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1.
Biologicals ; 85: 101754, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38428357

RESUMEN

The Eighth Asian National Control Laboratory (NCL) Network meeting, entitled "Biological Products Quality Control and Self-Sufficiency Strategy focusing on plasma-derived medicinal products (PDMPs)" was held in Seoul on 31 August 2023. The participants were NCL experts from Indonesia, Japan, Malaysia, the Philippines, Vietnam, and the Republic of Korea. Special lectures included the PDMPs self-sufficiency strategies of the World Health Organization (WHO) and Indonesian Food and Drug Authority, and a case study on Global Benchmarking Tool (GBT) assessment for vaccines by the Korea Ministry of Food and Drug Safety. The NCL delegates shared their current experiences with national lot releases and biological standardisation. The meeting contributed to a mutual understanding of the progress of the PDMPs self-sufficiency among Asian countries, the WHO's support strategies, and the NCL's plan for the preparation of the WHO GBT assessment. In the panel discussion, all participants agreed that building capacity in blood safety in the Asian region and harmonisation of relevant international regulatory requirements will support appropriate emergency preparedness, particularly source materials in the region, and will build the foundation for resolving the PDMPs supply insecurity that has worsened after the COVID-19 pandemic in some countries.


Asunto(s)
Pandemias , Humanos , Pandemias/prevención & control , Asia , Indonesia , Organización Mundial de la Salud , República de Corea
2.
Artículo en Inglés | MEDLINE | ID: mdl-38285378

RESUMEN

We aimed to evaluate the effects of obesity treatment with behavioral therapy (BT) and cognitive behavioral therapy (CBT) interventions compared with multiple comparators and find effective techniques or combinations of techniques in BT and CBT interventions for weight loss. We systematically searched electronic databases and selected randomized controlled trials using CBT or BT intervention for obesity treatment in overweight adults or adults with obesity without psychological symptoms. Both pairwise meta-analysis and network meta-analysis were performed to comprehensively evaluate the comparative effects between interventions. We classified the techniques used in BT and CBT interventions and compared the treatment effects between techniques. Compared with no treatment as a common comparator, CBT was most effective for weight loss, followed by BT, usual care (UC), and minimal care (MC). CBT was a more effective intervention than BT, but the effect of CBT compared to BT was not remarkable in network estimates. The most used BT techniques were feedback and monitoring, and the most used CBT technique was cognitive restructuring. Our results indicated that CBT and BT are effective interventions for weight loss, and that successful weight loss requires more aggressive interventions such as BT or CBT than MC and UC.

3.
Biologicals ; 82: 101679, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-37146358

RESUMEN

This study aimed to establish a second national standard for hepatitis B immunoglobulin (HBIG) that can be used for potency assays of hepatitis B and normal immunoglobulin. The candidate material was manufactured using a process approved as Good Manufacturing Practice. The freeze-dried candidate preparation was tested for physicochemical and biological properties, including pH, residual moisture, molecular size distribution, and potency. A collaborative study was performed involving four laboratories, including the National Institute of Food and Drug Safety Evaluation, as an official national control laboratory in Korea and manufacturers. The potency was calibrated against the second international standard for HBIG using two enzyme immunoassays: enzyme-linked immunosorbent assay and electrochemiluminescence immunoassay. Results from 240 assays were obtained from four laboratories, and combined potency estimates were obtained by calculating the geometric means. Intra- and inter-laboratory variability showed acceptable geometric coefficients of variation of 1.3-6.0 and 3.2-3.6%, respectively. The candidate preparation showed satisfactory stability in accelerated thermal degradation and real-time stability tests. Based on these results, the potency value of 105 IU/vial was assigned (95% confidence intervals: 100.0-109.2 IU/vial), and it was deemed suitable to serve as the Korean national standard for HBIG.


