ObjectiveTo establish the specific chromatogram and quantitative analysis of multi-components by single-marker（QAMS） based on linear calibration using two reference substances（LCTRS）， explore the consistency between Hedyotis Herba dispensing granules and standard decoction， and evaluate the quality of the dispensing granules. MethodsHigh performance liquid chromatography（HPLC） specific chromatogram was established based on 15 batches of Hedyotis Herba standard decoction and 10 batches of the dispensing granules， and LCTRS was used to locate chromatographic peaks. The actual retention times of 7 characteristic peaks in the specific chromatogram was measured on 24 different types of C₁₈ columns， taking deacetyl asperulosidic acid and asperulosidic acid as the dual standard compounds， the retention times of the other 5 characteristic peaks were predicted and validated. Based on this， QAMS was developed to determine the contents of four components（deacetyl asperulosidic acid， deacetyl asperulosidic acid methyl ester， asperulosidic acid， and p-coumaric acid）. Then， the relative correction factors of deacetyl asperulosidic acid， deacetyl asperulosidic acid methyl ester and p-coumaric acid were calculated using the reference peak of asperulosidic acid in the dual standard compounds， and each component was quantified accordingly. Finally， the consistency between the dispensing granules and standard decoction was assessed by taking extract rate of the standard decoction， consistency of the specific chromatograms， contents and transfer rates of the indicator components as indexes， and the quality of the dispensing granules was evaluated. ResultsThere were 7 common peaks in the characteristic chromatogram of samples of Hedyotis Herba standard decoction and the dispensing granules， and four of them were identified by reference standards， namely deacetyl asperulosidic acid（peak 1）， deacetyl asperulosidic acid methyl ester（peak 3）， asperulosidic acid（peak 6） and p-coumaric acid（peak 7）. The similarity between the dispensing granules and the standard decoction was >0.9. The absolute deviation in the predicted retention time for each component by LCTRS was lower than that of the relative retention time method. The extract rate of the 15 batches of Hedyotis Herba standard decoction ranged from 7.89% to 14.60%， the contents of deacetyl asperulosidic acid， deacetyl asperulosidic acid methyl ester， asperulosidic acid and p-coumaric acid were 6.62-19.70， 3.83-17.99， 1.57-6.69， 1.62-4.52 mg·g^-1， and the transfer rates of these components from decoction pieces to the standard decoction were 22.89%-39.60%， 34.03%-62.24%， 24.25%-43.70%， and 40.58%-73.71%， respectively. The extract rate， index component contents and transfer rates from decoction pieces to the three batches of Hedyotis Herba dispensing granules（P1-P3）， produced by manufacturer A， were similar to those of the standard decoction prepared from the same batch of decoction pieces， and all fell within the specified range. The contents of the 4 indicator components in 7 batches of the dispensing granules（P4-P10） from manufacturers B-E were all within the range of the content converted from the standard decoction based on the quantity of the dispensing granules. ConclusionThe established specific chromatogram and QAMS based on LCTRS are reasonable and reliable. Based on the evaluation indicators of standard decoction yield， consistency of specific chromatograms， contents and transfer rates of the four index components， the 10 batches of Hedyotis Herba dispensing granules from various manufacturers have exhibited good consistency with the standard decoction， indicating that the current production process is relatively reasonable.

To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine (ICWM) for ulcerative colitis (UC), we aim to develop a customized core outcome set (COS) that incorporates input from various stakeholders. The study design of this COS has been informed by the Core Outcome Measures in Effectiveness Trials Initiative Handbook, with adherence to the guidelines from the Core Outcome Set-STAndards for Reporting statement and Core Outcome Set-STAndardised Protocol Items recommendations. Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC, including healthcare professionals, patients, COS developers, COS users, and methodologists. The process will involve five stages: (1) conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains; (2) conducting semi-structured interviews to obtain important outcomes; (3) choosing the most important outcomes by conducting three-round Delphi surveys; (4) achieving a consensus in a face-to-face meeting to discuss the final COS; and (5) publication, dissemination and implementation of COS. Consequently, this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine (TCM) and ICWM interventions. Please cite this article as: Zhang X, Zhang L, Wang J, Lau CT, Wang N, Zhang X, Wang P, Li J, Han F, Bian Z. A protocol for developing, disseminating and implementing a core outcome set for clinical trials of integrative Chinese and Western medicine for ulcerative colitis. J Integr Med. 2025; 23(6):654-659.
Colitis, Ulcerative/therapy* ; Humans ; Medicine, Chinese Traditional ; Clinical Trials as Topic ; Integrative Medicine ; Research Design ; Outcome Assessment, Health Care ; Delphi Technique

