1.Influence of Gene Mutation on the Effectiveness of Arsenic-Containing Herbal Compound Formula in Treatment of Myelodysplastic Syndromes of Different TCM Patterns
Zichun WANG ; Zhuo CHEN ; Dexiu WANG ; Haiyan XIAO ; Weiyi LIU ; Ruibai LI ; Chi LIU ; Fengmei WANG ; Shanshan ZHANG ; Mingjing WANG ; Liu LI ; Xiaoqing GUO ; Hongzhi WANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2025;66(14):1463-1472
ObjectiveTo observe the effect of gene mutation on the effectiveness of arsenic-containing Chinese herbal compound formulas in the treatment of myelodysplastic syndromes (MDS) of different traditional Chinese medicine (TCM) patterns, so as to provide the basis for the clinical application. MethodsClinical data of 442 MDS patients who were treated with arsenic-containing herbal compound formulas were retrospectively collected, including the baseline demographic and clinical characteristics of the patients. Based on the TCM four examinations, the patients were divided into the spleen-kidney deficiency group as well as the qi-yin deficiency group, and according to the results of the next-generation sequencing (NGS) test, they were divided into the group with and without gene mutation respectively. The influence of gene mutation on the clinical effectiveness of patients with different TCM patterns was analyzed, the baseline demographic and clinical characteristics of the patients with different outcomes of the two TCM patterns were compared, and multivariate Logistic regression analysis was conducted on the influencing factors of the effective rate of MDS patients with gene mutation. ResultsA total of 190 cases were included in the spleen-kidney deficiency group (119 cases with gene mutation) and 43 cases in the qi-yin deficiency group (23 cases with gene mutation). No statistically significant differences were noted in effectiveness assessment, total effective rate, and total response rate between the spleen-kidney deficiency group and the qi-yin deficiency group (P>0.05). In the spleen-kidney deficiency group, the total effective rate of MDS with gene mutation was 65.55% (78/119), which was lower than 80.28% (57/71) of MDS without gene mutation, with statistical significance (P = 0.033), while no statistical differences in effectiveness assessment and total response rate were noted (P>0.05). In the qi-yin deficiency group, no statistical differences were observed in effectiveness assessment, total effective rate, and total response rate of the patients in with or without gene mutation (P>0.05). In the spleen-kidney deficiency group with gene mutation, the rate of complex karyotype (P = 0.031) and the mutation rate of CBL gene (P = 0.032) in the ineffective population were higher than those in the effective population, while the mutation rate of DDX41 gene in the effective population was higher than that in the ineffective population (P = 0.033). No statistically significant differences were found in other gene mutations, age, gender distribution, number of gene mutations, bone marrow hyperplasia degree, blast cell range, reticular fiber tissue proliferation or not, and prognosis of chromosomal abnormalities between the effective and ineffective populations (P>0.05). In the qi-yin deficiency group with gene mutation, no statistically significant differences were found in various items between populations with different outcomes (P>0.05). Multivariate Logistic regression analysis showed that complex karyotype, CBL mutation, and DDX41 mutation were independently associated with the effective rate of MDS with spleen-kidney deficiency and gene mutation (P<0.05). DDX41 mutation was an independent protective factor in the spleen-kidney deficiency group (OR>1), while complex karyotype and CBL mutation were independent risk factors (OR<1). ConclusionThe arsenic-containing TCM compound formulas exhibited better effectiveness in MDS with spleen-kidney deficiency pattern without mutation; and in MDS with spleen-kidney deficiency pattern without complex karyotypes, CBL mutation, and with DDX41 mutations. Furthermore, DDX41 mutation was an independent protective factor in the spleen-kidney deficiency group, while complex karyotype and CBL mutation were independent risk factors. In MDS with qi-yin deficiency pattern, gene mutation-related factors showed no significant impact on the effectiveness of arsenic-containing TCM compound formulas.
