1.Expert consensus on ethical requirements for artificial intelligence (AI) processing medical data.
Cong LI ; Xiao-Yan ZHANG ; Yun-Hong WU ; Xiao-Lei YANG ; Hua-Rong YU ; Hong-Bo JIN ; Ying-Bo LI ; Zhao-Hui ZHU ; Rui LIU ; Na LIU ; Yi XIE ; Lin-Li LYU ; Xin-Hong ZHU ; Hong TANG ; Hong-Fang LI ; Hong-Li LI ; Xiang-Jun ZENG ; Zai-Xing CHEN ; Xiao-Fang FAN ; Yan WANG ; Zhi-Juan WU ; Zun-Qiu WU ; Ya-Qun GUAN ; Ming-Ming XUE ; Bin LUO ; Ai-Mei WANG ; Xin-Wang YANG ; Ying YING ; Xiu-Hong YANG ; Xin-Zhong HUANG ; Ming-Fei LANG ; Shi-Min CHEN ; Huan-Huan ZHANG ; Zhong ZHANG ; Wu HUANG ; Guo-Biao XU ; Jia-Qi LIU ; Tao SONG ; Jing XIAO ; Yun-Long XIA ; You-Fei GUAN ; Liang ZHU
Acta Physiologica Sinica 2024;76(6):937-942
As artificial intelligence technology rapidly advances, its deployment within the medical sector presents substantial ethical challenges. Consequently, it becomes crucial to create a standardized, transparent, and secure framework for processing medical data. This includes setting the ethical boundaries for medical artificial intelligence and safeguarding both patient rights and data integrity. This consensus governs every facet of medical data handling through artificial intelligence, encompassing data gathering, processing, storage, transmission, utilization, and sharing. Its purpose is to ensure the management of medical data adheres to ethical standards and legal requirements, while safeguarding patient privacy and data security. Concurrently, the principles of compliance with the law, patient privacy respect, patient interest protection, and safety and reliability are underscored. Key issues such as informed consent, data usage, intellectual property protection, conflict of interest, and benefit sharing are examined in depth. The enactment of this expert consensus is intended to foster the profound integration and sustainable advancement of artificial intelligence within the medical domain, while simultaneously ensuring that artificial intelligence adheres strictly to the relevant ethical norms and legal frameworks during the processing of medical data.
Artificial Intelligence/legislation & jurisprudence*
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Humans
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Consensus
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Computer Security/standards*
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Confidentiality/ethics*
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Informed Consent/ethics*
2.Discovery of novel small molecules targeting hepatitis B virus core protein from marine natural products with HiBiT-based high-throughput screening.
Chao HUANG ; Yang JIN ; Panpan FU ; Kongying HU ; Mengxue WANG ; Wenjing ZAI ; Ting HUA ; Xinluo SONG ; Jianyu YE ; Yiqing ZHANG ; Gan LUO ; Haiyu WANG ; Jiangxia LIU ; Jieliang CHEN ; Xuwen LI ; Zhenghong YUAN
Acta Pharmaceutica Sinica B 2024;14(11):4914-4933
Due to the limitations of current anti-HBV therapies, the HBV core (HBc or HBcAg) protein assembly modulators (CpAMs) are believed to be potential anti-HBV agents. Therefore, discovering safe and efficient CpAMs is of great value. In this study, we established a HiBiT-based high-throughput screening system targeting HBc and screened novel CpAMs from an in-house marine chemicals library. A novel lead compound 8a, a derivative of the marine natural product naamidine J, has been successfully screened for potential anti-HBV activity. Bioactivity-driven synthesis was then conducted, and the structure‒activity relationship was analyzed, resulting in the discovery of the most effective compound 11a (IC50 = 0.24 μmol/L). Furthermore, 11a was found to significantly inhibit HBV replication in multiple cell models and exhibit a synergistic effect with tenofovir disoproxil fumarate (TDF) and IFNa2 in vitro for anti-HBV activity. Treatment with 11a in a hydrodynamic-injection mouse model demonstrated significant anti-HBV activity without apparent hepatotoxicity. These findings suggest that the naamidine J derivative 11a could be used as the HBV core protein assembly modulator to develop safe and effective anti-HBV therapies.
