OBJECTIVE:To study on the effect of iodine (I2) on the acid content titration in the preparations,and establish a method of eliminating I2 for accurate determination of total acid content. METHODS:Taking an example of Onychomycosis paint,I2 was reduced by sodium sulfide(Na2S)before titration analysis and compared with the standard method of traditional titration. Ac-cording to the two methods of consumption of different sodium hydrate(NaOH)volume,the effect of I2 on the determination of to-tal acid content in preparation was explored. RESULTS:Reduction method of Na2S can eliminate the effect of I2,the color of indica-tor changed acutely. The determined total acid and theoretical values were the same;the linear range of the concentration of total ac-id in onychomycosis paint was 3.926-7.290 mol/ml(r=0.9999);RSDs of precision,stability and reproducibility tests were no more than 0.04%;average recovery was 99.91%-100.10%(RSD=0.036%,n=6). CONCLUSIONS:I2 has effect on the determina-tion of total acid content,the disproportion reaction of I2 can generate hydriodic acid that can interfere acid-base titration's results, and the generated hydriodic acid can oxidize indicator to make the end point is not sensitive or even invariant color. Using Na2S can eliminate the effect of iodine on the preparation of acid titration,which has improved precision and reproducibility with accurate and reliable determination results.

Objective:This study aimed to discuss the risks associated with investigator-initiated pediatric drug clinical trials in terms of drug management and put forward relevant suggestions to improve the standardization and quality of pediatric clinical trials.Methods:The risk in the implementation of pediatric drug clinical trials initiated by domestic researchers were discussed and the countermeasures were put forward by reviewing literature, laws and regulations, and combining with the problems related to research drugs in project management.Results:In investigator-initiated pediatric drug clinical trials, the variety of research drug sources, such as sponsor donations, hospital pharmacy supplies, and community pharmacy provisions, posed distinct management risks that would require tailored attention. Moreover, the specific risk of pediatric medication should be fully considered during study execution. It was imperative for medical institutions to strengthen comprehensive management of research drugs to ensure the trial′s smooth operation.Conclusions:Investigator-initiated pediatric drug clinical trials serve as valuable supplements that expand new drugs′ trial scope for children. While actively conducting these trials, it is recommended that medical institutions should strengthen project approval reviews from the perspectives of drug supply, subject compensation and child dosage form, implement centralized management of research drugs, attach importance to ethical review of adverse drug events, strengthen personnel training and leverage information settlement, so as to improve work efficiency and research quality-ultimately providing support for pediatric pharmaceutical development efforts as well as promoting high-quality advancements within Chinese pediatrics medicine.

Objective To investigate the effect of percutaneous coronary intervention (PCI) on left ventricular remodeling and cardiac function in patients with myocardial infarction.Methods A total of 90 myocardial infarction patients in our hospital were as the research objects,a total of 45 cases underwent PCI surgery were in observation group,another 45 cases undergoing elective PCI surgery were in control group.The levels of N-terminal pro brain natriuretic peptide (NT-proBNP),norepinephrine (NE) and epinephrine (E),plasma renin (PRA),angiotensin Ⅱ (Ang Ⅱ),aldosterone (ALD) were detected before operation and on the first postoperative day.After 6 months of follow-up,the incidence of heart failure of two groups were compared.Results There was no significant difference between the two groups in preoperative NT-proBNP,NE,E,PRA,Ang Ⅱ and ALD levels (P ＞0.05),the observation group had decreased NT-proBNP,NE,E,PRA,Ang Ⅱ,ALD levels at 1 d after operation than operation before and the control group (P ＜ 0.05).At 1 month after surgery,the observation group had lower LVDEd,LVSEd,LAd,and higher LVEF than treatment before and control group (P ＜ 0.05).The incidence of heart failure after 6 months in the observation group and the control group was 1 1.1％,2 4.4 ％ respectively,and the difference was statistically significant (x2 =7.31,P ＜ 0.05).Conclusion Percutaneous coronary intervention (PCI) timing can affect the prognosis of patients with myocardial infarction.Compared with elective PCI,emergency PCI can inhibit the RAAS system and sympathetic activation,improve ventricular remodeling and left ventricular function after myocardial infarction,and reduce the incidence of secondary heart failure.

