ObjectiveTo explore the dose-effect relationship and safety of high， medium， and low doses of raw Astragali Radix in the modified Huangqi Chifengtang （MHCD） for treating proteinuria in immunoglobulin A （IgA） nephropathy， and to provide scientific evidence for the clinical use of high-dose Astragali Radix in the treatment of proteinuria in IgA nephropathy. MethodsA total of 120 patients with IgA nephropathy， diagnosed with Qi deficiency and blood stasis combined with wind pathogen and heat toxicity， were randomly divided into a control group and three treatment groups. The control group received telmisartan combined with a Chinese medicine placebo， while the treatment groups were given telmisartan combined with MHCD containing different doses of raw Astragali Radix （60， 30， 15 g）. Each group contained 30 patients， and the treatment period was 12 weeks. Changes in 24-hour urinary protein （24 hUTP）， traditional Chinese medicine （TCM） syndrome scores， effective rate， and renal function were observed before and after treatment. Safety was assessed by monitoring liver function and blood routine. ResultsAfter 12 weeks of treatment， 24 hUTP significantly decreased in the high， medium， and low-dose groups， as well as the control group （P<0.05， P<0.01）. The TCM syndrome scores in the high， medium， and low-dose groups also significantly decreased （P<0.01）. Comparisons between groups showed that the 24 hUTP in the high-dose group was significantly lower than in the medium， low-dose， and control groups （P<0.05， P<0.01）， and the 24 hUTP in the medium-dose group was significantly lower than in the control group （P<0.05）. The TCM syndrome scores in the high and medium-dose groups were significantly lower than in the low-dose and control groups （P<0.05， P<0.01）. The total effective rates for proteinuria in the high， medium， low-dose， and control groups were 92.59% （25/27）， 85.19% （23/27）， 60.71% （17/28）， and 57.14% （16/28）， respectively. The effective rates in the high and medium-dose groups were significantly higher than in the low-dose and control groups （χ²=13.185， P<0.05， P<0.01）. The effective rates for TCM syndrome scores in the high， medium， low-dose， and control groups were 88.89% （24/27）， 81.48% （22/27）， 71.43% （20/28）， and 46.43% （13/28）， respectively. The efficacy of TCM syndrome scores in the high and medium-dose groups was significantly higher than in the control group （χ²=14.053， P<0.01）. Compared with pre-treatment values， there was no statistically significant difference in eGFR and serum creatinine in the high and medium-dose groups. However， eGFR significantly decreased in the low-dose and control groups after treatment （P<0.05）， and serum creatinine levels increased significantly in the control group （P<0.05）. No statistically significant differences were observed in urea nitrogen， uric acid， albumin， total cholesterol， triglycerides， liver function， and blood routine before and after treatment in any group. ConclusionThere is a dose-effect relationship in the treatment of IgA nephropathy with high， medium， and low doses of raw Astragali Radix in MHCD. The high-dose group exhibited the best therapeutic effect and good safety profile.

Non-small cell lung cancer (NSCLC) is a malignant tumor with a high global incidence rate, accounting for about 10.54% of all new cancer cases and posing a serious threat to human health. Due to significant individual variations in the efficacy of immunotherapy among NSCLC patients, it is necessary to identify accurate detection indicators to screen appropriate populations, monitor treatment efficacy, and assist in prognosis assessment. Programmed death-ligand 1 (PD-L1), as an immunosuppressive molecule expressed on the surface of tumor cells and various immune cell membranes, can serve as a "companion diagnostic" or "supplementary diagnostic" tool to guide clinical treatment decisions for metastatic NSCLC patients. Given that tumor tissue PD-L1 testing is an invasive procedure and its reliability is still under debate, the assessment of PD-L1 expression via liquid biopsies, such as circulating tumor cells, will play a significant role in predicting treatment response and prognosis in NSCLC patients.

