目的 分析药品集中带量采购（集采）政策下医院药品供应保障实况，提出优化政策及保障的对策建议。方法 通过提取重庆市渝北区人民医院2023年1月—2024年12月集采药品供应采购数据，描述性统计分析集采药品供应情况。结果 采购的416个中标药品中，69个在购销合同期内短缺，短缺率16.59%。短缺原因与企业生产能力、季节性需求波动相关，季节性强，以慢性病药和抗感染药为主。结论 建议建立监测平台、完善报告制度、制定应急预案、评估供货能力，保障供应。
Objective To analyzes the current situation of hospital drug supply guarantee under the policy of centralized and volume-based procurement（hereinafter referred to as “central procurement”），and proposes optimization strategies and suggestions for the policy and guarantee．Methods By extracting the procurement data of drugs supplied through centralized procurement at Yubei District People’s Hospital in Chongqing from January 2023 to December 2024，descriptive statistical analysis of the drug supply situation through centralized procurement was conducted．Results Among the 416 selected drugs purchased，69 were in short supply during the contract period，with a shortage rate of 16.59%．The reasons for the shortage were related to the production capacity of the enterprise，seasonal demand fluctuations，strong seasonality，and mainly chronic diseases and anti-infective．Conclusions It is suggested to build a monitoring platform，improve the reporting system，formulate emergency plans，and evaluate the supply capacity to ensure supply．
目的 修订肺癌患者联合药物治疗间歇期症状评估问卷，并评价其信效度。方法 以中文版安德森症状评估量表及肺癌特异性模块为基础，经文献分析、专家会议和认知性访谈形成测试版问卷。于2023年10-12月便利选取福州、莆田2所三级甲等医院278例肺癌患者进行调查，评价其信效度及偏倚风险。结果 修订后问卷含7个症状系统、60个条目，跳转式作答后实际作答21个条目。总问卷Cronbach's α系数为0.856，各维度为0.639～0.747；内容效度指数为0.81。验证性因子分析显示模型拟合尚可（χ2/df=2.366，RMSEA=0.070，CFI=0.858），各维度因子载荷、组合信度及平均方差提取量均达到可接受标准，区分效度良好。COSMIN-RoB评价结果为良好。结论 该问卷信效度良好，可用于评估肺癌患者联合药物治疗间歇期症状严重程度。
Objective To revise the Symptom Assessment Questionnaire for Lung Cancer Patients During Combined Drug Therapy Intervals and evaluate its reliability and validity. Methods Based on the Chinese version of the M. D. Anderson Symptom Inventory and its lung cancer-specific module, a preliminary questionnaire was developed through literature review, expert panel discussions, and cognitive interviews. From October to December 2023, a convenience sample of 278 lung cancer patients was recruited from two tertiary hospitals in Fuzhou and Putian, China. Reliability, validity, and risk of bias were evaluated. Results The revised questionnaire comprised seven symptom-system domains and 60 items, with 21 items completed through a skip-logic design. The overall Cronbach's α coefficient was 0.856, and the coefficients for each domain ranged from 0.639 to 0.747. The content validity index of the questionnaire was 0.81. Confirmatory factor analysis demonstrated an acceptable model fit (χ2/df = 2.366, RMSEA = 0.070, CFI = 0.858). Factor loadings, composite reliability, and average variance extracted of all domains met acceptable standards, indicating good discriminant validity. The overall risk of bias was rated as good according to the COSMIN Risk of Bias checklist. Conclusion The revised questionnaire demonstrated satisfactory reliability and validity and can be used to assess symptom severity in lung cancer patients during combined drug therapy intervals.
