OBJECTIVE To provide reference for strengthening the standardized management of off-label drug use in cancer hospitals. METHODS The evaluation system for off-label drug use was established to standardize the application， approval， and filing process for off-label drug use in our hospital. The changes in off-label drug application quantity， proportion， disease category and drug category in our hospital were compared before （October 1st， 2021-September 30th， 2022） and after （October 1st， 2022- September 30th， 2023） the establishment of the evaluation system； drug items supported by high-level evidence screened by pharmacy department were analyzed statistically. RESULTS The number of off-label drug use applications in our hospital had gradually increased， from 306 pieces in the fourth quarter of 2021 to 3 828 pieces in the third quarter of 2023. In the year before the construction of the evaluation system， there were a total of 4 482 applications for off-label drug use， and in the year after the construction of the evaluation system， there were 11 840 applications for off-label drug use. After the construction of the evaluation system， the proportion of unregistered off-label drug use significantly decreased， compared to the same period last year （P＜0.05）. Among them， there were no unregistered applications for off-label drug use for digestive system tumors， head and neck tumors， and radioactive drugs； lymphoma， breast tumors，urogenital system tumors， cytotoxic drugs and new anti-tumor drugs all had a decrease of over 70% in unregistered off-label drug applications. Twenty-seven off-label drug use items related to 19 drugs supported by high-level evidence were screened by the pharmacy department of our hospital， among which 25 items were drug use beyond indication. CONCLUSIONS The establishment of off-label drug use evaluation system in cancer hospital is helpful to the rational use and refined management of clinical anti-tumor drugs.

OBJECTIVE：To establish th e method for the determination of related substances in fidaxomicin raw material. METHODS：The detection ability of NP-HPLC-UV ，RP-HPLC-ELSD and RP-HPLC-UV systems for the related substances in fidamycin raw material was investigated and the best chromatographic system was selected . The HPLC detection method for the related substances was established. The detection was performed on Agilent Eclipse XDB C 18 column with mobile phase A consisted of 0.2％ triethylamine buffer solution （pH 3.8）-acetonitrile（55∶45，V/V），mobile phase B consisted of 0.2％ triethylamine buffer solution（pH 3.8）-acetonitrile（20∶80，V/V）at the flow rate of 1.0 mL/min（gradient elution ）；the detection wavelength was set at 230 nm，and column temperature was 35 ℃；the sample size was 10 µL. Calculation of the content of related substances was principal component self-control method without correction factor. RESULTS ：The impurities C and F could not be separated effectively in NP-HPLC-UV system. In RP-HPLC-ELSD system ，only impurities C ，D，E and F could be detected. In RP-HPLC-UV system ，11 impurities could be detected. In the study of methodology ，the linear ranges were 0.5-20.0 μg/mL for fidaxomicin（R2＝0.999 9）；the LOD was 0.05 ng，LOQ was 0.15 ng；RSDs of reproducibility and intermediate precision tests were less than 2.0％（n＝6）；average recovery was 98.4％（RSD＝3.6％，n＝9）. The sum of impurities in 3 batches of raw materials were 0.53％，0.51％，0.51％，respectively. CONCLUSIONS ：The effect of detecting impurities by RP-HPLC-UV are the best. Established method is specific and sensitive ，and can be used for the determination of related substance in fidaxomicin raw material.

Fentanyl and fentanyl-related substances are a series of synthetic and powerful anesthetics represented by fentanyl. In recent years,the abuse and trafficking of these substances in many countries around the world are serious which poses a great threat to people"s health and social stability. This paper focuses on the abuse,pharmacological and toxicological action,detection methods and control of fentanyl and fentanyl-related substances and aims to enhance people"s understanding of their basic properties,current research and control so as to provide references for future research.