2.Herbal Textual Research on Olibanum in Famous Classical Formulas
Haiyan ZHOU ; Qingqing WANG ; Qi ZHANG ; Suping XIAO ; Meng CHEN ; Jianxin ZHOU ; Yeda ZHANG ; Danyang JIA ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(4):55-66
By consulting the ancient and moderm literature, this paper makes a textual research on the name, origin, quality evaluation, harvesting and processing of Olibanum, so as to provide a basis for the development of the famous classical formulas containing this medicinal material. According to the herbal textual research, the results showed that Olibanum was first described as a medicinal material by the name of Xunluxiang in Mingyi Bielu(《名医别录》), until Ruxiang had been used as the correct name since Bencao Shiyi(《本草拾遗》) in Tang dynasty. The main origin was Boswellia carterii from Burseraceae family. The mainly producing areas in ancient description were ancient India and Arabia, while the modern producing areas are Somalia, Ethiopia and the southern Arabian Peninsula. The medicinal part of Olibanum in ancient and modern times is the resin exuded from the bark, which has been mainly harvested in spring and summer. It is concluded that the better Olibanum has light yellow, granular, translucent, no impurities such as sand and bark, sticky powder and aromatic smell. There were many processing methods in ancient times, including cleansing(water flying, removing impurities), grinding(wine grinding, rush grinding), frying(stir-frying, rush frying, wine frying), degreasing, vinegar processing, decoction. In modern times, the main processing methods are simplified to cleansing, stir-frying and vinegar processing. Nowadays, the commonly used specifications include raw, fried and vinegar-processed products. Among the three specifications, raw products is the Olibanum after cleansing, fried products is a kind of Olibanum processed by frying method, vinegar-processed products is the processed products of pure frankincense mixed with vinegar. Based on the research results, it is recommended to select the resin exuded from the bark of B. carterii for the famous classical formulas such as Juanbitang containing Olibanum, processing method should be carried out in accordance with the processing requirements of the formulas, otherwise used the raw products if the formulas without clear processing requirements.
3.The value of the ratio of heparin binding protein to albumin in evaluating the state of shock syndrome in Kawasaki disease
Xiayan KANG ; Xinping ZHANG ; Jianghua FAN ; Haiyan LUO ; Yuanhong YUAN ; Zhenghui XIAO
Chinese Journal of Emergency Medicine 2024;33(3):365-370
Objective:To investigate the value of the ratio of heparin binding protein (HBP) to albumin (ALB) in diagnosis and predict the severity of Kawasaki disease shock syndrome (KDSS).Methods:This study was a retrospective study. Pediatric patients with Kawasaki disease (KD) admitted to the Children's Intensive Care Unit and department of Pediatric Emergency Center of Hunan Children's Hospital from January 2019 to May 2022 were enrolled. The HBP/ALB ratio was calculated according to HBP and serum ALB. The children were divided into three groups (low, medium, and high ratio groups) according to the median and upper and lower quartiles of the HBP/ALB ratio. The differences of each index among the three groups were compared. The receiver operating characteristic curves were drawn to evaluate the clinical value of the HBP/ALB ratio in diagnosis of KDSS and the severity of the disease.Results:A total of 111 cases were included in this study, including 28 cases in the low ratio group, 56 cases in the medium ratio group, and 27 cases in the high ratio group. There were 24 cases with coronary artery damage, 87 cases without coronary artery damage, 27 cases with abnormal ECG findings, and 17 children with KDSS (including 5 cases in the medium ratio group, and 12 cases in the high ratio group). The incidence of KDSS, coronary involvement, and abnormal electrocardiogram proportions in the high ratio group were significantly higher than those in the other two groups. Compared with low and medium ratio groups, the levels of cardiac troponin I, N-terminal pro-brain natriuretic peptide, lactate, stroke output variation, trends in thoracic fluid content, white blood cell count, C-reactive protein, procalcitonin, and D-dimer levels were higher in the high ratio group, while ALB and blood sodium levels were lower in the high ratio group (all P<0.05). There was no significant difference in above indicators between the low and medium ratio groups (all P>0.05). The HBP/ALB ratio had a higher area under the curve, sensitivity, and specificity (0.942, 0.882, and 0.883, respectively) in predicting KDSS compared to HBP alone (0.776, 0.842, and 0.670, respectively). Conclusion:The HBP/ALB ratio could reflect the severity of children with KD and has certain clinical value for prognostic evaluation.
