1.Real-World Study of 21-Day Venetoclax Plus Azacitidine Regimen in the Treatment of Newly Diagnosed Unfit-Acute Myeloid Leukemia.
Li-Ying AN ; Min CHEN ; Jin WEI ; Xing-Li ZOU ; Pan ZHAO ; Zhu YANG ; Xun NI ; Xiao-Jing LIN
Journal of Experimental Hematology 2025;33(5):1279-1286
OBJECTIVE:
To observe the efficacy and safety of 21-day venetoclax (VEN) plus azacitidine (AZA) (21-day VA) in newly diagnosed unfit acute myeloid leukemia (AML) patients in the real-world.
METHODS:
The clinical data of patients with unfit-AML who received 21-day VA regimen from December 2020 to July 2024 in our center and completed at least 1 cycle of therapeutic effect assessment was retrospectively collected to analyze the safety, efficacy and its influencing factors.
RESULTS:
A total of 59 patients were enrolled in our study, with a median age of 67(48-87) years old. After 1 cycle of therapy, the composite complete remission (cCR) rate was 74.5%, 54.2% of cases were negative for minimal residual disease (MRD). Among them, the MRD negative rate of patients with NPM1 mutation was significantly higher than that of patients without NPM1 mutation ( P =0.032). The median follow-up of patients was 19(2-38) months, the best cCR and MRD negative rates were 78% and 64.4%, respectively, the median overall survival (OS) time was 12 months, and the median progression free survival (PFS) time was 5 months. Multivariate Cox regression analysis showed less than 4 cycles of VA chemotherapy were independent risk factor for PFS and OS ( P < 0.05). After achieving remission, anemia and thrombocytopenia improved with the increase of the number of chemotherapy cycle.
CONCLUSION
In real-world, 21-day VA regimen still shows significant efficacy in the treatment of newly diagnosed unfit-AML, without adversely affecting remission rate and MRD negative rate of the first cycle.
Humans
;
Leukemia, Myeloid, Acute/drug therapy*
;
Aged
;
Middle Aged
;
Bridged Bicyclo Compounds, Heterocyclic/therapeutic use*
;
Sulfonamides/therapeutic use*
;
Azacitidine/therapeutic use*
;
Aged, 80 and over
;
Male
;
Female
;
Retrospective Studies
;
Nucleophosmin
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Remission Induction
;
Mutation
;
Treatment Outcome
2.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
3.Prognostic correlation analysis of multiple myeloma based on HALP score of peripheral blood before chemotherapy
Min CHEN ; Liying AN ; Xiaojing LIN ; Pan ZHAO ; Xingli ZOU ; Jin WEI ; Xun NI
Chinese Journal of Blood Transfusion 2025;38(1):61-67
[Objective] To explore the predictive value of HALP score for prognosis in patients with multiple myeloma (MM). [Methods] A retrospective analysis was conducted on laboratory indicators and related clinical data of newly diagnosed multiple myeloma (NDMM) patients, treated at the Affiliated Hospital of North Sichuan Medical College from January 2016 to October 2023, prior to their first treatment. The HALP score was calculated, and the optimal cutoff value for HALP was determined using X-tile software. Survival analysis was performed using Kaplan-Meier curves for high HALP and low HALP groups. Univariate and multivariate analyses were conducted using the Cox regression model, and a forest plot was generated using Graphpad Prism to illustrate factors that may impact patient prognosis. The predictive ability of HALP score combined with β2-microglobulin and ECOG score for prognosis in MM patients was evaluated using receiver operating characteristic curve (ROC) analysis. [Results] A total of 203 MM patients were included, with the optimal cutoff value for HALP score being 29.15 (P<0.05). Among them, 101 patients were in the low HALP score group, and 102 patients were in the high HALP score group. The results of univariate and multivariate analysis using the Cox regression model showed that a HALP score <29.15 was an independent risk factor for progression-free survival (PFS) and overall survival (OS) (P<0.05). ROC curve analysis indicated that the combination of HALP score with β2-microglobulin and ECOG score had a higher predictive value for prognosis in MM patients compared to using HALP score alone. [Conclusion] The HALP score is closely related to the prognosis of patients with NDMM. A low HALP score indicates a poorer prognosis, while the combination of HALP score with β2-microglobulin and ECOG score provides a higher predictive value when assessed together.
