OBJECTIVE To improve the quality standard of Zhuang medicine Yingbupu （Aralia armata）. METHODS A total of 23 batches of Yingbupu （A. armata） were studied. Their macroscopic characteristics and powder microscopic features were observed. TLC was employed for the qualitative identification of oleanolic acid and araloside A. Items such as water content， total ash， acid-insoluble ash， and ethanol-soluble extract were determined according to the methods specified in the 2020 edition of the Chinese Pharmacopoeia （part Ⅳ）. UPLC fingerprint was established for 23 batches of samples by using Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine （2012 edition）， and the contents of oleanolic acid and araloside A were determined. RESULTS The powder microscopic characteristics of the medicinal material were distinctive. Oleanolic acid and araloside A were detected by TLC in all 23 batches. Among the 23 batches of samples， the content ranges of moisture， total ash， acid-insoluble ash， and ethanol-soluble extract were 6.9% to 10.4%， 1.8% to 6.8%， 0.1% to 1.9%， and 2.8% to 8.4%， respectively. Based on the UPLC fingerprint， a total of 15 common peaks were obtained， and 9 of these common peaks were identified. The content ranges of oleanolic acid and araloside A in the 23 batches of samples were 0.86% to 2.69% and 0.16% to 1.10%， respectively. CONCLUSIONS This study has added items such as moisture and total ash content fingerprint， TLC identification. A preliminary quality standard has been established for the medicinal material of Yingbupu （A. armata）， stipulating that the moisture content should not exceed 11.0%， the total ash content should not exceed 5.0%， the acid-insoluble ash content should not exceed 2.5%， the ethanol-soluble extract（No. content should not be less than 4.0%， and the contents of zyyzdxk-2023165） oleanolic acid and araloside A should not be less than 1.00% and 0.45%（ calculated by a dried basis）， respectively.

Brain-computer interface (BCI) technology is an innovative and cutting-edge medical advancement that enables direct interaction between the brain and external devices, facilitating the reconstruction of daily functions for patients or serving as a method for neuro-regulation therapy. Although this technology offers a broad range of clinical applications, there are problems as potential risks, individual variations, and the need for long-term monitoring of its effects during utilization. Consequently, the comprehensive evaluation of its safety and effectiveness poses a considerable challenge for regulatory agencies. This study provides a concise introduction to the development history and various types of BCI technology, followed by a summary of the regulatory situation for different types of BCI medical devices in the United States. Furthermore, the regulatory requirements imposed by the US FDA on this product category are analyzed. Finally, the article concludes by presenting a summary and future perspective on the current development of BCI technology, with the aim of offering beneficial insights and guidance for the regulation of BCI medical devices.
Brain-Computer Interfaces ; United States ; United States Food and Drug Administration ; Humans ; Electroencephalography

Objective:To evaluate the clinical effect of orbital fat releasing and repositioning through supra-suborbicularis oculi fat (SOOF) in lower eyelid blepharoplasty.Methods:The authors retrospectively analyzed the clinical data of patients who received lower eyelid blepharoplasty in the Department of Plastic Surgery, Beijing Tsinghua Changgung Hospital from January 2017 to January 2023. Lower eyelid blepharoplasty with orbital fat releasing and repositioning through supra-SOOF was performed. The tear trough ligament and orbicularis retaining ligament were released between the orbicularis oculi muscle and SOOF via skin approach. Orbital septal fat was released to this space, lateral fat flap was fixed to the SOOF capsule, medial fat flap was fixed to the superficial fascia of the levator labii superioris muscle, orbital septum was repositioned, and lateral canthus was suspended. After the operation, lower eyelid morphology and complications were evaluated.Results:A total of 58 patients were enrolled, including 8 males and 50 females with the age of (49.8 ± 10.4) years (32 to 70 years). All patients had obvious lower eyelid bags on both sides, combining the tear trough deformity and (or) palabromalar groove. Fifty-seven patients were followed up for (29.1 ± 16.9) months (6-67 months). All patients were satisfied with the operation. The appearance of lower eyelid was greatly improved, with elimination of fat prominence and tear trough deformity. Mild lower eyelid ectropion was observed two cases 1 week after the operation, and were relieved by moderate massage 2 weeks postoperatively. In one case, mild lower eyelid retraction was observed 1 month postoperatively, with no complaint of discomfort or further treatments. Bulbar conjunctival hemorrhage occurred in 1 case and recovered without further interventions.Conclusion:Lower eyelid blepharoplasty with orbital fat releasing and reposting through supra-SOOF can effectively release the tear trough ligament and the orbicularis retaining ligament, with stronger fat fixation and less surgical difficulty. After the operation, eyelid contour was flat and tight with fewer complications and higher patient satisfaction.

