects showed in the experimental group and control group.ConclusionsZhuifeng Tougu Capsules can effectively improve knee joint function and significantly alleviate the pain of KOA.Trial registration: Clinical trial registration was completed with the China Clinical Trial Registration Center for this research protocol (No. ChiCTR2000028750) on January 2, 2020.

Efficacy and safety of rifampicin-based triple therapy for non-puerperal mastitis: A single-arm, open-label, prospective clinical trial

ObjectivesTo assess the efficacy and safety of rifampicin-based triple therapy (rifampicin, isoniazid, and ethambutol) for treating NPM. MethodsThis single-center, single-arm, prospective clinical trial was conducted at the Second Hospital of Shandong University (Jinan, China). Patients with pathologically diagnosed granulomatous lobular mastitis and periductal mastitis received triple drugs, i.e., rifampicin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day), until complete response or the investigator decided to discontinue treatment. The primary endpoint was the complete response rate (CRR) assessed by the investigator. The secondary endpoints included the overall remission rate (ORR), recurrence rate (RR), and safety. ResultsA total of 218 patients were enrolled in the study between January 1, 2013 and October 31, 2020. With a median follow-up time of 48 months, the CRR and the ORR were 78.44% and 94.04%, respectively. While 13 patients (5.96%) demonstrated no response and 19 relapsed (8.72%). Adverse events (AEs) were not common. The most common AEs during treatment were liver dysfunction (1.83%), gastrointestinal reactions (1.83%), fatigue (1.83%), erythema (1.38%), and menstrual disorders (0.92%). ConclusionRifampicin, isoniazid, and ethambutol demonstrated promising response rates with acceptable safety profiles in patients with NPM. Further confirmatory trial is warranted in the future. Trial registrationThe study was approved by the Ethics Committee of the Second Hospital of Shandong University and retrospectively registered at the China Clinical Trial Registration Center (registration number: ChiCTR2100049591).

Individualized PEEP without Recruitment Maneuvers Improves Intraoperative Oxygenation: A Randomized Controlled Study.

Individualized positive end-expiratory pressure (PEEP) combined with recruitment maneuvers improves intraoperative oxygenation in individuals undergoing robot-assisted prostatectomy. However, whether electrical impedance tomography (EIT)-guided individualized PEEP without recruitment maneuvers can also improve intraoperative oxygenation is unknown. To test this, fifty-six male patients undergoing elective robot-assisted laparoscopic prostatectomy were randomly assigned to either individualized PEEP (Group PEEPIND, n = 28) or a control with a fixed PEEP of 5 cm H2O (Group PEEP5, n = 28). Individualized PEEP was guided by EIT after placing the patients in the Trendelenburg position and performing intraperitoneal insufflation. Patients in Group PEEPIND maintained individualized PEEP without intermittent recruitment maneuvers, and those in Group PEEP5 maintained a PEEP of 5 cm H2O intraoperatively. Both groups were extubated in a semi-sitting position once the extubation criteria were met. The primary outcome was arterial oxygen partial pressure (PaO2)/inspiratory oxygen fraction (FiO2) prior to extubation. Other outcomes included intraoperative driving pressure, plateau pressure and dynamic, respiratory system compliance, and the incidence of postoperative hypoxemia in the post-operative care unit (PACU). Our results showed that the intraoperative median for PEEPIND was 16 cm H2O (ranging from 12 to 18 cm H2O). EIT-guided PEEPIND was associated with higher PaO2/FiO2 before extubation compared to PEEP5 (71.6 ± 10.7 vs. 56.8 ± 14.1 kPa, p = 0.003). Improved oxygenation extended into the PACU with a lower incidence of postoperative hypoxemia (3.8% vs. 26.9%, p = 0.021). Additionally, PEEPIND was associated with lower driving pressures (12.0 ± 3.0 vs. 15.0 ± 4.4 cm H2O, p = 0.044) and better compliance (44.5 ± 12.8 vs. 33.6 ± 9.1 mL/cm H2O, p = 0.017). Our data indicated that individualized PEEP guided by EIT without intraoperative recruitment maneuvers also improved perioperative oxygenation in patients undergoing robot-assisted laparoscopic radical prostatectomy, which could benefit patients with the risk of intraoperative hemodynamic instability caused by recruitment maneuvers. Trial registration: China Clinical Trial Registration Center Identifier: ChiCTR2100053839. This study was registered on 1 December 2021. The first patient was recruited on 15 December 2021.