Objective To improve differential diagnosis of tumefactive demyelinating lesions (TDL) and primary central nervous system lymphoma (PCNSL) by analyzing the clinicopathological features of the diseases.Methods The clinical features,neuroimaging findings and pathological characteristics of 4 patients with pathologically proven TDL and 9 patients with pathologically proven PCNSL were retrospectively analyzed.Computer tomography and magnetic resonance imaging were used for neuroimaging studies.The hematoxylin and eosin staining,Luxol Fast Blue staining and immunohistochemistry were used for pathological studies.Results (1) The features of lesions on brain imaging scan:CT in TDL patients showed low density.Enhanced MRI demonstrations were different in different courses:3 cases with ring enhancement,1 case with spotty strengthen;5 PCNSL cases showed hyperdensity in CT,1 case showed isodensity,and 3 cases low-density.MRI showed enhancement of uniform enhancement in PCNSL patients.(2) The features of lesions on pathology:the plaques of lesions in TDL patients were characterized by massive demyelination with relatively axonal preservation associated with prominent astrocytosis and profound infiltrates composed.Typical pathological features in PCNSL cases were that tumor cells around blood vessels showed the cuff-like arrangement.Due to use of hormones and other causes,pathological demonstrations of a part of PCNSL cases were atypical,which were easily confused with TDL.There were 4 cases with more than one biopsy for diagnosis.Conclusions (1) PCNSL with low or equal density in CT needs to be differentiated with TDL.(2) The pathological features of some cases of PCNSL after hormone therapy were similar to TDL.It is better not to use hormone before definite diagnosis.(3) The pathology of PCNSL may be related to the progression of the disease.Some of patients need to be re-biopsied.It is important to combine clinical imaging and pathology for diagnosis of the disease,and attention should be paid to followup.

Objective To evaluate the influence of the placement of instant hand disinfectant in compliance and qualified rate of hand hygiene of clinicians.Methods Hand hygiene compliance of clinicians in departments of gyne-cology,obstetrics,and general surgery were observed after the placement of instant hand disinfectant at the door-way of wards,hand specimens were taken to check hand hygiene effectiveness.Results Before and after placement of instant hand disinfectant at the doorway of wards of above departments,hand hygiene behaviors of 300 person-times were observed.Hand hygiene compliance rate among clinicians in department of gynecology,obstetrics,and general surgery increased from 32.33% to 74.33%,33.67% to 85.67%,and 26.33% to 64.00%,respectively(all P <0.001).Each department selected 98 hand hygiene specimens,the qualified rate was 98.98%,100.00% and 94.90% respectively.Conclusion The placement of instant hand disinfectant at the doorway of each ward can effec-tively improve clinicians’hand hygiene compliance and hand hygiene effectiveness.

This study evaluated, over a 4-month study period, the amount of apical root resorption occurring in maxillary central incisors following their retraction when employing either micro-implant or J-hook headgear anchorage. The prospective randomised clinical trial was conducted in Orthodontic Clinic, College of Stomatology, China from 2008-2009. Subjects are patients requiring fixed appliances on waiting list (n=20). In female Han Chinese patients aged from 16-26 years, standardized periapical radiographs from 10 randomly assigned patients with maxillary protrusions comprising the micro-implant group, and from 10 similar patients comprising the J-hook headgear group, were assessed for maxillary central incisor apical root resorption. Measurements before and after orthodontic therapy were also obtained from lateral cephalometric radiographs to calculate incisor horizontal retraction and vertical intrusion distances. Estimated retraction force vectors were calculated in horizontal and vertical directions for both treatment groups. Data analysis employed t-tests and the Pearson correlation test, with α=0.05 for statistical significance. The results showed that when compared with the J-hook group, significantly more apical root resorption shortening of the maxillary central incisors was observed in the micro-implant group (1.27 mm difference, 95% CI=0.70-1.84, P<0.001), which was associated with a significantly larger retraction distance (P=0.004) and a smaller vertical force component (P<0.0001). We are led to conclude that continuous activation of the nickel-titanium coil springs used in the micro-implant group resulted in significantly more apical root resorption shortening and maxillary central incisor retraction than when intermittent J-hook retraction was employed. The employment of continuous duration orthodontic forces presents a risk for increased apical root resorption that requires careful radiographic monitoring.
Adult ; Dental Implants ; Female ; Humans ; Incisor ; diagnostic imaging ; Maxilla ; diagnostic imaging ; Orthodontic Anchorage Procedures ; instrumentation ; methods ; Prospective Studies ; Radiography ; Root Resorption ; diagnostic imaging ; Tooth Apex ; diagnostic imaging ; Young Adult

