Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

Objective:This study aimed to determine the value of bone marrow biopsy (BMB) , bone marrow aspiration (BMA) , and positron emission tomography combined with computed tomography (PET/CT) in bone marrow (BM) involvement and prognosis evaluation in diffuse large B-cell lymphoma (DLBCL) .Methods:The clinical data of patients with DLBCL who underwent PET/CT, BMB, and BMA of the iliac crest were retrospectively analyzed in Peking Union Medical College Hospital from January 2015 to November 2017. The BM involvement on PET/CT was defined as the ratio of maximal standardized uptake values of iliac crest BM to liver parenchyma intensity ≥1.Results:A total of 76 patients without liver involvement were enrolled, there were 32 males, and the median age was 53 (17-79) . Moreover, 16 patients (21.1%) had BM involvement on PET/CT, 12 (15.8%) had positive BMB, and 13 (17.1%) had positive BMA. Excellent correlation between BMA and BMB ( κ=0.943) was found, including good correlation between PET/CT and BMB/BMA ( κ=0.763 and 0.776, respectively) . After a median follow-up of 52 (0-82) months, BM involvement by BMB ( P=0.037) and BMA ( P=0.007) were poor prognostic factors for overall survival, positive PET/CT had no significant effect on prognosis ( P>0.05) . Conclusion:PET/CT, BMB, and BMA are effective methods to detect BM involvement with great concordance. However, iliac crest BMB and BMA showed superior performance in prognosis evaluation.

Objective:To improve the understanding of newly diagnosed multiple myeloma (NDMM) patients with bone marrow (BM) monoclonal plasma cell ratio of less than 10%.Methods:The clinical characteristics, laboratory examination, response to treatment, and prognosis of 36 NDMM patients with BM plasma cell ratio of less than 10% at Peking Union Medical College Hospital from January 2009 to December 2017 were summarized retrospectively. In the same period, other age- and gender-matched 72 NDMM patients were selected as the control group, whose BM plasma cell ratio was equal to or greater than 10%.Results:First, the patients in the study group accounted for 4.4% of the whole MM population (36/818) , among which only 11 (30.6%) were classified as International Staging System (ISS) Ⅲ, which was significantly lower than that in the control group[45 (62.5%) ] ( P=0.002) . Extramedullary disease (EMD) was more common in the study group (33.3% vs 5.6%, P<0.001) . The median quantity of serum M protein (g/L) in the less than 10% group was 1.04 (0-50.10) , which was significantly lower than that in the control group [4.50 (0-63.10) ] ( P=0.016) , similar to the median quantity of 24-h urinary light chain (510 mg vs 2800 mg, respectively, P=0.023) . Second, the median progression-free survival (PFS) times of front-line regimen in the study and control groups were 26.4 and 19.9 months, respectively ( HR=1.703, 95% CI 0.167-0.233, P=0.002) . In addition, the overall survival (OS) times were 65.8 and 46.2 months, respectively ( HR=2.626, 95% CI 0.439-0.541, P=0.058) . Third, the study group was reclassified based on the quantity of M protein. The median OS times in patients with low/high tumor load were 66.4 and 24.0 months, respectively ( HR=2.349, 95% CI 0.603-0.696, P=0.046) . The median PFS times were 33.1 and 15.5 months, respectively ( HR=1.806, 95% CI 0.121-0.399, P=0.077) . Bortezomib-based regimens did not affect the clinical outcomes. Conclusion:The subpopulation of patients with MM with BM monoclonal plasma cell ratio less than 10% has specific clinical characteristics, including an early disease stage and a lower overall tumor load. Although more patients of this minor group presented with an extramedullary disease, their response rate to the initial treatment and survival outcome are better than those of patients with BM monoclonal plasma cell ratio more than 10%.

