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OBJECTIVE: To examine the correlation between ABO blood type and the incidence of lower extremity deep vein thrombosis (LEDVT) in elderly patients after hip fracture surgery, while identifying contributing factors to thrombogenesis. METHODS: We conducted a retrospective analysis of 159 elderly patients with hip fractures treated at Tianjin Hospital (Affiliated Hospital of Tianjin University) from December 2021 to December 2023. The cohort was divided into two groups: those with O blood type (45 patients) and those with non-O blood types (114 patients). We analyzed clinical data and the incidence of LEDVT between the groups. Logistic regression was used to identify independent risk factors for LEDVT, and receiver operator characteristic (ROC) curve analysis evaluated the predictive efficacy of these factors. RESULTS: The incidence of LEDVT was significantly higher in the non-O blood type group compared to the O blood type group (34.21% vs. 15.56%, P = 0.0408). Logistic regression identified high body mass index (BMI), comorbid hypertension, low platelet count (PLT), prolonged prothrombin time (PT), and non-O blood type as independent risk factors for LEDVT. The ROC curve for these predictors showed an area under the curve of 0.862, with a sensitivity of 75.22%, a specificity of 86.96%, and an accuracy of 78.62%. CONCLUSION: ABO blood type is correlated with the occurrence of LEDVT in elderly patients' post-hip fracture. Those with non-O blood type, alongside other factors such as high BMI, hypertension, low PLT, and extended PT, are at increased risk of developing LEDVT.
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BACKGROUND Deep vein thrombosis is a common pre- and post-operative complication in older patients with osteoporotic hip fractures. Pre-operative thrombus can increase the risk of surgery. This study examined the association between the time from fracture to admission (injury-admission time) and deep vein thrombosis in older patients with osteoporotic hip fractures. MATERIAL AND METHODS Doppler ultrasound screening of deep lower-extremity veins was performed in patients with osteoporotic hip fractures between June 2019 and December 2021. Clinical data, including medical history, injury-admission time, and laboratory tests, were collected retrospectively. RESULTS Of the 439 patients, deep vein thrombosis was found in 139 (31.66%). The injury-admission time was significantly longer in the thrombosis group, which was positively associated with deep vein thrombosis (odds ratio 1.010, 95% confidence interval 1.003-1.017). The area under the curve to predict deep vein thrombosis was 0.619. The best cut-off value, sensitivity, and specificity were 21 h, 46.76%, and 75%, respectively. When the injury-admission period exceeded 21 h, the prevalence of deep vein thrombosis was 45.8% and the thrombosis incidence was significantly higher than in the <21 h group (24.9%). CONCLUSIONS Our results suggest that screening for deep vein thrombosis should be routinely performed for patients with osteoporotic hip fractures, particularly for those with injury-admission time ≥21 h.
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Fracturas de Cadera , Fracturas Osteoporóticas , Trombosis , Trombosis de la Vena , Humanos , Anciano , Estudios Retrospectivos , Fracturas de Cadera/complicaciones , Factores de Riesgo , Trombosis de la Vena/complicaciones , Trombosis de la Vena/epidemiologíaRESUMEN
OBJECTIVES: The aims of the study are to understand the prevalence of osteoporosis in postmenopausal women in urban Tianjin, China and its related factors through a questionnaire and to assess the correlation between individual characteristics, physical mobility, psychological and emotional well-being, and prevalence, as well as people's awareness of osteoporosis. METHODS: We selected 240 postmenopausal women from 12 randomly selected streets in 6 administrative districts of Tianjin for bone mineral density measurement and a face-to-face questionnaire survey to obtain the relevant data. Female residents who had lived in the communities under the jurisdiction of the incorporated streets for more than 10 years and had been in menopause for 2 years were included. The women were made aware of the study, there were no communication barriers, and they were willing to undergo dual-energy absorptiometry and cooperate in completing the questionnaire. We used one-way analysis of variance, Fisher exact test, and Pearson correlation analysis for the statistical analysis. RESULTS: The overall prevalence of osteoporosis in postmenopausal women in the six districts of Tianjin was found to be 52.08%, and the χ 2 test for trend showed a clear trend of increasing with age ( P = 0.035). Body mass index was found to be the most significant personal characteristic affecting the prevalence of osteoporosis; the mean values of the nonosteoporosis and osteoporosis group were (25.45 ± 3.09) and (23.85 ± 3.16), respectively ( P < 0.001); previous fractures were closely associated with the prevalence of osteoporosis. Awareness about osteoporosis had not disseminated among the population, and 9.17% of the participants had never heard of the disease. While 75.42% and 72.92% of the participants, respectively, believe that the harm of osteoporosis cannot be compared with heart disease and cerebral infarction, 56.67% had never had an examination for osteoporosis and paid little to no attention to this disease. People still had major misconceptions about the hazards of osteoporosis and common-sense precautions that needed to be followed. CONCLUSIONS: Although osteoporosis is prevalent among postmenopausal women in urban Tianjin and is strongly linked to both history of fracture and body mass index, most women are only familiar with the disease's name and lack an understanding of the dangers it poses as well as the importance of early diagnosis and treatment. To ensure the prevention and control of osteoporosis, it is crucial to focus on increasing the examination and treatment rates and spreading awareness of the three-level diagnosis and treatment pattern among the public.
