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.Quality assessment of blood components prepared by an automatic whole blood processing system
Liu HE ; Xin JI ; Yuwei HU ; Ling FANG ; Haixia XU
Chinese Journal of Blood Transfusion 2026;39(3):384-390
Objective: To compare the Reveos automated blood processing system with the current method, and to evaluate the feasibility and validity of using the Reveos system for blood component preparation. Methods: Forty units of 400 mL whole blood samples were divided into two groups: 2C group (for two-component preparation) and 3C group (for three-component preparation). Each group was further divided into a Reveos subgroup and a control subgroup. Blood components were prepared using the Reveos system and the current centrifugation method respectively. The 2C group yielded suspended red blood cells and plasma, while the 3C group yielded suspended red blood cells, plasma, and platelets. Key quality indicators for red blood cells, plasma, and platelets were measured before and after separation. Inter-group differences were analyzed using SPSS 25.0. Results: The trend of changes in the main performance indicators of red blood cells, plasma, and platelets before and after separation was generally consistent between the Reveos group and the control group, with no significant differences for most performance indicators. The Reveos system outperformed the current method in several aspects: in the 3C group, the hematocrit (Hct) was significantly higher in the Reveos group than in the control group [(62.82%±1.64%) vs (53.62%±3.04)%, P<0.001]; the white blood cell count in red blood cell suspensions was significantly lower than that in the control group [(3.37±1.42)×10
/L vs (8.42±2.30)×10
/L, P<0.001]; plasma yield was 27.5% higher than that in the control group [(183.90±17.37) mL vs (144.28±20.53) mL, P<0.001]; and the platelet activation rate was significantly lower than that in the control group [(21.97±14.25)% vs (34.73±11.92)%, P=0.044]. Conclusion: The Reveos system demonstrates good consistency with the current method in preparing blood components, and outperforms the current method in terms of leukocyte reduction and red blood cell concentration.
3.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
;
Consensus
;
Dental Caries/etiology*
;
Dental Enamel/pathology*
;
Tooth Demineralization/etiology*
;
Tooth Remineralization
4.Pharmacognostic Investigation of Pulsatillae Radix along with Advances in Research on Its Chemical Constituents and Pharmacological Effects
Shuhui HUANG ; Haixia ZENG ; Liping CHENG ; Xiang ZHANG ; Xongning LIU ; Linping HUANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1592-1606
This paper presents a comprehensive study of Pulsatillae Radix,encompassing its pharmacognostic investigation,chemical constituents,and pharmacological effects.Pulsatillae Radix,first recorded in the Shen Nong's Herbal Classic,is known for its efficacy in cooling blood to stop dysentery,clearing heat,and detoxifying,and has been used to treat diseases such as enteritis caused by parasites,demonstrating potential as an antiviral candidate.Research has revealed that its major chemical constituents include triterpenoid saponins,triterpenic acids,and various other components,which collectively constitute the pharmacological foundation of Pulsatillae Radix.Significant pharmacological activities have been observed in antitumor,anti-inflammatory,antimicrobial,and antiviral aspects,providing a scientific basis for its broad application in the pharmaceutical field.
5.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.
6.Research progress and prospects of virus-like particles in tumor therapy
Chun LIU ; Guoxin CHEN ; Mengtian LI ; Yu ZHAO ; Zhongren MA ; Haixia ZHANG
China Oncology 2025;35(6):585-591
Virus-like particles(VLPs)are hollow nanoparticles composed of one or several virus structural proteins,which have a morphological structure similar to natural viruses but do not contain any genetic material.Due to the excellent innate immunogenicity and safety of VLPs,they are often used in the development of tumor vaccines.In addition,compared with traditional drug delivery vectors,VLPs have better biocompatibility and strong targeting ability,making them highly valued in the delivery of anti-tumor drugs.In recent years,the efficient delivery of gene editing tools using VLPs has provided new possibilities for tumor treatment.VLPs can inhibit tumor growth and spread through various mechanisms,such as activating immune responses to suppress tumor growth,stimulating the body's immune system,promoting the expression of tumor associated antigens,and enhancing the body's ability to recognize and clear tumor cells.These studies not only broaden the application scope of VLPs in the field of anti-tumor therapy,but also provide a broader prospect for future research and application.This article reviewed the research progress of VLPs derived from different viruses in preventive or therapeutic vaccines and drug delivery carriers,and explored new development strategies.