3.Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5–24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study
Lu WANG ; Ying-Jie DAI ; Yu CUI ; Hong ZHANG ; Chang-Hao JIANG ; Ying-Jie DUAN ; Yong ZHAO ; Ye-Fang FENG ; Shi-Mei GENG ; Zai-Hui ZHANG ; Jiang LU ; Ping ZHANG ; Li-Wei ZHAO ; Hang ZHAO ; Yu-Tong MA ; Cheng-Guang SONG ; Yi ZHANG ; Hui-Sheng CHEN
Journal of Stroke 2023;25(3):371-377
Background:
and Purpose Intravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset.
Methods:
In this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5–24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0–1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH).
Results:
Of the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46–2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0–2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group.
Conclusion
This phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5–24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.
4.Clinical application of bipolar tweezers-clamp for hepatic parenchymal transection.
Shu You PENG ; Cong Yun HUANG ; Jian Hua ZHU ; Li Ming WU ; Wen Ying LIU ; Yong TAN ; Zai Xing OUYANG ; Hao SONG
Chinese Journal of Surgery 2022;60(5):449-453
Objective: To investigate the clinical value of the bipolar tweezers-clamp for the hepatic parenchymal transection in the resection of hepatocellular carcinoma. Methods: From January 2020 to January 2021,63 patients with the hepatocellular carcinoma for hepatectomy at Department of Hepatopancreatobiliary Surgery,Yuebei People's Hospital Affiliated to Shantou University Medical College were analyzed retrospectively.According to the different instruments used in the hepatic parenchymal transection,the patients were divided into bipolar tweezers-clamp group and ultrasonic scalpel group.There were 32 patients in bipolar tweezers-clamp group,with age of (55.5±10.5)years(range:37 to 78 years),including 22 males and 10 females,tumor size was (6.0±3.4)cm(range:2.4 to 13.4 cm). There were 6 patients with portal vein tumor thrombus and 5 patients with portal hypertension. There were 31 patients in ultrasonic scalpel group,with aged(57.8±10.1)years(range:37 to 79 years),including 27males and 4 females,tumor size was(7.9±5.1)cm(range: 2.4 to 21.3 cm),3 patients with portal vein tumor thrombus and 2 patients with portal hypertension. The preoperative baseline data,operation time,blood loss,postoperative liver function and the complications were compared between two groups using t test,χ2 test and Fisher exact probabilityrespectively. Results: The operation was successfully completed in both groups.Compared with the ultrasonic scalpel group,the operation time was significantly shorter((219.3±76.4)minutes vs.(294.0±100.8)minutes,t=-3.322,P=0.002),the blood loss was less((250(475)ml vs. 500(1 050)ml,t=-2.307,P=0.026),the concentrate red blood cells transfusion volume was less(0.92(0.88)U vs. 2.32(4.00)U,Z=-1.987,P=0.047) in the bipolar tweezers-clamp group.The postoperative serum ALB level was higher in the bipolar tweezers-clamp group than that in the ultrasonic scalpel group((33.5±6.1)g/L vs. (29.5±4.2)g/L,t=3.226,P=0.020) on postoperative day 1;((35.7±4.5)g/L vs.(30.1±3.2)g/L,t=5.575,P<0.01) on postoperative day 3;((33.2±3.7)g/L vs. (31.0±4.4)g/L,t=3.020,P=0.004) on postoperative day 7. There was no significant difference in serum ALT,TBIL and PT level between the two groups(all P>0.05).No postoperative bile leakage occurred in both groups.The postoperative complications occurred in 8 cases(25.0%)in the bipolar tweezers-clamp group,including liver failure in one,and in 11 cases(35.5%)in the ultrasonic scalpel group,including liver failure in two(P>0.05). Conclusion: The bipolar tweezers-clamp is a safe and reliable method for the hepatic parenchymal transaction,which is quick and less bleeding during the hepatic resection.