Association of cardiovascular health at old age with all-cause mortality: a prospective cohort study in China

BackgroundCardiovascular disease has become the leading cause of death worldwide, but there is a lack of data on whether cardiovascular health (CVH) is associated with elderly mortality in China. We investigated the relationship between the ideal CVH score of Chinese elderly and the all-cause mortality.MethodsThe Beijing Elderly Comprehensive Health Cohort Study included a total of 4,499 participants aged 60 years and above. The CVH metric was calculated at baseline and had a score ranging from 0 to 12. The relationship of CVH metrics with all-cause mortality was investigated using Cox proportional hazard regression analysis. The robustness of results was tested using subgroup and sensitivity analysis.ResultsThe median CVH score among participants was 8.00 (2.00), with only 8.0% scoring 11–12 points. 667 deaths were observed during an average follow-up time of 8.2 years. Participants with a CVH score of 11–12 had a decreased risk of all-cause mortality when compared to those with a CVH score of 0–4(HR = 0.584, 95% CI: 0.373–0.913). Participants had a 7.5% lower risk of all-cause death with each unit higher CVH score (HR = 0.925, 95%CI: 0.885–0.967) with a linearly decreasing trend (P nonlinear = 0.575). The relationships were greater in younger elderly people and stroke patients (P interaction = 0.011 and 0.037. respectively). The consistency of significant trends in sensitivity analysis shows the robustness of association (P trend < 0.001).ConclusionsAmong the Chinese elderly, there was a linear relationship between improving CVH scores and a lower risk of all-cause mortality. Because of the enormous benefits brought by one point, strategies are essential for improving cardiovascular health attainment.Trial registrationThis study was registered at China Clinical Trial Registration Center (ChiCTR2100049866).

Discovery of extracellular vesicle-delivered miR-185-5p in the plasma of patients as an indicator for advanced adenoma and colorectal cancer

BackgroundWe aimed to evaluate whether extracellular vesicles (EV)-derived microRNAs (miRNAs) can be used as biomarkers for advanced adenoma (AA) and colorectal cancer (CRC).MethodsWe detected the changes in the plasma EV-delivered miRNA profiles in healthy donor (HD), AA patient, and I-II stage CRC patient groups using miRNA deep sequencing assay. We performed the TaqMan miRNA assay using 173 plasma samples (two independent cohorts) from HDs, AA patients, and CRC patients to identify the candidate miRNA(s). The accuracy of candidate miRNA(s) in diagnosing AA and CRC was determined using the area under the receiver-operating characteristic curve (AUC) values. Logistic regression analysis was performed to evaluate the association of candidate miRNA(s) as an independent factor for the diagnosis of AA and CRC. The role of candidate miRNA(s) in the malignant progression of CRC was explored using functional assays.ResultsWe screened and identified four prospective EV-delivered miRNAs, including miR-185-5p, which were significantly upregulated or downregulated in AA vs. HD and CRC vs. AA groups. In two independent cohorts, miR-185-5p was the best potential biomarker with the AUCs of 0.737 (Cohort I) and 0.720 (Cohort II) for AA vs. HD diagnosis, 0.887 (Cohort I) and 0.803 (Cohort II) for CRC vs. HD diagnosis, and 0.700 (Cohort I) and 0.631 (Cohort II) for CRC vs. AA diagnosis. Finally, we demonstrated that the upregulated expression of miR-185-5p promoted the malignant progression of CRC.ConclusionEV-delivered miR-185-5p in the plasma of patients is a promising diagnostic biomarker for colorectal AA and CRC.Trial registration The study protocol was approved by the Ethics Committee of Changzheng Hospital, Naval Medical University, China (Ethics No. 2022SL005, Registration No. of China Clinical Trial Registration Center: ChiCTR220061592).

