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Statins Cardiovascular Benefits Outweigh their Diabetogenicity: A Direct Comparison between Number Needed to Treat and Number Needed to Harm 他汀类药物对心血管的益处大于其致糖尿病性:治疗数量与危害数量的直接比较
Pub Date : 2015-06-22 DOI: 10.4172/2167-1052.1000185
Shimoyama S
Backgrounds: Although there are several metaanalyses showing that the risk of new onset diabetes mellitus (NODM) is more increased in statin or higher dose statin users than placebos or lower dose statin users, a small increase in the risk of NODM would be outweighed by the improved cardiovascular outcomes. However, these metaanalyses are accompanied by limitations of the inclusion of the studies with confounders. The aim of this study is to elucidate the risk-benefit balance by investigating the number needed to treat (NNT) and number needed to harm (NNH) in a simultaneous comparison according to the individual trial-based criteria of NODM and cardiovascular events. Methods: A systematic review of the literature retrieves 6 randomized controlled trials (RCTs) comparing statins vs. placebos and 5 RCTs comparing higher vs. moderate doses of statin. Only RCTs which documented the number of patients who developed DM and who experienced cardiovascular events are included. Results: NNH is consistently larger than NNT in trials of statin use vs. placebos, or in trials of higher vs. moderate dose. Furthermore, the benefit-risk ratios are consistently greater than 1 in most trial. Conclusions: These results suggest that the absolute risk of NODM by statin is offset by the benefit for reducing cardiovascular events. The evaluation of an individual trial-based risk-benefit balance could resolve the limitations of previous studies as well as provide further reinforced evidence that the merit of statin use for the purpose of lowdensity lipoprotein cholesterol lowering outweighs the NODM risk.
背景:虽然有几项荟萃分析显示,他汀类药物或高剂量他汀类药物的新发糖尿病(NODM)风险比安慰剂或低剂量他汀类药物的患者增加更多,但NODM风险的小幅增加将被心血管预后的改善所抵消。然而,这些荟萃分析伴随着包含混杂因素的研究的局限性。本研究的目的是通过调查需要治疗的数量(NNT)和需要伤害的数量(NNH)来阐明风险-收益平衡,同时根据基于个体试验的NODM和心血管事件标准进行比较。方法:系统回顾了6项比较他汀类药物与安慰剂的随机对照试验(rct)和5项比较高剂量与中剂量他汀类药物的随机对照试验(rct)。只有记录了糖尿病患者数量和经历心血管事件的随机对照试验被纳入研究。结果:在他汀类药物使用与安慰剂的试验中,或在高剂量与中等剂量的试验中,NNH始终大于NNT。此外,在大多数试验中,获益-风险比始终大于1。结论:这些结果表明,他汀类药物对NODM的绝对风险被其减少心血管事件的益处所抵消。基于个体试验的风险-收益平衡评估可以解决以往研究的局限性,并提供进一步的强化证据,证明他汀类药物用于降低低密度脂蛋白胆固醇的优点大于NODM风险。
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引用次数: 1
Indian Pharmacopoeia Commission's Partners for Promoting Public Health 印度药典委员会促进公共卫生的合作伙伴
Pub Date : 2015-05-26 DOI: 10.4172/2167-1052.1000181
Kalaiselvan, R. Kumar, Gyanendra Nath Singh
In order to promote the awareness and to monitor the adverse drugs reactions, one of the most noteworthy nation-wide programme initiated by IPC on 15th April 2011 under the aegis of Central Drugs Standard Control Organization (CDSCO), is Pharmacovigilance Programme of India (PvPI). IPC is a National Coordination Centre (NCC) for PvPI, meant for protecting the health of the public by assuring medicines safety. PvPI monitors the benefitrisk profile of medicines & generate independent, evidence based recommendations on safety of medicines & support CDSCO for formulating safety related regulatory decisions for medicines. With a view to establish a centre of excellence for pharmacovigilance in India, NCC-PvPI collaborated with the WHO-Uppsala Monitoring Centre (UMC), Sweden & participating in International Drug Monitoring Programme & now become a significant contributor for the global drug safety database. The WHO country office for India coordinates with NCC-PvPI in terms of providing technical support for organizing training programmes, awareness programmes,meetings and updating PV toolkit etc. PvPI has been continuously taken several steps for ensuring patient safety and well being of society, in this regards PvPI expanded its patient safety programme to 150 AMCs across the country & also collaborated with different National Health Programme (AEFI, NACO, RNTCP) as it has been always preeminent to established safety and efficacy of medicines used in these NHP(s). As consumers / patients are the important allies for any country's pharmacovigilance programme, PvPI has taken step towards encouraging consumers reporting by the release of medicines side effect reporting form for consumers in different regional languages. For the last two decades, pharmacovigilance has been gaining an increasing attention. It is now, high time for national authorities, multilateral agencies, nongovernmental organizations, healthcare institutions, pharmaceutical industries & lay public to work together for the effective implementation of PvPI across the country.
