The development of traditional Chinese medicine (TCM) diagnosis and treatment has undergone multiple paradigms, evolving from sporadic experiential practices to systematic approaches in syndrome differentiation and treatment and further integration of disease and syndrome frameworks. TCM is a vital component of the medical system, valued alongside Western medicine. Treatment based on syndrome differentiation embodies both personalized treatment and holistic approaches; however, the inconsistency and lack of stability in syndrome differentiation limit clinical efficacy. The existing integration of diseases and syndromes primarily relies on patchwork and embedded systems, where the full advantages of synergy between Chinese and Western medicine are not fully realized. Recently, driven by the development of diagnosis and treatment concepts and advances in analytical technology, Western medicine has been rapidly transforming from a traditional biological model to a precision medicine model. TCM faces a similar need to progress beyond traditional syndrome differentiation and disease-syndrome integration toward a more precise diagnosis and treatment paradigm. Unlike the micro-level precision trend of Western medicine, precision diagnosis and treatment in TCM is primarily reflected in data-driven applications that incorporate information at various levels, including precise syndrome differentiation, medication, disease management, and efficacy evaluation. The current priority is to accelerate the development of TCM precision diagnosis and treatment technology platforms and advance discipline construction in this area.

Objective Establish the method of bacterial endotoxins test for human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris).Methods The method of gel-clot technique and photometric technique(kinetic-turbidimetric assay and kinetic-chromogenic assay)for the determination of bacterial endotoxins was carried out according to the Appendix of China Pharmacopoeia in 2020 Vol Ⅲ 1143"bacterial endotoxins test"and Vol IV 9251"guidelines for bacterial endotoxin test".Results There is no interference after more than forty times dilution for gel-clot technique,the recovery rates of kinetic-turbidimetric assay and kinetic-chromogenic assay can also meet the requirements.Conclusion It is feasible to establish gel-clot technique,kinetic-turbidimetric assay and kinetic-chromogenic assay for bacterial endotoxin test of human papillomavirus bivalent(types 16,18)vaccine(pichia pastoris).

Objective:To determine the content of the released nickel ion through the 7 extraction media to extract the Ni-Ti wires and to plot the curve of the released nickel ion so as to identify a leaching medium that can be substituted for blood for in vitro Ni release evaluation. Methods:The release of Ni through microwave digestion/inductively coupled plasma mass spectrometry (ICP-MS) in the goat serum was determined. Because of the high content of Ni release, it could be determined by diluting the extraction medium, and other extraction media could be determined directly. Ni release standard curves were plotted by the release amount and different time point variables. Though the different extraction media Ni release curves confirm the specificity of extraction media instead of blood.Results:By analyzing the Ni release curves of seven leaching media, it was found that none of these seven extraction media was suitable for the evaluation of Ni release in in vitro leaching media. Considering the safety of the leaching medium and the simplicity of preparation, hydrochloric acid solution was chosen as the leaching medium, but the concentration needed to be diluted accordingly. Finally, a hydrochloric acid solution was created as an alternative to blood for the in vitro study of Ni release from Ni-Ti alloy cardiovascular products, with a volume fraction of 0.005%. Conclusions:The in vitro leaching medium that can replace blood was found to be hydrochloric acid for the time being, but its concentration was too high, resulting in too much Ni release as well, which deviated from the actual situation. Therefore, the hydrochloric acid solution was diluted step by step, and the Ni release curve was examined until it was close to the clinical release level, and the actual concentration was determined, thus laying a solid foundation for the subsequent evaluation of the safety and risk.

