The quality of drugs is a crucial premise for ensuring the safety and effectiveness of clinical medication, while quality control during the pharmaceutical process directly affects the quality and consistency of the final product formulation. However, there is a lack of a comprehensive and scientific system for assessing and optimizing the quality control level during the manufacturing process in the field of drug quality control. Therefore, this study proposed the concept of "pharmaceutical process omics", clarified its advantages in guiding drug production, and explored in depth the research approaches, diverse analytical techniques, and broad range of applications in drug quality control. In addition, this study anticipated the broad application prospects of pharmaceutical process omics in the field of drug quality control, aiming to provide a scientific basis for the development of pharmaceutical process quality control standards.
Quality Control ; Humans ; Drugs, Chinese Herbal/chemistry*

Turning to critical illness is a common stage of various diseases and injuries before death. Patients usually have complex health conditions, while the treatment process involves a wide range of content, along with high requirements for doctor′s professionalism and multi-specialty teamwork, as well as a great demand for time-sensitive treatments. However, this is not matched with critical care professionals and the current state of medical care in China. Telemedicine, which shortens the distance of medical professionals and the gap of disease diagnosis and treatments in various regions through electronic information, can effectively solve the current problem. Therefore, there is an urgent need to develop a standardized, high-quality visualization telemedicine round system .Therefore, experts have been organized to search domestic and foreign literature on telemedicine round for critically ill patients and to form this consensus based on clinical experiences so as to further improve the level of critical care treatments in regions.

Objective:To investigate a family with hereditary coagulation factor Ⅺ(FⅪ)deficiency,identify its possible genetic etiology,analyze the bleeding risk of the proband,and provide a blood transfusion regimen.Methods:The blood samples from the family members were collected,and the coagulation parameters of the proband and her family members were detected.Whole-exome sequencing was performed on the blood samples of the proband to identify gene variants,and validate the variants in the family using Sanger sequencing.Bioinformatics softwares were used to analyze the conservation of amino acid variant sites and the impact of the variations on protein function.The pathogenicity of the variant sites was analyzed according to the genetic variation classification criteria and guidelines of the American College of Medical Genetics and Genomics(ACMG).Thromboelastography(TEG)was used to assess the coagulation function of the family members and evaluate the transfusion regimen and its efficacy in the proband.Results:The activated partial thromboplastin time(APTT)of the proband was significantly prolonged to 96.7 seconds,and FⅪ activity(FⅪ:C)and FⅪ antigen(FⅪ:Ag)decreased to 1.3％and 1％,respectively,both of which were extremely reduced.The FⅪ:C of the proband's father was also significantly lower than the normal value.The TEG results showed that the coagulation function of the proband was reduced,while the coagulation function of other family members was normal.The F11 gene of the proband exhibited compound heterozygous variants of c.738G＞A(p.Trp246*)and c.128G8＞A(p.Ala430Thr).The proband's father carried a heterozygous missense variant of c.1288G＞A(p.Ala430Thr),while her mother,her eldest daughter,and her youngest daughter carried a heterozygous nonsense variant of c.738G＞A(p.Trp246*).According to the ACMG genetic variation classification criteria and guidelines,c.738G＞A(p.Trp246*)is classified as a pathogenic variant(PVS1+PS3-Moderate+PP4),and c.1288G＞A(p.Ala430Thr)is classified as a possible pathogenic variant(PS3-Moderate+PM1+PM3_Srong+PP4).p.Trp246 and p.Ala430 are highly conserved across different species.Swiss PdbViewer software analysis showed that p.Ala430Thr variant caused a change in the number of hydrogen bonds in FⅪ protein,affecting protein function.The following transfusion regimen was determined through TEG evaluation in vitro:600 ml of fresh frozen plasma(FFP)was administered 24 hours before surgery to prevent bleeding.And there was no significant bleeding during or after the surgery.Conclusion:The heterozygous nonsense variant ofc.738G＞A(p.Trp246*)and the heterozygous missense variant of c.1288G＞A(p.Ala430Thr)in the F11 gene are the pathogenic factors of this hereditary FⅪ deficiency family.