Asunto(s)
Inmunoglobulinas , Cooperación Internacional , Estándares de Referencia , República de Corea
4.
Biologicals ; 84: 101712, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37797484

RESUMEN

The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online. The theme of this meeting was 'Quality Control Issues and International Trends for Biologicals including Vaccines and Plasma-Derived Medicinal Products.' Three special speeches were presented on sharing the quality control system for biologicals, including NCLs' considerations in preparing the WHO Listed Authorities and sharing MFDS experiences. Furthermore, the participating NCLs shared country-specific issues related to national lot releases during the COVID-19 pandemic and acknowledged the meeting's crucial role in response preparedness for pandemic emergencies and enhancing regulatory capacity through coalitions and information exchange among NCLs. The NIFDS will cooperate closely with other Asian NCLs to enhance biological product quality control, aiming to establish regional standards and standardize test methods through collaboration.


Asunto(s)
Productos Biológicos , Vacunas , Humanos , Pandemias , Laboratorios , Corea (Geográfico) , Organización Mundial de la Salud
6.
J Med Internet Res ; 23(9): e29642, 2021 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-34315697

RESUMEN

BACKGROUND: The necessity of including observational studies in meta-analyses has been discussed in the literature, but a synergistic analysis method for combining randomized and observational studies has not been reported. Observational studies differ in validity depending on the degree of the confounders' influence. Combining interpretations may be challenging, especially if the statistical directions are similar but the magnitude of the pooled results are different between randomized and observational studies (the "gray zone"). OBJECTIVE: To overcome these hindrances, in this study, we aim to introduce a logical method for clinical interpretation of randomized and observational studies. METHODS: We designed a stepwise-hierarchical pooled analysis method to analyze both distribution trends and individual pooled results by dividing the included studies into at least three stages (eg, all studies, balanced studies, and randomized studies). RESULTS: According to the model, the validity of a hypothesis is mostly based on the pooled results of randomized studies (the highest stage). Ascending patterns in which effect size and statistical significance increase gradually with stage strengthen the validity of the hypothesis; in this case, the effect size of the observational studies is lower than that of the true effect (eg, because of the uncontrolled effect of negative confounders). Descending patterns in which decreasing effect size and statistical significance gradually weaken the validity of the hypothesis suggest that the effect size and statistical significance of the observational studies is larger than the true effect (eg, because of researchers' bias). CONCLUSIONS: We recommend using the stepwise-hierarchical pooled analysis approach for meta-analyses involving randomized and observational studies.


Asunto(s)
Proyectos de Investigación , Sesgo , Humanos
7.
Medicina (Kaunas) ; 57(2)2021 Jan 28.
Artículo en Inglés | MEDLINE | ID: mdl-33525358

RESUMEN

Meta-analyses have been conventionally performed to extract the firmest conclusions from randomized controlled trials while minimizing the risk of bias. However, the field of oncology does not always allow for collecting the best evidence. Radiation oncology is a discipline where intractable or rare diseases are commonly encountered; hence, more practical data suitable for detailed clinical evaluations are needed. This review discusses new viewpoints regarding meta-analyses by pointing out heterogeneities among clinical studies and issues related to analyzing observational studies, thus clarifying the practical utility of meta-analyses in radiation oncology. Limitations of previous systematic reviews or meta-analyses are also assessed to suggest future directions.


Asunto(s)
Oncología por Radiación , Sesgo , Humanos , Oncología Médica
8.
Medicina (Kaunas) ; 57(10)2021 09 22.
Artículo en Inglés | MEDLINE | ID: mdl-34684036

