1.Excavation and evaluation of tocilizumab and infliximab for adverse drug event signals among children
Yue TAN ; Ning-Ning GE ; Jing PENG ; Wen-Shuang QIU ; Xin ZHANG ; Lan-Fang LI
The Chinese Journal of Clinical Pharmacology 2024;40(5):732-736
Objective To analyze the risk of adverse drug events in pediatric clinical applications of tocilizumab versus inflixima.Methods Adverse event(AE)reporting data for tocilizumab versus infliximab in the U.S.Food and Drug Administration Adverse Event Reporting System database for the pediatric population from Q1 2013 to Q1 2023 were collected.AE risk signal mining was performed using the reporting odds ratio(ROR)method and the proportional reporting ratio(PRR)method.AEs were also classified and statistically analyzed according to the preferred system organ classification and preferred terminology(PT)of the International Dictionary of Medical Terminology.Results Data were extracted and cleaned to include 1 052 AE reports with 198 positive PT signals for tocilizumab as the suspected drug and 9 1 39 AE reports with 387 positive PT signals for infliximab as the suspected drug.The analyses suggested that the stronger positive risk signals for both drugs were focused on gastrointestinal disorders,infectious and invasive diseases,laboratory tests,musculoskeletal and connective tissue disorders,and blood,vascular,and lymphatic disorders.The risk signals for infliximab were focused on gastrointestinal disorders,infections,and infectious diseases,while the risk signals for tocilizumab were focused on the musculoskeletal muscle system.Conclusion Clinical use of both drugs in children has multi-system effects,tocilizumab may have effects on growth and development,and infliximab has effects on the gastrointestinal tract in children.
2.Chinese expert consensus on the diagnosis and treatment of traumatic cerebrospinal fluid leakage in adults (version 2023)
Fan FAN ; Junfeng FENG ; Xin CHEN ; Kaiwei HAN ; Xianjian HUANG ; Chuntao LI ; Ziyuan LIU ; Chunlong ZHONG ; Ligang CHEN ; Wenjin CHEN ; Bin DONG ; Jixin DUAN ; Wenhua FANG ; Guang FENG ; Guoyi GAO ; Liang GAO ; Chunhua HANG ; Lijin HE ; Lijun HOU ; Qibing HUANG ; Jiyao JIANG ; Rongcai JIANG ; Shengyong LAN ; Lihong LI ; Jinfang LIU ; Zhixiong LIU ; Zhengxiang LUO ; Rongjun QIAN ; Binghui QIU ; Hongtao QU ; Guangzhi SHI ; Kai SHU ; Haiying SUN ; Xiaoou SUN ; Ning WANG ; Qinghua WANG ; Yuhai WANG ; Junji WEI ; Xiangpin WEI ; Lixin XU ; Chaohua YANG ; Hua YANG ; Likun YANG ; Xiaofeng YANG ; Renhe YU ; Yongming ZHANG ; Weiping ZHAO
Chinese Journal of Trauma 2023;39(9):769-779
Traumatic cerebrospinal fluid leakage commonly presents in traumatic brain injury patients, and it may lead to complications such as meningitis, ventriculitis, brain abscess, subdural hematoma or tension pneumocephalus. When misdiagnosed or inappropriately treated, traumatic cerebrospinal fluid leakage may result in severe complications and may be life-threatening. Some traumatic cerebrospinal fluid leakage has concealed manifestations and is prone to misdiagnosis. Due to different sites and mechanisms of trauma and degree of cerebrospinal fluid leak, treatments for traumatic cerebrospinal fluid leakage varies greatly. Hence, the Craniocerebral Trauma Professional Group of Neurosurgery Branch of Chinese Medical Association and the Neurological Injury Professional Group of Trauma Branch of Chinese Medical Association organized relevant experts to formulate the " Chinese expert consensus on the diagnosis and treatment of traumatic cerebrospinal fluid leakage in adults ( version 2023)" based on existing clinical evidence and experience. The consensus consisted of 16 recommendations, covering the leakage diagnosis, localization, treatments, and intracranial infection prevention, so as to standardize the diagnosis and treatment of traumatic cerebrospinal fluid leakage and improve the overall prognosis of the patients.