OBJECTIVE To evaluate the consistency between the quetiapine LC-MS/MS kit and the laboratory-built method(reference method) in the detection results of quetiapine therapeutic drug monitoring. METHODS A total of 120 remaining plasma samples were collected from patients receiving quetiapine therapeutic drug monitoring from March to October in 2021. The plasma concentration of quetiapine was detected by kit and reference method respectively. The analysis of correlations and consistency was performed by outlier analysis, linear regression and Bland-Altman method. RESULTS No outliers were detected. The linear regression equation was Y=1.018X+4.400(r=0.998), indicating a good correlation. The Bland-Altman plot analysis showed good agreement between the two measurements. CONCLUSION The detection results of quetiapine LC-MS/MS kit and reference method are in good agreement. The kit can be used for clinical quetiapine treatment drug monitoring.

OBJECTIVE To optimize β-cyclodextrin(β-CD)inclusion process of Cinnamomi Ramulus Formula Granules vola-tile constituents by orthogonal test,based on standard relation and information entropy method.METHODS On the basis of single factor experiments,the ratio of β-CD to aromatic aqueous solution,the inclusion temperature,and the inclusion time were selected as the investigating factors;the inclusion rate,drug loading,and standard relation of cinnamic aldehyde in inclusion complex were used as the evaluation index.The information entropy method was used to determine the weight coefficient of each index,then the comprehen-sive score was calculated,the inclusion process conditions were optimized by orthogonal experiment.The inclusion complex was charac-terized by thin layer chromatography,ultraviolet absorption spectroscopy,Fourier infrared spectroscopy,and X-ray diffraction.RE-SULTS The best inclusion process was that the ratio of β-CD to aromatic aqueous solution was 3∶100(g·mL-1),the inclusion temperature was 50℃,and the inclusion time was 1 h.The average inclusion rate of the obtained inclusion compound was 80.84%,the drug loading was 8.63%,and the standard relation was 0.91.The results of thin-layer chromatography,ultraviolet,infrared spec-troscopy and other characterization experiments showed that the volatile components in the aromatic aqueous solution successfully en-tered the β-CD cavity,and the inclusion complex was successfully prepared.CONCLUSION The optimum inclusion process is sta-ble and feasible,which can provide references for the preparation process of Cinnamomi Ramulus Formula Granules.

Objective To investigate the effects of combined assessment of normal morphology sperm rate(MNS)with sperm DNA fragmentation index(DFI)on the outcomes of in vitro fertilization-embryo transfer(IVF-ET).Methods A retrospective analysis was conducted on the clinical data of 641 patients who underwent IVF-ET in our center from June 2020 to February 2023.According to MNS and DFI levels,the patients were divided into group A(MNS＜4％,DFI＜25％,403 cases),group B(MNS ≥4％,DFI ≥25％,9 ca-ses),group C(MNS≥4％,DFI＜25％,125 cases),group D(MNS＜4％,DFI≥25％,104 cases),group A1(MNS＜1％,DFI＜25％,106 cases)and group D1(MNS＜1％,DFI≥25％,60 cases).The general information,semen parameters,embryo develop-ment and pregnancy outcomes were compared among all the 6 groups.Results No statistically significant differences were found be-tween female and male age among these groups(P＞0.05).Significant differences were observed in sperm motility,progressive motili-ty,sperm concentration and fertilization rates(P＜0.05),but no differences of usable embryo rates,good-quality embryo rates,clinical pregnancy rates,early miscarriage rates,or live birth rates(P＞0.05)among the groups A,B,C,D,A1 and D1.Conclusion The decreased MNS and increased DFI in males were associated with reduced sperm motility and concentration,affecting fertilization rates in IVF-ET,but had no significant impact on clinical pregnancy outcomes.The combined assessment of MNS with DFI had limited pre-dictive value for IVF-ET pregnancy outcomes.

Purpose/Significance To investigate the effectiveness of experiential teaching in perinatal healthcare management contin-uing education.Method/Process The perinatal healthcare team of Peking Union Medical College Hospital holds a four-day experiential learning program for 30 maternity-related medical staffs from China.Through the self-administered experiential teaching questionnaire(ETQ)and satisfaction questionnaire,the researchers analyze the participants'post-teaching skill acquisition,clinical application abil-ity and educational needs,as well as their satisfaction with course content,course duration,teaching design,classroom atmosphere,and teaching format,which are quantified with Likert scale.Result/Conclusion The experiential teaching mode shows good teaching effects in perinatal healthcare management continuing education,and has higher application value.In the future,the researchers should combine it with theoretical teaching and carry out more comprehensive and structured periodic learning classes throughout the country,so as to im-prove both the theoretical foundation and practical ability of healthcare workers for better healthcare services for pregnant women.

