1.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
2.Uniportal endoscopic decompression and debridement for infectious diseases of spine with neurological deficits: a retrospective study in China
Hui LV ; Jianhong ZHOU ; Yuan GUO ; Sheng LIAO ; Hui CHEN ; Fei LUO ; Jianzhong XU ; Zhongrong ZHANG ; Zehua ZHANG
Asian Spine Journal 2025;19(2):205-216
Methods:
This retrospective study analyzed 32 consecutive IDS patients who underwent UEDD surgery. Clinical features, laboratory data (erythrocyte sedimentation rate and C-reactive protein), and treatment outcomes were analyzed.
Results:
Definite microorganisms were identified in 27 patients (84.3%), with 24 (88.9%) meeting cure criteria. The cure rate was significantly higher in the detected pathogen group compared to the undetected pathogen group (88.9% vs. 80%; χ²=19.36, p<0.0001). Metagenomic next generation sequencing (mNGS) provided faster diagnosis (41.72±6.81 hours) compared to tissue culture (95.74±35.47 hours, p<0.05). The predominant causative pathogen was Mycobacterium tuberculosis, followed by Staphylococcus aureus. Significant improvements were observed in Visual Analog Scale pain scores, from a mean of 7.9 preoperatively to 1.06 at 1 year postoperatively. The Oswestry Disability Index revealed a similar trend, showing significant improvement (p<0.05).
Conclusions
UEDD is a viable alternative to traditional open surgery for managing IDS in high-risk patients. UEDD offers a dual therapeutic-diagnostic advantage during the initial admission phase, enabling simultaneous debridement, neurological decompression, and targeted biopsy in a single intervention. Compared with traditional tissue culture, mNGS enables rapid microbiological diagnosis and extensive pathogen coverage.
3.Uniportal endoscopic decompression and debridement for infectious diseases of spine with neurological deficits: a retrospective study in China
Hui LV ; Jianhong ZHOU ; Yuan GUO ; Sheng LIAO ; Hui CHEN ; Fei LUO ; Jianzhong XU ; Zhongrong ZHANG ; Zehua ZHANG
Asian Spine Journal 2025;19(2):205-216
Methods:
This retrospective study analyzed 32 consecutive IDS patients who underwent UEDD surgery. Clinical features, laboratory data (erythrocyte sedimentation rate and C-reactive protein), and treatment outcomes were analyzed.
Results:
Definite microorganisms were identified in 27 patients (84.3%), with 24 (88.9%) meeting cure criteria. The cure rate was significantly higher in the detected pathogen group compared to the undetected pathogen group (88.9% vs. 80%; χ²=19.36, p<0.0001). Metagenomic next generation sequencing (mNGS) provided faster diagnosis (41.72±6.81 hours) compared to tissue culture (95.74±35.47 hours, p<0.05). The predominant causative pathogen was Mycobacterium tuberculosis, followed by Staphylococcus aureus. Significant improvements were observed in Visual Analog Scale pain scores, from a mean of 7.9 preoperatively to 1.06 at 1 year postoperatively. The Oswestry Disability Index revealed a similar trend, showing significant improvement (p<0.05).
Conclusions
UEDD is a viable alternative to traditional open surgery for managing IDS in high-risk patients. UEDD offers a dual therapeutic-diagnostic advantage during the initial admission phase, enabling simultaneous debridement, neurological decompression, and targeted biopsy in a single intervention. Compared with traditional tissue culture, mNGS enables rapid microbiological diagnosis and extensive pathogen coverage.
4.Uniportal endoscopic decompression and debridement for infectious diseases of spine with neurological deficits: a retrospective study in China
Hui LV ; Jianhong ZHOU ; Yuan GUO ; Sheng LIAO ; Hui CHEN ; Fei LUO ; Jianzhong XU ; Zhongrong ZHANG ; Zehua ZHANG
Asian Spine Journal 2025;19(2):205-216
Methods:
This retrospective study analyzed 32 consecutive IDS patients who underwent UEDD surgery. Clinical features, laboratory data (erythrocyte sedimentation rate and C-reactive protein), and treatment outcomes were analyzed.
