The prescription and technology of pharmaceutical preparations are the basis for ensuring the quality and efficacy of medicines. Pharmaceutical excipients are important part of pharmaceutical preparations. As it's known to all that some pharmaceutical excipients can affect the activity of CYP3A, and then may influence the metabolism and bioavailability of its substrates in vivo. Relative bioavailability is a key element of generic drug research in China and the United States. Our country is advancing the quality and efficacy consistency evaluation of generic drugs. Therefore, it is of great practical significance to understand the impact of pharmaceutical excipients on CYP3A and its guiding role in consistency evaluation.

ObjectiveTo summarize and compare the main traditional Chinese medicine （TCM） syndromes of Delta and Omicron variants of severe acute respiratory syndrome coronavirus 2 （SARS-CoV-2） carriers to provide references for the syndrome evolution and syndrome differentiation of SARS-CoV-2 infection. MethodThe TCM medical records of imported and local cases of infection with Delta and Omicron variants of SARS-CoV-2 in Changsha since September 23， 2021 to March 27， 2022 were collected， including 18 Delta variant cases and 36 Omicron variant cases. Their TCM diagnosis information and TCM pathogenesis were analyzed and compared. ResultThe common manifestations in Delta variant cases were cough， fever， chest distress/shortness of breath， sore muscles， nausea， dry mouth， dry or sore throat， thick and greasy tongue coating， and rapid and slippery pulse. The predominant pathogenesis was dampness-heat in the upper-energizer and heat stagnation in the lesser Yang combined with dampness. The occurrence of chest distress/shortness of breath， greasy tongue coating， slippery pulse， and the proportion of dampness-heat in the upper-energizer syndrome were higher in Delta variant cases than in Omicron variant cases （P<0.05）. The common manifestations in Omicron variant cases were itchy and sore throat， nasal congestion， running nose， fever， mild aversion to cold， dry mouth， dizziness， slightly reddish tongue with thin white coating， and rapid or wiry pulse. The predominant pathogenesis was wind-dryness invading defensive exterior， and heat stagnation in the lesser Yang. The occurrence of white-coated tongue and the proportion of wind-dryness invading defensive exterior syndrome were higher in Omicron variant cases than in Delta variant cases （P<0.05）. ConclusionThere are certain differences in TCM syndromes and the corresponding pathogenesis between Delta variant and Omicron variant cases in Changsha， Hunan. The Delta variant of SARS-COV-2 tends to induce dampness-heat syndrome， whereas Omicron variant infection tends to elicit wind-dampness syndrome， which is expected to provide a reference for the pathogenesis evolution of SARS-COV-2 infection.