为规范广州地区“港澳药械通”伦理审查工作，满足临床用药用械需求，保障患者用药用械安全，广州市医学会医学伦理分会、广州市医院协会“港澳药械通”工作专业委员会组织行业专家，结合相关政策法规要求与本地实践经验，广泛征求专家意见，经多次讨论，形成《广州地区“港澳药械通”伦理审查共识》。共识涵盖适用范围、术语和定义、伦理审查的原则、伦理审查的类别、伦理审查的流程、伦理审查的方式及多医疗机构申请的伦理审查等方面。共识旨在为广州地区“港澳药械通”指定医疗机构的伦理审查工作提供指导，统一审查标准，提高审查效率与质量，切实保护患者的合法权益，促进临床急需进口港澳药械的安全合理使用，从而促进粤港澳大湾区医疗健康事业发展。
To standardize the ethical review process of the “Hong Kong and Macao Drugs and Medical Devices Access” in Guangzhou，meet the clinical demand for drugs and medical devices，and ensure the safety of patients’ use of drugs and medical devices，the Medical Ethics Branch of Guangzhou Medical Association and the “Hong Kong and Macao Drugs and Medical Devices Access” Professional Committee of Guangzhou Hospital Association organized industry experts，combined with relevant policy and regulatory requirements and local practical experience，widely solicited expert opinions，the “Consensus on Ethical Review of Drugs and Medical Devices for Hong Kong and Macao in Guangzhou” were formed after several discussions．The consensus content covers aspects such as the scope of application，terms and definitions，principles of ethical review，categories of ethical review，procedures of ethical review，methods of ethical review，and Ethical Review for Multi-institutional Applications．The consensus aims to provide guidance for the ethical review work of designated medical institutions for the “Hong Kong and Macao Drugs and Medical Devices Access” in the Guangzhou area，unify the review standards，improve the efficiency and quality of the review，effectively protect the legitimate rights and interests of patients，promote the safe and rational use of clinically urgently imported medicines and medical devices Hong Kong Macao，and thereby promote the development of medical and health care in the Guangdong-Hong Kong-Macao Greater Bay Area．
目的 评估调脂药物靶点所介导的脂质表型（HMGCR、PCSK9和NPC1L1）与高血压肾病风险之间潜在的因果相关性。方法 使用来自欧洲人群公开可获得的全基因组关联研究（GWAS）汇总数据进行孟德尔随机化（MR）分析。采用与低密度脂蛋白胆固醇（LDL-C）相关的遗传变异,根据选定的调脂药物靶基因筛选工具变量,使用逆方差加权法作为主要MR分析方法,并进行敏感性分析确保结果的稳健性。结果 基因预测的LDL-C水平与较高的高血压肾病风险相关（OR=1.19,95% CI：1.03~1.38,P=0.021）。较高的HMGCR介导的LDL-C水平与高血压肾病风险存在正向因果相关性（OR=4.08,95% CI：2.86~5.81;P<0.001）。然而,PCSK9和NPC1L1介导的LDL-C水平与高血压肾病风险无相关性。Cochran Q检验、MR-PRESSO检测和MR-Egger截距测试显示工具变量之间不存在异质性或水平多效性。结论 HMGCR介导的LDL-C与高血压肾病的发病风险存在因果相关性,针对HMGCR基因的他汀类药物在高血压肾病的防治中可能具有潜在益处。
Objective To assess the potential causal relationship between lipid phenotypes mediated by lipid-lowering drug targets（HMGCR,PCSK9 and NPC1L1）and the risk of hypertensive nephropathy．Methods Mendelian randomization（MR）analysis was conducted using summary data from publicly available European ancestry genome-wide association studies（GWAS）．Genetic variants associated with low-density lipoprotein cholesterol（LDL-C）were used as instrumental variables based on selected lipid-lowering drug target genes screening tools．Inverse variance weighting was selected as the main MR analysis method,with sensitivity analyses conducted to ensure the robustness of the results．Results Genetically predicted LDL-C levels were associated with a higher risk of hypertensive nephropathy（OR=1.19,95% CI：1.03~1.38,P=0.021）．Higher LDL-C levels mediated by HMGCR were positively causally related to increased risk of hypertensive nephropathy（OR=4.08,95% CI：2.86~5.81;P<0.001）．However,LDL-C levels mediated by PCSK9 and NPC1L1 showed no significant association with the risk of hypertensive nephropathy．Cochran’s Q test,MR-PRESSO,and MR-Egger intercept tests showed no heterogeneity or horizontal pleiotropy among instrumental variables．Conclusions The findings of this study support the causal relationship between LDL-C mediated by HMGCR and increased risk of hypertensive nephropathy,suggesting potential benefits of statin therapy for hypertensive nephropathy．