Turning to critical illness is a common stage of various diseases and injuries before death. Patients usually have complex health conditions, while the treatment process involves a wide range of content, along with high requirements for doctor′s professionalism and multi-specialty teamwork, as well as a great demand for time-sensitive treatments. However, this is not matched with critical care professionals and the current state of medical care in China. Telemedicine, which shortens the distance of medical professionals and the gap of disease diagnosis and treatments in various regions through electronic information, can effectively solve the current problem. Therefore, there is an urgent need to develop a standardized, high-quality visualization telemedicine round system .Therefore, experts have been organized to search domestic and foreign literature on telemedicine round for critically ill patients and to form this consensus based on clinical experiences so as to further improve the level of critical care treatments in regions.

Objective To investigate the clinical characteristics and prognosis of pneumococcal meningitis(PM),and drug sensitivity of Streptococcus pneumoniae(SP)isolates in Chinese children.Methods A retrospective analysis was conducted on clinical information,laboratory data,and microbiological data of 160 hospitalized children under 15 years old with PM from January 2019 to December 2020 in 33 tertiary hospitals across the country.Results Among the 160 children with PM,there were 103 males and 57 females.The age ranged from 15 days to 15 years,with 109 cases(68.1% )aged 3 months to under 3 years.SP strains were isolated from 95 cases(59.4% )in cerebrospinal fluid cultures and from 57 cases(35.6% )in blood cultures.The positive rates of SP detection by cerebrospinal fluid metagenomic next-generation sequencing and cerebrospinal fluid SP antigen testing were 40% (35/87)and 27% (21/78),respectively.Fifty-five cases(34.4% )had one or more risk factors for purulent meningitis,113 cases(70.6% )had one or more extra-cranial infectious foci,and 18 cases(11.3% )had underlying diseases.The most common clinical symptoms were fever(147 cases,91.9% ),followed by lethargy(98 cases,61.3% )and vomiting(61 cases,38.1% ).Sixty-nine cases(43.1% )experienced intracranial complications during hospitalization,with subdural effusion and/or empyema being the most common complication[43 cases(26.9% )],followed by hydrocephalus in 24 cases(15.0% ),brain abscess in 23 cases(14.4% ),and cerebral hemorrhage in 8 cases(5.0% ).Subdural effusion and/or empyema and hydrocephalus mainly occurred in children under 1 year old,with rates of 91% (39/43)and 83% (20/24),respectively.SP strains exhibited complete sensitivity to vancomycin(100% ,75/75),linezolid(100% ,56/56),and meropenem(100% ,6/6).High sensitivity rates were also observed for levofloxacin(81% ,22/27),moxifloxacin(82% ,14/17),rifampicin(96% ,25/26),and chloramphenicol(91% ,21/23).However,low sensitivity rates were found for penicillin(16% ,11/68)and clindamycin(6% ,1/17),and SP strains were completely resistant to erythromycin(100% ,31/31).The rates of discharge with cure and improvement were 22.5% (36/160)and 66.2% (106/160),respectively,while 18 cases(11.3% )had adverse outcomes.Conclusions Pediatric PM is more common in children aged 3 months to under 3 years.Intracranial complications are more frequently observed in children under 1 year old.Fever is the most common clinical manifestation of PM,and subdural effusion/emphysema and hydrocephalus are the most frequent complications.Non-culture detection methods for cerebrospinal fluid can improve pathogen detection rates.Adverse outcomes can be noted in more than 10% of PM cases.SP strains are high sensitivity to vancomycin,linezolid,meropenem,levofloxacin,moxifloxacin,rifampicin,and chloramphenicol.[Chinese Journal of Contemporary Pediatrics,2024,26(2):131-138]

Age-dependent loss of skeletal muscle mass and function is a feature of sarcopenia, and increases the risk of many aging-related metabolic diseases. Here, we report phenotypic and single-nucleus transcriptomic analyses of non-human primate skeletal muscle aging. A higher transcriptional fluctuation was observed in myonuclei relative to other interstitial cell types, indicating a higher susceptibility of skeletal muscle fiber to aging. We found a downregulation of FOXO3 in aged primate skeletal muscle, and identified FOXO3 as a hub transcription factor maintaining skeletal muscle homeostasis. Through the establishment of a complementary experimental pipeline based on a human pluripotent stem cell-derived myotube model, we revealed that silence of FOXO3 accelerates human myotube senescence, whereas genetic activation of endogenous FOXO3 alleviates human myotube aging. Altogether, based on a combination of monkey skeletal muscle and human myotube aging research models, we unraveled the pivotal role of the FOXO3 in safeguarding primate skeletal muscle from aging, providing a comprehensive resource for the development of clinical diagnosis and targeted therapeutic interventions against human skeletal muscle aging and the onset of sarcopenia along with aging-related disorders.
Animals ; Humans ; Sarcopenia/metabolism* ; Forkhead Box Protein O3/metabolism* ; Muscle, Skeletal/metabolism* ; Aging/metabolism* ; Primates/metabolism*