Objective:To analyze the gene mutation types and frequence of thalassemia patients in Jingzhou area.Methods:A total of 721 suspected thalassemia patients who were visited in Jingzhou Central Hospital from June 2019 to June 2022 were selected as the research objects.There were 204 males and 517 females.PCR-reverse dot hybridization method was used to analyze the types and frequencies of 23 common α or β thalassemia gene mutations.Results:Among the 721 patients with suspected thalassemia,228 cases were positive for α or β thalassemia gene,with a total positive rate of 31.62％,including 87 cases of α-thalassemia,accounting for 38.16％,and 140 cases of β-thalassemia,accounting for 61.40％.There was 1 case of α β complex thalassemia,accounting for 0.44％.A total of 4 types of α-thalassemia gene mutations were detected,all of which were deletion types,including αα/--SEA(64/87,73.56％),αα/-α3.7(14/87,16.09％),--SEA/-α3.7(7/87,8.05％),αα/-α4.2(2/87,2.30％).Among 140 patients with β-thalassemia,138 were pure heterozygotes,and the genotypes of IVS-Ⅱ-654M(63/140,45.00％),CD41-42M(34/140,24.29％),CD17M(18/140,12.86％)and CD27-28M(10/140,7.14％)accounted for 89.29％of all mutations(125/140),2 cases of double heterozygosity(2/140,1.43％)were found,no homozygous β-thalassemia were detected;1 case of αβ complex thalassemia with genotype-α3.7/IVS-Ⅱ-654M was found.The incidence of difference types of thalassemia was statistically significant(x2=194.250,P＜0.001).The percentage of positive thalassemia genes was not significantly difference between male and female suspected patients(x2=0.199,P=0.655).Conclusion:The α-thalassemia gene mutation in Jingzhou area is dominated by αα/--SEA,and the IVS-Ⅱ-654M mutation is more common in β-thalassemia,and α β complex thalassemia is relatively rare,which can provide a reference for the formulation of prevention and treatment measures for thalassemia in Jingzhou area.

AIM To study the chemical constituents from the roots of Pfaffia glomerata(Spreng)Pedersen.METHODS The 95%and the 50%ethanol extract from P.glomerata were isolated and purified by silica gel,D101 macroporous resin,sephadex LH-20,polyamide,ODS,preparative HPLC and recrystallization,then the structures of obtained compounds were identified by physicochemical properties and spectral data.RESULTS Eighteen compounds were isolated and identified as 1,2,4-benzenetriol(1),polypodine B(2),(-)-syringaresinol-4-O-β-D-glucopyranoside(3),poststerone(4),stachysterone B(5),calonysterone(6),taxisterone(7),makisterone C(8),20,22-O-(R-ethylidene)-20-hydroxyecdysone(9),20,22-O-(R-3-methoxycarbonyl)propylidene-20-hydroxyecdysone(10),shidasterone(11),5α-20-hydroxy-ecdysone(12),abutasterone(13),25-hydroxydacryhainansterone(14),methyl-α-D-fructofuranoside(15),methyl-β-D-fructofuranoside(16),chikusetsusaponin Ⅳamethyl ester(17),uridine(18).CONCLUSION Compounds 1-6,8-16,18 are isolated from P.glomerata for the first time,and compounds 1,3-6,8-16,18 are isolated from the genus of Pfaffia for the first time.

Objective To explore the predictive factors of axillary lymph node metastasis in breast cancer,and to provide a basis for clinical decision-making under the DIP payment mode of medical insurance.Methods A total of 715 patients with breast cancer were divided into the metastasis group(n=309)and the non-metastasis group(n=406)according to the postoperative paraffin pathological results.Data of age＞60 years old,menopausal status,body mass index(BMI)＞24 kg/m2,hyperglycemia(GLU＞6.1 mmol/L),high triglycerides(TG＞1.7 mmol/L),maximum diameter of the tumor,the distance between the tumor and nipple and the quadrant where the tumor located were compared between the two groups.The expression levels of estrogen receptor(ER),progesterone receptor(PR),nuclear proliferation antigen(Ki-67)and human epidermal growth factor receptor-2(Her-2)in breast cancer tissue samples were detected by histological grading and immunohistochemistry.The consistency,sensitivity and specificity of chest CT and breast ultrasound were examined,taken the pathological diagnosis as the gold standard.Results Compared with the non-metastatic group,the proportion of maximum diameter of tumor＞2 cm,histological grade Ⅲ,high Ki-67 and high ER expression,tumor located in the outer upper quadrant,the distance＞3 cm between tumor and nipple were increased in the metastatic group,and the proportion of high level of TG was decreased in the metastatic group(P＜0.05).The consistency between chest CT and pathological diagnosis was better than that of breast ultrasound(Kappa was 0.493 and 0.353 respectively,P＜0.05).Logistic regression analysis showed that histological grade Ⅲ,high expression of ER,maximum diameter of tumor＞2 cm,and chest CT diagnosis were risk factors for axillary lymph node metastasis(P＜0.05).Conclusion The combined application of the predictive factors of axillary lymph node metastasis of breast cancer could provide certain reference for clinical decision-making under the background of DIP payment mode of medical insurance.

Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75％(27/36);boys accounted for 64％(23/36).Among the 36 neonates,31(86％)had disease onset within 3 days after birth,and 19(53％)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61％)had left cerebral infarction and 13(36％)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75％)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72％)and seizures in 10 neonates(34％).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33％,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44％(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.

