1.A non-controlled, multicenter open-label study to evaluate the safety, tolerability and efficacy of caspofungin in the treatment of invasive candidiasis and esophageal candidiasis
Dongfang LIN ; Jianmin WANG ; Yunsong YU ; Mingzhe HAN ; Zhixiang SHEN ; Shiduo SONG ; Yingyuan ZHANG
Chinese Journal of Infection and Chemotherapy 2014;(5):375-381
Objective This study was designed to evaluate the safety ,tolerability and efficacy of intravenous caspofungin for treatment of invasive candidiasis and esophageal candidiasis in Chinese adults .Methods This was a non-controlled ,multicenter ,candidiasis .All the 63 patients were included in the safety set (SS) and the full analysis set (FAS) .In the SS ,19 SAEs occurred in 14 patients .All these SAEs were unrelated to caspofungin .There were 73 caspofungin-related non-serious AEs in 31 patients (49 .2% ) .Five patients (7 .9% ) had both clinical AEs and laboratory abnormalities .Eight patients (12 .7% ) had clinical AEs (mainly rashes) ,and 27 patients (42 .9% ) had laboratory abnormalities ,mainly increases in liver enzymes alanine transaminase and aspartate transaminase and reduction in blood potassium .About 91 .7% of the clinical AEs were mild to moderate .Treatment was discontinued in 1 patient (1 .6% ,1/63) due to AEs .The overall efficacy was 58 .1% (36/62) in the FAS and 70 .0% (35/70) in the per-protocol set (PPS) .In the FAS ,the therapeutic efficacy was 57 .6% (34/59) for invasive candidiasis and 66 .7% (2/3) for esophageal candidiasis .In the PPS , the therapeutic efficacy was 68 .8% (33/48 ) for invasive candidiasis and 100% (3/3 ) for esophageal candidiasis .Conclusions The AEs of caspofungin were mostly mild to moderate in the treatment of invasive candidiasis and esophageal candidiasis in Chinese adults .Only one patient terminated therapy due to drug-related AE .Caspofungin is safe and effective for the treatment of invasive candidiasis and esophageal candidiasis in Chinese adults .
2.Diffusion tensor imaging in differential diagnosis of clear cell renal cell carcinoma and transitional cell carcinoma
Mingzhe XU ; Ailian LIU ; Qingwei SONG ; Meiyu SUN ; Lihua CHEN ; Zheng HAN
Chinese Journal of Interventional Imaging and Therapy 2017;14(5):297-301
Objective To evaluate the value of ADC and FA of diffusion tensor imaging (DTI) in differentiating clear cell renal cell carcinoma (ccRCC) and transitional cell carcinoma (TCC) of kidney pelvis.Methods Thirty-eight histopathology proven ccRCC and TCC patients (29 cases of ccRCC and 9 cases of TCC) were retrospectively enrolled.All the patients were performed abdominal MR fat saturation T1WI,fat saturation T2WI,LAVA and DTI (b=0,600 s/mm2).MR images were reviewed and analyzed by two radiologists in a double-blind manner with the value of ADC and FA measured using the Functool on AW 4.4 workstation.The data of two observers were analyzed with intra-class correlation coefficients (ICC) to assess inter-observer consistency.The differences of ADC values and FA values between ccRCC and TCC were compared by independent t-test.The ROC curves were used to analyze and compare the diagnostic value of DTI in differentiating ccRCC and TCC.Results The inter-observer agreements were good (ICC>0.75).The ADC value of ccRCC was statistically higher than that of TCC ([2.03 ± 0.49] × 10-3 mm2/s vs [1.57 ± 0.43] × 10-3 mm2/s,P =0.015).But the FA value of ccRCC was statistically lower than that of TCC ([0.24±0.10] vs [0.42±0.22],P=0.002).The area under the ROC curve of ADC was 0.761 (P<0.05),and the sensitivity and specificity were 79.3% and 77.8%.The ADC threshold for differentiating ccRCC from TCC was 1.59× 10-3 mm2/s.The area under the ROC of FA was 0.762 (P< 0.05),and the sensitivity and specificity were 66.7 % and 93.1%.The FA threshold for differentiating ccRCC from TCC was 0.326.Conclusion MR DTI can effectively discriminate ccRCC and TCC.FA values has good diagnostic specificity in differentiating between ccRCC and TCC.
