Association Between Herpes Simplex Virus II Infection and Rheumatoid Arthritis in US Adults: A Population-Based Propensity Score-Matching Study.

BACKGROUND/OBJECTIVE: The potential correlation between herpes simplex virus (HSV) and human papillomavirus (HPV) infections and rheumatoid arthritis (RA) has not been definitively established. Further research is needed to determine the relationship between the development of RA and the presence of these viral infections. METHODS: A case-control study was conducted with data from the National Health and Nutrition Examination Survey between 2009 and 2014. Our analysis examined the association between HSV I, HSV II, HPV oral polymerase chain reaction (PCR), HPV vaginal PCR, and RA. We identified adults aged 20 to 49 years with a primary diagnosis of RA using the National Health and Nutrition Examination Survey database codes (MCQ191 = 1 [years 2009-2010]; MCQ195 = 2 [years 2011-2014]) and excluded patients with incomplete data on key variables and primary outcomes. RESULTS: The study included 8620 patients, with 150 patients diagnosed with RA and 1500 patients without RA. Patients with RA had a significantly higher prevalence of HSV II infection compared with those without RA (36.34% vs. 24.72%, p = 0.015) after propensity score matching. No significant differences were observed for HSV I, HPV oral PCR, and HPV vaginal PCR between the 2 groups. Patients with RA were older; were more likely to be female, obese, and non-Hispanic White; and had a higher prevalence of comorbidities than those without RA. CONCLUSIONS: This population-based propensity score-matching study provides evidence of an association between HSV II infection and RA in US adults. Further research is needed to fully elucidate the relationship between viral infections and RA, with the aim of developing effective risk reduction strategies and innovative treatments for RA.

Application of Bispectral Index System (BIS) Monitor to Ambulatory Pediatric Dental Patients under Intravenous Deep Sedation.

Purpose Intravenous sedation has been well accepted to allow dental restoration in uncooperative children while avoiding aspiration and laryngospasm; however, intravenous anesthetics such as propofol may lead to undesired effects such as respiratory depression and delayed recovery. The use of the bispectral index system (BIS), a monitoring system reflective of the hypnotic state, is con-troversial in the reduction in the risk of respiratory adverse events (RAEs), recovery time, the in-travenous drug dosage, and post-procedural events. The aim of the study is to evaluate whether BIS is advantageous in pediatric dental procedures. Methods A total of 206 cases, aged 2-8 years, receiving dental procedures under deep sedation with propofol using target-controlled infusion (TCI) technique were enrolled in the study. BIS level was not monitored in 93 children whereas it was for 113 children, among which BIS values were maintained between 50-65. Physiological variables and adverse events were recorded. Statistical analysis was conducted using Chi-square, Mann Whitney U, Independent Samples t and Wilcoxon signed tests, with a p value of <0.05 considered to be statistically significant. Results Although no statistical significance in the post-discharge events and total amount of propofol used was observed, a clear significance was identified in periprocedural adverse events (hypoxia, apnea, and recurrent cough, all p value < 0.05) and discharge time (63.4 ± 23.2 vs. 74.5 ± 24.0 min, p value < 0.001) between these two groups. Conclusions The application of BIS in combination with TCI may be beneficial for young children undergoing deep sedation for dental procedures.

A Retrospective Comparison of Three Patient-Controlled Analgesic Strategies: Intravenous Opioid Analgesia Plus Abdominal Wall Nerve Blocks versus Epidural Analgesia versus Intravenous Opioid Analgesia Alone in Open Liver Surgery.

