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Consumption of oral anticancer drugs in Norway compared by different units of measurements – introduction of new DDDs 挪威不同计量单位的口服抗癌药物消费量比较——引入新的DDD
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4041
Kristine M Olsen, Live Storehagen Dansie, I. Litleskare, H. Blix
Background: Antineoplastic agents (ATC group L01) have not been assigned DDDs due to highly interindividualvariation in dosages. Consumption data has therefore been presented in other measurement units such as grams of active ingredient. However, the protein kinase inhibitors (PKIs) are a rapidly growing drug group that was introduced to the market recently and are administered orally in a fixed dose. DDDs were therefore established for the PKIs in 2020. In this study we aim to assess whether the newly assigned DDDs would better express drug utilisation patterns in Norway than the current units of measurement.Methods: Sales data for PKIs (ATC level L01E) by grams, cost, units and packages for 2019 were collectedfrom the Norwegian Drug Wholesales Statistics and data on number of prescriptions and prevalence for 2019were collected from the Norwegian Prescription Database (NorPD). DDDs were calculated by applying thevalues of the new DDDs.Results: The proportions of the different substances varied according to the unit of measurement. DDDs andpackages had the highest similarity and correlated better than grams with the prevalence of use in theNorwegian population. BCR-ABL tyrosine kinase inhibitors was the largest group accounting for 31% ofthe total consumption (DDD/1000 inhabitants/day) and imatinib was the most sold PKI in all units of measurement except cost.Conclusions: Using an international agreed unit of measurement gives reliability to the study result. Assignment of DDDs to PKIs will improve the quality of drug utilisation studies in this area.
背景:抗肿瘤药物(ATC L01组)由于剂量的高度个体差异,尚未指定DDD。因此,消耗数据以其他测量单位表示,例如活性成分的克数。然而,蛋白激酶抑制剂(PKIs)是一种快速增长的药物,最近被引入市场,并以固定剂量口服给药。因此,在2020年为PKI确定了DDD。在这项研究中,我们旨在评估新分配的DDD是否比目前的计量单位更好地表达挪威的药物利用模式。方法:从挪威药品批发统计局收集2019年PKI(ATC L01E级)按克、成本、单位和包装的销售数据,从挪威处方数据库(NorPD)收集2019年处方数量和流行率数据。DDDs是通过应用新DDDs的值来计算的。结果:不同物质的比例因计量单位而异。在挪威人群中,DDDs和包装的相似性最高,与使用流行率的相关性好于克。BCR-ABL酪氨酸激酶抑制剂是最大的组,占总消费量的31%(DDD/1000居民/天),伊马替尼是除成本外所有计量单位中最畅销的PKI。结论:使用国际公认的计量单位可以使研究结果具有可靠性。将DDDs分配给PKI将提高该领域药物利用研究的质量。
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引用次数: 0
A common data model for harmonization in the Nordic Pregnancy Drug Safety Studies (NorPreSS) 北欧妊娠药物安全研究(NorPreSS)中统一的通用数据模型
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4053
J. Cohen, C. Cesta, L. Kjerpeseth, M. Leinonen, Óskar Ö. Hálfdánarson, Ø. Karlstad, P. Karlsson, M. Andersen, K. Furu, V. Hjellvik
It is necessary to carry out large observational studies to generate robust evidence about the safety of drugs used during pregnancy. In the Nordic countries, nationwide population-based health registers that document all births and dispensed prescribed drugs are valuable resources for such studies. A common data model (CDM) is a data harmonization and structuring tool that enables a unified and streamlined analytic approach for studies including data from multiple countries or databases. We describe a CDM developed for the Nordic Pregnancy Drug Safety Studies (NorPreSS), including details on data sources and structure of the data tables. We also provide an overview of the advantages and disadvantages of the approach (e.g. sharing of data analysis programs versus extra initial work to create CDM datasets from raw data).
