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 study the abnormal use of anti-tumor dr ugs i n the clinic in order to provide reference for rational use of drugs in the clinic. METHODS ：Referring to foreign and domestic anti-tumor drug use guidelines and literatures ，Guidelines for Clinical Use of New Anti-tumor Drugs （2018 edition），Off-label Drug Use List （2019 edition），Practical Oncology （secondary edition），anti-tumor drug package inserts approved by FDA and package inserts of anti-tumor drug listed in China ，abnormal use of antitumor drugs （including instructions ，special indications ，and the order of administration of new anti-tumor drugs ） was summarized and analyzed. RESULTS & CONCLUSIONS ：The off-label use of anti-tumor drugs were summarized in this paper ， including 11 drug varieties and 4 kinds of off-label drug items ，such as off-label drug use plan （recombinant human endostatin ， rituximab），off-label administration route （pemetrexed disodium ，bortezomib，bevacizumab），off-label administration lines （erlotinib，gefitinib），off-label drug dosage （actinomycin D ，gemcitabine，ifosfamide，etoposide）. They should be carefully selected and strictly monitored in clinical use ，and treatment plan should be adjusted according to needs. Among the special indications，cyclophosphamide，cytarabine，methotrexate and cisplatin were used in large doses ，which were 2 000-2 400 mg/m2， 2 000 mg/m2，12 g/m2 and 80-120 mg/m2，respectively；individual differences should be paid attention to and therapeutic drug monitoring should be carried out if necessary. In the scheme of combination of new anti-tumor drugs or traditional chemotherapy drugs，there were 5 categories and 11 items in total ，such as combination of molecular targeted anti-tumor drugs with traditional chemotherapy drugs （such as docetaxel at first ，gefitinib at the same time or later ），combination of target immunocheckpoint drugs with traditional chemotherapy drugs （such as platinum at first ，then nivolumab ），and molecular targeted anti-tumor drugs combination（such as pertuzumab and trastuzumab should be given in sequence ，in either order ）. In clinical use ，histopathological diagnosis should be made clear ， and drugs with specific targets should be used after gene detection and strictly follow the indications.

Objective To investigate the effect of different serum sodium levels on heart function and prognosis in very elderly patients with heart failure. Methods Totally 152 elderly patients(aged ≥ 85 years)with hyponatremia were enrolled.Based on the serum sodium level ,they were divided into mild(125 mmol/L ≤ Na+ < 135 mmol/L) ,moderate(125 mmol/L ≤ Na+ < 135 mmol/L) ,and severe hyponatremia(Na+ < 115 mmol/L)groups ,and 76 patients with normal blood sodium level(Na+ ≥ 135 mmol/L)were selected as control group. The general data ,levels of serum creatinine and N-terminal pro-brain natriuretic peptide (NTproBNP)and prognosis were compared among the above groups. Results Compared with the control group ,patients with severe hyponatremia were much older ,with more diuretics administration ,higher level of serum creatinine , lowerlevelofeGFRandleftventricularejectionfractions[(38.1±3.9)％ vs.(45.2±9.7)％ ].There were higher incidences of coronary atherosclerotic heart disease [72.4％ (n=21)vs. 56.6％ (n=43)] ,diabetes[41.4％ (n=12)vs. 23.7％ (n=18)] ,chronic renal insufficiency [22.6％ (n=8)vs. 11.8％ (n=9)] ,stroke[20.6％ (n=6)vs. 9.2％ (n=7)]in patients with severe hyponatremia compared with other groups. The severe hyponatremia group showed significantly higher levels of NTproBNP [(4823. 9 ± 588. 1 )ng/L v s. (1124. 4 ± 349. 1 )ng/L ,(1836. 2 ± 369. 3 )ng/L ,(2894. 1 ± 687. 3 )ng/L ]and higher rates of mortality [27.6％ (n=8) vs.5.3％ (n=4) ,7.6％ (n=6) ,13.6％ (n=6)]as compared to the control group ,mild and moderate hyponatremia groups. Furthermore ,length of stay in hospital were markedly longer in patients with severe hyponatremia than those with mild and moderate hyponatremia[(11.1 ± 7.1)d vs. (19.6 ± 5.7)d ,(16.1 ± 4.2)d] . Conclusions Hyponatremia is a common type of electrolyte disorder in very elderly patients with heart failure ,and severe hyponatremia may predictand increased risk of death.