3.Genetic Subtypes and Pretreatment Drug Resistance in the Newly Reported Human Immunodeficiency Virus-Infected Men Aged≥50 Years Old in Guangxi.
Ning-Ye FANG ; Wen-Cui WEI ; Jian-Jun LI ; Ping CEN ; Xian-Xiang FENG ; Dong YANG ; Kai-Ling TANG ; Shu-Jia LIANG ; Yu-Lan SHAO ; Hua-Xiang LU ; He JIANG ; Qin MENG ; Shuai-Feng LIU ; Qiu-Ying ZHU ; Huan-Huan CHEN ; Guang-Hua LAN ; Shi-Xiong YANG ; Li-Fang ZHOU ; Jing-Lin MO ; Xian-Min GE
Acta Academiae Medicinae Sinicae 2023;45(3):399-404
Objective To analyze the genetic subtypes of human immunodeficiency virus (HIV) and the prevalence of pretreatment drug resistance in the newly reported HIV-infected men in Guangxi. Methods The stratified random sampling method was employed to select the newly reported HIV-infected men aged≥50 years old in 14 cities of Guangxi from January to June in 2020.The pol gene of HIV-1 was amplified by nested reverse transcription polymerase chain reaction and then sequenced.The mutation sites associated with drug resistance and the degree of drug resistance were then analyzed. Results A total of 615 HIV-infected men were included in the study.The genetic subtypes of CRF01_AE,CRF07_BC,and CRF08_BC accounted for 57.4% (353/615),17.1% (105/615),and 22.4% (138/615),respectively.The mutations associated with the resistance to nucleoside reverse transcriptase inhibitors (NRTI),non-nucleoside reverse transcriptase inhibitors (NNRTI),and protease inhibitors occurred in 8 (1.3%),18 (2.9%),and 0 patients,respectively.M184V (0.7%) and K103N (1.8%) were the mutations with the highest occurrence rates for the resistance to NRTIs and NNRTIs,respectively.Twenty-two (3.6%) patients were resistant to at least one type of inhibitors.Specifically,4 (0.7%),14 (2.3%),4 (0.7%),and 0 patients were resistant to NRTIs,NNRTIs,both NRTIs and NNRTIs,and protease inhibitors,respectively.The pretreatment resistance to NNRTIs had much higher frequency than that to NRTIs (2.9% vs.1.3%;χ2=3.929,P=0.047).The prevalence of pretreatment resistance to lamivudine,zidovudine,tenofovir,abacavir,rilpivirine,efavirenz,nevirapine,and lopinavir/ritonavir was 0.8%, 0.3%, 0.7%, 1.0%, 1.3%, 2.8%, 2.9%, and 0, respectively. Conclusions CRF01_AE,CRF07_BC,and CRF08_BC are the three major strains of HIV-infected men≥50 years old newly reported in Guangxi,2020,and the pretreatment drug resistance demonstrates low prevalence.
Male
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Humans
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Middle Aged
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Reverse Transcriptase Inhibitors/therapeutic use*
;
HIV Infections/drug therapy*
;
Drug Resistance, Viral/genetics*
;
China/epidemiology*
;
Mutation
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HIV-1/genetics*
;
Protease Inhibitors/therapeutic use*
;
Genotype
4.The influence of subjective comfort of working environment on occupational stress of railway station workers.
