1.Efficacy Analysis of RCT of Arsenic-containing TCM Compound in Treatment of Myelodysplastic Syndrome Based on MMRM and Win Ratio
Daxiang SUN ; Peizhen JIANG ; Haixia DI ; Bing WU ; Qifeng LIU ; Jian LIU ; Jiahe LIANG ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):251-259
ObjectiveThis paper aims to conduct a secondary analysis of a randomized controlled trial on the treatment of myelodysplastic syndrome (MDS) with deficiency of both the spleen and kidney and blockage of toxin and blood stasis with an arsenic-containing traditional Chinese medicine compound, by applying the mixed model for repeated measure (MMRM) and the method of stratified composite outcome with win ratio. The analysis includes the assessment of hematological efficacy and the composite outcome evaluation of adverse reactions, so as to more comprehensively assess the therapy of this regimen. MethodsThe MMRM and win ratio methods were used to evaluate the efficacy of a prospective,multi-center,double-blind,randomized controlled study. The blood routine (hemoglobin concentration,neutrophil count, and platelet count) and biochemical indexes (aspartate aminotransferase,alanine aminotransferase,serum creatinine,and serum ferritin) of the patients were detected at the time of enrollment and at the end of each course of treatment in the laboratory department of Xiyuan Hospital. The patients' syndromes at the time of enrollment and after treatment were recorded and scored according to the therapy standard of traditional Chinese medicine for diseases and syndromes. MMRM was used to analyze the blood routine indexes of the experimental group and the control group. This method has the advantages of high data reliability and dynamic efficacy under intervention and time. The win ratio method was used to evaluate the composite outcome of traditional Chinese medicine syndrome scores and biochemical indexes according to the priority and to verify the clinical safety of arsenic-containing traditional Chinese medicine compound. ResultsThe results of MMRM analysis showed that the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly compared with that before treatment in the group,while that in the placebo group decreased significantly (P<0.01). When compared with that after treatment in the placebo group,the hemoglobin concentration of patients in the group with arsenic-containing traditional Chinese medicine compound increased significantly,and the mean difference of least squares (LS) was statistically significant (P<0.01). When compared with those before treatment in the group,there were no statistically significant differences in the neutrophil count and platelet count in both groups. After treatment,there were no statistically significant differences in the neutrophil count, platelet count, and the mean difference of LS between the two groups. The analysis results of win ratio showed that the group with arsenic-containing traditional Chinese medicine compound had a significant advantage in the comparison of composite outcomes,with a win ratio (95% CI) of 2.01 (1.24-3.27) (P<0.01),and that the possibility of "winning" in terms of safety was 2.01 times that of the placebo group. The safety advantage of the group with arsenic-containing traditional Chinese medicine compound mainly came from the traditional Chinese medicine syndrome scores,renal function indexes, and iron reserve capacity indexes,and the number of winning times was less than that of losing times in the comparison of liver function outcomes. ConclusionThe MMRM analysis proves that the arsenic-containing traditional Chinese medicine compound can significantly improve the hemoglobin concentration of patients with myelodysplastic syndrome with refractory cytopenia and multilineage dysplasia (MDS-RCMD) of the type of deficiency of both the spleen and kidney and blockage of toxin and blood stasis. This conclusion is not interfered with by time trends and individual relationships and methodologically improves the credibility of the therapy of the arsenic-containing traditional Chinese medicine compound in treating MDS. Four outcomes are evaluated by the win ratio method,namely traditional Chinese medicine syndromes,liver function,renal function, and iron reserve capacity,proving that the arsenic-containing traditional Chinese medicine compound has the comprehensive advantages of improving the survival quality of the patients and reducing adverse reactions. The win ratio outcome provides clear comparative indexes for the evaluation of adverse reactions,making it easier for regulatory authorities,medical staff, and patients to understand the safety of the arsenic-containing traditional Chinese medicine compound in clinical application.
