Objective To compare the clinical efficacy, safety, and patient’ prognosis of catheter-directed thrombolysis (CDT) via anterior tibial vein and popliteal vein approaches in the treatment of acute lower extremity deep vein thrombosis (DVT). Methods A retrospective analysis was conducted on the clinical data of 195 patients diagnosed with acute mixed lower extremity DVT and treated with CDT in the Department of Interventional and Vascular Surgery, Affiliated Hospital of Nantong University from January 2020 to December 2023. Patients were divided into an observation group (anterior tibial vein approach, n＝97) and a control group (popliteal vein approach, n＝98) according to the puncture route. Baseline data, thrombolysis-related indices (urokinase dosage, coagulation function indices), efficacy measures (degree of thrombus dissolution, leg circumference difference, visual analogue scale [VAS] score, venous clinical severity score [VCSS]), recovery parameters (time to ambulation, length of hospital stay), complication rates, and long-term prognosis measures (Villalta score, incidence of post-thrombotic syndrome [PTS]) were compared between the two groups. Results There was no statistically significant difference in urokinase dosage and levels of coagulation function indices between the two groups. Postoperatively, the leg circumference difference at 15 cm below the knee, VAS score, and VCSS score were significantly lower in the observation group than in the control group (P＝0.001). The observation group had higher grade Ⅲ dissolution rates in the popliteal and anterior tibial veins compared to the control group (P＜0.05), while differences of dissolution rates in the iliac and femoral veins were not statistically significant. The observation group had shorter length of hospital stay and earlier ambulation times than the control group (P＝0.001). There were no significant differences in complication rates, Villalta scores, or PTS incidence between the two groups. Conclusions CDT via the anterior tibial vein puncture approach for acute mixed lower extremity DVT is superior to the popliteal vein approach in promoting resolution of lower extremity swelling, alleviating pain, improving venous clinical symptoms, and achieving higher thrombus dissolution rates in the popliteal and anterior tibial veins. It also enables faster recovery and demonstrates good safety.

In recent years, with the development of big data application technology, the real-world data and the corresponding generated real-world evidence have attracted the attention of healthcare regulatory authorities around the world. Regulators recognize that real-world research with specific purposes using real-world data can provide important evidence for regulatory decisions. A total of 90 instances of publicly released on the application of real-world evidence to support regulatory decisions of U. S. Food and Drug Administration are explored, and the positioning and value of real-world evidence in U. S. Food and Drug Administration regulatory decisions are summarized and analyzed, providing references for the use of real-world data and real-world evidence to promote medical devices whole cycle regulation in China.
United States ; United States Food and Drug Administration ; Equipment and Supplies ; Device Approval ; China

[This corrects the article DOI: 10.1016/j.apsb.2018.08.009.].

Proteolysis-targeting chimeras (PROTACs) have shown considerable therapeutic potential across diverse fields such as cancer, inflammation, and neurodegenerative diseases, with numerous candidates already progressing into clinical trials. More recently, their application in antiviral therapy has been rapidly gaining momentum. This review systematically outlines the mechanistic foundations and design principles of PROTACs, highlights recent advances targeting coronaviruses (including SARS-CoV-2), hepatitis C virus, human immunodeficiency virus, and influenza viruses, and critically assesses key challenges—particularly the limited diversity of E3 ligase ligands, suboptimal oral bioavailability, and the lack of integrated platforms for druggability evaluation. Looking ahead, innovations in ligand discovery, pathway modulation, delivery technologies, and conditionally activated PROTAC designs are anticipated to overcome these barriers, ushering in a new era of precise and effective antiviral therapeutics.

