Adverse events in different administration routes of semaglutide: a pharmacovigilance study based on the FDA adverse event reporting system.

Background: With the continuously increasing incidence of type 2 diabetes, glucagon-like peptide-1 (GLP-1) receptor agonists, known for their dual benefits of effectively controlling blood glucose levels while also reducing weight and lowering cardiovascular disease risks, have been widely employed in the treatment of this condition. In recent years, semaglutide has garnered significant attention as the only injectable and orally administered glucagon-like peptide-1 receptor agonist (GLP-1RA). However, it is important to note that different routes of administration may lead to varying adverse events in patients. The aim of this study is to compare the adverse event profiles of semaglutide across different routes of administration by analyzing the adverse event reporting system of the U.S. Food and Drug Administration (FDA). The findings from this analysis will provide valuable insights for clinical practice and drug surveillance. Methods: Data was extracted from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, specifically focusing on the period from the fourth quarter of 2017 to the fourth quarter of 2023. A comparative analysis was conducted using disproportionality analysis, reporting odds ratio (ROR), and stratified analysis methods to assess and compare the signals of adverse events (AE) and the time to onset of adverse reactions associated with different routes of administration of semaglutide from 2017 to 2023. Results: A total of 22,287 adverse reaction records related to semaglutide were identified in the FAERS database. A comparative analysis was performed on 16,346 records of subcutaneous administration and 2,496 records of oral administration. Different routes of administration can lead to varying adverse reaction outcomes. Compared to oral administration, subcutaneous injection is more likely to result in adverse events related to the endocrine system. Oral administration is more likely to induce adverse events in the gastrointestinal system. Additionally, it significantly accelerates the onset of adverse reactions. The comparative analysis of all relevant results indicates that semaglutide can lead to different adverse reaction events depending on the route of administration. Furthermore, there are significant differences in the time of onset for these adverse reactions. Conclusion: Semaglutide exhibits variations in adverse reaction events and the time of onset across different routes of administration. Therefore, when selecting the route of administration for semaglutide, clinicians should consider the risk of adverse events and weigh them against the clinical benefits. Based on these considerations, appropriate guidance and recommendations can be provided to patients.

Replantation of lamina spinous process ligament complex and miniature titanium plate shaping internal fixation in the treatment of tumors in the spinal canal.

OBJECTIVE: Purpose This study aims to explore the clinical efficacy of laminospinous process ligament complex reimplantation combined with mini-titanium plate fixation in the treatment of thoracolumbar intraspinal tumors. METHODS: A retrospective analysis was performed on 43 cases of intraspinal tumors treated with thoracolumbar intraspinal tumor resection from August 2018 to March 2021, and 27 cases underwent laminospinous process ligament complex reimplantation combined with micro titanium plate shaping. Fixation (laminar replantation group), and 16 patients underwent laminectomy combined with pedicle screw internal fixation (laminectomy group). The operation time, blood loss, drainage tube removal time, cerebrospinal fluid leakage, spinal instability, and the incidence of secondary spinal stenosis were compared between the two groups. The pain VAS score, ODI score, and modified Macnab at the last follow-up were compared between the two groups. And the laminar fusion rate of the laminoplasty group was measured. RESULTS: Both groups successfully completed the surgery and obtained complete follow-up. The incidence of cerebrospinal fluid leakage and secondary spinal canal stenosis in the laminectomy group was lower than that in the laminectomy group, and the difference was statistically significant (P < 0.05). There was no statistically significant difference in the incidence of spinal instability between the two groups (P > 0.05). The operation time and intraoperative blood loss in the laminectomy group were less than those in the laminectomy group, and the drainage tube removal time was earlier than that in the laminectomy group. The difference was statistically significant (P < 0.05). At the final follow-up, there was no statistically significant difference in the pain VAS score, ODI score, and modified Macnab between the two groups (P > 0.05), but they were all significantly improved compared with preoperative ones. Fusion evaluation was conducted on the laminoplasty group. Two years after surgery, the fusion rate was 97.56% (40/41). CONCLUSIONS: The application of laminospinous process ligament complex reimplantation combined with mini titanium plate fixation during thoracolumbar intraspinal tumor resection can effectively reconstruct the spinal canal and posterior column structure, reduce the incidence of cerebrospinal fluid leakage and secondary spinal stenosis. The laminar fusion rate is high.

One-hole split endoscopy technique versus unilateral biportal endoscopy technique for L5-S1 lumbar disk herniation: analysis of clinical and radiologic outcomes.