随着中西医结合的不断深入,医学工作者在临床工作中发现,西药因囿于西医体系,很难在中医药理论体系指导下的临床诊疗上发挥作用,极有必要走西药中药化之路,以弥补这一方面的不足。本文以阿司匹林为主要范例,从推测西药的中药性质入手,总结归纳几种研究方法及注意事项,并大致总结目前研究西药中药化上的诸多不足,同时收集汇总目前相关文献中提到的西药的中药性质,以抛砖引玉,供后续研究者参考。
With the continuous deepening of Chinese medicalization of western medicine,it is not difficult to find that western medicine is limited to the western medicine system,which is hard to play a role in clinical diagnosis and treatment under the guidance of traditional Chinese medicine（TCM）system．It is extremely necessary to take the road of TCM of western medicines to make up for the deficiencies．In this paper,we take aspirin as the main example,start from the speculation of the nature of western medicines,summarize several research methods and notes,and generally summarize the many shortcomings of the current research on the Chinese medicalization of western medicines,and at the same time,collect and summarize the TLM nature of western medicines mentioned in the relevant literature,to provide a reference for the subsequent researchers．
药物递送系统对于各类疾病意义非凡,但传统药物载体面临细胞毒性强、组织相容性低、半衰期短和靶向性弱等诸多挑战。血小板及其相关衍生物作为新型药物载体具有更为显著的优势。由于血小板自身的生理特点,以及在肿瘤、心血管疾病、血栓性疾病、感染等多种疾病中发挥的病理生理作用,血小板能够弥补传统药物载体的缺陷,具有极大的临床转化意义。该文总结了血小板相关药物递送系统目前的研究进展,以期为新型药物载体研究提供参考。
Drug delivery systems are important for various diseases,but conventional therapeutic drug have many shortcomings,such as high cytotoxicity,low histocompatibility,short half-life and weak targeting．Platelets and their derivatives have more significant advantages as novel drug carriers．Platelets play an important role in the pathophysiology of a wide range of diseases including oncology,cardiovascular diseases,thrombosis and infection．In this paper,we summarized the current research progress of platelet-related drug delivery systems to provide a reference for the research of novel drug delivery systems．
目的 为临床合理使用替考拉宁以及更好地管理接受替考拉宁治疗的患者。方法 从药学角度对2022年日本《2022 JSC/JSTDM临床实践指南:替考拉宁治疗药物监测》(简称《指南》)涉及替考拉宁治疗的9个临床问题进行解读。结果 《指南》指出药-时曲线下面积/最小抑菌浓度是替考拉宁的关键药动学/药效学参数。替考拉宁治疗药物监测(TDM)的目的是明确目标谷浓度(Cmin),对于严重或复杂的耐甲氧西林金黄色葡萄球菌(MRSA)感染,指南建议替考拉宁Cmin为20~40 mg/L。肾功能正常或轻度受损的非复杂性的MRSA感染,目标Cmin为15~30 mg/L。严重和/或复杂性MRSA感染,如感染性心内膜炎和骨髓炎,替考拉宁Cmin为20~40 mg/L。结论 《指南》针对不同病理状态下患者替考拉宁目标Cmin的确定,为临床治疗中替考拉宁TDM、个体化给药提供参考。
Objective To make rational use of teicoplanin and better management of patients treated with teicoplanin. Methods Nine clinical issues related to the treatment of teicoplanin in Clinical practice guidelines for therapeutic drug monitoring of teicoplanin: a consensus review by the Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring (Japan, 2022) were interpreted from the perspective of pharmacy. Results The guidelines indicated that the area under drug-time curve/minimum inhibitory concentration was the key pharmacokinetic/pharmacodynamic parameters of teicoplanin.The purpose of therapeutic drug monitoring (TDM) of teicoplanin is to specify the target trough concentration (Cmin), which guidelines recommend for severe or complex methicillin-resistant Staphylococcus aureus (MRSA) infection is 20-40 mg/L.The target Cmin for uncomplicated MRSA infection with normal or mildly impaired renal function is 15-30 mg/L.For severe and/or complex MRSA infections, such as infective endocarditis and osteomyelitis, the Cmin of teicoplanin was 20-40 mg/L. Conclusions The guidelines are aimed at the determination of target Cmin of teicoplanin in patients with different pathological conditions, and provide reference for individual drug administration and teicoplanin TDM in clinical treatment.
