The blood products industry in China,the United States,the European Union and Japan are at different stages of development,with very different laws,regulations and regulatory systems.This paper uses methods such as literature review,policy comparison,and case study.By analyzing and comparing the blood product regulatory policies in various countries,it is found that compared with the United States,the European Union and Japan,China has differences in several areas,including plasma quarantine period,plasma fractionation processes and intermediate products,segmented production of blood products,and import management policies.It is suggested that we should learn from foreign regulatory experiences,and explore the establishment of blood product regulatory policies suitable for China's national conditions.Recommendations include optimizing China's source plasma quarantine period and blood product production process management policies,promoting multiple sites and segmented production of blood products,and establishing flexible blood product import and export management systems.These measures aim to provide references for promoting the development of the blood product industry and improving the accessibility of medications for the public.

Objective To develop a systematic and scientific assessment-adaptation-evaluation framework for wheelchair cushions.Methods A mixed-methods approach integrating literature review,qualitative interviews and Delphi expert consultation was employed.First,27 relevant studies were identified through systematic literature searches,comprehensively synthesizing wheelchair cushion types,performance indicators,key assessment/adaptation elements and evalua-tion methods.Second,semi-structured interviews were conducted with 24 wheelchair users and six assistive tech-nology specialists.Interview transcripts were analyzed using Colaizzi's phenomenological analysis to extract themes and deeply explore user needs and practitioner experiences.Based on the literature and interview find-ings,the research team developed a preliminary protocol comprising an assessment form,an adaptation process table and an effectiveness evaluation form.Finally,20 multidisciplinary experts participated in a two-round Del-phi consultation.Experts rated the importance of items using a 5-point Likert scale.Consensus was analyzed us-ing Kendall's W coefficient and the coefficient of variation(CV),supplemented by mean importance scores and full-score frequency to refine the protocol.Results The consultation demonstrated excellent expert engagement(100%response rate)and strong authority(Cr=0.90).The finalized protocol comprised of an assessment form(four primary domains/21 secondary items),an ad-aptation protocol(two primary domains/eight secondary items)and an evaluation form(two primary domains/15 secondary items).Statistical analysis revealed Kendall's W=0.20(P<0.05),mean importance scores of(4.48±0.72),CV=(0.15±0.05),and full-score frequency of(60.80±16.39)%,indicating acceptable consensus.Conclusion The assessment-adaptation-evaluation method for wheelchair cushions constructed in this study is scientific,comprehensive and operable,and can provide a standardized tool for clinical personalized adaptation.Future studies should enhance the applicability of the method in diverse clinical settings.

Objective To explore the efficacy and safety of 0.02％atropine eye drops for the treatment of nearwork-induced transient myopia(NITM)in adolescents.Methods A total of 131 adolescents with NITM were randomly divided into experimental(receiving 0.02％atropine eye drops)and control(receiving placebo)groups.Changes in the initial NITM values before medication and at 14 and 30 days after medication were observed.Alterations in intraocular pressure and accommodation amplitude were monitored,and the occurrence of complications,such as photophobia and near vision impairment,were recorded.Results The baseline NITM did not differ significantly between the two groups.On day 14 and day 30,the NITM values in the experimental group were significantly reduced compared to the baseline,with differences of 0.31 D±0.20 D and 0.30 D±0.16 D,which were significantly greater than those in the control group(0.21 D±0.98 D and 0.20 D±0.18 D,P＜0.001).The efficacy rate of NITM treatment in the experimental group was 84.4％,which was sig-nificantly higher than that in the control group(29.9％).After 30 days of treatment,no severe systemic or ocular adverse reactions were observed in the experimental group.Mild photophobia was the main adverse reaction.Conclusion 0.02％atropine eye drops can effec-tively reduce the initial NITM value in adolescents within a month of its use,with no severe complications and good tolerance.A clinical trial of atropine eye drops at different concentrations to reduce NITM over a longer period is warranted.

Objective:To explore the effect of combining ultrasound stimulation with continuous passive movement (CPM) on triceps crus spasms and the motor functioning of children with spastic cerebral palsy.Methods:Sixty children with spastic cerebral palsy were randomly divided into a control group, a CPM group, and a combined treatment group, each of 20. All received routine rehabilitation treatment (including exercise therapy, electrical stimulation and massage), while the CPM and combined groups were additionally provided with CPM and CPM + ultrasound stimulation, respectively. All of the children were treated once a day, 6 times a week, for 4 consecutive weeks. Before and after the treatment, the Tardieu scale (MTS) was used to assess the degree of triceps spasm, and the Berg Balance Scale (BBS), the Gross Motor Function Test (GMFM-88), and 10m walking speed (10MWT) were employed to assess motor function.Results:After the treatment, the average MTS scores, BBS scores and GMFM-88 scale scores in the D and E areas of all 3 groups had improved significantly compared with before the treatment, with those of the observation and CPM groups significantly better than among the control group. With the knee flexed and extended, the Tardiu scale R1, R2 and X values of the combined treatment group were significantly better than those of the CPM group, on average. The combined group′s average BBS score and its average score in the D-zone of the GMFM-88 were also significantly better than the CPM group′s averages.Conclusions:Ultrasound combined with continuous passive movement can effectively relieve triceps spasm in children with cerebral palsy, and improve their static posture control during squatting, sitting and standing.

