Real-world study (RWS), based on multi-source data from real medical environments, is gradually becoming an important supplement to traditional randomized controlled trials, and its application in the field of transfusion medicine is becoming increasingly widespread. This article systematically reviews the definition and methodological system of RWS, examines its application cases in clinical blood transfusion research, and discusses the advantages, limitations, and future research directions of RWS, aiming to provide a reference for evidence-based research in blood transfusion medicine.

Real-world study (RWS), based on multi-source data from real medical environments, is gradually becoming an important supplement to traditional randomized controlled trials, and its application in the field of transfusion medicine is becoming increasingly widespread. This article systematically reviews the definition and methodological system of RWS, examines its application cases in clinical blood transfusion research, and discusses the advantages, limitations, and future research directions of RWS, aiming to provide a reference for evidence-based research in blood transfusion medicine.

Objective To evaluation the bioequivalence of telmisartan tablets(80 mg)between test formulation and reference formulation in Chinese healthy subjects.Methods A single-center,randomized,open-label,two-preparations,single administration,partial repeat crossover of three sequences in three postprandial cycles and complete repeat crossover of two sequences in four fasting cycles,bioequivalence test was designed.Chinese healthy subjects were included in the bioequivalence trial,with 33 randomly assigned to the postprandial group and 32 randomly assigned to the fasting group.In each period,blood samples was collected before and after administration.The plasma concentration of the drug was determined by LC-MS/MS,using WinNonlin version 8.3 calculate the pharmacokinetic parameters and perform a statistical analysis using SAS version 9.4.Results The main pharmacokinetic parameters of telmisartan tablets after oral administration of test or reference were as follows.Fasting group Cmax were(556.10±456.06)and(580.99±533.50)ng·mL-1;AUC0-t were(3 475.15±3 785.16)and(3 450.54±3 681.02)ng·mL-1·h;AUC0-∞ were(3 214.06±2 272.06)and(3 194.84±2 187.45)ng·mL-1·h.The 90％confidence intervals of the geometric mean ratio of Cmax,AUC0-t,AUC0-∞ were within the requirements of the equivalent range of bioequivalence(80.00％-125.00％).Postprandial group Cmax were(299.26±124.72)and(291.29±126.34)ng·mL-1;AUC0-t were(3 682.24±2 799.72)and(3 636.71±2 158.42)ng·mL-1·h;AUC0-were(3 544.53±1 553.06)and(3 969.38±2 528.22)ng·mL-1·h.The 90％confidence intervals of the geometric mean ratio of Cmax,AUC0-t,AUC0-∞ were within the requirements of the equivalent range of bioequivalence(80.00％-125.00％).Conclusion Under fasting and fed conditions,two kinds of telmisartan tablets are bioequivalent in Chinese healthy subjects.

Objective To investigate the effect of pachymic acid(PA)on HIEC-6 inflammatory response of intestinal epithelial cells infected by Fusobacterium nucleatum(Fn)and its possible mechanism.Methods HIEC-6 cells were divided into control group,model group(1× 108 CFU·mL-1 Fn infection),experimental-L group(1× 108 CFU·mL-1 Fn+2 μmol·L-1 PA),experimental-M group(1× 108CFU·mL-1 Fn+4 μmol·L-1 PA),experimental-H group(1× 108 CFU·mL-1 Fn+8 μmol·L-1 PA),pcDNA-TLR4 group(1 × 108 CFU·mL-1 Fn+8 μmol·L-1 PA+transfected pcDNA-TLR4).After 12 h of treatment,the cell proliferation was detected by cell counting kit-8(CCK-8)test and Edu test respectively.The expression of inflammatory cytokines was detected by enzyme-linked immunosorbent assay(ELISA)and real-time quantitative polymerase chain reaction(RT-qPCR)respectively.The apoptosis was detected by flow cytometry.Western blot assay was used to detect the expression level of cell related proteins.Results The apoptosis rates of control,model,experimental-L,experimental-M,experimental-H and pcDNA-TLR4 groups were(3.51±0.31)％,(23.38±1.85)％,(16.74±0.54)％,(12.10±1.44)％,(8.89±0.63)％and(14.87±0.88)％,respectively;IL-8 content were(23.25±1.41),(79.69±4.37),(68.94±2.63),(51.46±2.56),(34.18±2.63)and(71.09±5.08)pg·mL-1,respectively;IL-1β contents were(8.81±0.49),(51.65±2.13),(35.98±3.47),(24.83±2.47),(14.79±1.25)and(43.89±1.59)pg·mL-1.Compared between model group and control group,compared between experimental-L,experimental-M,experimental-H groups and model group,compared between pcDNA-TLR4 group and experimental-H group,the differences of the above indexes were all statistically significant(all P＜0.05).Conclusion Pachymaric acid may improve the apoptosis of Fn infected intestinal epithelial cells by inhibiting TLR4/NF-κB pathway and inflammatory response.