4.Detection method of bipolar HF leakage current in HF surgical equipment
An-Ni ZENG ; Qiu-Nan DU ; Jian-Xun HOU
Chinese Medical Equipment Journal 2024;45(4):88-92
Bipolar HF leakage current testing was carried out for two pieces of HF surgical equipment respectively by using a combination of different equipment and different connection methods according to the test method in GB 9706.202-2021 Medical electrical equipment-Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.It's pointed out relatively accurate measurements could be obtained when the HF analyzer was accessed to the circuit only as a test resistor and/or ammeter.References were provided for bipolar HF leakage current detection in HF surgical equipment.[Chinese Medical Equipment Journal,2024,45(4):88-92]
5.Evaluation analysis of prognosis in diffuse large B-cell lymphoma based on HALP score
Qiuyuan PENG ; Ling ZHOU ; Jin WEI ; Pan ZHAO ; Xiaojing LIN ; Xun NI
Chongqing Medicine 2024;53(19):2937-2942
Objective To investigate the prognostic evaluation value of the HALP score composed of hemoglobin,albumin,lymphocytes and platelets before chemotherapy in the patients with diffuse large B-cell lymphoma(DLBCL).Methods The clinical data and laboratory indicators before chemotherapy in the pa-tients with DLBCL newly diagnosed in this hospital from January 2015 to October 2022 were retrospectively analyzed.The optimal cut-off value of HALP was calculated by X-tile software.The patients were grouped ac-cording to the optimal cutoff value,the Chi-square test was used to analyze the difference in the constituent ra-tio of clinical characteristics among different HALP score groups,the survival curves of the progression-free survival(PFS)time and overall survival(OS)time among the groups with different scores were drawn by u-sing the Kaplan-Meier method,the Cox univariate and multivariate analysis regression model was adopted to analyze the prognostic influencing factors in DLBCL patients,and the predictive ability of HALP score for PFS time and OS time in DLBCL patients was evaluated by using the receiver operating characteristic(ROC)curve.Results A total of 132 patients with DLBCL were included,the optimal cutoff value of HALP score was 21.23 points.There were 54 cases in the low HALP score group and 78 cases in the high HALP score group.The low HALP score group was correlated with the later clinical stage,higher IPI and NCCN-IPI scores,higher LDH level and lower overall response rate(ORR)(P<0.05).Compared to the high HALP score group,the PFS time and OS time in the low HALP score group were shorter(P<0.05).The Cox uni-variate and multivariate regression model analysis results indicated that the HALP score≤21.23 points was an independent risk factor affecting the PFS time(HR=1.811,P=0.031).The ROC curve results suggested that the combination of HALP score combined with IPI score or NCCN-IPI score had higher predictive value for PFS time and OS time in DLBCL patients compared to use IPI or NCCN-IPI alone.Conclusion The HALP score is correlated with the prognosis of DLBCL patients,and could early identify the high-risk DLBCL patients with poor prognosis.The HALP score,IPI score and NCCN-IPI score combined evaluation has higher predictive value.