RESUMEN

Background and objective: Although transarterial chemoembolization (TACE) has been the commonest local modality for hepatocellular carcinoma (HCC), incomplete repsonse occurs especially for tumors with a large size or difficult tumor accessment. The present meta-analysis assessed the efficacy and feasibility of external beam radiotherapy (EBRT) as a salvage modality after incomplete TACE. Materials and Methods: We systematically searched the PubMed, Embase, Medline, and Cochrane databases. The primary endpoint was overall survival (OS), and the secondary endpoints included the response ratem toxicity of grade 3, and local control. Results: Twelve studies involving 757 patients were included; the median of portal vein thrombosis rate was 25%, and the pooled median of tumor size was 5.8 cm. The median prescribed dose ranged from 37.3 to 150 Gy (pooled median: 54 Gy in *EQD2). The pooled one- and two-year OS rates were 72.3% (95% confidence interval (CI): 60.2-81.9%) and 50.5% (95% CI: 35.6-65.4%), respectively; the pooled response and local control rates were 72.2% (95% CI: 65.4-78.1%) and 86.6 (95% CI: 80.1-91.2%) respectively. The pooled rates of grade ≥3 gastrointestinal toxicity, radiation-induced liver disease, hepatotoxicity, and hematotoxicity were 4.1%, 3.5%, 5.7%, and 4.9%, respectively. Local control was not correlated with intrahepatic (p = 0.6341) or extrahepatic recurrences (p = 0.8529) on meta-regression analyses. Conclusion: EBRT was feasible and efficient in regard to tumor response and control; after incomplete TACE. Out-field recurrence, despite favorable local control, necessitates the combination of EBRT with systemic treatments. *Equivalent dose in 2 Gy per fraction scheme.


Asunto(s)
Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Carcinoma Hepatocelular/terapia , Quimioembolización Terapéutica/efectos adversos , Humanos , Neoplasias Hepáticas/terapia , Recurrencia Local de Neoplasia/terapia , Tasa de Supervivencia , Resultado del Tratamiento
9.
Clin Orthop Relat Res ; 478(10): 2324-2339, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32332245

RESUMEN

BACKGROUND: Extracorporeal shock wave therapy (ESWT) has been used in various musculoskeletal disorders, including lateral epicondylitis. However, in 2005, a meta-analysis of randomized controlled trials showed that ESWT provides minimal or no benefit in terms of pain and function in patients with lateral epicondylitis. Since the review, several randomized controlled trials including different types of ESWT such as radial type for lateral epicondylitis have been published. Investigations of the effect modifiers such as symptom and follow-up duration on the effects of ESWT on lateral epicondylitis have not been performed. QUESTIONS/PURPOSES: (1) Does ESWT reduce pain and improve grip strength in patients with lateral epicondylitis? (2) Which type of ESWT, radial or focused, is more effective? (3) Is the duration of symptoms associated with the efficacy of ESWT for lateral epicondylitis? (4) Do improvements in pain scores remain in patients with longer follow-up? METHODS: The PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were searched up to July 2019 for articles published in English or Korean. Studies were included if patient allocation was randomized, the sample was composed of patients with lateral epicondylitis, interventions were ESWT (focused or radial), comparison group only received sham stimulation or no additional treatment, and the study outcome was pain intensity or grip strength. The quality of the evidence was assessed using the Cochrane risk of bias tool. Twelve studies including 1104 participants fulfilled the inclusion criteria and were included in the meta-analysis. The mean difference for pain reduction and improvement in grip strength was calculated. RESULTS: The meta-analysis showed no clinically important difference in the VAS score (2.48 ± 7.55 versus 3.17 ± 9.78, mean difference -0.68 [95% confidence interval -1.17 to -0.19]; p = 0.006) and grip strength (38.02 ± 70.56 versus 34.85 ± 108.26, mean difference 3.33 [95% CI 0.93 to 5.73]; p = 0.007) after ESWT relative to the comparison group's score. Even though radial ESWT showed more improvement than focused, the mean difference for VAS did not exceed the minimal clinically important differences threshold. There were no clinically important effects on the VAS scores of patients with lateral epicondylitis (2.78 ± 5.57 versus 3.92 ± 6.29, mean difference -1.13 [95% CI -1.84 to -0.42]; p = 0.002) and focused ESWT did not improve pain in patients with lateral epicondylitis. In the subgroup analysis, ESWT was effective in patients with a symptom duration of more than 6 months (2.28 ± 8.48 versus 3.31 ± 11.81, mean difference -0.95 [95% CI -1.75 to -0.15]; p = 0.02) but not for those with shorter symptom duration. The effects did not last beyond 24 weeks (2.52 ± 9.19 versus 3.34 ± 5.93, mean difference -0.82 [95% CI -2.57 to 0.93]; p = 0.36). CONCLUSIONS: ESWT did not show clinically important improvement in pain reduction and grip strength. Radial ESWT, symptom duration of longer than 6 months, and short follow-up duration (less than 24 weeks) were related to better effects. Further studies are needed to determine the appropriate protocol and elucidate the effects according to the intervention type and specific disease condition. LEVEL OF EVIDENCE: Level I, therapeutic study.