3.Randomized, blind, parallel-controlled and multiple-centre clinical trial on the effectiveness and safety of leuprolide acetate in the treatment of endometriosis
Meilu BIAN ; Shuhui HUANG ; Wenhong DENG ; Jinghui SONG ; Zhiqing LIANG ; Yan ZHANG ; Ying JIN ; Hong ZHU ; Mingzhe LIU ; Quyuan WANG ; Yu YANG ; Qingyun CHEN
Chinese Journal of Obstetrics and Gynecology 2015;(3):188-193
Objective To evaluate the effectiveness and safety of leuprolide acetate in the treatment of endometriosis. Methods From Nov. 2007 to Oct. 2012, the patients who confirmed to be endometriosis were randomly divided into test group of 113 cases and control group of 116 cases. The test drug was the sustained-release agent of leuprolide acetate. The control drug was Enantone. The drugs were used for 3 times in total. After treatment, the ovarian mass volumes measured with type-B ultrasound, the scores of the patient′s subjective symptoms during non-menstrual and menstruation days, the pelvic signs during non-menstrual days, the changes of hormones [estradiol (E2), FSH, LH], and adverse events were observed. Results After the treatment, the rate of changes of ovarian mass volume (among them, at 12 weeks after the first injection, the median was -55.83% in the test group, -68.22% in the control group, P=0.336), the distinct improvement rate of symptom scores and pelvic signs during non-menstrual days [among them, at 12 weeks after the first injection, the rate of lower abdomen pain was 47.5%(48/101) in the test group, 44.0%(44/100) in the control group, P=0.881], the hormone (E2, FSH, LH) levels [among them, at 12 weeks after the first injection, the serum level of E2, was (33±38) pmol/L in the test group, (38± 40) pmol/L in the control group, P=0.414;the serum level of FSH, was (5.1±2.8) U/L in the test group, (5.3± 2.3) U/L in the control group, P=0.666;the serum level of LH, was (0.6±0.8) U/L in the test group, (0.6±0.9) U/L in the control group, P=0.907], had no statistically significant difference between the two groups (all P>0.05). The distinct improvement rate and improvement rate of symptom (lower abdomen pain, low back pain) scores during menstruation days at 12 weeks after the first injection, the rates of lower abdomen pain were 73.9%(34/46), 15.2%(7/46) respectively in the test group, 72.3%(34/47), 2.1%(1/47) respectively in the control group, had statistically significant difference between the two groups (P=0.026). There was no serious adverse event occurred in both two groups. The incidence rate of adverse event was 33.6%(38/113) in test group, 23.2% (27/116) in control group, there was no significant difference between the two groups (P=0.082). Conclusion Leuprolide acetate is effective and safe in the treatment of endometriosis.
4.Survey on the intake of dietary nutrients for 132 aduit patients with acute and chronic leukemia
Ziliang XU ; Yuntang WU ; Zhong SUN ; Rui LI ; Hongqiang LI ; Yumei QI ; Jichang SONG ; Jianxiang WANG ; Mingzhe HAN ; Fengkui ZHANG ; Lugui QIU ; Xiaofan ZHU ; Zhijian XIAO ; Renchi YANG ; Yizhou ZHENG ; Sizhou FENG ; Zhongchao HAN
Journal of Leukemia & Lymphoma 2009;18(1):29-31,34
Objective To study the dietary nourishment of adult patients with leukemia and compare acute leukemic patients with chronic leukemic patients. Methods Adopting dietary review of 24 hours and seven consecutive days of dietary records method to obtain the food category and quantity of 122 patients with acute leukemia and 10 patients with chronic leukemia. Using statistic software SPSS11.0 to calculate the patients'intake of various kinds of nutfiments. and the difiences between acute and chronic leukemic patients were analyzed. Results The rate of most ontrients of patients'intake reaches RNI/AI is lower,especially vitamin A,vitamin C and caleium.There's a tendency that intake diet,energy and nourishments of acute leukemic patients is lower than that of those chronic leukemic patients. Conclusion There is a tendency of unbalanced dietary intakes in leukemic patients.including the low intakes.There is the tendency that nutritional status of acute leukemic patients iS poorer than that of chronic leukemic patients.