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Fracturas Óseas , Osteoporosis Posmenopáusica , Osteoporosis , Femenino , Humanos , Posmenopausia , Prevalencia , Osteoporosis/epidemiología , Densidad Ósea , Fracturas Óseas/epidemiología , China/epidemiología , Factores de Riesgo , Osteoporosis Posmenopáusica/epidemiología , Osteoporosis Posmenopáusica/diagnóstico , Absorciometría de FotónRESUMEN
Background: Although Andrographis paniculata (AP) exhibits various biological functions such as anticancer, anti-inflammatory, antimalarial, antimicrobial, antioxidant, cardioprotective and immunomodulatory, its role in estrogen deficiency-related osteoporosis remains unclear. Methods: Ovariectomy (OVX)-induced estrogen deficiency-related osteoporotic mouse models and sham mouse models were established using 8-week-old female C57BL/6J mice. Micro-computed tomography (µCT) scanning was performed to assess the skeletal phenotype. The differentiation potential of bone marrow mesenchymal stem cells (BMSCs) from the OVX and sham groups was assessed by osteogenic or adipogenic induction medium in vitro. To verify the effects of AP, alizarin red S (ARS) staining, alkaline phosphatase (ALP) staining and oil red O (ORO) staining, reverse transcription assay and quantitative real-time polymerase chain reaction were applied to detect the lineage differentiation ability of BMSCs. Results: µCT scanning showed that AP treatment attenuated the osteoporotic phenotype in OVX-induced estrogen deficiency-related osteoporotic mice. The results of ARS staining, ALP staining, ORO staining and quantitative real-time polymerase chain reaction indicated that BMSCs from OVX-induced osteoporotic mice displayed a significant reduction in osteogenic differentiation and an increase in adipogenic differentiation, which could be reversed by AP treatment. Conclusions: Our findings suggested that AP regulated the differentiation potential of BMSCs and ameliorated the development of estrogen deficiency-related osteoporosis, which might be an effective therapeutic method for estrogen deficiency-related osteoporosis.
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The current study evaluated the efficacy and safety of a denosumab biosimilar, QL1206 (60 mg), compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk. At 31 study centers in China, a total of 455 postmenopausal women with osteoporosis and high fracture risk were randomly assigned to receive QL1206 (60 mg subcutaneously every 6 months) or placebo. From baseline to the 12-month follow-up, the participants who received QL1206 showed significantly increased bone mineral density (BMD) values (mean difference and 95% CI) in the lumbar spine: 4.780% (3.880%, 5.681%), total hip :3.930% (3.136%, 4.725%), femoral neck 2.733% (1.877%, 3.589%) and trochanter: 4.058% (2.791%, 5.325%) compared with the participants who received the placebo. In addition, QL1206 injection significantly decreased the serum levels of C-terminal crosslinked telopeptides of type 1 collagen (CTX): -77.352% (-87.080%, -66.844%), and N-terminal procollagen of type l collagen (P1NP): -50.867% (-57.184%, -45.217%) compared with the placebo over the period from baseline to 12 months. No new or unexpected adverse events were observed. We concluded that compared with placebo, QL1206 effectively increased the BMD of the lumbar spine, total hip, femoral neck and trochanter in postmenopausal Chinese women with osteoporosis and rapidly decreased bone turnover markers. This study demonstrated that QL1206 has beneficial effects on postmenopausal Chinese women with osteoporosis and high fracture risk.