4.Application of electromagnetic-guided placement of nasoenteral feeding tubes among aged bedridden patients
Xiao MA ; Haiyan SHI ; Xiang WANG ; Jun WANG ; Zhongyan HAN ; Huaguo ZHANG
Chinese Journal of Nursing 2024;59(1):70-76
Objective To investigate the application effect of electromagnetic navigation bedside nasoenteral intubation technology in elderly bedridden patients.Methods A total of 92 elderly patients with tube feeding in bed in a tertiary A hospital in Beijing from June 2021 to December 2022 were selected by convenience sampling method,and they were divided into an experimental group and a control group with 46 patients in each group by random number table method.The experimental group adopted the electromagnetic navigation bedside nasoenteral catheterization technique and the control group adopted the blind catheterization method.The total success rate of catheterization,the success rate of the first catheterization,the time taken for catheterization,the proportion of catheter tip reaching jejunum,and the incidence of catheter-related complications were compared between the 2 groups.Results There were no shedding cases in both groups.The success rate of total catheterization was 95.7%in the experimental group and 80.4%in the control group.The success rate of first catheterization was 95.7%in the experimental group and 71.7%in the control group.The time taken for catheterization was(12.37±4.19)min in the experimental group and(19.22±5.48)min in the control group.The proportion of catheter tip reaching the jejunum was 60.9%in the experimental group and 28.3%in the control group.The above data were compared between the 2 groups,and the differences were statistically significant(P<0.05).In terms of the incidence of catheter-related complications,the incidence of epistaxis in the experimental group was 6.5%and it was 21.7%in the control group,and the difference was statistically significant(P=0.036).The positive rate of fecal occult blood test was 2.2%in the experimental group and 17.4%in the control group,and the difference was statistically significant(P=0.030).There was no significant difference in the incidence of nausea,vomiting and abdominal distension between the 2 groups(P>0.05).No serious complications such as catheter ectopic placement,pneumothorax and perforation occurred in the 2 groups.Conclusion The application of electromagnetic navigation bedside nasoenteral intubation technology for elderly bedridden patients has a high success rate and takes a short time,which can improve the proportion of catheter tip reaching the jejunum and reduce the incidence of epistaxis and fecal occult blood test.
5.Altered gray matter volume and resting-state functional connectivity in migraine patients without aura
Zhengwei CHEN ; Cunxin LIN ; Yueji LIU ; Dan LIU ; Liangqun RONG ; Xiue WEI ; Lijie XIAO ; Haiyan LIU
Chinese Journal of Neurology 2024;57(4):366-374
Objective:To investigate the underlying neuroimaging mechanism of migraine without aura (MwoA) by using methods of voxel-based morphometry (VBM) and resting-state functional connectivity (FC).Methods:Twenty-five MwoA patients admitted to Department of Neurology, the Second Affiliated Hospital of Xuzhou Medical University from September 2020 to June 2023 were recruited as MwoA group, and 22 volunteers were recruited as healthy control (HC) group. Demographic, clinical characteristics, scores of Hamilton Anxiety Scale (HAMA), Hamilton Depression Rating Scale (HAMD) and Montreal Cognitive Assessment (MoCA) of all subjects were collected; MwoA patients also received Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and headache Visual Analogue Scale assessments. All subjects underwent high-resolution 3D-T 1 and resting-state functional magnetic resonance imaging scanning. The SPM12 software was used to