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BACKGROUND: Total knee joint replacement (TKR) is an effective method for the treatment of severe knee osteoarthritis. With an increasing number of surgeries, complications such as lower limb edema, pain, and limited mobility have caused a heavy burden. Manual lymphatic drainage (MLD) may be a solution to solve the problem. The study aims to evaluate the efficacy of MLD in reducing knee edema, pain, and improving range of motion (ROM) in patients after TKR. METHODS: A search was conducted in PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIPs, WanFang database, and Google Scholar from inception to June 2023. Only randomized controlled trials (RCTs) that compared the effects of MLD and non-MLD (or another physiotherapy) on improving knee edema, pain, and ROM after TKR were included. Stata 16.0 was used for meta-analysis. GRADE was used to assess the quality of evidence. RESULTS: In total, 7 RCTs with 285 patients were identified. There were no significant differences found in the ROM of knee flexion (standardized mean difference (SMD) = 0.03, 95% confidence interval (CI): -0.22, 0.28, P = 0.812) and the ROM of knee extension (SMD= -0.30, 95%CI: -0.64, 0.04, P = 0.084). No differences were observed in the lower extremity circumference after TKR (SMD= -0.09, 95%CI: -0.27, 0.09, P = 0.324). For postoperative pain, there was no significant advantage between the MLD and non-MLD groups (SMD= -0.33, 95%CI: -0.71, 0.04, P = 0.083). CONCLUSIONS: Based on the current evidence from RCTs, manual lymphatic drainage is not recommended for the rehabilitation of patients following total knee replacement.
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Artroplastia do Joelho , Humanos , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/reabilitação , Drenagem Linfática Manual , Ensaios Clínicos Controlados Aleatórios como Assunto , Edema/terapia , Dor Pós-OperatóriaRESUMO
OBJECTIVES: To characterize the indications approved by the US Food and Drug Administration (FDA) on the basis of early phase clinical trials (EPCTs) and compared with that of phase three randomized controlled trials. STUDY DESIGN AND SETTING: We collected the publicly available FDA documents of targeted anticancer drugs approved between January 2012 and December 2021. RESULTS: We identified 95 targeted anticancer drugs with 188 indications approved by the FDA. One hundred and twelve (59.6%) indications were approved on the basis of EPCTs, with a significant increase of 22.2% per year. Of 112 EPCTs, 32 (28.6%) were dose-expansion cohort trials and 75 (67.0%) were single-arm phase 2 trials, respectively, with a significant increase of 29.7% and 18.7% per year. Compared with indications approved on the basis of phase three randomized controlled trials, the indications approved on the basis of EPCTs had significantly higher odds in receiving accelerated approval and lower odds in the number of entered patients of pivotal trials. CONCLUSIONS: Dose-expansion cohort trials and single-arm phase 2 trials played a critical role in EPCTs. EPCT was a major trial type in providing evidences for the FDA approvals of targeted anticancer drugs.
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Antineoplásicos , Aprovação de Drogas , Estados Unidos , Humanos , Estudos Transversais , United States Food and Drug Administration , Antineoplásicos/uso terapêuticoRESUMO
Cancer precision medicine with biomarker of cancer driver gene (CDG) has been achieved by many small-molecular kinase inhibitors (SMKIs) approved by the US Food and Drug Administration (FDA). Publicly available FDA documents were collected for all SMKI cancer drugs approved between January 2001 and December 2021. Characteristics of indication and pivotal trial were compared. We identified 62 SMKI cancer drugs with 150 indications approved by the FDA between 2001 and 2021. Of these, 55 indications (36.7%) were CDG biomarker-directed. There was a significant increase of 20.5% per year in the number of approved CDG biomarker-directed indications. CDG biomarker-directed indications were associated with significantly higher odds in receiving accelerated approval (odds ratio [OR] = 2.728; 95% CI, 1.246-5.973; P = .012), designating orphan drug (OR = 3.952; 95% CI, 1.758-8.883; P < .001), initial submission of the application (OR = 2.246; 95% CI, 1.063-4.746; P = .034) and in solid cancer (OR = 7.613; 95% CI, 2.958-19.590; P < .001), and were associated with significantly lower odds in using randomized controlled trials (RCTs) (OR = 0.103; 95% CI, 0.032-0.338; P < .001) with less number of entered patients (OR = 0.998; 95% CI, 0.997-1.000; P = .048). The number of CDG biomarker-directed indications in approved SMKIs increased significantly in past two decades, with higher proportion of approvals using special expedited development and approval pathways at the FDA. Further RCTs should be conducted to prove long-term effectiveness and safety.