Objective To investigate the effect of uterine distension fluid temperature on the body tem-perature and pain degree of the patients with abnormal uterine bleeding caused by endometrial polyps during hysteroscopy diagnosis and treatment.Methods A total of 114 patients who visited the hysteroscopic clinic of this hospital from April 2022 to April 2024 were enrolled as the study subjects.The patients were randomly divided into two groups by using the simple random allocation method.The group A(n=51)used the warm 0.9％sodium chloride solution at 36-37 ℃ as the uterine distention solution,while the group B(n=63)used a room temperature 0.9％sodium chloride solution at 22-23 ℃ as the uterine distention solution.During the diagnosis and treatment process,thevisual analog scale(VAS)was used to assess the degree of pain.The VAS scores before surgery(T0),entering the vagina(T1),passing through the cervical internal opening(T2),ente-ring the uterine cavity(T3),during operation(T4),at the end of surgery(T5),and at 30 min after surgery end(T6)were compasred between the two groups;the body temperatures at T0,T5 and T6 were compared be-tween the two groups.Results There was no statistically significant difference in the body temperature at T0 time point between the two groups(P＞0.05).The body temperature at T5 and T6 time points in the group A was higher than that in the group B,and the differences were statistically significant(P＜0.05).There was no statistically significant difference in the VAS scores at T0 and T6 time points between the two groups(P＞0.05).The VAS scores at T1,T2,T3,T4 and T5 time points in the group A were lower than those in the group B,and the differences were statistically significant(P＜0.05).Conclusion The application of warm uterine distention solution in hysteroscopy diagnosis and treatment could maintain the stable body temperature of the patients,reduce the severity of pain,thus increases the patient comfort level.

Objective To establish an ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry(UPLC-QTOF-MS)method for identifying the active ingredients of Zhizi Houpu decoction,and to predict its material basis and mechanism of anti-insomnia effects using network pharmacology.Methods The chemical components of Zhizi Houpu decoction were identified according to UHPLC-QTOF-MS ion fragmentation rule combined with compound library and literature review.Components with oral bioavailability(OB)≥30％and drug-like properties(DL)≥0.18 were selected to construct the Zhizi Houpu decoction-active ingredients-target network.The STRING database and the Database for Annotation,Visualization,and Integrated Discovery(DAVID)were used to screen key target proteins.Subsequently,enrichment analysis was performed for biological processes,molecular functions,cellular components,and signaling pathways.Results A total of 107 chemical components were identified,including 35 compounds related to insomnia and 11 anti-insomnia targets such as AKT serine/threonine kinase 1,tumor protein 53,and prostaglandin-endoperoxide synthase 2.Gene Ontology functional enrichment analysis indicated that Zhizi Houpo decoction may exert its effects through cellular components such as the presynaptic membrane,dendrite,and plasma membrane,by participating in biological processes like chemical synaptic transmission,G protein signaling pathway,and neuron apoptosis,and by regulating molecular functions such as G protein-coupled serotonin receptor activity.Kyoto Encyclopedia of Genes and Genomes pathway enrichment analysis revealed that its anti-insomnia effects were mainly concentrated in pathways such as neuroactive ligand-receptor interaction,calcium signaling pathway,serotonergic synapse,and cyclic adenosine monophosphate signaling pathway.Conclusion The anti-insomnia effect of Zhizi Houpo decoction is the result of a synergistic action involving multiple components,multiple targets,and multiple pathways.Its material basis and mechanism of action are primarily related to regulating biological processes such as neurotransmitter metabolism,synaptic function,neuronal apoptosis,and inflammatory response.

Objective To prepare Xuanyang Jiedu cream and to study its pharmacodynamics.Methods The herbal decoction process of Xuanyang Jiedu cream was optimized by orthogonal design method.The prescription of the cream preparation was screened according to the external properties,malleability and stability of cream.Forty normal guinea pig were randomly divided into four groups(10 in each group):blank group,model group,ketoconazole cream group,and Xuanyang Jiedu cream group.The guinea pig model of tinea corporis was established to investigate the efficacy of Xuanyang Jiedu cream in the treatment of superficial fungal disease.Results The optimal extraction conditions were 3 extractions,water added for 20 times,and 1.5 h of extraction time.The number of extractions and the amount of water significantly affected on the extraction process of the liquid extract.The optimized Xuanyang Jiedu cream looked smooth and creamy,with moderate viscosity and good stabilities of centrifuge,cold and heat resistance.After 14 d treatment,there were still obvious erythema,scales and papules on the lesions in the model group.The scores of erythema,scales and papules in the Xuanyang Jiedu cream group and the ketoconazole cream group were lower than those in the model group(P<0.05).Conclusion Xuanyang Jiedu cream has antifungal activity and may be a new treatment for skin superficial mycosis.

