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1.
Acta Pharmacol Sin ; 44(2): 446-453, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35896694

RESUMEN

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.


Asunto(s)
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 , Posmenopausia
2.
J Clin Pharm Ther ; 46(5): 1441-1458, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34254696

RESUMEN

WHAT IS KNOWN AND OBJECTIVE: The benefits of local infiltration analgesia (LIA) in knee arthroplasty (KA) have been well-documented. However, it is unknown whether adding a corticosteroid to the composition of the LIA is beneficial. This study aimed to investigate the efficacy and safety of administering periarticular steroids intraoperatively in patients who underwent KA through a systematic review and meta-analysis. METHODS: A systematic search was conducted to identify relevant randomized controlled trials in the PubMed, Embase, Web of Science and Cochrane databases up to January 19th, 2021 to perform a meta-analysis. Outcome variables included pain scores, total opioid consumption, knee range of motion (ROM) and postoperative complications. RESULTS: Corticosteroid injections did not reduce pain scores at 6, 12, 24 or 72 h postoperatively, although a minimal degree of transient pain relief was achieved at 48 h postoperatively compared with those in the placebo group, nor was there a significant difference in total opioid consumption. However, patients receiving corticosteroids did exhibit a transient ROM increase on postoperative days 1, 2 and 3. Since the minimal clinically important difference (MCID) for ROM is unclear, it is unknown if the improvement in ROM is clinically significant. WHAT IS NEW AND CONCLUSION: Our specific end-point analysis demonstrated that corticosteroid administration did not provide pain relief or reduce opioid consumption compared with placebo. However, corticosteroids might provide a statistically significant, though transient and minimal improvement in knee ROM after KA, although no firm conclusions about the benefits of administering corticosteroids in KA can be made based on the available evidence.


Asunto(s)
Corticoesteroides/uso terapéutico , Anestésicos Locales/uso terapéutico , Artroplastia de Reemplazo de Rodilla/métodos , Dolor Postoperatorio/tratamiento farmacológico , Corticoesteroides/administración & dosificación , Analgésicos Opioides/administración & dosificación , Anestésicos Locales/administración & dosificación , Humanos , Inyecciones Intraarticulares , Manejo del Dolor/métodos , Complicaciones Posoperatorias/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Rango del Movimiento Articular
3.
Med Sci Monit ; 25: 6436-6445, 2019 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-31454342

RESUMEN

BACKGROUND The aim of this study was to review the efficacy and safety of intra-articular (IA) viscosupplementation (VS) for hip osteoarthritis (OA). MATERIAL AND METHODS We searched Medline, Clinical Trial Register Center, EMBASE, and Cochrane databases for randomized controlled trials (RCTs) comparing VS with placebo injection for hip OA. We included suitable studies, assessed the quality of studies, and extracted data on pain reduction, function improvement at different time points, and safety profiles. The comparisons of pain and function outcome were performed by meta-analysis. RESULTS Five high-quality randomized controlled studies trials (RCTs) with 591 patients with hip OA were identified. Although several trials demonstrated a significant decline in pain in VS groups during follow-up compared to baseline, without severe adverse events, the pooled analysis did not show VS was superior to placebo at any time windows [7-14 days: standardized mean difference (SMD): -0.18; 95% CI, -0.47 to 0.10, p=0.21; 28-30 days: 0.02 (-0.15, 0.19), p=0.82; or at final visit: -0.14 (-0.46, 0.18), p=0.38]. Similar results were also observed in the combined data of functional results. CONCLUSIONS IA VS does not reduce pain or improve function significantly better than placebo in a short-term follow-up. The benefits and safety of VS should be further assessed by sufficiently-sized, methodologically sound studies with validated assessment of more clinically relevant end-points.