BACKGROUND: Lumbar disk herniation (LDH) is one of the most common diseases of the spine, especially occurring in L4-5 and L5-S1 intervertebral disks, and surgery is a choice when conservative treatment is ineffective. The purpose of this study is to investigate the clinical efficacy and radiologic outcomes of one-hole split endoscopy (OSE) technique versus unilateral biportal endoscopy (UBE) technique in the treatment of L5-S1 lumbar disk herniation (LDH). METHODS: A total of 133 patients of a single center surgically treated for L5-S1 LDH between 2019 and 2021 were retrospectively included in this study, of which 70 were treated by UBE technique and the rest were treated by OSE technique. Hospitalization time, operative time, intraoperative blood loss, fluoroscopy times, incision length and related complications were recorded. Bone resection area (BRA), articular process resection rate, range of motion (ROM), sagittal translation (ST), disk height (DH), Visual Analog Score (VAS), Oswestry Disability Index (ODI) and Macnab criteria were used to evaluated the clinical efficacy. RESULTS: There was no statistically significant difference in hospitalization time or fluoroscopy times between the two groups. The operation time was shorter in the UBE group than that in the OSE group; however, the incision length was longer. Intraoperative blood loss and BRA were larger in the UBE group than in the OSE group. There was no significant difference in ROM, ST, DH, or postoperative facet resection rate between the two groups. There was no significant difference in ROM, ST, or postoperative facet resection rate compared with preoperative indicators in each group, but there was a significant difference in DH among distinct groups. At any time point, the lower back and leg VAS and ODI in each group were significantly improved compared to those before the operation, with no significant difference between the two groups. There was one case of dural tear in the UBE group. One case of transient hypoesthesia occurred in each of the two groups. The excellent-good rates of the UBE group and the OSE group were 88.6% and 90.5%, respectively. CONCLUSION: The OSE technique is an effective minimally invasive surgical option as well as the UBE technique in the treatment of L5-S1 LDH.

One-hole split endoscope technique for migrated lumbar disc herniation: a single-centre, retrospective study of a novel technique.

BACKGROUND: Lumbar disc herniation (LDH) is one of the most common diseases of the spine, and migrated LDH is a more serious type, associated with nerve root function injury or abnormality. Regarding the increasing surgery adoption of treating migrated LDH, we aimed to investigate the clinical efficacy and safety of discectomy with a novel technique-one-hole split endoscope (OSE) technique. METHODS: This was a retrospective analysis of migrated LDH treated between December 2020 and September 2021. Hospitalization time, operative duration, intraoperative blood loss, number of fluoroscopy exposures, incision length, postoperative facet preservation rate, number of excellent-good cases, lower back and leg visual analogue score (VAS), Oswestry Disability Index (ODI) and surgical complications were compared between high-grade migration group (82 cases) and low-grade migration group (148 cases). The Macnab criteria was used to evaluate the clinical outcome. The Shapiro‒Wilk test was used to test measurement data, and the χ2 test was used to test counting data. RESULTS: There was no significant difference in hospitalization time, operative duration, intraoperative blood loss, number of fluoroscopy exposures, incision length or postoperative facet preservation rate between the two groups by independent sample t test or nonparametric test. At any time point, the lower back and leg VAS and ODI of the two groups were significantly improved compared to those before the operation, but there was no significant difference between the two groups at the same time point by two-way repeated measures ANOVA. There were two cases of postoperative nerve root stimulation symptoms in the high-grade migration group and three cases in the low-grade migration group. There was one patient reoperated in the high-grade migration group. There was no significant difference in number of excellent-good cases between the two groups. The overall excellent-good rate was 89.6%. CONCLUSION: The OSE technique has the advantages of less trauma, faster recovery, complete removal of the nucleus pulposus and a satisfactory early clinical efficacy in the treatment of migrated LDH.

Scientific evidence of sodium-glucose cotransporter-2 inhibitors for heart failure with preserved ejection fraction: an umbrella review of systematic reviews and meta-analyses.