Effective removal of cardiac interference noise is essential to improve the accuracy of thoracic impedance respiration measurements.A cascaded LMS adaptive filter which can effectively remove the cardiac interference noise is proposed according to the characteristics of the real thoracic impedance respiration signal.The comparisons with several commonly used denoising algorithms reveal that the proposed algorithm can better remove cardiac interference while retaining the respiratory component of the original thoracic impedance respiration signal.The feasibility and accuracy of the proposed algorithm are further verified using real respiratory data with cardiac interference,and the experimental data show that the proposed method has a signal-to-noise ratio of(23.568±3.037)dB,a mean square error of 0.002±0.001,and a mean absolute error of 0.033±0.011,which fully confirms its effectiveness and stability.

Objective:To explore the effect of combining ultrasound stimulation with continuous passive movement (CPM) on triceps crus spasms and the motor functioning of children with spastic cerebral palsy.Methods:Sixty children with spastic cerebral palsy were randomly divided into a control group, a CPM group, and a combined treatment group, each of 20. All received routine rehabilitation treatment (including exercise therapy, electrical stimulation and massage), while the CPM and combined groups were additionally provided with CPM and CPM + ultrasound stimulation, respectively. All of the children were treated once a day, 6 times a week, for 4 consecutive weeks. Before and after the treatment, the Tardieu scale (MTS) was used to assess the degree of triceps spasm, and the Berg Balance Scale (BBS), the Gross Motor Function Test (GMFM-88), and 10m walking speed (10MWT) were employed to assess motor function.Results:After the treatment, the average MTS scores, BBS scores and GMFM-88 scale scores in the D and E areas of all 3 groups had improved significantly compared with before the treatment, with those of the observation and CPM groups significantly better than among the control group. With the knee flexed and extended, the Tardiu scale R1, R2 and X values of the combined treatment group were significantly better than those of the CPM group, on average. The combined group′s average BBS score and its average score in the D-zone of the GMFM-88 were also significantly better than the CPM group′s averages.Conclusions:Ultrasound combined with continuous passive movement can effectively relieve triceps spasm in children with cerebral palsy, and improve their static posture control during squatting, sitting and standing.

Objective To explore the efficacy and safety of 0.02％atropine eye drops for the treatment of nearwork-induced transient myopia(NITM)in adolescents.Methods A total of 131 adolescents with NITM were randomly divided into experimental(receiving 0.02％atropine eye drops)and control(receiving placebo)groups.Changes in the initial NITM values before medication and at 14 and 30 days after medication were observed.Alterations in intraocular pressure and accommodation amplitude were monitored,and the occurrence of complications,such as photophobia and near vision impairment,were recorded.Results The baseline NITM did not differ significantly between the two groups.On day 14 and day 30,the NITM values in the experimental group were significantly reduced compared to the baseline,with differences of 0.31 D±0.20 D and 0.30 D±0.16 D,which were significantly greater than those in the control group(0.21 D±0.98 D and 0.20 D±0.18 D,P＜0.001).The efficacy rate of NITM treatment in the experimental group was 84.4％,which was sig-nificantly higher than that in the control group(29.9％).After 30 days of treatment,no severe systemic or ocular adverse reactions were observed in the experimental group.Mild photophobia was the main adverse reaction.Conclusion 0.02％atropine eye drops can effec-tively reduce the initial NITM value in adolescents within a month of its use,with no severe complications and good tolerance.A clinical trial of atropine eye drops at different concentrations to reduce NITM over a longer period is warranted.

In recent years, the concept of membrane anatomy has gain continuous extension and breakthrough in multiple specialized fields such as gastrointestinal surgery. Compared with traditional surgery, radical resection of gastrointestinal tumors based on the concept of membrane anatomy has shown significant advantages in therapeutic effects. However, in practical application, this concept still faces many problems and challenges, among which how to accurately identify membrane structures and achieve effective membrane navigation during surgery has become a key concern. To address the above issues, our team developed and established the Deepguide membrane navigation system, aiming to overcome the difficulties in membrane identification and navigation, and solve the critical problem of insufficient membrane integrity rate after gastrointestinal tumor surgery. This paper systematically reviews the creation process and clinical application scenarios of the Deepguide membrane navigation system, and prospects its future application prospects and development directions, to provide a useful reference for the development of membrane anatomy surgery and the research and development of navigation technologies.