Asunto(s)
Osteoartritis de la Cadera/tratamiento farmacológico , Viscosuplementación , Ensayos Clínicos como Asunto , Humanos , Inyecciones Intraarticulares/efectos adversos , Dolor/tratamiento farmacológico , Garantía de la Calidad de Atención de Salud , Resultado del Tratamiento , Viscosuplementación/efectos adversos
4.
Int J Med Sci ; 15(13): 1458-1465, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30443165

RESUMEN

Aseptic loosening is the most common complication of joint replacement. Previous studies showed that acrylic bone cement loaded with a commercially-available alendronate powder (APAC) had good promise against wear debris-mediated osteolysis for prevention of aseptic loosening. The purpose of the present study was to investigate the effect of adding alendronate powder to an acrylic bone cement on quasi-static mechanical properties (namely, compressive strength, compressive modulus, tensile strength, and flexural strength), fatigue life, porosity, and microstructure of the cement. The results showed that adding up to 1 wt./wt.% alendronate powder exerted no detrimental effect on any of the quasi-static mechanical properties. However, the fatigue life of APAC decreased by between ~17% and ~27 % and its porosity increased by between ~ 5-7 times compared with corresponding values for the control cement (no alendronate powder added). Fatigue life was negatively and significantly correlated with porosity. Considering that fatigue life of the cement plays a significant role in joint replacement survival, clinical use of APAC cannot be recommended.


Asunto(s)
Alendronato/química , Polimetil Metacrilato/química , Fatiga , Humanos , Porosidad
5.
BMC Musculoskelet Disord ; 19(1): 19, 2018 01 17.
Artículo en Inglés | MEDLINE | ID: mdl-29343245

RESUMEN

BACKGROUND: Although thrombosis complication is rare after arthroscopic meniscus surgery, deep vein thrombosis and pulmonary embolism can be fatal. The associated risk factors and whether anticoagulant prevention after arthroscopic knee surgery is necessary have not reach consensus. Here we present a case of deep vein thrombosis and pulmonary embolism after a common arthroscopic meniscectomy. CASE PRESENTATION: The patient had no risk factors except ipsilateral leg varicose veins. She present swell at knee and calf from postoperative 3 weeks, and developed dyspnea, palpitation, and nausea on 33th day, pulmonary embolism was confirmed with CT angiography at emergency department. After thrombolysis and anticoagulation therapy were administered, the patient improved well and discharged. And the intravenous ultrasound confirmed thrombosis of popliteal vein and small saphenous vein. Who don't have common risk factors for venous thromboembolism. CONCLUSIONS: Despite the low incidence of thromboembolic complications after simple arthroscopy surgery, its life-threatening and devastating property make clinicians rethink the necessity of thromboprophylaxis and importance of preoperative relative risk factors screening.


Asunto(s)
Artroscopía/efectos adversos , Embolia Pulmonar/diagnóstico por imagen , Lesiones de Menisco Tibial/diagnóstico por imagen , Lesiones de Menisco Tibial/cirugía , Trombosis de la Vena/diagnóstico por imagen , Artroscopía/tendencias , Femenino , Humanos , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Embolia Pulmonar/etiología , Trombosis de la Vena/etiología
6.
J Arthroplasty ; 30(7): 1281-6, 2015 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-25735501

RESUMEN

The analgesic efficacy and safety of periarticular multimodal drug injection (PMDI) compared with femoral nerve block (FNB) for postoperative pain management in total knee arthroplasty (TKA) still remains controversial. We therefore conducted a meta-analysis to quantitatively compare PMDI to FNB in TKA. 10 randomized controlled trials (RCTs) with 744 TKAs in 728 patients were included in this study. The meta-analysis showed that single shot FNB may have better pain relief in the early postoperative period compared with single shot PMDI, and continuous PMDI provided postoperative analgesia comparable to that of continuous FNB. No significant difference was seen in regard to the complications between the two groups. However, due to the variation of the included studies, no firm conclusions can be drawn.


Asunto(s)
Artroplastia de Reemplazo de Rodilla/métodos , Nervio Femoral , Inyecciones Intraarticulares/métodos , Bloqueo Nervioso/métodos , Dolor Postoperatorio/tratamiento farmacológico , Analgésicos Opioides/uso terapéutico , Artroplastia de Reemplazo de Rodilla/efectos adversos , Humanos , Inyecciones Intraarticulares/efectos adversos , Tiempo de Internación , Bloqueo Nervioso/efectos adversos , Manejo del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Tamaño de la Muestra
7.
Med Sci Monit ; 20: 2439-47, 2014 Nov 26.
Artículo en Inglés | MEDLINE | ID: mdl-25424061