Objective:To evaluate the clinical effect of orbital fat releasing and repositioning through supra-suborbicularis oculi fat (SOOF) in lower eyelid blepharoplasty.Methods:The authors retrospectively analyzed the clinical data of patients who received lower eyelid blepharoplasty in the Department of Plastic Surgery, Beijing Tsinghua Changgung Hospital from January 2017 to January 2023. Lower eyelid blepharoplasty with orbital fat releasing and repositioning through supra-SOOF was performed. The tear trough ligament and orbicularis retaining ligament were released between the orbicularis oculi muscle and SOOF via skin approach. Orbital septal fat was released to this space, lateral fat flap was fixed to the SOOF capsule, medial fat flap was fixed to the superficial fascia of the levator labii superioris muscle, orbital septum was repositioned, and lateral canthus was suspended. After the operation, lower eyelid morphology and complications were evaluated.Results:A total of 58 patients were enrolled, including 8 males and 50 females with the age of (49.8 ± 10.4) years (32 to 70 years). All patients had obvious lower eyelid bags on both sides, combining the tear trough deformity and (or) palabromalar groove. Fifty-seven patients were followed up for (29.1 ± 16.9) months (6-67 months). All patients were satisfied with the operation. The appearance of lower eyelid was greatly improved, with elimination of fat prominence and tear trough deformity. Mild lower eyelid ectropion was observed two cases 1 week after the operation, and were relieved by moderate massage 2 weeks postoperatively. In one case, mild lower eyelid retraction was observed 1 month postoperatively, with no complaint of discomfort or further treatments. Bulbar conjunctival hemorrhage occurred in 1 case and recovered without further interventions.Conclusion:Lower eyelid blepharoplasty with orbital fat releasing and reposting through supra-SOOF can effectively release the tear trough ligament and the orbicularis retaining ligament, with stronger fat fixation and less surgical difficulty. After the operation, eyelid contour was flat and tight with fewer complications and higher patient satisfaction.

Objective To assess the retention and excretion fractions for uranium intake via wounds in the organs of adult reference computational phantom, and to improve the evaluation of health risks associated with radioactive isotopes intake via wounds. Methods A software for evaluation of the internal radiation dose was developed by combining the wound model in International Commission on Radiological Protection Report 156 and the systemic models in the International Commission on Radiological Protection Report 130 and the subsequent Occupational Intakes of Radionuclides series reports. This study was conducted to calculate the uranium retention fractions in adult reference individuals following ingestion through wounds of seven categories of uranium: weakly retained, moderately retained, strongly retained, very strongly retained, colloids, particles, and fragments. We assessed the retention fractions in the wound sites, bones, and liver, as well as the excretion fractions in urine and feces, and compared these results with authoritative results. Results The retention and excretion fractions of ²³⁸U and ²³⁵U in different forms of intake via wounds showed consistent variations. The retention fractions of weak and moderate uranium in wounds could be ignored after 1 000 d. The retention fractions of strong, avid, and colloid uranium were 10⁻⁴ to 10⁻⁵ after 10 000 d. A significant portion of the uranium present in the forms of particles and fragments exhibited long-term retention in wounds. The bone retention fractions were 1 to 2 orders of magnitude higher than the liver retention fractions. Following the intake of soluble and insoluble uranium, the retention fractions in these two organs decreased and increased, respectively, compared with those observed on the first day. The urinary excretion fractions were approximately 2 orders of magnitude higher than the fecal excretion fractions. Following the intake of soluble and particulate uranium, the excretion fractions decreased. At 1 000 d after the intake of uranium in the form of fragments, the urinary and fecal excretion fractions were 10⁻⁶ and 10⁻⁸, respectively. Conclusion The calculation results validated the accuracy of the established models, providing data support for the assessment of internal exposure doses in individuals following uranium wound contamination incidents.