BACKGROUND:There is an increasing demand for orthodontic treatment,and periodontally accelerated osteogenic orthodontics(PAOO)technique can make it possible to move orthodontic teeth that are limited by thin alveolar bone. OBJECTIVE:To investigate the biomechanics of orthodontic tooth movement before and after periodontally accelerated osteogenic orthodontics(PAOO)surgery to increase alveolar bone volume using the three-dimensional finite element method. METHODS:A patient undergoing PAOO surgery before orthodontic treatment to increase bone volume on the labial side of the mandibular anterior region was selected.The patient was under invisible orthodontics.Two three-dimensional finite element models were constructed based on the patient's preoperative and 6-month postoperative cone beam CT data.Both models simulated the movement of tooth 33:experiment Ⅰ:distal-central movement of 0.25 mm;experiment Ⅱ:lingual movement of 0.25 mm;and experiment Ⅲ:intrusion movement of 0.10 mm.The stress distribution and initial displacement trend of tooth 33,periodontal ligament and surrounding alveolar bone under the action of the invisible aligner were analyzed before and after the PAOO procedure. RESULTS AND CONCLUSION:Dental stress analysis:In the same orthodontic tooth movement,the maximum Von-Mises stress and overall stress values of tooth 33 were all higher before surgery than after surgery;there were similar distribution areas of maximum equivalent stress and overall distribution trends of Von-Mises stress before and after surgery.Periodontal ligament stress analysis:In the same orthodontic tooth movement,the maximum Von-Mises stress and overall stress values of the periodontal ligament were higher before surgery than after surgery,and there were similar distribution areas of the maximum equivalent stress and overall distribution trends of Von-Mises stress before and after surgery.Alveolar bone stress analysis:In the same orthodontic tooth movement,the maximum Von-Mises stress values of the alveolar bone around tooth 33 were higher before surgery than after surgery,while the equivalent stress distribution showed a gradual decrease from the top of the alveolar ridge to the root.Initial displacement analysis:In the same orthodontic tooth movement,the initial displacements in the main displacement direction for all six observation points of tooth 33 were smaller before surgery than after surgery,and showed a tendency to gradually decrease from the tooth tip to the apex.Therefore,there were differences in the biomechanical characteristics of orthodontic tooth movement before and after the PAOO surgery.With the clear aligner,the postoperative equivalent stress values on the dentition,periodontal ligament,and surrounding alveolar bone were lower than before the surgery,and the initial displacements of the orthodontic teeth after the surgery are larger than before.These findings suggest that PAOO can release the restriction of thin alveolar bone on the movement of orthodontic tooth by increasing alveolar bone thickness,effectively improving the force on the roots,periodontal ligament,and alveolar bone,avoiding the stress concentration on orthodontic tooth in the thin alveolar bone area that can cause complications when moving,and improving the efficiency of tooth movement.

Objective To observe the value of chocolate balloon(controlled dilatation technique)for vascular preparation of endovascular treatments for lower extremity arteriosclerosis obliterans(ASO).Methods Data of 110 patients with lower extremity ASO who underwent vascular preparation with chocolate balloon were retrospectively analyzed.The type of ASO,with calcification or not and so on were recorded,and the success rate of vascular preparation with chocolate balloon and the therapeutic effect of endovascular treatments for ASO were evaluated.Results Among 110 patients,unilateral lower extremity ASO were found in 100 cases,while bilateral lower extremities ASO were noticed in 10 cases,including 100(100/120,83.33%)chronic occlusive lesions,8(8/120,6.67%)stenotic lesions and 12(12/120,10.00%)thrombotic lesions.Calcification with grade 3-4 were observed in 50 lesions(50/120,41.67%).The technical success rate of vascular preparation with chocolate balloon was 92.50%(111/120),while 7(7/120,5.83%)lesions developed flow-limiting dissection after chocolate balloon dilatation and 2(2/120,1.67%)lesions had significant residual stenosis that did not meet the technical success criteria,which underwent stent implantation without drug-coated balloon(DCB).Besides,flow-limiting dissection were noticed in 15 lesions after DCB,hence salvage stents were implanted.The success rate of endovascular treatments of ASO was 100%.Conclusion Chocolate balloon(controlled dilation technique)was valuable for vascular preparation of endovascular treatments for lower extremity ASO.