Asunto(s)
Tratamiento con Ondas de Choque Extracorpóreas/métodos , Codo de Tenista/terapia , Fuerza de la Mano , Humanos , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
10.
Telemed J E Health ; 26(8): 1016-1034, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-31855113

RESUMEN

Background: Factors affecting the effectiveness of telemonitoring in home blood pressure telemonitoring (HBPT) must be examined in an integrated analysis in urban hypertensive patients. Materials and Methods: In a systematic review of electronic databases, we retrieved 1,433 citations and selected 34 comparisons. Specified moderators were the duration of the intervention, the frequency of remote transmission of blood pressure (BP) data, the additional intervention, and the intervention pathway. Results: For the duration of follow-up of HBPT, the weighted mean difference (WMD) in systolic blood pressure (SBP) between two groups was 11.900 mmHg (p-value <0.001) at 2 months and 3.024 mmHg (p = 0.002) at 12 months. The WMD in SBP was 5.512 mmHg (p < 0.001) in cases where data were transmitted daily and 1.818 mmHg (p = 0.084) for monthly transmission. For the group in which further interventions with HBPT were conducted, the WMD in SBP was 3.813 mmHg (p < 0.001). For patients who did not receive additional interventions, the WMD was 2.747 mmHg (p = 0.005). For the pathway of HBPT, the WMD was 6.800 mmHg (p = 0.053) when BP values were remote transmitted through letter, 3.041 mmHg (p = 0.001) through mobile phone/web, 2.224 mmHg (p = 0.043) through telephone-linked computer system, and 4.352 mmHg (p < 0.001) through telephone. Conclusions: The effects of moderators of HBPT systems utilized with urban hypertensive patients differ from those in interventions that did not distinguish urban from rural areas. Results for duration of implementation and frequency of data transmission were significant. Among the interventions using telecommunications, the telephone was the most effective in comparison to other channels.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial , Hipertensión , Presión Sanguínea , Humanos
11.
Telemed J E Health ; 26(6): 744-759, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-31532328

RESUMEN

Background:Remote home blood pressure monitoring (RBPM) has been shown as effective in managing hypertension in underserved areas. Effects on urban patients, who are more easily provided with high-quality medical services, are still unclear. We systematically review previously published randomized controlled trials on the effect of RBPM for urban hypertensive patients.Methods:We searched electronic databases for studies published in English up to October 2018. Studies comparing the use of RBPM to face-to-face care were included. Outcome measures were changes in office blood pressure (BP) and the rate of BP control.Results:We identified 1,433 potential references for screening, of which 27 were eligible for review. Substantial heterogeneity was evident for the investigated variables. A significant standardized mean difference (SMD) was observed for RBPM for systolic BP, but the effect size was small compared to face-to-face care and was clinically irrelevant in avoiding cardiovascular events (0.212, 95% confidence interval 0.148-0.275; p < 0.001). For diastolic BP, the SMD between the two groups was small (0.170, p < 0.001) and the effect of RBPM was irrelevant in preventing cardiovascular events. The effect on the rate of BP control was significantly high for the intervention group (relative risk: 1.136; p = 0.018).Conclusions:This review demonstrates that RBPM performed on urban hypertensive patients has limited value and seems not to be superior to ordinary care in avoidance of cardiovascular events. Further studies are needed to provide more reliable information about the effectiveness of RBPM in preventing hypertensive cardiovascular complications.