To investigate the role of chamagogic polysaccharides (polysaccharides of Brassica rapa L., BRPs) against doxorubicin (DOX) cardiotoxicity and related mechanisms, H9c2 cells were selected for the study, and the effects of BRPs on DOX induced damage in H9c2 cells were detected by cell counting kit-8 (CCK-8); H9c2 cells were divided into the control group, the model group, and the drug group (0.5-3 mg·mL^-1); the control group was cultured under normal conditions, and the remaining groups were induced for 24 h by 1 μmol·L^-1 DOX after treatment. Apoptosis was detected by flow cytometry; the levels of lactate dehydrogenase (LDH), superoxide dismutase (SOD) and malondialdehyde (MDA) were measured in each group; intracellular reactive oxygen species (ROS) and mitochondrial membrane potential (MMP) were detected. Western blot was used to detect the expression of proteins related to the apoptosis and transcription factor NF-E2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) pathway. Compared with the control group, DOX-induced H9c2 cell injury was characterized by decreased cell viability, increased apoptosis, elevated LDH and MDA levels, decreased SOD activity, significantly increased ROS levels, and significantly decreased MMP; the level of B cell lymphoma-2 (Bcl-2) protein decreased, and the level of Bcl-2 associated X protein (Bax) increased significantly; In the model group, the expression levels of Nrf-2, HO-1, quinone oxidoreductase 1 (NQO1) were reduced, and the expression levels of Kelch-like ECH-associated protein 1 (Keap1) and phosphorylated p38 mitogen-activated protein kinase were significantly increased, Moreover, BRPs (0.5-3 mg·mL^-1) increased the protein expression levels of Nrf2, HO-1, and NQO1, and decreased the levels of Keap1 and phosphorylated p38 mitogen-activated protein kinase. In summary, the ability of BRPs to protect H9c2 cells and inhibit apoptosis may be related to their regulation of the Nrf2/HO-1 pathway to antagonize oxidative stress.

italic>Platycodon grandiflorum (Jacq.) A. DC is one of the most commonly used bulk medicinal herbs. It has important value in the fields of medicine, food and cosmetics, and its market demand is increasing year by year, and it has a good development prospect. In this study, based on 403 distribution records and 8 environmental variables, we used Maxent model to predict the potential distribution of P. grandiflorum under climate change. The results showed that the model simulation effect was the best when the Maxent parameter was FC (feature combination) = LQPH (L: linear features; Q: quadratic features; P: product features; H: hinge features) and RM (regularization multiplier) = 2.1, AUC (area under curve) = 0.901, and the model prediction showed that P. grandiflorum was widely distributed in 28 provinces of China under the current climate conditions, with a suitable area of 2 337 419.98 km². Under the influence of climate change in the future, the area of suitable habitat of P. grandiflorum showed a decreasing trend, and the distribution center as a whole showed a trend of northward and eastward shift. The distribution area of P. grandiflorum in the three main producing areas is affected by climate change, and the overall trend is that the future suitable distribution area of Chifeng in Inner Mongolia increases, while the future suitable distribution area of Zibo in Shandong and Taihe, Bozhou in Anhui decreases or even disappears under the SSP5-8.5 scenario (shared socioeconomic pathways). It is suggested to maintain and protect the ecological environment and germplasm resources of the reserved area suitable for the growth of P. grandiflorum, and increase the cultivation research in the expansion area of P. grandiflorum, so as to lay a foundation for the subsequent expansion of P. grandiflorum planting and to promote the protection and sustainable development of P. grandiflorum resources.