Background: Adequate pain control is of crucial importance to patient recovery and satisfaction following abdominal surgeries. The optimal analgesia regimen remains controversial in liver resections. Methods: Three groups of patients undergoing open hepatectomies were retrospectively analyzed, reviewing intravenous patient-controlled analgesia (IV-PCA) versus IV-PCA in addition to bilateral rectus sheath and subcostal transversus abdominis plane nerve blocks (IV-PCA + NBs) versus patient-controlled thoracic epidural analgesia (TEA). Patient-reported pain scores and clinical data were extracted and correlated with the method of analgesia. Outcomes included total morphine consumption and numerical rating scale (NRS) at rest and on movement over the first three postoperative days, time to remove the nasogastric tube and urinary catheter, time to commence on fluid and soft diet, and length of hospital stay. Results: The TEA group required less morphine over the first three postoperative days than IV-PCA and IV-PCA + NBs groups (9.21 ± 4.91 mg, 83.53 ± 49.51 mg, and 64.17 ± 31.96 mg, respectively, p < 0.001). Even though no statistical difference was demonstrated in NRS scores on the first three postoperative days at rest and on movement, the IV-PCA group showed delayed removal of urinary catheter (removal on postoperative day 4.93 ± 5.08, 3.87 ± 1.31, and 3.70 ± 1.30, respectively) and prolonged length of hospital stay (discharged on postoperative day 12.71 ± 7.26, 11.79 ± 5.71, and 10.02 ± 4.52, respectively) as compared to IV-PCA + NBs and TEA groups. Conclusions: For postoperative pain management, it is expected that the TEA group required the least amount of opioid; however, IV-PCA + NBs and TEA demonstrated comparable postoperative outcomes, namely, the time to remove nasogastric tube/urinary catheter, to start the diet, and the length of hospital stay. IV-PCA with NBs could thus be a reliable analgesic modality for patients undergoing open liver resections.

Associations Between Sarcopenia, Heart Failure and Myocardial Infarction in Patients With Systemic Lupus Erythematosus and Rheumatoid Arthritis.

Objectives: To evaluate associations between sarcopenia, type of autoimmune disease and risk of heart failure (HF) and myocardial infarction (MI) in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). Methods: In this population-based, cross-sectional study, discharge data from the 2005-2014 US Nationwide Inpatient Sample (NIS) of hospitalized patients with SLE or RA were extracted and analyzed. Univariate and multivariable regression analyses were conducted to determine associations between sarcopenia, type of autoimmune disease and risk of HF/MI. Results: After exclusions, 781,199 hospitalized patients diagnosed with SLE or RA were included. Among the study cohort, 127,812 (16.4%) were hospitalized with HF, and 12,781 (1.6%) were hospitalized with MI. Sarcopenia was found in only 0.1% of HF/MI patients. Logistic regression analyses revealed that sarcopenia was not significantly associated with presence of either HF or MI. Patients with RA had significantly lower odds of HF than SLE patients (aOR = 0.77, 95%CI: 0.76, 0.79) or MI (aOR = 0.86, 95%CI: 0.82, 0.91). Conclusion: In the US, among hospitalized adults diagnosed with SLE or RA, patients with RA are significantly less likely to have HF or MI than those with SLE. Whether sarcopenia leads to increased HF or MI remains inconclusive. Further studies are warranted to investigate the pathophysiology underlying discrepancies between RA and SLE regarding risk for MI or HF.

Performance of two frailty screening tools among patients with cancer in Taiwan.

BACKGROUND: Comprehensive Geriatric Assessment (CGA) is the gold standard for detecting frailty in elderly patients with cancer. Since CGA is time- and resource-consuming, many alternative frailty screening tools have been developed; however, it remains unknown whether these tools are suitable for older and adult patients with cancer. Therefore, we used the data collected for a large longitudinal study to compare the diagnostic performances of two frailty screening tools (Geriatric 8 [G8] and Flemish version of the Triage Risk Screening Tool [fTRST]) to identify frailty risk profile among patients with cancer. METHODS: Patients aged ≥20 years with newly diagnosed cancer were enrolled. Frailty screening with G8, fTRST, and CGA were performed before anti-cancer treatment. Diagnostic characteristics obtained using G8 and fTRST were analyzed by C-index, and the validity of G8 and fTRST was also determined. RESULTS: 40.9% of the 755 patients with cancer displayed frailty on CGA. Both G8 and fTRST showed high sensitivity (80.6-88.4%) and negative predictive value (81.0-81.2%). The C-index of G8 was higher than that of fTRST (0.77 vs 0.71, p = .01). Moreover, the best G8 and fTRST cut-off points were ≤13 and ≥ 2, respectively. The validities of G8 and fTRST were also confirmed; however, frailty age differences were not observed in our study. CONCLUSION: Frailty is a common problem for patients with cancer, and routine frailty screening is essential for both older and adult patients. G8 and fTRST are simple and useful frailty screening tools, while G8 is more suitable than fTRST for Taiwanese patients with cancer.

