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ABSTRACT Objective To describe the radiological characteristics of hepatocellular carcinoma (HCC) lesions that achieved a complete response following drug-eluting bead transarterial chemoembolization (DEB-TACE) preceding liver transplantation. Methods This single-center case-control study enrolled patients with hepatocellular carcinoma who underwent neoadjuvant DEB-TACE therapy, were followed up with contrast-enhanced magnetic resonance imaging or computed tomography, and were successively evaluated according to the modified Response Evaluation Criteria in Solid Tumors. The HCCs were divided into two groups based on their diameter (Group A: ≤3cm; Group B: 3cm). Viability was assessed using the Kaplan-Meier method according to tumor size categories. The relationship between tumor variables was analyzed using bivariate Cox regression. Results Three-hundred and twenty-eight patients with 667 hepatocellular carcinomas who underwent their first DEB-TACE session were enrolled. A total of 105 hepatocellular carcinomas in 59 patients exhibited complete response after the initial DEB-TACE session and were divided into Group A (92 HCCs) and Group B (13 HCCs). The diameter in Group A decreased significantly compared to the pre-procedure size until the second assessment (p<0.001), with no subsequent reduction in diameter, despite maintaining a complete response. In Group B, the reduction in diameter remained significant compared with the initial value until the sixth imaging evaluation (p=0.014). The average reduction was 45.1% for Group B and a maximum of 14.9% in Group A. Conclusion HCCs >3cm exhibited a greater reduction in size and a longer time to recurrence. HCCs ≤3cm had a shorter relapse time. The recurrence rates were similar. These findings may aid in planning for liver transplantation.
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OBJECTIVE To establish evaluation criteria for rational drug use of atosiban in clinic， and to provide reference for rational drug use of atosiban in clinic. METHODS Based on the drug instructions of atosiban acetate injection and related guidelines， the experts of the Evaluation Group of Rational Drug Use formulated the evaluation criteria of rational drug use， including 5 primary indexes and 8 secondary indexes. The weight coefficients of secondary indexes were calculated by analytic hierarchy process （AHP）， and the use of atosiban acetate injection in 190 pregnant women from the Third Affiliated Hospital of Guangzhou Medical University （referred to as “our hospital”） was evaluated retrospectively by technique for order preference by similarity to an ideal solution （TOPSIS）. The evaluation results were divided into three levels including reasonable， basic reasonable and unreasonable application based on the relative approach degree. RESULTS Among 190 pregnant women， 49 （25.8%） were treated with atosiban reasonably， 39 （20.5%） were treated with atosiban basic reasonably， and 102 （53.7%） were treated with atosiban unreasonably. The evaluation results obtained by AHP-TOPSIS method were consistent with the actual situation in clinic. The main problems of the unreasonably use were super indications， unreasonable usage and dosage， over the course of treatment and the lack of proper economic consideration. CONCLUSIONS The rationality evaluation criteria of atosiban’s clinical application are established by AHP-TOPSIS method； the evaluation results obtained by this method are quantifiable， scientific and reliable. The unreasonable use of atosiban is common in our hospital， and the management should be strengthened in clinical application.
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Objective To establish the drug use evaluation ( DUE) of Dolasetron, evaluate the rationality of the clinical use of Dolasetron and provide a reference for the rationally clinical use of Dolasetron．Methods On the basis of Dolasetron DUE criteria, a retrospective analysis was made in 794 hospitalized patients from January 2021 to June 2021. Results The drug use evaluation criterion on Dolasetron consisted of drug indications, drug use process, the result of drug use and indication management. Conclusion There are some inappropriate medication problems in Dolasetron utilization in the hospital. The DUE criterion is very practical which could be used to standardize the clinical utilization of Dolasetron.