Objective:To investigate the effect of different incubation time of aminolevulinic acid (ALA) on photodynamic inhibition of Propionibacterium acnes biofilms. Methods:Propionibacterium acnes biofilms were formed in 24-well plates with pre-placed cell slides and 96-well plates. The formation of the biofilm structure was observed by confocal laser scanning microscopy (CLSM) , and the growth activity of the biofilm was assessed by the tetrazolium salt XTT assay. The in vitro successfully constructed biofilm models were divided into 6 groups: negative control group receiving neither ALA treatment nor LED radiation, ALA group incubated with ALA alone for 30 minutes, LED group receiving LED radiation alone, ALA-PDT1 group, ALA-PDT2 group and ALA-PDT3 group incubated with ALA for 15, 30 and 60 minutes respectively followed by LED radiation. After the treatment, CLSM was performed to observe the biofilm structure, as well as to determine the dead/living bacteria ratio, and XTT assay to assess the growth activity of the biofilm. Differences among groups were analyzed using one-way analysis of variance and least significant difference- t test. Results:CLSM showed that the Propionibacterium acnes biofilm model was successfully constructed in vitro. The dead/living bacteria ratios were 0.90 ± 0.16, 1.75 ± 0.19, and 2.57 ± 0.32 in the ALA-PDT1 group, ALA-PDT2 group and ALA-PDT3 group respectively, which were significantly higher than the dead/living bacteria ratio in the negative control group (0.31 ± 0.01; t= 55.56, 138.62, 74.64, respectively, all P<0.001) ; the biofilm viability value was significantly lower in the ALA-PDT1 group, ALA-PDT2 group and ALA-PDT3 group (0.35 ± 0.02, 0.26 ± 0.02, 0.18 ± 0.01, respectively) than in the negative control group (0.43 ± 0.00; t= 35.66, 2.64, 110.96, respectively, all P < 0.001) . CLSM showed that the structure of the Propionibacterium acnes biofilm was destroyed under the action of ALA-PDT, and the destruction was aggravated with the prolongation of incubation time of ALA. Conclusion:The prolongation of incubation time of ALA can enhance the inhibitory effect of ALA-PDT on Propionibacterium acnes biofilms.

Objective:To analyze the clinical manifestations, blood biochemistry indexes, imaging and genetic characteristics of mitochondrial encephalomyopathy with lactic academia and stroke 1ike episodes (MELAS) in children, so as to provide the basis for the diagnosis of MELAS and reduce the misdiagnosis rate.Methods:The clinical data of children with MELAS admitted to the Second Affiliated Hospital of Wenzhou Medical University from January 2000 to December 2020 were retrospectively analyzed, and healthy children undergoing physical examination during the same period were selected as control group.The clinical data were compared between two groups, and the clinical manifestations, blood biochemistry indexes, electrocardiogram, cardiac ultrasound, cranial imaging and genetic testing were analyzed.Results:A total of eight children in MELAS group were collected, including three males and five females.The average age of onset was(9.90±3.89)years.There were eight children in control group, including four boys and four girls, with an average age of(7.92±2.51)years.Among the eight children with MELAS, there were six cases of vomiting, eight cases of epilepsy, five cases of headache, two cases of growth retardation, one case of mental retardation, one case of diabetes, and one case of peripheral neuropathy.The levels of lactate, lactate dehydrogenase, creatine kinase, and pyruvate in MELAS group were higher than those in control group, and the differences were statistically significant( P<0.05). Brain MRI abnormalities were observed in all patients, among which five patients had lesions located in the cerebral cortex, mostly in the parietal occipital temporal lobe, one patient had lesions located in the basal ganglia, and two patients had lesions in both cortex and basal ganglia.MRS of five cases showed inverted lactate peak with bimodal change.The electroencephalogram of eight cases showed slow wave of background activity, and epileptic discharge was observed in two cases.Seven children with MELAS had mtDNA locus mutation M. 3243A>G, and one patient had M. 8344A>G mutation.Eight cases were treated with symptomatic and supportive therapy, and were followed up for 3-5 years, most of them were hospitalized repeatedly because of similar chief complaints.The course of disease was prolonged and repeated, and the symptoms were relieved and discharged after about one week of hospitalization. Conclusion:The clinical manifestations of MELAS in children are diverse, and early diagnosis is difficult.Blood biochemistry, imaging characteristics and genetic testing results are helpful for early diagnosis, early treatment and delaying the progression of the disease.