有必要开展大型观察性研究,以获得有关妊娠期间使用药物安全性的有力证据。在北欧国家,以全国人口为基础的记录所有出生和分发处方药物的健康登记册是此类研究的宝贵资源。公共数据模型(CDM)是一种数据协调和结构化工具,能够对包括来自多个国家或数据库的数据在内的研究采用统一和简化的分析方法。我们描述了为北欧妊娠药物安全研究(NorPreSS)开发的CDM,包括数据来源和数据表结构的细节。我们还概述了该方法的优点和缺点(例如,共享数据分析程序与从原始数据创建CDM数据集的额外初始工作)。
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引用次数: 8
The Norwegian Society for Pharmacoepidemiology 挪威药物流行病学学会
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4039
A. Lupattelli, Ø. Karlstad, A. Engeland, L. Småbrekke, Kristine Olsen, Aina Øvrebust, M. Waaseth
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引用次数: 0
Registry data for use in health technology assessments in Norway – Opportunities and challenges 用于挪威卫生技术评估的登记数据——机遇和挑战
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4042
G. Hagen, T. Wisløff
Decisions on uptake of medicines and medical devices on health insurance schemes are increasingly based ona health technology assessment (HTA) process. In Norway, the process has included reimbursement of outpatientmedicines for two decades. During the past years, in-patient medicines, medical devices and morerecently vaccines are all included in the HTA system. In the present article, we outline the Norwegian HTAsystem including its central components and partners. HTA as a scientific approach puts evidence on efficacy,safety and value of interventions into a broader perspective, explicitly considering relevant factors, among theselegal, ethical and organisational aspects of the intervention. Although several combinations of aspects arepossible, the most common is an assessment of the relative effectiveness and cost-effectiveness of theintervention. Randomised controlled trials have long been considered the mainstay for assessment of clinicaleffectiveness pre-launch, while registry data have been used to inform safety post-lunch, by pharmacovigilance.Recently, we have seen a move towards more use of “real world evidence”, i.e. data from non-RCT sources,mainly from registries. A model-based approach is often used to assess cost-effectiveness, in this context,different types of evidence from different sources are often synthesized. In this paper we describe the centralcomponents of HTA with special emphasis on different observational data sources, such as the unique Norwegianhealth registries. We finally speculate on future directions for use of observational data in HTA, both in aglobal and Norwegian setting.
医疗保险计划中药物和医疗器械的使用决策越来越多地基于健康技术评估(HTA)过程。在挪威,这一过程已经包括了20年的门诊医疗费用报销。在过去的几年里,住院药品、医疗器械和最近的疫苗都被纳入HTA系统。在本文中,我们概述了挪威HTAsystem,包括其核心组成部分和合作伙伴。HTA作为一种科学方法,将干预措施的有效性、安全性和价值的证据放在更广阔的视野中,明确考虑干预措施的法律、伦理和组织方面的相关因素。尽管有几个方面的组合是可能的,但最常见的是对干预的相对有效性和成本效益的评估。长期以来,随机对照试验一直被认为是启动前评估临床有效性的支柱,而注册数据已被药物警戒用于午餐后的安全性。最近,我们看到越来越多地使用“真实世界证据”,即来自非随机对照试验来源的数据,主要来自登记处。通常使用基于模型的方法来评估成本效益,在这种情况下,通常会综合来自不同来源的不同类型的证据。在本文中,我们描述了HTA的中心组成部分,特别强调了不同的观测数据来源,例如独特的挪威健康登记处。最后,我们推测了HTA中观测数据的未来使用方向,包括在阿格洛巴尔和挪威环境中。
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引用次数: 0
INSPIRE: A new opportunity for cancer pharmacoepidemiology research INSPIRE:癌症药物流行病学研究的新机遇
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4043
E. Enerly, Lena Holmstrøm, Anna Skog, K. O. Knudsen, J. Nygård, B. Møller, G. Ursin
Until recently, there has been limited overview of the hospital administered cancer medications. The Cancer Registry of Norway has the approval to collect data on medical oncology treatment provided to each patient, but the reporting has so far been manual, time consuming and incomplete. Apart from conducting costly chart reviews, it has not been possible to carry out studies on hospital administered cancer medications. Efforts trying to improve manual reporting have not been sufficient and the most effective way of collecting data on cancer medications is through the hospital systems used for ordering/administering medical oncological treatment. The INSPIRE (INcreaSe PharmaceutIcal REporting) project was initiated to automatically and electronically collect data on cancer medication from the hospitals systems to the Cancer Registry. The project is a unique collaboration between 12 pharmaceutical companies, the Association of Pharmaceutical Companies in Norway, the Norwegian Cancer Society, Inven2, the Cancer Registry of Norway and the four Regional Health Trusts. In this article we describe the INSPIRE project, the data collection, and when and what kind of data that will be available. These new medication data at the Cancer Registry provide new opportunities for cancer pharmacoepidemiology research in Norway.
