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Background: Knee osteoarthritis (KOA) is a chronic degenerative joint disease, which is the most common type of osteoarthritis. The clinical manifestations are pain, swelling, and dysfunction of the knee joint, which seriously reduces the quality of life of patients and causes a huge social burden. At present, western medicine mainly focuses on symptomatic treatment, such as anti-inflammatory and pain relief, joint cavity injection, joint replacement, etc. The curative effect has certain limitations. Xianling Gubao capsule has some advantages in the treatment of KOA, but it lacks high-quality clinical research to verify it. Therefore, the purpose of this study is to evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. Methods: A randomized, double-blind, double-simulation, parallel controlled trial design was used to study the efficacy and safety of Xianling Gubao capsules in the treatment of KOA. The patients were randomly divided into a treatment group and the control group according to 1:1. The treatment group: Xianling Gubao capsule + glucosamine hydrochloride capsule simulation agent treatment; the control group: glucosamine hydrochloride capsule + Xianling Gubao capsule simulation agent treatment. Both groups received standard treatment for 8 weeks and followed up for 30 days. And at the same time, pay attention to its efficacy and safety indicators. Observation indicators include: the western Ontario and McMaster universities osteoarthritis index, hospital for special surgery knee score, liver and kidney function, adverse reactions, etc. Data analysis was performed using SPSS 25.0 software. Discussion: This study will evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. The results of this experiment will provide evidence support for Xianling Gubao capsule in the treatment of KOA. Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/ERM9C
Background: Knee osteoarthritis (KOA) is a chronic degenerative joint disease, which is the most common type of osteoarthritis. The clinical manifestations are pain, swelling, and dysfunction of the knee joint, which seriously reduces the quality of life of patients and causes a huge social burden. At present, western medicine mainly focuses on symptomatic treatment, such as anti-inflammatory and pain relief, joint cavity injection, joint replacement, etc. The curative effect has certain limitations. Xianling Gubao capsule has some advantages in the treatment of KOA, but it lacks high-quality clinical research to verify it. Therefore, the purpose of this study is to evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. Methods: A randomized, double-blind, double-simulation, parallel controlled trial design was used to study the efficacy and safety of Xianling Gubao capsules in the treatment of KOA. The patients were randomly divided into a treatment group and the control group according to 1:1. The treatment group: Xianling Gubao capsule + glucosamine hydrochloride capsule simulation agent treatment; the control group: glucosamine hydrochloride capsule + Xianling Gubao capsule simulation agent treatment. Both groups received standard treatment for 8 weeks and followed up for 30 days. And at the same time, pay attention to its efficacy and safety indicators. Observation indicators include: the western Ontario and McMaster universities osteoarthritis index, hospital for special surgery knee score, liver and kidney function, adverse reactions, etc. Data analysis was performed using SPSS 25.0 software. Discussion: This study will evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. The results of this experiment will provide evidence support for Xianling Gubao capsule in the treatment of KOA. Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/ERM9C
Background: Knee osteoarthritis (KOA) is a chronic and degenerative bone and joint disease, with KOA, cartilage degeneration, destruction and subchondral bone remodeling as the main pathological features. Its clinical symptoms are knee pain, swelling, limited activity, and long course of disease can cause joint deformities. At present, the early treatment of Western medicine is mainly the use of nonsteroidal drugs for anti-inflammation and removing pain, but because the efficacy of these drugs is unstable, the disease is easy to repeat after treatment, and the clinical effect is not good. Although Biqi capsule has advantages in the treatment of KOA, there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Biqi capsule in the treatment of KOA. Methods: This is a prospective randomized controlled trial to study the efficacy and safety of Biqi capsule in the treatment of KOA. The patients were randomly divided into a treatment group and a control group according to 1:1. Among them, treatment group: Biqi capsule combined with diclofenac sodium sustained release tablets; Control group: Diclofenac sodium sustained-release tablets alone. Both groups were treated with standard treatment for 2 weeks and were followed up for 30 days to pay attention to the efficacy and safety indexes. Observation indicators included: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Hospital for Special Surgery Knee Score (HSS), liver and kidney function, adverse reactions, and so on. SPSS 25.0 software is used for data analysis. Discussion: This study will evaluate the efficacy and safety of Biqi capsule in the treatment of KOA, and the results of this experiment will provide a clinical basis for Biqi capsule in the treatment of KOA. Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/6HB9D