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Objective:To analyze the relationship between serologically biochemical response and the disease progression trend and prognosis evaluated by traditional structural imaging in patients with radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) treated by apatinib.Methods:A retrospective study was performed on apatinib-treated (phase Ⅱ) patients ( n=19; 9 males, 10 females; age 46.0 (41.0, 57.5) years) with locally advanced/metastatic RAIR-DTC in Peking Union Medical College Hospital from March 2016 to June 2022. The relationships between serum thyroglobulin (Tg) and response evaluation criteria in solid tumors (RECIST) 1.1 structural imaging efficacy evaluation and disease progression trend were analyzed. The relationships between change of Tg after dose adjustment and the change of maximum diameter of target lesions in structure imaging were also discussed. Mann-Whitney U test and Wilcoxon signed-rank test were used to analyze the data. Results:During the median 49.41 months follow-up, the baseline Tg was 363.20(13.08, 2 490.50) μg/L. The Tg time-to-response was 0.47(0.47, 0.98) months, which was 1.80 (1.30, 1.90) months for RECIST 1.1. After 2, 4 and 8 weeks of initial treatment, the median Tg of the whole cohort decreased by 38.68%, 64.70% and 78.94%, respectively. After 8 weeks, the reducing degree of maximum diameter of target lesions was 33.48%. According to the best response, patients were divided into two groups: partial response (PR) group ( n=15) and stable disease (SD) group ( n=4). The median decreasing degree of Tg in PR group and that in SD group were 87.00% and 28.79%, and the reducing degree of maximum diameter of target lesions in corresponding groups were 45.00% and 21.22%. According to the final efficacy evaluation, patients were further divided into two groups: progressive disease (PD) group ( n=13) and non-PD (including PR and SD) group ( n=5). The median increasing degree of Tg in PD group was higher than that in non-PD group (381.55% vs 175.43%; U=10.00, P=0.037). The increasing degree of Tg and that of the maximum diameter of target lesions were 167.31% and 2.14% after the 1st adjustment, which were 231.06% and 9.73% after the 2nd adjustment. The differences of changes in Tg and maximum diameter of target lesions before and after the 1st dose adjustment were statistically significant ( z values: -3.06 and -2.23, P values: 0.002 and 0.026). Conclusion:During the apatinib treatment of RAIR-DTC, Tg can reflect the therapeutic effect of apatinib earlier than traditional imaging (RECIST 1.1), indicating the disease progression trend more sensitively.
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Resumo Introdução Em um contexto de crescente restrição fiscal após 2014, as avaliações de políticas públicas têm tomado um caráter cada vez mais economicista, privilegiando a eficiência dos programas e ações em detrimento de outros critérios avaliativos. Objetivo Este texto procura resgatar a historicidade do "fazer avaliativo", trazendo-a à luz da constituição do Estado de Bem-Estar nos países centrais ao longo do século XX, destacando as ênfases temáticas e metodológicas que o campo de avaliação foi assumindo em cada período. Método Texto resultante de revisão bibliográfica e discussão ensaística. Resultados Remetendo-se essa discussão para o Brasil, evidenciam-se os limites do "eficiencismo" como critério primaz em relação a outros valores públicos assegurados no desenho e na implementação de políticas públicas pela Constituição de 1988 e outros documentos normativos. Conclusão Tal viés avaliativo, em contexto de baixas taxas de crescimento econômico e limitações impostas pelo Teto dos Gastos Federais, traz risco concreto de interrupção da trilha civilizatória que o país vinha seguindo nos últimos 30 anos.
Abstract Background In a context of increasing fiscal constraint after 2014, public policy evaluations have become increasingly economical, favoring the efficiency of programs and interventions over other evaluation criteria. Objective This paper brings the historicity of "evaluative doing", presenting it along the constitution of the welfare state in central countries throughout the twentieth century, highlighting the thematic and methodological emphases that the evaluation field has assumed in each period. Method Text resulting from literature review and essay discussion. Results This discussion is referred to Brazil to demonstrate the limits of "efficiency" as a prime criterion over other public values ensured in the design and implementation of Public Policies by the 1988 Constitution and other normative documents. Conclusion Such an evaluation bias, in the context of low economic growth rates and limitations imposed by the Federal Public Spending Law, brings a concrete risk of interruption of the civilization path that the country has been following for the past 30 years.