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Antineoplásicos , Neoplasias , Estados Unidos , Humanos , United States Food and Drug Administration , Estudos Transversais , Aprovação de Drogas , Antineoplásicos/uso terapêutico , Biomarcadores , Neoplasias/tratamento farmacológico , Neoplasias/genéticaRESUMO
Objectives: Limited evidence has suggested that cefoperazone-sulbactam causes coagulation disorders and bleeding.Methods: The authors conducted a retrospective study to compare patients receiving cefoperazone-sulbactam versus those treated with cefoperazone-tazobactam or ceftazidime. Propensity-score matching was used to explore whether treatment with cefoperazone-sulbactam increased the risk of prothrombin time (PT) prolongation, coagulation disorders, and bleeding, or decreased platelets (PLT).Results: The cohort included 23,242 patients. Among patients receiving cefoperazone-sulbactam, the risk of PT prolongation, coagulation disorders, decreased PLT, and bleeding was 5.3%, 9.2%, 15.7%, and 4.2%, respectively. Propensity-score matching analyses suggested that cefoperazone-sulbactam increased the risk of PT prolongation (aOR 2.26, 95% CI 1.61-3.18), coagulation disorders (aOR 1.81, 95% CI 1.43-2.30), and decreased PLT (aOR 1.46, 95% CI 1.25-1.72), but not increase bleeding (aOR 1.05, 95% CI 0.79-1.40) compared with ceftazidime. Patients receiving cefoperazone-sulbactam had higher risk of PT prolongation (aOR 1.53, 95% CI 1.11-2.10), coagulation disorders (aOR 1.53, 95% CI 1.21-1.95), but not decreased PLT (aOR 0.93, 95% CI 0.81-1.07) or bleeding (aOR 1.11, 95% CI 0.87-1.42), compared with those receiving cefoperazone-tazobactam.Conclusion: Cefoperazone-sulbactam may be associated with a higher risk of PT prolongation and coagulation disorders compared with cefoperazone-tazobactam and ceftazidime.
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Transtornos da Coagulação Sanguínea/induzido quimicamente , Cefoperazona/efeitos adversos , Hemorragia/induzido quimicamente , Sulbactam/efeitos adversos , Adolescente , Adulto , Idoso , Antibacterianos/efeitos adversos , Plaquetas/efeitos dos fármacos , Ceftazidima/efeitos adversos , Quimioterapia Combinada/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Protrombina/estatística & dados numéricos , Tazobactam/efeitos adversos , Adulto JovemRESUMO
BACKGROUND: Cascade analysis is an effective method to analyze the processing data of an event, such as a provided service or a series of examinations. This study aimed to develop a primary cervical cancer screening cascade in China to promote the quality of the screening process. METHODS: We designed a cervical cancer screening cascade in China according to the program flow chart. It had three stages, each with two steps and one result. Data from 117,522 women aged 35 to 64 years in the Rural Cervical Cancer Surveillance Project from January 1, 2014, to December 31, 2014, were collected to analyze the main results of the cascade. The data and proportion are used to describe the follow-up of cervical cancer and pre-cancer detection rate. RESULTS: In 2014, 117,522 (80.94% of all cases reported by the Rural Cervical Cancer Surveillance Project) women aged 35 to 64 years had not received cervical cytology in the previous 3 years. The pre-cancer and cancer detection rates were 256.12/100,000 and 16.16/100,000, respectively. A total of 3031 cases failed to follow-up through the screening process, and 1189, 1555, and 287 cases were lost at cervical cytology, colposcopy, and histopathological screening stages, respectively. The estimated cases of pre-cancer and cancer cases would have been 544 and 34, respectively, and the estimated detection rates of pre-cancer and cancer would have been 462.89/100,000 and 28.93/100,000, respectively. CONCLUSION: In order to increase the detection rate of cervical cancer, cervical cancer screening staff should focus on increasing the rate of follow-up of those who are positive for cervical cancer screening (ie, those with positive cytology results), especially for the 40 to 44 years age range.