为了提高认识并监测药物不良反应,IPC在中央药物标准控制组织(CDSCO)的支持下于2011年4月15日启动了印度药物警戒规划(PvPI),这是最值得注意的全国性规划之一。IPC是PvPI的国家协调中心(NCC),旨在通过确保药品安全来保护公众健康。PvPI监测药物的利益-风险概况,并就药物安全性提出独立的、基于证据的建议,并支持CDSCO制定与药物安全相关的监管决策。为了在印度建立一个药物警戒卓越中心,印度国家预防犯罪委员会与世卫组织-瑞典乌普萨拉监测中心(UMC)合作并参与国际药物监测规划,现在已成为全球药物安全数据库的重要贡献者。世卫组织印度国家办事处在为组织培训规划、提高认识规划、会议和更新光伏工具包等提供技术支持方面与印度国家控制委员会进行协调。在这方面,PvPI将其患者安全方案扩大到全国150个AMCs,并与不同的国家卫生方案(AEFI、NACO、RNTCP)合作,因为它一直在这些NHP中使用的药物的安全性和有效性方面表现出色。由于消费者/患者是任何国家药物警戒规划的重要盟友,PvPI已采取步骤,通过以不同区域语言向消费者发布药物副作用报告表,鼓励消费者进行报告。在过去的二十年中,药物警戒得到了越来越多的关注。现在正是国家当局、多边机构、非政府组织、卫生保健机构、制药行业和公众共同努力,在全国有效实施PvPI的时候了。
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引用次数: 1
Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission 消费者直接向PvPI报告adr,印度药典委员会的立场文件
Pub Date : 2015-05-23 DOI: 10.4172/2167-1052.1000184
M. Kalaivani, Kalaiselvan, K. Dabhi, G. Singh
Patients/consumers are end user of medicines and should play important role in reporting the Adverse Drug Reactions (ADRs) to pharmacovigilance system. Consumers can provide detailed first-hand in formation about their experiences with medicines and how these medicines have affected their life. Direct consumer reporting leads to earlier identification and accumulation of signals and may provide neglected details related to psychiatric feelings and quality of life. Consumers may report ADRs due to “over the counter” (OTC) medicines, herbal medicines, and ADRs related to excipients and potential interactions. Direct patient/ consumer reporting will also rectify the under-reporting by patients to physician and will change the attitude related to importance of patient’s experience. NCC-PvPI (National Coordination Centre-Pharmacovigilance Programme of India), IPC (Indian Pharmacopoeia Commission) had launched “Medicines Side Effect Reporting form for Consumer” (blue form) at the National level conference on “Participation of patient/consumer organization in PvPI” on 1st August, 2014, which encourages patient or his/her representative (relative) to report ADRs directly either by submitting the form to the NCC-PvPI or to the nearest AMC (Adverse Drug Reaction Monitoring Centres) under PvPI. Consumers can also reports through toll free helpline number: 1800-180-3024 or email id: pvpi.compat@gmail.com to NCC-PvPI.