Objective:To compare the image quality, radiation dose, and total iodine content of abdominal computed tomography (CT) enhancement scanning of overweight and obese patients with different scanning protocols, and to explore the optimal keV image serial for abdominal CT.Methods:A total of 90 overweight or obese patients [24 kg/m 2 ≤ body mass index (BMI) < 28 kg/m 2 or BMI ≥ 28 kg/m 2] were divied into groups A, B and C, with 30 patients in each group. Group A used Gemstone spectral imaging (GSI) mode and contrast medium with 320 mg I/ml, group B used low tube voltage mode (100 kVp) and contrast medium with 370 mg I/ml, and group C used conventional tube voltage mode (120 kVp) and contrast medium with 370 mg I/ml. Monochromatic energy images at 50-70 keV (5 keV interval) were reconstructed for the arterial and portal vein phases of group A. Radiation dose and total iodine content were recorded and calculated for the 3 groups. The region of interest was placed on the organ, blood vessel, and erector spinae muscle at same level. The CT values and image noise values were measured, and the contrast-to-noise ratio (CNR) was calculated. All images were scored subjectively in double-blinded by two radiologists. One-way analysis of variance or Kruskal-Wallis H test were used to compare The CT values, CNRs, and subjective scores of each subgroup image in group A, group B and group C, and the radiation doses and total iodine contents in 3 groups were compared. The optimal keV value for group A was selected. Results:At 50-60 keV, the CT values and CNRs of arterial and portal vein phases in group A were higher ( P < 0.05) than or similar to those in groups B and C ( P > 0.05), and the subjective scores were lower than those of groups B and C at 50 and 55 keV ( H = 34.47, 41.27, P < 0.05), whereas there was no statistically significant difference at 60 keV ( P > 0.05). At 65 and 70 keV, only the CT value and CNR of the renal cortex in group A at the 65 keV of arterial phase were higher than those in groups B and C ( F = 102.38, 29.47, P < 0.001). The subjective scores were not significantly between groups B and C ( P > 0.05). There were no statistically significant difference between CT values, CNRs, or subjective scores in group B and group C ( P > 0.05). The effective doses in groups A and B were 24.72% and 25.78% lower than those in group C, respectively. Compared to groups B and C, the total iodine content in group A decreased by 12.50% and 13.34%, respectively. Conclusions:GSI model combined with a low-concentration contrast medium in abdominal CT for overweight and obese patients can meet the image quality requirements while reducing patient total iodine content and radiation dose. The optimal keV value of enhanced abdominal CT for double phases was 60 keV.

Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.