Asunto(s)
Hipertensión , Presión Sanguínea , Determinación de la Presión Sanguínea , Monitoreo Ambulatorio de la Presión Arterial , Humanos , Hipertensión/terapia
12.
J Korean Med Sci ; 34(50): e318, 2019 Dec 30.
Artículo en Inglés | MEDLINE | ID: mdl-31880415

RESUMEN

BACKGROUND: The aim of this study was to assess the prognostic value of massive transfusion (MT), critical administration threshold (CAT), and resuscitation intensity (RI) for the mortality of trauma patients with severe hemorrhage. METHODS: Seventeen relevant articles were obtained by searching the PubMed databases through February 15, 2019. The estimated mortality rates and injury severity scores were obtained through a meta-analysis. In addition, diagnostic test accuracy (DTA) reviews were conducted to obtain the sensitivity, specificity, diagnostic odds ratio, and the summary receiver operating characteristic curve. RESULTS: At 24 hours, the estimated mortality rates were 0.194, 0.126, and 0.168 in assessments using MT, CAT, and RI, respectively. In addition, the pooled sensitivity of CAT (0.89; 95% confidence interval [CI], 0.82-0.94) was significantly higher than that of MT (0.63; 95% CI, 0.57-0.68) and RI (0.69; 95% CI, 0.63-0.75). Overall, the pooled specificity of MT and CAT was 0.82 (95% CI, 0.80-0.83) and 0.85 (95% CI, 0.83-0.88), respectively, while the pooled sensitivity was 0.49 (95% CI, 0.44-0.54) and 0.50 (95% CI, 0.38-0.62), respectively. CONCLUSION: CAT may be a more sensitive predictor for 24-hour mortality than other predictors. Furthermore, RI also appears to be a useful predictor for 24-hour mortality. Both MT and CAT showed high specificity for overall mortality.


Asunto(s)
Transfusión Sanguínea , Hemorragia/diagnóstico , Hemorragia/mortalidad , Resucitación , Área Bajo la Curva , Bases de Datos Factuales , Hemorragia/patología , Humanos , Pronóstico , Curva ROC , Factores de Riesgo , Índice de Severidad de la Enfermedad
13.
Geriatr Nurs ; 40(3): 296-301, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30528039

RESUMEN

Despite cumulative and integrative evidence of registered nurse (RN) staffing on nursing home residents' outcomes worldwide, few studies integrate the effects of residents' case mix, healthcare markets, and nurse staffing on psychotropic-medication use and weight loss in Korea. This article examined the relationship between nurse staffing and residents' quality-of-care outcomes, controlling for long-term healthcare market characteristics in Korea. Using a multilevel cross-sectional design, a disproportionate stratified random sampling was used. Of 87 nursing homes contacted, 60 agreed to participate. Weighted linear regression was used to test the hypotheses. RN hours per resident day (HPRD) had a statistically significant positive impact on reducing the number of residents with psychotropic medication (ß = - .331, p = .008). Greater RN HPRD positively marginally related to fewer residents with cognitive impairment (ß = - 0.201, p = .139). Higher turnover of RN staff related to decreased proportions of residents with weight loss (ß = - .331 p = .008). Policymakers should cautiously consider requiring mandatory nurse staffing in nursing homes in Korea, where it is still acceptable to have certified nurse aids as substitutes for RNs.


Asunto(s)
Enfermeras y Enfermeros/provisión & distribución , Casas de Salud/organización & administración , Admisión y Programación de Personal/organización & administración , Estudios Transversales , Sector de Atención de Salud/economía , Sector de Atención de Salud/organización & administración , Humanos , Asistentes de Enfermería/estadística & datos numéricos , Admisión y Programación de Personal/economía , Reorganización del Personal/estadística & datos numéricos , República de Corea
14.
J Korean Med Sci ; 33(44): e275, 2018 Oct 29.
Artículo en Inglés | MEDLINE | ID: mdl-30369857