The effect of dietary carbohydrate and calorie restriction on weight and metabolic health in overweight/obese individuals: a multi-center randomized controlled trial

BackgroundBoth low‐carbohydrate (LC) and calorie-restricted (CR) diets have been shown to have metabolic benefits. However, the two regimens have yet to be thoroughly compared. We conducted a 12-week randomized trial to compare the effects of these diets separately and in combination on both weight loss and metabolic risk factors in overweight/obese individuals.MethodsA total of 302 participants were randomized to LC diet (n = 76), CR diet (n = 75), LC + CR diet (n = 76), or normal control (NC) diet (n = 75) using a computer-based random number generator. The primary outcome was the change in body mass index (BMI). The secondary outcomes included body weight, waist circumference, waist-to-hip ratio, body fat, and metabolic risk factors. All participants attended health education sessions during the trial.ResultsA total of 298 participants were analyzed. BMI change over 12 weeks was − 0.6 (95% CI, − 0.8 to − 0.3) kg/m2 in NC, − 1.3 (95% CI, − 1.5 to − 1.1) kg/m2 in CR, − 2.3 (95% CI, − 2.6 to − 2.1) kg/m2 in LC, and − 2.9 (95% CI, − 3.2 to − 2.6) kg/m2 in LC + CR. LC + CR diet was more effective than LC or CR diet alone at reducing BMI (P = 0.001 and P < 0.001, respectively). Furthermore, compared with the CR diet, the LC + CR diet and LC diet further reduced body weight, waist circumference, and body fat. Serum triglycerides were significantly reduced in the LC + CR diet group compared with the LC or CR diet alone. Plasma glucose, homeostasis model assessment of insulin resistance, and cholesterol concentrations (total, LDL, and HDL) did not change significantly between the groups during the 12-week intervention.ConclusionsThe reduction of carbohydrate intake without restricting caloric intake is more potent to achieve weight loss over 12 weeks when compared to a calorie-restricted diet in overweight/obese adults. The combination of restricting carbohydrate and total calorie intake may augment the beneficial effects of reducing BMI, body weight, and metabolic risk factors among overweight/obese individuals.Trial registrationThe study was approved by the institutional review board of Zhujiang Hospital of Southern Medical University and registered at the China Clinical Trial Registration Center (registration number: ChiCTR1800015156).

Evaluation and subgroup analysis of the efficacy and safety of intensive rosuvastatin therapy combined with dual antiplatelet therapy in patients with acute ischemic stroke

ObjectivesWe investigated the efficacy of intensive rosuvastatin therapy plus 7-day dual antiplatelet therapy (DAPT) in reducing stroke recurrence for patients with acute ischemic stroke (AIS) and compared subgroups of patients.MethodsWe enrolled patients with AIS whose time of onset to medication was ≤ 72 h, and the baseline scores of NIHSS (bNIHSS) were 0–10. The patients received intensive rosuvastatin therapy plus 7-day DAPT with aspirin and clopidogrel (study group) or rosuvastatin plus single antiplatelet therapy (SAPT, control group). The primary outcomes were recurrence of ischemic stroke, bleeding, statin-induced liver injury, and statin-associated myopathy (SAM) within 90 days. We also performed a subgroup analysis to assess the heterogeneity of the two therapy regimens in reducing recurrent stroke.ResultsRecurrent stroke occurred in 10 patients in the study group and 42 patients in the control group (hazard ratio [HR], 0.373, 95% confidence interval [CI], 0.178–0.780; P = 0.009). Bleeding events occurred in 9 patients in the study group and 14 patients in the control group (HR, 1.019; 95%CI, 0.441–2.353; P = 0.966). Statin-induced liver injury and SAM were not recorded. Intensive rosuvastatin plus 7-day DAPT was generally effective in reducing the risk of recurrent stroke, except in the subgroup with bNIHSS ≤ 2. The therapy was particularly efficient in the elderly, male, high-bNIHSS, and hypertension, diabetes, and hyperlipidemia subgroups, with P < 0.02.ConclusionsWithout increasing bleeding and statin-associated adverse events, intensive rosuvastatin therapy plus 7-day DAPT significantly reduced the risk of recurrent stroke, especially for subgroups with high-risk factors. Clinical trial registration. China Clinical Trial Registration Center (ChiCTR1800017809).

Effect of Somatosensory Interaction Transcutaneous Electrical Acupoint Stimulation on Cancer-related Fatigue and Immunity: A Randomized Controlled Trial.

