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5PSQ-146 ‘Real life’ effectiveness and safety assessment of foscarnet 5PSQ-146膦甲酸酯的“实际生活”有效性和安全性评价
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.265
A. Perez, A. Pueyo, J. P. Pascual, A. C. Navasal, L. C. Poderoso, M. Moreno, A. P. Rello, A. Martínez, R. A. Sazatornil
Background and importance Cytomegalovirus (CMV) infection is an important cause of mortality, especially in haematological patients. Foscarnet has been used to treat ganciclovir resistant CMV infections. Only a few studies assessing safety and effectiveness of foscarnet have been reported so far. Aim and objectives To evaluate the effectiveness and safety of foscarnet in the treatment of CMV infection in a third level hospital. Material and methods A retrospective observational study was conducted in patients who received foscarnet as treatment for CMV viraemia from January 2018 to April 2020. Variables collected were: age, sex, pathology, time of treatment, pattern, basal (start of foscarnet) and final (when foscarnet was suspended) viral load (VL), basal and nadir glomerular filtrate (GF) and metabolic toxicity (basal and nadir serum electrolytes). The results were obtained from the electronic history and prescription software (Farmatools). Results 39 patients, 22 men, were included, and mean age was 55.8±14.9 years (26–82). 71.8% were haematological patients, of whom 41.0% had received bone marrow transplantation. Mean time in treatment was 11±6.6 days (1–27). The dosage pattern was 90 mg/kg/12 hours in 69.2%. 23.0% started treatment as prophylaxis with undetectable VL. In the remaining patients, median basal VL was 1135 IU/mL (3.34–65400), final VL was undetectable in 46.1% and in those who did not negatively affect the median final VL was 215 IU/mL (34.5–6690). Mean reduction in VL was 90.4±17.9% (18–100). There was a 64.1% reduction in GF (mean reduction of 25.6±21.2% and 36.7±22.0% over >65 years). Metabolic toxicity, according to the CTCAE classification (V.4.0), hypokalaemia (grade 1 in 10.2% patients, grades 2 and 3 in 33.3%, grade 4 in 5.1% and the rest were not altered) and hypophosphataemia (grade 1 in 10.2%, grades 2 and 3 in 33.3% and grade 4 in 2.5%) were studied. In addition, hypomagnesaemia (grade 1 in 12.8%) and hypocalcaemia (grade 2 in 28.2% and grade 3 in 33.3%) were also observed. 41.0% of patients died during or immediately after treatment with foscarnet. Their average age was 61±14.4 (27–82) years and 81.2% presented haematological pathologies. Conclusion and relevance Despite the high mortality observed, foscarnet effectively reduced viraemia due to CMV infection, with a high rate of viral negativisation. Further studies are needed to extend the toxicity data and improve the quality of care. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性巨细胞病毒(CMV)感染是导致死亡的重要原因,特别是在血液病患者中。Foscarnet已被用于治疗更昔洛韦耐药巨细胞病毒感染。迄今为止,仅有少数评估膦甲酸酯安全性和有效性的研究报告。目的评价磷磷在某三甲医院治疗巨细胞病毒感染的有效性和安全性。材料与方法对2018年1月至2020年4月接受氟膦酸钠治疗巨细胞病毒血症的患者进行回顾性观察研究。收集的变量包括:年龄、性别、病理、治疗时间、模式、基础(开始使用foscarnet)和最终(停用foscarnet时)病毒载量(VL)、基础和最低点肾小球滤液(GF)和代谢毒性(基础和最低点血清电解质)。结果由电子病历和处方软件(Farmatools)获得。结果39例患者,男性22例,平均年龄55.8±14.9岁(26 ~ 82岁)。71.8%为血液病患者,其中41.0%接受过骨髓移植。平均治疗时间11±6.6 d(1-27)。69.2%的患者给药模式为90mg /kg/ 12h。23.0%的患者在VL检测不到的情况下开始预防性治疗。在其余患者中,中位基础VL为1135 IU/mL(3.34-65400), 46.1%的患者无法检测到最终VL,而在没有负面影响的患者中,中位最终VL为215 IU/mL(34.5-6690)。VL平均降低90.4±17.9%(18-100)。GF减少64.1%(65岁以上平均减少25.6±21.2%和36.7±22.0%)。代谢毒性,根据CTCAE分级(V.4.0),研究了低钾血症(10.2%的患者为1级,33.3%的患者为2级和3级,5.1%的患者为4级,其余未改变)和低磷血症(10.2%的患者为1级,33.3%的患者为2级和3级,2.5%的患者为4级)。此外,还观察到低镁血症(12.8%为1级)和低钙血症(28.2%为2级,33.3%为3级)。41.0%的患者在氟膦酸钠治疗期间或治疗后立即死亡。平均年龄61±14.4(27-82)岁,81.2%出现血液学病理。结论及相关性尽管观察到高死亡率,但磷膦酸钠能有效减少巨细胞病毒感染引起的病毒血症,病毒阴性率高。需要进一步的研究来扩展毒性数据并提高护理质量。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
5PSQ-196 Association between phosphodiesterase 5 inhibitor use and incident dementia in prostate cancer patients treated with androgen deprivation therapy 5PSQ-196磷酸二酯酶5抑制剂的使用与雄激素剥夺治疗前列腺癌患者痴呆发生率的关系
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.315
Kc Chang, SC Shao, Jm Liu, E. Lai
Background and importance Recent studies have indicated that androgen deprivation therapy (ADT) increased the dementia risk in prostate cancer (PCa) patients. Phosphodiesterase 5 inhibitors (PDE5i) with nitric oxide mediated vasodilation can increase blood flow in the brain. However, no current studies have explored the association between PDE5i exposure and dementia in PCa patients treated with ADT. Aim and objectives To determine the association between PDE5i exposure and incident dementia in PCa patients treated with ADT. Material and methods We conducted a retrospective cohort study using the Chang Gung Research Database (CGRD) in Taiwan. We included PCa patients newly receiving ADT between 2009 and 2016. We conducted a three step matching and modified landmark approach to identify PDE5i users and non-users after ADT use. The landmark date was defined as 1 year following the start of