Objective:To prepare the whole bladder acellular matrix (BAM) using the self-designed perfusion decellularization system, and evaluate the feasibility of constructing the tissue engineering bladder with the adipose-derived stem cells (ADSCs).Methods:This study was conducted from October 2020 to April 2021. The self-designed perfusion decellularization system was used, and four different decellularization protocols (group A, group B, group C and group D) were formulated, according to the flow direction of the perfusate and the action time of different decellularization solutions. Among them, the urethral orifice of the bladder tissue was used as the outflow tract of the perfusion fluid in groups A and B. The top of the bladder was cut off and used as the outflow tract of the perfusion fluid in groups C and D. In groups A and C, 1% Triton X-100 was treated for 6 h, and 1% sodium dodecyl sulfate (SDS) was treated for 2 h. In groups B and D, 1% Triton X-100 was treated for 7 h, and 1% sodium dodecyl sulfate (SDS) was treated for 1 h. In addition, the tissue in the normal bladder group was directly obtained from the natural bladder tissue, which did not require perfusion, cryopreservation and thawing. The fast and efficient decellularization protocol was screened out through HE, DAPI, Masson trichrome and Alcian Blue staining and quantitative analyses to prepare the whole bladder scaffold. The prepared BAM was used as the scaffold material, and the ADSCs were used as the seeding cells to construct the tissue engineering bladder. HE and DAPI staining were used to observe the distribution of ADSCs on the BAM.Results:HE and DAPI staining showed that there was no obvious nuclear residue in the group C. Masson trichrome and Alcian Blue staining showed that the collagen structure and glycosaminoglycan were well preserved in the group C. There was no significant difference in bladder wall thickness between the group C and the normal bladder group [(975.44±158.62)μm vs.(1 064.49±168.52)μm, P > 0.05]. The DNA content in the group C [(43.59 ±4.59) ng/mg] was lower than that in the normal bladder group, group A, group B and group D [(532.50±26.69), (135.17±6.99), (182.49±13.69) and(84.00±4.38)ng/mg], and the difference was statistically significant ( P<0.05). The collagen content [(10.98 ± 0.29)μg/mg] and glycosaminoglycan content [(2.30±0.18)μg/mg] in group C were not significantly different with those in the normal bladder group [(11.69±0.49) and (2.36±0.09)μg/mg, P>0.05]. Scanning electron microscopy showed that a large number of pore structures could be observed on the surface of the prepared BAM in groups A-D and were facilitated to cell adhesion. The isolated and cultured ADSCs were identified by flow cytometry to confirm the positive expression of CD90 and CD29, and the negative expression of CD45 and CD106. Live/dead staining and CCK-8 detection confirmed that the prepared BAM in the group C had no cytotoxicity. HE and DAPI staining showed that a large number of ADSCs were distributed on the surface and inside of the tissue engineering bladder. Conclusions:The whole bladder shape BAM prepared by the self-designed perfusion decellularization system could be used as the scaffold material for bladder tissue engineering, and the constructed tissue engineering bladder could be used for bladder repair and reconstruction.

Objective:To investigate the effect of total anatomical reconstruction (TAR) during robot-assisted radical prostatectomy (RARP) .Methods:The clinical data of 99 patients with RARP performed by a single doctor in our hospital from January 2018 to January 2021 were analyzed retrospectively.There were 38 patients in the TAR+ vesicourethral anastomosis (VUA) group and 61 patients in the VUA group. There were no significant differences between the two groups in the age of patients [ 65.5 (60.8, 71.0) years vs. 66.0 (61.5, 69.0) years], body mass index[ (24.92±2.65) kg/m 2 vs. (25.51±2.80) kg/m 2], prostate volume [28.13 (25.21, 36.53) ml vs. 26.33 (19.75, 47.84) ml], PSA [15.67 (9.02, 31.49) ng/ml vs. 14.58 (9.23, 30.06) ng/ml], neoadjuvant therapy [50.0% (19/38) vs. 63.9% (39/61)], Gleason score (6/7/8/9-10 scores: 8/16/5/9 cases vs. 16/25/9/11 cases) and clinical T stage (T 1/T 2/T 3 stage: 4/29/5 cases vs. 3/53/5 cases)(all P>0.05). The TAR technique was performed as follows. ①The two layers of posterior reconstruction involved the residual Denonvilliers fascia, the striated sphincter and medial dorsal raphe (MDR), and the vesicoprostatic muscle (VPM), the fascia which was 1-2 cm from the cranial side of the bladder neck and MDR. ②The one layer of anterior reconstruction involved detrusor apron, tissues around the urethra and the visceral and parietal layers of the endoplevic fascia. The VUA technique was suturing the bladder neck and urethra consecutively. Perioperative indexes were compared between the two groups. Results:All 99 operations were successfully completed. There were no statistically significant differences between the TAR+ VUA and VUA groups in operation time [ (174.16±47.21) min vs. (188.70±45.39) min], blood loss [ 50 (50, 100) ml vs. 100 (50, 100) ml], incidence of postoperative complications [10.5% (4/38) vs. 14.8% (9/61)], phathological T stage [pT 2/pT 3~4 stage: 25/12 cases vs. 42/19 cases, P=0.895], and the time of indwelling catheter [ 21.0 (19.0, 21.0) d vs. 21.0 (21.0, 21.0) d] (all P>0.05). The difference in postoperative length of stay between the two groups was statistically significant[6.0 (5.0, 6.0) d vs. 7.0 (6.0, 7.5)d, P<0.001]. Follow-up was performed for 1 year after surgery. The recovery rate of urinary continence 3 months after surgery in TAR+ VUA and VUA groups were 86.8% (33/38) vs. 65.6% (40/61), which were statistically significant( P=0.019). There were no significant differences between TAR+ VUA and VUA groups in recovery rate of urinary continence 1 months after surgery [47.4% (18/38) vs. 45.9% (28/61)], 6 months after surgery [94.7% (36/38) vs. 85.2% (52/61)], and 12 months after surgery [94.7% (36/38) vs. 93.4% (57/61)] (all P>0.05). Conclusions:TAR technique has good surgical safety, and can promote recovery of early urinary continence after RARP.