A scaffold fabricated with lysine/nerve growth factor (NGF)/poly (lactic acid coglycolic acid) copolymer (PLGA) and acellular pigskin was evaluated in vitro as a potential artificial nerve scaffold. Properties of the scaffold such as microstructure, mechanical property, degradation behavior in PBS and water, Schwann cell adhesion property, and release of NGF were investigated. Results showed PLGA had permeated into the porous structure of acellular pigskin; its breaking strength was 8.308 MPa, breaking extensibility was 38.98%, elastic modulus was 97.27 MPa. The porosities of the scaffold ranged from 68.3% to 81.2% with densities from 0.62 g/cm3 to 0.68 g/cm3. At 4 weeks of degradation in vitro, maximum mass loss ratio was 43.3%. The release of NGF could still be detected on the 30th day, and its accumulative release rate was 38%. Lysine added into the scaffold neutralized the acidoid preventing degradation of PLGA to maintain a solution pH value. Schwann cells had grown across the scaffold after co-cultivation for 15 days. These in vitro properties of the pigskin based composite might indicate its potentiality to be an artificial nerve scaffold.
Acellular Dermis ; Animals ; Biocompatible Materials ; Guided Tissue Regeneration ; Lactic Acid ; pharmacology ; Lysine ; pharmacology ; Nerve Growth Factors ; chemistry ; pharmacology ; Nerve Regeneration ; Polyglycolic Acid ; pharmacology ; Swine ; Tissue Engineering ; Tissue Scaffolds

OBJECTIVE: To analyze efficacy and safety of percutaneous nephrolithotomy (PCNL) in the management of staghorn calculi with solitary kidney. METHODS: Between April 2009 and December 2011, 13 patients with renal staghorn calculi in solitary kidney were treated by PCNL in our hospital. The therapeutic effects and complications were the main points of the analysis. RESULTS: Of the 13 patients, surgery time was 92-164 (117.2±21.5) min; 9 cases underwent PCNL through a single access tract, 4 cases through multi-access tracts. The stone removal rate in one session of PCNL was 76.9%, and the total clearance rate was 92.3%. Hemoglobin dropped 11-32 (16.4±4.6) g/L; one case required blood transfusion; no patient had embolism. Hospital stay was 5-10 (6.9±1.5) days postoperatively. Serum creatinine before PCNL in these patients was 83-237 (146.24±38.73) μmol/L compared to 81-242 (134.56±21.52) μmol/L by the end of the 1-month follow-up period (not statistically different). Similar findings were observed in glomerular filtration rates: before PCNL it was 42-114 (71.32±20.82) mL/min and by the end of the 1-month follow-up it was 55-117 (79.40±22.14) mL/min (not statistically different). CONCLUSION PCNL is effective and safe for the treatment of staghorn stones in solitary kidney, and has advantages such as short surgical duration, fewer complications, rapid recovery, short hospital stay, effective stone removal rate, and so on.
Adolescent ; Adult ; Aged ; Female ; Humans ; Kidney Calculi ; surgery ; therapy ; Male ; Middle Aged ; Nephrostomy, Percutaneous ; methods ; Retrospective Studies ; Treatment Outcome ; Young Adult

This study evaluated, over a 4-month study period, the amount of apical root resorption occurring in maxillary central incisors following their retraction when employing either micro-implant or J-hook headgear anchorage. The prospective randomised clinical trial was conducted in Orthodontic Clinic, College of Stomatology, China from 2008-2009. Subjects are patients requiring fixed appliances on waiting list (n=20). In female Han Chinese patients aged from 16-26 years, standardized periapical radiographs from 10 randomly assigned patients with maxillary protrusions comprising the micro-implant group, and from 10 similar patients comprising the J-hook headgear group, were assessed for maxillary central incisor apical root resorption. Measurements before and after orthodontic therapy were also obtained from lateral cephalometric radiographs to calculate incisor horizontal retraction and vertical intrusion distances. Estimated retraction force vectors were calculated in horizontal and vertical directions for both treatment groups. Data analysis employed t-tests and the Pearson correlation test, with α=0.05 for statistical significance. The results showed that when compared with the J-hook group, significantly more apical root resorption shortening of the maxillary central incisors was observed in the micro-implant group (1.27 mm difference, 95% CI=0.70-1.84, P<0.001), which was associated with a significantly larger retraction distance (P=0.004) and a smaller vertical force component (P<0.0001). We are led to conclude that continuous activation of the nickel-titanium coil springs used in the micro-implant group resulted in significantly more apical root resorption shortening and maxillary central incisor retraction than when intermittent J-hook retraction was employed. The employment of continuous duration orthodontic forces presents a risk for increased apical root resorption that requires careful radiographic monitoring.