RESUMEN

BACKGROUND: We compared the efficacy between trifocal and bifocal diffractive intraocular lens (IOL) implantation. METHODS: Through PubMed, MEDLINE, EMBASE, and CENTRAL, we searched potentially relevant articles published from 1990 to 2018. Defocus curves, visual acuities (VAs) were measured as primary outcomes. Spectacle dependence, postoperative refraction, contrast sensitivity (CS), glare, and higher-order aberrations (HOAs) were measured as secondary outcomes. Effects were pooled using random-effects method. RESULTS: We included 11 clinical trials, with a total of 787 eyes (395 subjects). The trifocal IOL group showed better binocular distance VA corrected with defocus levels of -0.5, -1.0, -1.5, and -2.5 diopter than the bifocal IOL group (All P ≤ 0.004). The trifocal IOL group showed better monocular uncorrected distance and intermediate VAs (mean difference [MD], -0.04 logarithm of the minimum angle of resolution [logMAR]; 95% confidence interval [CI], -0.07, -0.01; P = 0.006 and MD, -0.07 logMAR; 95% CI, -0.13, -0.01; P = 0.03, respectively). Postoperative refraction, glare, CS, and HOAs were not significantly different from each other. CONCLUSION: The overall findings indicate that trifocal diffractive IOL implantation is better than the bifocal diffractive IOL in intermediate VA, and provides similar or better in distance and near VAs without any major deterioration in the visual quality.


Asunto(s)
Anteojos , Lentes Intraoculares Multifocales/clasificación , Agudeza Visual , Adulto , Anciano , Extracción de Catarata , Ensayos Clínicos como Asunto , Sensibilidad de Contraste , Femenino , Humanos , Implantación de Lentes Intraoculares , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Prospectivos , Encuestas y Cuestionarios
15.
Pain Manag Nurs ; 19(3): 267-276, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29269181

RESUMEN

OBJECTIVES: We performed a systematic review of the evidence for the effectiveness of bed rest after dural puncture to update current evidence on the topic. DESIGN: The design was a systematic review and meta-analysis. DATA SOURCES: We searched 10 electronic databases in English (Medline, CINAHL, EMBASE, and the Cochrane Controlled Trial Register) and Korean (KISS, KMBASE, NDSL, and RISS) using the terms "post-dural puncture headache," "spinal anesthesia," "epidural anesthesia," and "bed rest" to identify reports discussing the effectiveness of bed rest in preventing post-dural puncture headache (PDPH) after spinal anesthesia from 1980 to 2014. Review/Analysis Methods: Original studies such as randomized and nonrandomized controlled trials, where participants were allocated to an intervention or control group, were included. A total of eight studies that met the inclusion criteria were independently reviewed and encoded by two review authors. To ensure the quality of the eight studies, levels of risk of bias were assessed by two different researchers. The main outcome was the prevalence of PDPH. RESULTS: The included studies indicated that PDPH prevalence did not differ between the group assigned to 24 hours of bed rest and the group assigned to early ambulation. In subgroup analysis, the effect size of clinical factors (severity of headache, day of onset, and needle gauge) and the study characteristics (language and sample size) did not differ between groups. CONCLUSION: This meta-analysis of studies suggested that long-term bed rest after spinal anesthesia may not be effective in preventing PDPH.


Asunto(s)
Reposo en Cama , Ambulación Precoz , Cefalea Pospunción de la Duramadre/prevención & control , Bases de Datos Factuales , Humanos , Proceso de Enfermería , Cefalea Pospunción de la Duramadre/enfermería , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo
16.
Gastrointest Endosc ; 81(5): 1141-9.e1-7, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25765772