Herbal Formula SS-1 Increases Tear Secretion for Sjögren's Syndrome.

Background: Sjögren's syndrome (SS) is an autoimmune inflammatory disease that primarily affects the exocrine glands, leading to glandular dysfunction. The hallmark symptoms of SS are dry eyes and mouth, compromising the quality of life of patients and decreasing their capacity to perform their daily activities. Objective: This study aims to evaluate the efficacy of the herbal formula SS-1 for its potential therapeutic benefits for patients with Sjögren's syndrome. Materials and Methods: The bioactivity profile of SS-1 was determined using four different SS-1 concentrations across 12 human primary cell systems of the BioMAP profile. After that, a randomized, double-blind, crossover, placebo-controlled trial was performed including 57 patients treated with SS-1 for 28 weeks. Results: Biologically multiplexed activity profiling in cell-based models indicated that SS-1 exerted anti-proliferative activity in B cells and promoted anti-inflammatory and immunomodulatory activity. In the clinical trial, Schirmer's test results revealed significant improvements in both eyes, with increases of 3.42 mm (95% CI, 2.44-4.41 mm) and 3.45 mm (95% CI, 2.32-4.59 mm), respectively, and a significant reduction in artificial tear use, which was -1.38 times/day, 95% CI, -1.95 to -0.81 times/day. Moreover, the increases in B-cell activating factor (BAFF) and B-cell maturation antigen (BCMA) levels were dampened by 53.20% (295.29 versus 555.02 pg/ml) and 58.33% (99.16 versus 169.99 pg/ml), respectively. Conclusion: SS-1 treatment significantly inhibited B-cell maturation antigen. No serious drug-related adverse effects were observed. Oral SS-1 administration may be a complementary treatment for Sjögren's syndrome.

Increased FIO2 influences SvO2 interpretation and accuracy of Fick-based cardiac output assessment in cardiac surgery patients: A prospective randomized study.

INTRODUCTION: The study aimed to reveal how the fraction of inspired oxygen (FIO2) affected the value of mixed venous oxygen saturation (SvO2) and the accuracy of Fick-equation-based cardiac output (Fick-CO). METHODS: Forty two adult patients who underwent elective cardiac surgery were enrolled and randomly divided into 2 groups: FIO2 < 0.7 or >0.85. Under stable general anesthesia, thermodilution-derived cardiac output (TD-CO), SvO2, venous partial pressure of oxygen, hemoglobin, arterial oxygen saturation, arterial partial pressure of oxygen, and blood pH levels were recorded before surgical incision. RESULTS: Significant differences in FIO2 values were observed between the 2 groups (0.56 ±â€Š0.08 in the <70% group and 0.92 ±â€Š0.03 in the >0.85 group; P < .001). The increasing FIO2 values lead to increases in SvO2, venous partial pressure of oxygen, and arterial partial pressure of oxygen, with little effects on cardiac output and hemoglobin levels. When comparing to TD-CO, the calculated Fick-CO in both groups had moderate Pearson correlations and similar linear regression results. Although the FIO2 <0.7 group presented a less mean bias and a smaller limits of agreement, neither group met the percentage error criteria of <30% in Bland-Altman analysis. CONCLUSION: Increased FIO2 may influence the interpretation of SvO2 and the exacerbation of Fick-CO estimation, which could affect clinical management. TRIAL REGISTRATION: ClinicalTrials.gov ID number: NCT04265924, retrospectively registered (Date of registration: February 9, 2020).

Incidence, Patient-Related Risk Factors, and Outcomes of Postoperative Pneumonia after Cholecystectomy: A Population-Based Cohort Study.