Background: It remains controversial whether sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are effective in treating heart failure with preserved ejection fraction (HFpEF). Purpose: The objective of this umbrella review is to provide a summary of the available evidence regarding the efficacy and safety of SGLT-2is for the treatment of HFpEF. Methods: We extracted pertinent systematic reviews and meta-analyses (SRs/MAs) from PubMed, EMBASE, and the Cochrane Library that were published between the inception of the database and December 31, 2022. Two independent investigators assessed the methodological quality, risk of bias, report quality, and evidence quality of the included SRs/MAs in randomized controlled trials (RCTs). We further evaluated the overlap of the included RCTs by calculating the corrected covered area (CCA) and assessed the reliability of the effect size by performing excess significance tests. Additionally, the effect sizes of the outcomes were repooled to obtain objective and updated conclusions. Egger's test and sensitivity analysis were used to clarify the stability and reliability of the updated conclusion. Results: This umbrella review included 15 SRs/MAs, and their methodological quality, risk of bias, report quality, and evidence quality were unsatisfactory. The total CCA for 15 SRs/MAs was 23.53%, indicating a very high level of overlap. The excess significance tests did not reveal any significant results. Our updated MA demonstrated that the incidence of the composite of hospitalization for heart failure (HHF) or cardiovascular death (CVD), first HHF, total HHF, and adverse events as well as the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and 6 min-walk distance (6MWD) were all substantially improved in the SGLT-2i intervention group compared to the control group. However, there was limited evidence that SGLT-2is could improve CVD, all-cause death, plasma B-type natriuretic peptide (BNP) level, or plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level. Egger's test and sensitivity analysis proved that the conclusion was stable and reliable. Conclusions: SGLT-2 is a potential treatment for HFpEF with favourable safety. Given the dubious methodological quality, reporting quality, evidence quality, and high risk of bias for certain included SRs/MAs, this conclusion must be drawn with caution. Systematic Review Registration: https://inplasy.com/, doi: 10.37766/inplasy2022.12.0083, identifier INPLASY2022120083.

Efficacy of Acupuncture in the Treatment of Essential Hypertension: An Overview of Systematic Reviews and Meta-Analyses.

Background: Acupuncture is widely used in the clinical treatment of essential hypertension (EH). This overview is aimed at summarizing current systematic reviews of acupuncture for EH and assessing the methodological bias and quality of evidence. Methods: Two researchers searched and extracted 7 databases for systematic reviews (SRs)/meta-analyses (MAs) and independently assessed the methodological quality, risk of bias, reporting quality, and quality of evidence of randomized controlled trials (RCTs) included in the SRs/MAs. Tools used included the measurement tool to assess systematic reviews 2 (AMSTAR-2), the risk of bias in systematic (ROBIS) scale, the checklist of preferred reporting items for systematic reviews and meta-analyses (PRISMA), and the grading of recommendations assessment, development, and evaluation (GRADE) system. Results: This overview included 14 SRs/MAs that use quantitative calculations to comprehensively assess the various effects of acupuncture in essential hypertension interventions. The methodological quality, reporting quality, risk of bias, and quality of evidence for outcome measures of SRs/MAs were all unsatisfactory. According to the results of the AMSTAR-2 assessment, all SRs/MAs were of low or very low quality. According to the results of the ROBIS evaluation, a few SRs/MAs were assessed as low risk of bias. According to the results of the PRISMA checklist assessment, SRs/MAs that were not fully reported on the checklist accounted for the majority. According to the GRADE system, 86 outcomes were assessed under different interventions in SRs/MAs, and 2 were rated as moderate-quality evidence, 23 as low-quality evidence, and 61 as very low-quality evidence. Limitations of the included SRs/MAs included the lack of necessary items, such as not being registered in the protocol, not providing a list of excluded studies, and not analyzing and addressing the risk of bias. Conclusion: Currently, acupuncture may be an effective and safe treatment for EH, but the quality of evidence is low, and caution should be exercised when applying this evidence in clinical practice.

Association between handgrip strength and heart failure in adults aged 45 years and older from NHANES 2011-2014.

Growing evidence indicates that handgrip strength (HGS) is a conspicuous marker for assessing some diseases affecting middle-aged and elderly individuals. However, research regarding HGS and heart failure (HF) is sparse and controversial. Hence, we aimed to investigate the association between HGS and HF among adults aged 45 years and older in the United States. In this cross-sectional study, we included 4524 adults older than 45 years who were part of the National Health and Nutrition Examination Survey. A generalized additive model was used to estimate the association between HGS and HF. Age, gender, race, income, education, body mass index, smoking status, drinking status, diabetes, hypertension, stroke, vigorous physical activity, total energy intake, total protein intake, total sugars intake, and total fat intake covariates were adjusted using multiple regression models. And further subgroup analysis was conducted. We documented 189 cases of HF, including 106 men and 83 women. HGS was negatively associated with HF after adjusting for all the covariates (odds ratio = 0.97, 95% confidence interval = 0.96-0.99; P < 0.001). Compared with the lowest quintile, the highest quintile was associated with an 82% lower incidence of HF (odds ratio = 0.18, 95% confidence interval = 0.08-0.43; P < 0.001). Subgroup analysis showed that the results remained stable. In US adults older than 45, HGS was negatively associated with HF after adjusting for covariates. This finding had the potential to draw attention to the physiological and pathological effects of decreased muscle function on HF and may influence further prospective studies with intervention trials.

