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Objective:To assess the performance of Al 18F-prostate specific membrane antigen (PSMA)-BCH PET/CT in the detection and localization of early recurrent prostate cancer after radical prostatectomy. Methods:From July 2021 to July 2022, a cohort of 51 patients (age: 49-80(64.8±6.9) years) who underwent Al 18F-PSMA-BCH for biochemical recurrence with the prostate specific antigen (PSA) level less than 2 μg/L in Peking University Cancer Hospital & Institute were retrospectively analyzed. The patients were stratified into 4 groups (PSA<0.2 μg/L, 0.2 μg/L≤PSA<0.5 μg/L, 0.5 μg/L≤PSA<1 μg/L, 1 μg/L≤PSA<2 μg/L groups) according to different PSA levels. Lesions detected by Al 18F-PSMA-BCH PET/CT were recorded as prostate bed (including bed of seminal vesicles); pelvic, paraaortic, mediastinal/supraclavicular and axillary lymph nodes; bone lesions and visceral lesions. The detection rates among different groups were compared by Fisher exact test. Results:Of 51 patients, 30(58.8%) had evidence of abnormal uptake suggestive of recurrent prostate cancer, with 60.0%(18/30) had disease confined to the pelvis, including 26.7%(8/30) had prostate bed recurrence, 26.7%(8/30) had pelvic lymph nodes, 6.6%(2/30) had prostate bed recurrence with pelvic lymph nodes, while 40.0%(12/30) had extra pelvic disease. The detection rates of Al 18F-PSMA-BCH PET/CT in PSA<0.2 μg/L, 0.2 μg/L≤PSA<0.5 μg/L, 0.5 μg/L≤PSA<1 μg/L and 1 μg/L≤PSA<2 μg/L groups were 39.1%(9/23), 6/11, 8/9 and 7/8, respectively. There were no significant differences of detection rates between PSA<0.2 μg/L group and 0.2 μg/L≤PSA<0.5 μg/L group ( P=0.397) and also between 0.5 μg/L≤PSA<1 μg/L group and 1 μg/L≤PSA<2 μg/L group ( P=0.929). Conclusion:Al 18F-PSMA-BCH has a high detection rate for early recurrent prostate cancer, even at low PSA levels less than 0.2 μg/L.
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Objective:To investigate the clinical value of endoscopic ultrasound elastography versus contrast-enhanced computed tomography in the risk stratification of gastrointestinal stromal tumors (GISTs). Methods:Clinical and imaging data were obtained from 77 patients who were confirmed to have GISTs and underwent endoscopic or surgical treatment at Wenzhou Central Hospital between May 2019 and April 2021. Endoscopic ultrasound elastography based on a five-point scoring system and hypotonic gastrointestinal contrast-enhanced computed tomography were performed for preoperative risk stratification of GISTs. The two techniques were compared in terms of the accuracy of preoperative risk stratification of GISTs. The imaging features of the two techniques were summarized.Results:According to the postoperative pathological results, 13 patients were at high risk, 13 patients were at medium risk, 35 patients were at low risk, and 16 patients were at extremely low risk. These patients were divided into two groups according to postoperative pathological results: a low-risk group (low risk + extremely low risk) and a medium- and high-risk group (high + medium risk). In the low-risk group ( n = 51), 42 patients were identified by endoscopic ultrasound elastography to have low-risk GISTs and were recommended to receive endoscopic treatment, while the rest 9 patients were identified to have medium-risk GISTs. Contrast-enhanced computed tomography findings revealed that 30 patients had low-risk GISTs and were recommended to receive endoscopic treatment, and 21 patients had medium-risk GISTs. In the medium- and high-risk group ( n = 26), 4 patients were identified by endoscopic ultrasound elastography to have low-risk GISTs, and 22 patients had medium- or high-risk GISTs. Contrast-enhanced computed tomography findings revealed that 9 patients were identified to have low-risk GISTs, and 17 patients had medium- or high-risk GISTs. Endoscopic ultrasound elastography yielded an overall diagnostic accuracy of 83.11% (64/77), while contrast-enhanced computed tomography had an overall diagnostic accuracy of 61.04% (47/77). Endoscopic ultrasound elastography outperformed contrast-enhanced computed tomography in accurate risk stratification of GISTs ( χ2 = 4.66, P < 0.05). In terms of predicting high-risk GISTs, endoscopic ultrasound elastography had a sensitivity of 84.62% and a specificity of 82.35%, both were higher than those of contrast-enhanced computed tomography (sensitivity: 65.38%; specificity: 58.82%), but the differences in sensitivity and specificity between the two techniques were not significant (sensitivity: Fisher's exact test P = 0.590, specificity: χ2 = 0.93, P > 0.05). Conclusion:Endoscopic ultrasound elastography appears to have a better overall diagnostic accuracy in the risk stratification of GISTs compared with contrast-enhanced computed tomography. The combined use of these two techniques may offer a better comprehensive understanding of the perilesional structure and organ involvements and distant metastasis than a single technique, thereby providing a reliable reference for the choice of treatment for GISTs.