BACKGROUND: Cholecystectomy is one of the most common surgical procedures performed worldwide. The objective of this large, population-based cohort study is to explore the risk factors of pneumonia after cholecystectomy in Taiwan. METHODS: From the Taiwanese National Health Insurance Research Database, we selected all patients who underwent cholecystectomy by using ICD-9-codes, from January 1, 1998, to December 31, 2016. The patients were separated into two groups based on the presence or absence of postoperative pneumonia. Basic information, comorbidities, and postoperative complications were evaluated using a t-test or chi-square test. There were 6056 patients in the pneumonia group and 24224 patients in the control group. These two groups were shown in a ratio of 1 : 4 and were matched by age and sex. The log-rank test was used to examine differences in postoperative mortality between patients with and without pneumonia. Preoperative risk factors were analyzed using logistic regression analysis, after adjusting for age and sex. RESULTS: The final dataset included 282184 cholecystectomy patients. Of these patients, 6056 (2.15%) had postoperative new-onset pneumonia. The patient-related risk factors for pneumonia after cholecystectomy in the order of relevance were chronic obstructive pulmonary disease, congestive heart failure, cerebrovascular disease, diabetes mellitus, surgical type, hemodialysis, coronary artery disease, and liver cirrhosis. Compared to patients without postcholecystectomy pneumonia, those with postcholecystectomy pneumonia had higher rates of mortality (within first month, 1.72% vs. 2.28%, P < 0.005) and admission to intensive care unit (15.02% vs. 41.80%, P < 0.0001) and longer hospital stays (10.71 vs. 18.55 days, P < 0.0001). CONCLUSION: Our results show that postcholecystectomy associated with pneumonia had higher rates of morbidity and mortality in this clinical population. Early identification and possible management of risk factors for pneumonia could improve outcomes of cholecystectomy and lower the risk for patient comorbidities after surgery.

Effect of Mycophenolate Mofetil Therapy on Recurrence of Hepatocellular Carcinoma after Liver Transplantation: A Population-Based Cohort Study.

Hepatocellular carcinoma (HCC) recurrence after liver transplantation is associated with immunosuppressants. However, the appropriate immunosuppressant for HCC recipients is still debated. Data for this nationwide population-based cohort study were extracted from the National Health Insurance Research Database of Taiwan. A total of 1250 liver transplant recipients (LTRs) with HCC were included. We analyzed the risk factors for post-transplant HCC recurrences. Cumulative defined daily dose (cDDD) represented the exposure duration and was calculated as the amount of dispensed defined daily dose (DDD) of mycophenolate mofetil (MMF). The dosage effects of MMF on HCC recurrence and liver graft complication rates were investigated. A total of 155 LTRs, having experienced post-transplant HCC recurrence, exhibited low survival probability at 1-, 3-, 5-, and 10-year observations. Our results demonstrated increased HCC recurrence rate after liver transplantation (p = 0.0316) following MMF administration; however, no significant increase was demonstrated following cyclosporine, tacrolimus, or sirolimus administration. Notably, our data demonstrated significantly increased HCC recurrence rate following MMF administration with cDDD > 0.4893 compared with cDDD ≤ 0.4893 or no administration of MMF (p < 0.0001). MMF administration significantly increases the risk of HCC recurrence. Moreover, a MMF-minimizing strategy (cDDD ≤ 0.4893) is recommended for recurrence-free survival.

A panel of biomarkers in the prediction for early allograft dysfunction and mortality after living donor liver transplantation.

Early allograft dysfunction (EAD) is associated with graft failure and mortality after living donor liver transplantation (LDLT). In this study, we report biomarkers superior to other conventional clinical markers in the prediction of EAD and all-cause in-hospital mortality in LDLT patient cohort. Blood samples of living donor liver transplant recipients were collected on postoperative day 1 and analyzed by liquid chromatography coupled with mass spectrometry (LC-MS). Significant metabolites associated with the prediction of EAD were identified using orthogonal projection to latent structures-discriminant analysis (OPLS-DA). A few lipids, more specifically, lysoPC (16:0), PC (18:0/20:5), betaine and palmitic acid (C16:0) were found to effectively differentiate EAD from non-EAD on postoperative day 1. A combination of these four metabolites showed an AUC of 0.821, which was further improved to 0.846 by the addition of a clinical parameter, total bilirubin. The panel exhibits a high prognostic accuracy in prediction of all-cause in-hospital mortality and mortality within 7 postoperative days with AUCs of 0.843 and 0.954. These results show the combination of metabolomics-derived biomarkers and clinical parameters demonstrates the power of panels in diagnostic and prognostic evaluation of LDLT.