A Novel Gene Signature Based on CDC20 and FCN3 for Prediction of Prognosis and Immune Features in Patients with Hepatocellular Carcinoma.

Long-term survivals of patients with hepatocellular carcinoma (HCC) remain unfavorable, which is largely attributed to active carcinogenesis. Growing studies have suggested that the reliable gene signature could act as an independent prognosis factor for HCC patients. We tried to screen the survival-related genes and develop a prognostic prediction model for HCC patients based on the expression profiles of the critical survival-related genes. In this study, we analyzed TCGA datasets and identified 280 genes with differential expressions (125 increased genes and 155 reduced genes). We analyzed the prognosis value of the top 10 dysregulated genes in HCC patients and identified three critical genes, including FCN3, CDC20, and E2F1, which were confirmed to be associated with long-term survival in both TCGA and ICGC datasets. The results of the LASSO model screened CDC20 and FCN3 for the development of the prognostic model. The CDC20 expression was distinctly increased in HCC specimens, while the FCN3 expression was distinctly decreased in HCC. At a suitable cutoff, patients were divided into low-risk and high-risk groups. Survival assays revealed that patients in high-risk groups exhibited a shorter overall survival than those in low-risk groups. Finally, we examine the relationships between risk score and immune infiltration abundance in HCC and observed that risk score was positively correlated with infiltration degree of B cells, T cell CD4+ cells, neutrophil, macrophage, and myeloid dendritic cells. Overall, we identified three critical survival-related genes and used CDC20 and FCN3 to develop a novel model for predicting outcomes and immune landscapes for patients with HCC. The above three genes also have a high potential for targeted cancer therapy of patients with HCC.

The Systemic Immune-Inflammation Index May Be a Novel and Strong Marker for the Accurate Early Prediction of Acute Kidney Injury in Severe Acute Pancreatitis Patients.

OBJECTIVE: This research was performed to investigate the correlation between acute kidney injury (AKI) and systemic immune-inflammation index (SII) in severe acute pancreatitis (SAP) patients. METHODS: The study included 218 SAP patients from Chongqing Jiangjin Center Hospital during January 2016 to October 2020. The SII was defined as platelet × neutrophil/lymphocyte ratio. After univariate analysis, logistic regression analysis was used for analyzing independent risk factors of AKI in SAP patients. Receiver operating characteristic (ROC) curve was used for analyzing the prognostic value of the SII. RESULTS: AKI occurred in 74 cases and its incidence rate was 33.9%. The median SII value of AKI patients was higher than that of patients without AKI. After multivariate analysis, SII, age, triglyceride (TG), neutrophil ratio (NEU-R), C-reactive protein (CRP), aspartate aminotransferase (AST), and serum albumin (ALB) were independent predictors of AKI. Serum ALB was an independent protective factor. The optimum threshold truncation value of SII was 2880.1*10^9/L. Compared with other inflammatory factors, SII had a better prediction efficiency. CONCLUSION: The SII, TG, NEU-R, CRP, and ALB were significant independent predictors of AKI in SAP patients. Serum TG, NEU-R, CRP, and SII were risk factors. Serum ALB was a protective factor. The SII may be a novel, simple, and strong marker for the accurate early prediction of AKI in SAP patients.

Effect of Shenmai Injection on Long-Term Prognosis of Patients with Chronic Heart Failure: A Multicenter, Large Sample Capacity, Long-Term Follow-Up Retrospective Cohort Study.

