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Objective:To investigate the efficacy and safety of daratumumab in relapsed and refractory multiple myeloma (RRMM).Methods:The efficacy and adverse events (AEs) of daratumumab based regimens were retrospectively analyzed in 37 patients with RRMM from Peking University People′s Hospital, Beijing Hospital and Fu Xing Hospital affiliated to Capital Medical University in China. The deadline for inclusion was December, 2019.Results:Among the 37 patients, 35 patients were available for response evaluation. The overall response rate (ORR) was 68.6%, which was better in patients receiving 16 mg/kg daratumumab than in those with fixed doses of 800 mg daratumumab [ORR: 78.3%(18/23) vs. 40.0%(4/10)]. The percentage of infusion related reactions of daratumumab was 27.0%(10/37). The most common hematological AEs were lymphocytopenia and thrombocytopenia, with the incidences of grade 3 or more severe 59.5%(22/37) and 43.2%(16/37) respectively. Pulmonary infections(37.8%, 14/37) were the most common non-hematological AEs. One patient with positive hepatitis B surface antigen (HBsAg) and two patients dependent on dialysis were safely treated with daratumumab.Conclusion:Daratumumab is highly effective in relapsed and refractory multiple myeloma. Adverse reactions are mild and well tolerable.
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Objective To investigate the immune status characteristics of primary ITP patients with abnor-mal auto-antibodies. Methods A total of 110 patients were enrolled in our study,who were admitted in Fu-Xing Hospital affiliated to Capital Medical University from January 2001 to July 2015.According to whether the patients have autoimmune diseases and the presence of auto-antibodies,we divided the patients into 3 groups,including the primary ITP with abnormal auto-antibodies(PITP-ANA)group,the primary ITP(PITP)group and the second-ary ITP(SITP)group.We compared the T-cell subsets,regulatory T cells,B lymphocytes,changes of immunoglob-ulin and bone marrow biopsy and cytology of patients among the three groups,retrospectively. Results The per-centage of CD3+T cells(61.72 ± 10.60)% in PITP-ANA group was lower than that in PITP group(69.57 ± 11.99)%. The percentage of CD8+T lymphocyte(24.00 ± 7.67)% was significantly lower than that of PITP group (30.59 ± 11.08)%(P<0.05).The proportion of Treg in PITP group,PITP-ANA group and SITP group were(6.12 ± 1.41)%,(7.50 ± 2.76)% and(8.49 ± 2.47)%,respectively,with statistically significant differences.The ra-tio of CD19+T cell in PITP-ANA group(25.75 ± 9.98)%was significantly higher than that in PITP group(16.16 ± 8.19)%(P < 0.01). The concentration of IgG、IgA、κ light chain and λ light chain in PITP group,PITP-ANA group and SITP group showed an upward trend and the highest level was in the SITP group,with statistically signifi-cant differences among the three groups. A variety of abnormal auto-antibodies could be found in both PITP-ANA group and SITP group. Conclusions We consider that the immune function abnormity of patients in PITP-ANA group were worse than that in PITP group,because the concentration of immunoglobulin,the percentage of B lym-phocyte and Treg ratio are higher in than those in PITP group.
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Objective To explore the expression and clinical significance of proliferation associated antigen Ki-67 in acute myeloid leukemia (AML). Methods A total of 45 AML patients (including 36 newly diagnosed AML patients and 9 recurrent AML patients) and 20 healthy volunteers (healthy group) were enrolled from October 2012 to January 2016 in Department of Hematology in Fuxing Hospital. The expression of Ki-67 in bone marrow blast cells were detected by flow cytometry (FCM). The relation between Ki-67 level and clinical characteristics, and the prognostic significance of Ki-67 were studied. Results The positive rate of Ki-67 in newly diagnosed AML, recurrent AML patients and healthy controls were (10.38±8.41)%, (20.99± 11.49) % and (40.77±11.97) %, respectively. The positive rate of Ki-67 in newly diagnosed AML patients or recurrent AML patients were significantly lower than that in healthy controls (all P0.05). There was no significant difference of overall survival between high Ki-67 expression group and low Ki-67 expression group in newly diagnosed AML patients [(780±110) d vs. (788±118) d, P=0.927]. Conclusions The proliferation of blast cells in AML patients is lower than that in healthy controls. Detecting the level of Ki-67 may provide a reference for choosing the cell cycle specific chemotherapy drugs in clinical practice. Monitoring Ki-67 during AML process contributes to monitoring disease progression and predicting recurrence.