直到最近,关于医院管理的癌症药物的概述还很有限。挪威癌症登记处获准收集向每位患者提供的肿瘤医学治疗的数据,但迄今为止的报告都是手工编写的,耗时且不完整。除了进行昂贵的图表审查外,还不可能对医院给药的癌症药物进行研究。试图改进手工报告的努力还不够,收集癌症药物数据的最有效方法是通过用于订购/管理医学肿瘤治疗的医院系统。INSPIRE(增加药物报告)项目的启动是为了自动和电子地从医院系统收集癌症药物数据到癌症登记处。该项目是12家制药公司、挪威制药公司协会、挪威癌症协会、Inven2、挪威癌症登记处和四个区域卫生信托基金之间的独特合作。在本文中,我们将描述INSPIRE项目、数据收集以及何时以及何种类型的数据可用。癌症登记处的这些新的药物数据为挪威的癌症药物流行病学研究提供了新的机会。
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引用次数: 4
An 11-year nationwide registry-linkage study of opioid maintenance treatment in pregnancy in Norway 挪威一项为期11年的全国性阿片类药物维持治疗登记联系研究
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4047
I. Odsbu, M. Mahic, S. Skurtveit, I. Lund, M. Handal
Aim: We aimed to describe opioid maintenance treatment (OMT) to pregnant women in Norway and study thebackground characteristics of the pregnant women compared to the general population of pregnant women andto a previous clinical cohort study of OMT in pregnancy.Methods: Population-based cohort study with linked data from the Norwegian Medical Birth Registry, theNorwegian Prescription Database, the Norwegian Patient Registry, and Statistics Norway. The study populationconsisted of women giving birth between 2005-2015 in Norway. We defined OMT pregnancies as pregnancieswhere the woman was dispensed OMT medications (methadone, buprenorphine, or buprenorphine/naloxone) at least once during pregnancy.Results: The study population consisted of 420,808 women with 645,440 pregnancies ending in a live birth inNorway in 2005-2015 (the general pregnant population). Of these, 261 women (0.6‰) had altogether 306OMT pregnancies. The mean number of pregnancies was 28 OMT pregnancies per year and quite stable duringthe study period. Women with OMT pregnancies were older, smoked tobacco more frequently, had lowereducation, and fewer of them had a partner, compared to the general population of pregnant women. In mostpregnancies, the women were treated with buprenorphine (n=183 (59.8%)), while in 120 (39.2%) pregnancies,the woman received methadone. From 2008, buprenorphine replaced methadone as the most frequently useddrug. In only 38 (12.4%) pregnancies, OMT treatment was initiated in pregnancy. In 201 (66%) pregnancies,the woman used OMT medications in all trimesters. For these women, the mean amount of dispensed drug was3.4 DDD/day (85 mg/day) in pregnancy for methadone and 1.9 DDD/day (15.2 mg/day) for buprenorphine.Conclusion: The number of OMT pregnancies per year has been low and stable in the period 2005-2015.Following Norwegian recommendations, there has been a shift from treatment with methadone towardsbuprenorphine. The women receiving OMT during pregnancy had more risk factors for adverse outcomes thanthe general pregnant population but were quite similar to the previous clinical cohort.
