Off-label use means that the intended use of the drug is not included in the instructions approved by the National Medical Products Administration,including unapproved indication,dosage,the course of treatment,route of administration,or population.The formulation of Pharmaceutical Supply Services-Key Medications Management-Off-label Uses is based on relevant laws,regulations,normative documents,guidelines,literatures,and expert opinions,and follows the principles of scientificity,versatility,instructiveness,and operability.This standard regulates and standardizes the institutional and organizational construction,process management,and the whole process of quality management and evaluation improvement of off-label uses,which is the basis for medical institutions to carry out off-label uses management.This article introduced the formulation process of the off-label uses standard and analyzed the key contents of the standard,which would help medical institutions to better comply with and meet the requirements of this standard in the practice of off-label use management.

Drugs under special management include narcotic drugs,psychotropic drugs,toxic drugs for medical use,radiopharmaceuticals,and pharmaceutical precursor chemicals.Supervising and guiding the clinical use of drugs under special management is one of the important responsibilities of the Pharmaceutical Management and Drug Therapy Committee(Group)of medical institutions.The standard for drugs under special management is led by the Pharmaceutical Professional Committee of the China Hospital Association,which standardizes 16 key elements of organizational management,process management,and quality control management drugs under special management in medical institutions.It can guide the standardized implementation of Pharmaceuticals under special control work in various levels and types of medical institutions.This article elaborates on the methods and contents of formulating standards for Pharmaceuticals under special management,to provide reference and inspiration for medical institutions to carry out special drug drug management and daily related work.

The management of clinical application of antimicrobial drugs is an important part of the pharmaceutical management and pharmacy services in medical institutions.Based on national policies and regulations,this standard focuses on the whole life cycle of antimicrobial drugs in medical institutions.It is developed based on the principles of scientific validity,universality,guidance and operability,formed by sorting out problems,collecting opinions,expert argumentation and deliberation.It is the first group standard to standardize the clinical application management of antimicrobial drugs.This paper introduces and analyzes the team composition,problem sorting and compilation process,and various elements of the standard in the process of formulating the standard,and provide a reference for the majority of peers who use it.

Antineoplastic drugs refer to the drugs that act at the cellular and molecular levels to inhibit tumor growth or eliminate tumors through pathways such as cell killing,immune regulation,and endocrine regulation.Antineoplastic drugs generally including chemotherapeutic drugs,molecular targeted therapeutic drugs,immunotherapeutic drugs,and endocrine therapeutic drugs.The management and rational application of antineoplastic drugs in medical institutions are related to the safety of patient treatment.The standard for management of antineoplastic drugs use in clinical is compiled by the Pharmaceutical Affairs Committee of China Hospital Association,which specification requirements 18 key elements in the organizational management and system,medication management,drug monitoring and evaluation of antineoplastic drug management in healthcare institutions.This standard is applicable to all levels and types of healthcare institutions carrying out oncology diagnosis and treatment.This paper describes the methodology and basic content of the standard,hoping to providing a reference for medical institutions to carry out relevant work.

Objective:To analyze the epidemiological characteristics and spatiotemporal characteristics of human brucellosis in Henan Province.Methods:Data of human brucellosis in Henan Province from 2005 to 2021 were collected through the China Disease Prevention and Control Information System, and a descriptive epidemiological method was used to analyze the epidemic profile of brucellosis in Henan Province and the three distribution characteristics. Global and local spatial autocorrelation were used to analyze the spatial distribution and the hot spots of brucellosis in Henan Province, respectively, and spatiotemporal scanning was used to analyze the spatiotemporal clustering regions of brucellosis in Henan Province.Results:A total of 39 862 brucellosis cases were reported in Henan Province from 2005 to 2021, with an average annual incidence of 2.44/100 000, and the number of cases showed an overall increasing trend each year (χ 2trend = 11 127.85, P = 0.001). The onset months were mainly concentrated from March to July, accounting for 59.00% (23 517/39 862), with May as the peak (5 478 cases). Cases of brucellosis were reported in 157 counties (cities, districts) of the province. The ratio of male to female was 2.52∶1.00 (28 542/11 320). Farmers were the main occupation, with 32 985 cases (82.75%). The age of onset was mainly 45 to 65 years old, with 20 226 cases (50.74%). The global spatial autocorrelation analysis showed that the global Moran's I was > 0, Z > 1.96, and P < 0.05 in all years except 2006 - 2008, showing spatial clustering. Further local spatial autocorrelation analysis was performed, and high-high and low-low clustering areas existed in 2012 - 2021 ( P < 0.01). Spatiotemporal scanning analysis showed that there was one spatiotemporal cluster in the high incidence area and two spatiotemporal clusters in the low incidence area. The high incidence cluster was centered in Neixiang County, covering 48 counties (cities, districts) including Song County and Ruzhou City, and the aggregation time was from 2014 to 2021. The two low incidence clusters were centered in Yongcheng City and Boai County, covering 58 and 18 counties (cities, districts), respectively, and the aggregation time was 2016 - 2021 and 2005 - 2012, respectively. Conclusion:The overall incidence of brucellosis in Henan Province is on the rise from 2005 to 2021, with middle-aged and elderly male farmers as the main affected population, and there are spatiotemporal clusters of brucellosis in Henan Province.