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Detecção Precoce de Câncer/métodos , Programas de Rastreamento/métodos , Neoplasias do Colo do Útero/diagnóstico , Adulto , China , Colposcopia , Feminino , HumanosRESUMO
The circadian clock is crucial for sustaining rhythmic biochemical, physiological, and behavioral processes in living creatures. In this study, we isolated and characterized two circadian clock genes in Macrobrachium nipponense, period (Mnper) and timeless (Mntim). The complete Mnper cDNA measures 4283bp in length with an open reading frame encoding 1292 amino acids, including functional domains such as PER-ARNT-SIM (PAS), cytoplasmic localization domain (CLD), TIM interaction site (TIS), and nuclear localization signal (NLS). The deduced Mntim protein comprises1540 amino acids with functional domains such as PER interaction site (PIS), NLS, and CLD. Tissue distribution analyses showed that the two genes were highly expressed in the eyestalk and brain in both males and females, as well as being expressed in the ovary. The expression profiles of Mnper and Mntim were determined in the eyestalk, brain, and ovary under simulated breeding season and non-breeding season conditions. The expression profiles of both Mnper and Mntim appeared to be unaffected in the eyestalk. However, the expression of both genes exhibited significant seasonal variations in the brain, and thus we assumed the brain to be their functional location. The expression profiles under different simulated seasons and the variations during different ovarian stages indicate that both genes might be involved with female reproduction. Especially the mRNA levels in the brain varied greatly during these stages indicating that the clock function in the brain is closely related to ovarian development and female reproduction. And the reproductive roles of clock genes need to be elucidated.
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Proteínas de Ciclo Celular/genética , Palaemonidae/genética , Proteínas Circadianas Period/genética , Diferenciação Sexual/genética , Sequência de Aminoácidos/genética , Animais , Proteínas de Ciclo Celular/biossíntese , Relógios Circadianos/genética , Clonagem Molecular , Feminino , Regulação da Expressão Gênica no Desenvolvimento , Ovário/crescimento & desenvolvimento , Ovário/metabolismo , Palaemonidae/crescimento & desenvolvimento , Proteínas Circadianas Period/biossíntese , RNA Mensageiro/genética , RiosRESUMO
Brucellosis, a zoonotic disease, was made statutorily notifiable in China in 1955. We analyzed the incidence and spatial-temporal distribution of human brucellosis during 1955-2014 in China using notifiable surveillance data: aggregated data for 1955-2003 and individual case data for 2004-2014. A total of 513,034 brucellosis cases were recorded, of which 99.3% were reported in northern China during 1955-2014, and 69.1% (258, 462/374, 141) occurred during February-July in 1990-2014. Incidence remained high during 1955-1978 (interquartile range 0.42-1.0 cases/100,000 residents), then decreased dramatically in 1979-1994. However, brucellosis has reemerged since 1995 (interquartile range 0.11-0.23 in 1995-2003 and 1.48-2.89 in 2004-2014); the historical high occurred in 2014, and the affected area expanded from northern pastureland provinces to the adjacent grassland and agricultural areas, then to southern coastal and southwestern areas. Control strategies in China should be adjusted to account for these changes by adopting a One Health approach.
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Brucelose/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Animais , Brucelose/história , Brucelose/microbiologia , Brucelose/transmissão , Criança , Pré-Escolar , China/epidemiologia , Notificação de Doenças , Reservatórios de Doenças , Feminino , Mapeamento Geográfico , História do Século XX , História do Século XXI , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Vigilância da População , Estações do Ano , Análise Espaço-Temporal , Adulto Jovem , Zoonoses/epidemiologiaRESUMO
Due to their small footprint and flexible siting, rechargeable batteries are attractive for energy storage systems. A super-valent battery based on aluminium ion intercalation and deintercalation is proposed in this work with VO2 as cathode and high-purity Al foil as anode. First-principles calculations are also employed to theoretically investigate the crystal structure change and the insertion-extraction mechanism of Al ions in the super-valent battery. Long cycle life, low cost and good capacity are achieved in this battery system. At the current density of 50 mAg(-1), the discharge capacity remains 116 mAhg(-1) after 100 cycles. Comparing to monovalent Li-ion battery, the super-valent battery has the potential to deliver more charges and gain higher specific capacity.
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OBJECTIVE: To assess the public health risk of human infection from a novel bunyavirus - severe fever with thrombocytopenia syndrome virus (SFTSV) - in China. METHODS: The likelihood of disease spread and the magnitude of public health impact were assessed to clarify overall risk. Literature about hazard, exposure and contextual factors associated with SFTSV infection was collected and reviewed. Information on SFTSV cases and the population in six provinces under surveillance was compared. RESULTS: SFTSV is a member of the Phlebovirus genus of the Bunyaviridae family. A widely distributed tick species, Haemaphysalis longicornis, can act as the vector; thus the disease is likely to spread in China. Symptoms of SFTSV infection are nonspecific, but have led to multiorgan dysfunction in severe cases. High-risk populations include farmers and older females. Evidence of human-to-human transmission within family and hospital has been reported. The capacity for treatment and diagnosis of SFTSV are adequate in rural communities in China, and community awareness of the disease should be high. DISCUSSION: There is a low to moderate public health risk related to SFTSV human infection in China. There is potential for an increase in the number of cases reported as awareness increases and when surveillance is expanded.
