Osteoporosis increases the fracture and mortality risk of patients and has a higher disease burden than some cancers. Therefore, global concerns regarding the prevention and treatment of osteoporosis have been raised. However, fast-aging Taiwan lacks national epidemiological data on osteoporosis in recent years. We aimed to establish and update epidemiological data on osteoporosis by analyzing national data from 2008 to 2019. We estimated the prevalence and incidence of osteoporosis in patients aged ≥50 years based on claims data from Taiwan's National Health Insurance database from 2008 to 2019. We also analyzed the key parameters of fracture care (anti-osteoporosis medication use, bone mineral density examination rate, and length of hospital stay) to understand the secular trend of management and related clinical outcomes (imminent refracture rate and mortality). The number of prevalent osteoporosis increased from 2008 to 2015 and remained constant until 2019; however, the age-standardized prevalence and incidence rates declined from 2008 to 2019 (3.77%–2.91% and 2.08%–1.02%, respectively). The overall incidence rates of hip and spine fractures decreased significantly by 34% and 27%, respectively. For patients with hip and spine fractures, the immanent refracture rates were 8.5% and 12.9% and the 1-year mortality rate remained stable at approximately 15% and 6%, respectively. The age-standardized prevalence and incidence rates decreased remarkably from 2008 to 2019, while the number of prevalent osteoporosis remained steady. Patients with hip fractures encountered a high 1-year mortality rate, while the risk of imminent refracture was notable for patients with spine fractures.
Background: The use of bisphosphonates has been reported to have potential beneficial effects on knee osteoarthritis, but existing studies have limitations. The purpose of this study was to examine the association of bisphosphonate use with the risk of undergoing total knee arthroplasty and with the consumption of pain medication among osteoporotic patients with knee osteoarthritis. Methods: We identified patients who were newly diagnosed with knee osteoarthritis among a cohort of patients with osteoporosis from 2009 to 2012 in the National Health Insurance Research Database in Taiwan. We further categorized these patients into 2 groups: those who were treated with bisphosphonates (bisphosphonate users) and those who were not treated with any anti-osteoporosis drug (nonusers). Bisphosphonate treatment adherence was calculated by the medication possession ratio (MPR) as the proportion of days of bisphosphonate treatment within a fixed duration; an MPR of ≥80% was considered high adherence. The primary and secondary outcomes of interest were undergoing total knee arthroplasty and the use of pain medication, respectively. Analyses using Cox proportional hazard models with propensity-score adjustment were performed to estimate the association between bisphosphonate use and the risk of undergoing total knee arthroplasty. The incremental change in the mean accumulated defined daily doses of pain medications among both bisphosphonate users and nonusers was calculated. Results: We identified 16,276 bisphosphonate users and 123,791 nonusers of any anti-osteoporosis drug among the patients with osteoporosis who were newly diagnosed with osteoarthritis. Bisphosphonate use was significantly associated with a decreased risk of total knee arthroplasty (adjusted hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.69 to 0.83; p < 0.001). In patients with a follow-up period of ≥24 months and an MPR of ≥80%, the effect size was significantly greater (adjusted HR, 0.66; p = 0.048). Over the 5 years of follow-up, we found a significantly greater decrease in the use of pain medication among bisphosphonate users than among nonusers (p < 0.001; Chow test). Conclusions: Among patients with osteoporosis and osteoarthritis, bisphosphonate use was associated with a significantly lower risk of total knee arthroplasty, especially in patients with high adherence and longer treatment duration. A lower consumption of pain medication was also found for bisphosphonate users among the patients with osteoporosis and osteoarthritis. Level of Evidence: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.
Summary The prevention of hepatitis B virus (HBV) reactivation during rituximab treatment for diffuse large B‐cell lymphoma (DLBCL) is important in the HBV‐endemic area. This population‐based study examines the impact of antiviral prophylaxis for DLBCL patients with HBV infections. We identified 3702 adult patients with newly diagnosed DLBCL between 2011 and 2015 receiving R‐CHOP, R‐CVP, CHOP or CVP from the Taiwan Cancer Registry. We further stratified them into three groups: HBsAg‐negative patients (HBV‐negative, N = 2921), HBV carriers who received antiviral prophylaxis (HBV + Px, N = 711), and HBV carriers who did not receive antiviral prophylaxis (HBV + No Px, N = 70). HBV + Px patients were the youngest, and 69·4% received entecavir for antiviral prophylaxis. The median overall survival (mOS) of HBV‐negative and HBV + Px patients was similar (74·23 months and not reached, respectively). However, the mOS of HBV + No Px patients was only 35·61 months ( P = 0·0028 compared with HBV + Px patients), indicating that antiviral prophylaxis improves OS in HBsAg‐positive DLBCL patients. The multivariate analysis showed that the HBV status and antiviral prophylaxis was an independent prognostic factor. In conclusion, our population‐based study illustrates the importance of antiviral prophylaxis in HBsAg‐positive DLBCL patients. Under antiviral prophylaxis, the survival of DLBCL patients with HBV infections was comparable to that of HBV‐negative patients.