目的:我们旨在描述挪威孕妇的阿片类药物维持治疗(OMT),并将孕妇的背景特征与一般孕妇人群和先前妊娠期OMT的临床队列研究进行比较。方法:基于人群的队列研究,相关数据来自挪威医学出生登记处、挪威处方数据库、挪威患者登记处和挪威统计局。研究人群包括2005-2015年间在挪威分娩的妇女。我们将OMT妊娠定义为妇女在妊娠期间至少服用一次OMT药物(美沙酮、丁丙诺啡或丁丙诺啡/纳洛酮)。结果:研究人群包括2005-2015年挪威420,808名妇女,645,440例妊娠以活产结束(一般妊娠人群)。其中,261名妇女(0.6‰)总共有306OMT妊娠。平均每年有28例OMT妊娠,在研究期间相当稳定。与一般孕妇相比,直接子宫内膜移植怀孕的妇女年龄较大,吸烟频率较高,受教育程度较低,有伴侣的人数较少。大多数孕妇使用丁丙诺啡(183例,占59.8%),120例(39.2%)孕妇使用美沙酮。从2008年开始,丁丙诺啡取代美沙酮成为最常用的药物。只有38例(12.4%)妊娠期间开始了OMT治疗。在201例(66%)妊娠中,该妇女在所有妊娠期都使用OMT药物。在这些女性中,美沙酮的平均配药量为3.4 DDD/天(85毫克/天),丁丙诺啡的平均配药量为1.9 DDD/天(15.2毫克/天)。结论:2005-2015年,每年OMT妊娠数较低且稳定。根据挪威的建议,已经从美沙酮治疗转向丁丙诺啡治疗。在怀孕期间接受OMT治疗的妇女比一般怀孕人群有更多的不良后果风险因素,但与之前的临床队列非常相似。
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引用次数: 3
Antibacterial use by birth year and birth season in children 0-2 years in Norway 挪威0-2岁儿童按出生年份和出生季节的抗菌药物使用情况
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4044
Sanna Beckstrøm, K. Svendsen, L. Småbrekke
Introduction: Consumption of antibacterials in children follows seasonal cycles, and time to first treatment depends on birth season. The aim of this study was to describe dispensing rate, one-year periodic prevalence, and age at first prescription in children aged 0-2 years in Norway.Methods: We used data from the Norwegian prescription database and included all dispensed prescriptions on systemic antibacterials in 2008-2017 during the first three years of life to children born 2005-2014. We calculated age by subtracting birth month and birth year from date of collection of prescription. We used multiple linear regression to investigate the effect of birth season on age at first dispensed prescription.Results: We included 714 262 prescriptions to 281 888 individuals (53.1% boys). In 2016, one-year-old boys had the highest periodic prevalence (35.6%) and the highest dispense rate (545/1000 individuals), followed by one-year-old girls (32.6%, 478/1000 individuals). The lowest prevalence and dispense rate in all age groups was found towards the end of the period. Winter months had the highest proportion of dispensed prescriptions, and children born in autumn were significantly younger when collecting their first prescription. On average, boys collected their first prescription 26 days younger compared to girls.Conclusion: One-year-olds have the highest periodic prevalence and the highest dispense rate. This contrast with results from other studies on Norwegian data and is probably attributed to our use of birth month for calculation of age. Children born in autumn were younger when collecting their first prescription compared to other birth seasons. It is unknown whether this has any long-term clinical implications.