RESUMEN

Osteonecrosis or avascular osteonecrosis (AVN) of the femoral head is a devastating multifactorial disease that affects 20 000 persons each year in the United States. The purpose of this systematic review was to determine the efficacy and safety of alendronate for adult AVN during short- and long-term follow-up. Electronic databases were searched for randomized or nonrandomized clinical trials, cohort, case-control studies, and series of cases in which alendronate was used for treatment of adult AVN of the femoral head. Relevant articles with adequate data on reduction of pain, improvement of articular function, slowing of bone collapse progression, or need for total hip arthroplasty (THA) were included after applying inclusion and exclusion criteria. Eight articles involving 788 hips with evidence level 1b to 3b were included in this systematic review. Most studies suggested a positive short-term efficacy of alendronate treatment in reducing pain, improving articular function, slowing of bone collapse progression, and delaying the need for THA for adult AVN patients. The favorable long-term results were also presented in those treated patients after 10-year follow-up. In addition, there were no severe adverse effects associated with alendronate treatment observed during short- and long-term follow-up, and most of the included studies suggested use of alendronate in early AVN with small necrotic lesion to achieve better outcomes. The findings support consideration of alendronate use for adult AVN, particularly with early stage and small necrotic size. The lack of large-scale, randomized, and double-blind studies justifies new studies to demonstrate the detailed indication and the optimized strategy of alendronate treatment. Level of evidence: Level 3a.


Asunto(s)
Alendronato/uso terapéutico , Necrosis de la Cabeza Femoral/tratamiento farmacológico , Adolescente , Adulto , Anciano , Alendronato/efectos adversos , Demografía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
8.
Int J Mol Sci ; 15(11): 20117-33, 2014 Nov 05.
Artículo en Inglés | MEDLINE | ID: mdl-25380520

RESUMEN

There are still many challenges to acquire the optimal integration of biomedical materials with the surrounding tissues. Gene coatings on the surface of biomaterials may offer an effective approach to solve the problem. In order to investigate the gene multilayers mediated differentiation of mesenchymal stem cells (MSCs), gene functionalized films of hyaluronic acid (HA) and lipid-DNA complex (LDc) encoding cartilage oligomeric matrix protein (COMP) were constructed in this study via the layer-by-layer self-assembly technique. Characterizations of the HA/DNA multilayered films indicated the successful build-up process. Cells could be directly transfected by gene films and a higher expression could be obtained with the increasing bilayer number. The multilayered films were stable for a long period and DNA could be easily released in an enzymatic condition. Real-time polymerase chain reaction (RT-PCR) assay presented significantly higher (p<0.01) COMP expression of MSCs cultured with HA/COMP multilayered films. Compared with control groups, the osteogenic gene expression levels of MSCs with HA/COMP multilayered films were down-regulated while the chondrogenic gene expression levels were up-regulated. Similarly, the alkaline phosphatase (ALP) staining and Alizarin red S staining of MSCs with HA/COMP films were weakened while the alcian blue staining was enhanced. These results demonstrated that HA/COMP multilayered films could inhibit osteogenic differentiation and promote chondrogenic differentiation of MSCs, which might provide new insight for physiological ligament-bone healing.


Asunto(s)
Proteína de la Matriz Oligomérica del Cartílago/genética , Diferenciación Celular/genética , Condrogénesis/genética , Células Madre Mesenquimatosas/citología , Células Madre Mesenquimatosas/metabolismo , Osteogénesis/genética , Proteína de la Matriz Oligomérica del Cartílago/metabolismo , Regulación de la Expresión Génica , Proteínas Fluorescentes Verdes/metabolismo , Células HEK293 , Humanos , ARN Mensajero/genética , ARN Mensajero/metabolismo , Reacción en Cadena en Tiempo Real de la Polimerasa , Espectrofotometría Ultravioleta , Coloración y Etiquetado , Propiedades de Superficie , Transfección , Agua
9.
J Arthroplasty ; 28(6): 913-7, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23523490

RESUMEN

We objectively appraised available evidence regarding the threshold for the number of polymorphonuclear leukocytes required in frozen section tests used to diagnose periprosthetic infection. Pooled summary estimates for sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio (OR) were compared for ten and five polymorphonuclear leukocytes per high power field as the threshold. The total cohort included 1011 patients and the rate of infection was 19.2%. Although there was no difference in sensitivity or diagnostic OR, specificity was significantly higher for ten than for five polymorphonuclear leukocytes per high power field (p=0.007) In sum, a threshold of 10 polymorphonuclear leukocytes is better for diagnosing periprosthetic infections.