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Objective:To analyze the clinical teachers′ cognitive evaluation of the residency training system and faculty competency through a survey , which in the standardized residency training bases of Zhejiang province, in the hope of providing a basis for exploring and reforming the training and the mechanism.Methods:A web-based questionnaire survey was made from December 2017 to December 2019 on clinical teachers at training bases in Zhejiang province. Data cleaning and statistical analysis were made under Anaconda1 9.7, multiple groups of numerical variables were analyzed by one-way ANOVA, and classified variables were subject to χ2 analysis, while the analysis was carried out after binarization in the statistical calculation of multi-choice items. Results:3 141 of valid questionnaires were received. The clinical teachers at large highly recognize the competency degree expected of the teachers, while those items of relatively lower recognition were " the ability to regularly publish research papers" " the ability to guide the trainees′ living style" , and " the ability to use multimedia teaching materials" (41.13%, 46.23%, and 47.02% respectively). 77.36% of the teachers reported that they need coordination and management ability training, while 83.38% need teaching ability training. The proportion of teachers in need of teaching ability training was influenced by both professional title( χ2=18.703, P < 0.001)and seniority( χ2=14.471, P=0.006). For the subjective criteria by the teachers on faculty competency assessment criteria, the scoring ranks from high to low were clinical ability, medical ethics, and teaching awareness(8.91±1.35, 8.86±1.52 and 8.64±1.47 respectively). For the operability criteria, the scoring ranks from high to low were professional title, education, and faculty training(8.47±1.80, 8.36±1.86 and 8.19±1.91 respectively), while the outcomes were influenced by the administrative title, professional title and seniority( P < 0.05). Only 39.03% and 33.37% of clinical teachers were satisfied or somewhat satisfied with the existing incentives for residency training. Conclusions:The teachers′ recognition of the criteria for faculty competency evaluating and the need for teacher training were influenced by their characteristics, and they were unsatisfied with the existing incentive policies. These suggest comprehensive factors in formulating the evaluation standards, and measures for progressive faculty training and for improved incentive policies.
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Immune checkpoint inhibitors have already been the promising novel treatment of cancer therapy. The response pattern of immunotherapy is different from that of traditional cytotoxic therapies and may present delayed response, pseudoprogression or hyperprogression. Traditional RECIST is difficult to identify new treatment response patterns, thus underestimating the efficacy of immunotherapy. Therefore, a series of criteria for evaluating the efficacy of immunotherapy, such as iRECIST, emerged. This paper reviews the recent progress and application of imaging methods in the evaluation criteria of immunotherapy efficacy.
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OBJECTIVE：To establish the eva luation criteria for the rationality of tumor nutritional standardized treatment ，and to provide reference for nutritional standardized treatment in tumer patients . METHODS ：Based on domestic and foreign guidelines or expert consensus ，the rationality evaluation standard of tumor nutritional standardized treatmentwas formulated in our hospital （Bozhou Municipal People ’s Hospital ）. 50 nutritional treatment medical records in our hospital from Jan. to Jun. 2019 were evaluated by weighted TOPSIS ；according to the evaluation results ，nutritional intervention was carried out ，and 50 nutritional treatment medical records （group B ）from Aug. to Dec. 2019 were re-evaluated by the same method after intervention. RESULTS ： The established evaluation criteria for the rationality of tumor nutritional standardized treatment in our hospital included 18 indicators，such as malnutrition diagnosis ，description of the nature of malnutrition ，nutrition screening and evaluation ，etc. After analysis ，the rational rate of nutritional treatment was only 18％ in group A （Ci of ideal solution with 9 medical records≥0.6），and 78％ in group B （Ci of ideal solution with59 medical records ≥0.6）. There was statistical significance in the rationality of nutritional treatment before and after nutritional intervention （Ci≥0.6）（P＜0.05）. CONCLUSIONS ：The established rational evaluation method of tumor nutritional standardized treatment is feasible ，and the evaluation results are intuitive and reasonable. Nutrition intervention is helpful to reduce the irrational rate of nutritional treatment.