compare the difference in gray matter volume (GMV) between the 2 groups by VBM method. The GRETNA software was adopted to calculate the whole brain FC with anatomical automatic labeling 90 as the regions of interest, and the difference in FC between the 2 groups was statistically analyzed by two-sample t-test. Pearson partial correlation was used to analyze the correlation between brain GMV and FC changes and clinical features and scale scores of MwoA patients. Results:There existed no statistically significant difference between the 2 groups in age, gender, education, scores of HAMA, HAMD and MoCA (all P>0.05). Migraine Disability Assessment Questionnaire, Headache Impact Test-6 and headache Visua Analogue Scale scores of MwoA patients were (8.86±4.55), (50.27±6.35) and (6.68±1.73). Compared with the HC group, GMV was significantly decreased in the right superior frontal gyrus (SFG), right cingulate gyrus (CG) and left thalamus in the MwoA group ( P<0.05, false discovery rate corrected). In addition, the MwoA group showed decreased FC between left thalamus and right cuneus, left lingual gyrus (LG) and bilateral precuneus; decreased FC between right thalamus and right cuneus, right LG and right precuneus; decreased FC between right cuneus and left precuneus and right SFG; decreased FC between left LG and bilateral precuneus, decreased FC between right LG and right precuneus and left SFG; decreased FC between left precuneus and bilateral SFG, and between right precuneus and right SFG (edge P<0.001, component P<0.05, network-based statistics correction, interation=2 000). In MwoA patients, the FC (z-value) between left thalamus and right cuneus was negatively correlated with the duration of disease ( r=-0.530, P=0.011). Conclusions:MwoA patients showed decreased GMV in right SFG, CG and left thalamus. In MwoA patients, FC between thalamus and visual network (VN) and default mode network (DMN) was significantly decreased, and FC among VN, DMN and executive control network was significantly decreased. These changes in brain structure and function may be an adaptive change in the central sensitivity and responsiveness to pain stimuli, and may be an important neuroimaging mechanism of MwoA.
6.Application of OSCE-guided Scenario-based Practical Teaching Model in Clinical Pharmacist Training
Tiantian TANG ; Yiwen XIAO ; Haiyan YUAN ; Qiong LU ; Ying WANG ; Wenhui LIU ; Shenglan TAN ; Bikui ZHANG ; Daxiong XIANG ; Yan CHENG ; Yangang ZHOU ; Ping XU
Chinese Journal of Modern Applied Pharmacy 2024;41(10):1409-1414
OBJECTIVE
To explore the specific application and evaluation effect of objective structured clinical examination(OSCE)-guided scenario-based practical teaching mode in training clinical pharmacists.
METHODS
Fifty-six trainees who participated in the clinical pharmacist training program in the Second Xiangya Hospital of Central South University from October 2020 to September 2022 were selected as the research objects. OSCE-guided teaching was conducted, and the application effect of OSCE-guided teaching mode in clinical pharmacist training was explored and analyzed by using theoretical examination results and OSCE assessment results as evaluation indicators.
RESULTS
Through comparative analysis, it was found that the OSCE-guided teaching mode not only enabled students to better grasp the theoretical knowledge points required by the training outline, but also improved their clinical thinking ability, problem-solving ability, and communication and coordination skills to varying degrees.
CONCLUSION
For clinical pharmacist trainees, the OSCE teaching mode is conducive to the comprehensive improvement of clinical pharmacist skills and is suitable for cultivating clinical pharmacists who are capable of independently carrying out clinical pharmacy services in the new situation.