RESUMEN

BACKGROUND: Controversies persist regarding the effect of intragastric injection of botulinum toxin A for the treatment of obesity. OBJECTIVE: To assess the efficacy of intragastric botulinum toxin injection for the treatment of obesity. DESIGN: A systematic literature review was conducted by using the core databases. Pre- and posttreatment body weight data were extracted and analyzed by using Hedges' g. A random-effects model was applied. The methodological quality of the enrolled studies was assessed by the risk of bias table and Newcastle-Ottawa Scale. Publication bias was evaluated via the funnel plot, trim and fill method, Egger's test, and rank correlation test. SETTING: Meta-analysis of 8 studies. PATIENTS: A total of 115 patients (79 treated vs 36 placebo). INTERVENTION: Intragastric botulinum toxin A injection. MAIN OUTCOME MEASUREMENTS: Hedges' g, calculated from pre- and posttreatment body weight data and comparison of body weight changes between treatment and placebo group. RESULTS: The treatment group was associated with weight loss in a pre/post comparative approach and compared with the placebo group (Hedges' g: -0.443; 95% confidence interval, -0.845 to -0.040; P = .031; and Hedges' g: -0.521; 95% confidence interval, -0.956 to -0.085; P = .019). Wide area injection including the fundus or body rather than the antrum only was associated with weight loss. Multiple injections (>10) were associated with weight loss. However, a large amount of botulinum toxin A (500 IU) was not associated with weight loss. Sensitivity analyses showed consistent results. Meta-regression for the botulinum toxin A dose and number of injections showed consistent results. Publication bias was not detected. CONCLUSION: In this analysis, intragastric injection of botulinum toxin A is effective for the treatment of obesity.


Asunto(s)
Peso Corporal/efectos de los fármacos , Toxinas Botulínicas Tipo A/administración & dosificación , Fármacos Neuromusculares/administración & dosificación , Obesidad/tratamiento farmacológico , Toxinas Botulínicas Tipo A/uso terapéutico , Relación Dosis-Respuesta a Droga , Humanos , Fármacos Neuromusculares/uso terapéutico , Resultado del Tratamiento
17.
J Korean Med Sci ; 30(6): 749-56, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-26028928

RESUMEN

Controversies persist regarding the effect of Helicobacter pylori eradication on the development of metachronous gastric cancer after endoscopic resection of early gastric cancer (EGC). The aim of this study was to assess the efficacy of Helicobacter pylori eradication after endoscopic resection of EGC for the prevention of metachronous gastric cancer. A systematic literature review and meta-analysis were conducted using the core databases PubMed, EMBASE, and the Cochrane Library. The rates of development of metachronous gastric cancer between the Helicobacter pylori eradication group vs. the non-eradication group were extracted and analyzed using risk ratios (RRs). A random effect model was applied. The methodological quality of the enrolled studies was assessed by the Risk of Bias table and by the Newcastle-Ottawa Scale. Publication bias was evaluated through the funnel plot with trim and fill method, Egger's test, and by the rank correlation test. Ten studies (2 randomized and 8 non-randomized/5,914 patients with EGC or dysplasia) were identified and analyzed. Overall, the Helicobacter pylori eradication group showed a RR of 0.467 (95% CI: 0.362-0.602, P < 0.001) for the development of metachronous gastric cancer after endoscopic resection of EGC. Subgroup analyses showed consistent results. Publication bias was not detected. Helicobacter pylori eradication after endoscopic resection of EGC reduces the occurrence of metachronous gastric cancer.


Asunto(s)
Gastroscopía/estadística & datos numéricos , Infecciones por Helicobacter/prevención & control , Neoplasias Primarias Secundarias/epidemiología , Neoplasias Primarias Secundarias/prevención & control , Neoplasias Gástricas/epidemiología , Neoplasias Gástricas/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada/estadística & datos numéricos , Comorbilidad , Femenino , Infecciones por Helicobacter/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Neoplasias Primarias Secundarias/patología , Factores de Riesgo , Neoplasias Gástricas/patología , Resultado del Tratamiento
18.
Dig Dis Sci ; 59(8): 1862-9, 2014 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-24619279