Blood Loss, Surgical
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Carcinoma, Hepatocellular/surgery*
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Female
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Hemorrhage
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Hepatectomy/methods*
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Humans
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Hypertension, Portal/surgery*
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Liver Failure
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Liver Neoplasms/surgery*
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Male
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Retrospective Studies
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Treatment Outcome
5.Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
Lin CAI ; Jian-Zhong ZHANG ; Xu YAO ; Jun GU ; Quan-Zhong LIU ; Min ZHENG ; Shi-Fa ZHANG ; Jin-Hua XU ; Cheng-Xin LI ; Hao CHENG ; Qing GUO ; Wei-Li PAN ; Shen-Qiu LI ; Ruo-Yu LI ; Zai-Pei GUO ; Zhi-Qi SONG ; Shan-Shan LI ; Xiu-Qin DONG ; Linda WANG ; Rong FU ; Pascaline REGNAULT ; Pascal CHAREF ; Rafal MAZUR ; Manmath PATEKAR
Chinese Medical Journal 2020;133(22):2665-2673
BACKGROUND:
Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS:
This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS:
A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION:
Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
Antibodies, Monoclonal/therapeutic use*
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Antibodies, Monoclonal, Humanized
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China
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Double-Blind Method
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Humans
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Psoriasis/drug therapy*
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Severity of Illness Index
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Treatment Outcome
6.Analysis of special ehealth service for corona virus disease 2019 (COVID-19) pneumonia.
Wen FENG ; Liang Nan ZHANG ; Jing Yuan LI ; Tian WEI ; Ting Ting PENG ; Dong Xu ZHANG ; Zai Xin GUO ; Wei Song WANG
Journal of Peking University(Health Sciences) 2020;52(2):302-307
OBJECTIVE:
To analyze how governments, hospitals and information technology(IT) companies use Internet technology to provide online health services during the early stage of corona virus disease 2019 (COVID-19) epidemic in January 2020 in China, and then provide suggestions and coping strategies for the later stage and post-epidemic time.
METHODS:
We searched for information on ehealth services related to the outbreak of COVID-19 in China. The sources of information were mainstream search engines such as Baidu and the popular interactive social platforms such as Webchat. The keywords were "Internet+pneumonia", "Internet clinic", "pneumonia online clinic" and so on. The time of information was from January 20 to February 3, 2020. The key information was extracted and encoded by two persons back-to-back. The coding information included: name of organization provider, launching time, location of provider, service items, user, health workers engaging in the service, and so on. The coded information was entered and analyzed with SPSS 24.0 and Excel.
RESULTS:
There were totally 57 projects launched by local governments, hospitals and IT companies. Most of them were launched from January 24th to 27th, the hospital and government projects services regionally, especially in eastern provinces. In this study, 90.48% of the enterprises and 100.00% of the hospitals had online fever clinic and consultation services for COVID-19, 66.67% of the enterprises and 37.04% of the hospitals serviced derivative health problems. Only a few projects provided tele-medical consultation. There were individual projects that provided online health management for home quarantine people. Physicians were the main force of various projects. In some hospital projects, there were also nurses, pharmacists and professional technicians to provide featured consultation.
CONCLUSION
Ehealth is useful and helpful for the health care system to rapidly cope with health demand during instantaneous and post epidemic time. Regional distribution of ehealth is unbalanced. There are institutional and technical feasibilities for the emergency application of Internet technology. However, community health centers seldom provide ehealth or connect with tertiary hospitals with Internet. Therefore, all kinds of providers within healthcare system should promote emergence ehealth. Tele-medical diagnosis and referral should be developed by local governments during COVID-19. The application of "Internet+medical treatment" in community medical institutions and synergy among various institutions should be promoted.