Objective To investigate the regulatory effect of CsA on the expression of NK cell inhibitory receptor ILT4 and cytotoxicity of NK cells.Methods NK cells treated with CsA ( 10 mg/L) or DMSO for 12,24 and 36 h were chosen as three experimental groups and control groups respectively.RTqPCR and flow cytometry were performed to detect the alteration of ILT4 at the mRNA and protein level respectively.The expression of HLA-G in human gastric cancer cell line BGC-823 and human placental choriocarcinoma cell line JEG-3 were measured at the same time,and then the cytolytic activity of the untreated NK cells and NK cells treated with CsA for 36 h against BGC-823 and JEG-3 cells was determined with MTT.One-way analysis of variance was employed to compare the different ILT4 expression at different time points after medication; Dunnett test was performed to carry out the pairwise comparison between each mean.The difference of HLA-G expression between JEG-3 cells and BGC-823 cells,and the difference of NK cell cytolytic activity against JEG-3 cells and BGC-823 cells were analyzed by student's t-test.Results RT-qPCR assay indicated that the relative levels of ILT4 mRNA in NK cells treated with CsA for 12,24 and 36 h in turn were 0.99 ± 0.27,1.79 ± 0.29,6.79 ± 0.64,and those of their contrast groups treated with DMSO were 0.86 ±0.11,0.94 ±0.12,1.06 ±0.17.The expression of ILT4 in NK cells treated with CsA for 24 h or 36 h was higher than that in NK cells of their contrast groups respectively ( t value of 4.69,14.99,P ＜0.05,respectively),but there was no significant difference between the two groups of NK cells treated for 12 h ( t =0.78,P ＞0.05 ).Through flow cytometry,the positive rates of ILT4 protein expression in NK cells treated with CsA for 12,24 and 36 h [(5.16 ± 0.42 ) ％,( 6.23 ± 0.48 ) ％,( 23.8 ± 1.5 ) ％]were higher than those in NK cells after treatment with DMSO for 12,24 and 36 h respectively[(3.08 ±0.19)％,(3.35 ±0.12)％,(3.36 ±0.21 )％ ;t value of 7.70,10.06,20.72,P＜0.01,respectively].The expression of ILT4 in NK cells treated for 36 h was much higher than that in NK cells for 12 and 24 h at the mRNA and protein level (t value of 16.38,14.12 ;21.81,20.56,P ＜ 0.01,respectively).Meanwhile the killing rates of NK cells treated with 10∶1 effector-target ratio CsA on BGC-823 cells (low HLA-G expression) were ( 8 1.96 ± 2.80 ) ％ ( before treatment) and ( 60.23 ± 1.57 ) ％ ( after treatment),which were higher than those on JEG-3 cells (HLA-G-overexpression) [(53.46 ±2.21 )％ ( before treatment),(28.30 ± 1.85 ) ％ ( after treatment)].The changes of cytotoxicity of NK cells treated with CsA against target cells showed that CsA inhibited the killing activity of NK cells to BGC-823 and JEG-3 cells (t value of 11.74,15.16,P＜0.01,respectively),and the inhibitory rates were (26.48 ±2.42)％ and (47.10 ±1.59 ) ％ respectively.CsA had a higher killing rate inhibition on JEG-3 than on BGC-823 ( t =12.31,P ＜0.01 ).Conclusion CsA induces upregulation of ILT4 in NK cells,and the cytotoxicity of NK cells to tumor cells can be affected by interaction of ILT4 and HLA-G.