Objective To investigate the correlation between the expression of purinergic ligand-gated ion channel 7 receptor(P2X7R)and connective tissue growth factor(CTGF)in serum and cognitive function and clinical symptoms in patients with schizophrenia.Methods A total of 160 patients with schizophrenia who were diagnosed and treated in Department of Mental Intensive Care of Wuhan Wudong Hospital from January 2021 to January 2023 were collected as the observation group,and 160 healthy volunteers who underwent physical examinations were collected as the control group for the study.According to the Positive and Negative Symptom Scale(PANSS),patients were evaluated for their clinical and psychiatric symptoms(positive and negative symptoms,general pathological symptoms,and additional symptoms).The patients were grouped into a high score group(PANSS total score≥70 points,n=72)and a low score group(PANSS total score＜70 points,n=88).MATRICS consensus cognitive battery(MCCB)was applied to evaluate the cognitive abilities of patients;enzyme-linked immunosorbent assay(ELISA)was applied to detect serum P2X7R and CTGF levels.Spearman method was applied to analyze the correlation between serum P2X7R,CTGF levels and PANSS scores,and MCCB scores in patients with schizophrenia.Results Compared with the control group,the serum levels of P2X7R(610.71±107.83ng/L vs 384.78±80.62 ng/L)and CTGF(1.85±0.36μg/L vs 1.40±0.21μg/L)in the observation group were increased,with differences of statistical significance(t=21.226,13.658,all P＜0.05).The scores of variety items of MCBB of patients with schizophrenia in the observation group were lower than those in the control group,with differences of statistical significance(t=14.845～24.862,all P＜0.05),the positive symptom score(21.10±3.42score),negative symptom score(23.37±5.03 score),general pathological symptom score(39.48±8.11score),additional symptom score(8.26±1.22 score),and PANSS total score(92.21±12.50score)of schizophrenia patients in the high group were higher than those in the low group(13.65±3.04,15.62±3.91 score,30.14±6.15 score,5.20±0.94score,64.61±5.30score),with differences of statistical significance(t=14.576,10.964,8.280,17.915,18.764,all P＜0.05).The serum levels of P2X7R and CTGF in patients with schizophrenia in the high group were higher than those in the low group,with differences of statistical significance(t=12.233,5.923,all P＜0.05).The levels of serum P2X7R and CTGF in patients with schizophrenia were positively correlated with PANSS score(r=0.464～0.580,all P＜0.05),and negatively correlated with MCCB score[r=-0.603～-0.439,all P＜0.05].Conclusion The serum levels of P2X7R and CTGF in patients with schizophrenia are elevated,they are closely related to the clinical symptoms and cognitive function of patients.

Objective To investigate the effect of ursodeoxycholic acid(UDCA)on the symptoms after severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection in patients with primary biliary cholangitis(PBC)and their family member.Methods A questionnaire survey was conducted to collect related information from 171 PBC patients who attended The First Affiliated Hospital of Air Force Medical University before March 22,2023 and 128 family members,including demographic information,comorbidities,UDCA administration,SARS-CoV-2 infection,vaccination,symptoms,therapeutic medication,and the changes in liver disease-related symptoms.The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between two groups,and the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups.Results The median age was 51 years in the PBC patients and 49 years in the family members,with no significant difference between the two groups(P>0.05).Compared with the family member group,the PBC group had significantly lower body mass index(22.2±2.4 kg/m2 vs 23.3±2.9 kg/m2,P<0.001)and proportion of male individuals(10%vs 55%,P<0.001).All PBC patients received UDCA at a dose of 13—15 mg/kg,and SARS-CoV-2 infection rate was 100%in both groups.The family members had a significantly higher SARS-CoV-2 vaccination rate than the PBC patients(91%vs 57%,P<0.001).Compared with the family members,the PBC patients had significantly milder symptoms of sneezing,nasal obstruction,chest pain,and abnormal taste(P<0.05).Compared with the family members,the PBC patients had significantly lower rates of use of compound cold medicine(11%vs 20%,P<0.05)and Lianhua Qingwen capsules(12%vs 21%,P<0.05).For the PBC patients after SARS-CoV-2 infection,the liver disease-related symptoms such as fatigue,abdominal distension,dry mouth and dry eyes,pruritus,and yellow skin were aggravated by 37%,2%,27%,10%,and 3%,respectively.Conclusion Compared with the immediate family members of PBC patients who do not take UDCA,the PBC patients receiving UDCA do not show a reduction in SARS-CoV-2 infection rate,but UDCA may have a certain effect on alleviating infection-related symptoms in such patients.PBC patients may still experience the aggravation of liver disease-related symptoms after SARS-CoV-2 infection,and the long-term effect on PBC patients after SARS-CoV-2 infection should be taken seriously in clinical practice.

