The NI (non-inferiority) trial design based on the likelihood ratio test eliminates the dependency on the conventional NI margin, and it explicitly uses the MCID (minimum clinical important difference) that links ...The NI (non-inferiority) trial design based on the likelihood ratio test eliminates the dependency on the conventional NI margin, and it explicitly uses the MCID (minimum clinical important difference) that links the statistical analysis to the clinical sense. Different from the conventional trial design, the new methodology is self-adaptive to the change in the sample size and overall cure rate, and it has an asymptotic property. It is shown that MCID is de-composite into constant MCID and statistical MCID. Along with this concept, the concept of the allowed inferiority does not exist, the interpretation of the trial result is more accurate and consistent to the statistical theory as well as the clinical interpretations.展开更多
There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant b...There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant benefits may be marginal and may not be related to clinical meaningfulness. The typical treatment vs. placebo comparison necessitated by ‘gold standard' randomised controlled trials(RCTs) is not necessarily applicable. The complex multimorbidity of end of life care involves considerations of the patient's physical, psychological, social and spiritual needs. In addition, the field of palliative care covers a heterogeneous group of chronic and incurable diseases no longer limited to cancer. Adequate sample sizes can be difficult to achieve, reducing the power of studies and high attrition rates can result in inadequate follow up periods. This review uses examples of the management of cancer-related fatigue and death rattle(noisy breathing) to demonstrate the current state of EBM in palliative care. The future of EBM in palliative care needs to be as diverse as the patients who ultimately derive benefit. Non-RCT methodologies of equivalent quality, validity and size conducted by collaborative research networks using a ‘mixed methods approach' are likely to pose the correct clinical questions and derive evidencebased yet clinically relevant outcomes.展开更多
Objective: The aim of this study was to discuss HIF-la expression and vasculogenic mimicry (VM) in hepatocel- lular carcinoma (HCC) and their relationship with the clinical pathological features and clinical sign...Objective: The aim of this study was to discuss HIF-la expression and vasculogenic mimicry (VM) in hepatocel- lular carcinoma (HCC) and their relationship with the clinical pathological features and clinical significance. Methods: Two hundred and seven specimens from patients in The Affiliated Hospital of North Sichuan Medical College who received hepatic cell carcinoma resection were tested by immunohistochemistry and double staining of CD31 and PSA. Then detected the expression of HIF-la, VM, and analysed the relationship between clinical pathology. Results: The HIF-la positive rate was 71.01% and its expression was associated with liver cirrhosis, tumor size and TNM stage (P 〈 0.05). HIF-la protein expres- sion was positively associated with the VM (y = 0.1988, P = 0.0041). Conclusion: Hypoxia may be the reason for VM in high invasive HCC, regulating the tumor microenvironment may have great significance in inhibiting invasion and metastasis of HCC.展开更多
Objective: The aim of this study was to investigate the clinical value and relevance on the serum β2-microglobulin (β2-MG) of patients with thyroid cancer. Methods: One thousand and two normal cases, 95 thyroid ...Objective: The aim of this study was to investigate the clinical value and relevance on the serum β2-microglobulin (β2-MG) of patients with thyroid cancer. Methods: One thousand and two normal cases, 95 thyroid cancer patients and 243 nodular goiter patients were selected to measure serum β2-MG levels using double-antibody sandwich enzyme-linked immunosorbent assay (ELISA). Results: The positive rate of 7.78% in normal population (78/1002) and 31.57% in thyroid cancer patients (30/95). There were significant differences between the normal population and thyroid cancer patients (X2 = 55.352; P = 0.000). The positive rate of 7.81% in nodular goiter patients (19/243) and there were no significant differences between the normal population and nodular goiter patients (X2 = 0.0004; P = 0.986), but significant differences between nodular goiter patients and thyroid cancer patients (x2 = 31.106; P = 0.000). Meanwhile, the significant difference of the positive rate existed in between the various pathological types of thyroid cancer (X2 = 10.015; P = 0.007), anaplastic thyroid cancer patients with the highest positive rate and The significant difference was found between the positive lymph node metastasis groups and negative lymph node metastasis groups (x2 = 4.441; P = 0.035), the presence of distant metastasis group and absence of distant metastasis group (X2 = 9.795; P = 0.002). Conclusion: Serum β2-MG levels and prognosis of thyroid cancer patients was negatively correlated. It showed important clinical value to detect the level of β2-MG in the early diagnosis, prognosis and the clinical observation for thyroid cancer patients.展开更多
文摘The NI (non-inferiority) trial design based on the likelihood ratio test eliminates the dependency on the conventional NI margin, and it explicitly uses the MCID (minimum clinical important difference) that links the statistical analysis to the clinical sense. Different from the conventional trial design, the new methodology is self-adaptive to the change in the sample size and overall cure rate, and it has an asymptotic property. It is shown that MCID is de-composite into constant MCID and statistical MCID. Along with this concept, the concept of the allowed inferiority does not exist, the interpretation of the trial result is more accurate and consistent to the statistical theory as well as the clinical interpretations.