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Biosimilares Farmacéuticos , Conservadores de la Densidad Ósea , Osteoporosis Posmenopáusica , Osteoporosis , Femenino , Humanos , Biosimilares Farmacéuticos/efectos adversos , Densidad Ósea , Conservadores de la Densidad Ósea/uso terapéutico , Remodelación Ósea , Denosumab/uso terapéutico , Denosumab/farmacología , Método Doble Ciego , Pueblos del Este de Asia , Osteoporosis/tratamiento farmacológico , Osteoporosis Posmenopáusica/complicaciones , Osteoporosis Posmenopáusica/tratamiento farmacológico , PosmenopausiaRESUMEN
Objective: To investigate the effectiveness of a Chinese patent medicine, Jintiange capsules with the main component of artificial tiger bone powder, combined with alfacalcidol on muscle strength and balance of the lower extremities in patients with primary osteoporosis. Design: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial. Subjects and methods: A total of 400 patients diagnosed with primary osteoporosis or osteopenia were recruited and randomized into the Jintiange or control groups. During the 52-week treatment, the participants in the Jintiange group were treated with Jintiange capsules (1.2 âg each time, 3 times per day) and calcium carbonate simulant, while those in the control group were treated with calcium carbonate (element calcium 0.3 âg, twice a day) and a Jintiange capsule simulant. Alfacalcidol (0.25 âµg/d) was applied in both groups. The timed up and go test (TUG), chair rising test (CRT), and tandem gait test (TGT) were performed to evaluate balance, muscle strength and fall risk of the participants. Results: There were 154 participants in the Jintiange group, and 157 participants in the control group were included in the per-protocol set. Comparing the data at week 52 from those at baseline, the TUG time decreased from 9.60 â± â2.25 âs to 8.53 â± â2.06 âs (p â< â0.001) in the Jintiange group and decreased from 9.50 â± â1.91 âs to 9.11 â± â1.95 âs (p â< â0.001) in the control group; the CRT time decreased from 11.49 â± â4.05 âs to 8.57 â± â2.13 âs (p â< â0.001) and 11.17 â± â3.21 âs to 9.74 â± â1.98 âs (p â< â0.001) in the Jintiange and control groups, respectively; the number of correct steps in the TGT increased significantly in both the control (7.40 â± â1.27 vs. 7.69 â± â0.87, p â< â0.01) and Jintiange groups (7.21 â± â1.58 vs. 7.60 â± â1.12, p â< â0.001). At the end of the study, the TUG and CRT results in the Jintiange group were superior to those in the control group (all p value â< â0.05), while no obvious difference was found in the TGT between the two groups. At week 52, the high fall risk proportions in the Jintiange group were significantly lower than those in the control group according to TUG (3.25% vs. 9.55%, p â= â0.023) and CRT (20.78% vs. 33.76%, p â= â0.01). Conclusion: Jintiange capsules combined with alfacalcidol can effectively improve muscle strength and the balance of the lower extremities and reduce fall risk in patients with primary osteoporosis/osteopenia. The translational potential of this article: Artificial tiger bone powder, a traditional Chinese patent medicine, can improve muscle strength and balance and reduce fall risks effectively among patients with primary osteoporosis. It might be a therapeutic option for osteoporosis individuals combined with sarcopenia to improve their muscle function.
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The efficacy of generic teriparatide in improving BMD at lumbar spine in patients with osteoporosis was similar to that of alendronate. It provided a new choice for osteoporosis treatment in Chinese population. INTRODUCTION: To determine whether the efficacy of generic teriparatide is noninferior to alendronate for Chinese postmenopausal women with osteoporosis. METHODS: Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate. Primary outcome was percentage change in BMD at the lumbar spine from baseline to 48 weeks and was assessed for non-inferiority. The same outcome was further assessed for superiority as a secondary endpoint. RESULTS: Three hundred ninety-one and 196 participants were randomly assigned to the teriparatide or alendronate group, of whom 379 and 194 receiving at least one dose of teriparatide and alendronate treatment were eligible for the efficacy analysis. Teriparatide was non-inferior to alendronate for BMD change at lumbar spine (treatment difference: 0.7%, 95% CI: - 0.3 to 1.7%), which excluded the predefined non-inferiority margin of - 1.5%. However, teriparatide was not statistically superior to alendronate in improving BMD at lumbar spine (P = 0.169). At 48 weeks, changes in BMD at total hip were - 1.0% and 2.2% in teriparatide and alendronate group, respectively (P < 0.001). The incidence of new fracture showed no statistical difference between groups (P = 0.128). Serum P1NP and ß-CTX levels significantly increased in the teriparatide group and markedly decreased in alendronate group (all P < 0.001 vs baseline). The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia. CONCLUSIONS: Teriparatide was not inferior to alendronate in increasing BMD at lumbar spine in Chinese postmenopausal women, and they achieved these effects through different mechanisms.
