[Objective] To conduct a retrospective statistical comparison of alanine aminotransferase (ALT) test values in blood donors prior to blood collection, aiming to analyze the objective characteristics of the population with elevated ALT levels (ALT>50 U/L) and provide reference data for adjusting the screening eligibility threshold for ALT. [Methods] The preliminary ALT screening data of 30 341 blood donor samples collected prior to blood donation from three smart blood donation sites at the Shenzhen Blood Center between 2022 and 2023 were extracted and compared with data from a health examination department of a tertiary hospital in Shenzhen (representing the general population, n=24 906). Both datasets were categorized and statistically described. A retrospective analysis was conducted to examine the associations between ALT test results and factors such as donors' gender, age, ethnicity, donation site, donation season, and frequency of blood donation. [Results] The ALT levels in both blood donors and the general population were non-normally distributed. The 95th percentile of ALT values was calculated as 61.4 U/L (male: 67.8 U/L, female: 39.3 U/L) for blood donors and 58.1 U/L (male: 63.7 U/L, female: 51.2 U/L) for the general population. The non-compliance rates (ALT>50 U/L) were 7.65% (2 321/30 341) in blood donors and 7.08% (1 763/24 906) in the general population. There were significant differences (P<0.05) in the ALT failure rate among blood donors based on gender, age, and donation site, but no significant differences (P>0.05) during the blood donation season. There was no statistically significant difference (P>0.05) in the positive rates of four serological markers (HBsAg, anti HCV, HIV Ag/Ab, anti TP) for blood screening pathogens between ALT unqualified and qualified individuals (2.05% vs 1.5%). If the ALT qualification threshold was raised from 50 U/L to 90 U/L, the non qualification rates of male and female blood donors would decrease from 9.82% (2 074/21 125) to 2.23% (471/21 125) and from 2.70% (249/9 216) to 0.75% (69/9 216), respectively. Among the 154 blood donors who donated blood more than 3 times, 88.31% of the 248 ALT test results were in the range of 50-90 U/L. Among them, 9 cases had ALT>130 U/L, and ALT was converted to qualified in subsequent blood donations. [Conclusion] There are differences in the ALT failure rate among blood donors of different genders and ages, and different blood donation sites and operators can also affect the ALT detection values of blood donors. The vast majority of blood donors with ALT failure are caused by transient and non pathological factors. With the widespread use of blood virus nucleic acid testing, appropriately increasing the ALT qualification threshold for blood donors can expand the qualified population and alleviate the shortage of blood sources, and the risk of blood safety will not increase.

Objective:To discuss and analyze the current situation of the application and approval of new Chinese medicine in China; To provide a reference for the research and development of new Chinese medicines in the future.Methods:The drug registration data were retrieved from Xanda database from January 1, 2016 to December 31, 2022, and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties, registration categories, therapeutic areas, prescription sources, dosage form distribution, development cycle, clinical research and control drugs.Results:From 2016 to 2022, the total number of application for new Chinese medicines was 265. The number of registration classification 1.1 of new compound drugs was the largest. The dosage forms of new drugs were mainly granules, capsules, and tablets. Indications mainly focused on respiratory, neuropsychiatric, digestion and cardio-cerebrovascular diseases, etc. From 2016 to 2022, the total number of approval for new Chinese medicines was 29, of these, 19 from 2021 to 2022. The number of registration classification 1.1 of new Chinese medicines was the largest. The treatment fields are mainly respiratory system, gynecology and neuropsychiatric diseases, etc. The dosage forms of new drugs were mainly granules, capsules, and tablets. The number of drugs in prescriptions was 6-15. High-frequency drugs included Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Scutellariae Radix, Pinelliae Rhizoma, Poria and Gypsum Fibrosum. Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number. The development period was approximately between 10-20 years. The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion:The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines, helping to develop more high-quality Chinese medicines.