OBJECTIVE: To explore the effect of Shenmai Injection (SMI) on the long-term prognosis of patients with chronic heart failure (CHF). METHODS: The Hospital Information System was used to extract data of CHF patients, and the retrospective cohort study was conducted for analysis. In non-exposed group, standardized Western medicine treatment and Chinese patent medicine or decoction were applied without combination of SMI while in the exposed group, SMI were applied for more than 7 days. Evaluation indicators are followed with New York Heart Association functional classification (NYHA classification), left ventricular ejection fraction (LVEF), N-terminal brain natriuretic peptide precursor (NT-ProBNP), cardiogenic death and heart failure (HF) readmission. Statistical analysis includes Kaplan-Meier analysis and Cox regression which are used to explore the relationship between SMI and outcome events. RESULTS: A total of 1,211 eligible CHF patients were involved and finally 1,047 patients were followed up successfully. After treatment, the cases of NYHA classification decline in the exposed and non-exposed groups accounted for 64.30% and 43.45%, respectively; the improvement values of LVEF were 8.89% and 7.91%, respectively; the improvement values of NT-ProBNP were 909 pg/mL and 735 pg/mL, respectively. After exposure on SMI, the rates of cardiogenic death and HF readmission reduced from 15.43% to 10.18% and 38.93% to 32.37%. According to Kaplan-Meier analysis, the log-rank P value of SMI and cardiogenic death was 0.014, while the counterpart of SMI and HF readmission was 0.025. Cox regression analysis indicated that for cardiogenic death, age, cardiomyopathy, diabetes, and NYHA classification were risk factors while ß-blockers, aldosterone receptor antagonists, Chinese patent medicine/decoction and SMI were protective factors. Likewise, for HF readmission, age, cardiomyopathy, and NYHA classification were risk factors while SMI was a protective factor. CONCLUSION: Combination with SMI on the standardized Western medicine treatment can effectively reduce cardiogenic mortality and readmission rate in CHF patients, and thereby improve the long-term prognosis.

Association between hyperuricaemia and clinical pathological characteristics of patients with IgA nephropathy.

OBJECTIVE: To study the association of hyperuricaemia with clinical and pathological characteristics of patients with IgA nephropathy, and to clarify adverse effects of hyperuricaemia on the onset and progression of IgA nephropathy. METHODS: A total of 244 patients with IgA nephropathy enrolled in Jiangjin Center Hospital were divided into a group with normal serum uric acid level and a group with elevated level. Age, gender, course of disease, blood pressure, liver function, renal function, blood lipid levels, blood glucose level, 24-hour urine protein level and pathological grades were recorded. The correlations of serum uric acid level with clinical indices and pathological grades were analyzed. RESULTS: The incidence rate of IgA nephropathy complicated with hyperuricaemia was 25.4%. The two groups had significantly different course of disease, body mass index (BMI), and levels of urea nitrogen, creatinine, triglyceride and urine protein (p<0.05). The group with elevated serum uric acid level had higher Lee's grade, tubulointerstitial lesion grade and renal arteriolar lesion grade. Patients with IgA nephropathy were prone to hyperuricaemia, being closely correlated with BMI, course of disease, blood pressure, triglyceride level and renal function. High pathological grades were important indices for poor prognosis. CONCLUSIONS: The serum uric acid levels of patients with IgA nephropathy should be monitored to effectively control hyperuricaemia and to avoid its complications.

A 5-Year Survival Prediction Model for Chronic Heart Failure Patients Induced by Coronary Heart Disease with Traditional Chinese Medicine Intervention.

OBJECTIVE: This study aimed to construct a 5-year survival prediction model of coronary heart disease (CHD) induced chronic heart failure (CHF), which is supported by the traditional Chinese medicine (TCM) factor, and to verify the model. METHODS: Inpatients from January 1, 2012, to December 31, 2017, in seven hospitals in Shandong Province were studied. The random number table was used to randomly divide the seven hospitals into two groups (training set and verification set). In the training set, the least absolute shrinkage selection operator regression was first used to screen the independent variables. Logistic regression was then applied to construct a survival prediction model. The following nomogram visualizes the prediction model results. Finally, C-indices, calibration curves, and decision curves were used to discriminate and calibrate the established model and evaluate its practicability in the clinic. Bootstrap resampling and the verification set were used for internal and external verification, respectively. RESULTS: A total of 424 eligible patients were included in the model construction and verification. In this 5-year survival prediction model of patients with CHF induced by CHD, eight independent predictors were included. The series of C-indices for the training set, bootstrap resamples, and verification set was 0.885, 0.867, and 0.835, respectively, demonstrating the credibility of our model. Additionally, the receiver operating characteristic curve, calibration curve, and clinical decision curve analysis of the training and verification sets showed that this 5-year survival prediction model was good in discrimination, calibration, and clinical practicability. CONCLUSION: This work highlights eight independent factors affecting 5-year mortality in patients with CHF induced by CHD after discharge and further helps reallocate medical resources rationally by precisely identifying high-risk groups. The constructed prediction model not only plays a credible role in prediction but also demonstrates TCM intervention as a protective factor for the 5-year death of patients with CHF induced by CHD, thereby advancing the use of TCM in CHF.