Objective To explore the clinical characteristics of the neuromyelitis optica spectrum disorders (NMOSD) with the area postrema syndrome as the initial symptom.Methods A total of 14 cases were enrolled in the study with the diagnose of NMOSD and the area postrema syndrome as the initial symptom.All the clinical data and imaging profiles by the contrasted magnetic resonance imaging (MRI) of the head and spinal cord were collected and analyzed.Results The median age of onset was (38.1 ± 17.0)years old and the gender ratio of female to male was 10:4.The serum aquaporin-4 (AQP4)-IgG was positive in 11 subjects and several autoimmune antibodies was positive in 7 subjects.The lesions revealed by MRI of the head mainly located in the area postrema and ependymal periphery which often presented as the linear medullary lesion,while linear lesions over three pieces of vertebra were shown by MRI of the spinal cord which mainly in the grey matter and with aH shape around the spinal central canal.Misdiagnose happened in 11 subjects with seven of gastroesophageal reflux disease,two of neurogenic vomiting,one of spinal cord tuberculosis and one of stroke.Conclusions NMOSD should be considered in patients with unexplained intractable nausea,vomiting and/or hiccups lasted for 48 hours or above,especially in those with positive nervous signs.Contrasted MRI and serum AQP4-IgG need to be performed in the suspected patients.Early detection is crucial for patients with NMOSD.

Objective:To explore correlation among heart structure , cardiac function and premature ventricular systo‐le (PVS) of different loads ,.Methods :A total of 220 PVS patients treated in our hospital were selected .According to PVS number‐to‐24h total heart rate ratio ,they were divided into low load group (<10% ,n=50) ,medium load group (10% ~20% ,n=108) and high load group (>20% ,n=62) .Another 68 subjects without PVS were regarded as normal control group .Cardiac function indexes and serum level of N terminal pro brain natriuretic peptide (NT‐proBNP) were measured in all groups ,and their correlation was analyzed .Results :Compared with normal control group ,there were significant rise in QT interval ,QRS wave duration and corrected QT interval in medium and high load groups , P<0.05 or <0.01. Compared with normal control group ,there were significant rise in left atrial di‐ameter ( LAD ) , left ventricularoutflow tract dimension ( LVOT ) , left ventricular end‐diastolic dimension (LVEDd) ,right ventricular end‐diastolic dimension (RVEDd) ,left ventricular end‐diastolic volume (LVEDV) , stroke volume (SV) ,left ventricular mass index (LVMI) and NT‐proBNP level ,and significant reduction in left ventricular ejection fraction (LVEF) in medium and high load group ,P<0.05 or <0.01. Bivariate linear correla‐tion analysis indicated that PVS load was significant linear positively correlated with QRS wave duration ,corrected QT interval ,LVEDd ,RVEDd and NT‐proBNP level (r=0.42~0.65 ,P<0.01 all);and significant linear inverse‐ly correlated with LVEF (r= -0.62 ,P=0.001) .Conclusion:Changes may occur in left ventricular structure and function along with PVS load rises .Therefore ,attention should be paid on monitoring related indexes in order to perform early intervention .

Objective To survey a prevalence of osteoporosis and prevalence of osteoporosis combined with hyponatremia in elderly hospitalized patients,and their risk factors.Methods We enrolled 2496 elderly hospitalized patients with detected plasma levels of sodium,calcium,25 (OH) D3,PTH,plasma PINP,and β-CTX.At the same time,sex,age,height,weight,smoking history,drinking history and BMI(kg/m2) in form of a questionnaire were recorded and calculated.The risk factors for osteoporosis were analyzed using multivariate Logistic regression method.Results The osteoporosis prevalence was 12.2％ (305/2496 inpatients)with 31.5 ％ (96/305)in male,68.5％ (209/305)in female(x2 =4.651,P=0.031).The prevalence of osteoporosis with hyponatremia was 27.5 ％ (84/305),with 24.8 ％ (21/84) in male and 75.2 ％ (63/84) in female(x2 =9.251,P=0.025).As compared with three groups of non-osteoporosis,normal serum Na+ with and without osteoporosis,the osteoporosis patients with hyponatremia were more aged,in a higher proportion of women and smokers,in lower BMI,and in low levels of serum sodium,BMD 25(OH)D3 (F=13.783,0.861,7.146,24.520,0.548,x2 =15.113、4.472;P =0.001,0.000,0.021,0.015,0.003,0.021,0.005).Multivariate Logistic regression analysis showed that aging,female,low BMI,smoking history,drinking history,low plasma 25(OH)D3 level,low plasma PINP level,and high plasma β-CTX level were the risk factors for osteoporosis(OR 4.215,2.271,3.176,2.013,1.237,3.987,1.843,1.972;all P＜0.05).Conclusions The osteoporosis prevalence is high in elderly patients,especially in old women.The risk factors for osteoporosis are diverse,and clinical conditions of osteoporosis patients with hyponatremia are much more severe than the others.More efforts should be given to them and need to be focused on the complications of osteoporosis.