A preinstalled nasopharyngeal airway in the right nasal passageway to facilitate nasogastric intubation in anesthetized and intubated patients: a prospective randomized controlled trial.

BACKGROUND: Nasogastric intubation (NGI) is usually challenging in patients under general anesthesia, with reported success rate at the first attempt to be less than 50%. The aim of this study was to investigate whether a preinstalled nasopharyngeal airway (NPA) in the right nasal passageway can facilitate NGI in anesthetized and intubated patients. METHODS: A prospective randomized controlled trial including 108 patients scheduled for elective intra-abdominal surgeries requiring a nasogastric tube (NGT) was conducted. Fifty-three patients were randomized to receive NGI through a preinstalled NPA in the right nasal passageway (Group NPA) and 55 patients to receive NGI via the right nostril (Group O). The primary outcomes were success rates of NGI at first attempt, success rates of NGI in accumulative attempts, durations of successful NGI at the first attempt and success rates of NGI for the rescuing methods. The secondary outcomes were bleeding incidence and hemodynamic changes induced by NGI. RESULTS: Success rate of NGI at the first attempt was 83.0% in Group NPA compared with 47.3% in Group O [P < 0.001; absolute risk reduction (ARR) = 35.7%, 95% confidence interval (CI) = 19.1-52.4%; relative risk reduction (RRR) = 67.8%] and success rate of NGI in accumulative attempts (two attempts maximum) was 88.7% in Group NPA compared with 63.6% in Group O (P = 0.002; ARR = 25.0%, 95% CI = 9.7-40.4%; RRR = 68.9%). Duration for NGI successful at the first attempt in Group NPA was significantly longer than that in Group O (56.3 vs. 27.1 s; P < 0.001; Mean difference = 29.2 s, 95% CI = 20.0-38.4 s). Neither bleeding incidence nor hemodynamic response is significantly different between the two study groups. CONCLUSIONS: The study indicates a preinstalled NPA in the right nasal passageway facilitates NGI in anesthetized and intubated patients as an initial NGI method and as a rescuing method for patients undergoing two unsuccessful initial attempts of NGI without a preinstalled NPA. However, the NPA method proved to take more time than the routine method for NGI successful at the first attempt. TRIAL REGISTRATION: The study was conducted after receiving approval from Institutional Review Board of Chang Gung Memorial Hospital, Linkou branch, Taiwan (registration number 201800138A3; April 11, 2018), and the clinicaltrials.gov (NCT03697642; Principal Investigator: Ting-Yang Huang; Date of registration: October 4, 2018; https://www.clinicaltrials.gov/NCT03697642 ).

Impact of chronic kidney disease severity on causes of death after first-ever stroke: A population-based study using nationwide data linkage.

BACKGROUND: Stroke is prevalent in patients with chronic kidney disease (CKD) and is associated with high mortality, but the causes of death after stroke among different CKD stages are not well known. AIMS: We aimed to investigate whether the severity of CKD would impact on the causes of death after first-ever stroke. METHODS: This retrospective multicenter cohort study included stoke patients with CKD between 2007 and 2012. The cause of death and date of death were ascertained by linking the National Death Registry Database of Taiwan. Clinical outcomes, 1-month, and 1-year mortality rates, and major causes of death were compared according to five CKD stages (G1 to G5) in the ischemic and hemorrhagic stroke separately. RESULTS: Of these patients, 9,878 were first-ever ischemic stroke (IS) patients, and 1,387 were first-ever hemorrhagic stroke (HS) patients. Patients with CKD G5 had the highest one-year mortality rate with hazard ratio 5.28 [95%CI, 3.94-7.08] in IS and 3.03 [95%CI, 2.03-4.54] in HS when compared to G1 patients. Leading causes of one-year death after IS were stroke, cancer, and pneumonia in early (G1-3) CKD patients, while diabetes mellitus, CKD, and stroke itself contributed to the major mortality in CKD G5 patients. An inverse association between eGFR decrement and the proportion of deaths caused by stroke itself was observed in CKD G2-5 patients after IS. Stroke was the leading cause of one-year death among all CKD patients after HS. CONCLUSIONS: Asides from high mortality, late-stage CKD patients had different causes of death from early CKD patients after stroke. This study highlights the need to imply different treatment strategies in late-stage CKD post-stroke patients to improve their prognosis.

