After the completion of a clinical trial, its conclusion generally depends on the results of statistical analysis of the main outcome, that is, whether the P-value in the hypothesis test is less than the α level of the hypothesis test, usually α=0.05. The size of the P-value indicates the sufficient degree of reason for making the hypothesis judgment, and can be interpreted as to determine whether a conclusion is statistically significant but does not involve the difference in the degree of drug effects or other effects. Fragility index, which is, the minimum number of patients required to change the occurrence of a target outcome event to a non-target outcome event from a statistically significant outcome to a non-significant outcome, can be used to assist in understanding of clinical trial statistical inference results and assisting in clinical decision making This paper discusses the concept, calculation method and clinical application of the fragility index, and recommends that the fragility index be routinely reported in all future randomized controlled trials to help patient clinicians and policymakers make appropriate and optimal decisions.
ObjectiveTo explore the different imaging manifestations of osteonecrosis of the femoral head (ONFH) and their correlation with the occurrence of pain during the peri-collapse period.MethodsThe 372 patients (624 hips) with ONFH in the peri-collapse stage who were admitted between December 2016 and October 2019 and met the selection criteria were selected as the research objects. Among them, there were 270 males and 102 females, with an average age of 35.3 years (mean, 15-65 years). There were 120 cases of unilateral hip and 252 cases of bilateral hips. There were 39 cases (39 hips) of traumatic ONFH, 196 cases (346 hips) of hormonal ONFH, 102 cases (178 hips) of alcoholic ONFH, and 35 cases (61 hips) of idiopathic ONFH. Among them, there were 482 hips with pain symptoms and 142 hips without pain. The pain duration was less than 3 months in 212 hips, 3-6 months in 124 hips, 6-12 months in 117 hips, and more than 12 months in 29 hips. According to the Association Research Circulation Osseous (ARCO) staging, the ONFH was rated as stage Ⅱ in 325 hips and stage Ⅲ in 299 hips. The patients were grouped according to ONFH etiology and ARCO staging, and hip joint pain and X-ray film (crescent sign and cystic changes), CT (subchondral bone fractures and cystic changes), and MRI (bone marrow edema, joint effusion, and subchondral hypointensity zone) were compared. Spearman rank correlation was used to determine the correlation between ONFH pain duration and X-ray film, CT, and MRI imaging manifestations.ResultsThere were significant differences (P<0.05) between ONFH patients with different etiologies in crescent sign on X-ray film, subchondral bone fracture on CT, and joint effusion on MRI. And there were significant differences (P<0.05) between ONFH patients with different ARCO stages in hip pain duration and all imaging manifestations. Correlation analysis showed that the pain duration of ONFH patients was correlated with all imaging manifestations (P<0.05). The cystic change on CT was correlated with the subchondral hypointensity zone and joint effusion grade on MRI, and subchondral hypointensity zone and joint effusion grade on MRI were also correlated (P<0.05).ConclusionThe cystic changes, subchondral hypointensity zone, and joint effusion are closely related to the collapse of the femoral head and hip pain in patients with ONFH in the peri-collapse stage. The above-mentioned signals in stage Ⅱ ONFH indicate the instability of the femoral head, which is to predict the development of ONFH and the rational choice of hip-preserving treatment methods provides a basis.
Objective To investigate the diagnostic significance of fine needle aspiration cytology (FNAC) combined with BRAFV600E gene detection in the diagnosis of cervical lymph node metastasis of thyroid cancer. Methods Atotal of 140 patients with suspected cervical lymph node metastasis of thyroid cancer were collected as the research objects, and all patients were given ultrasound-guided FNAC and detection of BRAFV600E gene. The significance of the diagnosis was analyzed according to the gold standard after pathological examination. Results All the 140 patients underwent surgical treatment. For FNAC, the sensitivity was 63.6% (84/132), the specificity was 100% (8/8), the accuracy was 65.7% (92/140), the positive predictive value was 100% (84/84), and the negative predictive value was 14.3% (8/56). For detection of BRAFV600E gene, the sensitivity was 84.8% (112/132), the specificity was 100% (8/8), the accuracy was 85.7% (120/140), the positive predictive value was 100% (112/112), and the negative predictive value was 28.5% (8/28). For FNAC combined with BRAFV600E gene detection, the sensitivity was 90.9% (120/132), the specificity was 100% (8/8), the accuracy was 91.4% (128/140), the positive predictive value was 100% (120/120), and the negative predictive value was 40.0% (8/20). The area under curve of receiver operating characteristic for FNAC, detection of BRAFV600E gene, and FNAC combined with BRAFV600E gene detection were 0.818, 0.924, and 0.955, respectively. Conclusion FNAC combine with BRAFV600E gene detection improves the accuracy of neck lymph node metastasis in patients with thyroid cancer, which is worthyof performed.