Objective To observe the clinical efficacy of acupuncture combined with acupoint catgut embedding therapy on back-shu and front-mu points and external application on shenque(RN8)point for premature ovarian failure(POF).Methods A total of 62 patients with POF were randomly divided into the observation group and the control group,with 31 patients in each group.The observation group was treated with acupuncture combined with acupoint catgut embedding therapy on back-shu and front-mu points and external application on shenque point,and the control group was treated with hormone replacement therapy.After three months of treatment,the clinical efficacy of the two groups was evaluated,and the changes in the traditional Chinese medicine(TCM)syndrome scores,as well as the ovarian volume,number of antral follicle,and antral follicle diameter of the patients in the two groups before and after treatment were observed.The changes of serum follicle stimulating hormone(FSH),luteinizing hormone(LH)and estradiol(E2)levels before and after treatment were compared between the two groups.Results(1)The total effective rate was 93.55%(29/31)in the observation group and 80.64%(25/31)in the control group.The efficacy of the observation group was significantly superior to that of the control group,and the difference was statistically significant(P＜0.05).(2)After treatment,the serum FSH,LH and E2 levels of patients in the two groups were significantly improved(P＜0.05),and the improvement in the observation group was significantly superior to that in the control group,with statistically significant differences(P＜0.05).(3)After treatment,ovarian volume,number of antral follicle,and antral follicle diameter were significantly improved in the two groups(P＜0.05),and the improvement in the observation group was significantly superior to that in the control group,and the difference was statistically significant(P＜0.05).Conclusion The treatment of POF with acupuncture combined with acupoint catgut embedding therapy on back-shu and front-mu points and external application on shenque point can significantly improve the clinical symptoms of the patients,conducive to the recovery of ovarian function,and significantly improve the sex hormone levels of the patients,with precise clinical efficacy.

Objective To explore the characteristics of vaginal microecology and vaginitis distribution of female patients in Xi'an,so as to provide reliable reference for clinical treatment.Methods A total of 102 124 women in Shaanxi Provincial People's Hospital from January 2018 to August 2023 were selected as the research objects.Vaginal secretions were collected from patients,and the vaginal microecology was detected and analyzed.Results Among 102 124 female patients,99.87%had vaginal microecological imbalance.The main disease types were vulvovaginal candidiasis(VVC),accounting for 16.03%,bacterial vaginitis(BV),accounting for 9.61%and trichomonal vaginitis(TV),accounting for 1.34%.Statistical analysis showed that the age of VVC,BV and TV patients was mainly 21～30 years old.The prevalence of VVC and BV in summer and autumn was higher than that in other seasons,while the prevalence of TV was relatively high in summer.In addition,there were 27 552 cases of simple vaginitis(26.98%)and 1 443 cases of mixed vaginitis(1.41%)in 101 995 female patients with vaginal microecology imbalance.In patients with mixed vaginitis,the BV+VVC combination accounted for the vast majority(79.00%),and the age group was mainly between 21 and 40 years old.Among the 28 995 patients with vaginitis,4 308 patients(14.86%)had recurrence,and the recurrence rate of simple vaginitis(11.44%,3 152/27 552)was much lower than that of mixed vaginitis(80.11%,1 156/1 443).Conclusion The main type of female simple vaginitis in Xi'an is VVC,which has a high prevalence in summer and autumn.The main type of mixed vaginitis is BV+VVC,Compared with simple vaginitis,patients with mixed infection are more likely to relapse.