A nomogram for prediction of early allograft dysfunction in living donor liver transplantation.

Liver transplantation is the treatment of choice for end-stage liver diseases. However, early allograft dysfunction (EAD) is frequently encountered and associated with graft loss or mortality after transplantation. This study aimed to establish a predictive model of EAD after living donor liver transplantation. A total of 77 liver transplants were recruited to the study. Multivariate analysis was utilized to identify significant risk factors for EAD. A nomogram was constructed according to the contributions of the risk factors. The predictive values were determined by discrimination and calibration methods. A cohort of 30 patients was recruited to validate this predictive model. Four independent risk factors, including donor age, intraoperative blood loss, preoperative alanine aminotransferase (ALT), and reperfusion total bilirubin, were identified and used to build the nomogram. The c-statistics of the primary cohort and the validation group were 0.846 and 0.767, respectively. The calibration curves for the probability of EAD presented an acceptable agreement between the prediction by the nomogram and the actual incidence. In conclusion, the study developed a new nomogram for predicting the risk of EAD following living donor liver transplantation. This model may help clinicians to determine individual risk of EAD following living donor liver transplantation.

Diversity of sexual activity and correlates among women with gynecological cancer.

OBJECTIVE: Sexual dysfunction has been reported in women following treatment for gynecological cancer. However, the actual sexual activities adopted by these women are not well understood. The aims of this study were to (1) explore a relatively new concept, diversity of sexual activities (DSA), and (2) identify factors associated with DSA in women with gynecological cancer. METHODS: This cross-sectional study included 136 Taiwanese long-term partnered women with gynecologic cancer treated in a large medical center. DSA was measured with the Diversity of Sexual Activities Scale, which assesses the number of sexual activities adopted in the past 6 months. Covariates included sexual knowledge and sexual attitudes, perceived changes in relationships of intimacy since treatment, and demographic and clinical factors. RESULTS: The mean age of participants was 51.2 years (SD = 8.66); cancer diagnoses were cervical (50.7%), endometrial (31.6%), and ovarian (17.6%). The mean number of sexual activities was 2.88 (SD = 2.63); 29.4% of participants had no physical contact with their partners after treatment. The participants reported a significantly decreased overall satisfaction toward adopted sexual activities after cancer treatment. Lower DSA was associated with older age and receiving a combination of chemotherapy and radiotherapy. CONCLUSIONS: Cancer treatment has a significant impact on sexual activity in women with gynecological cancer. Around 30% of participants reported not having any physical contact with their partners since receiving cancer treatment. Sexual rehabilitation counseling that emphasizes alternative forms of sexual expression is suggested.

Protective effects of ischemic preconditioning against neuronal apoptosis and dendritic injury in the hippocampus are age-dependent.

Ischemic preconditioning with non-lethal ischemia can be protective against lethal forebrain ischemia. We hypothesized that aging may aggravate ischemic susceptibility and reduce brain plasticity against preconditioning. Magnetic resonance diffusion tensor imaging (DTI) is a sensitive tool to detect brain integrity and white matter architecture. This study used DTI and histopathology to investigate the effect of aging on ischemic preconditioning. In this study, adult and middle-aged male Mongolian gerbils were subjected to non-lethal 5-min forebrain ischemia (ischemic preconditioning) or sham-operation, followed by 3 days of reperfusion, and then lethal 15-min forebrain ischemia. A 9.4-Tesla MR imaging system was used to study DTI indices, namely fractional anisotropy (FA), mean diffusivity (MD), and intervoxel coherence (IC) in the hippocampal CA1 and dentate gyrus (DG) areas. In situ expressions of microtubule-associated protein 2 (MAP2, dendritic marker protein) and apoptosis were also examined. The 5-min ischemia did not cause dendritic and neuronal injury and any significant change in DTI indices and MAP2 in adult and middle-aged gerbils. The 15-min ischemia-induced significant delayed neuronal apoptosis and early dendritic injury evidenced by DTI and MAP2 studies in both CA1 and DG areas with more severe injury in middle-aged gerbils than adult gerbils. Ischemic preconditioning could improve neuronal apoptosis in CA1 area and dendritic integrity in both CA1 and DG areas with better improvement in adult gerbils than middle-aged gerbils. This study thus suggests an age-dependent protective effect of ischemic preconditioning against both neuronal apoptosis and dendritic injury in hippocampus after forebrain ischemia.

