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: Through analyzing the current handling capabilities for complex cases in blood transfusion compatibility detection and the application status of artificial intelligence-assisted (AI-assisted) technologies, this study explores the establishment of an effective AI-augmented protocol for managing challenging blood transfusion compatibility detection. Methods: This research systematically analyzes, designs, and explores an AI-augmented operational workflow for resolving challenging blood transfusion compatibility detection cases. Through three representative case studies, we evaluate its effectiveness, accuracy, and efficiency in addressing real-world diagnostic challenges. Results: The AI-augmented operational model demonstrates significant efficacy in resolving complex blood transfusion compatibility challenges, including complex blood typing, antibody specificity identification, challenging cross-matching, and transfusion strategy formulation. Conclusion: AI-augmented technologies demonstrate immense potential in resolving complex blood transfusion compatibility detections. By enabling intelligent, automated, precise, and standardized solutions, they significantly enhance diagnostic accuracy and operational efficiency, which is critical for ensuring transfusion safety and advancing personalized transfusion medicine. This study delineates both the advantages and existing limitations of AI implementation, explores future developmental trajectories, and provides a theoretical framework and practical implementation pathways for deeper integration of AI in transfusion medicine.

ObjectiveTo establish an ultra-high performance liquid chromatography-tandem triple quadrupole mass spectrometry（UHPLC-QqQ-MS） for determination of the active ingredients in Erdongtang， and to predict the targets and pathways of anti-insulin resistance action of this formula. MethodThe analysis was performed on an ACQUITY UPLC BEH C₁₈ column（2.1 mm×100 mm， 1.7 μm） with the mobile phase of 0.1% formic acid aqueous solution（A）-acetonitrile（B） for gradient elution（0-3 min， 90%-87%A； 3-6 min， 87%-86%A； 6-9 min， 86%-83%A； 9-11 min， 83%-75%A； 11-18 min， 75%-70%A； 18-19 min， 70%-52%A； 19-22 min， 52%A； 22-25 min， 52%-5%A； 25-27 min， 5%-90%A； 27-30 min， 90%A）. The contents of active ingredients in Erdongtang was detected by electrospray ionization（ESI） and multiple reaction monitoring（MRM） mode under positive and negative ion modes. On this basis， network pharmacology was applied to predict the targets and pathways of Erdongtang exerting anti-insulin resistance effect. ResultThe 20 active ingredients in Erdongtang showed good linear relationships within a certain mass concentration range， and the precision， stability， repeatability and recovery rate were good. The results of determination showed that the ingredients with high content in 15 batches of samples were baicalein（1 259.39-1 635.78 mg·L^-1）， baicalin（1 078.37-1 411.52 mg·L^-1）， the ingredients with medium content were mangiferin（148.59-217.04 mg·L^-1）， timosaponin BⅡ（245.10-604.89 mg·L^-1）， quercetin-3-O-glucuronide（89.30-423.26 mg·L^-1）， rutin（46.91-1 553.61 mg·L^-1）， glycyrrhizic acid（55.97-391.47 mg·L^-1）， neomangiferin（37.45-127.03 mg·L^-1）， nuciferine（0.89-63.48 mg·L^-1）， hyperoside（6.96-136.78 mg·L^-1）， liquiritin（30.89-122.78 mg·L^-1）， liquiritigenin（26.64-110.67 mg·L^-1）， protodioscin（58.57-284.26 mg·L^-1）， the ingredients with low content were wogonin（7.16-20.74 mg·L^-1）， pseudoprotodioscin（5.49-22.96 mg·L^-1）， ginsenoside Rb₁（7.31-23.87 mg·L^-1）， ginsenoside Rg₁（10.78-28.33 mg·L^-1）， ginsenoside Re（7.78-24.76 mg·L^-1）， ophiopogonin D（2.08-4.29 mg·L^-1）， methylophiopogonanone A（0.74-1.67 mg·L^-1）. The results of network pharmacology indicated that the mechanism of anti-insulin resistance exerted by Erdongtang might be related to the phosphatidylinositol 3-kinase/protein kinase B（PI3K/Akt） signaling pathway. ConclusionThe established UHPLC-QqQ-MS has the advantages of simple sample processing， strong exclusivity and high sensitivity， and can simultaneously determine the contents of the main ingredients from seven herbs in Erdongtang， which can lay the foundation for the development of Erdongtang compound preparations. The results of the network pharmacology can provide a reference for the mechanism study of Erdongtang in the treatment of type 2 diabetes mellitus.