Betacoronavirus
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COVID-19
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China
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Coronavirus Infections
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Humans
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Pandemics
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Pneumonia, Viral
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SARS-CoV-2
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Telemedicine
7.Pilot study of the effect of WeChat medication education on patients using warfarin
Zai-Wei SONG ; Zhi-Yuan TAN ; Shu-Jie DONG ; Rong-Sheng ZHAO ; Rui TIAN ; Suo-Di ZHAI ; Li YANG
The Chinese Journal of Clinical Pharmacology 2018;34(1):60-62
Objective To explore the method of WeChat medication education for patients used by pharmacists,and to investigate the effect of WeChat medication education at Peking university third hospital.Methods Totally 30 patients who used warfarin at Peking university third hospital were enrolled.A series of subscriptions concerning warfarin medication education were sent to patients and/or their caregivers by WeChat regularly.The medication knowledge score after/before the intervention were assessed.Results The score of patients' warfarin medication knowledge before intervention was (14.20 ± 1.97) points,and after that the score was (16.63 ± 1.74) points,showing an improvenent with significance (P < 0.001).Questions about adverse events of warfarin were most likely to be answered by mistake and the score of relevant questions was only (0.97 ± 0.80) points and (1.07 ± 0.81) points,respectively (P > 0.05) before and after intervention.Conclusion It is of great significance for pharmacists to provide warfarin medication education.It is proved effective to improve patients' recognition of warfarin medication by means of WeChat subscriptions.
8.Impacts of the regional cooperative chest pain center on the therapeutic time and the short term outcome of patients with ST segment elevated myocardial infarction
qin Guo CHEN ; hao Jian LI ; zhu Wen ZHANG ; yong Jia LIANG ; yong Zai ZHANG ; dong Han LEI ; cai Ming SONG
Chinese Journal of Interventional Cardiology 2017;25(10):579-583
Objective To investigate the impact of the regional cooperative chest pain center (CPC) on therapeutic time and short term outcome after primary percutaneous coronary intervention (PCI) of patients with ST segment elevated myocardial infarction.Methods 372 patients with ST segment elevated myocardial infarction were enrolled in the study who had received were operated primary PCI 18 months before and after the regional cooperative CPC was set up.There were 156 patients in the green channel group before the setup of CPC and 216 patients in the CPC group.Total ischemia time,first medical contact (FMC) time,FML-to-balloon (FMC2B) time,door-to-balloon (D2B) time,hospital mortality rates,cardiac failure rates on the next day after PCI,length of CCU stays and hospital stays were compared between the two groups.Results Compared to the green channel group,total ischemia time[(281.0±102.7)min vs.(365.2±115.6)min,P<0.05],FMC time [(174.3±97.5) min vs.(225.4±104.6) min,P<0.05],FMC2B time [(106.7±61.2) min vs.(139.8±75.7) min,P<0.05] and D2B time [(75.2±45.4) min vs.(102.4±53.7) min,P<0.05] of the CPC group were significant shorter.The rates of reaching the standard of FMC2B time (70.83% vs.34.62%,P<0.001) and D2B time (75.93% vs.40.38%,P<0.001)were significantly higher in the CPC group.Cardiac failure rates on the next day after PCI was lower in the CPC group (14.35% vs.23.72%,P=0.021),and CCU stays was shorter [(64.3±13.72)h vs.(92.6±15.65)h,P=0.043].Conclusions Establishment of a standardized regional cooperative CPC requires combination and consideration of the characteristics of local resources FMC2B time and D2B time of STEMI patients can be shorten by a standardized CPC lending to further shortening of total ischemia time and improvement in cardiac function.
9.Relationship between ACE gene insertion or deletion polymorphism and left ventricular mass in newborns admitted to the neonatal intensive care unit.