ADT, and we defined PDE5i users as patients initiating PDE5i before and after the landmark date. We matched PDE5i users to non-users by (1) age, (2) prostatic specific antigen and (3) 1:4 propensity scores for comorbidity and co-medication. We followed the patients from the landmark date until the incident diagnosis of dementia, last date of clinical visit or 31 December 2019. We performed multivariate Cox proportional hazard models to compare the dementia risk between PDE5i users and non-users. Results We included 4557 PCa patients starting ADT treatment, with a mean age of 69.5 (SD 7.0) years. After matching, we identified 161 PDE5i users and 644 non-PDE5i users. A total of 5.1 person years of PDE5i users and 4.6 person years of PDE5i non-users were included. Compared with non-users of PDE5i, PCa patients treated with ADT initiating PDE5i had a lower risk of dementia (adjusted HR=0.17, 95% CI 0.04 to 0.70) in the modified landmark analyses. Conclusion and relevance PDE5i use in PCa patients treated with ADT was associated with a decreased risk of subsequent dementia. Future large scale studies are suggested to confirm our findings. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性近年来的研究表明,雄激素剥夺治疗(ADT)增加了前列腺癌(PCa)患者痴呆的风险。磷酸二酯酶5抑制剂(PDE5i)与一氧化氮介导的血管舒张可以增加脑血流量。然而,目前还没有研究探讨PDE5i暴露与ADT治疗的PCa患者痴呆之间的关系。目的和目的确定PDE5i暴露与ADT治疗的PCa患者发生痴呆之间的关系。材料与方法本研究利用台湾长庚研究数据库(CGRD)进行回顾性队列研究。我们纳入了2009年至2016年间新接受ADT治疗的PCa患者。我们进行了三步匹配和改进的里程碑方法来识别ADT使用后的PDE5i用户和非用户。里程碑日期定义为ADT开始后1年,我们将PDE5i使用者定义为在里程碑日期之前和之后开始使用PDE5i的患者。我们根据(1)年龄,(2)前列腺特异性抗原和(3)合并症和联合用药的1:4倾向评分将PDE5i使用者与非使用者进行匹配。我们从具有里程碑意义的日期开始跟踪患者,直到痴呆事件诊断,最后一次临床就诊日期或2019年12月31日。我们使用多变量Cox比例风险模型来比较PDE5i使用者和非使用者之间的痴呆风险。我们纳入了4557例开始ADT治疗的PCa患者,平均年龄为69.5岁(SD 7.0)。匹配后,我们确定了161个PDE5i用户和644个非PDE5i用户。PDE5i使用者共5.1人年,非PDE5i使用者共4.6人年。与未使用PDE5i的PCa患者相比,在修改的里程碑分析中,使用ADT启动PDE5i的PCa患者患痴呆的风险较低(调整HR=0.17, 95% CI 0.04至0.70)。PDE5i在接受ADT治疗的PCa患者中的使用与随后痴呆的风险降低相关。建议未来进行大规模研究以证实我们的发现。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
NP-019 Development of a conversion factor between defined daily doses of adults and neonates 确定成人和新生儿每日剂量之间的换算系数
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.366
C. Bueno, M. G. Navarro, E. Alonso, F. Parrilla, MJ Cabañas Poy, M. G. López, C. M. F. Llamazares, O. Neth
Background and importance Absence of a standardised method to measure antimicrobial consumption in the neonatal population Aim and objectives Establish a conversion factor that makes possible to relate the defined daily dose (DDD) of the adult population and the DDD of the neonatal population. Materials and methods National, multicentre and retrospective study. It had the participation of 10 third-second level hospitals and a multidisciplinary team: hospital pharmacists, paediatricians, neonatologists and infectious disease experts. First, after selecting the antimicrobials for study based on the literature and routine clinical practice, the Delphi methodology was used to agree on the recommended dose for its most common indication in the neonatal population. Two rounds of consultation with the group of experts were carried out. For those antimicrobials whose dose was not agreed upon, the dose established in Pediamecum was selected. The weight and gestational age of the neonates ( Subsequently, the DDD in grams of each antimicrobial were calculated. Finally, the conversion factor was obtained by comparing the DDD designed for neonates (DDDn) with the DDD validated by the WHO for adults (DDDa). For the analysis of the results, the statistical package IBM SPSS Statistics version 19 was used. Results 4820 neonates were selected. The mean weight was 2687 g(6080–440). The conversion factor (DDDn/DDDa) of the parenterally administered antimicrobials were: amikacin (0.04), amoxicillin (0.03), amoxicillin-clavulanate (0.09), ampicillin (0.04), liposomal amphotericin B (0.38), azithromycin (0.05), aztreonam (0.06), cefazolin (0.04), cefepime (0.07), cefotaxime (0.07), ceftazidime (0.07), ceftriaxone (0.07), ciprofloxacin(0.05), erythromycin(0.13), fluconazole(0.08), gentamicin (0.04), imipenem-cilastatin (0.07), linezolid (0.07), meropenem (0.04), metronidazole (0.03), micafungin (0.05), penicillin G sodium (0.03), piperacillin-tazobactam (0.04), teicoplanin (0.04), and vancomycin (0.04) Those obtained from oral antimicrobials were: amoxicillin (0.05), amoxicillin-clavulanate (0.08), azithromycin (0.09), cefadrozil (0.04), cefixime (0.05), ciprofloxacin (0.05), clindamycin (0.03), cloxacillin (0.07), erythromycin (0.13), fluconazole (0.08), Fosfomycin (0.09), itraconazole (0.04), linezolid (0.07), metronidazole (0.04) and vancomycin (0.05). Conclusion and relevance Analysing the demographic characteristics of the neonatal population, the DDD of the antimicrobial group can be standardised, this allows establishing a conversion factor with respect to the adult DDD. A new study to confirm the validity of designed neonatal DDD and hence the conversion factor between neonatal DDD and adult DDD is underway.