Objective: To explore the basic characteristics of conventional echocardiography of apical hypertrophic cardiomyopathy (ApHCM) patients complicating with left ventricular apical aneurysm (LVAA). Methods: This is a retrospective study. Patients who underwent echocardiography and cardiac magnetic resonance (CMR) and were diagnosed with ApHCM complicated with LVAA by CMR at Fuwai Hospital, Chinese Academy of Medical Sciences from August 2012 to July 2017 were enrolled. According to whether LVAA was detected by echocardiography, the enrolled patients were divided into two groups: LVAA detected by echocardiography group and LVAA not detected by echocardiography group. Clinical data of the two groups were compared to analyze the causes of missed diagnosis by echocardiography. Results: A total of 21 patients were included, of whom 67.0% (14/21) were males, aged (56.1±16.5) years. Patients with chest discomfort accounted for 81.0% (17/21), palpitation 38.1% (8/21), syncope 14.3% (3/21). ECG showed that 21 (100%) patients had ST-T changes and 18 (85.7%) had deep T-wave invertion. Echocardiography revealed ApHCM in 17 cases (81.0%) and LVAA in 7 cases (33.3%). The mean left ventricular apical aneurysm diameter was 33.0 (18.0, 37.0) mm, and left ventricular ejection fraction was (66.5±6.6) %, and left ventricular apex thickness was (21.0±6.3) mm. Left ventricular outflow tract obstruction was presented in 4 cases and middle left ventricular obstruction in 10 cases. The mean left ventricular apical aneurysm diameter of LVAA detected by echocardiography was greater than that of LVAA not detected by echocardiography (25.0 (18.0, 28.0) mm vs. 16.0 (12.3, 21.0) mm, P=0.006). Conclusions: Conventional echocardiography examination has certain limitations in the diagnosis of ApHCM. Smaller LVAA complicated with ApHCM is likely to be unrecognized by echocardiography. Clinicians should improve their understanding of this disease.
Male ; Humans ; Female ; Apical Hypertrophic Cardiomyopathy ; Retrospective Studies ; Stroke Volume ; Cardiomyopathy, Hypertrophic/diagnostic imaging* ; Ventricular Function, Left ; Echocardiography ; Heart Aneurysm/diagnostic imaging*

Objective: To explore the basic characteristics of conventional echocardiography of apical hypertrophic cardiomyopathy (ApHCM) patients complicating with left ventricular apical aneurysm (LVAA). Methods: This is a retrospective study. Patients who underwent echocardiography and cardiac magnetic resonance (CMR) and were diagnosed with ApHCM complicated with LVAA by CMR at Fuwai Hospital, Chinese Academy of Medical Sciences from August 2012 to July 2017 were enrolled. According to whether LVAA was detected by echocardiography, the enrolled patients were divided into two groups: LVAA detected by echocardiography group and LVAA not detected by echocardiography group. Clinical data of the two groups were compared to analyze the causes of missed diagnosis by echocardiography. Results: A total of 21 patients were included, of whom 67.0% (14/21) were males, aged (56.1±16.5) years. Patients with chest discomfort accounted for 81.0% (17/21), palpitation 38.1% (8/21), syncope 14.3% (3/21). ECG showed that 21 (100%) patients had ST-T changes and 18 (85.7%) had deep T-wave invertion. Echocardiography revealed ApHCM in 17 cases (81.0%) and LVAA in 7 cases (33.3%). The mean left ventricular apical aneurysm diameter was 33.0 (18.0, 37.0) mm, and left ventricular ejection fraction was (66.5±6.6) %, and left ventricular apex thickness was (21.0±6.3) mm. Left ventricular outflow tract obstruction was presented in 4 cases and middle left ventricular obstruction in 10 cases. The mean left ventricular apical aneurysm diameter of LVAA detected by echocardiography was greater than that of LVAA not detected by echocardiography (25.0 (18.0, 28.0) mm vs. 16.0 (12.3, 21.0) mm, P=0.006). Conclusions: Conventional echocardiography examination has certain limitations in the diagnosis of ApHCM. Smaller LVAA complicated with ApHCM is likely to be unrecognized by echocardiography. Clinicians should improve their understanding of this disease.
Male ; Humans ; Female ; Apical Hypertrophic Cardiomyopathy ; Retrospective Studies ; Stroke Volume ; Cardiomyopathy, Hypertrophic/diagnostic imaging* ; Ventricular Function, Left ; Echocardiography ; Heart Aneurysm/diagnostic imaging*