儿童抗菌药物的使用遵循季节性周期,首次治疗的时间取决于出生季节。本研究的目的是描述挪威0-2岁儿童的配药率、一年周期患病率和首次处方年龄。方法:我们使用挪威处方数据库的数据,并纳入了2005-2014年出生的儿童在2008-2017年生命前三年的所有全身性抗菌药物处方。我们通过从处方收集日期减去出生月份和出生年份来计算年龄。采用多元线性回归研究出生季节对首次配药年龄的影响。结果:纳入处方714 262张,共281 888例,其中男性占53.1%。2016年1岁男孩周期性患病率最高(35.6%),配药率最高(545/1000人),1岁女孩次之(32.6%,478/1000人)。所有年龄组的流行率和配药率在这一时期接近尾声时都是最低的。冬季月份的配药比例最高,秋季出生的儿童首次配药年龄明显低于冬季出生的儿童。平均而言,男孩比女孩早26天拿到第一张处方。结论:1岁儿童的周期性患病率最高,配药率最高。这与挪威数据的其他研究结果形成对比,可能是由于我们使用出生月份来计算年龄。与其他出生季节相比,秋天出生的孩子在收集第一次处方时年龄更小。目前尚不清楚这是否有任何长期的临床意义。
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引用次数: 1
Farmakoepidemiologi – et fagfelt i stadig utvikling 药物流行病学——一个不断发展的领域
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4038
I. Buajordet, Helle Wallach Kildemoes, R. Selmer, Marit Waaseth
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引用次数: 0
Medical care contact for infertility and related medication use during pregnancy – a European, cross-sectional web-based study 不孕不育的医疗保健联系和妊娠期间的相关药物使用——一项基于网络的欧洲横断面研究
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4051
Miljana Ilic, H. Nordeng, A. Lupattelli
Aims: The aim of the study was two-fold: i) to determine the prevalence of medical care contact for infertility in European countries; ii) to map overall and long-term/chronic medication use during pregnancy in women who sought medical care due to infertility.Methods: This is a sub-study of the Multinational Medication Use in Pregnancy Study, a cross-sectional, web-based study conducted from October 2011 to February 2012. We included 8097 participants from Europe who were pregnant or new mothers. We collected data on overall and long-term/chronic medication use, medical care seeking due to infertility, and whether women eventually conceived spontaneously or with the aid of infertility treatment.Results: Medical care contact for infertility was lower in Western Europe (prevalence estimate: 10.0-15.3%), compared with Northern (15.2-17.5%) or Eastern (17.4-20.9%), but Poland had the lowest estimate (8.0%). Overall, 660 (8.2%) women sought medical care due to infertility but conceived spontaneously; 548 (6.8%) conceived aided by fertility treatment, and 6889 (85.0%) women did not seek help. Use of any medication was comparable across the three groups (range 80.4-82.5%), but women seeking help for infertility (21.8-24.6%) took more often long-term/chronic medications than women who did not (14.8%).Conclusion: Medical care contacts for infertility varies greatly across European countries. Women who had medical contact due to infertility used more often chronic medications in pregnancy than women who did not, pointing to more co-morbidities and risk pregnancies.
目的:该研究的目的有两个:一)确定欧洲国家不孕不育医疗接触的流行率;ii)绘制因不孕而寻求医疗护理的妇女在怀孕期间的总体和长期/慢性药物使用情况。方法:这是一项跨国妊娠药物使用研究的子研究,该研究是一项横断面、基于网络的研究,于2011年10月至2012年2月进行。我们纳入了8097名来自欧洲的孕妇或新妈妈。我们收集了关于整体和长期/慢性药物使用、不孕不育寻求医疗护理以及女性最终是自发受孕还是在不孕不育治疗的帮助下受孕的数据。结果:与北欧(15.2-17.5%)或东欧(17.4-20.9%)相比,西欧不孕不育的医疗接触率较低(患病率估计值:10.0-15.3%),但波兰的估计值最低(8.0%)。总的来说,660名(8.2%)妇女因不孕不育而寻求医疗护理,但是自发受孕的;548名(6.8%)妇女在生育治疗的帮助下怀孕,6889名(85.0%)妇女没有寻求帮助。三组中任何药物的使用情况都是可比的(范围为80.4-82.5%),但寻求不孕不育帮助的女性(21.8-24.6%)比不寻求帮助的女性更经常服用长期/慢性药物(14.8%)。结论:欧洲国家不孕不育的医疗护理联系方式差异很大。由于不孕而与医生接触的女性在怀孕期间比没有接触的女性更经常使用慢性药物,这表明有更多的合并症和怀孕风险。
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引用次数: 1