背景和重要性缺乏衡量新生儿人群抗菌素消耗的标准化方法目的和目的建立一个转换因子,使成人人群的定义日剂量(DDD)和新生儿人群的DDD之间的关系成为可能。材料与方法国家、多中心、回顾性研究。它有10个三二级医院和一个多学科小组参与:医院药剂师、儿科医生、新生儿专家和传染病专家。首先,在根据文献和常规临床实践选择抗菌药物后,采用德尔菲方法就新生儿人群中最常见的适应症的推荐剂量达成一致。与专家组进行了两轮协商。对于那些剂量未达成一致的抗菌剂,选择Pediamecum中确定的剂量。测定新生儿体重和胎龄(随后计算各抗菌药物的DDD(克))。最后,将新生儿DDDn (design for neonatal DDDn)与WHO认可的成人DDDa (certified for adult DDDa)进行比较,得出转换因子。对结果的分析使用IBM SPSS Statistics version 19统计软件包。结果入选新生儿4820例。平均体重2687 g(6080-440)。抗菌药物的转换因子(DDDn/DDDa)为:阿米卡星(0.04)、阿莫西林(0.03)、阿莫西林-克拉维酸酯(0.09)、氨苄西林(0.04)、两性霉素B(0.38)、阿奇霉素(0.05)、氨曲南(0.06)、头孢唑啉(0.04)、头孢吡肟(0.07)、头孢噻肟(0.07)、头孢他啶(0.07)、头孢曲松(0.07)、环丙沙星(0.05)、红霉素(0.13)、氟康唑(0.08)、庆大霉素(0.04)、亚胺培南-西司他汀(0.07)、利奈唑胺(0.07)、美罗培南(0.04)、甲硝唑(0.03)、米卡芬金(0.05)、青霉素G钠(0.03)、哌拉西林-他唑巴坦(0.04)、口服抗菌药物中获得的结果为:阿莫西林(0.05)、阿莫西林-克拉维酸酯(0.08)、阿奇霉素(0.09)、头孢丙唑(0.04)、头孢克肟(0.05)、环丙沙星(0.05)、克林霉素(0.03)、氯西林(0.07)、红霉素(0.13)、氟康唑(0.08)、磷霉素(0.09)、伊曲康唑(0.04)、利奈唑胺(0.07)、甲硝唑(0.04)、万古霉素(0.05)。结论和相关性分析新生儿人群的人口统计学特征,抗菌药物组的DDD可以标准化,这允许建立一个相对于成人DDD的转换因子。一项新的研究证实了新生儿DDD设计的有效性,因此新生儿DDD和成人DDD之间的转换因子正在进行中。
{"title":"NP-019 Development of a conversion factor between defined daily doses of adults and neonates","authors":"C. Bueno, M. G. Navarro, E. Alonso, F. Parrilla, MJ Cabañas Poy, M. G. López, C. M. F. Llamazares, O. Neth","doi":"10.1136/EJHPHARM-2021-EAHPCONF.366","DOIUrl":"https://doi.org/10.1136/EJHPHARM-2021-EAHPCONF.366","url":null,"abstract":"Background and importance Absence of a standardised method to measure antimicrobial consumption in the neonatal population Aim and objectives Establish a conversion factor that makes possible to relate the defined daily dose (DDD) of the adult population and the DDD of the neonatal population. Materials and methods National, multicentre and retrospective study. It had the participation of 10 third-second level hospitals and a multidisciplinary team: hospital pharmacists, paediatricians, neonatologists and infectious disease experts. First, after selecting the antimicrobials for study based on the literature and routine clinical practice, the Delphi methodology was used to agree on the recommended dose for its most common indication in the neonatal population. Two rounds of consultation with the group of experts were carried out. For those antimicrobials whose dose was not agreed upon, the dose established in Pediamecum was selected. The weight and gestational age of the neonates ( Subsequently, the DDD in grams of each antimicrobial were calculated. Finally, the conversion factor was obtained by comparing the DDD designed for neonates (DDDn) with the DDD validated by the WHO for adults (DDDa). For the analysis of the results, the statistical package IBM SPSS Statistics version 19 was used. Results 4820 neonates were selected. The mean weight was 2687 g(6080–440). The conversion factor (DDDn/DDDa) of the parenterally administered antimicrobials were: amikacin (0.04), amoxicillin (0.03), amoxicillin-clavulanate (0.09), ampicillin (0.04), liposomal amphotericin B (0.38), azithromycin (0.05), aztreonam (0.06), cefazolin (0.04), cefepime (0.07), cefotaxime (0.07), ceftazidime (0.07), ceftriaxone (0.07), ciprofloxacin(0.05), erythromycin(0.13), fluconazole(0.08), gentamicin (0.04), imipenem-cilastatin (0.07), linezolid (0.07), meropenem (0.04), metronidazole (0.03), micafungin (0.05), penicillin G sodium (0.03), piperacillin-tazobactam (0.04), teicoplanin (0.04), and vancomycin (0.04) Those obtained from oral antimicrobials were: amoxicillin (0.05), amoxicillin-clavulanate (0.08), azithromycin (0.09), cefadrozil (0.04), cefixime (0.05), ciprofloxacin (0.05), clindamycin (0.03), cloxacillin (0.07), erythromycin (0.13), fluconazole (0.08), Fosfomycin (0.09), itraconazole (0.04), linezolid (0.07), metronidazole (0.04) and vancomycin (0.05). Conclusion and relevance Analysing the demographic characteristics of the neonatal population, the DDD of the antimicrobial group can be standardised, this allows establishing a conversion factor with respect to the adult DDD. A new study to confirm the validity of designed neonatal DDD and hence the conversion factor between neonatal DDD and adult DDD is underway.","PeriodicalId":11998,"journal":{"name":"European Journal of Hospital Pharmacy","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81034809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
5PSQ-130 Intravenous potassium chloride: is the medication use process secure? 5PSQ-130静脉氯化钾:用药过程安全吗?