Asunto(s)
Secciones por Congelación , Neutrófilos , Infecciones Relacionadas con Prótesis/patología , Humanos , Reproducibilidad de los Resultados
10.
J Expo Sci Environ Epidemiol ; 33(1): 69-75, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-35750749

RESUMEN

BACKGROUND: Environmental exposures such as perfluoroalkyl substances (PFASs) were considered potential risks for bone mineral density (BMD). OBJECTIVE: To examine the associations between PFASs and BMD among the U.S. population. METHODS: This study included a total of 6416 participants from the National Health and Nutrition Examination Survey (NHANES 2005-2014). Multiple linear regression models were used to analyze the associations between serum PFASs and BMD and the coefficient ß with 95% confidence intervals (95% CI) was calculated as the effect estimate. Covariates such as age, race, BMI, smoking, alcohol intake, milk intake, and physical activity were adjusted in these models. Additionally, gender and menopausal period were considered in further subgroup analyses. RESULTS: Based on the combined data of NHANES 2005-2014, the effects from exposure to PFASs on BMD were found with gender and menopausal status differences. Positive associations were found in PFOA (ß = 0.010; 95% CI: 0.003, 0.016), PFHxS (ß = 0.007; 95% CI: 0.003, 0.012), and PFNA (ß = 0.001; 95% CI: 0.001, 0.017) in total population. Negative associations for PFOA (ß = -0.020; 95% CI: -0.029, -0.012), PFOS (ß = -0.011; 95% CI: -0.028, -0.011), PFHxS (ß = -0.019; 95% CI: -0.025, -0.013), PFDE (ß = -0.010; 95% CI: -0.016, -0.005), and PFNA (ß = -0.011; 95% CI: -0.021, -0.002) were found in women, while no significant association was found in men. In further subgroup analyses, women in pre-menopause status showed consistent negative associations. SIGNIFICANCE: PFASs exposure may be associated with BMD and gender and menopausal status confound the associations.


Asunto(s)
Ácidos Alcanesulfónicos , Contaminantes Ambientales , Fluorocarburos , Masculino , Humanos , Femenino , Densidad Ósea , Encuestas Nutricionales , Fluorocarburos/efectos adversos
11.
Clin Orthop Relat Res ; 470(10): 2785-99, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22729693

RESUMEN

BACKGROUND: Osteoporotic vertebral compressed fractures (VCFs) are the most common osteoporotic fractures. Although percutaneous vertebroplasty (PVP) reportedly relieves pain and improves function, a recent pooled analysis from two multicenter randomized controlled trials concluded the improvement in pain and disability treated with PVP was similar to those with sham surgery. QUESTIONS/PURPOSE: Using meta-analysis we therefore asked whether compared with either nonoperative therapy or a sham injection for patients with VCF, PVP would (1) better relieve pain, (2) provide greater improvement in pain-related disability, and (3) increase the recurrence of vertebral fractures. METHODS: We searched PubMed, EMBASE, Medline, and the Cochrane library using the keywords "vertebroplasty AND osteoporosis OR fracture". We included nine of the 469 articles identified. Using a random effects model, we calculated the weighted mean differences to evaluate the pain reduction at different times as the primary outcome. Pain-related disability was assessed by a quality of life (QOL) measure. Improvement of QOL and recurrence of vertebral fractures were the secondary outcomes. We used subgroup analysis to reinvestigate pain relief and function improvement of PVP based on two different controls: nonoperative therapy and sham injection. The total number of patients was 886. RESULTS: Pain scoring was similar between the PVP group and the sham injection group at 1 to 29 days and 90 days. However, compared with nonoperative therapy, PVP reduced pain at all times studied. QOL in the PVP group was improved or tended to be improved compared with QOL for both control groups. The risk of new fractures was similar between the PVP groups and both control groups. CONCLUSIONS: Different control groups may have accounted for the different conclusions in the literature regarding the ability of PVP to relieve pain and restore function recovery. Compared with nonoperative treatment PVP relieved pain better and improved QOL. PVP did not increase the risk of new fractures. LEVEL OF EVIDENCE: Level II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.