2.Clinical application of KASP-based RHCE genotyping in RhD-positive patients
Xiaoyu LIAN ; Mengdan LI ; Xiaoyu GUAN ; Li TIAN ; Chenying WANG ; Di WU ; Tianqiong LUO ; Xiaolin DU ; Xin JI ; Haixia XU ; Jue WANG ; Ling LI ; Zhong LIU
Chinese Journal of Blood Transfusion 2026;39(5):596-602
Objective: To develop a RHCE genotyping assay based on kompetitive allele-specific PCR (KASP) and assess its clinical accuracy for RhCE blood group determination. Methods: KASP primers were designed to interrogate three RHCE loci: the 109 bp insertion/deletion in intron 2, c. 307T>C, and c. 676C>G. A total of 1 194 RhD-positive inpatients from Chengdu were typed by both KASP genotyping and manual tube serology. Discordant samples (n=10) were retested by both methods and further resolved by Sanger sequencing. An additional 377 cases were tested for the c. 48C>G locus to evaluate the predictive accuracy of individual loci and combined locus testing for RhC antigen. Results: Genotyping concordance with serology was 100.0% for both the c. 676C>G locus (RhE/Rhe) and the c. 307T>C locus (Rhc). For RhC prediction using the 109 bp insertion, overall accuracy was 99.7% (1 191/1 194); the 3 discordant cases were confirmed by Sanger sequencing to be false negatives attributable to 109 bp deletion in intron 2. Testing the c. 48C>G allele for RhC prediction yielded 7 false positives, with an accuracy of 98.1% (370/377). RhC antigen status was determined by combining the 109 bp insertion and the c. 48C allele. After excluding 10 samples with inconsistent results between the two loci, the accuracy reached 100% in the remaining 367 samples. When both loci were applied in combination, accuracy reached 100% in the 367 cases with concordant results. Among the 1 194 patients, CCee (45.8%) and CcEe (31.7%) were the most common RhCE phenotypes. The e antigen had the highest positivity rate (92.2%), and the Ce haplotype was the most frequent (66.9%). Conclusion: The KASP-based RHCE genotyping method achieves high accuracy for clinical RhCE typing. Combining the 109 bp insertion/deletion with the c. 48C allele significantly improves RhC antigen prediction compared with either locus alone. This method was applied to RhCE genotyping of 1 194 RhD-positive inpatients in Chengdu, providing local RhCE phenotype and haplotype distribution data to support RhCE-matched transfusion practice.
3.Constructing Index System for Rational Drug Use Management of Key Monitoring Drugs Based on Delphi Method and Analytic Hierarchy Process
Li LING ; Cheng SI ; Haixia ZHANG ; Qiaoling ZHU ; Weihong GE ; Xiaoyan WU
Herald of Medicine 2025;44(3):503-508
Objective To construct an evaluation index system for rational drug use management of key monitoring drugs,and to provide references for medical institutions.Methods The preliminary index framework was formed by researching the policies and regulations,management norms,and guiding principles related to key monitoring drugs.Two rounds of Delphi questionnaire survey were conducted with 26 experts to improve and optimize the index system.The weights of the indicators were obtained by constructing the judgment matrix by analytic hierarchy process(AHP).Results The recovery rates of the two rounds of questionnaire were both 100%,and the authority coefficient was 0.87.The key monitoring drug rational use management evaluation index system was finally constructed to include three primary indicators[ex-ante management(0.253 6),in-process management(0.503 1),and ex-post management(0.243 2)],15 secondary indicators[including prescription review(0.302 6),formulate rational drug use norms(0.133 1),supernormal early warning management(0.103 2)],and 62 tertiary indicators[inclu-ding formulate strict prescription review rules(0.152 5),pharmacists prescription intervention strength(0.085 7)and effective-ness management(0.052 5)].and the index judgment matrix passed the consistency test.Conclusion The evaluation index system for the rational drug use management of key monitoring drugs constructed can satisfy the closed loop of the supervision and management process,achieve the prior reminder,monitoring,and post-supervision,and provide references for medical institutions to ensure the refinement and standardization of the management process.
4.Analysis of the Chemical Compositions of Olibanum of Different Origins Based on UPLC-Q/TOF-MS Combined with Multi-variate Statistics Methods
Qin HE ; Ganming YAN ; Haixia YIN ; Na ZHU ; Yi WU ; Guocai LI
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(5):668-677
OBJECTIVE To analyze the differential chemical composition of Olibanum of different origins and to provide some references for the identification of Olibanum origin and the quality standards.METHODS The chemical compositions of Olibanum were analyzed by UPLC-Q/TOF-MS.Multivariate statistical methods were used to analyze Olibanum and processed products to screen the differential compounds in Olibanum of different origins.RESULTS Using positive and negative ion scanning modes,a total of 108 compounds were identified in Olibanum.The compounds were mainly terpenes,among which triterpenes were the highest.And through multivariate statistical analysis,it was found that there were significant differences in the chemical compositions of Olibanum of different regions,with a total of 34 differential compounds;furthermore,specific compounds unique to Olibanum from other sources were identified.CONCLUSION Different regions of Olibanum could be distinguished based on their differential chemical composi-tions.This study could serve as a basis for identifying different origins of Olibanum,and also provide experimental data for subsequent research on the pharmacological substance basis of Olibanum.