Qiu Yan XU ; Huan XUE ; Jie YANG ; Shu Ning HE ; Ya Jia LAN ; Qin ZHANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2022;40(4):267-271
Objective: To explore the influential factors of job stress suffered by workers in railway stations, the level of job stress of were measured and subjective comfort of employees targeting to working environment were reported. Methods: In March 2019, a cluster sampling study was designed to collect the personal characteristics, job characteristics and subjective comfort degree of working environment of 432 employees in Chongqing railway stations. Meanwhile, job stress was assessed using the effort-reward imbalance scale. Chi-square test was used to compare the difference of occupational stress detection rate among different stratified factors such as occupational characteristics. Logistic regression was applied to analyze the influential factors of occupational stress. Results: The detection rate of job stress of workers in the railway stations was 31.02% (134/432) . The detection rate of job stress was higher among the divorced workers in railway stations, those earning less than 5, 000 yuan per month, those with 10-20 years' length of service, those who worked as a conductor and other workers including baggageman, station master on duty and assistant engineer (χ(2)=9.61, 14.76, 23.28, 11.06, P=0.008, 0.002, 0.000, 0.011) . The detection rate of job stress was higher among those whose working environment subjective feelings were uncomfortable, the differences were statistically significant (P<0.001) . The results showed that the occupational stress of the staff in the railway stations was influenced by their subjective feeling of air quality, noise and Space Layout (P<0.05) . The risk factors of occupational stress were air quality, noise and uncomfortable space layout (OR=0.571, 0.068, 0.441, P=0.051, 0.054, 0.007) . Conductor, other (Bellboy, Duty Station Master, assistant engineer) were the risk factors of occupational stress (OR=1.884, 2.703, P=0.065, 0.019) . The employees of station A and station B were the risk factors of occupational stress (OR=4.681, 1.811, P=0.002, 0.067) . Conclusion: The higher detection rate of job stress of workers in the railway stations is correlated with the subjective comfort degree of the working environment of the workers.
Cross-Sectional Studies
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Humans
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Job Satisfaction
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Occupational Stress/epidemiology*
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Stress, Psychological
;
Surveys and Questionnaires
;
Workplace
5.Preliminary results of multicenter studies on ABO-incompatible kidney transplantation
Hongtao JIANG ; Tao LI ; Kun REN ; Xiaohua YU ; Yi WANG ; Shanbin ZHANG ; Desheng LI ; Huiling GAN ; Houqin LIU ; Liang XU ; Zhigang LUO ; Peigen GUI ; Xiangfang TAN ; Bingyi SHI ; Ming CAI ; Xiang LI ; Junnan XU ; Liang XU ; Tao LIN ; Xianding WANG ; Hongtao LIU ; Lexi ZHANG ; Jianyong WU ; Wenhua LEI ; Jiang QIU ; Guodong CHEN ; Jun LI ; Gang HUANG ; Chenglin WU ; Changxi WANG ; Lizhong CHEN ; Zheng CHEN ; Jiali FANG ; Xiaoming ZHANG ; Tongyi MEN ; Xianduo LI ; Chunbo MO ; Zhen WANG ; Xiaofeng SHI ; Guanghui PEI ; Jinpeng TU ; Xiaopeng HU ; Xiaodong ZHANG ; Ning LI ; Shaohua SHI ; Hua CHEN ; Zhenxing WANG ; Weiguo SUI ; Ying LI ; Qiang YAN ; Huaizhou CHEN ; Liusheng LAI ; Jinfeng LI ; Wenjun SHANG ; Guiwen FENG ; Gang CHEN ; Fanjun ZENG ; Lan ZHU ; Jun FANG ; Ruiming RONG ; Xuanchuan WANG ; Guisheng QI ; Qiang WANG ; Puxun TIAN ; Yang LI ; Xiaohui TIAN ; Heli XIANG ; Xiaoming PAN ; Xiaoming DING ; Wujun XUE ; Jiqiu WEN ; Xiaosong XU
Chinese Journal of Organ Transplantation 2020;41(5):259-264
Objective:To summarize the patient profiles and therapeutic efficacies of ABO-incompatible living-related kidney transplantations at 19 domestic transplant centers and provide rationales for clinical application of ABOi-KT.Methods:Clinical cases of ABO-incompatible/compatible kidney transplantation (ABOi-KT/ABOc-KT) from December 2006 to December 2009 were collected. Then, statistical analyses were conducted from the aspects of tissue matching, perioperative managements, complications and survival rates of renal allograft or recipients.Results:Clinical data of 342 ABOi-KT and 779 ABOc-KT indicated that (1) no inter-group differences existed in age, body mass index (BMI), donor-recipient relationship or waiting time of pre-operative dialysis; (2) ABO blood type: blood type O recipients had the longest waiting list and transplantations from blood type A to blood type O accounted for the largest proportion; (3) HLA matching: no statistical significance existed in mismatch rate or positive rate of PRA I/II between two types of surgery; (4) CD20 should be properly used on the basis of different phrases; (5) hemorrhage was a common complication during an early postoperative period and microthrombosis appeared later; (6) no difference existed in postoperative incidence of complications or survival rate of renal allograft and recipients at 1/3/5/10 years between ABOi-KT and ABOc-KT. The acute rejection rate and serum creatinine levels of ABOi-KT recipients were comparable to those of ABOc-KT recipients within 1 year.Conclusions:ABOi-KT is both safe and effective so that it may be applied at all transplant centers as needed.