Objective To establish and compare rat models of psoriasis with blood-heat syndrome and blood-stasis syndrome.Methods The blood-heat syndrome model was induced by compound heat potion decoction and imiquimod.The blood-stasis syndrome model was induced by fatigue,hunger,cold dampness,panic and imiquimod.The groups were evaluated for TCM syndromes,psoriasis lesions,pathological tissue,spleen index,hemorheology and key gene expression levels.Results The blood-heat syndrome model group showed significant differences from the control group in syndrome manifestations,PASI score,Baker score,spleen index and plasma viscosity(P<0.05).The blood-stasis model group showed significant differences from the control group in syndrome manifestations,body weight,PASI score,Baker score,spleen index,whole blood viscosity(60s-1),whole blood viscosity(10s-1)and plasma viscosity(P<0.05).The key gene expression levels were different among all syndrome groups.Conclusion The animal models had the typical features of psoriasis and matched the signs of blood-heat syndrome and blood-stasis syndrome of TCM.The models can provide a basis for explaining the scientific meaning of TCM syndrome differentiation in treating psoriasis.

Objective To observe the clinical effect of Jiu-Wei-Yong-An granule combined with cetirizine in the treatment of damp-heat accumulation syndrome of eczema. Methods 108 eczema patients with syndrome of damp-heat accumulated in the skin, treated in the Department of Traditional Chinese Surgery in the First Affiliated Hospital of Naval Medical University from December 2021 to March 2023, were selected. They were randomly divided into an observation group and a control group, 54 cases in each. Both groups took cetirizine tablets orally for basic treatment. The observation group was given Jiu-Wei-Yong-An granules, and the control group was given placebos of the same. The clinical efficacy before and after treatment in the two groups was observed and compared, including TCM syndrome scores, eczema area and severity index （EASI）, visual analogue scale （VAS）, and adverse reactions. Results After treatment, the total effective rate of the observation group （88.9%） was higher than that of the control group （77.8%）, and the difference was statistically significant （P<0.05）. After treatment, the TCM syndrome score, EASI and VAS in the observation group were significantly lower than those in the control group （P<0.05）, and the difference was statistically significant. There was no significant difference in the total rate of adverse reactions between the two groups （P>0.05）. Conclusion The combination of Jiu-Wei-Yong-An granules and cetirizine tablets in the treatment of damp-heat eczema showed significantly better clinical outcomes in the observation group compared to the control. It effectively improved patient conditions, reduced skin lesion areas, and alleviated itching, with both safety and efficacy that merit clinical promotion.

Objective To evaluate the clinical efficacy of Traditional Chinese Medicine （TCM）external treatment methods in alleviating skin pruritus caused by eczema through a Meta-analysis. Methods Randomized clinical trials investigating the use of TCM external treatment methods for skin pruritus caused by eczema were searched in databases including China National Knowledge Infrastructure （CNKI）, VIP, Wanfang, Sinomed, PubMed, Embase, LILACS, and Cochrane, up to December 2024. Two reviewers independently screened and entered the statistical data, conducted bias risk assessment by the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0, and performed Meta-analysis using RevMan 5.4.1. Results Ultimately, 14 studies involving 1 788 patients were included. Compared to the control group, TCM external treatment methods （treatment group）showed better improvement in pruritus scores （Z=11.88, P<0.000 01）, better improvement in Eczema Area and Severity Index （EASI） scores （Z=23.15, P<0.000 01）, higher overall clinical efficacy rate （Z=6.21, P<0.000 01）, better improvement in TCM symptoms （Z=5.49, P<0.000 01）, and lower clinical recurrence rate （Z=2.88, P=0.004）. Three of the included studies mentioned adverse reactions, with the treatment group showing lower adverse reactions than the control group. Conclusion The external treatment of TCM was more effective in treating skin pruritus caused by eczema compared to the control group. Given the biases and heterogeneity in the included literature, this conclusion needs to be further substantiated by more large-scale, multi-center, randomized, controlled, and double-blind studies.