Objective:To develop a color-moment based model for frozen-section diagnosis of thyroid lesions, and to evaluate the model′s value in the frozen-section diagnosis of thyroid cancer.Methods:In this study, 550 frozen thyroid pathological slides, including malignant and non-malignant cases, were collected from Taizhou Central Hospital (Taizhou University Hospital), China, between June 2018 and January 2020. The 550 digitalized frozen-section slides of thyroid were divided into training set (190 slides), validation set (48 slides), test set A (60 slides) and test set B (252 slides). The tumor regions on the slides of malignant cases in the training and validation sets were labeled by pathologists. The labeling information was then used to train the thyroid frozen-section diagnosis models based on the voting method and those based on the color moment. Finally, the performance of two pathological slide diagnosis models was evaluated using the test set A and test set B, respectively.Result:The classification accuracy of the thyroid frozen-section diagnosis model based on the voting method was 90.0% and 83.7%, using test sets A and B, respectively, while that based on color moments was 91.6% and 90.9%, respectively. For actual frozen-section diagnosis of thyroid cancer, the model developed in this study had higher accuracy and stability.Conclusion:This study proposes a color-moment based frozen-section diagnosis model, which is more accurate than other classification models for frozen-section diagnoses of thyroid cancer.

Objective:To develop a convolutional neural network based model for assisting pathological diagnoses on thyroid liquid-based cytology specimens.Methods:Seven-hundred thyroid TCT slides were collected, scanned for whole slide imaging (WSI), and divided into training and test sets after labeling the correct diagnosis (benign versus malignant). The extracted regions of interest after noise filtering were cropped into pieces of 512 × 512 patch on 10 × and 40 × magnifications, respectively. A classification model was constructed using deeply learning algorithms, and applied to the training set, then automatically tuned in the test set. After data enhancement and parameters optimization, accuracy, sensitivity, specificity, positive predictive value and negative predictive value of the model were calculated. Results The training set with 560 WSI contained 4 926 cell clusters (11 164 patches), while the test set with 140 WSI contained 977 cell clusters (1 402 patches). YOLO network was selected to establish a detection model, and ResNet50 was used as a classification model. With 40 epochs training, results from 10× magnifications showed an accuracy of 90.01%, sensitivity of 89.31%, specificity of 92.51%, positive predictive value of 97.70% and negative predictive value of 70.82%. The area under curve was 0.97. The average diagnostic time was less than 1 second. Although the model for data of 40× magnifications was very sensitive (98.72%), but its specificity was poor, suggesting that the model was more reliable at 10× magnification. Conclusions:The performance of a deep-learning based model is equivalent to pathologists′ diagnostic performance, but its efficiency is far beyond. The model can greatly improve consistency and efficiency, and reduce the missed diagnosis rate. In the future, larger studies should have more morphology diversity, improve model′s accuracy and eventually develop a model for direct clinical use.