Efficacy and safety of Shenfuqiangxin pills in complementary treatment of chronic heart failure: A protocol for systematic review and meta-analysis.

BACKGROUND: As the last link in the chain of cardiovascular events, chronic heart failure (CHF) has high morbidity, high mortality, and poor prognosis. It is one of the main causes of death and disability worldwide. Shenfuqiangxin Pills (SFQX) is widely used as a Chinese herbal medicine (CHM) prescription for CHF, but there is still a lack of strict evidence-based medical evidence. Therefore, we make a protocol for evaluating the efficacy and safety of SFQX for CHF. METHODS: According to the search strategy, randomized controlled trials (RCTs) of SFQX for CHF will be retrieved from 8 databases without limitation of publication date or language. First of all, the literature was screened according to the eligibility criteria, and use the Cochrane Collaboration's tool to assess the quality of the included literature. Then, using software for traditional meta-analysis. Finally, using GRADE method to assess the strength of recommendations. RESULTS: This study will evaluate the efficacy and safety of SFQX for CHF, thereby providing more evidence support for clinical decision-making in CHF. CONCLUSION: Our research will provide more references for the clinical medication of patients with CHF. PROTOCOL REGISTRATION NUMBER: INPLASY202110019.

Culture-negative versus culture-positive in pyogenic spondylitis and analysis of risk factors for relapse.

OBJECTIVES: This study aims to compare and analyze the clinical features, diagnosis, treatment and prognosis of culture-negative and culture-positive primary pyogenic spondylitis. METHODS: In a retrospective analysis, 202 cases of adult primary pyogenic spondylitis with complete clinical data in our hospital from January 2013 to January 2020 were divided into two groups according to bacterial culture results: culture negative (n = 126) and culture positive (n = 76). We compare the clinical characteristics, diagnosis, treatment and prognosis of patients with different culture results. RESULTS: The culture positive rate was 37.62% (76/202). There were no significant differences in age, gender, affected segment, spinal abscess, diabetes mellitus, course of disease, surgery, recurrence, and follow-up time between the two groups (p>.05). There were statistically significant differences in hospital admission erythrocyte sedimentation rate (ESR), admission C-reactive protein (CRP), admission white blood cell (WBC) count, discharge ESR, discharge CRP, ESR decline rate, CRP (p<.05). There were statistically significant differences in the rate of decline, hospitalization days, and body temperature ≥38 °C (p<.05). Higher CRP levels on admission, antibiotic treatment time <6 weeks, and body temperature ≥ 38 °C are independent risk factors for infection recurrence. CONCLUSIONS: The culture-negative group's admission WBC, admission ESR, admission CRP, discharge ESR, discharge CRP, ESR decline rate, CRP decline rate, and hospital stay were lower than the culture positive group, the difference was statistically significant (p<.05). The independent risk factors for infection recurrence are higher CRP levels in hospital admission, antibiotic treatment time <6 weeks, and body temperature ≥ 38 °C.

Inactive and inefficient: Warming and drought effect on microbial carbon processing in alpine grassland at depth.

Subsoils contain >50% of soil organic carbon (SOC) globally yet remain under-investigated in terms of their response to climate changes. Recent evidence suggests that warmer, drier conditions in alpine grasslands induce divergent responses in SOC decomposition and carbon accrual in top- versus subsoils. However, longer term effects on microbial activity (i.e., catabolic respiration vs. anabolic growth) and belowground carbon cycling are not well understood. Here we utilized a field manipulation experiment on the Qinghai-Tibetan Plateau and conducted a 110-day soil incubation with and without 13 C-labeled grass litter to assess microbes' role as both SOC "decomposers" and "contributors" in the top- (0-10 cm) versus subsoils (30-40 cm) after 5 years of warming and drought treatments. Microbial mineralization of both SOC and added litter was examined in tandem with potential extracellular enzyme activities, while microbial biomass synthesis and necromass accumulation were analyzed using phospholipid fatty acids and amino sugars coupled with 13 C analysis, respectively. We found that warming and, to a lesser extent, drought decreased the ratio of inorganic nitrogen (N) to water-extractable organic carbon in the subsoil, intensifying N limitation at depth. Both SOC and litter mineralization were reduced in the subsoil, which may also be related to N limitation, as evidenced by lower hydrolase activity (especially leucine aminopeptidase) and reduced microbial efficiency (lower biomass synthesis and necromass accumulation relative to respiration). However, none of these effects were observed in the topsoil, suggesting that soil microbes became inactive and inefficient in subsoil but not topsoil environments. Given increasing belowground productivity in this alpine grassland under warming, both elevated root deposits and diminished microbial activity may contribute to new carbon accrual in the subsoil. However, the sustainability of plant growth and persistence of subsoil SOC pools deserve further investigation in the long term, given the aggravated N limitation at depth.