Összefoglaló. Bevezetés: A lakosság idősödésével növekvő betegségteher egyéni és társadalmi szinten is fokozódó nyomást jelent. Célkitűzés: Felmérni a hazai általános felnőtt lakosságnak a korlátozottsággal, a gondozási igényekkel és a munkavégzéssel kapcsolatos időskori szubjektív várakozásait. Módszer: Online keresztmetszeti felmérést végeztünk. A korlátozottsággal kapcsolatos várakozásokat a hivatalos szakstatisztikákban alkalmazott globális tevékenységkorlátozottsági mutató (Global Activity Limitation Indicator, GALI) segítségével elsőként vizsgáltuk. A jelen és szubjektíve várt munkavégzést, gondozási igényt, gondozói tevékenységet, valamint a jelen egészségi állapotot és szociodemográfiai helyzetet vizsgáló kérdéseket is feltettünk. Statisztikai analízis: A mintában mért adatokat lokális polinom segítségével simítottuk, és a 60/70/80/90 éves korra adott szubjektív várakozásokkal hasonlítottuk össze. A szubjektív várakozásokat meghatározó tényezőket intervallumregresszióval becsültük. Eredmények: 1000 kitöltőtől 914 érvényes választ kaptunk. Az átlagéletkor (± szórás) 51,2 (± 15,2) év, a minta 55,8%-a nő volt. A férfiak között a fizetett munkát végzők (p<0,001), a nők között az informális gondozók aránya volt magasabb (p = 0,010). Az átlagos (± szórás) szubjektíve várható élettartam (81,0 ± 11,1 év) a minta statisztikailag várható élettartamánál (79,6 ± 3,7 év) 1,3 évvel volt hosszabb (p<0,001), azonban az átlagos, szubjektíve várható egészséges élettartam (64,6 ± 15,2 év) 5,3 évvel volt rövidebb a statisztikailag várható értéknél (70,0 ± 4,2 év; p<0,001). A szubjektíve várható egészséges élettartamot és gondozási igényt elsősorban a válaszadók jelenlegi egészségi állapota befolyásolta. Az életmód és a szubjektíve várható egészséges élettartam között nőknél nem találtunk összefüggés, míg a túlzott gyakorisággal alkoholt fogyasztó vagy elhízott férfiak hosszabb egészséges élettartamra számítottak. A szubjektív várakozások meghatározó tényezői jelentős nemi különbségeket mutattak. Következtetés: Az egészséggel, munkával és gondozással kapcsolatos szubjektív várakozások eltérőek a populációban mért valós adatoktól, és különböznek a nemek között. Orv Hetil. 2021; 162(23): 911–923. Summary. Introduction: The growing disease burden due to ageing populations poses a challenge on both individuals and societies. Objective: To explore the general population’s subjective expectations concerning disability, care needs and employment at older ages. Method: We conducted an online cross-sectional survey. We were the first to measure subjective health expectations using the Global Activity Limitation Indicator (GALI) of official health statistics. Respondents’ actual status and subjective expectations concerning employment, care needs and informal caregiver status, self-perceived health and sociodemographic factors were queried. Statistical analysis: We estimated sample characteristics by local polynomial smoothing and compared with subjective expectations at ages of 60/70/80/90 years. Determinants of subjective expectations were analyzed via interval regression. Results: From 1000 subjects, 914 provided valid responses. Mean (± SD) age was 51.2 (± 15.2) years, and 55.8% of respondents were women. Paid employment was more frequent among men (p<0.001), while informal caregiver status among women (p = 0.010). Mean (± SD) subjective life expectancy (81.0 ± 11.1 years) was 1.3 years longer (p<0.001) than actuarial life-expectancy (79.6 ± 3.7 years), while mean subjective healthy life expectancy (sHLE) (64.6 ± 15.2 years) was 5.3 years shorter than actuarial healthy life expectancy (70.0 ± 4.2 years; p<0.001). sHLE and care needs were mainly determined by respondents’ self-perceived health. Lifestyle risks were not associated with sHLE in women, while pervasive drinker or obese men expected longer healthy life span. Determinants of sHLE showed considerable gender differences. Conclusion: Subjective expectations concerning health, employment and care needs differ from actual values of the general population, with considerable gender differences. Orv Hetil. 2021; 162(23): 911–923.
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