RESUMEN

BACKGROUND AND AIMS: Although endoscopic submucosal dissection (ESD) has grown popular in resecting lesions in the stomach, the application of ESD to the esophagus has been limited by greater technical difficulty. An increasing number of series have recently reported the application of ESD to esophageal lesions. The aim of the present systemic review and meta-analysis was to evaluate the efficacy and safety of ESD for esophageal lesions. METHODS: Comprehensive literature searches (1999-2012) were performed on studies that reported ESD for the removal of esophageal neoplasia. Primary outcome measures were pooled estimates of complete resection rate and en bloc resection rate. Secondary outcome measures were pooled estimates of complication rates. RESULTS: A total of 15 studies provided data on 776 ESD-treated lesions. The pooled estimate of complete resection rate was 89.4% (95% CI 86.2-91.9%). The pooled estimate of en bloc resection was 95.1% (95% CI 92.6-96.8%). The pooled estimates of complications of ESD such as bleeding, perforation, and stenosis were 2.1, 5.0, and 11.6%, respectively. CONCLUSIONS: ESD appeared to be an extremely effective technique to achieve complete resection of esophageal neoplasia. The very low rate of complications also shows the potential safety of this approach.


Asunto(s)
Carcinoma de Células Escamosas/cirugía , Neoplasias Esofágicas/cirugía , Esofagoscopía , Disección , Humanos , Resultado del Tratamiento
19.
J Epidemiol Community Health ; 78(6): 367-373, 2024 May 09.
Artículo en Inglés | MEDLINE | ID: mdl-38448227

RESUMEN

BACKGROUND: Hypertension, a major public health problem worldwide, has been linked to lifestyle factors and work conditions, with conflicting evidence on the association between long work hours and risk of hypertension. METHODS: We conducted a systematic review and meta-analysis of observational studies to investigate the relationship between working hours and hypertension or blood pressure, assessed the risk of bias and performed subgroup analyses. The protocol was registered with the International Prospective Register of Systematic Reviews. RESULTS: The pooled OR for the association between long working hours and risk of hypertension was 1.09 (95% CI: 0.88 to 1.35) in the 15 studies that used hypertension as the outcome. In the three studies that used blood pressure as the outcome, diastolic blood pressure was higher among those with long working hours compared with those with non-long working hours (1.24 mm Hg, 95% CI: 0.19 to 2.29). In subgroup analysis, the pooled OR for the association between long working hours and risk of hypertension was 1.28 (95% CI: 1.14 to 1.44) and 1.00 (95% CI: 0.64 to 1.56) in women and men, respectively. CONCLUSIONS: Although this study could not clearly confirm the relationship between long working hours and hypertension, the subgroup analysis suggests that long working hours may be associated with hypertension, particularly among women. More reliable research is needed to establish causality. PROSPERO REGISTRATION NUMBER: CRD42023406961.


Asunto(s)
Hipertensión , Tolerancia al Trabajo Programado , Femenino , Humanos , Masculino , Presión Sanguínea , Hipertensión/epidemiología , Factores de Riesgo , Tolerancia al Trabajo Programado/fisiología
20.
Adv Health Sci Educ Theory Pract ; 18(5): 1103-20, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-23283571

RESUMEN

Problem-based learning (PBL) has been identified as an approach that improves the training of nurses by teaching them how to apply theory to clinical practice and by developing their problem-solving skills, which could be used to overcome environmental constraints within clinical practice. A consensus is emerging that there is a need for systematic reviews and meta-analyses regarding a range of selected topics in nursing education. The purpose of this study was to conduct a meta-analysis of the available literature in order to synthesize the effects of PBL in nursing education. Using a number of databases, we identified studies related to the effectiveness of PBL in nursing. An analysis was conducted on a range of outcome variables, including overall effect sizes and effects of evidence and evaluation levels, learning environment, and study characteristics. We found that the effect of PBL in nursing education is 0.70 standard deviations (medium-to-large effect size). We also found that PBL has positive effects on the outcome domains of satisfaction with training, clinical education, and skill course. These results may act as a guide for nurse educators with regard to the conditions under which PBL is more effective than traditional learning strategies.


Asunto(s)
Educación en Enfermería/métodos , Aprendizaje Basado en Problemas , Humanos
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