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OBJECTIVE: Using simple quantitative methods to describe the seasonal distribution of rabies in different provinces of China and to analyze how it was influenced by geographical settings, to provide evidence for risk assessment and prediction of potential epidemics of rabies. METHODS: A total number of 17 800 clinical and laboratory confirmed rabies cases, reported by 29 provinces, from 2005 to 2011 and related data were collected from National Disease Reporting Information System. Data on related latitudes and longitudes of different provinces were obtained from the National Geographic Information Center. Excel 2003 was used to draw the national and provincial seasonal distribution curves while SPSS 18.0 was used to calculate parameters as P(25), P(50), P(75), inter-quartile range Q and kurtosis so as analyze the linear correlation between P(25), kurtosis and the latitude of different provinces respectively. RESULTS: The nation-wide incidence of rabies was low in February. The peaks fell in summer and autumn, especially in August. Seasonal distribution curves of P(25), P(50), P(75), inter-quartile range (Q) and kurtosis were different among provinces. Compared to the low latitude areas, high latitude areas had higher P(25), smaller Q and higher kurtosis. In 9 provinces where the annual reported number of cases more than 100, the related coefficients (r) between latitude and both P(25), kurtosis were 0.9342 and 0.8528 respectively (P < 0.05). CONCLUSION: There was a distinct seasonality of rabies occurrence in China which was correlated to the geographical settings which was more obvious in the higher latitude areas.
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Geografia , Raiva/epidemiologia , Estações do Ano , China/epidemiologia , Epidemias , Humanos , IncidênciaRESUMO
OBJECTIVE: To compare the different surveillance system evaluation guidelines proposed by US Center for Disease Control and Prevention (CDC) and WHO, so as to develop an evaluation strategy suitable for communicable disease surveillance systems in China. METHODS: Systematic collection and review on the guidelines that were proposed by US CDC and WHO. Situation analysis together with feasibility analysis were linked to the analysis of evaluation strategy used in China. RESULTS: US CDC guidelines were more appropriate for evaluating those single or simple systems that focusing on those 'system characteristics' while the. WHO protocols were more appropriate for evaluating the multi-system or complicated system which focusing on data related to 'system functions'. The US CDC guidelines had been widely used in China and it was the right moment to start to evaluate the functions. CONCLUSION: More flexible and comprehensive strategy based on national conditions is needed when constitute the national communicable disease surveillance evaluation guidelines. The multi-step strategy described in this article could be used as reference.
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Controle de Doenças Transmissíveis , Vigilância da População/métodos , Centers for Disease Control and Prevention, U.S. , Humanos , Avaliação de Programas e Projetos de Saúde , Estados Unidos , Organização Mundial da SaúdeRESUMO
BACKGROUND: In recent years, problems like insufficient coordination, low efficiency, and heavy working load in national communicable disease surveillance systems in China have been pointed out by many researchers. To strengthen the national communicable disease surveillance systems becomes an immediate concern. Since the World Health Organization has recommended that a structured approach to strengthen national communicable disease surveillance must include an evaluation to existing systems which usually begins with a systematic description, we conducted the first survey for communicable disease surveillance systems in China, in order to understand the situation of core and support surveillance activities at province-level and county-level centers for disease control and prevention (CDCs). METHODS: A nationwide survey was conducted by mail between May and October 2006 to investigate the implementation of core and support activities of the Notifiable Disease Reporting System (NDRS) and disease-specific surveillance systems in all of the 31 province-level and selected 14 county-level CDCs in Mainland China The comments on the performance of communicable disease surveillance systems were also collected from the directors of CDCs in this survey. RESULTS: The core activities of NDRS such as confirmation, reporting and analysis and some support activities such as supervision and staff training were found sufficient in both province-level and county-level surveyed CDCs, but other support activities including information feedback, equipment and financial support need to be strengthened in most of the investigated CDCs. A total of 47 communicable diseases or syndromes were under surveillance at province level, and 20 diseases or syndromes at county level. The activities among different disease-specific surveillance systems varied widely. Acute flaccid paralysis (AFP), measles and tuberculosis (TB) surveillance systems got relatively high recognition both at province level and county level. CONCLUSIONS: China has already established a national communicable disease surveillance framework that combines NDRS and disease-specific surveillance systems. The core and support activities of NDRS were found sufficient, while the implementation of those activities varied among different disease-specific surveillance systems.