5.Repair potential of heat-treated rat bone marrow mesenchymal stem cells in infarcted myocardium
Rongli ZHANG ; Erlie JING ; Jia SONG ; Yanyong BI ; Wen WANG ; Zheng ZHOU ; Wenjing ZHAI ; Xing CHEN ; Weihua ZHAI ; Fang LIU ; Hua WANG ; Zhiyong WANG ; Yusshi BAO ; Hong DU ; Shihong WANG ; Mingzhe HAN
Chinese Journal of Organ Transplantation 2009;30(2):107-110
Objective To study the effects of heat shock treatment of rat bone marrow mesenehymal stem cells(MSCs),the apoptosis ratio of treated-cells under low serum condition and the treated-cells transplantation on left ventricular function in rats with myocardiaIinfarction.Methods MSC8 were heat-treated under 42℃for 30 min,then the heat shock protein-70(HSP-70)was detected bv Western blot.The apoptosis ratio of heat-treated MSCs under low serum condition was tested by Annexin kit.The treated-MSCs labeled with Dil were transplanted into infarcted myocardium and 8 weeks later,the cardiac function of rats in each group was evaluated by echocardiography and cardiac catheterization.Results The immunophenotype of heat-treated MSCs did not vary,Western blot confirmed a higher level expression of HSP-70 in the treated-MSCs group as compared with that in the control group.The early apoptosis ratio was lower in treated-MSCs measured by flow cytometry with annexin staining than that of MSCs when cultured with low serum medium.After 8 weeks,LVEF,LVSP,+dp/dtmax,and-dp/dtmax were significantly higher,and the LVEDP was significantly lowar in heat-treated MSCs transplantation group than that in the control group.Conclusions Heat shock pretreatment of MSCs enhances the tolerance of MSCs to low serum medium,whereas does not lcad to the change of the cell immunophenotype.Transplantation of heattreated MSCs might improve the cardiac function in a rat myocardialinfarction model.
6.Role of IL-10 gene polymorphisms in promotor region in HLA matched sibling donor allogeneic hematopoietic stem cell transplantation
Xiaojin CAI ; Axia SONG ; Hua WANG ; Ping ZHANG ; Guixin ZHANG ; Fan YANG ; Jialin WEI ; Qiaoling MA ; Zhangsong YAN ; Erlie JIANG ; Yong HUANG ; Dongling YANG ; Mei WANG ; Yi HE ; Sizhou FENG ; Mingzhe HAN
Chinese Journal of Organ Transplantation 2012;(12):732-736
Objective To explore the impact of IL-10 gene polymorphisms on the outcome in HLA matched sibling hematopoietic stem cell transplantation (HSCT).Methods PCR-sequencespecific primer (PCR-SSP) assay was used to analyze the SNP of IL-10 in 77 recipient and donor pairs:-1082 A/G,-819 T/C,-592 C/A.Results IL-10 ATA/ATA (1082,-819,-592) genotype in recipients significantly decreased the incidence of grade Ⅱ-Ⅳ acute graft vursus-host disease (aGVHD) (6.1% vs.25.0 %,P<0.05),reduced 5-year transplant-related mortality (TRM) (10.7 %± 5.9% vs.29.7% ± 5.2%,P<0.05) and increased disease free survival (DFS) (81.8% ± 6.7% vs.56.8% ± 7.5%,P<0.05).With regard to the donor genotype,the incidence of grade Ⅱ-Ⅳ aGVHD,extensive chronic GVHD,5-year TRM and DFS had no signicant difference between IL-10 ATA/ATA and non ATA/ATA subgroup.Multivariable analysis also revealed that IL-10 non-ATA/ATA genotype in recipients and high-risk status of disease were two independent risk factors for DFS (HR =2.911,P =0.029; HR =2.686,P =0.027).Conclusion In HLA-matched sibling HSCT,the presence of recipient IL-10 ATA/ATA significantly decreased the incidence of grade Ⅱ-Ⅳ aGVHD and TRM,and increased DFS.
7.Application of transmesenteric vein extrahepatic portosystemic shunt to treat extrahepatic portal vein obstructive disease
Weixiao LI ; Mingzhe CUI ; Deyang SONG ; Jiangbo CHEN ; Danghui LU ; Dongbin ZHANG ; Shuiting ZHAI
Chinese Journal of Radiology 2021;55(9):903-909
Objective:To explore the feasibility, safety and effectivity of applying transmesenteric vein extrahepatic portosystemic shunt (TEPS) to treat extrahepatic portal vein obstructive disease (EHPVOD).Methods:From December 2020 to April 2021, 12 patients with EHPVOD in the Vascular Surgery Department of Zhengzhou University People′s Hospital were prospectively enrolled in the study. The infra-umbilical median longitudinal minilaparotomy was performed to expose the branch of superior mesenteric vein (SMV). RUPS-100 was introduced into the trunk of SMV. A balloon with a diameter of 20 mm was introduced through right internal jugular vein (RIJV) into inferior vena cava (IVC). Under fluoroscopy, RUPS-100 was used to puncture the balloon in IVC. A stiff guide wire was used to establish the pathway between RIJV and SMV. Finally the portosystemic shunt between IVC and SMV was established with a covered stent-graft. The total operative time, the time of establishing portosystemic shunt alone, the dosage of contrast agent, the preoperative and postoperative pressure of SMV were recorded. Paired t test was used to compare the preoperative and postoperative pressure of SMV. Results:All 12 patients were successfully performed TEPS. The total operative time was (113±32) min, the time of establishing portosystemic shunt alone was (31±5) min, the dosage of contrast agent was (129±48) ml. The postoperative pressure of SMV [(14.3±2.1) mmHg] decreased significantly ( t=20.125, P<0.01) compared to baseline [(27.8±2.7) mmHg]. All portal hypertension symptoms released after the operations.There was 1 case of delayed incision healing, 1 case of bacteremia and 1 case of slight hepatic encephalopathy, but all of them were cured. There was no death case. Postoperative CT showed all portosystemic shunts were patent. Conclusion:TEPS is a new, safe, effective and feasible treatment method for patients of acute and chronic EHPVOD.