Hormonal contraceptive use in Norway, 2006-2020, by contraceptive type, age and county: A nationwide register-based study 2006-2020年挪威按避孕类型、年龄和县分列的激素避孕药具使用情况:一项基于登记的全国性研究
Q3 Medicine Pub Date : 2021-08-16 DOI: 10.5324/nje.v29i1-2.4046
K. Furu, Ellen Barth Aares, V. Hjellvik, Ø. Karlstad
Aim: Our aim was to study hormonal contraceptive use among women in Norway during 2006-2020 according to age groups and geography, including choice of contraceptive method, type of prescriber for long-acting reversible contraceptives, and prescriber’s adherence to the national health authority recommendations.Material and methods: We conducted a nationwide drug utilization study including all women aged 16-49 years in Norway during 2006-2020. The Norwegian Prescription Database (NorPD) includes detailed information about all dispensed prescription medications from Norwegian pharmacies to individuals in ambulatory care, including year of dispensing, patient’s year of birth and county of residence, and the prescriber’s profession.Results: This study shows a slight increase in overall use of hormonal contraceptives among 16-49-year-olds during 2006-2018, increasing from 36% of the population to 40%. Combined oral contraceptives (COCs) was the most commonly used hormonal contraceptive method in all age groups. The use of COCs decreased during the period and the decline was greatest in those below 25 years. From 2016 80% of all new users of COCs received the recommended COC containing levonorgestrel. Use of estrogen-free contraceptives, long-acting reversible contraceptives (LARCs) and gestagen pills, has increased. After 2014 the use of LARCs, especially subdermal implant, increased steeply among younger women. Oslo had the lowest proportion of users of hormonal contraceptives among teenagers and young adults during the whole period, while among 30-49-yearolds Oslo was more in line with the other counties.Conclusion: Combined oral contraceptives (COC) was the most used hormonal contraceptive method in all age groups. However, the use of COCs decreased during the period, especially in those < 25 years, where a corresponding increase in the use of LARC has taken place, mainly from 2014 onwards. Four out of five women who initiated COC received the recommended COC type and the steep increase in use of estrogen-free LARCs in recent years implies that Norwegian prescribers have high compliance with the recommendations from the health authorities.
目的:我们的目的是研究挪威妇女在2006-2020年期间按年龄组和地理位置使用激素避孕药的情况,包括避孕方法的选择、长效可逆避孕药的处方者类型以及处方者对国家卫生当局建议的依从性。材料和方法:我们在2006-2020年期间对挪威所有16-49岁的女性进行了一项全国性的药物利用研究。挪威处方数据库(NorPD)包括从挪威药房到个人门诊护理的所有处方药物的详细信息,包括配药年份,患者出生年份和居住县,以及处方者的职业。结果:该研究显示,2006年至2018年期间,16-49岁人群中激素避孕药的总体使用量略有增加,从占人口的36%增加到40%。复方口服避孕药(COCs)是所有年龄组中最常用的激素避孕方法。在此期间,COCs的使用有所减少,其中25岁以下的降幅最大。从2016年起,80%的COC新使用者接受了含有左炔诺孕酮的推荐COC。无雌激素避孕药、长效可逆避孕药(LARCs)和孕激素丸的使用有所增加。2014年以后,LARCs的使用,尤其是皮下植入,在年轻女性中急剧增加。在整个期间,奥斯陆在青少年和年轻人中使用激素避孕药的比例最低,而在30-49岁的人群中,奥斯陆与其他县更为一致。结论:复方口服避孕药(COC)是各年龄组最常用的激素避孕方法。然而,COCs的使用在此期间有所减少,特别是在< 25年的时间段内,LARC的使用出现了相应的增加,主要是从2014年开始。在开始服用复方避孕药的妇女中,五分之四接受了推荐的复方避孕药类型,近年来无雌激素LARCs的使用急剧增加,这意味着挪威的开处方者高度遵守卫生当局的建议。
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引用次数: 6
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Norsk Epidemiologi
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