6.Clinical Significance of Common Gene Mutations in 53 Patients with Acute Myeloid Leukemia Harboring 11q23/MLL Rearrangements.
Shu-Xiao BAI ; Yan-Lei GONG ; Jing-Ren ZHANG ; Chun-Xiao WU ; Jun ZHANG ; Hui-Ying QIU ; Hong-Jie SHEN ; Jian-Nong CEN ; Su-Ning CHEN ; Jin-Lan PAN
Journal of Experimental Hematology 2020;28(3):717-723
OBJECTIVE:
To investigate the clinical significance of AML patients with 11q23/MLL rearrangement, and to evaluate the effect of those mutations on the AML patients.
METHODS:
53 cases involving translocations of chromosome 11q23 were identified by chromosome banding analysis. MLL rearrangements were detected by fluorescence in situ hybridization and/or multiplex nested PCR. The samples were screened for mutations in the candidate genes FLT3-ITD, FLT3-TKD, TET2, N-RAS, ASXLI, EZH2, DNMT3, C-Kit, NPM1, WT1, CEBPA by using genomic DNA-PCR and deep-sequencing.
RESULTS:
21/53 MLL-rearranged AML cases showed at least one additional chromosomal aberrations. The most common additional aberration was +8. Gene mutations were observed in 23 cases (43.4%) and most cases showed singal mutation. N-RAS mutation was more frequent (8 cases, 15.1%), followed by WT1 mutation in 4 cases (7.5%), FLT3-ITD mutation in 3 cases, ASXL1 mutation in 2 cases, DNMT3A mutation in 2 cases, EZH2 mutation in 1 case, c-Kit17 mutation in 1 case, FLT3-TKD mutation in 1 case, and FLT3-ITD and TKD mutation coexistent in 1 case. No mutation was detected in CEBPA, NPM1, C-KIT8, TET2. Median OS for gene mutated patients was 8.5 months and 13 months for no mutated patients. Median OS for patients who received hematopoietic stem cell transplantation (HSCT) was 22.5 months and 7.5 months for patients who olny received chemotherapy.
CONCLUSION
A relatively high mutation frequency is observed in AML patients with 11q23/MLL rearrangements and most cases shows single mutation. The RAS signaling pathway alterations are most common. Gene mutation does not affect the OS of these patients, who show poor prognosis. A significantly higher Hb at initial diagnosis in FLT3 mutated patients is significantly higher than that in FLT3 wild-type cases. Patients who underwent HSCT show a better prognosis than those only received chemotherapy.
Chromosomes, Human, Pair 11
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Hematopoietic Stem Cell Transplantation
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Humans
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In Situ Hybridization, Fluorescence
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Leukemia, Myeloid, Acute
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Mutation
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Prognosis
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fms-Like Tyrosine Kinase 3
7.Chromosomal aberrations detection in chronic lymphocytic leukemia by conventional cytogenetics using DSP30 and IL-2.