7.The value of spectral CT in guiding percutaneous transthoracic needle biopsy
Jinhui YAO ; Jie SUN ; Jin DU ; Xuetao ZHANG ; Xin LI ; Haixia LIU ; Chong LEI
Journal of Practical Radiology 2025;41(5):845-848
Objective To explore the applicative value of spectral CT in increasing positive rates of lung cancer puncture and reducing complications during CT guided percutaneous transthoracic needle biopsy(PTNB).Methods The pathological results and complica-tion incidences of 260 PTNB patients were analyzed retrospectively.All patients were divided into three groups:group A(conventional CT group,103 cases)used a scheme based on conventional enhanced CT;group B(PET/CT group,84 cases)used a scheme combining the maximum standardized uptake value(SUVmax)with conventional enhanced CT;group C(spectral CT group,73 cases)used a scheme of quantitative spectral CT parameters and images.Results Group A included 103 cases in total,of which 87 were positive(84.47%),41 pneumothorax(39.81%),and 31 hemorrhage(30.10%).Group B totaled 84 cases,including 82 positive cases(97.62%),19 cases of pneumothorax(22.62%),and 11 cases of hemorrhage(13.10%).Group C was of 73 cases,including 70 positive cases(95.89%),16 cases of pneumothorax(21.92%),and 10 cases of hemorrhage(13.70%).There were statistically significant differ-ences in biopsy positive rates,pneumothorax incidences,and hemorrhage incidences among groups A,B,and C(P<0.05).There were also statistically significant differences in biopsy positive rates,pneumothorax incidences,and hemorrhage incidences between groups A and B or groups A and C(P<0.016 7),respectively.However,no statistically significant differences were found between groups B and C in biopsy positive rates,pneumothorax incidences,and hemorrhage incidences(P>0.016 7).Conclusion Spectral CT can improve the positive rate of lung cancer and reduce the risk of pneumothorax and hemorrhage with PTNB.
8.Study on different test methods to evaluate the drying effect of flexible endoscope
Xianhuang LI ; Ziyi HUANG ; Liuji CHEN ; Jing ZHEN ; Haixia LIU ; Yanxia ZHANG ; Xun ZHANG ; Xi HUANG ; Jiuhong MA
China Journal of Endoscopy 2025;31(11):34-39
Objective To compare the effectiveness of cobalt chloride test papers and borescope in evaluating the drying of endoscopes,providing a reference for clinical selection of appropriate assessment tools.Methods 10 gastroscopes and 10 colonoscopes procedures were selected from November 2023 to March 2024 for circulation experiments.After endoscope reprocessing,they were randomly divided into five groups with different drying times(30 s,3 min,6 min,9 min,and 12 min)with 200 samples.Cobalt chloride test paper and borescope were used to evaluate the drying effectiveness.Results The qualified rate of gastrointestinal endoscope by borescope was significantly higher than that by cobalt chloride test paper,but cobalt chloride test paper was obviously better than that by borescope in convenience and cost-effectiveness.The borescope had the function of visualization,and the quantitative positioning observation of residual droplets showed that there were a large number of droplets left after gastrointestinal endoscope drying for 30 s,and the number of droplets was obviously reduced after drying for 3 min.Among them,the gastroscope was mainly light(1~5 drops/strip)and none(0 drops/strip),and the colonoscope was mainly moderate(6~10 drops/strip)and light droplets.Compared with different drying times,there was a significant statistical difference in the number of residual droplets in the endoscope(P<0.01),and the localized droplets mainly remained in the distal bending part and the proximal bifurcation part of the lumen.Conclusion Both cobalt chloride test papers and borescope are important methods for assessing endoscope drying efficacy,each with its own advantages and limitations.Clinicians can use both methods in combination to comprehensively evaluate the overall dryness of endoscopes,thereby ensuring the safety and effectiveness of the endoscope reprocessing process.
9.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.
10.Allogeneic hematopoietic stem cell transplantation for the treatment of BCR::ABL-negative neutrophilic myeloid neoplasms: a clinical analysis of 12 cases
Tingting HAN ; Yun HE ; Jing LIU ; Yao CHEN ; Fengrong WANG ; Jingzhi WANG ; Yuhong CHEN ; Haixia FU ; Lanping XU ; Xiaohui ZHANG ; Xiaojun HUANG ; Yu WANG
Chinese Journal of Hematology 2025;46(9):827-832
Objective:To investigate the efficacy and safety of allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the treatment of BCR::ABL-negative chronic neutrophilic leukemia (CNL) and MDS/MPN with neutrophilia.Methods:This study retrospectively analyzed 12 cases of CNL and MDS/MPN with neutrophilia that underwent allo-HSCT from March 2017 to June 2024, comprising 7 males and 5 females with a median age of 48 ( IQR: 28, 59) years. The 2-year overall survival (OS), disease-free survival (DFS), cumulative incidence of relapse (CIR), and transplantation-related mortality (TRM) rates were analyzed. Complications were also assessed. Results:Of the 12 patients, 6 received matched sibling HSCT and 6 received haploidentical HSCT. All patients had successful engraftment, and the median times of neutrophil and platelet engraftment were 17 ( IQR: 11, 24) days and 15 ( IQR: 9, 28) days, respectively. Grade Ⅱ–Ⅳ acute graft versus host disease (GVHD) and chronic GVHD occurred in 2 and 4 cases, respectively. The 2-year OS, DFS, CIR, and TRM rates were (65.6 ± 16.4) %, (41.7 ± 16.6) %, (47.2 ±18.2) %, and (11.1 ± 11.4) %, respectively, after a median follow-up time of 637 ( IQR: 330, 943) days. One patient died from treatment-related complications due to respiratory failure caused by coronavirus disease 2019. Two patients died due to relapse. Conclusion:Allo-HSCT can be applied as a safe and effective approach to treat CNL and MDS/MPN with neutrophilia.

Result Analysis
Print
Save
E-mail