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.249
F. Charbonneau, A. Desbuquois, A. Liebbe, M. Boisgontier
Background and importance Potassium chloride (KCl) for injection is identified as a high risk medicine and a ‘never events’. The development of quality assurance strategies for the KCl use process is essential to minimise risk. Aim and objectives To assess compliance with guidelines for KCl prescription, pharmaceutical evaluation and administration for KCl use to identify priorities for improvement. Material and methods A prospective observational study was conducted including patients treated with intravenous KCl (outside the intensive care unit) over 4 non-consecutive days from February to March 2020. The KCl use guidelines of the French National Agency for Medicines and Products Safety was considered as a reference. Data collected were: for the prescribing stage: indication, information that must appear on the prescription, concentration and flow rate; for the pharmaceutical evaluation stage: entry of pharmaceutical intervention (PI) for a non-compliant prescription; and for the administration stage: labelling, administered concentration and flow rate. Data were collected from the electronic medical records and the observation of KCl administration. Results During the study period, 34 patients (53% men) were included, with a median age of 76 years (range 26–94). The KCl use process was compliant for 6% (2/34). The prescribing stage was non-compliant (NC) for 88% (30/34): 76% (26/34) with NC indication, 53% (18/34) with incomplete prescription and 12% (4/34) too concentrated. The pharmaceutical evaluation stage was NC for 83% (25/30): it was missing in 58% (15/26) of non-indication PI, 89% (16/18) of missed information PI and 75% (3/4) of NC concentration PI. The administration stage was NC for 68% (23/34): 53% (18/34) with incomplete labelling and 15% (5/34) too concentrated. The flow rate was 100% compliant. Conclusion and relevance This study highlights a lack of compliance with recommendations. Because of this audit, we have identified an action plan for improvement: raising awareness of KCl good practices among physicians, pharmacists and nurses; identification of high risk medicines by a specific logo on software; and setting up intravenous KCl prescription protocols and an automatic reassessment request after 2 days. For pharmacists, it will be necessary to set up a simulation for pharmaceutical evaluation on fictional cases. For nurses, the labelling rules should be recalled. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性注射用氯化钾(KCl)被确定为一种高风险药物和“永不发生的事件”。为KCl的使用过程制定质量保证策略对于最小化风险至关重要。目的和目标评估氯化钾处方、药品评价和氯化钾使用管理指南的遵守情况,以确定改进的重点。材料与方法前瞻性观察研究于2020年2月至3月对静脉注射氯化钾(非重症监护病房)治疗4天的患者进行了前瞻性观察研究。法国国家药品和产品安全局的KCl使用指南被认为是一种参考。收集的数据有:处方阶段:指征、处方上必须出现的信息、浓度和流速;药物评价阶段:对不合规处方进行药物干预(PI);在给药阶段:标记,给药浓度和流速。数据来源于电子病历和KCl给药情况的观察。结果在研究期间,纳入34例患者(53%为男性),中位年龄76岁(26-94岁)。KCl使用过程合规率为6%(2/34)。处方阶段不符合(NC)占88% (30/34),NC指征占76%(26/34),处方不完全占53%(18/34),过于浓缩占12%(4/34)。83%(25/30)的药物评价阶段为NC, 58%(15/26)的非适应症PI、89%(16/18)的遗漏信息PI和75%(3/4)的NC浓度PI为缺失阶段。给药阶段为NC(68%(23/34): 53%(18/34)),标记不完整,15%(5/34)过于集中。流量100%合规。结论和相关性本研究突出了缺乏对建议的遵从性。由于这次审核,我们确定了一项改进行动计划:提高医生、药剂师和护士对KCl良好做法的认识;通过软件上的特定标识识别高风险药品;建立静脉氯化钾处方方案和2天后自动重新评估请求。对于药师来说,有必要建立一个虚构病例的药物评价模拟。对于护士,标签规则应该被召回。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 1
5PSQ-172 Experience with tocilizumab in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 托珠单抗治疗SARS-CoV-2感染的经验
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.291
C. Galan, M. Villanueva, D. G. Vaquero, R. Rodríguez, Jf Rangel Mayoral
Background and importance Tocilizumab is an immunosuppressive agent which has demonstrated high efficacy in clinical trials for the treatment of coronavirus because its mechanism of action seems to inhibit the inflammatory cascade. Aim and objectives To evaluate the efficacy and safety of tocilizumab during the global pandemic. Material and methods A descriptive, observational, prospective study was conducted in patients receiving treatment with tocilizumab for SARS-CoV-2 during the pandemic in March 2020. Clinical data were collected: sex, age, medical history, diagnosis, hospitalisation days, patients admitted to the intensive care unit (ICU), patients who required mechanical ventilation, dose of tocilizumab, time from onset of symptoms to administration, concomitant drugs for SARS-CoV-2, final situation and adverse reactions. The data were obtained from the electronic medical records. All patients met the criteria established by the Spanish Agency of Medicines and Medical Devices (AEMPS): adequate biochemical parameters and absence of ongoing infections. Results 130 patients were included in the study, 8 patients met the criteria of AEMPS, 75% were men and mean age was 70 (57–83) years. Background: 50% had arterial hypertension, 37.5% heart disease, 25% diabetes, 25% chronic obstructive pulmonary disease and 12.5% active neoplasia. The diagnosis was severe pneumonia in all cases. The average duration of hospitalisation was 29 (4–73) days. 50% of patients were admitted to the ICU and required mechanical ventilation. In 75%, the dose was 600 mg and the rest required 400 mg, all single doses. The average time from symptom onset to drug administration was 15 (10–30) days. Concomitant drug therapy for SARS-CoV-2: 100% hydroxychloroquine with azithromycin, 87.5% lopinavir/ritonavir, 37.5% methylprednisolone boluses, 25% oral methylprednisolone and 12.5% interferon-s-1b. 87.5% of patients were discharged. No adverse reactions were reported. Conclusion and relevance Treatment with tocilizumab could be considered a safe and effective option in patients with severe SARS-CoV-2 pneumonia. Further studies are necessary to confirm these preliminary results. Adjustment of the treatments to the criteria established by the regulatory agencies and the recording of health outcomes could contribute to more efficient therapies. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性托珠单抗是一种免疫抑制剂,其作用机制似乎是抑制炎症级联反应,在治疗冠状病毒的临床试验中显示出很高的疗效。目的和目的评价托珠单抗在全球大流行期间的有效性和安全性。材料和方法在2020年3月大流行期间接受托珠单抗治疗的SARS-CoV-2患者中进行了一项描述性、观察性、前瞻性研究。收集临床资料:性别、年龄、病史、诊断、住院天数、入住重症监护病房(ICU)的患者、需要机械通气的患者、托珠单抗剂量、从症状出现到给药的时间、伴随治疗SARS-CoV-2的药物、最终情况和不良反应。数据是从电子病历中获得的。所有患者均符合西班牙药品和医疗器械管理局(AEMPS)制定的标准:充分的生化参数和无持续感染。结果纳入研究的患者130例,符合AEMPS标准的患者8例,男性占75%,平均年龄70(57 ~ 83)岁。背景:50%患有动脉高血压,37.5%患有心脏病,25%患有糖尿病,25%患有慢性阻塞性肺疾病,12.5%患有活动性肿瘤。所有病例的诊断结果均为重症肺炎。平均住院时间为29(4-73)天。50%的患者入住ICU并需要机械通气。75%的人的剂量是600毫克,其余的人需要400毫克,都是单次剂量。从症状出现到给药的平均时间为15(10-30)天。SARS-CoV-2的联合药物治疗:100%羟氯喹联合阿奇霉素、87.5%洛匹那韦/利托那韦、37.5%甲基强的松龙丸、25%口服甲基强的松龙和12.5%干扰素-s-1b。出院率为87.5%。无不良反应报告。结论与相关性托珠单抗治疗严重SARS-CoV-2肺炎是一种安全有效的选择。需要进一步的研究来证实这些初步结果。调整治疗方法以符合监管机构制定的标准,并记录健康结果,可有助于提高治疗效率。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
NP-020 Antineoplastic and other hazardous drugs: risk potential and exposure – less is more! NP-020抗肿瘤和其他危险药物:潜在风险和暴露-越少越好!
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.367
A. Burch, R. Pfeuti, J. Mack, G. Vella, F. Negrini
Background and importance Chemicals are subject to mandatory requirements for hazardous substances (GHS; Globally Harmonized System of Classification and Labelling of Chemicals). By contrast, references to measures to protect hospital staff from the hazardous aspects of drugs such as cancerogenicity, mutagenicity or reproductive toxicity (CMR) in the summaries of product characteristics (SPCs) are meagre; intuitive concepts for nurses in a hospital are scarce. Aim and objectives The aim of this project was first to establish a concept, which assessed the hazards to staff while handling CMR-drugs and second to define appropriate measures based on this, which minimise the exposure to substances with CMR-potential. Materials and methods To achieve this, an assessment of the intrinsic risk potential of the substances used therapeutically in the hospital was conducted (1; 2). After this, the activities using the different dosage forms of CMR-drugs were evaluated and measures for exposure minimisation were specified accordingly. Results The drugs with CMR-potential have been marked in the drug administration guides provided by the hospital pharmacy of the hospital pharmacy. Additionally, the activities, paired with the diverse dosage forms, have been classified in risk categories from 1 (highest) to 6 (lowest) (own classification; presented as pyramid and flow-chart). Measures to minimise the risk for staff while handling CMR-drugs were specified according to the STOP principle: substitution, technical/organisational/personal protection measures. The latter are dependent on the classification of the ‘dosage form/activity’ in the risk categories determined by the hospital pharmacy. Conclusion and relevance This procedure for the risk assessment of drugs with CMR-potential and the introduction of safety measures depending on the classification of dosage form/activity in risk categories results in a minimisation of the risk to staff while handling these drugs. The risk, which is per definition the product of the risk potential and exposure, tends towards zero with the introduced measures. References and/or acknowledgements We thank E Whittome for the very helpful translation of this abstract and B Kissling and P Massarotto for the intense discussions. IARC. Agents Classified by the IARC Monographs. volumes 1-123. [Online] https://monographs.iarc.fr/list-of-classifications-volumes/. National Institute for Occupational Safety and Health (NIOSH). List of Antineoplastic and Other Hazardous Drugs in Healtcare Settings. [Online] 2016. https://www.cdc.gov/niosh/docs/2016-161/.