Prunus mume is an edible and medicinal material, and Mume Fructus is its processed product, which was first recorded in Shennong's Classic of Materia Medica(Shen Nong Ben Cao Jing). It is an effective drug for stopping diarrhea with astringents and promoting fluid production to quiet ascaris. By consulting the ancient herbal works of the past dynasties, modern codes, and other rela-ted literature, this paper sorted out the medicinal evolution of Mume Fructus, examined the ancient efficacy of Mume Fructus and the main indications, and summarized the inclusion of Mume Fructus in national and provincial standards. It is recorded in the ancient herbal works of the past dynasties that Mume Fructus can be processed by various methods such as roasting, stir-frying or micro-frying, stir-frying with charcoal, single steaming, steaming with wine, and steaming after soaking in wine or vinegar, and prepared into pills, powders, and ointments, which are used in the treatment of fatigue, diabetes, malaria, dysentery, ascariasis, and other diseases. Mume Fructus has been included in nine editions of Chinese Pharmacopoeia and 19 provincial and municipal preparation specifications. The processing method of Mume Fructus is determined, namely, clean P. mume should be softened by moistening in water or steaming and pitted. By reviewing the effects of processing on its chemical composition, pharmacological effects, and its modern clinical application, this paper identified the following issues. The ancient application methods of Mume Fructus are diverse but less commonly used in modern times, there is a lack of standardized research on the processing, and the research on the changes caused by the difference in Mume Fructus before and after processing is not deep. Therefore, it is necessary to further investigate the change pattern of its chemical composition before and after processing and its correlation between its medicinal activity to standardize the processing technology and provide a solid basis for the use of Mume Fructus in parts and its quality control.
Drugs, Chinese Herbal/pharmacology* ; Materia Medica/analysis* ; Fruit/chemistry* ; Quality Control ; Prunus/chemistry* ; Medicine, Chinese Traditional

Objective: To analyze the etiological and epidemiological characteristics of Vibrio cholerae in Beijing during 2015-2021 and provide evidence for the prevention and control of cholera. Methods: The V. cholerae strains isolated in Beijing during 2015-2021 were analyzed by serotyping and virulence genes detection. Pulsed field gel electrophoresis (PFGE) was performed for the molecular typing of the strains. Based on the collected epidemiological and clinical data of cholera cases,the epidemiological characteristics of cholera were analyzed by descriptive epidemiology method. Results: A total of 76 Vibrio cholerae O1 strains were isolated in Beijing during 2015-2021, including 61 strains from human, 10 strains from environment and 5 strains from seafood. The 76 strains consisted of 68 Ogawa strains and 8 Inaba strains. Six Ogawa strains isolated from sporadic cases carried ctxAB. After NotⅠ digestion, 76 strains were divided into 33 PFGE patterns. From 2015 to 2021, a total of 38 cholera epidemics were reported in Beijing, most of them were sporadic ones, accounting for 92.11% (35/38). A total of 45 cases were reported, and the cases occurred during June-September accounted for 97.78% (44/45). Cholera cases occurred in 9 districts of Beijing, and the cases reported in Chaoyang district accounted for 42.22% (19/45) and in Changping district accounted for 31.11% (14/45). The age of the cholera cases ranged from 19 to 63 years. Except for one case with unknown clinical symptoms, 44 cases had diarrhea symptoms with 84.09% (37/44) of the cases reporting diarrhea (3-9 times/day), followed by yellow watery stool (95.45%, 42/44), abdominal pain (68.18%, 30/44), nausea and vomiting (40.91%, 18/44) and fever (36.36%, 16/44). Conclusion: Vibrio cholerae strains isolated in Beijing during 2015-2021 were mainly O1 serotype Ogawa,most of which were non-toxigenic. The PFGE of the strains varied. Cholera epidemics occurred in 9 districts of Beijing, but most were sporadic ones with incidence peak during June-September.
Adult ; Beijing/epidemiology* ; Cholera/epidemiology* ; Diarrhea/epidemiology* ; Electrophoresis, Gel, Pulsed-Field ; Humans ; Middle Aged ; Vibrio cholerae O1/genetics* ; Young Adult