Heng Fang LIU ; Hai Wen HUANG ; Shu Xiao BAI ; Yan Lei GONG ; Chun Xiao WU ; Zheng Ming JIN ; Yuan Yuan WANG ; Qian YANG ; Jun ZHANG ; Hui Ying QIU ; Su Ning CHEN ; Jin Lan PAN
Chinese Journal of Hematology 2020;41(2):143-148
Objective: To study the value of unmethylated cytosine guanine dinucleotide oligodeoxynucleotide (DSP30) and IL-2 in the conventional cytogenetic (CA) detection of the chromosomal aberrations in chronic lymphocytic leukemia (CLL) . Methods: Bone marrow or peripheral blood cells of CLL patients were cultured with DSP30 plus IL-2 for 72 h, following which R-banding analysis was conducted. Fluorescence in situ hybridization (FISH) was performed in 85 patients. CA results were compared with data obtained by FISH. Results: Among 89 CLL patients, the success rate of chromosome analysis was 94.38% (84/89) . Clonal aberrations were detected in 51 patients (51/84, 60.71%) . Of them, 27 (27/51, 52.94%) were complex karyotype. Among 85 CLL patients tested by FISH, chromosomal abnormalities were detected in 74 (74/85, 87.06%) patients, of which 2 (2/74) patients were complex karyotypes, accounting for 2.70%. Of the 85 CLL patients examined by FISH, 50 had abnormal karyotype analysis, 30 had normal karyotype, 5 failed to have chromosome analysis. Among them, 25 cases showed clonal aberrations by FISH assay but normal by CA, and 4 cases were normal by FISH but displayed aberrations in chromosome analysis, and totally 78 (91.76%) cases with abnormality detected by the combination of the two methods. The frequency of 13q- abnormality detected by FISH was significantly higher than that by CA analysis (69.41%vs 16.67%, P<0.001) , while the frequency of 11q-,+12 and 17p- detected by two methods showed no significant difference (P>0.05) . The detection rate of complex abnormalities in conventional karyotype analysis was higher than that in FISH (50.98%vs 2.70%) . In addition, 11 low-risk and 9 intermediate-risk patients according to FISH results showed complex karyotype by cytogenetics, and were classified into high-risk cytogenetic subgroup. Conclusion: DSP30 and IL-2 are effective in improving the detection rate of CA in CLL patients (60.71%) and CA is more effective to detect complex karyotype. However, FISH had a higher overall abnormality detection rate (87.06%) than CA, especially for 13q-. The combination of CA and FISH not only enhanced the detection rate of clonal aberrations to 91.76%, but also provided more precise prognosis stratification for CLL patients, thus to provide more information for clinical implication.
Chromosome Aberrations
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Cytogenetics
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Humans
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In Situ Hybridization, Fluorescence
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Interleukin-2
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Leukemia, Lymphocytic, Chronic, B-Cell
8.Severe acute respiratory syndrome coronavirus 2 infection in renal transplant recipients: A case report.
Qiu Yu LI ; Qin CHENG ; Zhi Ling ZHAO ; Ni Ni DAI ; Lin ZENG ; Lan ZHU ; Wei GUO ; Chao LI ; Jun Hong WANG ; Shu LI ; Qing Gang GE ; Ning SHEN
Journal of Peking University(Health Sciences) 2020;52(4):780-784
The novel coronavirus is a newly discovered pathogen in late December 2019, and its source is currently unknown, which can lead to asymptomatic infection, new coronavirus pneumonia or serious complications, such as acute respiratory failure. Corona virus disease 2019 (COVID-19) is a new type of respiratory disease that is currently spreading all over the world and caused by this coronavirus. Its common symptoms are highly similar to those of other viruses, such as fever, cough and dyspnea. There is currently no vaccine or treatment for COVID-19. Everyone is susceptible to infection with this disease, and owing to the long-term use of immunosuppressants, the immunity of kidney transplant recipients is suppressed, and it is more likely to be infected with the disease. At present, its impact on kidney transplant recipients is unclear. This article reports the clinical features and therapeutic course of novel coronavirus infection in a patient after renal transplantation. A 37-year-old female patient who received a kidney transplant 6 months before was diagnosed with novel coronavirus pneumonia. The patient's symptoms (such as fever, chills, dry cough, muscle aches), laboratory tests (such as decreased white blood cell count, elevated liver enzymes and D-dimer, positive viral nucleic acid test), and chest CT (multiple left lower lung plaque ground glass shadow) were similar to those of non-transplanted novel coronavirus pneumonia patients. In terms of treatment, because the immunity of kidney transplant recipients has been suppressed for a long time, it is a very common strategy to suspend the use of immunosuppressive agents. Therefore, the patient immediately discontinued the immunosuppressive agent after admission, so that she could restore immunity against infection in a short time. At the same time, the use of glucocorticoids was also very important. Its immunosuppressive and anti-inflammatory effects played a large role in the treatment process.In addition, prophylactic antibiotics was needed, and nephrotoxic drugs should be used with caution. Finally, following discounting the use of immunosuppressant and a low-dose glucocorticoid-based treatment regimen, COVID-19 in this renal transplant recipient was successfully cured. The cure of this case was of great significance, and this adjuvant nonspecific antiviral therapy could provide a template for the treatment of other such patients.