背景和重要性化学品受有害物质(GHS;全球化学品统一分类和标签制度)。相比之下,在产品特性摘要中很少提及保护医院工作人员免受药物危险方面的措施,如致癌性、诱变性或生殖毒性(CMR);医院护士缺乏直观的概念。目的和目标本项目的目的首先是建立一个概念,评估工作人员在处理cmr药物时的危害,其次是在此基础上确定适当的措施,以最大限度地减少接触具有cmr潜力的物质。为了实现这一目标,对医院治疗中使用的物质的内在风险潜力进行了评估(1;在此之后,使用不同剂量形式的cmr药物的活性进行了评估,并相应地规定了最小化暴露的措施。结果医院药房提供的用药指南中标注了具有cmr电位的药物。此外,这些活动与不同的剂型相结合,被划分为从1(最高)到6(最低)的风险类别(自己的分类;以金字塔和流程图表示)。根据STOP原则规定了将员工在处理cmr药物时的风险降至最低的措施:替代、技术/组织/个人保护措施。后者取决于医院药房确定的风险类别中“剂型/活性”的分类。结论和相关性本程序对具有cmr潜力的药物进行风险评估,并根据剂型/活性在风险类别中的分类引入安全措施,可将工作人员在处理这些药物时面临的风险降至最低。根据定义,风险是潜在风险和暴露的乘积,随着引入的措施,风险趋向于零。我们感谢E Whittome翻译了这篇摘要,感谢B Kissling和P Massarotto进行了深入的讨论。研究。IARC专著分类的药物。卷1 - 123。[网络]https://monographs.iarc.fr/list-of-classifications-volumes/。国家职业安全与卫生研究所。医疗机构中抗肿瘤药物和其他危险药物清单。2016年(在线)。https://www.cdc.gov/niosh/docs/2016-161/。
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引用次数: 1
3PC-058 Physicochemical stability of meropenem in polypropylene syringes at 41.7 mg/mL for intensive care units 重症监护病房用41.7 mg/mL聚丙烯注射器中美罗培南的理化稳定性
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.33
G. Loeuille, J. Vigneron, E. D’huart, A. Charmillon, B. Demoré
Background and importance Meropenem is a broad spectrum antibiotic used to treat severe infectious. The maximum dose recommended is 6 g/day. A stability not exceeding 24 hours has been demonstrated by many research teams in different publications. Only two studies were performed at 40 mg/mL in polypropylene syringes with conflicting stability results: 4 hours and 8 hours. Meropenem is a time dependent antibiotic; its continuous administration improves its efficiency. Aim and objectives The objective of this work was to study the stability of meropenem solutions at 41.7 mg/mL (2 g in 48 mL), diluted in 0.9% sodium chloride (0.9% NaCl) or dextrose 5% (D5W), in polypropylene syringes not protected from light, after preparation and after 4 and 8 hours at 20–25°C. Material and methods Three syringes for each condition were prepared. At the time of analysis, one sample from each preparation was analysed by high performance liquid chromatography coupled to a photodiode array detector at 297 nm. The method was validated according to the ICH Q2 (R1). Physical stability was evaluated by visual and subvisual inspection (turbidimetry by UV spectrophotometry at 350, 410 and 550 nm, as recommended by the European Consensus Conference). pH values were measured. Results The method was validated with an r² of 0.9999. The coefficients of variation on repeatability and intermediate precision were Conclusion and relevance In D5W, meropenem was unstable, with chemical and physical instability. Meropenem was stable at 41.7 mg/mL in polypropylene syringes diluted in NaCl 0.9% for 8 hours. This new stability data allows continuous administration. References and/or acknowledgements Curti C, et al. Stability studies of antipyocyanic beta-lactam antibiotics used in continuous infusion. Pharmazie 2019. Carlier M, et al. Stability of generic brands of meropenem reconstituted in isotonic saline. Minerva Anestesiologica 2014. Conflict of interest No conflict of interest
背景和重要性美罗培南是一种用于治疗严重感染性疾病的广谱抗生素。建议最大剂量为6克/天。许多研究小组在不同的出版物中证明了不超过24小时的稳定性。只有两项研究在聚丙烯注射器中以40 mg/mL进行,稳定性结果相互冲突:4小时和8小时。美罗培南是一种时间依赖性抗生素;它的持续管理提高了它的效率。目的:研究41.7 mg/mL (2 g/ 48ml)的美罗培南溶液,用0.9%氯化钠(0.9% NaCl)或5%葡萄糖(D5W)稀释后,在不避光的聚丙烯注射器中制备后,在20-25℃下放置4和8小时的稳定性。材料与方法每种条件制备3支注射器。在分析时,每种制剂中的一个样品通过高效液相色谱耦合到297 nm的光电二极管阵列检测器进行分析。方法按照ICH Q2 (R1)进行验证。通过目视和亚目视检查评估物理稳定性(根据欧洲共识会议的建议,采用350、410和550 nm的紫外分光光度法进行浊度测定)。测量pH值。结果该方法有效,r²= 0.9999。在D5W中,美罗培南不稳定,存在化学不稳定性和物理不稳定性。在氯化钠0.9%稀释的聚丙烯注射器中,美罗培南稳定浓度为41.7 mg/mL,维持8小时。这个新的稳定性数据允许连续管理。Curti C等。持续输注抗脓毒酸-内酰胺类抗生素的稳定性研究。Pharmazie 2019。Carlier M等。仿制药美罗培南在等渗盐水中复配的稳定性。麻醉学杂志2014。利益冲突无利益冲突
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引用次数: 0
4CPS-344 Prescription auditing of the 3 monthly formulation of paliperidone palmitate in adult patients with schizophrenia 成人精神分裂症患者3个月服用棕榈酸帕利哌酮的处方审核
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.176
S. Nobili, N. Rossetti, S. Davies, L. Gambitta, E. Calzavara, E. Magni, S. Vimercati
Background and importance The 3 monthly formulation of paliperidone palmitate (3MPP) was introduced to the Italian market in 2017 for the treatment of schizophrenia in adult patients. 