Objective:To explore the application experience of autologous fat transplantation in improving the facial contour of young cosmetic patients.Methods:From October 2017 to October 2020, the plastic surgery department of Beijing Tsinghua Changgung Hospital admitted 10 young cosmetic patients with poor facial contours, including 1 male and 9 females, aged 18-35 years, with an average of 28 years. Autologous subcutaneous fat was harvested by liposuction and static purification and then injected into the areas with poor facial contour with an amount of 10%-30% over.Results:The facial contour of 10 young cosmetic patients was well improved, and there were no postoperative complications such as facial asymmetry, local uneven skin, skin infection and necrosis or fat embolism. 8 cases were filled once and 2 cases were filled twice. The patients were followed up for 6-24 months and the postoperative effect was good. The excellent and good rate evaluated by patients, plastic surgeon and the third party doctor was more than 80%.Conclusions:The use of autologous fat to improve the facial contour of young cosmetic patients is easy to operate with less trauma and good effect, which is worthy of promotion.

Objective: To investigate the risk factors for yersiniosis, so as to provide insights into prevention of yersiniosis. Methods: The patients with yersiniosis admitted to the clinics in the surveillance site of Chengbei Township of Jin'an District and Chengnan Township of Yu'an District in Lu'an City from 2013 to 2021 were included as the case group, and the healthy family members matched to cases were selected as the family control group, while normal residents with a 1︰2 match in the same village, gender, and age difference within 5 years were included in the community control group. Participants' demographics, hand-washing and eating habits, living environment hygiene, poultry and livestock feeding were collected using questionnaire surveys, and factors affecting yersiniosis were identified using a multivariable conditional logistic regression model. Results: There were 43 cases in the case group, with a median (interquartile range) age of 45 (34) years, 91 cases in the family control group, with a median (interquartile range) age of 36 (36) years and 86 cases in the community control group, with a median (interquartile range) age of 46 (34) years. Multivariable conditional logistic regression analysis showed that compared with the family control group, the habit of drinking unboiled water (OR=6.721, 95%CI: 1.765-25.588), and direct consumption of food stored in the refrigerator (OR=7.089, 95%CI: 1.873-26.829) were risk factors for yersiniosis in the case group; and compared with the community control group, not washing hands after contacting with poultry and livestock (OR=50.592, 95%CI: 2.758-927.997), habit of eating raw vegetables and fruits (OR=5.340, 95%CI: 1.022-27.887), direct consumption of food stored in the refrigerator (OR=19.973, 95%CI: 2.118-188.336), and unclean refrigerator (OR=12.692, 95%CI: 1.992-80.869) were risk factors for yersiniosis in the case group. Compared with the family and community control groups, not washing hands after contacting with poultry and livestock (OR=4.075, 95%CI: 1.427-11.637), habit of drinking unboiled water (OR=4.153, 95%CI: 1.331-12.957), habit of eating raw vegetables and fruits (OR=4.744, 95%CI: 1.609-13.993), and direct consumption of food stored in the refrigerator (OR=5.051, 95%CI: 1.773-14.395) were risk factors for yersiniosis in the control group. Conclusion Unhealthy habits such as eating raw vegetables and fruits, drinking unboiled water, direct consumption of food stored in the refrigerator, unclean refrigerator, and not washing hands after contacting poultry and livestock may increase the risk of yersiniosis.

Objective: To construct a model for clinical identification of spotted fever (SF) and severe fever with thrombocytopenia syndrome (SFTS), so as to provide insights into early identification of SF and SFTS. Methods: The clinical data of laboratory-confirmed SF and SFTS patients in secondary and tertiary hospitals in Lu'an City, Anhui Province from May 2017 to May 2021 were retrieved from Chinese Disease Prevention and Control Information System. Factors affecting SF were identified using a logistic regression model, and the model for early identification of SF and SFTS was created. The model fitting effect was evaluated using Hosmer-Lemeshow test, and the value of the model for identification of SF and SFTS was evaluated using the area under the receiver operating characteristic curve (AUC). Results: Data of 62 SF cases and 115 SFTS cases were included. Multivariable logistic regression analysis showed that rash (β=5.994), C-reactive protein (β=4.409), white blood cell (β=-3.176) and platelet (β=-3.234) were included in the model, which were scored 6, 4, -3 and -3, with a total score ranging from -5 to 10. Hosmer-Lemeshow test revealed a high model fitting effect (χ2=3.245, P=0.662). The AUC of the model was 0.992, and the sensitivity and specificity were 0.935 and 0.991 if the cutoff was 1. Conclusion A model for early identification of SF and SFTS that includes four variables of rash, C-reactive protein, white blood cell and platelet has been created, which has a high accuracy.