Objective To explore the mechanism of Yipi Yanggan Prescription in the treatment of precancerous lesion of liver in rats based on M1 type macrophage polarization-chronic inflammation-liver cell malignant transformation.Methods Totally 90 Wistar rats were randomly divided into blank group,model group,Hugan Tablet group and Yipi Yanggan Prescription high-,medium-and low-dosage groups,with 15 rats in each group.The blank group was injected distilled water intraperitoneally,and the other groups were injected 5 mL/kg of diethylnitrosamine intraperitoneally at 50 mg/kg per week(twice per week)for 16 weeks to induce the precancerous lesion of liver model.Starting from the second day of modeling,Yipi Yanggan Prescription high-,medium-and low-dosage groups were orally administered with 1.2,0.6 and 0.3 g/mL Yipi Yanggan Prescription,respectively.The Hugan Tablet group was orally administered with 921 mg/kg Hugan Tablet solution,the blank group and model group were orally administered with an equal amount of physiological saline for 16 consecutive weeks.The appearance of the liver was observed,ELISA was used to detect serum ALT,AST,ALP,AFU,as well as TNF-α,IL-6,iNOS and MCP-1 content,HE staining and Masson staining were used to observe the morphology of liver tissue,immunohistochemistry was used to detect the expressions of liver cell malignancy markers OV6,CK19,CD133 and EpCAM,qPCR was used to detect the mRNA expressions of CK19,CD133 and EpCAM in liver tissue,immunofluorescence co-localization was used to detect the co-expressions of M1 type macrophage markers CD68 with IL-6 and TNF-α.Results Compared with the blank group,the liver of the model group rats was hard,with a rough surface and dull edges,and a large number of nodules were visible,the contents of serum ALT,AST,ALP,AFU,TNF-α,IL-6,iNOS and MCP-1 significantly increased(P<0.01),there were large areas of dysplasia nodules,inflammatory cell infiltration,and increased collagen fibers in liver tissue,the expressions of OV6,CK19,CD133 and EpCAM in liver tissue significantly increased,and the co-expressions of CD68 with IL-6 and TNF-α significantly increased(P<0.01).Compared with the model group,the number and size of liver nodules in each treatment group of rats decreased,the contents of serum ALT,AST,ALP,AFU,TNF-α,IL-6,iNOS and MCP-1 were significantly decreased(P<0.01),hepatocellular dysplasia and inflammatory cell infiltration were significantly improved,collagen fibers decreased,and the expressions of OV6,CK19,CD133 and EpCAM in liver tissue were significantly decreased,the co-expressions of CD68 with IL-6 and TNF-α significantly decreased(P<0.05,P<0.01).Conclusion Yipi Yanggan Prescription may alleviate inflammation by inhibiting polarization of M1 type macrophages,improve liver cell malignancy,and exert therapeutic effects on rats with precancerous lesion of liver induced by diethylnitrosamine.

Objective:To investigate the effects of thinned anterolateral thigh perforator flaps combined with finger splitting and webplasty in sequential treatment of degloving destructive wound of total hand.Methods:This study was a retrospective observational study. From January 2012 to January 2023, a total of 15 cases who met the inclusion criteria with degloving destructive wound of total hand were admitted to Ningbo No.6 Hospital, including 10 males and 5 females, aged 17-75 years. The wounds were all combined with exposed bones or tendon. Emergency debridement and vacuum sealing drainage were performed in all cases before flap transplantation in stage Ⅰ. After thorough debridement, the wound area was 11.0 cm×3.0 cm-23.0 cm×13.5 cm. One or both anterolateral thigh perforator flaps with size of 12.5 cm×5.0 cm-25.0 cm×15.5 cm were designed, cut, and thinned to repair the skin and soft tissue defects of the hand. The donor site was sutured directly or repaired with medium-thickness skin graft from the opposite thigh. As needed, the flap was reconstructed by finger splitting and webplasty once or more times every 3 months after stage Ⅰoperation. The survival and complications of flap and wound healing at the donor site were observed after stage Ⅰoperation. The appearance of flap, two-point discrimination distance, and hand function were observed during the follow-up. At the final follow-up, the function of the affected hand was evaluated by the trial standards for evaluation of partial function of upper extremity by the Hand Surgery Society of Chinese Medical Association.Results:After the operation of stage Ⅰ, all the flaps of 15 cases of patients survived completely, including 1 case that had arterial crisis of flap but survived completely after exploration and re-anastomosis of blood vessels; all the wounds at the donor site healed. During the follow-up period of 6 to 18 months after stage Ⅰ, the flap was slightly swollen, with a little pigmentation, and the two-point discrimination distance in the finger flap was 8-11 mm. The fingers could complete the basic life actions such as flexion, extension, pinch, and grip. At the final follow-up, 3 cases were excellent, 9 cases were good, and 3 cases were acceptable in function evaluation of the affected hand.Conclusions:For degloving destructive wound of total hand, free transplantation of one or both thinned anterolateral thigh perforator flaps is used for repair in stage Ⅰ, and finger splitting and webplasty are used to reconstruct the flaps in the later stage, which can basically restore the pinch and grip function of the affected hand that is required for daily life, and is worthy of clinical promotion.