Objective: To evaluate the feasibility and potential value of comprehensive geriatric assessment (CGA) in elderly (≥60 years) patients with newly diagnosed acute myeloid leukemia (AML) in China. Methods: The CGA results of 83 newly diagnosed AML (non-APL) patients from 16 hospitals in Beijing and Tianjin between March 2016 and December 2017 were prospectively collected and analyzed. The clinical data, treatment and follow-up information were also collected. Results: Of 83 newly diagnosed elderly AML patients, 81 patients (97.6%) completed all designated CGA assessment. The median number of impaired scales of the CGA assessment in the studied population was 2(0-6). Sixteen patients (19.3%) showed no impairments according to the geriatric assessment scales implem ented by this study. The distributions of impaired scales were as follows: impairment in ADL, 55.4%; IADL impairment, 42.2%; MNA-SF impairment, 48.2%; cognitive impairment, 15.7%; GDS impairment, 31.7%; HCT-CI impairment, 19.5%, respectively. In patients with "good" ECOG (n=46), the proportion of impairment for each CGA scale ranged from 6.5% to 37.0% and 32 patients (68.9%) had at least one impaired CGA scale. Survival analysis showed that the number of impaired scales of the CGA was significantly correlated with median overall survival (P=0.050). Conclusions CGA was a tool with feasibility for the comprehensive evaluation in elderly AML patients in China. Combined with age and ECOG, CGA may be more comprehensive in assessing patients’ physical condition.

Objective To explore the diagnostic value of morphology in patients with blastic plasmacytoid dendritic cell leukemiafrom bone marrow cell.Methods Clinical data of 5 patients with BPDCN leukemia in Peking Union Medical College Hospital from 2011 to 2016were collected.The morphological characteristics of the cell size,nuclei,chromatin and cytoplasm of the BPDCNtumor cells in the bone marrow smears were observed under the microscope.Results The clinical manifestation of the 5 cases involved skin lesions (5/5,100％),lymphadenopathy (4/5,80％),hepatomegaly (3/5,60％),splenomegaly (4/5,80％).Immunophenotype showed all cases were positive for CD4,CD56 and CD123.The morphologiesof BPDCN cell characterized by heterogenous clls,were frequent,including,frequent mediumsized cells with a round or irregular nucleus,lacy chromatin,basophilic cytoplasm with lack of granules,marked large pseudopodia and vacuolation which may arranged as pearl necklace along the cytoplasmic outline.They might mimicking pseudomonoblast,Pseudolymphoblast or Pseudolymphoma cell.Conclusions Plasmacytoid dendritic cells had some peculiar morphological features,the patients suffered from the clinical manifestation of skin lesion may highly suggested the diagnosis of BPDCN,Flow cytometry and pathological biopsy are necessary for the final diagnosis of BPDCN.

Objective: To explore the clinical characteristics, treatment, and prognosis of patients with blastic plasmacytoid dendritic cell neoplasm. Method: Clinical records of 6 patients diagnosed with blastic plasmacytoid dendritic cell neoplasm in our hospital from January 2008 to May 2016 were collected and retrospectively analyzed. Results: Six patients manifested with initial symptoms of skin lesions, other common symptoms included bone marrow involvement (5/6) , lymphadenectasis (4/6) , splenomegaly (4/6) , and hepatomegaly (3/6) . In addition, extra-nodal involvement except skin was also observed, including breast (1/6) , maxillary sinus (1/6) , vertebrae (1/6) , and central nervous system (1/6) . Characteristic immunophenotype, CD4, CD56, and CD123 were all positive. All these patients were treated with acute lymphoblastic leukemia type (ALL-type) chemotherapy and complete remission (CR) were reached in 4 patients. The median follow-up was 9.5 (7-37) months, median progression free survival was 7 months; while median overall survival was 9 months. A total of 3 patients died during the follow-up, which were all happened in the first year after diagnosis, and all resulted from the relapse or disease progression. Conclusion Blastic plasmacytoid dendritic cell neoplasm is highly aggressive, in which the skin lesions are always manifested as initial symptoms, and bone marrow involvement, lymphadenectasis, splenomegaly, and hepatomegaly is also common. Characteristic immunophenotype include the positivity of CD4, CD56, and CD123. Effective and standard therapy is limited in this disease, which indicates the poor prognosis.