Tong-Yan HAN ; Xin-Li WANG ; Yun-Pu CUI ; Hong-Mao YE ; Zai-Ling LI ; Xiao-Mei TONG ; Mei-Hua PIAO ; Song LI
Chinese Journal of Contemporary Pediatrics 2010;12(10):767-770
OBJECTIVETo study the relationship between angiotensin converting enzyme (ACE) gene insertion/deletion (I/D) polymorphism and left ventricular mass (LVM) in newborns admitted to the neonatal intensive care unit (NICU).
METHODSSeventy-two newborns admitted to the NICU were enrolled. ACE genotypes were determined by genomic DNA which was isolated from heel-prick blood. Disease status of the newborns was evaluated by the Neonatal Critical Score (draft) on postnatal day 1. LVM and LVM index (LVMI) were evaluated by echocardiography on postnatal days 1-3.
RESULTSDD genotype was identified in 11 cases, ID genotype in 31 cases, and II genotype in 30 cases. There were no significant differences in clinical characteristics, critical score and body measurements in newborns with different genotypes. The DD genotype group showed significantly lower LVMI than the group with ID+II genotypes (29±4 g/m2 vs 35±8 g/m2; P<0.05).
CONCLUSIONSACE gene polymorphism is associated with the LVMI in newborns admitted to the NICU. The LVMI of DD genotype carriers is significantly lower than that of ID+II genotypes carriers, which suggests that D allele may be associated with the growth and development of left ventricular.
Echocardiography ; Female ; Gene Deletion ; Genotype ; Heart Ventricles ; diagnostic imaging ; Humans ; Intensive Care Units, Neonatal ; Male ; Mutagenesis, Insertional ; Peptidyl-Dipeptidase A ; genetics ; Polymorphism, Genetic
10.A novel single nucleotide polymorphism-based method for quantitative assessment of chimerism after allogeneic stem cell transplantation..
Yu SHAO ; Jian-Min WANG ; Sheng-Lan GONG ; Zai-Long CAI ; Wei-Ping ZHANG ; Xian-Min SONG ; Li-Ping WANG
Chinese Journal of Hematology 2010;31(2):92-96
OBJECTIVETo develop a novel single nucleotide polymorphism (SNP)-PCR based method for quantitative detection of chimerism after allogeneic haemopoietic stem cell transplantation (allo-HSCT), and to explore its feasibility, accuracy and superiority.
METHODS18 SNP loci were sereened to identify informative markers for detecting chimerism in each donor/recipient pair before transplantation. Then the chimerism rate of each informative marker was analyzed by real-time quantitative PCR (RQ-PCR). The accuracy and sensitivity were verified by multiple proportion dilution and analogy chimerism compared with quantitative detection of short tandem repeat (STR)-PCR, fluorescence in situ hybridization (FISH) and fusion gene.
RESULTS(1) The average slope of the 17 time amplications of the internal control plasmid was -3.39, the average intercept was 39.97, correlation coefficients were more than 0.995, which was close to the theoretical level. The intra- and interassay variability was 0.50% and 1.1%, respectively, which were both in the allowed ranges. A linear correlation with artificial mixed chimerism is above 0.99 and a sensitivity of 0.01% proved reproducible. (2) At least one informative marker could be found in over 95% of 40 donor/recipient pairs. The results of the chimerisms derived from SNP-PCR were consistent with that from STR-PCR (96.7%), FISH and fusion gene analasis (P > 0.05); the quantitative results of special fusion gene transcripts were negtive in complete chimerism samples, and positive in mixed chimerism samples.
CONCLUSIONSThis new assay which overcome the PCR competition and plateau biases of STR-PCR provides an accurate, reliable and rapid quantitative assessment of mixed chimerism after allo-transplantation. It is highly promising for of clinical application and may take the place of STR-PCR in the conventional chimerisim assessment.
Chimerism ; Hematopoietic Stem Cell Transplantation ; Humans ; In Situ Hybridization, Fluorescence ; Polymorphism, Single Nucleotide ; Stem Cell Transplantation ; Transplantation Chimera ; Transplantation, Homologous

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