Asunto(s)
Fracturas Osteoporóticas/cirugía , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia , Humanos , Resultado del Tratamiento
12.
Arch Orthop Trauma Surg ; 132(1): 81-6, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21814773

RESUMEN

BACKGROUND: The Trigen short reconstruction trochanteric antegrade nail (TAN) is considered most suitable for the small skeletons of Asian patients. We have evaluated the results of TAN for intertrochanteric fractures in Asian patients. METHODS: Between January 2006 and March 2009, 174 fractures in 164 patients were treated by TAN in our department. Epidemiological data, radiological changes, fracture types, cortical bone indices, clinical outcomes, and complications over a mean of 26 months were analyzed retrospectively. RESULTS: We observed a 17.0% fracture rate at the tip of the nail, a poor reduction rate of 15.9%, and a 41.4% cracking rate of the lateral trochanter for type 31-A3 fracture. Review of these cracking cases showed that they were all type 31-A3 unstable fractures combined with comminuted lateral trochanter fractures. Two shaft fractures required revision, with other fractures showing no delayed union, nonunion or infection. No screw breakage but one cut-out occurred, which received total hip arthroplasty revision. All other fractures healed at last. Risk of distal shaft fractures was not associated with patient age, gender, fracture type or cortical bone index. CONCLUSION: Despite the theoretically better design of TAN and the healing of most fractures and good activity at last follow-up, poor reduction and coxa vara caused by insertion of the nail could not be completely avoided, and the design of the distal part of the nail had the potential to cause femoral shaft fracture. Future improvements are necessary to enable the use of this system in Asians.


Asunto(s)
Pueblo Asiatico , Clavos Ortopédicos , Fijación Intramedular de Fracturas/instrumentación , Fracturas de Cadera/cirugía , Diseño de Prótesis , Adulto , Anciano , Anciano de 80 o más Años , Pérdida de Sangre Quirúrgica/estadística & datos numéricos , Clavos Ortopédicos/efectos adversos , Femenino , Fracturas de Cadera/etnología , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Diseño de Prótesis/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento
13.
Int J Med Robot ; 18(3): e2369, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35060271

RESUMEN

BACKGROUND: Previous articles about MAKO robotic-assisted total hip replacement (THR) were mainly in patients with comparatively normal anatomy. METHODS: From July 2020 to June 2021, we performed MAKO robotic-assisted THR in three hip-fused patients. We assessed the accuracy of prostheses implantation, collected clinical data, and discussed the value of this technique in this kind of patients. RESULT: All three patients achieved good leg length and prostheses position. A patient got femoral artery injury during the surgery. Moreover, she developed a thrombus. All three patients got acceptable Visual Analogue Scale scores and function recovery 6 months later. CONCLUSION: MAKO robotic-assisted THR achieved excellent prosthesis position in hip fused patients. More cases are needed to confirm this advantage. The function recovery was acceptable. Caution should be paid to protect the surrounding abnormal arteries, especially in a limited surgical field.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Procedimientos Quirúrgicos Robotizados , Femenino , Humanos , Resultado del Tratamiento
14.
Arch Osteoporos ; 17(1): 14, 2022 01 12.
Artículo en Inglés | MEDLINE | ID: mdl-35020038

RESUMEN

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.


Asunto(s)
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 Prospectivos
15.
J Arthroplasty ; 26(4): 665.e13-6, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-20663637

RESUMEN

All metal implants release metal ions because of corrosion. Although 20% to 25% of patients develop metal sensitivity after total joint arthroplasty, which is 10% higher than that in the general population, only very few highly susceptible patients exhibit symptoms. Even patients with known metal allergy often do not react to their metal prosthesis. Systemic allergic contact dermatitis is particularly uncommon with total knee arthroplasty because there is no metal-on-metal contact between the femoral and tibial components. We present a case report of 62-year-old man with dermatitis most likely caused by chromium after total knee arthroplasty and review the relevant literature. Although this complication is very rare, it sometimes can be painful enough for the patient to undergo revision surgery.


Asunto(s)
Artroplastia de Reemplazo de Rodilla/instrumentación , Cromo/efectos adversos , Dermatitis/diagnóstico , Dermatitis/etiología , Prótesis de la Rodilla/efectos adversos , Artritis Reumatoide/cirugía , Artroplastia de Reemplazo de Rodilla/métodos , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Niobio , Reoperación , Resultado del Tratamiento , Circonio
16.
Zhonghua Yi Xue Za Zhi ; 91(47): 3316-9, 2011 Dec 20.
Artículo en Zh | MEDLINE | ID: mdl-22333195

