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.Continuous lumbar drainage improves prognosis in patients with acute hydrocephalus after aneurysmal subarachnoid hemorrhage
Tangmin WEN ; Jun SU ; Jiahe TAN ; Yuanjun XIN ; Xudong CHE ; Yidan LIANG ; Jiewen DENG ; Xiaolin YANG ; Zhaohui HE
Journal of Army Medical University 2024;46(4):384-390
Objective To analyze the influence of drainage volume on prognosis of acute hydrocephalus(AHC)after aneurysmal subarachnoid hemorrhage(aSAH)by continuous lumbar drainage.Methods A retrospective trial was conducted on 82 AHC patients after aSAH admitted to the First Affiliated Hospital of Chongqing Medical University between January 2017 and January 2022.In 6 months after discharge,modified Rankin Scale(mRS)score was used to evaluate the prognostic outcomes.Univariate and multivariate logistic regression analyses were performed on demographic factors,severity of subarachnoid hemorrhage(SAH)at admission,medical history,cerebral vasospasm,and lumbar drainage data.Then a nomogram prediction model was constructed.Results Univariate analysis found that World Federation of Neurosurgical Societies(WFNS)score,Hunt-Hess grade,modified Fisher grade,time for continuous lumbar drainage,shunt dependence,cerebral vasospasm,and drainage volume were factors affecting the prognosis of the patients.Then logistic regression analysis revealed that high WFNS score(OR:3.25,95%CI:1.11~9.48),high modified Fisher grade(OR:3.66,95%CI:1.08~12.35),shunt dependence(OR:15.56,95%CI:1.22~198.57),and cerebral vasospasm(OR:22.24,95%CI:3.08~160.68)were independent predictors for mRS score,while volume of continuous lumbar drainage(OR:0.57,95%CI:0.40~0.82)was an independent protective factor.ROC curve analysis indicated a good predictive performance of the model(AUC=0.898,95%CI:0.935~0.861).Internal validation through Bootstrap method demonstrated excellent discriminatory ability of the model(C-index=0.950,95%CI:0.904~0.996;adjusted C-index:0.934).Conclusion Increased volume of lumbar drainage is an independent protective factor for poor prognosis following aSAH and can improve the prognosis of SAH patients.
3.Research and clinical primary application on 3D modeling and printing of fetal hearts based on ultrasound spatio-temporal image correlation imaging technology
Na HOU ; Yitong GUO ; Zekai ZHANG ; Yuntao CHEN ; Zhuojun MAO ; Jiahe LIANG ; Jiangpu YI ; Tiesheng CAO ; Lijun YUAN
Chinese Journal of Ultrasonography 2022;31(4):295-303
Objective:To explore the feasibility and accuracy of three-dimensional (3D) modeling methods based on ultrasound imaging data for normal and abnormal fetal cardiac structures, and to construct a methodology system for 3D printing of fetal heart based on ultrasound.Methods:A total of 93 fetuses examined in Tangdu Hospital of Air Force Military Medical University from January to December 2019 were selected. Fetal echocardiography was obtained using spatio-temporal image correlation (STIC). Ninety-three hearts were 3D modeled by blood flow modeling, blood pool modeling and cavity modeling, and printed by stereolithography technique. The data measured on the 3D digital models and 3D printed solid models were compared with the corresponding fetal echocardiographic images respectively in order to evaluate the accuracy of the modeling methods.Results:The fetal cardiac blood flow models based on Doppler flow image data showed the malformation and trend of small blood vessels. The fetal cardiac structure models printed based on blood pool modeling displayed the malformation of heart and large blood vessels. Models printed based on cavity modeling method accurately displayed valve and structural defects.For 83 normal fetal hearts, the long diameters of left and right ventricles measured on echocardiography [(15.3±1.9)mm, (13.2±1.9)mm] were compared with those measured on digital models [(15.1±1.9)mm, (12.9±1.9)mm] and 3D printed models[(15.1±1.9)mm, (13.0±1.9)mm], respectively, and there were no significant differences between any two groups of them ( P>0.05). Bland-Altman showed good consistency for all measurements within and between operators. Conclusions:The three modeling methods, including blood flow modeling, blood pool modeling and cavity modeling, have their own advantages in displaying different types of fetal heart malformations. Appropriate modeling methods should be selected for 3D modeling and printing to make up for the limitations of single modeling method. The consistency between measurements on 3D models and those on echocardiography is high, and the repeatability between operators is good.