5.Single-port transoral robotic surgery for laryngeal and pharyngeal benign lesions
Yilin SHEN ; Bin YE ; Jichang WU ; Haixia HU ; Cui FAN ; Zhihong SHI ; Jidong QIN ; Mingliang XIANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):345-349
Objective:To share our experience of single-port transoral Da Vinci robotic surgery for laryngeal and pharyngeal benign tumors.Methods:Three patients aged over 18 years and diagnosed respectively with epiglottic cyst, aryepiglottic fold cyst and thyroglossal duct cyst at tongue base were included who received operations in Hainan Hospital of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital of Hainan) between August 1, 2023 and April 10, 2024. There were 1 male and 2 females, with an average age of 59 years old. The clinical diagnosis of these 3 patients was respectively epiglottic cyst, aryepiglottic fold cyst and thyroglossal duct cyst at tongue base. Intraoperative conversion rate, blood loss, operation time, hospital stay, pain score and swallowing function score were analyzed.Results:All three patients successfully underwent the operations with the single-port Da Vinci robotic system. The clean-contaminated resection rate of the tumors was 100%. The conversion rate was nil. The blood loss was 0-7 ml. The operation time was 5-30 minutes. There were no adverse events such as loosening of teeth and soft tissue abrasions of pharyngeal side wall. The rate of oral feeding within 24 hours after surgery was 100%. No postoperative coughing, bleeding, or dyspnea occurred. The average length of hospital stay was 3.7 days. The VAS score decreased 3 days after surgery compared to 1 day after surgery. The swallowing function recovered 1 month after surgery.Conclusion:The single-port transoral robotic surgery for laryngeal and pharyngeal benign lesions is safe and efficient, with fewer complications.
6.Population Characteristics of Arsenic-containing TCM Compounds in the Treatment of Platelets in Myelodysplastic Syndrome
Jian LIU ; Wenru WANG ; Peizhen JIANG ; Kaizhi LU ; Qinlong ZHENG ; Haixia DI ; Lijuan YAO ; Bing WU ; Jiangwei WAN ; Qifeng LIU ; Ruibai LI ; Xudong TANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(9):154-160
Objective To compare the differences of baseline characteristics of patients with myelodysplastic syndrome(MDS)who achieved platelet(PLT)response after arsenic-containing TCM compounds combined with Western medicine treatment.Methods Totally 72 MDS patients were selected from 12 outpatient departments and wards,such as Xiyuan Hospital,China Academy of Chinese Medical Sciences,Dongfang Hospital,Beijing University of Chinese Medicine from October 2021 to October 2024.Among them,45 patients received arsenic-containing TCM compounds combined with Western medicine treatment,27 patients received Western medicine treatment.The blood routine[white blood cell(WBC)count,hemoglobin,PLT,neutrophil count],TCM syndrome scores,safety indicators,and adverse events were observed before and after three courses of treatment.The efficacy of all patients was evaluated,and the baseline characteristics of patients who achieved PLT response in the arsenic-containing TCM compounds group and the Western medicine treatment group were compared.Results Comparing the differences of baseline characteristics of the two groups,it was found that the patients who achieved PLT response in the arsenic-containing TCM compounds group were compared with those in the Western medicine treatment group:Age<60 years old(P=0.038),longer disease duration(P=0.012),lower WBC(P=0.017),lower reticulocyte percentage(P=0.037),lower blood urea nitrogen(P=0.046),lower high-density lipoprotein cholesterol(P=0.014),and lower N-terminal pro-B-type natriuretic peptide(P=0.034),abnormal electrocardiogram(P=0.013),high blasts(P=0.009),grade 0 reticular fiber staining(P<0.01),normal chromosome karyotype(P<0.01),gene mutation(P<0.01)and high TCM syndrome scores(P=0.013)were found.Conclusion Arsenic-containing TCM compounds consisting of Qinghuang Powder and Bushen Jianpi Decoction combined with Western medicine is used to treat MDS.Patients with age<60 years old,long disease duration,low WBC count,low reticulocyte percentage,low blood urea nitrogen,low high-density lipoprotein cholesterol,low N-terminal pro-B-type natriuretic peptide,abnormal electrocardiogram,high blasts,grade 0 reticular fiber staining,normal chromosome karyotype,gene mutation and high TCM syndrome score are more likely to obtain PLT response.
