Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.

Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT) / 白血病·淋巴瘤

Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

The role of spo0A gene in growth and sporulation of Clostridium difficile / 中国感染与化疗杂志

Objective To investigate the role of spo0A gene in growth and sporulation of Clostridium difficile clinical isolates. Methods ClosTron gene knock-out system was used to knock out the spo0A gene of C. difficile strain C25. Bacterial growth curve was plotted by measuring D600 with spectrophotometer in different phases of bacterial growth. Malachite green staining technique was used to count the number of vegetative cells and spores under optical microscope. The sporulation rate was calculated. Results The spo0A mutant and its C25 parental strain showed similar patterns of growth. However, after knock-out of spo0A gene, an asporogenous phenotype was built, while the parental strain could produce spores as usual.Conclusions The spo0A gene plays a key role in sporulation but not growth of C. difficile strain.

Analysis of myelogram and clinical pathogenesis of 196 cases of patients with pancytopenia syndrom / 国际检验医学杂志

Objective To explore the etiological spectrum of pancytopenia ,in order to improve the diagnostic accuracy . Methods Retrospectively analysed myelogram and clinical data of 196 cases of patients with pancytopenia syndrom .Results The dominant cause of pancytopenia syndrom in 196 cases of patients was hematological diseases (accounted for 68 .9% ) ,including acute leukemia (14 .8% ) ,myelodysplastic syndrome (12 .2% ) ,aplastic anemia(11 .2% ) and immune‐related pancytopenia(10 .2% );while non‐hematologic diseases accounted for 31 .1% ,including connective tissue diseases (10 .7% ) ,chronic liver disease(7 .2% ) and in‐fection(6 .2% ) .Conclusion Etiology of pancytopenia syndrom is complex ,which should be comprehensively analysed with closely contacting clinics ,in order to clarify the cause ,reduce misdiagnosis and missed diagnosis and improve the diagnostic accuracy .

Exploration on value of CD64 and procalcitonin in early diagnosis of pediatric bacterial diarrhea / 国际检验医学杂志

Objective To detect peripheral blood neutrophil CD64 and procalcitonin(PCT)in children with diarrhea ,and to ex‐plore significance for differential diagnosis of diarrhea in children .Methods A total of 180 cases of children with diarrhea treated in this hospital from July 2012 to May 2014 were selected as subjects ,and were classified into three groups :bacterial diarrhea group (n=60) ,viral diarrhea group(n=60)and non infectious diarrhea group(n=60) .The levels of peripheral blood neutrophil CD64 and PCT were determined in all three groups ,and the diagnostic values of CD64 index and PCT were evaluated .Results The peripheral blood neutrophil CD64 index and level of PCT in the bacterial diarrhea group were significantly higher than those in the viral diar‐rhea group and non infectious diarrhea group ,and the positive rates of CD64 index and PCT in the bacterial diarrhea group were sig‐nificantly higher than those in the viral diarrhea group and non infectious diarrhea group ,all had statistically significant differences (P<0 .05) .The specificity and positive predictive value of CD 64 index in diagnosing bacterial diarrhea were significantly higher than those of PCT ,both had statistically significant differences (P<0 .05) .The relative analysis showed that the CD64 index was positively correlated with level of PCT (r=0 .865 ,P<0 .05) .Conclusion The CD64 index and PCT level of children with bacterial diarrhea increase significantly ,which indicates that the detection of CD64 index and PCT have significant clinical value in early diag‐nosis of bacterial diarrhea .

Clinical feature and antifungal susceptibility analysis of 111 cases of invasive fungal disease / 中国感染与化疗杂志

Objective To describe the clinical features of invasive fungal disease in Huashan Hospital,Fudan University from January 2004 to December 2006.Methods The medical data were reviewed retrospectively for the patients with fungal infection, which was confirmed by positive fungal culture or microscopic examination with blood,sterile body fluid,deep tissue,sputum specimen or isolation of Aspergillus spp.and Cryptococcus spp.from bronchoalveolar lavage.The proven and probable cases of invasive fungal disease were included in this analysis.Results A total of 111 patients were diagnosed as invasive fungal dis-ease,including 104 proven cases and 7 probable cases.Sixty-one cases were community-acquired and the other 50 were nosoco-mial.The most common site of infection was bloodstream (51,45.9%),followed by central nervous system (44,39.6%)and respiratory system (14,12.6%).The most common pathogens were Candida spp.(50,45%),Cryptococcus (47,42.3%) and Aspergillus spp. (12, 10.8%). The community-acquired fungal infections were mostly found in central nervous system (44,72.1%),and respiratory system (12, 19.7%),mainly caused by Cryptococcus and Aspergillus. The nosocomial fungal infections occurred primarily in blood-stream (96.0%),mainly due to Candida spp.No underlying disease or risk factor was identified in more than half of the pa-tients with community-acquired infection,while almost all the patients with nosocomial fungal infection had underlying disease and predisposing factors.Indwelling venous catheter was closely associated with nosocomial bloodstream infection.Indwelling venous catheter lasted for more than 1 week in 64.7% of the patients with Candida bloodstream infection.The same fungal strain was isolated from both the cather and blood of the same patient in 11 cases.The overall mortality of these invasive fungal diseases was 14.4% (16/111).The mortality rate was 18.0% (9/50)in the patients with nosocomial invasive fungal infection, and 11.5% (7/61)in the patients with community-acquired invasive fungal infection.Conclusions The most common site of in-vasive fungal infection is bloodstream,followed by central nervous system,and respiratory system.Majority of the fungal patho-gens are Candida spp.,Cryptococcus and Aspergillus spp.The community-acquired invasive fungal disease is primarily meningitis caused by Cryptococcus.The nosocomial invasive fungal disease is mainly bloodstream infection caused by Candida spp.

Experimental Study on Chitosan Used as An Excipient and Its Preparation Borneolum and Borax Pellicle / 医学研究杂志

0.05),however,it can shorten curative time obviously on Ⅱ type dental ulcer.Simultaneously,the general reaction and focal mucosa of borneolum and borax pellicle group had no obvious variation before and after the test.Conclusions Chitosan has no effect on min-pigs' nerve,cardiovascular and respiratory system;and it is relatively safe given by mouth or peritoneal injection.The borneolum and borax pellicle can shorten curative time obviously on Ⅱtype dental ulcer.