ObjectiveTo investigate the dynamic changes of nodule volume in benign thyroid tumors after radiofrequency ablation (RFA), and to analyze the predictive value of risk factors for nodule regeneration. MethodsA total of 165 patients with benign thyroid nodules who received RFA treatment in the People’s Hospital of Yuechi County from June 2019 to June 2021 were retrospectively collected and divided into small nodule volume group (≤15 mL, n=116) and large nodule volume group (>15 mL, n=49) according to the median nodule volume at admission. The clinical data and serological data of the two groups were compared. Multivariate Cox proportional hazard regression model was used to adjust confounding factors to explore the relationship between initial nodule volume, vascular density, nodule location near critical structure and postoperative nodule regeneration in patients with benign thyroid nodules. According to the proposed Nomogram of the model, Bootstrap method was adopted for sampling verification, calibration curve was adopted to evaluate the calibration degree of the model, and area under the curve (AUC) of receiver operating characteristics (ROC) curve was adopted to evaluate the model differentiation. ResultsIn the small volume nodule group, the proportion of unilateral nodule was higher, and the preoperative beauty score, preoperative symptom score, radiofrequency power, ablation time, total energy, operative time, intraoperative blood loss and hospital stay were lower or short, P<0.05. The change value of thyroid stimulating hormone (TSH), free triiodothyronine (FT3), catalase (CAT) after operation in small volume nodule group were higher than those in the large nodule volume group (P<0.05), but change value of the free thyroxine (FT4), malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) were lower than those in the large nodule volume group (P<0.05). At 1, 3, 6, 12, and 24 months after RFA operation, the nodule volume of the two groups decreased successively, and volume reduction rate (VRR) increased successively. The changes of nodule volume and VRR in the small nodule volume group were better than those in the large nodule volume group. In the large nodule group, the nodule volume was larger at 1, 3, 6, 12, and 24 months after operation, and the VRR was higher at 1 month after operation, the regeneration time was shorter, the number of residual nodules was higher, and the initial ablation rate (IAR) was lower (P<0.05). After adjusting for age, gender and other factors, the correlation effect value increased with the increase of initial volume and blood vessel density, and the differences in trend test were statistically significant (Ptrend <0.05). Nodules located near the critical structure had an increased risk of regeneration (OR=1.76, P<0.001). The Nomogram constructed according to the multi-factor model has good differentiation (AUC before and after ROC curve validation were 0.854 and 0.814, respectively) and accuracy (mean absolute error of 0.023). ConclusionsRFA achieved clinically relevant volume reduction in both ≤15 mL and >15 mL of single benign thyroid nodules, lasting for at least 2 years. However, the nodule VRR and cosmetic effect were better in the small volume nodule group, and the initial nodule volume, blood vessel density and location were closely related to nodule regeneration. The Nomogram model showed good differentiation and accuracy in predicting the risk of nodule regeneration, providing strong support for clinical decision-making.
Objective To measure the rate of changes of the cardiac troponin T (cTnT) and serum urea nitrogen (N), serum creatinine (Cr), estimated glomerular filtration rate (eGFR) of acute type A aortic dissection (AAAD) patients before and after surgery, and to explore the prognostic significance of the rate of changes. Methods We retrospectively analyzed 77 AAAD patients' clinical data between August 2015 and March 2016 from the department of the cardiothoracic surgery in Nanjing Drum Tower Hospital. There were 57 males and 20 females with an average age of 51.1±13.1 years. The test results of cTnT, N, Cr, eGFR were recorded. Patients were divided into three groups based on the duration of ventilation: less than 48 hours, 48 hours to 7 days, longer than 7 days, and divided into two groups based on whether postoperative dialysis was performed: dialysis group and non-dialysis group. Results In the groups with different duration of ventilation, the rate of cTnT change differed significantly. The rate of Cr and eGFR change in the group with the duration of ventilation longer than 7 days showed significantly different compared to other two groups. We found that the rate of Cr and eGFR change were statistically significant between the dialysis group and the non-dialysis group. In the receiver operating characteristic curve (ROC), the optimal cut-off value of the Cr growth rate for predicting postoperative dialysis therapy was 58.1%, and the optimal cut-off value of the eGFR decline rate was 45.5%. Conclusion The rate of changes in cTnT, N, Cr and eGFR can be used as a reliable mean to evaluate respiratory and renal function for AAAD patients in the early stage, which will facilitate an early assessment of the prognosis of AAAD patients.