Objective To prepare rat models of liver stagnation syndrome constipation-type irritable bowel syndrome(IBS-C)using single and multi-factor modeling method with different indicators,to provide ideal experimental animal models of IBS-C.Methods Forty-two SD rats were divided randomly into blank(Normal),cold-water gavage(Cold),restraint(Restrain),tail-clamping(Tail),cold-water gavage + restraint(C + R),and cold-water gavage + tail-clamping groups(C + T).Body weight,food intake,water intake,and survival status,as well as open-field behavior,fecal Bristol score,visceral sensitivity,and small intestine propulsion were observed in each group during the modeling period.Pathological changes in the rat colon were observed by hematoxylin and eosin staining,and the serum and colon contents of 5-hydroxytryptamine(5-HT)and vasoactive intestinal peptide(VIP)were determined by enzyme-linked immunosorbent assay.Results The body weight in each group decreased after modeling(P<0.05,P<0.01),the food and water intakes decreased,and serum 5-HT levels increased.The number of fecal particles and Bristol score decreased while the colon 5-HT content increased in the Cold group(P<0.05,P<0.01);the total distance and average speed of the restraint group in the open field decreased(P<0.01);the preference for sugar water in the Tail group decreased(P<0.01);the preference for sugar water,total open-field distance,small intestine propulsion rate,defecation particles,and Bristol score all decreased,while the colon 5-HT content increased and the VIP content decreased in the C + T group(P<0.05,P<0.01);and the total distance,average speed,and VIP content in the colon decreased in the C + R group(P<0.05).Except for the Tail group,all the model groups showed visceral hypersensitivity(P<0.05,P<0.01)compared to the blank group at various pressure values on days 7 and 14 of modeling.Pathological observations showed no significant inflammatory cell infiltration or pathological changes in any of the model groups.Conclusions The combination of ice-water gastric lavage and tail clamping can be used to establish a rat model of liver depression syndrome in IBS-C.This may be the best of the five tested method,and the resulting model may lay the foundation for further systematic and in-depth research into the mechanism of traditional Chinese medicine in preventing and treating IBS-C.

Objective:To explore the safety and effectiveness of medium-frequency electrotherapy for increasing the volume of the latissimus dorsi muscle.Methods:Fifteen adult New Zealand white rabbits were randomly divided into three groups, namely group A, group B, and group C, with 5 rabbits in each group. This was a self-control study, with the right latissimus dorsi muscle as the experimental group and the left latissimus dorsi muscle as the control group. The three groups corresponded to three different current intensity levels: 7.062 mA for group A (6th gear), 10.593 mA for group B (9th gear), and 14.124 mA for group C (12th gear). After the 12th, 24th, and 36th sessions of the experiment, ultrasonography was used to collect the thickness of the latissimus dorsi muscle. After the 36th electrostimulation, the latissimus dorsi muscle samples were collected to measure their in vivo muscle thickness and wet weight and were then sent for HE and MASSON staining.Results:After the 12th, 24th, and 36th electrostimulation sessions, ultrasonographic sampling in groups A and B showed an increase in the thickness of the right latissimus dorsi muscle compared to the left; for example, the thickness on the right of group B increased by 37.8%. The wet weight data collected after the 36th electrostimulation in groups A and B showed an increase in the right latissimus dorsi muscle compared to the left; for example, the wet weight on the right of group B increased by 5.04%.Conclusions:Different electrostimulation modes of medium-frequency therapy technology can induce muscle fiber thickening or atrophy. In this experiment, the 9th gear (10.593 mA) of medium-frequency therapy technology may be a suitable choice for inducing muscle fiber thickening, and the 12th gear (14.124 mA) may be a suitable choice for inducing skeletal muscle thinning.