Background:This study was intended to evaluate the clinical effect of somatosensory interaction transcutaneous electrical acupoint stimulation (SI-TEAS) on cancer-related fatigue (CRF) and its safety.Methods:The study protocol had been registered in China Clinical Trial Registration Center with registration number: ChiCTR2100045655. CRF patients were equally divided into SI-TEAS Group, Acupressure Group and Sham Acupressure Group to receive SI-TEAS, acupressure and sham acupressure treatments 5 times a week. The fatigue levels of patients in the 3 groups were measured by the Piper Fatigue Scale during the baseline period and after 4 and 8 weeks (of treatment). The cell immunity of these patients was determined by detecting the T-lymphocyte subsets and NK cells.Result:Of the 300 participants, 279 have gone through the independent rehabilitation intervention study, including 94 in the SI-TEAS Group, 92 in the Acupressure Group, and 93 in the Sham Acupressure Group. Intergroup comparisons of fatigue degree and cell immunity, namely SI-TEAS Group versus Acupressure Group, Acupressure Group versus Sham Acupressure Group, and SI-TEAS Group versus Sham Acupressure Group, showed that group changes observed during the baseline period and different time points after Week 4 and 8 were statistically different (P<0.05). The SI-TEAS Group had the sharpest decreases in the behavioral, sensory, emotional and cognitive dimensions of fatigue, and the total score, followed by the Acupressure Group, while the Sham Acupressure Group did not show significant changes; the SI-TEAS Group experienced the sharpest increases in the absolute counts of CD3+ T cells, CD4+ T cells, CD8+ T cells, CD4+/CD8+ T cells, and NK cells, followed by the Acupressure Group, while the Sham Acupressure Group did not show significant changes.Conclusion:SI-TEAS could significantly relieve the fatigue of CRF patients and improve their cell immunity, which maybe a useful and effective option for reducing CRF in clinical practice.

Schizophrenia patients with a metabolically abnormal obese phenotype have milder negative symptoms

BackgroundSchizophrenia patients with a metabolically abnormal obese (MAO) phenotype have been shown poor cardiovascular outcomes, but the characteristics of their current psychiatric symptoms have not been characterized. This study mainly explored the psychiatric symptoms of schizophrenia patients with the MAO phenotype.MethodsA total of 329 patients with schizophrenia and 175 sex- and age-matched people without schizophrenia from Anhui Province in China were enrolled. The Positive and Negative Syndrome Scale (PANSS) was used to evaluate the mental symptoms of the schizophrenia patients. The MAO phenotype was defined as meeting 1–4 metabolic syndrome criteria (excluding waist circumference) and having a body mass index (BMI) ≥ 28 kg/m2. And, metabolically healthy normal-weight (MHNW) phenotype was defined as meeting 0 criteria for metabolic syndrome and 18.5 ≤ BMI < 24 kg/m2.ResultsOverall, 15.8% of the schizophrenia patients and 9.1% of the control group were consistent with the MAO phenotype, and the prevalence of MAO in the schizophrenia group was higher than that in the control group. Among the patients with schizophrenia, the MAO group had lower negative factor, cognitive factor and total PANSS scores than the MHNW group. However, when confounding factors were controlled, only the negative factor remained lower significantly.ConclusionWe found that schizophrenia patients with the MAO phenotype had reduced negative symptoms, which may indicate an internal mechanism linking metabolic disorders and negative symptoms.Trial registrationThis study was registered in the China Clinical Trial Registration Center (No. chiCTR 1,800,017,044).

The efficacy and safety of Chinese traditional medicine injections on patients with coronavirus disease 2019: A protocol for systematic review and meta analysis.

Introduction:The pandemic caused by the coronavirus disease 2019 (COVID-19) infection has exposed vulnerable populations to an unprecedented global health crisis. Research reported that Chinese traditional medicine injections were used in patients with COVID-19 infection and showed significant effects, and there have been no systematic review and meta-analyses to investigate the effects and safety of Chinese traditional medicine injections.Materials and methods:This systematic review and meta-analysis protocol is based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 statement. The literature search will involve Cochran library, Web of science, PubMed, MEDLINE, Embase, China Biology Medicine Database, China National Knowledge Infrastructure Database, VIP, Wang Fang database, and China Clinical Trial Registration Center for articles and research published form December 2019. This search will include randomized controlled trials and nonrandomized studies. The Cochrane Collaboration's tool for randomized controlled trial studies and the Quality Assessment Tool for Quantitative Studies for nonrandomized studies will be used to assess the risk of bias among the studies included in the systematic review. Review Manager 5.3 software will be used for the meta-analysis, and odds ratio are calculated as the primary outcomes. Subgroup analyses will then be performed based on the characteristics of the interventions and populations included in the studies examined.Ethics and dissemination:This systematic review protocol is designed to provide evidence regarding the effects and safety of Chinese traditional medicine injections on patients with COVID-19, such evidence may be useful and important for clinical treatment decisions. The results should be disseminated through publication in a peer-reviewed journal. Since the data and results used in the systematic review will be extracted exclusively from published studies, approval from an ethics committee will not be required.