Objective:To use machine learning to predict the efficacy of accelerated corneal collagen cross-linking (A-CXL) surgery, identify prognostic factors, and construct models to predict postoperative disease progression.Methods:A single-center retrospective study was conducted.A total of 82 keratoconus patients (112 eyes) who underwent A-CXL surgery at the West China Hospital of Sichuan University between March and December 2021 were enrolled.Preoperative and follow-up examinations included anterior segment evaluation by slit-lamp microscopy, corneal topography using Pentacam, and corneal biomechanical indices using Corvis ST.Disease progression was defined as an increase in maximum keratometry (Kmax) of ≥1 D from the preoperative level at the last follow-up.Various machine learning algorithms were employed to analyze corneal topography, biomechanical parameters and corneal densitometry values to identify prognostic factors and construct models for predicting postoperative disease progression.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of West China Hospital, Sichuan University (No.2023496).Written informed consent was obtained from each subject.Results:During follow-up, 15.1% (17/112) of the eyes showed progression after A-CXL.The preoperative astigmatism and stress-strain index (SSI) in the progression group were (-5.41±2.72)D and 1.41±0.78, respectively, which were significantly higher than (-3.30±2.54)D and 0.95±0.98 in the non-progression group ( t=2.80, 2.03; both P<0.05).Cox regression analysis identified preoperative astigmatism (hazard ratio [HR]=1.20), SSI (HR=1.10), and anterior corneal densitometry of 2-6 mm (CDA6) (HR=2.10) as significant risk factors for post-A-CXL progression.Among various machine learning models developed and validated, the area under the curve (AUC) values for logistic regression, multilayer perceptron (MLP) model, and random forest (RF) exceeded 0.700.For F1-score, the AUC values for logistic regression, MLP, and RF were 0.870, 0.880, and 0.880, respectively.The network structure of the visualized MLP was a single-layer, 24-neurons neural network with 80% accuracy in predicting whether progression occurred after A-CXL.The clinical nomogram developed in conjunction with astigmatism, SSI, and CDA6 predicted the cumulative probability of progression at 0.5, 1, and 2 years postoperatively based on the sum of the specified values for each variable, and based on the optimal cutoff value, keratoconus corneas could be classified into high-, intermediate-, and low-risk groups, respectively.The time-dependent subject operating characteristic curves of the nomogram showed AUCs of 0.734, 0.685, and 0.935 at 0.5, 1, and 2 years postoperatively, respectively, all of which performed well in predicting progression. Conclusions:Preoperative astigmatism, SSI, and CDA6 are significant risk factors for post-A-CXL progression in keratoconus.The MLP model can accurately predict postoperative disease progression, and the clinical nomogram combining preoperative astigmatism, SSI, and CDA6 can effectively differentiate between low-, medium-, and high-risk postoperative progression outcomes.

AIM:This study aims to investigate the mechanisms underlying skeletal muscle mitochondrial damage associated with decline in exercise function during high-altitude de-adaptation,using a mouse model.METHODS:Twen-ty-four healthy male C57BL/6J mice were randomly assigned to two groups:a high-altitude de-adaptation group and a plain control group.The model group was exposed to a low-pressure,low-oxygen chamber simulating an altitude of 7 000 meters for two weeks,followed by eight days of rearing in a plain environment.The control group was maintained in a plain envi-ronment for the same duration.Grip strength and pole-climbing tests were conducted on the 1st,3rd,and 5th days post-re-turn to assess muscle strength and motor coordination.Treadmill exercises were performed on the 4th and 8th days to eval-uate exercise endurance.After the treadmill exercise on the 8th day,serum,liver,and skeletal muscle tissues were col-lected.Levels of lactic acid(LA),glucose(GLU),creatine kinase(CK),lactate dehydrogenase(LDH),alanine trans-aminase(ALT),and aspartate aminotransferase(AST)in serum,as well as glycogen levels in the liver and muscle,were analyzed.Additionally,the expression of proteins related to mitochondrial biogenesis,fission,fusion,and oxidative phos-phorylation in muscle tissues was assessed using Western blot.RESULTS:(1)The model group exhibited significant re-ductions in grip strength,increased pole-climbing T-turn and total times,and decreased total time and distance in the ex-haustion running test.(2)Serum levels of LA,CK,LDH,ALT,and AST were elevated,while GLU levels decreased,and glycogen levels in both the liver and muscle were reduced in the model group following the treadmill exercise.(3)Ab-normal indicators in the model group did not return to normal by the end of the de-adaptation period.(4)Western blot analysis revealed decreased expression of mitochondrial oxidative phosphorylation proteins(ATP6V1A and Mt-CO2)and mitochondrial biogenesis proteins(PGC-1α and FGF21),increased levels of mitochondrial fusion proteins(OPA1 and MFN1),and no significant changes in fission protein expression(FIS1 and DRP1)in muscle tissue from the model group.CONCLUSION:Exercise capacity in mice during the high-altitude de-adaptation period significantly declined,particu-larly in terms of muscle strength,motor coordination,and endurance.This decline is closely associated with abnormal pro-tein expression related to skeletal muscle mitochondrial energy metabolism and production.