Tumor is a serious threat to human health. At present, surgical resection, chemoradiotherapy, targeted therapy and immunotherapy are the main therapeutic strategies. Monoclonal antibody has gradually become an indispensable drug type in the clinical treatment of cancer due to its high efficiency and low toxicity. Phage antibody library technology (PALT) is a novel monoclonal antibody preparation technique. The recombinant immunoglobulin variable region of heavy chain (VH)/variable region of light chain (VL) gene is integrated into the phage vector, and the antibody is expressed on the phage surface in the form of fusion protein to obtain a diverse antibody library. Through the process of adsorption-elution-amplification, the antibody library can be screened to obtain the antibody molecule with specific binding antigen as well as its gene sequence. PALT has the advantages of short antibody production cycle, strong plasticity of antibody structure, large antibody yield, high diversity and direct production of humanized antibodies. It has been used in screening tumor markers and preparation of antibody drugs for breast cancer, gastric cancer, lung cancer and liver cancer. This article reviews the recent progress and the application of PALT in tumor therapy.
Humans ; Bacteriophages/genetics* ; Immunoglobulin Variable Region/genetics* ; Gene Library ; Antibodies, Monoclonal/therapeutic use* ; Immunotherapy ; Peptide Library

Objective:To explore the ideal method of minimally invasive anterior lumbar extraperitoneal approach.Methods:Twenty-one adult embalmed cadavers underwent longitudinal incision near the left rectus abdominis, the extraperitoneal space and peritoneal characteristics were observed; the L 2-S 1 disc was exposed through extraperitoneal approach, and the relationship between the anterior large vessels and the disc was observed. One hundred adult abdominal CT were collected to measure the distance between the extraperitoneal fat of anterior abdominal wall and the rectus abdominis and the anterior midline at L 2-S 1 segment. One hundred and fifty adult lumbar MRI were collected to measure the distance between the anterior great vessels and the anterior midline of the intervertebral disc. Fifty-six cases of lumbar fusion were performed by minimally invasive anterior lumbar extraperitoneal approach, including 25 males and 31 females, aged 29-71 years. L 2-L 4 in 8 cases was performed by left rectus abdominis oblique incision, and L 4-S 1 in 48 cases was performed by median left transverse incision, with a length of about 8 cm, the complications related to the surgical approach were evaluated. Results:L 2-L 4 was proximal to the arcuate line, the posterior sheath of rectus abdominis adhered to the peritoneum, which was easy to rupture when separated; the peritoneum gradually thickened from the outer edge of the sheath of rectus abdominis and extraperitoneal fat appears. L 4-S 1 could be exposed distal to the arcuate line, the posterior side of rectus abdominis was extraperitoneal fat, the extension of arcuate line to the lateral abdominal wall would be slightly separated proximally, and there were multiple iliopsoas veins in the medial side of psoas major muscle. L 5S 1 was between the right common iliac artery and the left common iliac vein far, the median sacral vessel was small or absent, and the sympathetic nerve was to the left. Extraperitoneal fat appeared 36.2±9.9 mm, 35.2±11.6 mm and 27.6±11.2 mm away from the outer edge of rectus abdominis at L 2, 3, L 3, 4 and L 4, 5 segments respectively, and covered the posterior side of rectus abdominis and reached the midline at L 5S 1 segment. The left edge of abdominal aorta was 14.9±5.1 mm, 13.9±4.6 mm and 19.7±5.9 mm away from the midline at L 2, 3, L 3, 4 and L 4, 5 level respectively; the inferior vena cava was located on the right side of the midline at L 2, 3 and L 3, 4 level, crossed the midline 4.6±8.7 mm at L 4, 5 level. At L 5S 1 level, the left common iliac vein and the right common iliac artery were 14.6±6.8 mm and 17.6±5.3 mm away from the midline respectively. Seventy-six patients were successfully and fully exposed by small incision through extraperitoneal approach. 1 case of L 4, 5 had iliac lumbar vein tear and hemostasis with bipolar electrocoagulation. The operation time was 70-120 min, with an average of 90 min; Intraoperative bleeding was 15-70 ml, with an average of 30 ml. No severe complication such as nerve and great vessel injury occurred. Conclusion:Minimally invasive lumbar anterior retroperitoneal approach has small trauma and sufficient exposure with good feasibility. L 2-L 4 can be exposed with supine position and oblique incision next to the left rectus abdominis muscle, and L 4~S 1 with French position and median left transverse incision.