OBJECTIVES: Accurate breast lesion surface localization can guarantee accurate biopsy and local treatment. But there is no guideline to regular equipment and methods for the localization of breast lesions. The conventional non-invasive localization method is marker-based localization. The advantages of this method are simple and efficient. The disadvantages are that markers disappear easily under coupling agents; the positioning length of markers cannot last long on skin; and healthcare associated infection due to many patients using the same marker pen is potentially unavoidable. Breast lesion sticker (called sticker for short) is a new-type localization medical instrument in 2020. Our study aims to explore the clinical value of a new lesion stickers in breast lesion surface localization via comparison of the sticker and marker pen localization methods. METHODS: This was a prospective cohort study. It was conducted in 67 patients who needed breast lesion surface localization before biopsy. The patients were randomly assigned into 2 groups. One group of patients used marker pen to mark breast lesion surface location by ultrasonography. The other group of patients used stickers. Patients labeled with markers on skin were swabbed agents before marking. Then the markers were checked by ultrasound scan. If the surface positions of breast lesion were not correct, the above procedure was repeated. In the sticker group, the stickers were released synchronously after the lesions were detected by ultrasound scan. Then locations were checked via scanning hole. If the surface positions of breast lesion were not correct, the above procedure was repeated. The accuracy of positioning, the length of positioning time and satisfaction of patients between the 2 groups were compared. The length of positioning time was calculated from the time when ultrasound detected the lesion to the time when the surface position of breast lesion was confirmed. The total score of patients' satisfaction was 5 points according to Service Quality Evaluation of SERVQUAL Scale, including sonographers' service attitude and their technical proficiency, other medical staffs' service attitude and their technical proficiency, hospital service procedures, positioning comfort, and positioning effects. RESULTS: All 67 patients were females, aged 18-66 (39.73±13.10). There were 35 patients in the marker pen group and 32 patients in the sticker group. The time length of group used marker pen to localization was 22-88 (52.20±2.90) s, and the sticker group was 3-15 (9.22±0.58) s in length. The length of positioning time for the stickers was significantly shorter than that of the marker (P<0.01). Both methods were accurate in the surface localization of lesions before operation. The total scores of patients' satisfaction was 4-5 (4.92±0.02) in the stickers group, and 1-5 (3.35±0.10) in the marker pen group. The patients' satisfaction scores with the sticker were significantly higher than those with the marker pen (P<0.01). The length of positioning time and patients' satisfication scores for sonographer with 20 years' working experience were shorter and higher than those of sonographer with 10 years' working experience, respectively (both P<0.05). CONCLUSIONS The new breast lesion positioning stickers have more advantages than the marker pen in localization efficiency. It could reduce the workload of medical workers and increase patients' satisfaction to some extent. The stickers can be used not only in the breast lesions surface localization, but also in the skin location of pleural effusion and ascites, the skin location of surface masses, the skin location of thyroid nodule, and many other clinical marker areas, to further expand the scope of clinical application and value of the stickers.
Breast/diagnostic imaging* ; Breast Neoplasms/diagnostic imaging* ; Female ; Humans ; Male ; Prospective Studies ; Skin

OBJECTIVES: Since the outbreak of coronavirus disease 2019 (COVID-19), it has spread rapidly in China and many other countries. The rapid increase in the number of cases has caused widespread panic among people and has become the main public health problem in the world. Severe patients often have difficult breathing and/or hypoxemia after 1 week of onset. A few critically ill patients may not only rapidly develop into acute respiratory distress syndrome, but also may cause coagulopathy, as well as multiple organs failure (such as heart, liver and kidney) or even death. This article is to analyze the predictive role of clinical features in patients with COVID-19 for severe disease, so as to help doctor monitor the severity-related features, restrain the disease progress, and provide a reference for improvement of medical treatment. METHODS: The clinical data of 208 patients with COVID-19 who were isolated and treated in Changsha Public Health Treatment Center from January 17, 2020 to March 14, 2020 were collected. All patients were the mild and ordinary adult patients on admission, including 105 males and 103 females from 19 to 84 (median age 44) years old. According to the "Program for the diagnosis and treatment of novel coronavirus (COVID-19) infected pneumonia (Trial version 7)" issued by the General Office of National Health Committee and Office of State Administration of Traditional Chinese Medicine as the diagnostic and typing criteria. According to progression from mild to severe disease during hospitalization, the patients were divided into a mild group (=183) and a severe transformation group (=25). The clinical features such as age, underlying disease, blood routine, coagulation function, blood biochemistry, oxygenation index, and so on were analyzed. Among them, laboratory tests included white blood cell (WBC), lymphocytes (LYM), neutrophil (NEU), hemoglobin (Hb), platelet (PLT), prothrombin time (PT), plasma fibrinogen (Fib), activated partial prothrombin time (APTT), thrombin time (TT), -dimer, total bilirubin (TBIL), albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), serum creatinine (Cr), creatine kinase (CK), creatine kinase isoenzyme-MB (CK-MB), lactate dehydrogenase (LDH), C-reactive protein (CRP), and oxygen partial pressure in arterial blood. Partial pressure of oxygen in arterial blood/fractional concentration of inspiratory oxygen (PaO/FiO) was calculated. The variables with statistical significance were analyzed by logistic regression analysis. RESULTS: Patients in the severe transformation group had more combined underlying diseases than those in the mild group (<0.05). From the perspective of disease distribution, patients in the severe transformation group had more combined hypertension (<0.05). In the severe transformation group, PT was significantly longer, the levels of Fib, ALT, AST, CK, LDH, and CRP were significantly higher than those in the mild group (<0.05 or <0.001), while LYM, ALB, and PaO/FiO were significantly lower than those in the mild group (<0.05 or <0.001). Logistic regression analysis was performed on clinical features with statistically significant differences. Combined with hypertension, LYM, PT, Fib, ALB, ALT, AST, CK, LDH, and CRP as independent variables, and having severe disease or not was the dependent variable. The results show that combined hypertension, decreased LYM, longer PT, and increased CK level were independent risk factors that affected the severity of COVID-19 (<0.05). CONCLUSIONS The patients with mild COVID-19 who are apt to develop severe diseases may be related to combined hypertension, decreased LYM, and longer PT, and increased CK level. For the mild patients with these clinical features, early intervention may effectively prevent the progression to severe diseases.
Adult ; Aged ; Aged, 80 and over ; Betacoronavirus ; China ; Coronavirus Infections ; diagnosis ; physiopathology ; Disease Progression ; Female ; Hospitalization ; Humans ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral ; diagnosis ; physiopathology ; Retrospective Studies ; Young Adult