Objective:To explore the latest progress of oncology drug clinical trials in China under COVID-19, as well as to provide decision-making evidence for related stakeholders. Research progress of oncology drug trials and approved cancer drugs in China in 2020 were systematically summarized and compared with 2019.Methods:Information Disclosure Platform for Drug Clinical Studies and China Food and Drug Administration Query System for Domestic and Imported Drug were searched for registered clinical trials and approved oncology drugs, respectively. The trial scope, stage, drug type, effect and mechanism of domestic and global pharmaceutical enterprises were compared between 2019 and 2020.Results:A total of 722 cancer drug trials registered in China in 2020, with an annual growth rate of 52.3%, accounting for 28.3% of all registered trials. Among them, 603 (83.5%) trials were initiated by domestic pharmaceutical enterprises, and 105 (14.5%) were international multicenter trials, phase I trials accounted for 44.5%. For all those trials, there were 458 cancer drug varieties, with an annual growth rate of 36.7%, and 361 (85.8%) were developed by domestic enterprises. Most of the investigational products were therapeutic innovative drugs (77.1%), major in tumor treatment (92.8%). In terms of mechanism, targeted drugs were the most popular, accounting for 76.6%, and programmed cell death-1 (PD-1) and epithelial growth factor receptor (EGFR) were the most common targets. In addition, there were 19 anticancer drugs from 17 companies approved in China in 2019, with 10 drugs from domestic companies. Lung cancer and breast cancer are the most common indications for both registered trials and marketed drugs. No statistically significant differences were found between 2020 and 2019 in terms of the distribution of trial sponsor, scope and stage, as well as the distribution of drug type, effect and mechanism ( P>0.05). Conclusions:During the Covid-19 epidemic period, clinical trials of oncology drugs in China progress smoothly and maintain a high growth rate. Series of innovative products obtained by domestic enterprises in 2020 is the main driving force of development of oncology drug clinical trials in China.

Background: Global spread and impact of the coronavirus disease 2019 (COVID-19) pandemic are determined to a large extent,by resistance to the pandemic and public response of all countries in the world;while a country's resistance and response are in turn determined by its political and socio economic conditions.To inform future disease prevention and control,we analyzed global data to exam the relationship between state vulnerabilities and COVID-19 incidences and deaths.Methods: Vulnerability was measured using the Fragile States Index (FSI).FSI is created by the Fund for Peace to assess levels of fragility for individual countries.Total FSI score and scores for 12 specific indicators were used as the predictor variables.Outcome variables were national cumulative COVID-19 cases and deaths up to September 16,2020,derived from the World Health Organization.Cumulative incidence rates were computed using 2019 National population derived from the World Bank,and case fatality rates were computed as the ratio of deaths/COVID-19 cases.Countries with incomplete data were excluded,yielding a final sample of 146 countries.Multivariate regression was used to examine the association between the predictor and the outcome measures.Results: There were dramatic cross-country variations in both FSI and COVID-19 epidemiological measurements.FSI total scores were negatively associated with both COVID-19 cumulative incidence rates (β =-0.0135,P ＜ 0.001) and case fatality rates (β =-0.0147,P ＜ 0.05).Of the 12 FSI indicators,three negatively associated with COVID-19 incidences were E1(Economic Decline and Poverty),E3 (Human Flight and Brain Drain),and S2 (Refugees and Internally Displaced Persons);two positively associated were P1 (State Legitimacy) and X1 (External Intervention).With regard to association with case fatality rates,C1 (Security Apparatus) was positive,and P3 (Human Rights and Rule of Law) and X1 was negative.Conclusion: With FSI measures by the Fund of Peace,overall,more fragile countries are less likely to be affected by the COVID-19 pandemic,and even if affected,death rates were lower.However,poor in state legitimacy and lack of external intervention are risk for COVID-19 infection and lack of security apparatus is risky for COVID-19 death.Implications of the study findings are discussed and additional studies are needed to examine the mechanisms underpinning these relationships.