Objective To explore the diagnostic value and safety of CT-guided percutaneous lung biopsy (CT-PLB) for pulmonary nodules. Methods A total of 438 patients with pulmonary nodules underwent CT-PLB for further diagnosis. Results The CT-PLB was performed successfully in all 438 patients. The positive biopsy rate at the first puncture was 94.9%, and 100.0% at the second puncture. The pathology results revealed 379 (86.5%) cases of malignant lesions, 37 cases of benign lesions, and 22 cases with uncertainty. The sensitivity, specificity and accuracy of CT-PLB were 97.9% (376/384), 94.4% (51/54), and 97.4% (427/438), respectively. The first puncture induced complications included pneumothorax in 33 (7.5%) cases, blood in phlegm in 62 (14.2%) cases, pleural reaction in 7 (1.6%) cases, and bleeding at the site of puncture in 6 (1.4%) cases. There was no occurrence of neoplasm needle track implantation. The second puncture induced complications included pneumothorax in 7 (46.6%) cases and blood in phlegm in 11 (73.3%) cases. The incidences of pneumothorax and blood in phlegm were significantly higher in the patients with chronic obstructive pulmonary disease (COPD), with pulmonary lesion size＜3 cm, or with penetration depth ≥5 cm (P＜0.05). Conclusions CT-PLB is a safe method with a relatively small trauma and has good diagnostic value for pulmonary nodules. The incidence of complications increases in patients with smaller pulmonary lesions, deeper puncture, or COPD.
ObjectiveTo study the diagnostic significance of modified Alvarado Score System for different types of acute appendicitis. MethodsClinical data of 1 930 cases of acute appendicitis, who underwent appendicectomy in The First Hospital of Yulin from Jan. 2004 to Jan. 2014, were retrospectively collected. Then the diagnostic significance of Modified Alvarado Score System was detected and evaluated by receiver operating characteristic (ROC) curve, and its correlation with postoperative pathological results was calculated. ResultsThe modified Alvarado score of cases in progressive group was higher than that of simplex group (7.5±1.3 vs. 3.6±0.7, P < 0.001). The areas under ROC curve of modified Alvarado Score System was 0.943 (95% CI:0.929-0.958, P < 0.001). The critically diagnostic points of Modified Alvarado Score System for differential diagnosis of simplex acute appendicitis and progressive acute appendicitis was 6 score, with sensitivity of 92.9%, specificity of 86.3%, positive predictive value of 96.9%, negative predictive value of 72.6%, positive likelihood ratio of 6.8, negative likelihood ratio of 0.1, and Youden index of 91.7%. ConclusionThis Modified Alvarado Score System has a certain significance for the type diagnosis of acute appendicitis.
ObjectiveTo investigate the expression and clinical significance of HIST1H1B gene in bladder cancer.MethodsInformation on HIST1H1B in the dataset GSE13507 was downloaded from the GEO database. Discrepancy in expression of HIST1H1B in normal tissues and bladder cancer tissues was analyzed by t-test. Survival analysis was performed by using Log-rank algorithm. The association between HIST1H1B gene expression and clinicpathological features was analyzed using Chi-square test. Gene enrichment analysis (GSEA) was performed to explore possible pathways of HIST1H1B involved in bladder cancer.ResultsHIST1H1B was down-regulated in normal tissues and highly expressed in bladder cancer tissues (P=0.002 5). The expression of HIST1H1B was associated with age, gender, T stage, M stage, N stage, disease stage, but not associated with invasiveness and progression. Whether in overall survival (HR=1.732, 95%CI 1.070 to 2.803) or tumor-specific survival (HR=2.000, 95%CI 0.996 to 4.017), patients with high expression of HIST1H1B were significantly lower than that in patients with low expression (P<0.05). GSEA results showed that HIST1H1B may influence the occurrence and development of bladder cancer by regulating MYC signaling pathway V2, G2M checkpoint, E2F signaling pathway, spermatogenesis, mitotic spindle, etc.ConclusionsHIST1H1B may be a biomarker for determining the prognosis of bladder cancer and a target for treatment of bladder cancer.