We report a case of coronavirus disease 2019 (COVID-19) patient who was cured by oral administration of nirmatrelvir/ritonavir (Paxlovid). The patient was treated with Paxlovid after being first infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron BA.5 variant. On the 11th day after SARS-CoV-2 nucleic acid test turned negative, SARS-CoV-2 nucleic acid test was positive again, and the threshold of nucleic acid cycle number was equivalent to that of the first infection. The results of two whole gene sequencing showed that it was the same virus strain infection, suggesting that the case was re-positive. Without specific treatment, SARS-CoV-2 nucleic acid detection in nasopharyngeal swab turned negative. It is not uncommon for Paxlovid to recover after treating COVID-19, and most of the patients can recover without specific treatment. However, it is necessary to further study the mechanism that may lead to the recovery of SARS-CoV-2.
Humans ; COVID-19 ; SARS-CoV-2/genetics* ; Administration, Oral ; Nucleic Acids

【Objective】 To explore the current status of positive psychological qualities among college students who had participated in voluntary blood donation in Changsha area, so as to demonstrate that scientific blood donation can promote mental health. 【Methods】 From May to June 2022, 1 440 college students in Changsha was selected as the research subjects by stratified random sampling method. They were divided into groups based on their experience of blood donation. A questionnaire survey was conducted using the General Information Questionnaire, the Chinese College Student Positive Psychological Product Quality Scale, and the Repeated Blood Donation Behavior Survey Scale. 【Results】 There were differences in the six dimensions of positive psychological quality among different family and friends in terms of their support for blood donation, blood donation status among different family members, understanding of voluntary blood donation knowledge (P<0.05). There were differences in positive psychological qualities among different levels of blood reimbursement experiences (cognitive dimension, moderation dimension, transcendence dimension), different blood donation times (moderation dimension, interpersonal dimension), different blood donation volumes (moderation dimension, fairness dimension), different comprehensive blood donation experiences (moderation dimension, transcendence dimension, interpersonal dimension, emotional dimension) and reasons for blood donation (cognitive dimension, moderation dimension, interpresonal dimension, emotional dimension, fairness dimension)(P<0.05). The positive psychological quality of college students was positively correlated with their intention to repeat blood donation behavior (P<0.01), and the difference was statistically significant. 【Conclusion】 The positive psychological quality of college students with blood donation experience in Changsha surpassed those without blood donation experience, and their positive psychological quality was positively correlated to their intention to repeated blood donation. Therefore, it is recommended to encourage voluntary blood donation among college students.