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ObjectiveTo investigate the association of Modified Response Evaluation Criteria in Solid Tumors (mRECIST) response with the prognosis of patients with unresectable hepatocellular carcinoma (HCC) after transarterial embolization (TACE). MethodsA retrospective analysis was performed for the clinical data of 190 patients with unresectable HCC who were consecutively admitted to Department of Liver Disease and Digestive Interventional Radiology, The First Affiliated Hospital of Air Force Medical University, and treated with TACE from January 2010 to December 2014. The mRECIST criteria were used to evaluate imaging response after TACE; the patients with complete response (CR) or partial response (PR) were enrolled as response group(n=89), and those with progressive disease (PD) or stable disease (SD) were enrolled as non-response group(n=101). The Kaplan-Meier method was used to calculate median survival time, and the log-rank test was used for comparison between groups; the Cox regression model was used to identify the influencing factors for prognosis. ResultsAccording to the mRECIST criteria, 39 patients (20.5%) achieved CR, 50 (26.3%) achieved PR, 67 (35.3%) had SD, and 34 (17.9%) had PD. The objective response rate based on mRECIST was 46.8% for the whole population. The response group had a significantly longer survival time than the non-response group, and the median survival time was 29.9 (95% confidence interval ［CI］: 25.0-34.8) months for the response group and 7.5 (95% CI: 5.7-9.3) months for the non-response group (P＜0.001). The multivariate analysis showed that mRECIST response (hazard ratio ［HR］=2.02, P＜0.001), hepatitis B (HR=4.03, P＜0.001), and portal invasion (HR=2.12, P=0.008) were independent risk factors for survival. ConclusionThe mRECIST response has a certain value in predicting the prognosis of patients with unresectable HCC after TACE.
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Context: Spirometry is an important tool to monitor treatment response in diseases such as chronic obstructive pulmonary disease and asthma. However, there is lack of evidence to support its application to evaluate response to chemotherapy in advanced lung cancer. It might be a useful adjunct to the imaging-based response evaluation which lacks functional assessment of lungs. Aims: The study was conducted to evaluate the change in spirometry in lung cancer patients after chemotherapy and to find its correlation with change in physical tumor size. Subjects and Methods: Sixty-two advanced lung cancer patients who were eligible for palliative chemotherapy were enrolled. Baseline tumor size evaluation using Response Evaluation Criteria in Solid Tumor (RECIST)-based scoring system, and spirometry was done. Four cycles of double agent (platinum doublets) chemotherapy were administered, after which treatment response was evaluated. Repeat spirometry was analyzed and correlated with changes in physical tumor size. Results: Twenty-five patients showed a response (all partial response) to four cycles of chemotherapy. Small cell carcinoma showed a better response rate than non-small cell carcinoma (78% vs. 39%). There was statistically significant improvement in forced expiratory volume in 1 (FEV1) (P = 0.01) and forced vital capacity (P = 0.03) in responders as compared to nonresponders. Change in FEV1 showed a statistically significant correlation with the change in tumor size (RECIST score) (r = –0.34; P = 0.04). Conclusions: Improvement in spirometry correlates with the tumor response as judged using RECIST criteria after chemotherapy. Further studies with bigger sample size are required to consolidate the results
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Liver transplantation, although recognized as the only effective radical treatment for severe liver disease, might be accompanied by high surgical risks, high perioperative mortality and high postoperative complications. Considering the shortage of donor liver and related surgical risks, it is necessary to strictly control the indication of operation and the opportunity of transplantation. Therefore, accurate diagnosis and comprehensive evaluation of the condition of patients with severe liver disease to be treated by liver transplantation is an important part in determining the treatment plan. At present, there are many evaluation criteria for severe liver disease. In addition to the classic ChildTurcotte-Pugh (CTP) score and model for end-stage liver disease (MELD) score, many other evaluation criteria have also been developed. All transplant centers have their own choices and thus there is no uniform diagnostic criterion, with disputes among various criteria, which is exactly what this paper aims to summarize.