6.Research progress on evaluation and prediction methods of dysphagia after occipitocervical fusion
Libin NI ; Xun LU ; Weiyi XIA ; Xiangyang WANG
Chinese Journal of Orthopaedics 2024;44(1):53-57
Occipitocervical fusion (OCF) is used to treat the instability of the cranio-cervical junction due to various reasons (such as trauma, rheumatoid arthritis, infection, tumor, congenital malformations and degeneration). A satisfactory fusion rate can be obtained and the stability of the occipital neck can be reconstructed by OCF. Dysphagia is one of the most common complications after OCF, which seriously affects the quality of life of patients after surgery. This article mainly focuses on the evaluation and prediction methods of dysphagia after OCF, and summarizes related research in the past 16 years, and provides guidance and direction for how to predict the occurrence of dysphagia during OCF and the evaluation of postoperative dysphagia. The evaluation of dysphagia is mainly conducted using the Bazaz dysphagia score, swallowing quality of life scale (SWAL-QOL) and eating assessment tool-10 (EAT-10) score. However, the clinical prediction of dysphagia is mainly based on the changes of cervical curvature parameters (O-C 2 angle, O-EA angle, Oc-Ax angle, PI angle). At present, there are many methods for clinical evaluation and prediction of dysphagia, but the best evaluation method is still uncertain. We reviews the evaluation and prediction methods of postoperative dysphagia of OCF, showing that the Bazaz dysphagia score, SWAL-QOL score and EAT-10 score scale are suitable for evaluating postoperative dysphagia of OCF. During OCF operation, adjustment of O-C 2 Angle >-5°, O-EA Angle >100°, Oc-Ax Angle >65°, and increase of postoperative PI Angle from preoperative PI Angle (that is, dPI Angle) ≥0° can reduce the probability of dysphagia to a certain extent.
7.Clinical observation of venetoclax combined with homoharringtonine and cytarabine in the treatment of acute myeloid leukemia
Ling ZHOU ; Qiuyuan PENG ; Pan ZHAO ; Jin WEI ; Xiaojing LIN ; Xingli ZOU ; Wenfeng LUO ; Jing WANG ; Kunying XIE ; Xianglong LI ; Yang LIU ; Xun NI
China Pharmacy 2024;35(14):1743-1747
OBJECTIVE To observe the short-term efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of acute myeloid leukemia (AML). METHODS The data of 40 newly diagnosed AML patients admitted to our hospital from October 2022 to November 2023 were retrospectively collected and divided into observation group and control group according to treatment plan, with 20 cases in each group. The patients in the control group were given Daunorubicin hydrochloride for injection+Cytarabine for injection, and the patients in the observation group were given Venetoclax tablets+ Homoharringtonine injection+Cytarabine for injection. The patients in both groups were given relevant medicine, with 28 days as one cycle. The short-term efficacy, negative rate of minimal residual disease (MRD), duration of granulocyte deficiency, duration of platelet (PLT) <20×109 L-1, transfusion volume of suspended red blood cells and platelet, and the occurrence of adverse drug reactions were evaluated in both groups after 1 cycle of induction chemotherapy. RESULTS The complete remission or complete remission with incomplete hematologic recovery (CR/CRi) rate in the observation group was significantly higher than control group (P<0.05), and the negative rate of MRD in the observation group was also significantly higher than control group (P<0.05). However, in low-, medium- and high-risk patients, there was no statistical significance in CR/CRi rates between the two groups (P>0.05). There were no significant differences in the duration of agranulocytosis, the duration of PLT <20×109 L-1, the amount of suspended red blood cell transfusion, the amount of platelet transfusion, the incidence of hematologic toxicity and the incidence of non-hematologic toxicity between 2 groups (P>0.05). CONCLUSIONS Venetoclax combined with homoharringtonine and cytarabine show good short-term efficacy and safety in the treatment of AML.