8.Analysis of neutron beam quality control test items in boron neutron capture therapy (BNCT) equipment
Jinsheng CHENG ; Mingsheng LI ; Bin SHI ; Shufeng ZHANG ; Yuntao LIU ; Mingzhe SONG ; Zizhu ZHANG ; Jun CHEN
Chinese Journal of Radiological Medicine and Protection 2023;43(8):614-619
Objective:To provide reference for establishing the testing method for quality control of neutron beam in boron neutron capture therapy (BNCT) equipment in China by testing the radiation characteristic parameters and dosimetry characteristic parameters of epithermal neutron beam in hospital neutron irradiator (IHNI).Methods:By comparing the uncertainties in the result of various test items with the deviation values recommended by the European Joint Research Center (EC-JRC), the feasibility of the relevant of testing method was analyzed and evaluated.Results:The uncertainty in epithermal neutron fluence rate was 2.7%. The uncertainty in ratio of thermal to epithermal neutron fluence rate was 3.1%. The uncertainty in ratio of fast neutron air kerma to epithermal neutron fluence rate was 9.3%. The uncertainty in ratio of gamma air kerma to epithermal neutron fluence rate was 8.7%. The uncertainty in spatial distribution of neutron fluence rate was 2.7%. The uncertainty in thermal neutron fluence rate in phantom was 1.8%. The uncertainty in neutron and gamma-ray dose rate in phantom was 17.1% and 4.0%, respectively.Conclusions:The uncertainty in neutron dose rate measurement result in phantom is higher, and further research is needed to improve the accuracy of the testing method. The uncertainty in the measurement result of other test items is lower, and the accuracy of the test result is expected to meet the allowable deviation value recommended by the European Joint Research Center, and the test method is feasible.
9.Vascular endothelial injury induced by anti-endothelial cell antibody in allogeneic hematopoietic stem cell transplantation.
Jianfeng YAO ; Axia SONG ; Zheng RUAN ; Lukun ZHOU ; Peng LIU ; Haiyan ZHU ; Haiyan GONG ; Shuxu DONG ; Yuanfu XU ; Erlie JIANG ; Aiming PANG ; Sizhou FENG ; Mingzhe HAN
Chinese Journal of Hematology 2015;36(6):469-474
OBJECTIVETo clarify the role of endothelial cells (ECs) injury induced by anti-endothelial cell antibody (AECA) in allogeneic hematopoietic stem cell transplantation (allo-HSCT).
METHODSSerum immunoglobulin (IgG) from allo-HSCT recipients were purified and incubated with human umbilical vein vascular endothelium (HUVEC) in vitro, then the functional changes and cell apoptosis were tested.