患者/消费者是药品的最终使用者,应在向药物警戒系统报告药物不良反应(adr)方面发挥重要作用。消费者可以提供详细的第一手信息,说明他们的用药经历以及这些药物如何影响他们的生活。直接的消费者报告导致信号的早期识别和积累,并可能提供与精神感受和生活质量相关的被忽视的细节。消费者可能会报告由于“非处方”(OTC)药物、草药以及与辅料和潜在相互作用相关的adr。患者/消费者直接报告也将纠正患者对医生的漏报,并将改变与患者体验重要性相关的态度。2014年8月1日,IPC(印度药典委员会)在“患者/消费者组织参与PvPI”国家级会议上推出了“消费者药物副作用报告表”(蓝色表格)。鼓励患者或其代表(亲属)直接向NCC-PvPI或就近的PvPI下的AMC(药物不良反应监测中心)提交表格报告不良反应。消费者也可以通过免费热线1800-180-3024或电子邮件pvpi.compat@gmail.com向NCC-PvPI举报。
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引用次数: 10
Antimicrobial (Drug) Resistance 抗微生物(药物)耐药性
Pub Date : 2015-05-16 DOI: 10.4172/2167-1052.S2-001
Rompikuntal Pk, Garlapati S
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引用次数: 2
Review on Antibiotic Resistance 抗生素耐药性研究进展
Pub Date : 2015-05-16 DOI: 10.4172/2167-1052.1000183
E. Crouch, L. Dickes, A. Kahle
Antibiotic resistance is the ability of bacteria and other microbes to resist the effects of an antibiotic. A primary characteristic of antibiotics is that they lose their effectiveness over time. In the last twenty years, the number of antibiotic classes and analogues in development has not kept pace with antibiotic resistance. Appropriate use of existing classes of antibiotics could improve the lifespan of these drugs. The side effects of antibiotic resistance include reduced patient outcomes and increasingly potent disease states. New government task forces have been developed to increase the level of research and federal involvement into this growing public health problem.
抗生素耐药性是细菌和其他微生物抵抗抗生素作用的能力。抗生素的一个主要特点是它们会随着时间的推移而失去效力。在过去的二十年中,正在开发的抗生素种类和类似物的数量没有跟上抗生素耐药性的步伐。适当使用现有种类的抗生素可以延长这些药物的使用寿命。抗生素耐药性的副作用包括降低患者预后和日益严重的疾病状态。已经成立了新的政府工作组,以提高对这一日益严重的公共卫生问题的研究水平和联邦政府的参与。
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引用次数: 13
In Vitro Antischistosomal Activity and Cytotoxicity of 5-Methoxylated Flavones fom Vochysia divergens, a Flood-Adapted Species from Brazilian Pantanal 巴西潘塔纳尔河流域洪水适应物种——桃蚜5-甲氧基化黄酮体外抗血吸虫活性和细胞毒性研究
Pub Date : 2015-05-13 DOI: 10.4172/2167-1052.1000182
L. P. Pimenta, K. Lc, Rhavena Graziela Liotti, M. Soares, Daniela P. Aguiar, M. Lg, P. F. Oliveira, D. Tavares, Andrade Ml, W. Cunha, P. Pauletti, J. Ah
Background: Vochysia divergens is native to the Amazon Basin and considered an invasive species in the Brazilian Pantanal. In this work, the ethanolic extract of V. divergens leaves was chemically investigated and evaluated in vitro against Schistosoma mansoni adult worms together with the isolated compounds. Methods: The samples were available at concentrations of 12.5, 25, 50 and 100 μM. The parasites were kept for 4 days and monitored every 24 h to evaluate their viability and motor activity comparing with the positive control praziquantel. The cell viability of isolated flavones as determined by XTT assays in V79 cells. Results: The flavones 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside, 5-methoxy luteolin and 3′,5-dimethoxy luteolin were isolated from V. divergens. Flavone 5-methoxy luteolin caused the death of 25% of male and female adult S. mansoni worms in 24 h at 100 μM and also reduced their motor activity. Flavones 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside and 3′,5-dimethoxy luteolin were able to slightly reduce the motor activity to 25% within 24 h at 25 μg/mL and 12.5 μg/mL, respectively, but only in male worms. The results were compared with the flavone luteolin. For XTT assay in V79 cells the IC50 values were 1468.4 ± 10.5 μM, 5946.6 ± 25,1 μM, > 7960.8 μM and 270.6 ±9.3 μM for compounds 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside, 5-methoxy luteolin, 3′,5-dimethoxy luteolin and luteolin, respectively. Conclusion: To the best of our knowledge, flavones 5-methoxy luteolin and 3′,5-dimethoxy luteolin are reported for the first time as constituents of V. divergens and the Vochysiaceae family.