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Objective The aim of the study was to investigate association of response depth and prognosis in epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC)patients treated with first-line tyrosine kinase inhibitors (TKIs).Methods The clinicopathological data and prognosis information of patients with locally advanced or metastatic (Ⅲ B or Ⅳ) lung adenocarcinoma with EGFR classical (19del or 21L858R) mutation who were treated in our hospital from 2015 to 2016 were collected.The tumor remission depth [stable disease (SD),partial response (PR),complete response (CR)] was measured by recist 1.1 standard.The survival curve was drawn by Kaplan-Meier method and log rank test was performed.Results During the study period,204 advanced lung adenocarcinoma patients with 19del or 21L858R mutation were treated with TKI drugs of the first generation.Among them,24 patients were lost or unable to evaluate the efficacy,20 patients were evaluated as progression disease (PD),62 patients as SD,98 patients as CR or PR.Disease control rate (DCR) and objective remission rate (ORR) were 88.9％ and 54.4％,respectively.The median progression free survival time (PFS) was 12.6 months (95％ CI:10.9-14.4 months) and 13.1 months (95％ CI:11.6-14.7) for patients assessed as SD (group A) and CR or PR (group B),respectively,with no significant difference (P =0.27).Subgroup analysis showed that the median overall survival of patients with EGFR 19del and 21L858R mutations was 12.5 months (95％ CI:9.9-15.4) and 12.7 months (95％ CI:9.4-16.1),respectively,with no significant difference (P =0.66);Similar result was also observed in Group B with a median PFS of 13.9 months (95％ CI:12.3-15.5 months) and 12.3 months (95％ CI:9.5-15.1 months) in patients who had EGFR 19del or 21L858R mutations (P =0.41).Conclusions Response depth was not a positive predictor for prognosis in EGFR-mutant NSCLC patients treated with first-line TKIs.
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Liuwei Dihuang Pills is a typical traditional Chinese medicine with "the same product made by many manufacturers". The quality and price of products made in various factories was different obviously. In this study, the quality differences of Liuwei Dihuang Pills were evaluated over multi-dimensions and throughout the whole production cycle involving raw materials, production process, quality control and post-marketing re-studies based on the "Chinese patent medicine evaluation standard with quality at the core" established earlier by our research group. The research results showed that the product quality of various manufacturers was significantly different, and the product quality was positively correlated with the market shares of enterprises, indicating that enterprises with more market shares paid more attention to product quality; and the sales determined the concern degree of enterprises on products, which was in line with general cognition. During the single-item evaluation of Liuwei Dihuang Pills, the score of raw material selection was relatively low, and the enterprises paid less attention to the initial raw materials. The whole production process was better, and the national compulsory implementation of "Production Quality Management Standard"(GMP) had a positive effect in improving product quality. Quality control could basically guarantee product quality. Intelligent manufacturing promoted by the government was beneficial to ensure product uniformity. The score rate of "quality evaluation" item was basically qualified, which indicated that the quality control level of Liuwei Dihuang Pills was acceptable as a whole, but there was still room for improvement. "Re-evaluation and Brand Construction" had the lowest scores, reflecting that enterprises did not pay enough attention to in-depth study and re-evaluation of "the same product made by many manufacturers". The evaluation results were in line with expectations, provided a reference example for the evaluation of high-quality Chinese patent medicine, a basis for the high-quality and good price of Chinese patent medicine, scientific data for improving medical insurance bidding, and thus facilitated promoting the healthy development of the traditional Chinese medicine industry.