RESUMEN

OBJECTIVE: To explore the intermediate outcomes of third-generation alumina-on-alumina total hip arthroplasty (THA). METHODS: A consecutive series of 165 primary alumina-on-alumina total hip arthroplasties were performed in 135 patients. Three patients died and 13 patients lost follow-up so that a total of 119 patients (146 hips) were available for study. The mean patient age was 53.4 ± 11.0 years old (range: 26 - 79). Hydroxyapatite. (HA)-coated press-fit acetabular cups were used in all cases. At femoral side, 123 cases were implanted with HA-coated uncemented stems and 23 cases implanted with high polished double taped cemented stems. All patients were evaluated clinically and radiographically after a minimal follow-up duration of 60 months. RESULTS: The preoperative mean Harris hip score of 49.6 ± 7.9 points improved to 91.7 ± 3.0 points at the last follow-up (P < 0.05). The 5-year survival for any reason lead to revision was 96.6%. Five hips were under revision, 1 for acetabular shell loosening and migration, 1 for Vancouver B2 periprosthetic fracture, 1 for fracture of pure alumina liner and 2 for infections. All other prostheses demonstrated no radiographic evidence of loosening. No periprosthetic osteolysis was found. There were 2 cases of dislocations and 2 patients presented postoperatively with "squeaking-like" hips. CONCLUSION: The clinical and radiographic outcomes after primary THA with third-generation ceramic-on-ceramic bearing surfaces are favorable after a minimal follow-up duration of 5 years. The modified alumina-on-alumina bearing implants offer a better option for younger and active patients.


Asunto(s)
Óxido de Aluminio , Artroplastia de Reemplazo de Cadera/instrumentación , Cerámica , Prótesis de Cadera , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Resultado del Tratamiento
17.
Infect Drug Resist ; 14: 2411-2418, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34211286

RESUMEN

BACKGROUND AND AIM: Periprosthetic joint infection (PJI) is one of the most devastating complications after total joint arthroplasty (TJA). However, the antibiotic resistance of infecting pathogens can significantly vary in different parts of the country. In the current study, we analyzed the demographic and microbiological profiles of knee and hip PJI over three years and compared the microbiological differences between them. METHODS: A multicenter retrospective study of PJI patients in 34 referral medical centers in mainland China from January 2015 to November 2017 was performed. RESULTS: A total of 925 PJI patients were recruited, 452 were identified as knee PJIs, and 473 were hip PJIs. The most common causative pathogens were Staphylococcus aureus (26.5%) and coagulase-negative staphylococci (14.3%). Methicillin-resistant staphylococci were involved in 25.6% (237/925) of all PJI cases. Mycobacterium and fungus only accounted for 6.5% (61) of all cases. Enteric gram-negative bacilli, anaerobes, and polymicrobial pathogens were more common in hip joint prostheses than in knee PJI (P = 0.014; P = 0.006; P = 0.002, respectively). CONCLUSION: While the majority of causative pathogens in PJI cases are staphylococcal species, the prevalence of atypical organisms and resistant pathogens should also be given attention and warrant the need for empiric antibiotic treatment.

18.
Orthop Surg ; 12(4): 1293-1303, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32589343

RESUMEN

OBJECTIVE: To assess the effectiveness and safety of oral bisphosphonates in increasing bone mineral density (BMD), reducing fractures, and improving clinical function in patients with osteogenesis imperfecta (OI). METHODS: Studies were eligible for inclusion if they were randomized controlled trials of directly comparing oral bisphosphonate therapy with placebo-group in OI patients. Data synthesis regarding to bone mineral density as measured by dual-energy X-ray absorptiometry (DEXA), decreased fracture incidence, change in biochemical markers of bone and mineral metabolism, bone histology, growth, bone pain, quality of life, and others were assessed, and meta-analysis done when possible. RESULTS: From 98 potential references and six randomized controlled studies a total of 263 participants receiving oral bisphosphonates and 143 placebo treatments contributed data to meta-analysis. Pooled meta-analysis of three studies suggested that there was significant difference between bisphosphonate treated group and placebo in number of patients with at least one fracture (mean difference 0.53, 95% confidence interval 0.32-0.89, P = 0.02). Pooled meta-analysis of two studies suggested that significant difference was noted between bisphosphonate treated group and placebo in mean percentage change in spine BMD (T-score) (mean difference 28.43, 95% confidence interval 7.09-49.77, P = 0.009). The similar effect was shown in the term of mean change (Z-score) in spine BMD. CONCLUSIONS: Significant improvement in lumbar areal BMD in patients affected with OI has been shown when treated with oral bisphosphonates, even though only a small population was enrolled. We cannot draw a definite conclusion that the increase in BMD can be translated into fracture reduction and clinical functional improvement. The optimal method, dose, type, initiation, and duration of oral bisphosphonates therapy still remains unclear. Well-designed, adequately-powered, placebo-controlled RCTs investigating the effects of oral bisphosphonates on fractures reduction and improvement in quality of life in both children and adults are studied here.