By summarizing the clinical use of different capsule endoscopes in small intestine,colon,stomach and esophagus,the relevant evaluation indicators of the clinical application of capsule endoscopes for patients with different diseases were sorted out.Combined with the review process of capsule endoscopes that have been marketed at home and abroad,the key points of clinical evaluation of capsule endoscopes products in China that need to be marketed through clinical trials were considered.The clinical evaluation focuses included main evaluation index,secondary evaluation index and safety evaluation index,and the main evaluation index could consider the consistency rate of lesion diagnosis results and the excellent rate of image quality.The inclusion criteria for clinical trials of capsule endoscopy products were the population who intended to use the product,and the exclusion criteria need to consider the circumstances that were not applicable to such products and the circumstances that were not applicable to enrollment.

Objective:To explore the feasibility of applying ArcherQA to independent dose verification of MR-guided online adaptive radiotherapy (ART) plans performed on Elekta Unity 1.5 Tesla (T) magnetic resonance-linear accelerator (MR-Linac).Methods:The dose calculation accuracy of ArcherQA under a specific magnetic field was validated using a homogeneous water phantom. A total of 32 patients who received MR-guided online ART on Elekta Unity were randomly selected by lottery, with 32 offline plans and 177 online plans for five treatment sites (brain, mediastinum, liver, kidney, and vertebral body) enrolled. Finally, the γ pass rates (threshold: 10%; criteria: 3 mm/3% and 2 mm/2%) were compared among the result upon independent dose verification of ArcherQA, measurements of ArcCheck, and calculations using the Monaco treatment planning system (TPS) to quantitatively evaluate the accuracy and efficiency of ArcherQA in independent dose verification of online plans on Elekta Unity.Results:ArcherQA was proven accurate in calculating the dose distribution of therapeutic photon beams under the specific magnetic field. With the 3 mm/3% criterion, the γ pass rates of verification result exceeded 99% in all square fields of a water phantom. Under the stricter 2 mm/2% criterion, the γ pass rates also surpassed 95% in all square fields except 20 cm × 20 cm field. Regarding the verification of treatment plans, the ArcherQA result were found to be highly consistent with those measured or calculated using ArcCheck and Monaco TPS, with the average γ pass rates exceeding 99% under the 3 mm/3% criterion and above 97% under the 2 mm/2% criterion. ArcherQA was acceptably efficient for independent dose verification of online plans, with 50 to 150 s, (108 s on average) required to complete the independent dose verification of 177 online plans.Conclusions:ArcherQA allows for accurately and efficiently calculating the dose distribution of therapeutic photon beams under a specific magnetic field, establishing it as an effective supplementary tool for independent dose calculation of MR-guided offline and online ART plans, thereby ensuring the safety of patient treatment plans.

Objective To explore the risk factors of complicating urogenic sepsis after percutaneous nephrolithotripsy(PCNL)and construct a nomogram prediction model.Methods The data of 291 patients with stage 1 PCNL in 940 Hospital of Joint Logistics Support Force from October 2016 to October 2021 were retrospectively analyzed.The patients were divided into the sepsis group and non-sepsis group according to whether complicating urogenic sepsis after operation.The general data,stone-related data,operation-related data and laboratory detection related data were included.The independent risk factors were screened by the univariate and multivariate logistic regression analysis,and the nomogram prediction model was constructed.Results The results of univariate and multivariate logistic regression analysis showed that age≥60 years old(OR=6.438,95％CI:1.548-26.769),urinary leukocyte 3+(OR=5.651,95％CI:1.614-31.766),urinary nitrite positive(OR=7.117,95％CI:1.190-42.561),operation time≥90 min(OR=4.626,95％CI:1.137-18.817)and perfusion volume 30 L(OR=3.312,95％CI:1.090-10.061)were the independent risk factors of postoperative complicating urogenic sepsis.C-index of the constructed nomogram prediction model in the modeling samples was 0.937,the calibrated C-index was 0.914,and the model predictive efficien-cy was good.Conclusion Age ≥60 years old,urinary leukocyte 3+,urinary nitrite positive,operation time 90 min and perfusion volume ≥30 L are the independent risk factors for complicating urogenic sepsis after PCNL;the constructed nomogram prediction model has a good predictive efficiency for the occurrence of post-operative urogenic sepsis.