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Drugs, Chinese Herbal/analysis , Medicine, Chinese Traditional , Nonprescription Drugs , Quality ControlABSTRACT
Objective@#The aim of the study was to investigate association of response depth and prognosis in epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC)patients treated with first-line tyrosine kinase inhibitors (TKIs).@*Methods@#The clinicopathological data and prognosis information of patients with locally advanced or metastatic (ⅢB or Ⅳ) lung adenocarcinoma with EGFR classical (19del or 21L858R) mutation who were treated in our hospital from 2015 to 2016 were collected. The tumor remission depth [stable disease (SD), partial response (PR), complete response (CR)] was measured by recist 1.1 standard. The survival curve was drawn by Kaplan-Meier method and log rank test was performed.@*Results@#During the study period, 204 advanced lung adenocarcinoma patients with 19del or 21L858R mutation were treated with TKI drugs of the first generation. Among them, 24 patients were lost or unable to evaluate the efficacy, 20 patients were evaluated as progression disease (PD), 62 patients as SD, 98 patients as CR or PR. Disease control rate (DCR) and objective remission rate (ORR) were 88.9% and 54.4%, respectively. The median progression free survival time (PFS) was 12.6 months (95% CI: 10.9-14.4 months) and 13.1 months (95% CI: 11.6-14.7) for patients assessed as SD (group A) and CR or PR (group B), respectively, with no significant difference (P=0.27). Subgroup analysis showed that the median overall survival of patients with EGFR 19del and 21L858R mutations was 12.5 months (95% CI: 9.9-15.4) and 12.7 months (95% CI: 9.4-16.1), respectively, with no significant difference (P=0.66); Similar result was also observed in Group B with a median PFS of 13.9 months (95% CI: 12.3-15.5 months) and 12.3 months (95% CI: 9.5-15.1 months) in patients who had EGFR 19del or 21L858R mutations (P=0.41).@*Conclusions@#Response depth was not a positive predictor for prognosis in EGFR-mutant NSCLC patients treated with first-line TKIs.
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We are planning a study focused on the gathering of clinical data for the purpose of formalizing diagnostic logic at 6 institutions specialized in Kampo-based medical examinations. However, during the planning stage, it has been recognized that there are a large number of Kampo formulas to be studied, and differences among faculties and individuals exist regarding how to identify each Kampo formula, methods of gathering findings, and the evaluation of efficacy. Here we report the solution proposal reached after building consensus among all participating faculties on these issues. After raising the issues, conferences were held for each of them, until a unanimous consensus was obtained. As a result, the following conclusions were reached. Thirty-three Kampo formulas were selected as targets for the formalization of diagnostic logic. In addition, the range of dosage forms, crude drug ingredients, and permissible dosages for each Kampo formula were determined. Regarding clinical findings for these Kampo medicines, the items to be collected and evaluation criteria were also established. The criteria for evaluating the validity and safety of each Kampo medicine were decided, together with the grading and timing of evaluation. We hope that our solution proposal reached after building consensus becomes the basis for Kampo research in the future.
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Resumen Este artículo presenta el estado del arte acerca de las evaluaciones de tecnología y los aportes que han sido realizados a nivel hospitalario en diversos países del mundo. La incorporación de tecnologías sanitarias está enfocado al mejoramiento de la calidad y la eficiencia en la prestación de los servicios de salud. La evaluación de tecnología son un proceso científico, multidisciplinario y multidimensional que tiene como objetivo contribuir y mejorar la toma de decisiones en los procedimientos de adquisición e incorporación tecnológica, mediante la evaluación comparativa de los efectos positivos y negativos de las tecnologías en hospitales. El propósito generalmente considera diversas alternativas, proporcionando la mejor selección de tecnología que compense las necesidades médicas en instituciones de salud. A nivel mundial han trabajado constantemente para mejorar los procesos de evaluación de tecnología en el ámbito nacional y hospitalario. La implementación de las metodologías de evaluación en hospitales permite contribuir a la disminución de los riesgos generados por el uso de los dispositivos o equipos médicos en relación con la seguridad de los pacientes implementando tecnologías eficaces para diversos tratamientos. En conclusión, la evaluaciones de tecnología es un proceso fundamental que proporciona información relevante para la toma de decisiones para las incorporaciones de nuevos dispositivos médicos en hospitales.