OBJECTIVES: To analyze the clinical characteristics of fecal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid-positive in patients with coronavirus dasease 2019 (COVID-19) and to provide a scientific basis for the prevention and control of this disease. METHODS: The clinical data of 16 patients with fecal SARS-CoV-2 nucleic acid positive, who hospitalized in the North Branch of the First Hospital of Changsha (Changsha Public Health Rescue Center) from January to February 2020, were retrospectively analyzed. Their clinical manifestations, laboratory data and imaging data were summarized. RESULTS: Among the 16 patients, there were 9 males (56.25%) and 7 females (43.75%), the ratio of males to females was 1∶1.29. The age of onset was (43.3±14.6) years. There were 15 patients with contact history of Wuhan, 1 patient with contact history of local patient.Twelve patients were common type (75%), and 4 patients were severe type (25%). Clinical symptoms included fever in 14 patients (87.5%), cough in 12 patients (75%), shortness of breath in 5 patients (31.25%), pharyngalgia in 10 patients (62.5%), fatigue in 7 patients (43.75%), and diarrhea in 4 patients (25%). There were 14 patients (87.5%) with normal or decreased white blood cell count, 11 patients (68.75%) with decreased lymphocyte count, 15 patients (93.75%) with increased erythrocyte sedimentation rate, 13 patients (81.25%) with increased hypersensitivity C-reactive protein, 5 patients (31.25%) with increased procalcitonin, and 8 patients (50%) with increased serum ferritin in peripheral blood, and stool routine was basically normal. Compared with the common type, there was significant difference in the white blood cell and lymphocyte counts in the severe type (<0.01); the infection indicators, such as hypersensitivity C-reactive protein and serum ferritin, were significantly increased, with significant difference (all <0.01); but the procalcitonin and erythrocyte sedimentation rate was not significantly different (both >0.05). Chest CT mainly showed patchy shadows and interstitial changes. According to imaging examination, 4 patients (25%) showed unilateral pneumonia and 12 patients (75%) showed bilateral pneumonia. CONCLUSIONS The patients have the clinical symptoms of COVID-19, but gastrointestinal symptoms (such as diarrhea) are more common, and the changes of white blood cell count, lymphocyte count, hypersensitivity C-reactive protein, ferritin are more obvious in severe patients.The positivity of fecal nucleic acid suggests the possibility of digestive tract transmission of SARS-CoV-2, and fecal nucleic acid testing can be used as a routine testing method in clinical practice.
Adult ; Betacoronavirus ; isolation & purification ; C-Reactive Protein ; analysis ; China ; Coronavirus Infections ; diagnosis ; physiopathology ; Diarrhea ; virology ; Feces ; virology ; Female ; Ferritins ; analysis ; Humans ; Leukocyte Count ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral ; diagnosis ; physiopathology ; Retrospective Studies

OBJECTIVES: Systemic lupus erythematosus (SLE) is a kind of autoimmune inflammatory connective tissue disease which seriously endangers human health. Genetic factors play a key role in the pathogenesis of SLE. This study aims to investigate a novel phospholipase D2 (PLD2) mutation associated with familial SLE, and further explore the underlying mechanism of the mutation in SLE. METHODS: The blood samples from a SLE patient, the patient's parents, and 147 normal controls were collected and DNA was extracted. Whole genome high-throughput sequencing was performed in the patient and her parents and the results were further analyzed by various bioinformatics methods. The wild type (wt), mutant type (mu), and negative control PLD2 plasmids were further constructed and transfected into 293 cells. The expression level of HRAS protein in 293 cells was detected by Western blotting. RESULTS: In this SLE family, the female SLE patient and her mother, 1 in generation II and 1 in generation III had typical clinical manifestations of SLE, and all of them had lupus nephritis at early stage. The genetic characteristics are consistent with autosomal dominant inheritance. A novel PLD2 heterozygous mutation (c.2722C>T) was found in the patient and her mother, but not in her father and other normal controls. Compared with wtPLD2 plasmid and negative control PLD2 plasmid, the expression of HRAS in 293 cells transfected with muPLD2 plasmid was significantly up-regulated (both CONCLUSIONS PLD2 c.2722C>T mutation may be one of the pathogeny of SLE in this family.
Case-Control Studies ; Female ; High-Throughput Nucleotide Sequencing ; Humans ; Lupus Erythematosus, Systemic/genetics* ; Lupus Nephritis ; Mutation ; Phospholipase D