Efficacy and safety of Lianhua Qingwen combined with conventional antiviral Western Medicine in the treatment of coronavirus disease (covid-19) in 2019: Protocol for a systematic review and meta-analysis.

Background:The novel coronavirus pneumonia (COVID-19) has spread to >200 countries and regions. There is no effective antiviral drug for COVID-19. Traditional Chinese medicine, such as Lianhua Qingwen, has achieved some curative effect in many countries, but its effect is not clear. We aim to assess the efficacy and safety of Lianhua Qingwen combined with Conventional antiviral Western Medicine in Clinical treatment of COVID-19 or asymptomatic infection.Methods:The following electronic bibliographic databases will be searched to identify relevant studies: CNKI, CBM, VIP and Wanfang databases, PubMed, EMBASE, MEDLINE, Cochrane central, and clinical trial registration centers, such as China Clinical Trial Registration Center (ChiCTR), Netherlands National Trial Registration Center (NTR) and clinical trials.gov. In addition, Manual retrieval of articles, conference papers, ongoing experiments, internal reports, among others, to supplement electronic retrieval. Select all eligible studies published before May 8, 2020.According to the Cochrane Handbook “bias risk” assessment tool, bias risk is independently assessed. The independent Newcastle Ottawa scale was used to conduct methodological quality assessment of nonrandomized trials. STATA15.1 and RevMan5.3 software were used to analyze meta outcomes of different intervention measures for the treatment of new crown pneumonia and the control group (conventional antiviral western medicine treatment) clinical efficacy.Results:This study will provide a relatively high-quality synthesis of current evidence of Lianhua Qingwen combined with Conventional antiviral Western Medicine in the treatment of COVID-19 from several aspects including the Clinical effective rate, CT improvement rate, severe conversion rate, antipyretic time, disappearance rate of fever symptoms, disappearance rate of cough symptoms, disappearance rate of asthenia symptoms, and adverse drug events.Conclusion:The conclusion of this review will provide evidence to judge whether Lianhua Qingwen combined with Conventional antiviral Western Medicine is an effective and safe intervention for COVID-19.Ethics and dissemination:This systemic review will evaluate the efficacy and safety of Lianhua Qingwen combined with Conventional antiviral Western Medicine in the treatment of COVID-19. Since all the data included are published, the systematic review does not need ethical approval.INPLASY registration number:INPLASY202060067

Evaluation of rehabilitation effect of five-step exercises on patients with radiculopathy of cervical vertebra.

Among all types of cervical spondylitis, cervical spondylitis radiculopathy (CSR) has the highest incidence. The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life. This study proposes to improve the recovery rate of patients with CSR, delay the recurrence, improve the symptoms of patients, and improve the quality of life of patients through the rehabilitation and exercise of five-step cervical vertebra exercises. For 90 patients with CSR that met the inclusion criteria, SPSS 23.0 software random number generator was used to randomly divide the patients into an experimental group and control group, with 45 cases in each group. The control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises on the basis of elementary nursing measures. The rehabilitation effect of five-step exercises on CSR patients was evaluated by Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM) before and after intervention. The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchproj.aspx) and in peer-reviewed journals or academic conferences. This study will examine the feasibility and preliminary effects of five-step exercises for the treatment of patients with CSR. This protocol was registered in Clinical Trials platform with the number ChiCTR1900027299.