Incorporation of Astragalus polysaccharides injection during concurrent chemoradiotherapy in advanced pharyngeal or laryngeal squamous cell carcinoma: preliminary experience of a phase II double-blind, randomized trial.

PURPOSE: Concurrent chemoradiotherapy (CCRT) is one of the standard treatments for patients with advanced head and neck squamous cell carcinoma (HNSCC). However, CCRT may lead to decreased quality of life (QoL) and treatment compliance. This study aimed to determine the effects of PG2 (Astragalus polysaccharides) injection on CCRT-associated adverse events (AEs) and patients' compliance with the CCRT course. METHODS: In this phase II double-blind randomized placebo-controlled trial, PG2 injection (sterile powder form) or placebo was administrated three times per week in parallel with CCRT to patients with HNSCC. The chemotherapy regimen included 50 mg/m2 cisplatin every 2 weeks with daily tegafur-uracil (300 mg/m2) and leucovorin (60 mg/day). RESULTS: The study was terminated prematurely due to the successful launch of a newly formulated PG2 injection (lyophilized form). A total of 17 patients were enrolled. The baseline demographics and therapeutic compliance were comparable between the CCRT/PG2 and CCRT/placebo groups. During CCRT, severe treatment-associated AEs were less frequent in the CCRT/PG2 group than in the CCRT/placebo group. Furthermore, less QoL fluctuations from the baseline during CCRT were noted in the CCRT/PG2 group than in the CCRT/placebo group, with a significant difference in the pain, appetite loss, and social eating behavior. The tumor response, disease-specific survival and overall survival did not differ between the two groups. CONCLUSION: This preliminary study demonstrated PG2 injection exhibited an excellent safety profile, and has potential in ameliorating the deterioration in QoL and the AEs associated with active anticancer treatment among patients with advanced pharyngeal or laryngeal HNSCC under CCRT. Further research in patients with other cancer types or treatment modalities may widen PG2's application in clinical settings.

The impact of kidney function on colorectal cancer patients with localized and regional diseases: An observational study from Taiwan.

BACKGROUND: Impaired kidney function is associated with different diseases. However, its impact on colorectal cancer has not been clarified. In order to understand the effect of preoperative kidney function on the outcome of patients with cancer, we analyzed colorectal cancer patients with localized or regional diseases. MATERIALS AND METHODS: In total, 3731 stage I to III colorectal cancer (CRC) patients were analyzed in Chang Gung Memorial Hospital. Modification of Diet in Renal Disease (MDRD) formula was used for estimated glomerular filtration rate (eGFR). Receiver operating characteristic (ROC) analysis for kidney function cut-off value; Chi-square method, independent t test, or analysis of variance (ANOVA) method for clinicopathological factors; Kaplan-Meier method for disease-free survival (DFS); Cox proportional hazard model for multivariate analysis. RESULTS: Among colon cancer patients, low eGFR (MDRD <70) was associated with more male patients, T2 stage, patients without adjuvant chemotherapy, and patients with elevated creatinine level. Low eGFR is a significant risk factor only for stage III colon cancer (hazard ratio 1.70, 95% CI: 1.28-2.26; P < 0.001). Furthermore, postoperative adjuvant chemotherapy did not significantly increase 5-year DFS for both high and low eGFR groups in stage II patients (5 yrs DFS, 94.8% vs. 84.1%, P = 0.098 for high eGFR subgroup; and 75.0% vs. 75.8%, P = 0.379 for low eGFR subgroup). However, significant improvement of 5-yrs DFS after chemotherapy was found in low eGFR stage III colon cancer patients (64.7% vs. 39.4%, P < 0.001 for low eGFR subgroup). In contrast, no significant DFS difference was caused by chemotherapy for high eGFR stage III subgroup (70.5% vs. 63.9%, P = 0.110). CONCLUSIONS: Although low eGFR is an independent risk factor for stage III colon cancer. However, the adjuvant chemotherapy impacts on stage III colon cancer patients differently according to eGFR status.