Objective To investigate the effect of percutaneous coronary intervention (PCI) on left ventricular remodeling and cardiac function in patients with myocardial infarction.Methods A total of 90 myocardial infarction patients in our hospital were as the research objects,a total of 45 cases underwent PCI surgery were in observation group,another 45 cases undergoing elective PCI surgery were in control group.The levels of N-terminal pro brain natriuretic peptide (NT-proBNP),norepinephrine (NE) and epinephrine (E),plasma renin (PRA),angiotensin Ⅱ (Ang Ⅱ),aldosterone (ALD) were detected before operation and on the first postoperative day.After 6 months of follow-up,the incidence of heart failure of two groups were compared.Results There was no significant difference between the two groups in preoperative NT-proBNP,NE,E,PRA,Ang Ⅱ and ALD levels (P ＞0.05),the observation group had decreased NT-proBNP,NE,E,PRA,Ang Ⅱ,ALD levels at 1 d after operation than operation before and the control group (P ＜ 0.05).At 1 month after surgery,the observation group had lower LVDEd,LVSEd,LAd,and higher LVEF than treatment before and control group (P ＜ 0.05).The incidence of heart failure after 6 months in the observation group and the control group was 1 1.1％,2 4.4 ％ respectively,and the difference was statistically significant (x2 =7.31,P ＜ 0.05).Conclusion Percutaneous coronary intervention (PCI) timing can affect the prognosis of patients with myocardial infarction.Compared with elective PCI,emergency PCI can inhibit the RAAS system and sympathetic activation,improve ventricular remodeling and left ventricular function after myocardial infarction,and reduce the incidence of secondary heart failure.

Objective To predict and verify the upstream regulatory microRNA (miRNA)of protein kinase D1 (PKD1),and to investigate its role in cerulein induced acute pancreatitis (AP)in rats. Methods Potential up-stream regulatory miRNA of PKD1 was predicted by using bioinformatics software. Dual luciferase reporter gene system and Western blot were applied to verify the regulation of PKD1 by the selected miRNA. Experimental AP was induced by 6 intraperitoneal injection of cerulein (20 μg/ kg)at hourly intervals after administration of the CY5 - labeled notar-get control (AP group,n = 20)or selected miRNA (treatment group,n = 20),respectively by intraperitoneal injection into rats. Other rats were divided randomly into a normal control group (n = 10)without any treatment. Besides 10 rats in either AP or treatment group were sacrificed 6 hours after the first injection of cerulein,and the rats were all sacri-ficed 24 hours after the first injection. The blood samples and pancreatic tissues of each rat were collected to test serum amylase and lipase activities,or to make hematoxylin - eosin stain for AP pathological scores as well as PKD1 immuno-histochemical staining,respectively. Results TargetScan 7. 1 software analysis showed that miR - 128 - 3p was the po-tential upstream regulatory miRNA of PKD1,which was verified by dual luciferase reporter gene system and Western blot detection. Compared to the normal control group,serum amylase and lipase activities after 6 h exposure to cerulein increased in both AP group and the treatment group[13313. 00(9424. 00 - 15995. 00)U/ L,13552. 00(10399. 50 -18408. 25)U/ L vs. 1430. 50(1214. 25 - 1543. 25)U/ L;547. 00 (515. 00 - 627. 00)U/ L,857. 50(522. 00 -1222. 25)U/ L vs. 34. 00(32. 50 - 34. 75)U/ L],and the differences were significant(χ2 = 8. 715,P < 0. 05;χ2 =9. 115,P < 0. 05),which indicated that the rat models of AP were successfully established. The immunohistochemical scores of PKD1 after 24 h exposure to cerulein decreased in the treatment group[0. 50(0 - 2. 75)scores],compared with the normal control group [4. 00(4. 00 - 8. 00)scores]and the AP group [4. 00(3. 75 - 8. 00)scores],and difference was significant(χ2 = 18. 302,P < 0. 05). Accordingly,the total pathological scores of HE staining decreased significantly in the treatment group,as compared to the AP group (3. 80 ± 0. 85 vs. 6. 90 ± 1. 15,t = 4. 481,P < 0. 01). The results showed that the inflammatory cell infiltration and tissue necrosis were significantly improved after miR -128 - 3p treatment. Conclusions miR - 128 - 3p is the upstream regulatory microRNA of PKD1 which protects pan-creata from necrotic injury and inflammatory cell infiltration in PKD1 - mediated acute pancreatitis.