Objective:To investigate the application value of fecal Syndecan-2 (SDC2) gene methylated SDC2 (m SDC2) detection in colorectal cancer (CRC) screening among urban residents in Guangzhou City. Methods:A cross-sectional study was conducted in Shitan Town, Zengcheng District, Guangzhou City from July to December 2022. A community-based screening program for CRC was conducted among residents aged 40-74 years old. m SDC2 detection was employed in the participants, and those with positive results should be recommended to receive colonoscopy examination. The positive rate of m SDC2 detection, colonoscopy compliance rate, detection rate of intestinal lesions and clinicopathological characteristics were observed. The relationship between cycle threshold (CT) value of m SDC2 and intestinal lesions was explored. Further, the cost-effectiveness of screening was evaluated. Results:A total of 8 189 fecal samples were collected from 8 877 participants with the recovery rate of 92.25%. 8 048 qualified samples were enrolled in this study, consisted of 3 182 males (39.54%) and 4 866 females (60.46%), with the average age of 56 years old (40-74 years). The positive rate of m SDC2 detection was 7.99% (643/8 048), and the compliance rate of colonoscopy was 73.10% (470/643). 20 cases (4.25%) of colorectal cancer, 109 cases (23.19%) of advanced adenoma, 145 cases (30.85%) of non-advanced adenoma, 79 cases (16.81%) of polyps were detected. The detection rate of intestinal lesions was 75.11% and indicated significant differences in gender and age. 20 CRCs included 15 of stage 0-I, 4 of stage Ⅱ-Ⅲ and 1 of unknown stage. The CT value of m SDC2 was negatively correlated with the proportion of advanced colorectal neoplasms ( χ2=16.063, P<0.001). The total cost of the screening was 4.339 5 million yuan, the screening benefit was 28.506 2 million yuan, and the benefit-cost ratio was 6.57. Conclusion:The CRC screening strategy of fecal m SDC2 detection combined with colonoscopy has high colonoscopy compliance and detection rate of intestinal lesions, which is conducive to the detection of early CRCs, and has good cost-effectiveness. This study suggests that this method may be applied to the general CRC screening in China and contribute to the prevention of CRC. The CT value of m SDC2 may have a certain suggestion on the malignant degree of intestinal tumors.

Objective:To investigate the application value of fecal Syndecan-2 (SDC2) gene methylated SDC2 (m SDC2) detection in colorectal cancer (CRC) screening among urban residents in Guangzhou City. Methods:A cross-sectional study was conducted in Shitan Town, Zengcheng District, Guangzhou City from July to December 2022. A community-based screening program for CRC was conducted among residents aged 40-74 years old. m SDC2 detection was employed in the participants, and those with positive results should be recommended to receive colonoscopy examination. The positive rate of m SDC2 detection, colonoscopy compliance rate, detection rate of intestinal lesions and clinicopathological characteristics were observed. The relationship between cycle threshold (CT) value of m SDC2 and intestinal lesions was explored. Further, the cost-effectiveness of screening was evaluated. Results:A total of 8 189 fecal samples were collected from 8 877 participants with the recovery rate of 92.25%. 8 048 qualified samples were enrolled in this study, consisted of 3 182 males (39.54%) and 4 866 females (60.46%), with the average age of 56 years old (40-74 years). The positive rate of m SDC2 detection was 7.99% (643/8 048), and the compliance rate of colonoscopy was 73.10% (470/643). 20 cases (4.25%) of colorectal cancer, 109 cases (23.19%) of advanced adenoma, 145 cases (30.85%) of non-advanced adenoma, 79 cases (16.81%) of polyps were detected. The detection rate of intestinal lesions was 75.11% and indicated significant differences in gender and age. 20 CRCs included 15 of stage 0-I, 4 of stage Ⅱ-Ⅲ and 1 of unknown stage. The CT value of m SDC2 was negatively correlated with the proportion of advanced colorectal neoplasms ( χ2=16.063, P<0.001). The total cost of the screening was 4.339 5 million yuan, the screening benefit was 28.506 2 million yuan, and the benefit-cost ratio was 6.57. Conclusion:The CRC screening strategy of fecal m SDC2 detection combined with colonoscopy has high colonoscopy compliance and detection rate of intestinal lesions, which is conducive to the detection of early CRCs, and has good cost-effectiveness. This study suggests that this method may be applied to the general CRC screening in China and contribute to the prevention of CRC. The CT value of m SDC2 may have a certain suggestion on the malignant degree of intestinal tumors.