3MPP is a useful treatment option for patients who are adequately treated with the 1 monthly formulation of paliperidone palmitate (PP) but who may benefit from longer dosing intervals. Aim and objectives To assess the appropriateness of 3MPP prescriptions and the effectiveness of treatment in our centre. Material and methods This was an observational retrospective study of patients with a 3MPP prescription between January 2018 and July 2020. The variables used to evaluate appropriateness were the number of switches from PP to 3MPP, dosage and administration time. Effectiveness was evaluated by recording treatment interruptions, dose variations and switch back to PP. Data were extracted from an administrative database and collected in Excel. Results 38 patients were included, 23 men (60.5%), with a mean age of 50±14 years. The dosages of 3MPP were: 175 mg in 5 patients (13.2%), 263 mg in 6 (15.8%), 350 mg in 18 (47.4%) and 525 mg in 9 (23.7%). In 30 patients (78.9%), the 3MPP prescription was appropriate. The number of switches was 35/38 (92.1%): 3 patients received a first prescription of 3MPP without a previous prescription of antipsychotic depot drugs from our centre. An appropriate dosage was selected in 33/35 patients (94.3%): 1 patient switched from PP 100 mg to 3MPP 263 mg and another from PP 150 mg to 3MPP 263 mg. An appropriate administration time was selected in 35/38 patients (92.1%): 1 patient took the drug every 4 months and two patients received only one administration of 3MPP. In total, six patients interrupted treatment (3 in 2019; 3 in 2020). Dose variation of 3MPP during treatment occurred in 2 patients: 1 switched from 3MPP 350 mg to 525 mg and the other from 3MPP 263 mg to 350 mg. Two patients returned to treatment with PP. Conclusion and relevance Most of the 3MPP prescriptions were appropriate. This treatment has been shown to be effective in this setting where clinical diagnosis and therapeutic choice are not simple and medication adherence is a clinical challenge. The intervention of the pharmacist by auditing prescriptions is important to further increase appropriate treatments in these patients. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性帕利哌酮棕榈酸酯(3MPP)于2017年被引入意大利市场,用于治疗成人精神分裂症患者。3MPP是一个有用的治疗选择,患者充分治疗1个月的配方棕榈酸帕利哌酮(PP),但谁可能受益于较长的给药间隔。目的和目的评价我院3MPP处方的适宜性和治疗效果。材料和方法本研究是一项观察性回顾性研究,研究对象为2018年1月至2020年7月期间服用3MPP处方的患者。用于评估适宜性的变量是从PP到3MPP的切换次数、剂量和给药时间。通过记录治疗中断、剂量变化和切换回PP来评估有效性。数据从管理数据库中提取并在Excel中收集。结果纳入38例患者,其中男性23例(60.5%),平均年龄50±14岁。3MPP的剂量为:175 mg 5例(13.2%),263 mg 6例(15.8%),350 mg 18例(47.4%),525 mg 9例(23.7%)。在30例(78.9%)患者中,3MPP处方是合适的。切换次数为35/38(92.1%):3例患者首次使用3MPP处方,既往未使用本中心抗精神病药物储备。33/35例患者(94.3%)选择了合适的剂量:1例患者从PP 100 mg切换到3MPP 263 mg,另1例患者从PP 150 mg切换到3MPP 263 mg。38例患者中有35例(92.1%)选择了合适的给药时间:1例患者每4个月服药一次,2例患者仅服用一次3MPP。共有6名患者中断治疗(2019年为3名;2020年3个)。2例患者在治疗期间出现3MPP剂量变化:1例从3MPP 350 mg切换到525 mg,另1例从3MPP 263 mg切换到350 mg。结论及相关性大多数3MPP处方是合适的。在这种情况下,临床诊断和治疗选择并不简单,药物依从性是一项临床挑战,这种治疗已被证明是有效的。药师通过审核处方的干预对于进一步增加对这些患者的适当治疗是重要的。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
4CPS-318 Compounding tacrolimus ophthalmic ointment 0.02% in the treatment of inflammatory and autoimmune ophthalmic syndromes: effectiveness and safety assessment 0.02%复方他克莫司眼膏治疗眼部炎症和自身免疫性综合征的有效性和安全性评价
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.150
S. Portillo-Haro, C. Castaño-Amores, E. Tejedor-Tejada
Background and importance Inflammatory/autoimmune ophthalmic syndromes (IAOS) are often treated with corticosteroids in severe cases. However, in some cases, corticosteroids can be contraindicated, poorly tolerated or ineffective. This situation is common in paediatric patients who have a worse risk–benefit balance. Currently, evidence about using ophthalmic tacrolimus in IAOS is based in studies with monitoring duration reaching at most 4 weeks. Aim and objectives To assess the effectiveness, tolerance and safety of compounded tacrolimus ophthalmic ointment 0.02% (CTOO) in the treatment of IAOS in paediatric and adult patients. Material and methods We conducted observational retrospective research in paediatric and adult patients, recruited in our hospital with IAOS. Patients started treatment with CTOO once–twice/day+adjuvant therapy (AT) in January 2016 to April 2020, for 1 year at least. Effectiveness was assessed with hyperaemia grade (none, mild, moderate, severe) at 3, 6, 12 months, and grade of change noticed (GCN) at 1 and 12 months as a patient reported outcome. Tolerance/safety was determined at 1 week and 1 year. Every discontinuation was notified. Results 30 patients (54 sick eyes) were recruited (27 women and 27 men). 32/54 were paediatric patients. The most common syndromes were vernal keratoconjunctivitis (18 eyes; 33.3%); atopic keratoconjunctivitis (14 eyes; 25.9%) and allergic conjunctivitis (8 eyes; 14.8%). Hyperaemia was moderate–severe in 28 eyes (51.8%). It was reduced to 22.2% at 3 months, and to 9.3% at 12 months. No hyperaemia on day 0 was found in 21 eyes (38.9%) and which increased to 30 eyes (55.6%) at 3 months and to 41 (75.9%) at 12 months. After 1 month, 15 eyes (27.7%) had recovery of big or cleared grade, in 32 eyes (59.2%) recovery was mild–moderate and in 7 eyes (13.0%) no improvement was noticed. After a year, 15 eyes (27.7%) had reached the cleared grade. In contrast, 4 eyes had a deterioration after the treatment. Tolerance in the first week was: good (23 eyes; 42.6%), moderate (25 eyes; 46.3%) and poor in 6 eyes (11.1%) with no discontinuations. Tolerance at 1 year was good in 40 eyes (74.1%). However, in two eyes herpes virus infection was reported. Conclusion and relevance This study had strong limitations: lack of placebo group, patients belonged to the same geographic zone and different adjuvant treatments were used. Strengths of the study were a balanced population, high prevalence of paediatric patients and a long monitoring period. CTOO+AT have shown effectiveness and safety, based on the outcomes considered, in IAOS. It might be a good alternative in cases of contraindications, poor tolerance or inefficacy to corticosteroids, especially in paediatric patients. References and/or acknowledgements Conflict of interest No conflict of interest