Efficacy and safety of Qishen Yiqi dripping pills as a complementary treatment for Heart Failure: A protocol of updated systematic review and meta-analysis.

BACKGROUND: Heart failure (HF) has become a serious global public health issue due to its high incidence, high mortality and extremely low quality of life. According to several clinical trials, Qishen Yiqi Dripping pills (QSYQ) combined with routine western medicine treatment can further enhance the curative effect of HF patients. However, most of the trials are small in sample size and poor in quality, which can only provide limited evidence-based medicine. The existing systematic reviews of efficacy and safety has provided evidence for the clinical application of QSYQ to a certain extent, but there are still 3 major defects. Here, we will perform a systematic review and meta-analysis that include the randomized clinical trial (RCT) of CACT-IHF, apply meta-regression and subgroup analysis to cope with multiple confounding factors, and add the clinical efficacy standards of TCM, all-cause death and readmission rates as reliable efficacy evaluation indicators. The purpose of this study was to rigorously evaluate the clinical efficacy and safety of QSYQ in the complementary treatment of HF with a well-designed systematic review and meta-analysis. METHODS: Following the strict search strategy, 9 databases will be searched to ensure a comprehensive search. We search the database from the establishment until November 30, 2020. This study will include RCTs of QSYQ in HF patients' complementary treatment. Two searchers will independently draft and carry out the search strategy, and the third member will further complete it. Two members independently screen literature, extract data and cross-check, and solve different opinions through discussion or negotiation with the third member. The risk bias will be evaluated based on Cochrane tool of risk of bias. Meta-regression and subgroup analysis are used to check and deal with the heterogeneity. The data analysis will be conducted by the statistical software Stata 16.0. RESULTS: The results of this research will be delivered in a peer-reviewed journal. CONCLUSION: This study expects to provide credible and scientific evidence for the efficacy and safety of QSYQ in HF's complementary treatment, and at the same time provide a convenient and effective choice for decision-makers and patients. PROTOCOL REGISTRATION NUMBER: INPLASY 2020120106. ETHICAL APPROVAL: Since this study is on the basis of published or registered RCTs, ethical approval and informed consent of patients are not required.

Studies on 11 Cases of Spinal Epidural Abscess and Literature Review.

OBJECTIVE: In the present study, we aimed to describe the clinical features, diagnosis, treatment, and prognosis of spinal epidural abscess (SEA). METHODS: The complete clinical data of 11 SEA patients who were treated in our hospital system from January 2015 to June 2018 were retrospectively analyzed. Moreover, the clinical features, diagnosis, treatment, and prognosis of 642 SEA cases collected from the foreign literature from 2010 to 2019 were also investigated. RESULTS: Among our 11 SEA patients, nine cases had purulent inflammation, two cases had tuberculosis, two cases had infection caused by Staphylococcus aureus, one case had infection caused by Streptococcus constellatus, one case had infection caused by Klebsiella pneumoniae, five cases showed negative bacterial culture, and two cases had Mycobacterium tuberculosis. All 11 cases showed focal spinal pain, eight cases exhibited neurological deficits, and six cases experienced fever. Nine of the 11 cases involved the lumbosacral spine, one case involved the thoracic spine, and one case involved the cervical spine. Eight patients had a longer course of disease (>2 weeks), all 11 patients had vertebral osteomyelitis, and nine patients had intervertebral discitis. One patient had motor dysfunction of arms and legs, one patient had lower limb motor dysfunction, one patient had limb numbness, one patient experienced relapse after the conservative treatment, and one patient experienced relapse after the surgical treatment. The follow-up time was 15-24 months. CONCLUSION: The classic diagnosis of triads (focal spine pain, neurological deficit, and fever) was less specific for SEA. MRI examination, blood culture, tissue culture, and biopsy could be used for the diagnosis for SEA. Suppuritis was a common cause of SEA. Early detection, early diagnosis and early treatment, as well as the selection of the most suitable treatment regimen based on comprehensive evaluation, played crucial roles in a better prognosis of SEA. There was no statistically significant difference in terms of the general condition, diagnosis, treatment and prognosis between the patients with negative and positive culture results (P>0.05). For SEA patient with negative culture, antibiotic treatment should be used empirically.