【Objective】 To understand the situation of free blood use of blood donors in Changsha to explore the correlation between free blood use of donors and repeated blood donation behaviors, so as to provide a theoretical basis for the recruitment of voluntary blood donations. 【Methods】 A total of 260 voluntary blood donors were selected by random sampling and divided into reimbursed group(n=97) and unreimbursed group(n=163), based on the results of a questionnaire, inquiring their using of free blood. 【Results】 The reimbursed group differed from the unreimbursed group in all dimensions, including behavioral attitude dimension(Z=3.250, P<0.05), subjective behavioral norm dimension(Z=4.576, P<0.05), and perceptual behavioral control dimension(Z=7.255, P<0.05) and the total score of the scale(Z=8.625, P<0.05), and the differences were statistically significant. 【Conclusion】 The intention to donate again was stronger in donors who experienced free blood use than those didn’t. Such donors are suitable candidates for blood donor recruitment. It is recommended to develop a suitable recruitment strategy for this population and further guarantee the clinical use of blood.

OBJECTIVES: With the continuous generation of new variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the pressure of epidemic prevention and control continues to increase in China. Omicron with stronger infectiousness, immune escape ability and repeated infection ability spread to many countries and regions around the world in a short period of time. China has also successively reported cases of imported Omicron infections. This study aims to understand the epidemiological characteristics of Omicron variant via analyzing the epidemiological characteristics of imported patients with Omicron in Hunan Province, and to provide reference for preventing and controlling the imported epidemics. METHODS: The clinical data of imported patients with coronavirus disease 2019 admitted to Hunan Province from December 16 to December 31, 2021 were retrospectively collected. The epidemiological information, general information, clinical classification, clinical symptoms, vaccination status, and lung CT were analyzed. Nasopharyngeal swabs and blood samples were collected. Virus nucleic acid was detected by magnetic beads method using SARS-CoV-2 detection kit. Ct values of ORF1ab gene and N gene were compared between asymptomatic infected patients and confirmed patients. The specific IgM and IgG antibodies were detected by chemiluminescence assay using SARS-CoV-2 IgM test kit and SARS-CoV-2 IgG test kit, respectively. Ct values of IgM and IgG antibodies were compared between asymptomatic infected patients and confirmed patients. RESULTS: Seventeen patients with Omicron variant infection were treated in Hunan, including 15 confirmed patients (5 common type and 10 mild type) and 2 asymptomatic infection patients. The 17 patients were all Chinese, they were generally young, and 16 were male. There were 9 patients with diseases. Of them 3 patients had respiratory diseases. All 17 patients had completed the whole process of vaccination, but only one person received a booster shot of SARS-CoV-2 vaccine. The clinical manifestations of the patients were mild, mainly including dry/painful/itchy throat, cough, and fatigue. The total protein and creatine in the asymptomatic infection and confirmed cases infected with Omicron variant were all within the normal range, but other biochemical indicators were abnormal. There were the significant differences in C-reactive protein and fibrinogen between asymptomatic infection and confirmed patients (both P<0.05). There were more patients with elevated C-reactive protein in confirmed patients than without confirmed ones. The detection rate of specific IgM and IgG antibodies on admission was 100%, and there was no significant difference in the specific antibody levels between asymptomatic infection and confirmed patients (P>0.05). There were no significant differences in Ct values of ORF1ab gene and N gene (21.35 and 18.39 vs 19.22 and 15.67) between the asymptomatic infection and the confirmed patients (both P>0.05). Only 3 patients had abnormal lung CT, showing a small amount of patchy and cord-like shadows. One of them had no abnormality on admission but had pulmonary lesions and migratory phenomenon after admission. CONCLUSIONS The patients with Omicron variant tend to be young people and have milder clinical symptoms, but the viral load is high and the infectiveness is strong. Therefore, the timely identification and effective isolation and control for asymptomatic infections and confirmed patients with mild symptoms are extremely important. In terms of epidemic prevention and control, the government still needs to strengthen the risk control of overseas input, adhere to normalized epidemic prevention and control measures, to effectively control the source of infection, cut off the route of transmission, and protect vulnerable people.
Asymptomatic Infections ; C-Reactive Protein ; COVID-19/virology* ; COVID-19 Vaccines ; China/epidemiology* ; Female ; Humans ; Immunoglobulin G ; Immunoglobulin M ; Male ; Retrospective Studies ; SARS-CoV-2