7.Altered functional connectivity of parietal opercular 2 in patients with vestibular migraine: a resting-state fMRI study
Zhengwei CHEN ; Cunxin LIN ; Yueji LIU ; Dan LIU ; Liangqun RONG ; Haiyan LIU ; Xiue WEI ; Lijie XIAO
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(8):812-819
Objective:To investigate the differences in resting-state functional connectivity (FC) between patients with vestibular migraine (VM) and migraine without aura (MwoA) in order to infer the possible neuroimaging mechanisms of VM.Methods:Thirty VM patients admitted to the Department of Neurology of the Second Affiliated Hospital of Xuzhou Medical University from December 2019 to December 2022 were selected as the experimental group (EG) (6 males and 24 females, with mean age of 38.3 years) and 26 MwoA patients as the control group (7 males and 19 females, mean age 35.5 years). General demographic and clinical data such as gender, age, year of education, course of disease and frequency of attacks were collected for all the patients, as well as data of Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), Montreal Cognitive Assessment (MoCA), headache Visual Arialogue Scale (VAS), Headache Impact Test 6 (HIT-6) and Migraine Disability Assessment Questionnaire (MIDAS). VM patients were also assessed by Dizziness Handicap Inventory (DHI), dizziness VAS and Vestibular Disorders Activities of Daily Living (VADL) scales. All patients underwent resting-sate functional Magnetic Resonance Imaging (fMRI) scans. Bilateral parietal opercular cortex 2 (OP2) and primary visual cortex (V1) were used as regions of interests (ROIs). Differences in FC between ROIs and other brain regions were calculated between the two groups. In view of the brain regions with significant differences, z-values of FC were extracted for each subject in the EG, and Pearson partial correlation analysis was conducted between z-values of FC and clinical characteristics of patients, P<0.05 was considered to have significant correlation. SPSS 22.0 was used for statistical analysis. Results:There was no significant difference in gender, age, years of education, course of disease, frequency of attack and scores of MoCA, HAMA and HAMD between the two groups ( P>0.05). Headache VAS, HIT-6 and MIDAS scores in VM patients were significantly lower than those in MwoA patients ( P<0.05). Compared with MwoA patients, the FC between left OP2 and bilateral precuneus and left thalamus was significantly increased in VM patients, and the FC between right OP2 and left thalamus and right anterior cingulate gyrus were significantly increased ( P<0.05, False Discovery Rate correction). Correlation analysis showed that the FC between left OP2 and left precuneus was positively correlated with DHI score in VM patients ( P=0.007, r=0.480), and the FC between right OP2 and left thalamus was positively correlated with the disease course in VM patients ( P=0.015, r=0.439). Conclusions:The pathogenesis of VM may be related to the altered FC of vestibular, pain and visual-motor networks, abnormalities of these neural pathways may be important imaging biomarkers of VM pathogenesis.
8.The Effect of Chuanxiong (Rhizoma Chuanxiong) & Tianma (Rhizoma Gastrodiae) Herbal Pair on the Periorbital Mechanical Pain Threshold and AMPK/TRPA1 Pathway in the Trigeminal Ganglion of Migraine Model Rats
Xiao ZUO ; Liqi LIANG ; Lanqi TANG ; Ruina MENG ; Bingying FANG ; Haifang WANG ; Haiyan CUI ; Xiaohua LIU
Journal of Traditional Chinese Medicine 2024;65(7):722-727