Results:
Definite microorganisms were identified in 27 patients (84.3%), with 24 (88.9%) meeting cure criteria. The cure rate was significantly higher in the detected pathogen group compared to the undetected pathogen group (88.9% vs. 80%; χ²=19.36, p<0.0001). Metagenomic next generation sequencing (mNGS) provided faster diagnosis (41.72±6.81 hours) compared to tissue culture (95.74±35.47 hours, p<0.05). The predominant causative pathogen was Mycobacterium tuberculosis, followed by Staphylococcus aureus. Significant improvements were observed in Visual Analog Scale pain scores, from a mean of 7.9 preoperatively to 1.06 at 1 year postoperatively. The Oswestry Disability Index revealed a similar trend, showing significant improvement (p<0.05).
Conclusions
UEDD is a viable alternative to traditional open surgery for managing IDS in high-risk patients. UEDD offers a dual therapeutic-diagnostic advantage during the initial admission phase, enabling simultaneous debridement, neurological decompression, and targeted biopsy in a single intervention. Compared with traditional tissue culture, mNGS enables rapid microbiological diagnosis and extensive pathogen coverage.
5.Efficacy and safety of sacral neuromodulation in the treatment of refractory interstitial cystitis/bladder pain syndrome
Qiangping ZHENG ; Jianzhong ZHANG ; Fei WANG ; Chaohua ZHANG ; Peng ZHANG
Journal of Modern Urology 2025;30(2):152-156
Objective: To summarize the long-term efficacy and safety of sacral neuromodulation (SNM) in treating refractory interstitial cystitis/bladder pain syndrome (IC/BPS),so as to provide clinical evidence for this therapeutic approach. Methods: This study retrospectively analyzed the data of 27 patients with refractory IC/BPS treated at our hospital during Jan.2015 and Dec.2021.All patients underwent SNM Ⅱ.The therapeutic effects were evaluated with Global Response Assessment (GRA).The preoperative and postoperative daily urinary frequency,nocturia frequency,functional bladder capacity,O'Leary-Sant score,pelvic pain,urgency and frequency (PUF) score,quality of life (QoL) score,and visual analogue scale (VAS) score were compared. Results: During the follow-up of (55.55±16.33) months,12 patients showed no symptom relief (GRA≤4),while 15 experienced symptom relief (GRA>4),resulting in an efficacy rate of 55.56% (15/27).The average daily urination frequency decreased from (28.74±13.84) to (24.74±16.33) times,the O'Leary-Sant score decreased from (30.19±5.35) to (25.63±9.34),PUF score decreased from (25.63±5.34) to (22.04±8.29),QoL score decreased from (5.67±0.55) to (4.33±1.57),and VAS score decreased from (8.04±1.91) to (5.33±3.09),the differences were statistically significant (P<0.05). No complications such as incision infections or pain at the implant site were observed. Conclusion: SNM is safe and effective for refractory IC/BPS,but there is a risk of long-term failure.Therefore,patients should be discreetly selected.
6.Effect of postoperative radiotherapy after complete resection in patients with stage ⅢA-N2 non-small cell lung cancer: A propensity score matching analysis
Zhengshui XU ; Minxia ZHU ; Jiantao JIANG ; Shiyuan LIU ; Jia CHEN ; Danjie ZHANG ; Jianzhong LI ; Liangzhang SUN ; Shaomin LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):1006-1012
Objective To evaluate the value of postoperative radiotherapy (PORT) in patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy. Methods Patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy were chosen from the SEER Research Plus Database [17 Registries, November 2012 Submission (2000-2019)]. The patients were divided into a PORT group and a non-PORT group according to whether the PORT was used. To balance baseline characteristics between non-PORT and PORT groups, R software was used to conduct a propensity score matching (PSM) with a ratio of 1 : 1 and a matching tolerance of 0.01. Both the Cox regression analysis and Kaplan-Meier survival analysis were conducted to evaluate the value of PORT in terms of overall survival (OS) and disease-specific survival (DSS). Results In total, 2468 patients with stage ⅢA-N2 non-small cell lung cancer were enrolled, including 1078 males and 1390 females with a median age of 65 (58-71) years. There were 1336 patients in the PORT group, and 1132 patients in the non-PORT group. Cox regression analysis showed that PORT was not significantly associated with OS (multivariate analysis: HR=1.051, 95%CI 0.949-1.164, P=0.338) and DSS (multivariate analysis: HR=1.094, 95%CI 0.976-1.225, P=0.123). No statistical difference was found in the OS or DSS between non-PORT group and PORT group after PSM analysis (P>0.05). Conclusion PORT does not have a survival benefit for patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy.