7.Efficacy of venetoclax combined with hypomethylating agents in the treatment of patients newly diagnosed with core binding factor acute myeloid leukemia
Siyi HAN ; Xiaoyan XU ; Meng ZHOU ; Haixia ZHOU ; Depei WU ; Yue HAN
Chinese Journal of Hematology 2025;46(8):738-742
Objective:To investigate the efficacy of venetoclax combined with hypomethylating agents (Ven-HMA), in patients with core binding factor acute myeloid leukemia (CBF-AML) intolerant to intensive induction therapy.Methods:This study retrospectively analyzed patients newly diagnosed with CBF-AML who were aged <60 years and who received Ven-HMA as induction therapy at the Department of Hematology, the First Affiliated Hospital of Soochow University, between January 2020 and June 2023. Baseline characteristics and treatment responses of the patients were collected.Results:A total of 70 treatment-na?ve patients receiving Ven-HMA induction therapy were enrolled, of which 38 were men and 32 women [median age: 43 (34 - 55) years]. Of the 70 patients, 44 (62.9%) achieved complete remission (CR) /CR with incomplete hematologic recovery (CRi), 16 (22.9%) achieved partial remission, and 10 (14.2%) exhibited no response after one induction cycle. Among the 32 t (8;21) -positive patients with AML, only 8 (25.0%) achieved CR/CRi, of whom 3 (37.5%) remained measurable residual disease (MRD) -positive; among the 38 inv (16) -positive patients, 36 (94.7%) achieved CR/Cri, of whom 12 (33.3%) remained MRD-positive. Patients harboring the CBFβ::MYH11 fusion gene showed significantly higher response rates to Ven-HMA induction than those with the RUNX1:: RUNX1T1 fusion gene ( P<0.01) . Conclusion:Ven-HMA represents a novel therapeutic strategy that exhibits significant efficacy in inv (16) -positive patients; however, it demonstrates relatively lower remission rates in t (8; 21) -positive patients.
8.Predictive value of the proportion of peripheral blood CD3+T cell subsets and the expression profile of inflammatory cytokines for the recurrence risk of patients with malignant pleural and peritoneal effusion after deep hyperthermia
Xingjun WU ; Yun BAO ; Qiuyan XU ; Haixia WANG ; Lu WANG
International Journal of Laboratory Medicine 2025;46(21):2607-2612,2620
Objective To construct and verify a recurrence risk prediction model for patients with malig-nant pleural and peritoneal effusion after deep hyperthermia based on the proportion of peripheral blood CD3+T cell subsets and the expression profile of inflammatory cytokines.Methods A retrospective analysis was conducted on the clinical characteristics,diagnosis and treatment processes of 188 patients with malignant pleural and peritoneal effusion who visited this hospital from September 2023 to May 2024.All patients re-ceived chemotherapy combined with deep hyperthermia and were divided into the non-recurrence group(n=130)and the recurrence group(n=58)based on whether malignant pleural and peritoneal effusion recurred within 3 months after the end of treatment.The differences in general clinical data,conventional tumor mark-ers at the end of treatment,the proportion of CD3+T cell subsets,and the expression profile levels of inflam-matory cytokines between the two groups of patients were compared.The risk factors for recurrence in pa-tients with malignant pleural and peritoneal effusion were screened through univariate and multivariate Logis-tic regression analyses,and a risk prediction model was established.The receiver operating characteristic(ROC)curve was applied to evaluate the effectiveness of this prediction model for the recurrence risk of pa-tients with malignant pleural and peritoneal effusion after chemotherapy combined with deep hyperthermia.Results The age of patients in the recurrence group,the proportion of stage Ⅳ patients,the levels of serum CEA,CA125,TGF-β,and the proportion of CD8+T cells were significantly higher than those in the non-recur-rence group(P<0.05),while the proportion of CD4+T cells,CD4+/CD8+,and the level of serum IL-10 were significantly lower than those in the non-recurrence group(P<0.05).The results of univariate and multivari-ate Logistic regression analysis indicated that CD4+T,CD8+T,CD4+/CD8+,IL-10,and TGF-β were all im-portant influencing factors for recurrence after chemotherapy combined with deep hyperthermia in patients with malignant pleural and peritoneal effusion(P<0.05).The AUC(95%CI)of the predictive model con-structed based on the above influencing factors by ROC curve analysis was 0.708(0.614-0.802),suggesting a high clinical predictive efficacy.Conclusion The predictive model constructed based on T-cell subset counts and serum inflammatory cytokines can effectively predict the recurrence risk of patients with malignant pleu-ral and peritoneal effusion after chemotherapy combined with deep hyperthermia.It has certain clinical value for the therapeutic effect evaluation of patients with malignant pleural and peritoneal effusion and for guiding the optimization of deep hyperthermia regimens.