Objective:To investigate the ways of pharmaceutical care performed by clinical pharmacists for the patients with severe infection. Methods:Through deciding the anti-infection therapeutic regimen, providing drug counselling and pharmacy education and focusing on adverse drug reactions, pharmacists offered suggestions for one patient with severe legionella pneumonia complicated with AECOPD. Results:The pharmaceutical care performed by clinical pharmacists could solve the problems and improve the compliance, safety, effectiveness and rationality in the drug treatment of the patient. Conclusion:According to the individual condition of patients, clinical pharmacists can realize their own values through looking for the breakthrough points of pharmaceutical care and participating in clinical practice.

Objective To explore the clinical features,neuroimaging and histopathological findings in patients with idiopathic hypertrophic cranial pachymeningitis (IHCP) with a nodular space occupying effect.Methods Four IHCP cases with a nodular space occupying effect diagnosed in our hospital were retrospectively studied.Results All the 4 patients were men with a mean onset age of 40.25 (33 ～ 50) years old.They all had long disease duration and relapses.The common symptoms of IHCP were chronic headache,multiple cranial nerve palsies and epileptic seizures.CT and MRI of the brain revealed prominent dural partial thickening,which indicated a mass or nodular space occupying effect that mimicked intracranial tumour-like meningioma.The histopathological findings of dura in 2 cases revealed connective tissue proliferation,scattered neutrophile granulocytes and plasmacytes infiltration.Combination therapy of corticosteroid or/and immunosuppressive drugs was effective for the IHCP patients.Conclusions IHCP patients with a nodular space occupying effect usually onset with chronic headache and are often recurrent.The combination therapy of corticosteroid or/and immunosuppressive drugs is effective.The image of the brain presents prominent dural partial thickening,indicating a mass or nodular space occupying effect,which often lead to confusion with intracranial tumours or granulomatosis.

BACKGROUNDOveractive bladder (OAB) is a series of symptoms with high prevalence in elderly people. This study was conducted using the overactive bladder symptom score (OABSS) to evaluate the efficacy of solifenacin succinate for the treatment of OAB.

METHODSThis was a prospective, multicenter, single-arm, 12-week study that enrolled 241 OAB patients. The patients received 5-10 mg/day solifenacin. Changes in OABSS, symptoms from voiding diary, perception of bladder condition (PPBC) score, international prostate symptom score (IPSS) and quality of life (QOL) were evaluated at weeks 0, 4, and 12. The relationship between OABSS and PPBC score or parameters of voiding diary was also evaluated.

RESULTSAt baseline, the mean OABSS for all patients was 9.41 ± 2.40, and was reduced significantly at week 12 (-3.76 points; 61.21%, P < 0.0001). The OABSS subscore, PPBC score, IPSS, and QOL were also significantly reduced during the study (P < 0.0001). The overall incidence of adverse events was 19.91% (44 cases). The gastrointestinal system was the most commonly affected (11.31%). Around 5.88% of the cases had adverse events related to the genitourinary system. There was a strong correlation between OABSS and urinary symptoms that was recorded in the 3-day voiding dairy.

CONCLUSIONSWe showed that solifenacin was clinically effective for relieving OAB symptoms, considering the balance between efficacy, patients' well-being, and tolerability. OABSS integrates four OAB symptoms into a single score and can be a useful tool for research and clinical practice.

Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists ; therapeutic use ; Prospective Studies ; Quality of Life ; Quinuclidines ; therapeutic use ; Solifenacin Succinate ; Tetrahydroisoquinolines ; therapeutic use ; Treatment Outcome ; Urinary Bladder, Overactive ; drug therapy

Background and purpose:Quinonoids can change the cell cycle distribution of tumor cells, and effect the radiosensitizing. This study aimed to investigate the radiosensitization effects, cell cycle and apoptosis of cryptotanshinone on H22 hepatoma-bearing mice. Methods:The mouse hepatoma H22 model was established, then divided into blank control group, irradiation alone group, high dose of cryptotanshinone group, cryptotanshinone (low, medium and high)+IR groups. After irradiated, observed the growth of tumor’s conditions, record epigenetic tumor irradiation time, calculated the delay time of tumor growth and enhancement factor (EF). After 22 days, mice were killed, stripped tumor, and calculated the inhibition rate. The cell cycle distribution and apoptosis were measured by lfow cytometry. Results:Cryptotanshinone (low, medium and high) groups inhibited the tumor growth better than the blank group, and had the signiifcant radiosensitizing effect. The enhancement factor was 1.22, 1.43,2.19, respectively. Cells were treated with cryptotanshinone which had significant effects on cell cycle, and induced apoptosis, which indicated signiifcant G2/M phase arrest and a decrease in S phase. Conclusion:Cryptotanshinone inhibited the tumor growth and had the radiosensitizing effects on H22 hepatoma-bearing mice. One of the mechanism may be that it might make significant G2/M phase arrest and S phase decreased, and induced apoptosis. So cells were more sensitive to radiation.