Abstract This article presents the state of the art about the evaluations of technology and the contributions that have been made at a hospital level in different countries of the world. The incorporation of health technologies is focused on the improvement of quality and efficiency in the provision of health services. The evaluation of technology is a scientific, multidisciplinary and multidimensional process that aims to contribute and improve decision making in the procedures of acquisition and technological incorporation, through the comparative evaluation of the positive and negative effects of technologies in hospitals. The purpose generally considers various alternatives, providing the best selection of technology that compensates for medical needs in health institutions. At the global level, they have constantly worked to improve the technology assessment processes at the national and hospital levels. The implementation of evaluation methodologies in hospitals allows contributing to the reduction of the risks generated using medical devices or equipment in relation to patient safety by implementing effective technologies for various treatments. In conclusion, the technology assessment is a fundamental process that provides relevant information for decision making for the incorporation of new medical devices in hospitals.
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Objective Early evaluate the feasibility and reproducibility of sorafenib-targeted therapy for hepatocellular carcinoma by RECIST1.1, mRECIST and three-dimensional volume measurement. Methods Seventy patients with pathology or typical imaging findings confirmed as hepatocellular carcinoma along with the sorafenib-targeted treatment for more than 2 months between October 2004 to April 2017 in the Fifth Affiliated Hospital of Sun Yat-sen University were retrospectively analyzed. Patients underwent chest, abdominal and pelvic CT scans and enhanced scans before and after 2 weeks of sorafenib treatment. Two physicians used RECIST 1.1, mRECIST, and volume measurement criteria to evaluate the efficacy of treatment. According to their averaged results, the patients were divided into two groups (control group and non-control group). Kaplan-Meier survival analysis was used to compare the prognostic values between different response evaluation criterias for early predicting the efficacy of sorafenib-targeted therapy in advanced hepatocellular carcinoma. Kappa test was used to assess the efficacy response consistency in intra-group and inter-group. Results Based on mRECIST and RECIST 1.1 measurements, the control group included 34 cases, and the non-control group included 36 cases. Based on semi-automatic volume measurement, the control group included 38 cases, and the non-control group included 32 cases. Before the treatment with sorafenib, the RECIST 1.1 and mRECIST methods were used. There was a high degree of consistency between the two doctors (Kappa values were 0.79 and 0.71, respectively), and the semi-automatic volume measurement method was extremely consistent (Kappa value was 0.90); the consistency in intra-observer by three different methods was extremely high (Kappa values were 0.91, 0.85, 0.97, respectively). After the treatment with sorafenib, the consistency between the two radiologists using RECIST 1.1 measurement was high (Kappa value was 0.65), the consistency of mRECIST measurement was moderate (Kappa value was 0.52), and the consistency of tumor volume measurement was extremely high (Kappa The value was 0.83), the consistency in intra-observer using the above three methods was high or very high (Kappa values were 0.86, 0.74, 0.90, respectively). The RECIST 1.1 and mRECIST measurements were less sensitive in early evaluation of sorafenib-targeted treatment, and there was no significant difference between the control group and the non-control group (P=0.578 and 0.613) while the semi-automatic volumetric measurement was sensitive (P=0.004). Conclusion Semi-automated three-dimensional volume measurement which has better intra-and inter-group consistency and reproducibility can reflect the efficacy of sorafenib-targeted therapy for hepatocellular carcinoma in early stage.
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Juvenile idiopathic arthritis (JIA) is a common chronic rheumatic disease in children.JIA can be complicated by infection,macrophage activation syndrome,growth retardation,and joint deformity during the diagnosis and treatment.If JIA patients are not given timely and adequate treatment,the prognosis is significantly worse than that of patients after treatment,and even about one-third of children with JIA will have persistent active disease into adulthood.In order to quickly assess whether there is any remission of the disease,it is necessary to provide timely basis for adjusting the treatment plan to reduce the occurrence of complications.Thus,an effective and feasible JIA assessment standard is needed.However,there is no uniform evaluation standard at home and abroad for the JIA assessment.This article summarizes the latest developments in the relevant JIA assessment standards,and discusses JIA-related assessment criteria in aspects of efficacy assessments and prognostic assessments.