9.Expert consensus on the prevention and treatment of enamel demineralization in orthodontic treatment.
Lunguo XIA ; Chenchen ZHOU ; Peng MEI ; Zuolin JIN ; Hong HE ; Lin WANG ; Yuxing BAI ; Lili CHEN ; Weiran LI ; Jun WANG ; Min HU ; Jinlin SONG ; Yang CAO ; Yuehua LIU ; Benxiang HOU ; Xi WEI ; Lina NIU ; Haixia LU ; Wensheng MA ; Peijun WANG ; Guirong ZHANG ; Jie GUO ; Zhihua LI ; Haiyan LU ; Liling REN ; Linyu XU ; Xiuping WU ; Yanqin LU ; Jiangtian HU ; Lin YUE ; Xu ZHANG ; Bing FANG
International Journal of Oral Science 2025;17(1):13-13
Enamel demineralization, the formation of white spot lesions, is a common issue in clinical orthodontic treatment. The appearance of white spot lesions not only affects the texture and health of dental hard tissues but also impacts the health and aesthetics of teeth after orthodontic treatment. The prevention, diagnosis, and treatment of white spot lesions that occur throughout the orthodontic treatment process involve multiple dental specialties. This expert consensus will focus on providing guiding opinions on the management and prevention of white spot lesions during orthodontic treatment, advocating for proactive prevention, early detection, timely treatment, scientific follow-up, and multidisciplinary management of white spot lesions throughout the orthodontic process, thereby maintaining the dental health of patients during orthodontic treatment.
Humans
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Consensus
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Dental Caries/etiology*
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Dental Enamel/pathology*
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Tooth Demineralization/etiology*
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Tooth Remineralization
10.Ultrasensitive wash-free quantification of breast cancer-derived small extracellular vesicles via a self-locked DNAzyme nanoprobe
Xiaohui CHEN ; Haixia LIU ; Ningyu MA ; Qianqian WU ; Hengyi CHEN ; Yi CHEN ; Wei TU ; Jinghan CAO ; Yang LUO
Chinese Journal of Laboratory Medicine 2025;48(3):396-401
Objective:To develop a self-locked DNAzyme nanoprobe-based fluorescence amplification strategy for wash-free and ultrasensitive detection of breast cancer-derived small extracellular vesicles (sEV).Method:A DNAzyme self-locked probe was designed to recognize the epithelial cell adhesion molecule (EpCAM) specifically expressed on breast cancer-derived sEVs. Upon binding to EpCAM, the DNAzyme-lock structure was opened, restoring the DNAzyme cleavage activity. The activated DNAzyme then cyclically cleaved the RNA site on the substrate strand. Fluorescently labeled substrate strands were used to detect sEVs at varying concentrations, and the detection limit and linear range were determined.Results:The DNAzyme self-locked probe successfully identified breast cancer-derived sEVs and generated a fluorescent signal through cyclic cleavage. The proposed method achieved wash-free detection of sEVs, with the fluorescence intensity showing a strong linear correlation with sEV concentration ( R2=0.98). The linear detection range was 1.0×10 2-1.0×1.0 7 particles/μl, with a detection limit of 59 particles/μl. Conclusion:This study established a wash-free and highly sensitive strategy for quantifying breast cancer-derived sEVs, which provides a promising technical approach for the early diagnosis of cancer.

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