7.Synthesis and biological activities of chlorin e6-based conjugate of fluorouracil as dual-mode antitumor photosensitizer
Jie SHEN ; Fei HUANG ; Xingjie ZHANG ; Jianzhong YAO
Journal of Pharmaceutical Practice and Service 2024;42(1):18-23
Objective To design and synthesize the conjugate (compound 1) of chlorin e6 (compound 3) with fluorouracil (5-Fu) as novel pH-responsive dual-mode antitumor photosensitizer by acyl hydrazone bond coupling, based on literature reports that combination of 5-Fu and photosensitizer possess synergistic anti-tumor effect, and investigate its photodynamic antitumor activity and mechanism. Methods Lead compound 3 was obtained by alkali degradation with 25% KOH-CH3OH on pheophorbide a (compound 4) which was prepared through acid hydrolysis of chlorophyll a in crude chlorophyll extracts from silkworm excrement. Reflux reaction of 5-Fu with P2S5 in pyridine formed crude 4-thio-5-fluorouracil which was followed to react with hydrazine hydrate (N2H4·H2O) in CH3OH to give 5-fluorouracil-4-hydrazone (compound 2). Then, treatment of compound 3 i.e. acid alkali degradation product of chlorophyll a in silkworm excrement with EDC·HCl generated its 171- and 152 cyclic anhydride which was followed to directly react with intermediate compound 2 to successfully get title compound 1. In addition, its pH-responsive 5-Fu release and photodynamic antitumor activity and their mechanisms in vitro were investigated. Results Compound 1 could responsively release 5-Fu at pH 5.0, with a cumulative release rate of 60.3% within 24 h. It exhibited much higher phototoxicity against melanoma B16-F10 and liver cancer HepG2 cells than talaporfin and its precursor compound 3, with IC50 value being 0.73 μmol/L for B16-F10 cells and 0.90 μmol/L for HepG2 cells, respectively. Upon light irradiation, it also could significantly induce cell apoptosis and intracellular ROS level and block cell cycle in S phase. Its structure was confirmed by UV, 1H-NMR, ESI-MS and elemental analysis data. Conclusion The conjugate compound 1 of compound 3 and 5-Fu has the advantages of strong PDT anticancer activity, high therapeutic index (i.e. dark toxicity/phototoxicity ratio) and responsively release 5-Fu at pH 5.0 etc. which shows “unimolecular” dual antitumor effects of PDT and chemotherapy and is worthy of further research and development.
8.Construction of a genomic database for Group A Streptococcus and the analysis of prophage distribution
Fanliang MENG ; Caixin XIANG ; Jianzhong ZHANG ; Yuanhai YOU
Chinese Journal of Applied Clinical Pediatrics 2024;39(1):49-53
Objective:To illustrate the characteristics of the distribution of prophages among the Group A Streptococcus(GAS) by mining the existing whole genome sequencing of the GAS, performing bioinformatic analyses, extracting data about prophages, and analyzing the state of prophages in the genome and genetic composition of some prophages. Methods:It was a retrospective study.Genome assembly sequences of GAS reported in GenBank till May 2020 were collected, and the important background information of these strains was sorted out to create a local genomic database.A phylogenetic tree of the whole genome of GAS was conducted using the bioinformatics software.The core genome was analyzed, and potential prophages and their integrity in the genome were predicted to obtain the characteristics of the distribution of prophages.Genotype types, number of core genes, and number, length and carrying rate of prophages in the database for GAS were analyzed.Results:A database containing the genome sequence of 2 529 GAS strains was established, involving 140 emm genotypes.These strains were isolated from 19 countries from East Asia, Europe, America and Oceania.Stratified by the disease background, these strains were mainly divided into invasive infection, non-invasive infection and immune sequelae.Prophage analysis of 1 798 genomes showed that at least one complete prophage was detected in 1 366 (76.0%) genomes.The number of complete prophages of each strain ranged from 0 to 6, and the length ranged from 32.8 to 62.6 kb, which was mainly 30-40 kb in length.The phiHKUssa, phiHKUvir and phiHKU488 were the most common prophages present in dominant clones circulated in China in recent years, which mainly carried virulence genes like the speC, spd1 and ssa. Conclusions:Prophages are widely distributed in the genome of GAS, which are of great significance in the evolution and expansion of dominating clones and thus reshape the population structure within the emm genotype.The establishment of a local genome database provides important baseline data for molecular epidemiological surveillance.