4.Clinical application of 3D printed titanium chest and rib implants in chest wall reconstruction
ZHANG Hao ; HUANG Lijun ; ZHU Yifang ; YANG Sanhu ; LIU Xi ; CAO Tiesheng ; LIANG Jiahe ; GUO Yitong ; WANG Lei ; LI Xiaofei
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2020;27(03):268-273
Objective In this study, three-dimensional printed (3DP) titanium implants were used for skeletal reconstructions after wide excision of chest wall. 3DP titanium implants were expected to provide a valid option with perfect anatomic fitting and personalized design in chest wall reconstruction. Methods There were 13 patients [mean age of 46 (24-78) years with 9 males and 4 females] who underwent adequate radical wide excision for tumors and chest wall reconstruction using 3DP titanium implants. Surgical data including patient demographic characteristics, perioperative clinical data and data from 1-year follow-up were collected and analyzed. Results Six patients of rib tumors, six patients of sternal tumors and one patient of sternal pyogenic osteomyelitis were finally selected for the study. The chest wall defect area was 221.0±206.0 cm2. All patients were able to maintain the integrity of the chest wall after surgery, and no abnormal breathing was found, achieving personalized and anatomical repair. Thirteen patients were successfully discharged from the hospital. Two patients developed pneumonia in the perioperative period. During the follow-up period in the first year after surgery, no implant related adverse reaction was observed, including implant rupture, implant shift, rejection reaction and allergies. One patient had wound ulcer after chemotherapy. Three patients had tumor recurrence, with the recurrence rate of 25.0%. Two patients died of tumor recurrence, with a mortality rate of 16.7%. Conclusion 3DP titanium implant is a safe and effective material for chest wall reconstruction.
5.Study of working memory in patients with no neurological syphilis disease
Dongmei FENG ; Songyou LIANG ; Junsheng CHEN ; Jiahe XU
Chinese Journal of Behavioral Medicine and Brain Science 2013;(5):420-422
Objective To investigate the differences of the working memory tasks' performance between the patients with no neurological syphilis disease and the health controls (HC).Methods 2-back test of N-back task paradigm were applied to measure the performances of working memory.A total of 30 patients with syphilis disease were compared with 35 gender-,age-,years of education-matched healthy persons,then compared the accurate rate and reaction time on the tasks between the two groups.Results Participants with anxiety or depression had to be excluded.The results showed that patients impaired on working memory task.The accurate rate and reaction time of the working memory of the patients was worse than that of the healthy persons ((65.31 ± 8.78) % vs (71.00 ±9.64)% ;(1521.14 ±290.57)ms vs (1296.08 ±253.20)ms respectively) (t=-2.472,P=0.016;t=3.337,P =0.001 respectively).The study indicated the reaction time of the working memory for the patients was negative correlation to the age of final diagnosis (r =-0.362,P =0.049).Conclusion The patients with no neurological syphilis disease show impairment on working memory.This probably because treponema pallidum injures the central nervous system.
6.Association of arteriosclerosis with mild cognitive impairment in type 2 diabetics
Gang CHEN ; Shali YANG ; Jiahe LIU ; Hong LI ; Jin YAO ; Feihuan FU ; Jixing LIANG ; Huibin HUANG ; Liantao LI ; Qiqin JIANG ; Lixiang LIN
Chinese Journal of Endocrinology and Metabolism 2010;26(11):971-972
Montreal cognitive assessment(MoCA, Beijing Version) was chosen as cognition assessment implement. 63 patients suffering from type 2 diabetes mellitus with mild cognitive impairment (MCI) were chosen to form a research group, and 27 patients with type 2 diabetes mellitus and normal cognitive function served as a control group. It was found that atherosclerosis played an important role in the pathogenesis of MCI in type 2diabetes, therefore, early prevention and management of atherosclerosis may help to improve the cognitive function.

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