Objectives: This study aimed to explore the influence of depression severity, disease course, treatment status, and other factors on cognitive function in adolescents with depressive disorders. Methods: Participants who met the inclusion criteria were enrolled in the study. Sociodemographic data of each participant were recorded, including age, sex, and family history of mental disorders. Zung’s Self-Rating Depression Scale was used to assess depression status in adolescents. Moreover, P300 and mismatch negativity (MMN) were used to objectively evaluate the participants’ cognitive function. Results: Only 26.8% of the adolescents with depression received standard antidepressant treatment. The latencies of N2 (267.80±23.34 ms), P3 (357.71±32.09 ms), and MMN (212.10±15.61 ms) in the adolescent depression group were longer than those in the healthy control group (p<0.01). Further analysis revealed that the latency of MMN was extended with increased levels of depression in adolescents.The MMN latency was short in participants with depression receiving standardized treatment. Furthermore, the latency of MMN was positively correlated with the severity and duration of depression (correlation coefficients were 0.465 and 0.479, respectively) (p<0.01). Conclusion Receiving standardized treatment and shortening the course of depression can reduce cognitive impairment in adolescents with depression.

ObjectiveTo study the effect of Bushen Huoxuetang on the apoptosis and the expression of B-cell lymphoma （Bcl-2）-associated X protein （Bax）/ Bcl-2 and cleaved cysteine-containing aspartate proteolytic enzyme-3 （cleaved Caspase-3） in the nude mouse model of bone metastasis of breast cancer， and explore the mechanism of Bushen Huoxuetang in inhibiting bone destruction. MethodThirty BALB/c female nude mice were randomly assigned into blank group （n=6） and model group （n=24）. The suspension of 4T1 breast cancer cells was injected into the tibia of mouse right lower limb to establish model of bone metastasis of breast cancer. The successfully modeled nude mice were randomly assigned into model group， Bushen Huoxuetang group， zoledronic acid group， and combined drug group， with 6 mice in each group. Bushen Huoxuetang was administrated at a dose of 36.67 g·kg^-1， once a day， and zoledronic acid was administrated by subcutaneous injection at a dose of 100 μg·kg^-1， twice a week. The combined drug group was administrated with the same doses of Bushen Huoxuetang group by gavage and zoledronic acid by subcutaneous injection. The mice in the blank group and the model group were administrated with the same volume of distilled water by gavage for 14 days. On the next day at the end of drug administration， the mice were sacrificed by cervical dislocation. The general situation and weight changes of the mice were examined. The right lower limb was collected， and X-ray scanning and hematoxylin-eosin （HE） staining methods were used for observation of pathological changes in the bone. The terminal deoxynucleotidyl transferase dUTP nick-end labeling （TUNEL） was employed to detect the apoptosis of bone tissue in nude mice， and Western blot to determine the expression of Bax/Bcl-2 and cleaved Caspase-3 in the bone tissue. ResultCompared with the blank group， the modeling reduced the body weight （P<0.01） and increased the right lower limb weight of the nude mice （P<0.01）. Compared with the model group， Bushen Huoxuetang， zoledronic acid， and their combination increased the body weight （P<0.01） and decreased the right lower limb weight （P<0.01）. Compared with the blank group， the other groups showed obvious tumor cell atypia， deep nuclear staining， and clear bone metastasis， and the model group showed obvious osteolytic damage in right lower limb and loss of proximal tibia and knee joint. Compared with the model group， Bushen Huoxuetang， zoledronic acid， and their combination reduced the osteolytic lesions in the right lower limb and recovered part of the bone structure， demonstrating an inhibitory effect on bone destruction. The TUNEL assay showed that the model group had lower apoptosis rate of bone metastatic tumor cells than the blank group， Bushen Huoxuetang group， zoledronic acid group， and combined drug group （P<0.01）. Compared with the blank group， the modeling down-regulated the expression of Bax and cleaved Caspase-3 （P<0.01） and up-regulated the expression of Bcl-2 （P<0.01）. Compared with the model group， Bushen Huoxuetang， zoledronic acid， and their combination up-regulated the expression of Bax （P<0.01） and cleaved Caspase-3 （P<0.05， P<0.01） and down-regulated the expression of Bcl-2 （P<0.05， P<0.01）. ConclusionBushen Huoxuetang may inhibit bone destruction in the nude mouse model of bone metastasis of breast cancer by up-regulating the expression of Bax， down-regulating the expression of Bcl-2， activating cleaved Caspase-3， and further inducing apoptosis.