背景:沃琪亚(Vochysia divergens)原产于亚马逊盆地,被认为是巴西潘塔纳尔河的入侵物种。本研究对发散叶乙醇提取物及其分离化合物进行了体外抗曼氏血吸虫作用的化学研究和评价。方法:样品浓度分别为12.5、25、50、100 μM。饲养4 d,每24 h监测一次,与阳性对照吡喹酮比较,评价寄生虫的活力和运动活性。XTT法测定分离的黄酮类化合物在V79细胞中的细胞活力。结果:分离得到3′,5-二甲氧基木犀草素-7- o -β-葡萄糖苷、5-甲氧基木犀草素和3′,5-二甲氧基木犀草素。黄酮类5-甲氧基木犀草素在100 μM下24 h内可致25%的雄性和雌性曼氏线虫死亡,并降低其运动活性。黄酮3′,5-二甲氧基木犀草素-7- o -β-葡萄糖苷和3′,5-二甲氧基木犀草素分别在25 μg/mL和12.5 μg/mL浓度下能在24 h内将运动活性略微降低25%,但仅在雄性蠕虫中有效。结果与黄酮类木犀草素进行了比较。XTT法检测V79细胞中3′,5-二甲氧基木犀草素-7- o -β-葡萄糖苷、5-甲氧基木犀草素、3′,5-二甲氧基木犀草素和木犀草素的IC50值分别为1468.4±10.5 μM、5946.6±25 μM、1 μM、> 7960.8 μM和270.6±9.3 μM。结论:据我们所知,5-甲氧基木犀草素和3,5 -二甲氧基木犀草素为首次报道的植物属。
{"title":"In Vitro Antischistosomal Activity and Cytotoxicity of 5-Methoxylated Flavones fom Vochysia divergens, a Flood-Adapted Species from Brazilian Pantanal","authors":"L. P. Pimenta, K. Lc, Rhavena Graziela Liotti, M. Soares, Daniela P. Aguiar, M. Lg, P. F. Oliveira, D. Tavares, Andrade Ml, W. Cunha, P. Pauletti, J. Ah","doi":"10.4172/2167-1052.1000182","DOIUrl":"https://doi.org/10.4172/2167-1052.1000182","url":null,"abstract":"Background: Vochysia divergens is native to the Amazon Basin and considered an invasive species in the Brazilian Pantanal. In this work, the ethanolic extract of V. divergens leaves was chemically investigated and evaluated in vitro against Schistosoma mansoni adult worms together with the isolated compounds. \u0000Methods: The samples were available at concentrations of 12.5, 25, 50 and 100 μM. The parasites were kept for 4 days and monitored every 24 h to evaluate their viability and motor activity comparing with the positive control praziquantel. The cell viability of isolated flavones as determined by XTT assays in V79 cells. \u0000Results: The flavones 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside, 5-methoxy luteolin and 3′,5-dimethoxy luteolin were isolated from V. divergens. Flavone 5-methoxy luteolin caused the death of 25% of male and female adult S. mansoni worms in 24 h at 100 μM and also reduced their motor activity. Flavones 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside and 3′,5-dimethoxy luteolin were able to slightly reduce the motor activity to 25% within 24 \u0000h at 25 μg/mL and 12.5 μg/mL, respectively, but only in male worms. The results were compared with the flavone luteolin. For XTT assay in V79 cells the IC50 values were 1468.4 ± 10.5 μM, 5946.6 ± 25,1 μM, > 7960.8 μM and 270.6 ±9.3 μM for compounds 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside, 5-methoxy luteolin, 3′,5-dimethoxy luteolin and luteolin, respectively. \u0000Conclusion: To the best of our knowledge, flavones 5-methoxy luteolin and 3′,5-dimethoxy luteolin are reported for the first time as constituents of V. divergens and the Vochysiaceae family.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"24 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2015-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85579615","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: 3