背景和重要性炎性/自身免疫性眼综合征(IAOS)在严重病例中经常使用皮质类固醇治疗。然而,在某些情况下,皮质类固醇可能是禁忌症,耐受性差或无效。这种情况常见于风险-收益平衡较差的儿科患者。目前,在IAOS中使用眼用他克莫司的证据是基于监测持续时间最多为4周的研究。目的和目的评价0.02%复方他克莫司眼软膏(CTOO)治疗儿童和成人ios的有效性、耐受性和安全性。材料和方法我们对在我院招募的患有IAOS的儿童和成人患者进行了观察性回顾性研究。患者于2016年1月至2020年4月开始接受CTOO 1 - 2次/天+辅助治疗(AT),疗程至少1年。以3个月、6个月、12个月时的充血等级(无、轻度、中度、重度)和患者报告的1个月和12个月时注意到的变化等级(GCN)来评估有效性。在1周和1年时测定耐受性/安全性。每一次停产都得到通知。结果共招募患者30例(54只眼),其中女27例,男27例。32/54为儿科患者。最常见的症状是春季角膜结膜炎(18眼;33.3%);特应性角膜结膜炎(14眼;25.9%)和过敏性结膜炎(8只眼;14.8%)。中度至重度充血28眼(51.8%)。3个月时降至22.2%,12个月时降至9.3%。第0天无充血21眼(38.9%),第3个月无充血30眼(55.6%),第12个月无充血41眼(75.9%)。1个月后,15眼(27.7%)恢复大级或清净级,32眼(59.2%)恢复轻中度,7眼(13.0%)无明显改善。一年后,15只眼(27.7%)达到清洁等级。治疗后4眼视力恶化。第一周的容忍度为:良好(23眼;42.6%),中度(25眼;46.3%),不良6眼(11.1%),无停药。1年耐受性良好的有40只眼(74.1%)。然而,在两只眼睛疱疹病毒感染的报道。结论与相关性本研究存在较强的局限性:缺乏安慰剂组,患者属于同一地理区域,使用不同的辅助治疗。该研究的优势在于人口平衡、儿科患者的高患病率和较长的监测期。根据ios考虑的结果,CTOO+AT已显示出有效性和安全性。它可能是一个很好的替代病例禁忌症,耐受性差或无效的皮质类固醇,特别是在儿科患者。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
4CPS-370 Pharmacists’ interventions before and after the use of a clinical decision support tool to detect drug related problems 4CPS-370药师使用临床决策支持工具检测药物相关问题前后的干预措施
Pub Date : 2021-03-01 DOI: 10.1136/EJHPHARM-2021-EAHPCONF.202
O. Urbina, P. Martín, Martinez, A. L. D. Torre, C. Blanco, Y. Llorens
Background and importance Drug related problems (DRP) and medication adverse events occur in hospitalised patients. Computer provider order entry (CPOE) systems with clinical decision support systems (CDSS) are a key process for the pharmacist’s routine prescription validation to improve medication prescribing and patient safety. Aim and objectives To evaluate the type and number of pharmacist interventions (PI) before and after the use of a CDSS tool added to the CPOE system. Material and methods A retrospective observational study was carried out in a 300 bed hospital between January 2019 and May 2020. Data collected were: DRG type, PI and detection method. First period (January–August 2019): pharmacist validation using CPOE and electronic health records (EHR) was performed. The CDSS was introduced in August 2019. The CDSS includes drug information related to dose adjustment according to renal function, monitoring of analytic parameters susceptible to being altered by the drug, and drug–drug/drug–food interactions that are continuously updated by pharmacists. When EHR and CPOE containing demographic, anthropometric and clinical data of the patient as well as pharmacological treatment are integrated with the CDSS, alerts are generated (potential DRP) in real time that are evaluated by pharmacists. When the alerts are considered relevant, pharmacists write a PI in the patient’s chart. Second period (August 2019 –May 2020): CDSS alerts were available for prescription validation. Results First period: 1574 PI. Second period: 1687 PI (1451 using the first period method and 236 using the CDSS alerts). PI as a result of the CDSS were about 14% of total PI, and their type and number comparing both periods are presented in table 1. Conclusion and relevance The number of PI made in the two periods was similar but the CDSS tool allowed pharmacists to detect certain types of DRP that use of the CPOE alone did not allow. Moreover, the use of this tool optimised the pharmacist’s medical prescription review time and facilitated the PI registration task. To increase the usefulness of the CDSS it is necessary to increase the number of relevant alerts introduced in this application. References and/or acknowledgements None. Conflict of interest No conflict of interest
背景和重要性住院患者存在药物相关问题和药物不良事件。配备临床决策支持系统(CDSS)的计算机供应商订单输入系统(CPOE)是药师日常处方验证的关键环节,可以提高处方的有效性和患者的安全性。目的和目的评价在CPOE系统中添加CDSS工具前后药师干预(PI)的类型和数量。材料与方法2019年1月至2020年5月在一家拥有300张床位的医院进行回顾性观察研究。收集的数据包括:DRG类型、PI和检测方法。第一阶段(2019年1月至8月):使用CPOE和电子健康记录(EHR)进行药师验证。CDSS于2019年8月推出。CDSS包括与根据肾功能调整剂量有关的药物信息,监测易被药物改变的分析参数,以及药剂师不断更新的药物-药物/药物-食品相互作用。当EHR和CPOE包含患者的人口统计学、人体测量学和临床数据以及药物治疗与CDSS集成时,会实时产生警报(潜在的DRP),并由药剂师进行评估。当这些警告被认为是相关的,药剂师会在病人的病历上写一个PI。第二阶段(2019年8月至2020年5月):CDSS警报可用于处方验证。结果第一期:1574 PI。第二个周期:1687 PI(使用第一周期方法为1451,使用CDSS警报为236)。CDSS导致的PI约占总PI的14%,其类型和数量比较两个时期见表1。结论和相关性两个时期的PI数量相似,但CDSS工具允许药剂师检测到单独使用CPOE无法检测到的某些类型的DRP。此外,该工具的使用优化了药剂师的医疗处方审查时间,方便了PI注册任务。为了增加CDSS的有用性,有必要增加在此应用程序中引入的相关警报的数量。参考文献和/或致谢利益冲突无利益冲突
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引用次数: 0
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European Journal of Hospital Pharmacy
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