Objective:To establish a risk prediction model for the occurrence of low 1 min Apgar scores in extremely premature infants (EPIs).Methods:From January 2017 to December 2021, EPIs delivered at our hospital were retrospectively analyzed and randomly assigned into training set group and validation set group in a 7∶3 ratio. 17 clinical indicators were selected as predictive variables and low Apgar scores after birth as outcome variables. Lasso regression and multi-factor logistic regression were used within the training set group to select the final predictors for the final model, and the calibration, distinguishability and clinical decision making curves of the final model were evaluated in the validation set group.Results:A total of 169 EPIs were enrolled, including 117 in the training set group and 52 in the validation set group. 4 indicators including gender, fetal distress, assisted conception and delivery time were selected as the final predictors in the final model. Both the training set group and the validation set group had good calibration curves. The area under the receiver operating characteristic curve (AUC) of the prediction model was 0.731, the sensitivity was 72.2%, the specificity was 60.5% and the AUC of the external validation curve was 0.704. The clinical decision making curve showed that the model had a greater benefit in predicting the occurrence of low Apgar score in EPIs within the threshold of 2% to 75%.Conclusions:The clinical prediction model established in this study has good distinguishability, calibration and clinical accessibility and can be used as a reference tool to predict low Apgar scores in EPIs.

Objective:To evaluate the predictive value of mechanical power (MP) on the risk of in-hospital mortality in critical ill patients in emergency department.Methods:A total of 105 critical ill patients with invasive mechanical ventilation in the Department of Emergency of Second Affiliated Hospital of Guangzhou Medical University between December 1, 2017 and October 31, 2020 were retrospectively analyzed. Based on the clinical prognosis, the patients were divided into the in-hospital survival group (80 patients) and the in-hospital death group (25 patients). The clinical data and ventilator parameters were recorded, and the MP of the two groups was calculated in order to assess the predictive efficacy of MP on in-hospital death.Results:Compared to the in-hospital death group, the oxygenation index PaO 2/FiO 2 was significantly higher (271 mmHg vs. 217 mmHg, P=0.020) and blood lactate (1.59 mmol/L vs. 2.56 mmol/L, P<0.001) and procalcitonin (0.31 ng/mL vs. 3.55 ng/mL, P=0.028), minute ventilation (7.03 L/min vs.8.32 mmol/L, P=0.013), MP (14.37 J/min vs. 16.12 J/min, P=0.041), SOFA score (5 vs. 8, P=0.001) and APACHE II score (16 vs. 22, P=0.041) were significantly lower in the in-hospital survival group. Multivariate Logistic regression analysis showed that PaO 2/FiO 2( OR=1.015, P=0.044), MP ( OR=1.813, P=0.039) and SOFA score( OR=2.651, P=0.010) were independent risk factors for predicting hospital mortality in patients with mechanical ventilation. The areas under the ROC curves (AUC) were 0.62, 0.63 and 0.75, respectively. Moreover, the MP combined with SOFA score for predicting in-hospital death was significantly higher than that of MP alone (0.77 vs. 0.63, P<0.05). Conclusions:MP is associated with in-hospital death in patients with invasive mechanical ventilation in emergency department. MP combined with SOFA score can enhance its predictive efficacy