Prevalence and clinical demography of hyperhomocysteinemia in Han Chinese patients with schizophrenia

Previous studies have shown that high homocysteine worsens the occurrence, symptoms, and prognosis of patients with schizophrenia. The purpose of this study was to evaluate the prevalence, clinical correlation, and demographic characteristics of hyperhomocysteinemia in Han Chinese schizophrenia patients. In this study, we enrolled 330 schizophrenia patients and 190 healthy controls. Positive and Negative Syndrome Scale (PANSS) was used to evaluate the psychiatric symptoms of patients with schizophrenia. The plasma homocysteine level was measured by the enzyme cycle method and the concentration of homocysteine > 15μmol/L was defined as hyperhomocysteinemia. The prevalence of hyperhomocysteinemia in Han Chinese schizophrenia patients and healthy controls was 55.05% and 26.98%, respectively. Schizophrenia patients with hyperhomocysteinemia had more male proportion, older age, higher smoking rate, lower HDL level, higher PANSS total score, and higher negative factor than those patients without hyperhomocysteinemia. Binary logical regression result showed that gender and age were the independent risk factors of hyperhomocysteinemia. Han Chinese patients with schizophrenia had high prevalence hyperhomocysteinemia than healthy controls, and elderly male patients have a higher risk of hyperhomocysteinemia. This study was registered in the China Clinical Trial Registration Center (chiCTR 1800017044).

Analysis of differential metabolites in lung cancer patients based on metabolomics and bioinformatics.

Aim: Based on metabonomics, the metabolic markers of lung cancer patients were analyzed, combined with bioinformatics to explore the underlying disease mechanism. Materials & methods: Based on case-control design, using UPLC-Q-TOF/MS, urine metabolites were detected in discovery and validation set. Multivariate statistical analysis were performed to identify potential markers for lung cancer. A network analysis was constructed to integrate lung cancer disease targets with the above metabolic markers, and its possible mechanism and biological significance were explained. Results: A total of 35 potential markers were identified, 11 of which overlapped. Five key markers have a good linear correlation with serum biochemical indicators. Conclusion: The occurrence and development of lung cancer are closely related to disturbance of D-Glutamine and D-glutamate metabolism, amino acid imbalance. This test was registered on China clinical trial registration center (www.chictr.org.cn/index.aspx), registration number was ChiCTR1900025543.

A mixed methods study to evaluate the effects of a teamwork enhancement and quality improvement initiative on nurses' work environment.

To test the effect of a teamwork enhancement and quality improvement program named 'Nurturing Effective Teams and Continuous Quality Improvement' on nurses' work environments in the hospital setting. Mixed-method study with quasi-experimental controlled trial and focus group interviews. Twelve units from two Philippine tertiary government hospitals will be matched and allocated to have 72 nurses receiving the teamwork enhancement and quality improvement program, or no intervention. The program focuses on enhancing the nurse autonomy, leadership and management support, teamwork, and workload management, delivered in two phases: (a) teamwork enhancement training using team strategies and tools to enhance the performance and patient safety; and (b) implementation of quality improvement projects using the model for improvement to identify priority unit issues and change ideas and tested using the Plan-Do-Study-Act cycle. The 6-month implementation includes two trainings and seven mentoring sessions with a quality improvement facilitator. Primary outcome is the nurses' work environment and secondary outcomes are job satisfaction, burnout risk, turnover intention, and perceived quality of care provided measured at the nurse-level using self-administered survey and measured at 0, 3, and 6months. Focus group interviews will be conducted among 14-16 nurse subjects to explore their experience during the program, while other stakeholders will be interviewed to reflect the program effects. Generalized equation modelling will be used to identify the program effects on the quantitative outcomes and content analysis will be used for qualitative data. Establishing measures to improve the nurses' work environments can be used to address poor nurse outcomes in high workload and low-resource settings. A favourable nurse work environment is the cornerstone to sustainable nursing workforce and positive outcomes. This study will provide explicit evidence to inform the effect of a structured evidence-based protocol in improving nurses' work environment given resource-limited context. China Clinical Trial Registration Center (CciCTR), Registration number ChiCTR1900021754 (March 8, 2019).