ObjectiveTo investigate the relationship between placental growth factor (PlGF) and the gastric cancer. MethodsThe cancer tissues (cancer tissue group) and para-cancer tissues (para-cancer tissue group) of 88 patients with gastric cancer who underwent surgery in Sichuan Mianyang 404 Hospital from Mar. 2013 to Dec. 2014 were collected retrospectively, to determine the expressions of PlGF mRNA and its protein by polymerase chain reaction (PCR) and immunohistochemistry method. In addition, blood samples of 30 normal persons (normal person group) who got examina-tion in Sichuan Mianyang 404 Hospital in Sep. 2014 and 88 patients with gastric cancer (gastric cancer group) were collected to detect the concentration of serum PlGF, by using enzyme linked immunosorbent assay (ELISA). Comparison of the expressions of PlGF mRNA and its protein between cancer tissue group and para-cancer tissue group, concentration of PlGF between cancer tissue group and normal person group were performed, as well as the relationship between expressions of serum PlGF mRNA/PlGF in gastric cancer tissues and clinicopathological features of patients with gastric cancer, and relationship between concentration of PlGF in blood and clinicopathological features of patients with gastric cancer was explored by univariate analysis. ResultsThe expression level of PlGF mRNA (0.569±0.166 vs. 0.037±0.020, t=-29.948, P=0.000) and positive-expression rate of PlGF[80.7% (71/88) vs. 5.7% (5/88), χ2=100.867, P=0.000] were significantly higher in cancer tissue group than those of para-cancer tissue group. And the concentration of PlGF in blood of patients in gastric cancer group was higher than that of normal person group[(57.247±9.800) ng/L vs. (10.351±1.715) ng/L, t=43.000, P=0.000]. The expressions of PlGF mRNA and its protein were both correlated with diameter of tumor, pT staging, pN staging, differentiation, and Borrmann type (P<0.050). The expression levels of PlGF mRNA and its protein in that patients with diameter of tumor greater than 4 cm, pT3-4 staging, pN3 staging, low differentiation, and Borrmann Ⅲ-Ⅳ staging were higher. While there were no significant correlation between expressions of PlGF mRNA/protein and age, gender, pM staging, and gastrointestinal type (P>0.050). Concentration of serum PlGF of gastric cancer patient wasn't significantly correlated with age, gender, diameter of tumor, pT staging, pN staging, pM staging, differentiation, Borrmann type, and gastrointestinal type (P>0.050). ConclusionThe abnormal expression of PlGF at gastric cancer tissues may play an important role in pathogenesis of gastric cancer.
Objective To investigate the role of preoperative serum thyroid stimulating hormone (TSH) in evaluating differentiated thyroid cancer (DTC). Methods A total of 551 patients with thyroid nodules met the study criteria, who got treatment in the First Affiliated Hospital of Jiamusi University between Aug. 2017 and Dec. 2017. And the patients were divided into DTC group (n=110) and benign group (n=441) according to the postoperative pathological results. The difference of serum TSH level between the 2 groups was compared and then explored the diagnostic significance of serum TSH level, thyroid imaging report and data system (TI-RADS), and serum TSH combined withTI-RADS. Results The serum TSH level was higher in the DTC group than that of the benign group (Z=5.198, P<0.05). The sensitivity of preoperative serum TSH level in the diagnosis of DTC was 80.9% (89/110), the specificity was 74.4% (328/441), and the area under receiver operating characteristic (ROC) curve was 0.660 ［95%CI was (0.602, 0.719), P<0.05］. The sensitivity of TI-RADS in the diagnosis of DTC was 82.7% (91/110), the specificity was 73.5% (324/441), and the area under the ROC curve was 0.772 ［95%CI was (0.711, 0.823), P<0.05］. The sensitivity of preoperative serum TSH combined with TI-RADS in the diagnosis of DTC was 91.8% (101/110), the specificity was 87.5% (386/441), and the area under the ROC curve was 0.831 ［95%CI was (0.786, 0.876), P<0.05］. Conclusions Preoperative serum TSH level may be a potential risk factor for the occurrence of DTC. Preoperative serum TSH level combined with TI-RADS classification can improve the accuracy of preoperative diagnosis of DTC, not only to reduce the misdiagnosis of thyroid cancer, but also can avoid excessive treatment.