Effect and safety of oral Chinese patent medicine for heart failure: A protocol for systematic review and network meta-analysis.

BACKGROUND: Heart failure (HF) is the terminal stage of various common cardiovascular diseases with quite a frequent readmission and a high mortality rate, and brings heavy financial burdens to families and society. Oral Chinese patent medicine (CPM) has been widely applied in the treatment of HF in China because of its simplicity, cheapness, convenience, and high efficiency. However, due to the large number and broad clinical selectivity of oral CPMs, there is a lack of uniformity and clinical application standardization. To choose more effective and safe medicine among so many oral CPMs is particularly essential for further improving the therapeutic effect. In this study, the efficacy and safety of different oral CPMs will be compared by a network meta-analysis (NMA), and the best CPM will be selected for the treatment of HF. METHODS: According to the search strategy, 4 English and 4 Chinese databases will be searched from the construction of the library to July 31, 2020. The NMA will include clinical randomized controlled trials (RCTs) of different oral CPMs in HF treatment. The methodological quality is assessed according to the bias risk assessment tool of Cochrane. The Bayesian NMA is performed by Aggregate Data Drug Information System (ADDIS), and the results are visualized using Stata 15.0 software. The GRADE approach is used to assess the quality of evidence and recommendation intensity. RESULTS: The NMA will identify the best oral CPM in the complementary treatment of HF. A peer-reviewed journal will publish the results of the study. CONCLUSION: This study can provide reliable evidence for the efficacy and safety of oral CPMs in the treatment of HF, and help decision-makers and patients to select more effective and safer oral CPM. PROTOCOL REGISTRATION NUMBER: INPLASY202090053.

Aspergillus spondylitis: case series and literature review.

BACKGROUND: Spinal fungal infections, especially spinal Aspergillus infections, are rare in the clinic. Here, we introduce the clinical features, diagnosis, treatment, and prognoses of 6 cases of Aspergillus spondylitis. METHODS: We retrospectively analysed the complete clinical data of patients with Aspergillus spondylitis treated in our hospital from January 2013 to January 2020. RESULTS: Aspergillus fumigatus was isolated in 4 cases, and Aspergillus spp. and Aspergillus niger were isolated in 1 case each. All six patients reported varying degrees of focal spinal pain; one patient reported radiating pain, one patient experienced bowel dysfunction and numbness in both lower limbs, and three patients had fever symptoms. One case involved the thoracic spine, one case involved the thoracolumbar junction, and 4 cases involved the lumbar spine. Three patients were already in an immunosuppressed state, and three patients entered an immunosuppressed state after spinal surgery. All six patients were successfully cured, and five required surgery. Of the 5 patients who underwent surgical treatment, 2 had spinal cord compression symptoms, and 3 had spinal instability. At the end of follow-up, 1 patient reported left back pain and 1 patient reported left limb numbness. CONCLUSION: The clinical manifestations of Aspergillus spondylitis are non-specific, and the diagnosis depends on typical imaging findings and microbiological and histopathological examination results. When there is no spinal instability, spinal nerve compression symptoms, or progressive deterioration, antifungal therapy alone may be considered. If spinal instability, spinal nerve compression, or epidural abscess formation is present, surgery combined with antifungal therapy is recommended.

Divergent accumulation of microbial necromass and plant lignin components in grassland soils.

The means through which microbes and plants contribute to soil organic carbon (SOC) accumulation remain elusive due to challenges in disentangling the complex components of SOC. Here we use amino sugars and lignin phenols as tracers for microbial necromass and plant lignin components, respectively, and investigate their distribution in the surface soils across Mongolian grasslands in comparison with published data for other grassland soils of the world. While lignin phenols decrease, amino sugars increase with SOC contents in all examined grassland soils, providing continental-scale evidence for the key role of microbial necromass in SOC accumulation. Moreover, in contrast to clay's control on amino sugar accumulation in fine-textured soils, aridity plays a central role in amino sugar accrual and lignin decomposition in the coarse-textured Mongolian soils. Hence, aridity shifts may have differential impacts on microbial-mediated SOC accumulation in grassland soils of varied textures.