目的 探讨药物服务干预对老年高血压患者的治疗及用药安全性的影响。方法 选取2020年6月—2021年12月潮州市中医药研究所门诊部和潮州市中医医院高血压患者90例为研究对象,采用随机数字表法分为观察组45例（给予药物服务干预）,对照组45例（给予常规用药指导）。比较干预后血压控制水平、健康知识认知、治疗依从性、自我管理行为、生活质量及药物不良反应等情况。结果 干预后,观察组舒张压、收缩压、不良反应发生率均低于对照组（P<0.05）。干预后,观察组健康知识认知水平、治疗依从率、自我管理行为评分、生活质量评分均高于对照组（P<0.05）。结论 采用药物服务干预的方式能够较好控制老年高血压患者血压水平,提升其健康知识认知水平与治疗依从性,改善自我管理行为状况,提高生活质量。
Objective To investigate the effect of drug service intervention on the treatment and drug safety of elderly patients with hypertension．Methods From June 2020 to December 2021,a total of 90 patients with hypertension from Chaozhou Institute of traditional Chinese Medicine and Chaozhou Hospital of Traditional Chinese Medicine were selected as the study objects,and were divided into observation group（45 cases,given drug service intervention）and control group（45 cases,given routine drug guidance）by random number table method．The blood pressure control level,health knowledge cognition level,treatment compliance,self-management behavior,quality of life and adverse drug reactions of elderly patients with hypertension were compared after intervention．Results After intervention,the incidence of diastolic blood pressure,systolic blood pressure and adverse drug reactions in the observation group were lower（P<0.05）．After intervention,the health knowledge cognition level,treatment compliance rate,self-management behavior score and quality of life score of the observation group were higher（P<0.05）．Conclusions The use of drug service intervention can better control the blood pressure level of elderly patients with hypertension,improve their health knowledge cognition and treatment compliance,improve self-management behavior and improve quality of life．
目的 对腹腔镜子宫肌瘤切除术围手术期应用抗菌药物的情况进行回顾性分析,并分析腹腔镜子宫肌瘤切除术围手术期感染的影响因素。方法 选择2018年5月—2021年5月在我院行腹腔镜子宫肌瘤切除术的患者72例进行回顾性分析。收集患者一般资料及抗生素使用情况,根据有无术后感染将患者分为2组,比较2组患者上述各资料,并采用多因素分析法判断各因素对腹腔镜子宫肌瘤切除术后感染的综合作用。结果 本次纳入的72例腹腔镜子宫肌瘤切除术患者共有16例出现术后感染,术后感染率为22.22%。多因素Logistic回归分析结果显示:年龄≥50岁、手术时间≥60 min、合并糖尿病为腹腔镜子宫肌瘤切除术围手术期感染的危险因素,预防性使用抗生素、术前≤2 h抗生素使用、术后抗生素使用≤48 h为保护性因素(P<0.05)。结论 腔镜子宫肌瘤切除术患者术后感染率为22.22%,抗菌药物使用时机及使用时间对腹腔镜子宫肌瘤切除术患者术后感染有重要的影响,此外患者年龄、手术时间、合并糖尿病情况也与患者术后感染有关。
Objective To retrospectively analyze the perioperative application of antibacterial drugs during laparoscopic myomectomy, and to analyze the influencing factors of infection during the perioperative period of laparoscopic myomectomy. Methods Seventy-two patients who underwent laparoscopic myomectomy in our hospital from May 2018 to May 2021 were selected for retrospective analysis. The patients were divided into two groups according to postoperative infection status. The above data were compared between the two groups, and the comprehensive effects of various factors on postoperative infection after laparoscopic myomectomy were determined by multivariate analysis. Results There were 16 cases of 72 