Asunto(s)
Densidad Ósea/efectos de los fármacos , Difosfonatos/uso terapéutico , Fracturas Óseas/prevención & control , Osteogénesis Imperfecta/tratamiento farmacológico , Conservadores de la Densidad Ósea/uso terapéutico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
19.
J Knee Surg ; 33(5): 466-473, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-30763954

RESUMEN

Rotational malalignment between the femoral and tibial components in total knee arthroplasty (TKA) can affect clinical outcomes, but there is no consensus on how to best determine tibia tray orientation. The posterolateral corner-locked (PLCL) technique may be a new method. This study aims to assess the applicability of this technique in a Chinese population. Forty normal Chinese volunteers were recruited and underwent computed tomography (CT) of the lower limbs. Knee model reconstructions and simulated standard tibial osteotomy were conducted digitally. The transepicondylar axis (TEA), the Akagi line, and the line connecting the medial third of the tibial tubercle with the midpoint of the posterior cruciate ligament (PCL) were projected to the tibial cross-section and marked. The PLCL technique was applied using either symmetrical or asymmetrical tibial tray templates, and the anteroposterior (AP) axis of the tibial tray was marked. The angles between the TEA and these lines were calculated, and the statistical differences were analyzed. The angle between the TEA and the Akagi line and between the TEA and the line connecting the medial third of the tibial tubercle with the midpoint of the PCL were 96.90 ± 5.57 and 107.31 ± 5.95 degrees, respectively. The angles between the TEA and the AP axis of the symmetrical and the asymmetrical design tibial trays were 94.01 ± 4.21 and 96.65 ± 4.70 degrees, respectively. Except for the Akagi line and AP axis of the asymmetrical tibial tray, statistical differences were found between all lines (p < 0.05). The PLCL technique is principally suitable for Chinese patients requiring TKA when using the tibial component referred to in this study, although it may result in slight external rotation.


Asunto(s)
Artroplastia de Reemplazo de Rodilla , Pueblo Asiatico , Articulación de la Rodilla/diagnóstico por imagen , Tibia/diagnóstico por imagen , Tibia/cirugía , Adulto , Algoritmos , China , Simulación por Computador , Femenino , Fémur/diagnóstico por imagen , Fémur/cirugía , Voluntarios Sanos , Humanos , Imagenología Tridimensional , Articulación de la Rodilla/fisiopatología , Articulación de la Rodilla/cirugía , Masculino , Persona de Mediana Edad , Rango del Movimiento Articular , Rotación , Tomografía Computarizada por Rayos X
20.
Zhongguo Gu Shang ; 33(3): 283-7, 2020 Mar 25.
Artículo en Zh | MEDLINE | ID: mdl-32233262

RESUMEN

Heterotopic ossification is the formation of pathological bone in non-skeletal tissues (including muscles, tendons or other soft tissues), and the pathogenesis is not completely clear. It is often caused by musculoskeletal trauma, postoperative bone and joint surgery, or damage of the nervous system, the clinical manifestations are joint swelling, pain, and movement disorders, which often occur around the hips, knees, and elbows. At present, the prevention of heterotopic ossification mainly includes drugs, radiotherapy, molecular biological mechanism intervention, and Chinese medicine-related measures. Among them, drugs and radiotherapy are more effective methods to prevent heterotopic ossification. The intervention of molecular biology mechanism to prevent heterotopic ossification has become a new research direction and focus of attention inrecent years, and is basically at the experimental research stage. The treatment of heterotopic ossification includes various methods such as drugs, physical therapy, and surgery. Among them, surgery is recognized as the most effective treatment, however there are still some controversies and disagreements about the choice of operation time and surgical methods.


Asunto(s)
Articulación del Codo , Artropatías , Osificación Heterotópica , Codo , Humanos , Osificación Heterotópica/prevención & control , Osificación Heterotópica/terapia , Resultado del Tratamiento
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