RESULTSAfter incubation with AECA positive IgG, soluble adhesion molecules significantly elevated in culture supernatant. When concentration of IgG was 160, 320, and 640 μg/ml, concentrations of soluble intercellular adhesion molecule-1 in supernatant were statistically higher in AECA positive groups [(117.10 ± 12.82) vs (78.17 ± 4.90) pg/ml, (151.30 ± 15.35) vs (89.46 ± 6.02) pg/ml, (239.00 ± 32.53) vs (127.80 ± 13.86) pg/ml, P<0.01)]. When concentration of IgG was 40, 80, 160, 320, and 640 μg/ml, concentrations of soluble vascular cell adhesion molecule-1 in supernatant were also statistically higher in AECA positive groups [(38.51 ± 3.76) vs (24.78 ± 2.59) pg/ml, (61.34 ± 6.99) vs (38.20 ± 3.17) pg/ml, (135.60 ± 24.46) vs (63.73 ± 5.08) pg/ml, (221.30 ± 29.40) vs (112.80 ± 8.91) pg/ml, (420.90 ± 31.70) vs (224.40 ± 20.79) pg/ml, P<0.01]. Clotting activity factors also elevated in culture supernatant after incubation with AECA positive IgG. When concentration of IgG was 80, 160, 320, and 640 μg/ml, concentrations of von Willebrand factor were statistically higher in AECA positive groups [(19.51 ± 0.72) vs (17.17 ± 0.60) ng/ml, P=0.0193; (22.97 ± 1.18) vs (18.27 ± 0.61) ng/ml, (26.40 ± 1.54) vs (19.53 ± 0.70) ng/ml, (34.35 ± 1.60) vs (23.81 ± 0.92) ng/ml, P<0.01]. When concentration of IgG was 320 and 640 μg/ml, concentrations of thrombomodulin were statistically higher in AECA positive groups [(57.50 ± 4.50) vs (40.31 ± 4.39) pg/ml, P=0.0132; (59.18 ± 4.11) vs (38.84 ± 5.16) pg/ml, P<0.01]. However, inflammatory factors (IL-1β, IL-6, IL-8 and ANG2) were not statistically different in AECA positive and negative groups (P>0.05). Moreover, IgG from AECA positive samples did not change the proliferation or cell apoptosis.
CONCLUSIONAECA from allo-HSCT recipients dysregulates ECs' function in vitro, but do not induce apoptosis, which is valuable in the pathophysiology of graft-versus-host disease (GVHD) and other complications after allo-HSCT.
Allografts ; Autoantibodies ; Endothelial Cells ; Endothelium, Vascular ; Graft vs Host Disease ; Hematopoietic Stem Cell Transplantation ; Humans ; Intercellular Adhesion Molecule-1 ; Interleukin-6 ; Umbilical Veins ; von Willebrand Factor
10.IL-18 single nucleotide polymorphisms in hematologic malignancies with HLA matched sibling donor allogeneic hematopoietic stem cell transplantation.
Xiaojin CAI ; Axia SONG ; Hua WANG ; Ping ZHANG ; Guixin ZHANG ; Fan YANG ; Jialin WEI ; Qiaoling MA ; Zhangsong YAN ; Erlie JIANG ; Yong HUANG ; Donglin YANG ; Mei WANG ; Yi HE ; Mingzhe HAN ; Sizhou FENG
Chinese Journal of Hematology 2014;35(3):215-220
OBJECTIVETo explore the impact of interleukin-18 (IL-18) single nucleotide polymorphisms on outcomes of hematologic malignancies with HLA-matched sibling donor hematopoietic stem cell transplantation (allo-HSCT).
METHODSSingle- nucleotide polymorphisms in IL-18 promoter was detected by PCR-sequence-specific primer analysis (PCR-SSP) in 93 recipients and their HLA matched sibling donors. Hematopoietic reconstitution, incidences of graft versus host disease (GVHD) and infections, transplant related mortality (TRM), and disease free survival (DFS) were analyzed.
RESULTSIn comparison with -137 G/C+C/C donor genotype, patients with -137 G/G donor genotype had shorter duration of neutrophil recovery [15(11-23) days vs 17(11-24) days, P=0.01], higher incidence of extensive chronic GVHD (20.6% vs 3.3%, P=0.029), but no difference in the interval of platelet recovery [20(11-46) days vs 20(7-38) days, P=0.844]. The incidence of extensive chronic GVHD in -607 C/C donor genotype (31.6%) was significantly higher than that (10.8%) in C/A + A/A donor genotype (P=0.024). Recipients with -607 C/C genotype also had higher incidence (33.3%) of extensive chronic GVHD than those with C/A+A/A genotype (10.7%, P=0.016). There were no differences in acute GVHD, TRM, and DFS between different genotypes.
CONCLUSIONIL-18 -137 G homozygous genotype in donor facilitated neutrophil reconstitution, but increased the risk of extensive chronic GVHD in patients with allo-HSCT.
Adolescent ; Adult ; Child ; Child, Preschool ; Disease-Free Survival ; Female ; Genotype ; Graft vs Host Disease ; epidemiology ; Hematologic Neoplasms ; genetics ; therapy ; Hematopoietic Stem Cell Transplantation ; adverse effects ; methods ; Humans ; Incidence ; Interleukin-18 ; genetics ; Male ; Middle Aged ; Polymorphism, Single Nucleotide ; Siblings ; Tissue Donors ; Transplantation, Homologous ; Young Adult