文摘There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant benefits may be marginal and may not be related to clinical meaningfulness. The typical treatment vs. placebo comparison necessitated by ‘gold standard' randomised controlled trials(RCTs) is not necessarily applicable. The complex multimorbidity of end of life care involves considerations of the patient's physical, psychological, social and spiritual needs. In addition, the field of palliative care covers a heterogeneous group of chronic and incurable diseases no longer limited to cancer. Adequate sample sizes can be difficult to achieve, reducing the power of studies and high attrition rates can result in inadequate follow up periods. This review uses examples of the management of cancer-related fatigue and death rattle(noisy breathing) to demonstrate the current state of EBM in palliative care. The future of EBM in palliative care needs to be as diverse as the patients who ultimately derive benefit. Non-RCT methodologies of equivalent quality, validity and size conducted by collaborative research networks using a ‘mixed methods approach' are likely to pose the correct clinical questions and derive evidencebased yet clinically relevant outcomes.
基金Supported by a grant from Key Breeding Project of North Sichuan Medical College(No.CBY11-A-ZP16)
文摘Objective: The aim of this study was to discuss HIF-la expression and vasculogenic mimicry (VM) in hepatocel- lular carcinoma (HCC) and their relationship with the clinical pathological features and clinical significance. Methods: Two hundred and seven specimens from patients in The Affiliated Hospital of North Sichuan Medical College who received hepatic cell carcinoma resection were tested by immunohistochemistry and double staining of CD31 and PSA. Then detected the expression of HIF-la, VM, and analysed the relationship between clinical pathology. Results: The HIF-la positive rate was 71.01% and its expression was associated with liver cirrhosis, tumor size and TNM stage (P 〈 0.05). HIF-la protein expres- sion was positively associated with the VM (y = 0.1988, P = 0.0041). Conclusion: Hypoxia may be the reason for VM in high invasive HCC, regulating the tumor microenvironment may have great significance in inhibiting invasion and metastasis of HCC.
文摘Objective: The aim of this study was to investigate the clinical value and relevance on the serum β2-microglobulin (β2-MG) of patients with thyroid cancer. Methods: One thousand and two normal cases, 95 thyroid cancer patients and 243 nodular goiter patients were selected to measure serum β2-MG levels using double-antibody sandwich enzyme-linked immunosorbent assay (ELISA). Results: The positive rate of 7.78% in normal population (78/1002) and 31.57% in thyroid cancer patients (30/95). There were significant differences between the normal population and thyroid cancer patients (X2 = 55.352; P = 0.000). The positive rate of 7.81% in nodular goiter patients (19/243) and there were no significant differences between the normal population and nodular goiter patients (X2 = 0.0004; P = 0.986), but significant differences between nodular goiter patients and thyroid cancer patients (x2 = 31.106; P = 0.000). Meanwhile, the significant difference of the positive rate existed in between the various pathological types of thyroid cancer (X2 = 10.015; P = 0.007), anaplastic thyroid cancer patients with the highest positive rate and The significant difference was found between the positive lymph node metastasis groups and negative lymph node metastasis groups (x2 = 4.441; P = 0.035), the presence of distant metastasis group and absence of distant metastasis group (X2 = 9.795; P = 0.002). Conclusion: Serum β2-MG levels and prognosis of thyroid cancer patients was negatively correlated. It showed important clinical value to detect the level of β2-MG in the early diagnosis, prognosis and the clinical observation for thyroid cancer patients.