Ultrasound cardiac output monitor and thermodilution for cardiac function monitoring in critical patients: a Meta-analysis

To assess the differences between ultrasound cardiac output monitor (USCOM) and thermodilution (TD) systematically in cardiac function monitoring of critically ill patients. The Chinese and English literatures about the clinical trials which using USCOM and TD to monitor cardiac function published in CNKI, Wanfang database, China biomedical literature database, VIP database, China Clinical Trial Registration Center, PubMed, Embase and Cochrane Library were searched by computer from the establishment to December 2018. Some indicators, like cardiac output (CO), cardiac index (CI), stroke volume (SV) and other parameters were used to evaluate cardiac function. Literature search, quality evaluation and data extraction were conducted independently by two authors. The tailored Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) was used for literature quality evaluation. EndNote X6 was used for literature screening and management. RevMan 5.3 was used for Meta-analysis. Funnel chart analysis was used for publication bias. A total of 26 studies involving 772 patients were included. Among them, there were 5 literatures found that the agreements of cardiac function between the USCOM and TD methods were poor. Meta-analysis showed that there was no significant difference between the two methods in CO and CI monitoring [CO: mean difference (MD) = -0.06, 95% confidence interval (95%CI) was -0.17 to 0.05, P = 0.31; CI: MD = -0.04, 95%CI was -0.13 to 0.05, P = 0.38]. Subgroup analysis of different TD methods [pulmonary artery catheter (PAC), pulse indicator continuous cardiac output (PiCCO)] and different windows of USCOM ultrasonic probe [aorta (AA), pulmonary artery (PA)] in CO monitoring was not shown significant difference yet (PAC: MD = -0.07, 95%CI was -0.18 to 0.04, P = 0.23; PiCCO: MD = 0.09, 95%CI was -0.31 to 0.50, P = 0.65; AA windows: MD = -0.14, 95%CI was -0.31 to 0.02, P = 0.09; PA windows: MD = -0.00, 95%CI was -0.15 to 0.14, P = 0.95; AA/PA windows: MD = 0.23, 95%CI was -0.40 to 0.86, P = 0.47). However, the difference in SV was statistically significant between the USCOM and TD method (MD = 1.48, 95%CI was 0.04 to 2.92, P = 0.04). Funnel chart showed that the literature distribution of CO and CI monitoring were basically symmetrical, indicating that the bias of literature publication is small. USCOM has good consistency with TD method in monitoring the cardiac function parameters of CO and CI, and different windows of ultrasonic probe of USCOM have no significant influence on the monitoring results, but there is significant difference in the consistency of the two methods in SV monitoring.

Ultrasound assessment of tensile stress in carotid arteries of healthy human subjects with varying age

BackgroundArterial remodeling is thought to reflect the adaptation of the vessel wall to mechanical and hemodynamic stimuli and contributes to the progression of cardiovascular and cerebrovascular diseases. Tensile stress (TS) is one of the mechanical properties of the artery wall. The purpose of this study was to investigate the tensile stress change (TS) of carotid artery with varying viscoelasticity in healthy subjects within two groups of different ages.MethodsForty-five subjects were recruited and randomly assigned into the group at the age above 50 years and below 50 years. The carotid arteries were examined by ultrasonography, using the techniques of shear wave elastography (SWE), shear wave dispersion (SWD) and radiofrequency (RF) -based ultrasound. The following values, including elastic modulus (SWER) and viscous index (SWDR), as well as the peak and mean TS of the left and right carotid arteries (L-PTS, R-PTS, L-MTS and R-MTS) were measured. The correlations between SWER, SWDR and tensile stress were evaluated.ResultsThe SWER and SWDR of carotid arteries are lower in the subjects ≥50 years old than the subjects younger than 50 years (SWER, 10.29 ± 9.57 kPa VS 17.24 ± 14.07 kPa; SWDR, 11.99 ± 3.51 (m/s)/kHz VS 13.97 ± 3.71 (m/s)/kHz, P < 0.05). The R-PTS was lower in the group with younger age (P < 0.05). Pearson correlation analysis showed that SWER of carotid artery was positively correlated with the parameters of tensile stress, R-PTS, R-MTS, L-PTS and L-MTS(r = 0.218, r = 0.359, r = 0.209 and r = 0.369, respectively, P < 0.05). However, SWDR of carotid arteries was not significantly associated with TS.ConclusionUltrasonic shear wave imaging could be used to quantitatively assess carotid viscoelasticity. The carotid TS was related to its elasticity while little related to its viscosity, suggesting that mechanical properties of the arterial wall might be better revealed.Trial registrationDate of our trial registration: 2018-06-11. Registered with the official website of China Clinical Trial Registration Center (ChiCTR1800016590)