Objective:To deliver understanding of the latest research progress on clinical trials and approval of dermatological drugs in China in 2020.Methods:A registration and information disclosure platform for drug clinical studies and a query system for domestic and imported drugs in the National Medical Products Administration of China were searched for registered clinical trials and approved dermatological drugs, respectively. The number and stages of clinical trials, indications and classification of involved products, and listed dermatological drugs in 2020 were summarized and depicted.Results:There were 157 dermatological drug trials registered in China in 2020, accounting for 6.16% of all the 2 548 clinical drug trials, including 127 (80.9%) initiated by Chinese pharmaceutical enterprises and 25 (15.9%) international multicenter trials. Among the 127 drug trials initiated by Chinese pharmaceutical enterprises, bioequivalence trials were mostly common, accounting for 55.9% (71/127) . Compared with global pharmaceutical enterprises, domestic pharmaceutical companies initiated significantly decreased proportions of international multicenter trials (1.9% [3/157] vs. 14.0% [22/157], P < 0.001) , but significantly increased proportions of phaseⅠclinical trials and bioequivalence trials (24.4% [31/127] vs. 10.0% [3/30], 55.9% [71/127] vs. 0, respectively, both P < 0.001) . Totally, 90 kinds of dermatological drug were involved in all the trials, psoriasis, atopic dermatitis and melanoma were the most common indications, and innovative drugs accounted for 53.3% (48/90) ; the proportion of innovative drugs was significantly lower in domestic pharmaceutical companies than in global pharmaceutical companies (43.2% [32/74] vs. 16/16, P < 0.001) . In addition, 28 dermatological drugs developed by 22 pharmaceutical companies were approved in China in 2020, of which 21 drugs were developed by domestic pharmaceutical companies. Conclusion:Clinical drug trials carried out by domestic pharmaceutical companies mostly focus on generic drugs, and it is still necessary for domestic pharmaceutical companies to further improve the innovation ability.

Objective:To investigate the clinical effect of the free medial femoral condylar bone flap in treatment of scaphoid nonunion.Methods:From May, 2012 to May, 2016, 15 patients, which were 10 males and 5 females and aged from 18 to 63 (mean 43.5±15.5) years, with scaphoid nonunion were treated with transfer of free medial femoral condyle bone flaps. After debridement of the fractural segment in surgery, the bone flap was transferred to scaphoid and had the bone defect filled. The artery of the bone flap was end-to-side or end-to-end anastomosed to the radial artery. The concomitant vein of the bone flap was end-to-end anastomosed to the concomitant vein of the radial artery. Thirteen patients were treated with the free osteoperiosteal medial femoral condylar graft, and 2 were treated with the free osteochondral medial femoral condylar graft. Fracture healing was evaluated based on X-ray evidence. The clinical effect was evaluated by visual analogue scale (VAS), strength of grip and modified Mayo wrist score. The t-test was used to compare the function between before and after surgery. Results:All patients were entered into a followed-up for an average of 32.5 (8-60) months, 11 of them took the follow-up reviews at the outpatient clinic and 4 via WeChat distanced interviews. All fractures of the 15 patients healed with an average healing time at 12.5 (10-16) weeks. The VAS score decreased from (3.5±1.5) before the surgery to (1.0±1.0) after the surgery. The strength of grip increased from (16.5±4.3) kg before the surgery to (31.5±3.5) kg at the last follow-up review. The modified Mayo wrist score increased from (46.2 ±11.4) before the surgery to (68.5 ±10.8) at the last follow-up review. The wrist function was excellent in 8 patients, good in 6 and fair in 1. There was significant difference in functional evaluation ( P<0.05). Conclusion:The transfer of free medial femoral condylar bone flap is effective in the treatment of scaphoid nonunion. This technique provides both of sufficient blood supply and a structural support for defected scaphoid bone and promotes the healing of fracture. Osteochondral flap transfer may be used as an alternative measure to prevent wrist osteoarthritis and collapse, in the case that there is an avascular necrosis of the proximal pole of the scaphoid. It has an advantage in the treatment of refractory scaphoid nonunion.