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Introduction. The safety and effi cacy of fi nished pharmaceutical products depend on its stabilityattribute. Stability requirements were included for fi rst time in Good manufacturing practice standardMNS 5524:2014. The pharmaceutical manufacturer is responsible to conduct stability studies and tosubmit the report as part of marketing authorization documentation.Purpose of the study. The purpose of this study is to conduct ongoing stability study of the mostlyproduced domestic medicine to monitor the product over its shelf-life.Materials and Methods. As a material used 2 locally produced Paracetamol (Acetaminophen INN) 500mg tablets (local manufacturer (LM) 1 with batch number 271110, LM 2 with batch number 441110). Asa method we used shelf-life specifi cation: Mongolian national standard of Paracetamol 500 mg tablets,MNS 4358:2007. Testing frequency was at 0 time (when tablets were produced) and at 12, 24 and 36months (study was covered the shelf-life).Results. In frame of this study we defi ned the most produced product as Paracetamol (AcetaminophenINN) 500 mg tablets. From the LICEMED- medicines registration record we found 8 tablets, containingAcetaminophen in 500 mg. Two of them were produced locally. These two products were involved inongoing stability study. Testing results showed that no any stability issues over the defi ned shelf life.Discussion. The shelf life was defi ned as 36 months, initially by manufacturers before productsregistered. After a marketing authorization has been granted, the stability of the fi nished pharmaceuticalproducts should be monitored according to a continuous appropriate program that should be permittedthe detection of any stability issue associated with the formulation in the container closure system inwhich it is marketed.Conclusions. After 36 months, testing results were in acceptable limits, selected products wereremaining their quality over the shelf-life.
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Background and Objectives: Leptospirosis is a potentially fatal bacterial disease that mimics many diseases; therefore, laboratory confi rmation is pivotal. Though microscopic agglutination test (MAT) is accepted as World Health Organisation (WHO) reference test, it has got many pitfalls such as being hazardous, tedious, cumbersome and expensive. Counterimmunoelectrophoresis (CIE) is popularly used for diagnosing many infectious diseases but rarely for Leptospirosis. The aim of this study is to fi nd suitability of CIE for the routine laboratory diagnostic purposes. Materials and Methods: Repeat sampling (paired sera) was possible from 401 subjects of which 181 were in-patients of Salem Government General and Private Hospitals and the remaining 220 MAT negative healthy College students gave their consent for the study. All the 802 sera samples were collected from January 2009 to November 2012 and subjected to the present study. After carrying out MAT and CIE on the suspected and control samples, a comparative evaluation was conducted. McNemars test method was used to fi nd out the signifi cant difference between the two tests in the early diagnosis. Result: The sensitivity, specifi city, Positive Predictive value (PPV), Negative Predictive value (NPV) and Effi ciency test for CIE were 96.80%, 89.28%, 95.23%, 92.59% and 94.47%, respectively. The corresponding values for MAT were 95.90%, 89.83%, 95.08%, 91.37% and 93.92%, respectively. There was no signifi cant difference between MAT and CIE at 95% and 99% confi dence intervals according to McNemars test. P value in the early stage of illness was greater for CIE than MAT when Polymerase Chain Reaction (PCR) was used as Gold Standard of diagnosis. Interpretation and conclusion: It was concluded that the CIE could be advantageous over MAT due to its safety, rapidity, simplicity, economic and easy for large number of samples. It can answer little earlier than MAT and found as reliable as that of MAT. Since both the tests had shown similar effi cacies in the later stage of the illness, the importance could be given to CIE due to early diagnosis.
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This single participant functional magnetic resonance imaging (fMRI) study investigates the effects of tapping force and speed on the activation characteristics in motor-related cortices during bilateral self-paced tapping of hand fi ngers. The participant performed four types of self-paced hand fi nger tapping which are soft-slow (SS), soft-fast (SF), hard-slow (HS) and hard-fast (HF) in an fMRI scan. A general linear model (GLM) was implemented in generating brain activation. Statistical inferences were then made about the brain activations using Gaussian random fi eld theory (RFT) at corrected signifi cant level (α = 0.05), given that there is no activation. The results indicate that the brain coordinates bilateral selfpaced tapping of hand fi ngers with the involvement of motor-related cortices which are bilateral precentral gyrus (PCG), bilateral cerebellum and supplementary motor area (SMA). The increase in tapping force accentuate signifi cant activation (p < 0.05 corrected) in bilateral PCG (Brodmann Area (BA) 6) in accordance with its function in triggering motor action such as controlling the tapping force. The increase in tapping speed causes a signifi cant (p < 0.05 corrected) increase in brain activation only in somatosensory associated region in the right superior parietal lobule (SPL) or right BA7. This suggests that SPL plays important roles in coordinating purposeful, skilled movements
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2 months had higher effective rate.PSAV and nPSA could not predict the effect of chemotherapy.