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Objective To establish an HPLC method for the determination of artesunate in artesunate and amodiaquine hydrochloride tablets. Methods WondaSil C18-WR column was used with mobile phase consisted of acetonitrile:phosphoric acid aqueous solution(adjust pH to 3,gradient elution);wavelength was 210 nm; flow rate was 1 mL/min and the column temperature was 30℃.Results The standard curve was linear in the range of 0.2~3.2 mg/mL(r=0.9997), average recoveries were 99.0%(RSD=1.35%, n=6).Conclusion The method is accurate and sensitive, and it can be used to control the quality of artesunate and amodiaquine hydrochloride tablets.
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Objective To evaluate the treatment efficacy of leukocyte reduction in hyperleukocytic acute myeloid leukemia (HAML) patients with leukostasis grading score (LGS).Methods The data of 54 HAML patients were analyzed retrospectively.The relationship between LGS and leukocyte stasis symptoms or early mortality was observed, and the impact of leukapheresis on LGS was analyzed.Results Among 54 patients with HAML, there were 1 case of M1, 16 cases of M2, 10 cases of M4, 20 cases of M5 and 7 cases of unclassified AML.Based on clinical symptoms and LGS system, 3 cases were LGS 0, 15 cases LGS 1, 17 cases LGS 2, and 19 cases LGS 3.In patients with LGS ≤ 2, the rates of type Ⅰ respiratory failure, central nevers system (CNS) symptoms and early mortality caused by leukostasis were significantly lower than those in patients with LGS 3 (P ＜ 0.05).The LGS of HAML patients was reduced by leukocyte reduction therapy (P ＜ 0.000 1).The LGS of HAML patients treated by leukapheresis and low dose chemotherapy was improved significantly than that of patients treated without leukapheresis (P =0.008).Among 37 cases receiving induction chemotherapy, 20 cases reached complete remission (CR) after the first cycle of induction chemotherapy.CR rate of patients with LGS ≤ 2 was no significantly different compared with that of patients with LGS 3 (P =0.703).Conclusions LGS can be used to evaluate the degree and the improvement status of leukostasis after treatment in HAML patients.The early death often occurres in patients with high LGS.Leukapheresis combined with low-dose chemotherapy can effectively improve the LGS of HAML patients.
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To explore the prevalence of hepatitis B virus (HBV) in multiple myeloma (MM) patients, as well as to compare the clinical characteristics and outcome between HBV infected and non-HBV infected patients. Methods:The serology markers of HBV were detected in 363 MM patients and 11227 cases of healthy controls through chemiluminescence. HBV-DNA was measured via real-time quantitative chain reaction. Results:Sixteen out of 363 MM patients (4.4%) were HBsAg-positive, showing significant difference with healthy controls (2.4%). No statistically significant differences were observed in terms of sex, age, type of monoclonal (M) protein, International Staging System (ISS) stage, stem cell transplantation, and risk stratification between HBsAg-positive and HBsAg-negative patients. No significant effect of HBV infection was found on the OS of MM patients. HBV reactivation was observed in two HBsAg-positive MM patients who were treated with combination chemotherapy, including bortezomib and dexamethasone. The replication of HBV could be inhibited by anti-HBV drugs. Conclusion:A higher prevalence of HBV infection was revealed in MM patients. Close monitoring of HBV replication should be conducted in MM patients with HBV infection before and during the courses of chemotherapy.
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Objective To analyze clinical and radiological characteristics of intracranial hemorrhage in hematological diseases to improve the recognition of them. Methods Thirty-one clinical data of intracranial hemorrhage cases with hematological diseases were reviewed. The basic diseases, clinical and radiological manifestations, and risk factors of mortality were analyzed. Results Intracranial hemorrhage usually occurred in patients with acute myeloid leukemia (AML) or idiopathic thrombocytopenic purpura (ITP),and 13 and 6 cases, respectively, in this group. Most patients presented with headache, restlessness, nausea,vomiting, conscious disturbance and no localization sign by physical examination. CT or MRI images often revealed focus of errlysis. Compared with CT scan, a higher detection rate of ICH could be realized by MRI scan. The total mortality in this group of ICH patients was 71% (22/31). Fever, white blood cell ＞5×109/L,platelet ＜50×109/L, hyperimmunoglobulinemia and disturbance of blood coagulation were risk factors for ICH of this group of patients. The mortality was higher in patients with no less than 2 risk factors[86.4 % (19/22)vs 33.3 % (3/9)] (x2 = 8.718, P = 0.003). Conclusion ICH is a serious complication for hematological patients. MRI scan is good at improving the diagnosis of ICH. It is of high risk of death in patients with no less than 2 risk factors such as fever, white blood cell higher than 5×109/L, platelet less than 50×109/L,hyperimmunoglobulinemia and disturbance of blood coagulation.