ObjectiveTo explore the possible mechanism of Chuanxiong (Rhizoma Chuanxiong) & Tianma (Rhizoma Gastrodiae) herbal pair in treating migraines based on AMP-activated protein kinase (AMPK)/transient receptor potential A1 channel (TRPA1) pathway. MethodsForty-eight healthy male SD rats were randomly divided into control group, model group, and Chuanxiong Tianma medication group, with 16 rats in each group. The control group and model group were given 10 ml/kg of normal saline by gavage, while the Chuanxiong Tianma medication group was given 0.675 g/kg of Chuanxiong Tianma herbal pair by gavage, once daily for 8 consecutive days in both groups. Migraime model was performed before the last administration, with subcutaneous injection of 10 ml/kg of normal saline in the control group, and subcutaneous injection of 10 ml/kg of nitroglycerin in the model group and Chuanxiong Tianma medication group. The Von Frey filament was used to measure the periorbital mechanical pain threshold of rats. The enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of calcitonin gene-related peptide (CGRP) in rat serum and cerebrospinal fluid. The nitric oxide (NO) assay kit was used to determine the NO level in serum and cerebrospinal fluid. RT-PCR was usedto detect the mRNA expression levels of immediate-early genes in the trigeminal ganglion of rats (c-Fos), CGRP, transient receptor potential V1 channel (TRPV1), AMPK alpha subunit (PRKAA), and TRPA1. Immunofluorescence was used to detect the number of c-Fos-positive cells in the trigeminal cervical complex (TCC) and the protein expression levels of phosphorylated AMPK (pAMPK) and TRPA1 in the trigeminal ganglion. ResultsCompared to those in the control group, the mechanical stimulation threshold and pAMPK protein expression in the model group decreased, while the levels of CGRP and NO in serum, c-Fos, CGRP, TRPV1 and TRPA1 mRNA levels in the trigeminal ganglion, TRPA1 protein expression, and the number of c-Fos-positive cells in the TCC significantly increased (P<0.05). Compared to those in the model group, the mechanical stimulation threshold and pAMPK protein expression in the Chuanxiong Tianma medication group significantly increased, while the levels of CGRP and NO in serum, c-Fos, CGRP, TRPV1 and TRPA1 mRNA levels in the trigeminal ganglion, TRPA1 protein expression, and the number of c-Fos-positive cells in the TCC significantly decreased (P<0.05). ConclusionChuanxiong Tianma herbal pair may improve migraine symptoms by regulating the AMPK/TRPA1 pathway in the trigeminal ganglion and increasing the mechanical pain threshold.
9.Effect of Sargassum and Glycyrrhizae Radix et Rhizoma Incompatible Pair with Haizao Yuhutang on Oxidative Stress in Liver of Goiter Rats
Xiao DONG ; Yi TIAN ; Xiaoqing LIU ; Can CAO ; Wenyong LIAO ; Xiangnan XU ; Meijing WU ; Haiyan LIU ; Shaohong CHEN ; Xue YU ; Angran FAN ; Linlin XIU ; Gansheng ZHONG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):37-45
ObjectiveTo observe the effects of Sargassum and Glycyrrhizae Radix et Rhizoma incompatible pair with the Haizao Yuhutang (HYT) on oxidative stress in the liver of goiter rats under the condition of 2 times the dose limit of the Pharmacopoeia of the People's Republic of China 2020. MethodA total of 128 male Wistar rats were randomly divided into a blank group, a model group, a euthyrox group (20 μg·kg-1), a HYT group (12.06 g·kg-1), a HYT without Sargassum (HYT-H) group (9.90 g·kg-1), a HYT without Glycyrrhizae Radix et Rhizoma (HYT-G) group (10.26 g·kg-1), a HYT without Sargassum and Glycyrrhizae Radix et Rhizoma (HYT-HG) group (8.10 g·kg-1), and a Sargassum and Glycyrrhizae Radix et Rhizoma (HG) group (3.96 g·kg-1). The blank group was given deionized water by gavage, and the others were given propylthiouracil (PTU) to replicate the goiter pathological model. Euthyrox was taken as a positive control drug, and the rest of the Chinese medicine groups were given the corresponding decoction by gavage, the material was collected 12 hours after the last dose. The serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and the contents of superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA), reactive oxygen species (ROS) in liver tissue were detected in each group. The pathological changes in the liver were observed via hematoxylin-eosin (HE) staining. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was utilized to detect the mRNA expressions of Kelch-like Ech-associated protein 1 (Keap1), nuclear factor E2-related factor 2 (Nrf2), heme oxygenase-1 (HO-1), p53 and Caspase-3 in liver tissues. Western blot was adopted to detect the protein expressions of Nrf2 and HO-1 in liver tissues in oxidative stress-related signaling pathways. ResultCompared with control group, the model group showed significantly increased serum ALT level and contents of MDA and ROS in liver tissues (P<0.05, P<0.01), significantly reduced activities of SOD and GSH-Px in the liver (P<0.01), significantly increased mRNA expression of Keap1 (P<0.01), and significantly decreased mRNA and protein expressions of Nrf2 and HO-1 (P<0.05, P<0.01). Compared with the model group, the HYT group manifested significantly reduced serum levels of AST, ALT, and ALP (P<0.05, P<0.01), significantly reduced contents of MDA and ROS in liver tissue (P<0.01), significantly increased the activities of SOD and GSH-Px (P<0.01), significantly decreased mRNA expressions of Keap1, p53, and Caspase-3 (P<0.01), and significantly increased mRNA and protein expressions of Nrf2 and HO-1 (P<0.05, P<0.01). ConclusionUnder the condition of 2 times the dose limit of the Pharmacopoeia of the People's Republic of China 2020, Sargassum and Glycyrrhizae Radix et Rhizoma incompatible pair with the HYT on oxidative stress in the liver of goiter rats had different effects. The HYT that contains Sargassum and Glycyrrhizae Radix et Rhizoma has a protective effect on the liver of goiter rats, and the effect is better than that of the HG group, the euthyrox group, and the incomplete groups. Its mechanism may be related to activating the Nrf2/HO-1 signaling pathway to alleviate liver oxidative stress and inhibiting the p53/Caspase-3 signaling pathway to reduce hepatocyte apoptosis.
10.A multicenter, prospective, phaseⅡ, single-arm study on the treatment of newly diagnosed multiple myeloma with domestic bortezomib in combination with lenalidomide and dexamethasone
Linna XIE ; Xin WANG ; Qiang HE ; Hui WANG ; Ji MA ; Haiyan ZHANG ; Nan LIU ; Guitao JIE ; Taiwu XIAO ; Hao ZHANG ; Haiguo ZHANG ; Zengjun LI ; Lijie XING
Chinese Journal of Hematology 2024;45(6):571-576
Objective:To explore the efficacy and safety of domestic bortezomib in combination with lenalidomide and dexamethasone in the treatment of newly diagnosed multiple myeloma (NDMM) .Methods:This multicenter, prospective, single-arm clinical study included 126 patients with NDMM admitted to seven hospitals between December 2019 and January 2022. All patients received domestic bortezomib in combination with lenalidomide and dexamethasone (BLD regimen), and the efficacy, prognostic factors, and safety were analyzed.Results:Among the 126 patients with NDMM, 118 completed four cycles of treatment, with an overall response rate (ORR) of 93.22% (110/118) and a ≥very good partial response (VGPR) rate of 68.64% (81/118). Ultimately, 114 patients completed at least eight cycles of treatment, with an ORR of 92.98% (106/114) and a ≥VGPR rate of 77.19% (88/114). Eighteen patients underwent autologous hematopoietic stem cell transplantation after completing 6-8 cycles of the BLD regimen, with an ORR of 100% (18/18) and a ≥VGPR rate of 88.9% (16/18). The proportion of patients achieving ≥VGPR increased with the treatment duration, and factors such as staging and age did not significantly affect efficacy. Single-factor analysis showed that R2-ISS stage Ⅲ/Ⅳ, blood calcium >2.27 mmol/L, and failure to achieve VGPR after six cycles were adverse prognostic factors for progression-free survival (PFS) ( P<0.05), whereas failure to achieve VGPR after six cycles was an adverse prognostic factor for overall survival (OS) ( P<0.001). Multifactor analysis demonstrated that failure to achieve VGPR after six cycles is an independent adverse prognostic factor for PFS ( P=0.002). The incidence of hematologic adverse reactions was 16.7% (19/114), and nonhematologic adverse reactions were mainly mild to moderate, with no significant cardiac or renal adverse reactions observed. Conclusion:The BLD regimen is effective in treating NDMM, in which patients with high-risk genetic features are still achieving a high ≥VGPR rate, and the overall safety is good.


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