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Conservadores de la Densidad Ósea , Osteoporosis Posmenopáusica , Osteoporosis , Alendronato/uso terapéutico , Densidad Ósea , China/epidemiología , Femenino , Humanos , Osteoporosis/tratamiento farmacológico , Osteoporosis Posmenopáusica/tratamiento farmacológico , Posmenopausia , Estudios Prospectivos , TeriparatidoRESUMEN
INTRODUCTION: To evaluate the relationship between the gut microbial composition and intestinal cholecalciferol absorption in patients with severe osteoporosis (SOP). MATERIALS AND METHODS: Eighteen patients with primary osteoporosis (OP) and 18 with SOP were included. Their clinical data were collected and their circulating concentrations of cholecalciferol and 25(OH)D3 were measured. Fecal samples were collected and their microbial contents were analyzed using 16S rDNA sequencing. RESULTS: The age, sex, body mass index, and body mass of the participants did not differ between the groups. The prevalence of gastrointestinal symptoms in the participants with SOP was significantly higher than that in the participants with OP. There were significant differences in the 25(OH)D3 and cholecalciferol concentrations between participants with SOP or OP and there was a significant positive correlation between the concentrations of these substance. The diversity of the gut microbiota in participants with SOP was significantly higher than that in participants with OP. Firmicutes was more abundant in the SOP group and the ratio of Firmicutes/Bacteroidetes in participants with SOP was higher. Conversely, Bifidobacterium was significantly less abundant, as were the order and family it belongs to. At the species level, Bifidobacterium was the most significant difference between the two groups. CONCLUSION: Differences in the intestinal microecology, especially Bifidobacterium, are associated with differences in the absorption of cholecalciferol and in the circulating 25(OH)D3 concentration, which may influence the progression of OP to SOP.
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Microbioma Gastrointestinal , Osteoporosis , Colecalciferol , Heces , Humanos , Absorción IntestinalRESUMEN
Zoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu®) showed its clinical efficacy consistency with original ZOL (Aclasta®) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu® in Chinese population. INTRODUCTION: Yigu® has been approved its bioequivalence to Aclasta®. However, the clinical efficacy and safety of Yigu® have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu® and Aclasta® in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL. METHODS: This was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5 mg Yigu® or Aclasta®. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12 months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12 months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6 months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups. RESULTS: A total of 458 postmenopausal women with osteoporosis were enrolled (n = 227, Yigu®; n = 231, Aclasta®). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu® and Aclasta® groups after 12 months of treatment. The mean difference of BMD change at the lumbar spine after 12 months between two groups was 0.15% (95% CI: - 0.71 to 1.00, equivalence margin: - 1.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and ß-CTX showed no difference between two groups after 14 days and 6 and 12 months of treatment. As regards the whole sample, BMD significantly increased after 12 months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (ß-CTX) and procollagen 1 N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups. CONCLUSION: Intravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu® was equivalent to Aclasta® with respect to efficacy and safety.
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Conservadores de la Densidad Ósea , Osteoporosis Posmenopáusica , Osteoporosis , Densidad Ósea , Difosfonatos/uso terapéutico , Método Doble Ciego , Femenino , Humanos , Osteoporosis/tratamiento farmacológico , Osteoporosis Posmenopáusica/tratamiento farmacológico , Posmenopausia , Estudios ProspectivosRESUMEN
We analyzed the incidence of medical complications after osteoporotic fractures and estimated its risk factors and cost impacts. Osteoporotic fractures can result in lots of serious medical complications, which is associated with patients' baseline characteristics such as patients' disease history and significantly increased patients' direct medical costs. PURPOSE: The purpose of the study is to investigate the incidence and identify the risk factors of medical complications after osteoporotic fracture, and quantify patients' economic burden. METHODS: Data were obtained from the Tianjin Urban Employee Basic Medical Insurance database (2009-2014). Patients aged ≥ 50 years, had ≥ 1 diagnoses of hip or vertebral fracture between 2010 and 2012, and continuously enrolled from 12 months before to 24 months after the first identified fracture were included. The incidence of medical complications was estimated within 12 months before and after fracture. Direct medical costs were measured and compared between patients with at least one medical complication and without any medical complications. Logistic regression was applied to identify risk factors for any medical complications. RESULTS: Three thousand seven hundred nineteen patients were identified; 45.0% had hip fracture, and 56.2% had vertebral fracture. After osteoporotic fracture, the accumulative incidence of the most common medical complications including constipation (25.6%, RR 1.38 [1.28, 1.48]), stroke (25.2%, 1.16 [1.09, 1.24]), pneumonia (17.0%, 1.55 [1.40, 1.73]), urinary tract infection (16.3%, 1.23 [1.12, 1.36]), and arrhythmia (11.8%, 1.39 [1.23, 1.56]) was significantly higher than that before fracture. Advanced age; male sex; retirement status; diagnosis of hypertension, chronic heart disease, cerebrovascular disease, hemiplegia, or Parkinson's disease; and higher direct medical costs at baseline were significant predictors of complications. The all-cause direct medical cost during 24-month follow-up was $5665. Medical complications significantly increased patients' direct medical costs. CONCLUSIONS: Osteoporotic fractures led to amount of medical complications, which significantly increased patients' economic burden. Complications correlate to various factors such as patients' disease history.