Background: Though denosumab is an effective treatment for osteoporosis, the rebound effect after discontinuation has drawn investigators' attention. It includes a dramatic loss of gained bone mineral density (BMD) and an increased risk of vertebral fractures. This prospective multi-institutional randomized controlled trial aims to investigate whether zoledronate prevents loss of BMD after discontinuation of denosumab. The trial was registered as Denosumab Sequential Therapy (DST) trial in March 2019 at clinicaltrials.gov , with the identifier NCT03868033. Methods: The study is conducted at National Taiwan University Hospital and its branches. Patients who have continuously received denosumab treatment for two or more years are surveyed for eligibility. Baseline characteristics and questionnaires of life quality are recorded after recruitment. BMD, circulating levels of bone turnover markers (BTMs), including serum N-terminal propeptide of type 1 collagen (P1NP) and C-terminal telopeptide (CTX), are checked before the stratified randomization to 4 groups. Biological sex and the T-scores are used to create 4 strata. The participants in group 1 adhere to regular denosumab therapy for another 2 years. All the other patients receive on-time zoledronate treatment in the first year. The participants in group 2, 3, and 4 have on-time denosumab, on-time zoledronate and drug holiday in the second year, respectively. BMDs are checked annually. Pre-scheduled checkpoints of BTMs are also arranged. For patient safety, rescue treatment with another injection of zoledronate will be applied to the patients on drug holiday if the CTX levels raise above the pre-specified threshold, 0.573 ng/mL for women and 0.584 ng/mL for men. The primary outcomes are the percentage changes of BMDs in lumbar spine, total hip and femoral neck. The secondary outcomes include the changes of serum level of the BTMs, new osteoporotic fractures, extra zoledronate injections needed in group 4 and the differences of quality of life. Discussion: We aim to provide evidence whether zoledronate prevents bone loss after denosumab cessation. To our knowledge, the study has the largest sample size. No other randomized controlled study included all the three different treatment strategies and a positive control. It is also the first associated randomized controlled trial outside Europe.
Background: This study was designed to obtain the chemical fingerprint and to investigate the effect of Phyllanthus urinaria on telomerase activity and apoptotic pathways in the human nasopharyngeal carcinoma cell line (NPC-BM1). Materials and Methods: The polyphenol compounds in P. urinaria were investigated by HPLC/MS. Cell viability with the treatment of P. urinaria, gallic acid, ellagic acid, quercetin and cisplatin was detected by MTT assay. TUNEL assay, DNA fragmentation analysis and caspase3 activity were used to confirm apoptotic changes. Telomerase activity was determined using the TRAP assay. RNA isolation and RT-PCR were used to analyze the related genes expression. All experiments on treatments with P. urinaria from 0–3 mg/ml were carried out for 24 h. Results: 5 major compounds including gallic acid, brevifolin carboxylic acid, corilagin, phyllanthusiin C and ellagic acid were identified as a plant fingerprint by HPLC/MS. With the MTT assay, we demonstrated that P. urinaria, gallic acid and ellagic acid reduce cell viability. The apoptosis features showed DNA fragmentation and increased caspase-3 activity associated with the down-regulation of Bcl-2, but not of Bax, p53, and PCNA (proliferating cell nuclear antigen) in P. urinaria-treated NPC-BM1 cells. Furthermore, treatment of NPC-BM1 cells led to an inhibition of hTERT (human telomerase reverse transcriptase), hTP1 (human telomerase-associated protein 1) and c-myc mRNA expression and to decreased telomerase activity. Conclusion: This study suggests that P. urinaria induces the death of NPC-BM1 cells in vitro through the induction of apoptosis and inhibited telomerase activity.