OBJECTIVETo assess the association of copy number variations (CNVs) of exon 11 of IL-23 receptor gene with susceptibility to active pulmonary tuberculosis among Chinese Uygurs.

METHODSIn this study, 250 subjects with active pulmonary tuberculosis (PTB) and 250 normal controls were recruited. A paired case-control study was conducted in the Chinese Uygur population in Xinjiang and the CNV of IL-23R was analyzed using Taqman real-time PCR.

RESULTSThe study showed that the frequencies of different copy number in exon 11 of IL-23R between PTB and control groups were statistically significant (χ(2)=13.35, P<0.01). There were significant difference in CNV of exon 11 in IL-23R between PTB patients and controls (χ(2)=14.95, P<0.01, OR=2.875, 95%CI: 1.655-4.994). The increase of copy number in exon 11 of IL-23R showed significantly different between PTB and control groups (χ(2)=10.475, P=0.0012, OR=2.611, 95%CI: 1.437-4.744).

CONCLUSIONThe CNV of exon 11 in IL-23R is associated with PTB in the Chinese Uygur population. The increase of the copy number in exon 11 of IL-23R may be a risk factor for PTB in Chinese Uygurs.

Adult ; Aged ; Asian Continental Ancestry Group ; ethnology ; genetics ; Case-Control Studies ; China ; ethnology ; DNA Copy Number Variations ; Exons ; Female ; Genetic Predisposition to Disease ; ethnology ; Humans ; Male ; Middle Aged ; Receptors, Interleukin ; genetics ; Tuberculosis, Pulmonary ; ethnology ; genetics ; Young Adult

Objective To investigate the distribution of carbapenem‐resistant Acinetobacter baumannii(CRAB) infections and its resistance to commonly used antibacterial drugs to provide a basis for infection control and rational use of antibacterial drugs in this area .Methods The clinical data and drug susceptibility test results in the patients with CRAB infection in our hospital from January 1 ,2013 to December 31 ,2014 were retrospectively analyzed .Results Eighteen strains of CRAB in community‐acquired in‐fection and 140 strains of CRAB in nosocomial infection were isolated ,the resistance rates to piperacillin/tazobactam ,gentamicin and tobramycin were higher than 80% ,which to ampicillin/sulbactam and levofloxacin were 64 .5% and 48 .2% respectively ,which to compound SMZ and amikacin were lower than 25% .The distribution of drug sensitivity results had no statistical difference between community CRAB infection and nosocomial CRAB infection (P>0 .05) .Conclusion The CRAB infection is mainly nosocomial in‐fection ,the empirical therapy could select compound SMZ and amikacin .

Objective To investigate the situation of pre-pregnancy health check in rural areas of Sichuan province and get the key difficult points during the process of carrying out the work.Methods According to the economic situation in Sichuan province and geographic distribution,random eight areas in Sichuan province (Chengdu,Neijiang,Nanchong,Ziyang,Meishan,Zigong,Les-han and Suining),investigate pregnant women in maternal and child health care institutions and family planning service institutions at all all levels in the areas above.Results Only 334 people (33.26%)underwent the pre-pregnancy health check during the 974 pregnant women in rural areas.The rate of planned pregnancy is low;the rate of unintended pregnancy is close to 40.00%.55.29%of the planned pregnancy women didn′t undergo the pre-pregnancy health check.And the factors that affect their behavior of under-going pre-pregnancy health check are whether planned pregnancy and personal attitude towards pre-pregnancy health check.Conclu-sion The rate of pre-pregnancy health check is low in the pregnant women from rural areas of Sichuan province,the health sector needs to make efforts to promote and enhance the awareness of the rural pregnant women to prevent birth defects and the initiative in participation.