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Objective@#To evaluate Chinese clinical practice guideline/consensus for digestive diseases published in the past five years in order to recommend the high-quality guidelines and help with the promotion and implementation of them.@*Methods@#From January 2013 to June 2018, the officially published Chinese practice guideline/consensus for digestive diseases were selected. The inclusion and exclusion criteria of the guideline/consensus was evaluated by "Evaluation Criteria for Chinese Clinical Practice Guidelines 2017(AGREE-China 2017)" . The guideline/consensus were independently scored by three evaluators and then calculated the average value. Descriptive analysis methods were used to analyze the Chinese clinical practice guideline/consensus for digestive diseases. Those with the total score more than 40.0 points were included in the recommended list.@*Results@#A total of 119 officially published clinical practice guideline/consensus of digestive diseases were retrieved, and 74 clinical practice guideline/consensus for digestive diseases were included in the evaluation. Among them, 18 (24.3%, 18/74) scored over 60.0 points, 31 (41.9%, 31/74) scored between 40.0 and 59.9 points. Finally 48 guideline or consesus were selected for the recommended list 19 cases of esophagus and gastrointestinal diseases, 18 cases of liver diseases, five cases of biliary and pancreafic diseases, and six cases of digestive endoscopy. The three guideline/consensus with the high scores (> 80.0 points) were The Fifth Chinese National Consensus Report on the Maragement of Helicobacter pylori Infection, Consensus on the Diagnosis and Treatmeat of Cholestatic Liver Disease (2015) and Guidelines for the Prevention and Treatment of Chroaic Hepatitis B (2015 Update). The higher the score of the guideline/consensus, the more scientific and rigorous the method, and the clearer the evaluation of evidence grade and the description of the formation of recommendations. Compared with international standards of guideline/consensus development, there are still some problems in Chinese guidelines or consensus such as no explanation of retrieval strategy, no basis of evidence classification and no description of the formation process from evidence to recommendation.@*Conclusions@#The quality of Chinese clinical practice guideline/consensus for digestive diseases has been improved year by year. However the scientific aspects need to be further improved. AGREE-China which demonstrates good validity, realiability and practicability is easy and clear to use.
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Traditional Chinese medicine animal models are widely used in the field of traditional Chinese medicine research. The combination of disease and syndrome models has become the trend of the development of traditional Chinese medicine animal models. In this paper, we find that model manufacturing still exists problems as following through literature review: the selected animals are not in conformity with the constitution of disease population; some diseases lack syndrome manifestation; the correlation between diseases and syndromes are not strong; the disease syndrome combined with animal model evaluation system is deficient and etc. The application of the model exists: ignore the periodicity of the model; ignore the impact of the environment on the animal model; toxicological research has the problem that normal animals are not suitable for TCM toxicology research. This paper proposes from six aspects: construct the animal model that conforms to the constitution of diseased population; expand the scope of use of the disease and syndrome combined animal model; use the theory of traditional Chinese medicine of “five transports and six qi”, “streamer midnight-midday ebb flow”, “seven emotions”, and “six kinky” climate box, and combined with “four diagnosis information” to solve the problem of weak correlation between diseases and syndromes; using “syndrome” index + “disease” indicators to improve the model evaluation criterion from four diagnostic information, biochemical indicators, molecular biology, and etc. Pay attention to the periodicity of the model, and pay particular attention to the influence of the environment on the formation of the animal model syndrome; In the toxicology research, the model animal should be used instead of the normal animal application, and the dosage of the traditional Chinese medicine should be adjusted to improve the efficacy of traditional Chinese medicine. Through the improvement of the above problems, it is expected to provide relevant reference for the improvement of the animal model of Chinese medicine and its correct application.