Adult
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Betacoronavirus
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COVID-19
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Coronavirus Infections
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Female
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Humans
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Kidney Transplantation
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Pandemics
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Pneumonia, Viral
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SARS-CoV-2
;
Transplant Recipients
9.Efficacy and Safety of MSC Infusion in Treatment of Children with Refractory LOHC: A Clinical Study.
Kun-Yin QIU ; Xiong-Yu LIAO ; Shu-Yi GUO ; Hao-Ning QI ; Jing-Jing LAN ; Jian-Pei FANG ; Ke HUANG ; Yang LI ; Hong-Gui XU ; Dun-Hua ZHOU
Journal of Experimental Hematology 2018;26(3):900-904
OBJECTIVETo study the curative effect and safety of menchymal stem cell infusion in treatment of children with refractory late-onset hemorrhagic cystitis(LOHC) after allogeneic HSCT.
METHODSThirty cases of children with refractory LOHC after allo-HSCT in our department between December 2010 and July 2016 were analyzed retrospectively, out of 30 cases 7 received MSC treatment. The used MSC of all were four-to-five generation MSC from bone marrows of third party donors, and were infused into patients with (1.87±0.456)×10/kg MSCs once a week (1-4 times in total) until the hematuria and odynuria symptoms being improved. To observe whether unfavorable reactions occurred after MSC treatment, the patients accepted daily physical examination and regular assistant examination. The cytokine levels were also measured and dynamically detected in 2 cases before and after MSC treatment.
RESULTSIn 30 children with refractory LOHC, the hematuria difficultly reached the remission after routine hydration, alkalizing and antiviral therapy, Among 25 cases who were received methylprednisolone, MTX and CTX therapy, 7 cases received MSC infusion for 1-4 times with dose of (1.87±0.456)×10/(kg·time) as a result, 7 cases of LOHC were cured. The TNF-α and IL-2R levels in 2 cases progressively decreased after MSC infusion, no occurence of fever, rash, embolism and so on were found in 7 cases received MSC infusion; the BKV detection showed that the viral load did not increase; the leukemia relapse or secondary cancer did not occure.
CONCLUSIONThe MSC treatment is safe and effective for refractory LOHC after allo-HSCT.
Child ; Cystitis ; Graft vs Host Disease ; Hematopoietic Stem Cell Transplantation ; Humans ; Mesenchymal Stem Cell Transplantation ; Retrospective Studies ; Transplantation, Homologous ; Treatment Outcome
10.JAK2V617F mutation and BCR-ABL fusion gene positive myeloproliferative neoplasm: two case report.
Yong WANG ; Jin Lan PAN ; Juan SHEN ; Jun ZHANG ; Shu Xiao BAI ; Yan Lei GONG ; Chun Xiao WU ; Jian Nong CEN ; Li YAO ; Hong Jie SHEN ; Jun Dan XIE ; Su Ning CHEN ; Hong Chun QIU
Chinese Journal of Hematology 2018;39(3):247-247

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