patients underwent laparoscopic myomectomy had postoperative infection, and the postoperative infection rate was 22.22%. Multivariate Logistic regression analysis showed that age over 50, operation time over 60 minutes, and with diabetes mellitus were the risk factors of perioperative infection in laparoscopic myomectomy. Prophylactic use of antibiotics, preoperative use of antibiotics in less than 2 hours and postoperative use of antibiotics in less than 48 hours were protective factors (P<0.05). Conclusions The infection rate of patients underwent laparoscopic myomectomy was 22.22%. The time and length of antibiotics use had important influence on postoperative infection of patients underwent laparoscopic myomectomy. In addition, age, operation time and complicated with diabetes mellitus were also related to postoperative infection.
目的 比较广东云浮市进行药品专区执行国家药品集中采购(GPO)前后呼吸系统疾病患儿住院医疗费用,分析其住院医疗费用的影响因素。方法 选择云城区2019—2020年0~14岁城乡儿童呼吸系统疾病住院患儿,采用单因素和多元回归统计方法分析住院医疗费用的影响因素。结果 呼吸系统疾病儿童平均住院医疗费用国家集采前(4 872.38元)高于国家药品集采后(4 620.25元,P<0.05),药费分别占参保及参合患儿住院医疗费用的35.35%和27.39%,统筹支付费用参保与参合儿童分别占46.85%和57.59%。年龄、住院天数、转归、有无合并症、疾病分类、应用GPO药物、入院分类为呼吸系统疾病患儿住院医疗费用的共同影响因素,其中住院医疗费用随着患儿年龄增加、转归良好及应用GPO药物费用而减少,为负性联系;余住院天数、有无合并症、疾病分类、入院分类则与住院总费用有着正性联系。结论 提高患儿的转归,缩短平均住院日,做好药品专区及集中采购工作可降低儿童呼吸系统疾病的住院费用。
Objective To compare the inpatient medical expenses of children with respiratory diseases before and after the implementation of national group purchasing organization(GPO) in Yunfu City, Guangdong Province, and analyze the influencing factors of inpatient medical expenses. Methods The hospitalized children aged 0~14 with respiratory diseases from 2019 to 2020 in Yuncheng district implemented the GPO were selected. The influencing factors of hospitalization expense were analyzed by single factor and multiple regression statistical methods. Results The average hospitalization expense of children with respiratory diseases before the GPO implemented (4 872.38 yuan) was higher than after (4 620.25 yuan, P<0.05); the drug expense accounted for 35.35% and 27.39% of the hospitalization expense of the insured urban and rural children, and integrated payment accounted for 46.85% and 57.59%. Age, hospitalization days, outcome, comorbidities, disease classification, application of GPO drugs and admission classification were the common influencing factors of hospitalization expense of children with respiratory diseases. Hospitalization expense decreased with the increase of age, good outcome and application of GPO drugs, which was a negative correlation. And there was a positive relationship between the rest factors and the total cost of hospitalization. Conclusions To improve the outcome of children, shorten the average length of stay, doing a good job in drug zone and group procurement can reduce the hospitalization cost of children with respiratory diseases.