Therapeutic drug monitoring (TDM) is recommended during treatment with valproic acid (VPA), as is the measurement of free VPA concentration (MfVPA). However, MfVPA is unavailable in many institutions. Based on the highly protein-bound characteristics of VPA, an albumin-adjusted formula has been proposed to predict free VPA concentration (PfVPA). Nevertheless, the factors affecting the accuracy of this formula remain unknown, as does the concordance between MfVPA and PfVPA. Adult patients receiving VPA and undergoing TDM were enrolled. Free and total serum concentration (TVPA) were categorized as subtherapeutic, therapeutic, or supratherapeutic based on the reference range of 5–15 and 50–100 μg/mL, respectively. Concordance was defined as MfVPA and PfVPA, or MfVPA and TVPA, falling within the same category. Multivariate logistic regression with generalized estimating equation was adopted to identify factors affecting concordance, and the receiver operating characteristic curve was applied to determine the cutoff values of predictors. A total of 98 data points from 51 participants were included for analysis. The concordance of MfVPA and PfVPA, and MfVPA and TVPA, was 72% and 44%, respectively. Blood urea nitrogen (BUN) (0.97 [0.95–0.99], P = 0.01) and TVPA (0.97 [0.95–0.99], P = 0.02) had a significant influence on the concordance of MfVPA and PfVPA. The cutoff values of TVPA and BUN for the accuracy of the albumin-adjusted formula were 56.4 μg/mL and 51.05 mg/dL, respectively. If MfVPA is not available, the albumin-adjusted formula should be applied before VPA dosage adjustment when TVPA is < 56.4 μg/mL and BUN is < 51.05 mg/dL.
This study analyzed the operation status of a Class III Grade I general hospital implementing single disease payment in 2020. Based on the clinical pathway, standard cost was established and the actual cost of the top five diseases that overspent was estimated. Compared with the standard cost, suggestions were put forward to set the standard cost of single disease reasonably and increase the cost control of single disease.
Abstract Background This study investigated and analyzed rectal cancer-related clinical trials registered on Chinese Clinical Trial Registry (Chi-CTR) by the end of 2018. We aimed to discuss the characteristics and developmental trends. Methods The Chi-CTR database was searched and all clinical trials related to rectal cancer extracted. The time limit for the search was from the establishment of the data library to December 31, 2018. The characteristics of registered clinical trials were then analyzed. Results A total of 70 clinical trials were retreived. Beijing, Shandong, and Guangzhou accounted for 47.1% of the total number of registered clinical trials. Sichuan and Sun Yat-sen Universities having the highest number of registrations. The registration status of the 55 trials was prospective registration. The top sources of funding were self-financing (41.4%), hospital funding (22.9%) and local finance (15.7%). Out of the 43 randomized controlled trials, 39 were either blank or missing in the blinded section. The sample size of clinical trials was high in 100 to 199 cases. Only eight of the 70 trials were multicenter clinical trials. Conclusions Relevant departments should increase the registration of clinical trials, increase the awareness of registration, and promote the development of high-quality clinical trials. At the same time, researchers should raise the awareness of clinical trial registration, and actively carry out multi-center clinical trials.
BACKGROUND Rural communities face unique challenges including limited healthcare access, financial constraints, and health disparities. These challenges result in shortages of healthcare professionals, insufficient health literacy, socio-cultural dynamics, geographical isolation, transportation difficulties, economic constraints, and inconsistent doctor-patient relationships, collectively contributing to barriers to accessing healthcare in rural areas. However, interventional research focused on overcoming barriers to access healthcare services in rural areas remains limited. OBJECTIVE This study assessed the effectiveness of a multicomponent intervention in increasing the hospital arrival and treatment rate of anti-osteoporosis medication (AOM), and the risk factors leading to the refusal of therapy in a rural community. METHODS Overall, 567 patients were randomly assigned to three groups: multicomponent integrated care (MIC), osteoporosis care only (OC), and usual care (UC). Five interventions were implemented in the MIC and OC groups: medical professionals and specialists, enhancing disease knowledge, overcoming geographic barriers, peer support, and dedicated case managers. However, only medical professionals and specialists, enhancing disease knowledge and a portion of overcoming geographic barriers were included in the UC group. RESULTS In the MIC group, 116 patients were admitted to hospital, with 85 (73.3%) visiting and 68 (58.6%) receiving AOM after interventions. In the OC group, 153 patients were referred to the hospital, of whom 124 (81 %) visited and 106 (69.3%) received AOM after intervention. However, in the UC group, only six (4.1%) visited and received AOM, of the 146 participants recommended for hospital after our screening. Significant differences were found between the MIC and UC groups regarding the proportion of patients who visited the hospital (P<.001) and those who received AOM (P<.001). Significant differences were also observed between the OC and UC groups (P<.001, P<.001, respectively). Multivariable logistic modeling identified risk factors hindering hospital visits, including male sex (odds ratio (OR) 3.54; 95% CI 1.46–8.59; P=.005), low education (OR 2.46; 95% CI 1.14–5.32; P=.02), multiple disabilities (OR 2.18; 95% CI 1.05–4.51; P=.04), and osteopenia diagnosis (OR 2.3; 95% CI 1.15–4.61; P=.02). CONCLUSIONS Our findings underscore the importance of supporting patients in accessing rural healthcare services, in addition to integrating professionals and specialists, and improving disease knowledge. We emphasize the need for multiple interventions to enhance osteoporosis treatment rates in rural communities. CLINICALTRIAL ClinicalTrials.gov NCT05104034
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