OBJECTIVES: With the increasing detection rate of lung nodules, the qualitative problem of lung nodules has become one of the key clinical issues. This study aims to evaluate the value of combining dynamic contrast-enhanced (DCE) MRI based on time-resolved imaging with interleaved stochastic trajectories-volume interpolated breath hold examination (TWIST-VIBE) with T₁ weighted free-breathing star-volumetric interpolated breath hold examination (T₁WI star-VIBE) in identifying benign and malignant lung nodules. METHODS: We retrospectively analyzed 79 adults with undetermined lung nodules before the operation. All nodules of patients included were classified into malignant nodules (n=58) and benign nodules (n=26) based on final diagnosis. The unenhanced T₁WI-VIBE, the contrast-enhanced T₁WI star-VIBE, and the DCE curve based on TWIST-VIBE were performed. The corresponding qualitative [wash-in time, wash-out time, time to peak (TTP), arrival time (AT), positive enhancement integral (PEI)] and quantitative parameters [volume transfer constant (Ktrans), interstitium-to-plasma rate constant (Kep), and fractional extracellular space volume (Ve)] were evaluated. Besides, the diagnostic efficacy (sensitivity and specificity) of enhanced CT and MRI were compared. RESULTS: There were significant differences in unenhanced T₁WI-VIBE hypo-intensity, and type of A, B, C DCE curve type between benign and malignant lung nodules (all P<0.001). Pulmonary malignant nodules had a shorter wash-out time than benign nodules (P=0.001), and the differences of the remaining parameters were not statistically significant (all P>0.05). After T₁WI star-VIBE contrast-enhanced MRI, the image quality was further improved. Compared with enhanced CT scan, the sensitivity (82.76% vs 80.50%) and the specificity (69.23% vs 57.10%) based on MRI were higher than that of CT (both P<0.001). CONCLUSIONS T₁WI star-VIBE and dynamic contrast-enhanced MRI based on TWIST-VIBE were helpful to improve the image resolution and provide more information for clinical differentiation between benign and malignant lung nodules.
Adult ; Humans ; Retrospective Studies ; Magnetic Resonance Imaging ; Plasma ; Tomography, X-Ray Computed ; Lung

ObjectiveTo review the classification of orthopedic insoles, common techniques of 3D printing orthopedic insoles, common materials and their application for flatfoot. MethodsLiteratures were retrieved from PubMed, Web of Science, CNKI and Wanfang Data from 2012 to 2022, and the relevant contents were summarized. ResultsA total of ten studies were finally included, from 5 countries, involving 290 participants, which published from 2019 to 2022. Orthotic insoles were classified as prefabricated, semi-custom, and custom, while custom ones were classified as traditional custom and 3D printed custom. 3D printed orthotic insoles were often made with selective laser sintering, fused deposition modeling (FDM) and PolyJet printing technologies, and commonly used materials included ethylene-vinyl acetate (EVA), polylactic acid, thermoplastic polyurethane, polyamide, and polypropylene. For flatfoot, 3D printed orthotic insoles could improve plantar pressure, relieve foot pain and the combined use of insole posting could control rearfoot valgus. Conclusion3D printed custom insoles can be made more efficiently and accurately than traditional custom insoles. The printing technologies and materials often chosen for 3D printed orthotic insoles are mainly FDM and EVA. 3D printed orthotic insoles is effective on plantar pressure, comfort and foot movement function of flatfoot.