8.The prognostic impact of ventricular arterial coupling in patients with traumatic hemorrhagic shock:a single center cohort study
Xun NI ; Shanshan LU ; Chi ZHANG ; Tingting DING ; Aihua LIN
Journal of Clinical Surgery 2024;32(12):1326-1329
Objective To explore the impact of ventricular arterial coupling on the prognosis of patients with traumatic hemorrhagic shock(HTS).Methods 60 HTS patients who were hospitalized in the emergency and critical care departments of Nanjing Drum Tower Hospital Group Suqian Hospital from January 2020 to December 2022 were included.They were divided into survival group(n=30)and death group(n=30)based on their prognosis.The acute physiological and chronic health score Ⅱ(APACHEⅡ),sequential organ failure(SOFA)score,lactate(Lac),and central venous oxygen saturation(ScvO2)of the two groups of patients were monitored,respectively,Compare the central venous pressure(CVP),cardiac index(CI),stroke volume index(SVI),global end diastolic volume index(GEDVI),systemic vascular resistance index(SVRI),and mean arterial pressure(MAP)of two groups of patients under continuous monitoring of pulse indicator cardiac output(PiCCO),and calculate the left ventricular arterial coupling(VAC)index.Results The Lac levels in the survival group and death group were(2.31±1.29)mmol/L and(3.98±1.01)mmol/L,respectively,with statistical significance(P<0.05);The ScvO2 values for the survival group and death group were(62.69±5.73)%and(60.3±5.35)%,respectively,with no significant statistical difference(P>0.05);The survival group showed a statistically significant decrease in APACHE Ⅱ score[(18.57±2.23)points vs(23.00±3.15)points]and SOFA score[(9.40±2.15)points vs(14.07±2.26)points]compared to the death group(P<0.05),with an increase in CI[(2.97±0.20)L/(min·m2)vs(2.73±0.27)L/(min·m2)],an increase in SVI[(50.11±4.31)ml/m2 vs(46.53±3.49)ml/m2],and a decrease in VAC[(1.34±0.19)vs(1.69±0.28)],and a statistically significant difference(P<0.05),However,there was no significant statistical difference in CVP[(9.19±1.20)mmHg vs(9.35±1.53)mmHg)],GEDVI[(715.73±101.72)ml/m2 vs(717.93±89.07)ml/m2],SVRI[(2 061.55±701.23)dyn·sec·cm-5·m-2 vs(2 164.31±732.16)dyn·sec·cm-5·m-2],and MAP[(92.21±10.81)mmHg vs(89.19±17.33)mmHg]between the survival and death groups(P>0.05);Logistic regression analysis showed that VAC(OR=1.41),Lac(OR=1.36),APACHE Ⅱ score(OR=1.25),SOFA score(OR=1.21),CI(OR=1.31),and SVI(OR=1.20)were risk factors for mortality in patients with traumatic hemorrhagic shock(P<0.05).Conclusion VAC has a certain impact on the prognosis of patients with traumatic hemorrhagic shock.
9.The prognostic impact of ventricular arterial coupling in patients with traumatic hemorrhagic shock:a single center cohort study
Xun NI ; Shanshan LU ; Chi ZHANG ; Tingting DING ; Aihua LIN
Journal of Clinical Surgery 2024;32(12):1326-1329
Objective To explore the impact of ventricular arterial coupling on the prognosis of patients with traumatic hemorrhagic shock(HTS).Methods 60 HTS patients who were hospitalized in the emergency and critical care departments of Nanjing Drum Tower Hospital Group Suqian Hospital from January 2020 to December 2022 were included.They were divided into survival group(n=30)and death group(n=30)based on their prognosis.The acute physiological and chronic health score Ⅱ(APACHEⅡ),sequential organ failure(SOFA)score,lactate(Lac),and central venous oxygen saturation(ScvO2)of the two groups of patients were monitored,respectively,Compare the central venous pressure(CVP),cardiac index(CI),stroke volume index(SVI),global end diastolic volume index(GEDVI),systemic vascular resistance index(SVRI),and mean arterial pressure(MAP)of two groups of patients under continuous monitoring of pulse indicator cardiac output(PiCCO),and calculate the left ventricular arterial coupling(VAC)index.Results The Lac levels in the survival group and death group were(2.31±1.29)mmol/L and(3.98±1.01)mmol/L,respectively,with statistical significance(P<0.05);The ScvO2 values for the survival group and death group were(62.69±5.73)%and(60.3±5.35)%,respectively,with no significant statistical difference(P>0.05);The