Objective To set up a computer-assisted polyp detection system under colonoscopy,and to preliminarily verify its effectiveness.Methods Based on Faster R-CNN algorithm and the open source implementation of the open source framework tensorflow and Faster R-CNN,a computer-assisted polyp detection system under colonoscopy was constructed.According to the size and difficulty of the training set,five test groups were set up:test group one,two,three and four contained 1 000,2 000,4 000 and 6 000 training samples,respectively.Test group five increased the probability of selecting the difficult samples based on 6 000 training samples.In different training sets,the sensitivity,specificity,other classification evaluation parameters,and the evaluation parameters of target detection such as recall and precision of this polyps detection system were calculated.Results Classification evaluation parameters showed that the sensitivities of test group one,two,three,four and five were 90.1％,93.3％,93.3％,93.3 ％ and 93.5 ％,respectively,and the difference was statistically significant (x2 =25.324,P＜0.01).The sensitivities of test group two,three,four and five were all higher than that of test group one,and the differences were statistically significant (x2 =13.964,13.508,13.508 and 13.386,all P＜ 0.006 25).There were no significant differences in specificity and positive predictive value among test groups (both P＞0.05).The negative predictive values of test group one,two,three,four and five were 90.4％,93.3％,93.3％,93.3％ and 93.5％,respectively,and the differences were statistically significant (x2 =21.862,P＜0.01).The negative predictive values of test group two,three,four and five were higher than that of test group one,and the differences were statistically significant (x2=11.447,11.564,11.755,13.760;all P＜0.006 25).As the training sample size increased from 1 000 to 2 000,the area under curve (AUC) increased by 2％,and further increased the sample size to 6 000,AUC increased by less than 1 ％.At this point maintaining the same sample size while increasing the proportion of difficult samples,AUC increased by 0.4％.The results of evaluation parameters of target detection showed that the recall rate of each test group was 73.6％,79.8％,79.5％,79.8％ and 83.3％,respectively,and the differences were statistically significant (x2 =71.936,P＜0.01).Among them,the recall rates of test group two,three and four were higher than that of test group one,and the differences were statistically significant (x2 =25.960,23.492 and 25.960,all P＜0.006 25),and the recall rate of test group five was higher than those of test group one,two,three and four,and the differences were statistically significant (x2=67.361,9.899,11.527 and 9.899;all P＜0.006 25).In addition,the precision rates of test group one,two,three,four and five were 87.9％,85.3％,90.2％,91.4％ and 89.2％,respectively,and the difference was statistically significant (x2=48.194,P＜0.01).The precision rates of test group three and five were higher than that of test group two,and the differences were statistically significant (x2 =24.508 and 15.223,both P＜0.006 25),and the precision rate of test group four was higher than those of test group one and two,and the differences were statistically significant (x2=13.524 and 39.120,both P＜0.006 25).As samples size and training difficulty increased,the values of F1-score and mean average precision increased steadily.Conclusions This study initially constructed a computer-assisted polyp detection system under colonoscopy.Currently the maximum sensitivity reached 93.5％,and the maximum recall rate reached 83.3％.Increasing the training set size may improve the polyp detection result to a certain degree,however it will reach a bottleneck.At this time,increasing the training difficulty can further improve the detection scores,especially the recall rate.

OBJECTIVE To optimize the free examination, traceability, cost settlement and privacy protection during the development of pediatric drug clinical trials by means of information technology, so as to improve the efficiency and quality of project operation. METHODS Based on the existing hospital information system, multi department joint designed and implemented an information system for the settlement of the diagnosis and treatment expenses for drug clinical trial, which realized the real-time settlement of medical costs for drug clinical trials without the need for advance reimbursement of subjects' guardians. RESULTS This system took into account both cost and function, and had good feasibility. It could effectively improve the operation efficiency of drug clinical institutions, ensure the traceability of diagnosis and treatment data, and optimize the experience and privacy protection of child subjects. CONCLUSION The development and design of this system can effectively improve the operating efficiency of pediatric drug clinical trials, and has a good reference for other new record institutions to solve such problems.