ObjectiveTo investigate the clinical effect of Shipiyin combined with diosmin in the treatment of lymphedema with spleen Yang deficiency syndrome（SYDS）after modified radical mastectomy and the specific effect on the function of the affected limb. MethodEighty-two patients with lymphedema with SYDS after modified radical mastectomy from outpatient and inpatient department of breast department and oncology department of the First Affiliated Hospital of Hunan University of Chinese Medicine were randomly divided into an observation group（41 cases） and a control group（41 cases）. The control group was given diosmin tablets（0.9 g per time， two times per day）on the basis of conventional treatment，and the observation group was given Shipiyin（one dose per day）on the basis of the control group. The course of treatment was 14 days. The clinical symptoms were observed and the limb circumference，traditional Chinese medicine（TCM） syndrome score，functional assessment of cancer therapy-breast cancer（FACT-B） score，disability of arm， shoulder and hand questionnaire（DASH） score，and joint range of motion were measured to analyze the TCM syndrome therapeutic effect and clinical efficacy. ResultAfter 14 days of treatment， the total effective rate of the observation group was 85.37% （35/41） and that of the control group was 63.41% （26/41） in the TCM symptoms， showing a statistically significant difference （Z=-2.212， P<0.05）. In terms of the clinical efficacy， the total effective rate in the observation group was 82.93% （34/41） and that in the control group was 75.61% （31/41）， indicating a statistically significant difference （Z=-2.061， P<0.05）. Compared with the situations before treatment， the scores of clinical symptoms such as the swelling of the upper limb， pain， sense of heaviness， stuffiness， fatigue， fullness， tightness， and skin keratosis and pruritus in the two groups were significantly lowered （P<0.01） after treatment. Compared with the control group， the observation group could better improve the swelling and fullness（P<0.01），as well as the feeling of pain，heaviness，stuffiness，fatigue，tightness，skin keratosis and pruritus （P<0.05）of the upper limbs of patients. The affected limb circumference， TCM syndrome score， and DASH score decreased significantly， while the FACT-B score and upper limb joint range of motion increased significantly in the two groups after treatment （P<0.01）. Compared with the control group， the observation group showed significantly reduced limb circumference at 10 cm proximal to the elbow striae， lowered TCM syndrome score， elevated FACT-B score（P<0.05）， decreased DASH score and improved range of motion of the upper limb joint （P<0.01） after treatment. ConclusionShipiyin combined with diosmin has better clinical efficacy in the treatment of lymphedema with SYDS after modified radical mastectomy than diosmin alone，which can better improve the clinical symptoms，signs，quality of life and limb functional activity of patients. This provides a new clinical program for the treatment of lymphedema after breast cancer surgery with integrated Chinese and western medicine.

Objective:To investigate the methylation status of SDC2, PPP2R5C and ADHFE1 genes in stool and their values in the screening of colorectal cancer and precancerous lesions.Methods:From August 2020 to March 2021, 64 patients with colorectal cancer, 72 patients with adenoma, 33 patients with hyperplastic polyps and 59 healthy people were recruited from Qingdao Central Hospital Affiliated to Qingdao University, and the morning stool samples were collected from the research subjects. The genomic DNA was extracted and modified with sulfite. The methylation status of SDC2, PPP2R5C and ADHFE1 genes were detected by methylation specific polymerase chain reaction (MSP), and the fecal occult blood test (FOBT) was performed. Taking the pathological results as the gold standard, receiver operating characteristic (ROC) curve and area under the curve (AUC) were used to compare the effect of combined detection of methylation of three genes and FOBT in predicting colorectal cancer and precancerous lesions. R-Studio software was used to construct a nomogram for the prediction of colorectal cancer with combined detection of gene methylation in stool and other clinical features, and the calibration and validation were performed.Results:The positive rates of combined detection of methylation of SDC2, PPP2R5C and ADHFE1 genes in stool were higher than those of FOBT in colorectal cancer+adenoma [74.3% (101/136) vs. 47.1% (64/136), χ2 = 23.20, P = 0.001], colorectal cancer [90.6% (58/64) vs. 70.3% (45/64), χ2 = 8.91, P = 0.003] and adenoma [59.7% (43/72) vs. 26.4% (19/72), χ2 = 14.43, P = 0.002]. There was no significant difference in the positive rates in hyperplastic polyps [21.2% (7/33) vs. 6.1% (2/33), χ2 = 0.12, P = 0.125] and healthy controls [10.2% (6/59) vs. 8.5% (5/59), χ2 = 4.01, P = 1.000]. The combined detection of gene methylation was better than FOBT in the prediction of colorectal cancer + adenoma [AUC: 0.85 (95% CI 0.80-0.91) vs. 0.71 (95% CI 0.64-0.78), P < 0.05], especially in the prediction of adenoma [AUC: 0.82 (95% CI 0.74-0.89) vs 0.64 (95% CI 0.57-0.69), P < 0.001]. The sensitivity and specificity of ADHFE1 gene methylation status in predicting colorectal cancer were high (90.6% and 96.6%). In colorectal cancer patients over 50 years old, the positive rate of combined detection of gene methylation was higher than that of FOBT [90.2% (55/61) vs. 68.9% (42/61), P < 0.05]. The nomogram calibration curve for predicting colorectal cancer constructed based on the combined detection of gene methylation and each clinical feature showed a high degree of concordance between the predicted and observed diagnostic performance of colorectal cancer. Conclusions:The methylation levels of SDC2, PPP2R5C AND ADHFE1 genes in stool are increased in patients with colorectal cancer or adenoma. The combined detection of gene methylation is expected to be a non-invasive method for the screening of colorectal cancer and precancerous lesions.