survival group showed a statistically significant decrease in APACHE Ⅱ score[(18.57±2.23)points vs(23.00±3.15)points]and SOFA score[(9.40±2.15)points vs(14.07±2.26)points]compared to the death group(P<0.05),with an increase in CI[(2.97±0.20)L/(min·m2)vs(2.73±0.27)L/(min·m2)],an increase in SVI[(50.11±4.31)ml/m2 vs(46.53±3.49)ml/m2],and a decrease in VAC[(1.34±0.19)vs(1.69±0.28)],and a statistically significant difference(P<0.05),However,there was no significant statistical difference in CVP[(9.19±1.20)mmHg vs(9.35±1.53)mmHg)],GEDVI[(715.73±101.72)ml/m2 vs(717.93±89.07)ml/m2],SVRI[(2 061.55±701.23)dyn·sec·cm-5·m-2 vs(2 164.31±732.16)dyn·sec·cm-5·m-2],and MAP[(92.21±10.81)mmHg vs(89.19±17.33)mmHg]between the survival and death groups(P>0.05);Logistic regression analysis showed that VAC(OR=1.41),Lac(OR=1.36),APACHE Ⅱ score(OR=1.25),SOFA score(OR=1.21),CI(OR=1.31),and SVI(OR=1.20)were risk factors for mortality in patients with traumatic hemorrhagic shock(P<0.05).Conclusion VAC has a certain impact on the prognosis of patients with traumatic hemorrhagic shock.
10.Final evaluation of the prevention and control plan of key parasitic diseases in Hubei Province, 2016-2019
ZHANG Juan ; XIA Jing ; ZHU Hong ; LIN Wen ; WU Dong-ni ; WAN Lun ; ZHANG Hua-xun
China Tropical Medicine 2023;23(5):468-
Abstract: Objective To evaluate the completion and final effect of key parasitic disease prevention and control planning tasks in Hubei Province from 2016 to 2019, summarize the experience, find out the problems, and provide the basis for the next stage of prevention and control. Methods According to the requirements of the Final Evaluation Plan of the National Plan for the Prevention and Control of Hydatid Disease and Other Major Parasitic Diseases (2016-2020), a retrospective survey method was adopted to collect relevant data on the implementation and safeguard measures of the prevention and control of major parasitic diseases, and population infection status in Hubei Province in 2016-2019. Results From 2016 to 2019, We carried out 2 920 992 person times of publicity and education, 209 times of prevention and control technology training, 7 680 person times of business training, with an average of 52 sessions and 1 920 person times per year. We have allocated 3.445 2 million yuan for the prevention and control of parasitic diseases, including 1.722 2 million Yuan froom provincial government, to achieved full coverage of safe drinking water in rural areas under the current national standards, and 7.687 9 million harmless toilets have been built in rural areas. From 2016 to 2019, we carried out 39 658 person times of monitoring and disease investigation, the infection rate of human liver fluke was 0, and the infection rate of soil transmitted nematode was 0.42%. While the annual infection rates varied, there was no statistically significant difference in infection rate between years (χ2=2.276, P>0.05), but there were statistically significant differences in the infection rates between various soil nematodes (χ2=112.807, P<0.01). From 2016 to 2019, a total of 5 393 people were detected at 17 monitoring points, with the serum positive rate of 3.93% for paragonimiasis, there was a statistically significant difference in serological positive rate between years (χ2=146.011, P<0.01); a total of 738 stream crabs were collected, and the infection rate of intermediate host was 16.26%, wtih a statistically significant difference in the infection rate of stream crabs between years (χ2=49.731, P<0.01). Conclusions From 2016 to 2019, we adhered to the prevention and control strategy of "prevention first, prevention and control combined", implemented comprehensively various prevention and control measures, and achieved remarkable results in Hubei Province. The key parasitic diseases have been in a low epidemic situation, meeting the requirements of the prevention and control objectives. But the transmission risk still exists, the next step is to continue to strengthen security and monitoring and consolidate the achievements of prevention and control.

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