Objective:To summarize the clinical phenotype and genotype features of 2 children with adenosine deaminase 2 (ADA2) deficiency, and to review the related literature so as to enhance the understanding of this disease.Methods:The phenotype and genotype of 2 cases with ADA2 deficiency who visited the Affiliated Hospital of Qingdao University from March to December 2019 were analyzed.Literature was searched from foreign and domestic databases and studied to summarize clinical and gene mutation characteristics of children with ADA2 deficiency.Results:(1) ADA2 gene mutation was found in both children.One case was characterized by recurrent fever, livedo reticularis, polyarteritis nodosa and immunodeficiency.The mutation site c. 571delC(p.Q191Sfs*5)of the ADA2 gene detected in this case was a homozygous mutation, which was a new mutation point and not reported in China or abroad previously.The other case was characterized by recurrent fever, panniculitis, vasculitis with legs, and immunodeficiency.The mutation site c. 1358A>G(p.Y453C)was a homozygous mutation that was not reported in China previously.(2)There were 171 cases of children diagnosed with ADA2 deficiency in foreign countries, but only 5 cases (3 previously reported cases and 2 cases in this study) were detected in China.The main clinical phenotypes were recurrent fever(5/5 cases), livedo reticularis(4/5 cases), panniculitis(1/5 cases), cutaneous gangrene(1/5 cases), growth retardation(1/5 cases), cerebral infarction(3/5 cases), humoral immunodeficiency(4/5 cases), blood system involvement(3/5 cases), and myalgia(2/5 cases), elevated inflammatory markers(C-reactive protein, erythrocyte sedimentation rate)(5/5 cases). Conclusions:Children with ADA2 deficiency have various clinical phenotypes, and a good understanding of phenotypes can improve the level of clinical diagnosis and treatment.The mutation point of c. 571delC is a novel ADA2 gene mutation type, which further enriches the ADA2 gene spectrum.

Objective:To investigate the distribution and influencing factors of the ocular biological parameters related to refractive development in school-age children.Methods:A cross-sectional study was performed.A total of 1 091 children aged 6-12 years old from July, 2017 to August, 2018, resident in downtown of Zhenjiang were enrolled in this study.The corneal radius of curvature (CR) and axial length/corneal radius of curvature ratio (AL/CR) were calculated after AL and corneal curvature (K) were measured by IOL Master.After pupillary dilatation with 0.5% tropicamide, cycloplegic retinoscopy was performed to identify refractive status.According to the spherical equivalent refraction (SER), all right eyes were classified into myopia, hyperopia and emmetropia.The comparison of the above parameters between different genders, as well as among different age groups and different refractive status groups were determined while the relative factors of the biological parameters and refractive status were analyzed by multivariate regression analysis.The study protocol was approved by the Ethics Committee of Affiliated People's Hospital of Jiangsu University (No.K-20190153-W).Results:There were statistical differences in AL, SER and AL/CR value among different age groups ( F=32.34, P<0.01; F=33.69, P<0.01; F=2.19, P=0.04), which showed that refractive status shifted to myopia as well as AL and AL/CR value were increased with age.Compared with the girls, the boys had significantly longer AL, greater CR, greater AL/CR value, and smaller K ( t=7.58, P<0.01; t=-7.48, P<0.01; t=-8.08, P<0.01; t=-2.14, P=0.03). There were statistical differences in AL and AL/CR value among different refractive status groups ( F=192.68, P<0.01; F=143.15, P<0.01). The myopia group had longer AL and greater AL/CR value than the other two groups.Children whose parents were not myopic and children who had outdoor activities more than 14 hours per week and did homework less than 20 hours per week and children who slept more than 9 hours per day had shorter AL, smaller AL/CR value, and were more inclined to hyperopia or emmetropia.The results of multivariate regression analysis suggested that children aged from 6-12 years old with older age, female, increased height, parental myopia, and more time in homework or less time in outdoor activities per week may be more likely to have myopia, and longer AL or bigger AL/CR value was correlated with older age, male, greater body mass index (BMI), increased height, myopia conditions of parents, more time of doing homework, and less time in outdoor activities. Conclusions:The SER shifts to myopia with age in 6 to 12-year-old school-age children in the downtown of Zhenjiang.And there are significant differences in AL, CR and AL/CR value between boys and girls.Female, older age, increased height, more time in homework, less time in outdoor activities, and parental myopia are associated with more negative SER.