Background::Pancreatic adenocarcinoma (PAAD) is an extremely lethal malignancy. Identification of the functional genes and genetic variants related to PAAD prognosis is important and challenging. Previously identified prognostic genes from several expression profile analyses were inconsistent. The regulatory genetic variants that affect PAAD prognosis were largely unknown.Methods::Firstly, a meta-analysis was performed with seven published datasets to systematically explore the candidate prognostic genes for PAAD. Next, to identify the regulatory variants for those candidate genes, expression quantitative trait loci analysis was implemented with PAAD data resources from The Cancer Genome Atlas. Then, a two-stage association study in a total of 893 PAAD patients was conducted to interrogate the regulatory variants and find the prognostic locus. Finally, a series of biochemical experiments and phenotype assays were carried out to demonstrate the biological function of variation and genes in PAAD progression process.Results::A total of 128 genes were identified associated with the PAAD prognosis in the meta-analysis. Fourteen regulatory loci in 12 of the 128 genes were discovered, among which, only rs4887783, the functional variant in the promoter of Ring Finger and WD Repeat Domain 3 ( RFWD3), presented significant association with PAAD prognosis in both stages of the population study. Dual-luciferase reporter and electrophoretic mobility shift assays demonstrated that rs4887783-G allele, which predicts the worse prognosis, enhanced the binding of transcript factor REST, thus elevating RFWD3 expression. Further phenotypic assays revealed that excess expression of RFWD3 promoted tumor cell migration without affecting their proliferation rate. RFWD3 was highly expressed in PAAD and might orchestrate the genes in the DNA repair process. Conclusions::RFWD3 and its regulatory variant are novel genetic factors for PAAD prognosis.

ObjectiveTo study the accumulation and absorption of dry matter and nutrients in Curcuma phaeocaulis from Sichuan， the origin of Curcumae Radix （tuber） and Curcumae Rhizoma （rhizome）， to explore the growth and development laws and nutrient demand characteristics of the medicinal species， and thus to lay a theoretical basis for rational fertilization. MethodThe plant growth indexes， dry matter accumulation， and nutrient content of C. phaeocaulis at different growth stages in Sichuan were measured and analyzed. ResultThis medicinal species featured the dominant growth of aboveground leaves and stems before October and growth of underground part （particularly the rhizomes and tubers） from October. During the whole growth period， the accumulation of nitrogen， phosphorus， potassium， calcium， magnesium， iron， manganese， zinc， and copper per plant was 2 450.31， 907.09， 3 171.18， 625.94， 493.38， 14.53， 2.24 ， 2.93， 0.46 mg， respectively， with the order of potassium > nitrogen > phosphorus > calcium > magnesium > iron > zinc > manganese > copper. ConclusionThe species needs sufficient potassium and nitrogen， appropriate amount of phosphorus， calcium， and magnesium， a small amount of iron， and very little zinc， manganese， and copper for growth， and potassium is particularly important. Nitrogen， phosphorus， and potassium fertilizers supply macroelements and nitrogen fertilizer should be supplemented at seedling stage， leafy stage， early rhizome expansion stage， tuber expansion stage， and the second expansion stage of rhizome. Phosphorus and potassium fertilizers should be applied at seedling stage， tuber expansion stage， secondary expansion stage of rhizome， and dry matter accumulation stage of tuber and rhizome. At seedling stage， leafy stage， early rhizome expansion stage， tuber expansion stage， and the second expansion stage of rhizome， a variety of medium and trace elements-containing foliar fertilizers should be used.

Objective:To investigate the impact of multidisciplinary diagnosis and treatment on postoperative 30-day mortality and complications in elderly patients with hip fracture.Methods:A retrospective analysis was conducted of the 260 elderly patients with hip fracture who had been treated by the mode of multidisciplinary diagnosis and treatment at Department of Orthopedics, Shenzhen Second People's Hospital from June 2018 to October 2019. The multidisciplinary group consisted of 66 males and 194 females with an age of 78.7 years ± 5.1 years, and 141 femoral neck fractures, 114 intertrochanteric fractures and 5 subtrochanteric fractures. They were compared with the 242 elderly patients with hip fracture (traditional group) who had been treated by the traditional mode from January 2017 to May 2018. The 2 groups were compared in terms of preoperative waiting time, 48-hour operation rate, 30-day mortality, and incidences of postoperative pneumonia and pressure ulcer.Results:There were no statistically significant differences in the preoperative general data or operative procedures between the 2 groups, showing comparability ( P>0.05). For the multidisciplinary group, preoperative waiting time was 41.9 h ± 36.5 h, significantly shorter than that for the traditional group (71.4 h ± 13.9 h), 48-hour operation rate 66.5% (173/260), significantly higher than that for the traditional group(8.7%, 21/242), incidence of postoperative pneumonia 3.1%(8/260), significantly lower than that for the traditional group(9.9%, 24/242), incidence of postoperative pressure ulcer (5.4%, 14/260), significantly lower than that for the traditional group(11.2%, 27/242), and 30-day mortality(2.3%, 6/260), significantly lower than that for the traditional group(5.8%, 14/242) (all P<0.05). Conclusions:Establishment of a mode of multidisciplinary diagnosis and treatment can significantly reduce the prolonged preoperative waiting time for elderly patients with hip fracture, thereby greatly reducing postoperative complications and postoperative 30-day mortality.