9.Expert opinions on operation rules of Morita therapy outpatient service
Jiangbo LI ; Zucheng WANG ; Yuhua CUI ; Yingzhi LU ; Weijie QU ; Haiyin ZHANG ; Fuqiang MAO ; Fengqing QIE ; Wanghong SHI ; Qinfeng ZHANG ; Lingyi PAN ; Ling ZHANG ; Jianzhong LI ; Guangcheng CUI ; Tongxian CHEN ; Xiuqing MA ; Wei RONG ; Jianjun ZHANG ; Qingfang ZHONG ; Yanchi ZHANG ; Boquan ZHANG ; Xinrui WANG ; Wenyou MA ; Qingtao REN ; Yongfa JING ; Huanzhong LIU ; Zhenjian YU ; Laitian ZHAO ; Tianming HAN ; Xue HAN
Chinese Mental Health Journal 2024;38(1):68-72
Morita therapy has been bom for more than 100 years.Inpatient Morita therapy is highly oper-able and easy to master.It can improve many refractory neuroses through four-stage treatment.But more neuroses are treated in outpatient clinics,and Morita therapy cannot be used in hospitalized patients.Therefore,the formula-tion of expert opinions on outpatient operations is particularly important.This paper is based on domestic and for-eign references,and after many discussions by domestic Morita therapy experts,and then drew up the first version of the expert opinions on operation of outpatient Morita therapy.Meanwhile the operation rule of Morita therapy in three stages of outpatient treatment was formulated:in the etiological analysis stage,under the theoretical guidance of Morita therapy,analyze the pathogenic factors,to improve treatment compliance and reduce resistance;during the operating stage,guide patients to engage in constructive and meaningful actions,realizing the achievement of letting nature take its course principle;in the cultivating character and enriching life stage,pay attention to positive infor-mation,expanding the scope and content of actions,improving the ability to adapt to complex life,and preventing recurrence caused by insufficient abilities.It will lay a foundation for the promotion of Morita therapy in domestic outpatient clinics,so that more patients with neurosis and other psychological diseases could receive characteristic Morita therapy treatment in outpatient clinics.
10.Research and analysis of the blending types and workload of PIVAS in China
Hongmei LYU ; Jing ZHAO ; Yuqi FU ; Jianzhong ZHANG
China Pharmacy 2024;35(18):2203-2206
OBJECTIVE To assess the blending types and workload of pharmacy intravenous admixture services (PIVAS) in China. METHODS By questionnaire survey, the working status of PIVAS in different levels of hospitals nationwide was investigated, involving the types of blending infusion, daily blending volume of hazardous drugs infusion, parenteral nutrition solution, general and antibacterial drug infusion, intravenous bolus drugs, skin test solution and intravenous agents, as well as the daily packing volume. RESULTS A sample of 750 PIVAS in 30 provinces (autonomous regions, municipalities) across China were surveyed by questionnaire, involving 621 tertiary hospitals and 90 secondary hospitals. The main types of liquid preparation were intravenous infusion, followed by parenteral nutrition solution, and chemotherapy pump (including chemotherapy infusion), accounting for 99.73%, 79.47% and 43.33%, respectively. The daily blending volume of hazardous drugs infusion, parenteral nutrition solution, general and antibacterial drug infusion, intravenous bolus drugs, skin test solution and intravenous agents in PIVAS of tertiary hospitals were 23.00 (9.00, 56.50) sets, 31.00 (13.97, 74.00) bags, 813.00 (375.00, 2 061.75) bags, 426.00 (210.00, 987.00) bags, 30.00 (6.00, 155.00) ampoules, 30.00 (7.13, 136.84) ampoules, 3 200.00 (1 684.50, 5 554.50) ampoules respectively, while the daily packing volume was 218.50 (52.26, 559.00) bags; above indexes of PIVAS in secondary hospital were 4.00(2.00,12.00)sets, 8.90(3.00,23.00)bags, 270.50(108.00, 2 061.75)bags, 157.00(71.00,987.00)bags, 5.85 (3.75,141.00) ampoules, 0 ampoule, 1 349.00(548.10,2 408.00)ampoules, 107.50(33.25,207.00)bags. CONCLUSIONS The scope of blending types of PIVAS has been significantly expanded, and tertiary hospitals are significantly higher than secondary hospitals in the blending and packing volumes of all types of intravenous fluids and drugs dispensed, showing obvious advantages in dealing with complex medications and high-risk treatments.

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