The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial.

BACKGROUND: In Asian countries, many patients with type 2 diabetes fail to achieve controlled glycated hemoglobin (HbA1c) levels while taking several classes of oral hypoglycemic agents (OHAs). Traditional Chinese medicine could be an alternative therapeutic option for poorly controlled type 2 diabetes. YH1 is a concentrated Chinese herbal extract formula that combines Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San. This randomized, double-blind, placebo-controlled pilot study evaluated YH1 as an add-on medication for poorly controlled type 2 diabetes. METHODS: Forty-six patients with poorly controlled type 2 diabetes were randomly assigned 1:1 to the YH1 or placebo group. Before the trial, all subjects had received three or more classes of OHAs with HbA1c > 7.0% (53 mmol/mol) and a body mass index ≥ 23 kg/m2. During the 12-week trial, participants continued to take OHAs without any dose or medication changes. The primary endpoint was the percentage change in HbA1c level. Per-protocol analysis was applied to the final evaluation. RESULTS: At week 12, there was an 11.1% reduction in HbA1c from baseline and a 68.9% increase in homeostatic model assessment (HOMA) of ß cell function in the YH1 group, which also exhibited significant reductions in two-hour postprandial glucose (-26.2%), triglycerides (-29.5%), total cholesterol (-21.6%), low-density lipoprotein cholesterol (-17.4%), body weight (-0.5%), and waist circumference (-1.1%). The changes in fasting plasma glucose, HOMA insulin resistance and symptom scores were not significantly different between the YH1 and placebo groups. No serious adverse events occurred during this clinical trial. CONCLUSIONS: This pilot study indicates that YH1 together with OHAs can improve hypoglycemic action and ß-cell function in overweight/obese patients with poorly controlled type 2 diabetes. YH1 is a safe add-on medication for OHAs and has beneficial effects on weight control and lipid metabolism. A larger study population with longer treatment and follow-up periods is required for further verification.

Adjunctive statin therapy reduces intracranial hemorrhage and 1-year mortality in patients with atrial fibrillation after acute ischemic stroke: A population-based epidemiological study from Taiwan.

BACKGROUND: Atrial fibrillation (AF)-related stroke causes severe disability and poor prognosis. Adjunctive statin therapy has been recommended for atherosclerotic-related stroke but not AF-related stroke. This study investigated the effects of statin in AF patients who experienced acute ischemic stroke. METHODS: Data from patients with AF experiencing first-ever ischemic stroke between 2001 and 2010 were collected from the Taiwan National Health Insurance Research Database and categorized into non-statin and statin groups. The statin group was further divided into pre-stroke statin (those who began statin therapy before stroke) and post-stroke statin (those who began statin therapy after stroke) groups. The risks for recurrent ischemic stroke, coronary artery disease (CAD), intracranial hemorrhage (ICH), and 1-year mortality were compared among the groups. RESULTS: A total of 43,242 patients were in the non-statin, 2858 in the pre-stroke statin and 4640 in post-stroke statin groups. Comparing the risk for recurrent stroke and CAD among the three groups, the pre-stroke statin and post-stroke statin groups did not exhibit a significant difference compared with the non-statin group. In terms of ICH risk, the statin group had a lower risk for ICH (odds ratio [OR] 0.79, 95% confidence interval [CI] 0.68-0.90; p = 0.0007) compared with the non-statin group. The overall 1-year mortality in both statin subgroups was lower than that in the non-statin group (pre-stroke statin, OR 0.55 [95% CI 0.49-0.61]; p < 0.0001 versus post-stroke statin, OR 0.53 [95% CI 0.48-0.58]; p < 0.0001). CONCLUSIONS: Statin therapy reduced the risk of ICH and 1-year mortality in AF patients who experienced acute ischemic stroke.