Pharmacoepidemiology and Drug Safety Concept: Indian Scenario 药物流行病学和药物安全概念:印度的情况
Pub Date : 2015-05-13 DOI: 10.4172/2167-1052.1000E130
Patil Js
The concept of Pharmacoepidemiology was come in existence in late seventies. It is a specialty which links both clinical pharmacology and epidemiology. This specialty ply important role in measurement of success or failure of drug therapy based on various factors which affect use of drugs by the community. In Indian scenario research in pharmacology an important medical specialty has suffered due to many reasons. Shortage of financial support from the administration of many medical colleges, difficulty in procuring and maintaining experimental animals or patients/healthy volunteers are the few reasons have literally pushed many researchers to choose pharmacoepidemiology as their area of research. It doesn’t mean that Indian pharmacologists are really having research interest in this sub specialty. It is more for reasons of convenience rather than that of genuine interest.
药物流行病学的概念是在70年代末出现的。它是一个连接临床药理学和流行病学的专业。该专业根据影响社区使用药物的各种因素,在衡量药物治疗的成功或失败方面发挥着重要作用。在印度,药理学的情景研究是一个重要的医学专业,由于许多原因而受到影响。许多医学院管理部门缺乏资金支持,难以获得和维持实验动物或患者/健康志愿者是促使许多研究人员选择药物流行病学作为其研究领域的几个原因。这并不意味着印度药理学家真的对这个子专业有研究兴趣。与其说是出于真正的兴趣,不如说是出于方便。
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引用次数: 4
Chemotherapy for Primary Adenocarcinoma of the Urinary Bladder: Case Report 原发性膀胱腺癌的化疗:1例报告
Pub Date : 2015-04-12 DOI: 10.4172/2167-1052.1000180
W. Xu, B. Yu, T. Xu, Z. Xu, H. Cai, Q. Zou
A 71-year-old man was admitted to the hospital because of frequent micturition, urgency of urination and vesical tenesmus for one month. For the recent one week, the symptoms above aggravated gradually, accompanied with indisposition and distention of lower abdomen. Cystoscopic examination revealed that the blister lesions which were transparent protruded into the hanging and lateral wall of the bladder. The pathological biopsy showed it was adenocarcinomas of the urinary bladder. The patient was treated with GC plus S-1 chemotherapy with a regular follow-up. The progress of the disease was evaluated according to the standard of curative effect of RECIST. Traditionally, GC is considered as first-line chemotherapy for urothilial cell carcinoma. In this study, we researched the efficacy of GC plus S-1 combination chemotherapy in the study.
1例71岁男性因尿频、尿急、膀胱尿急住院1个月。近一周,上述症状逐渐加重,并伴有小腹不适和腹胀。膀胱镜检查显示透明的水疱病变突出到膀胱的垂壁和侧壁。病理活检显示为膀胱腺癌。患者接受GC + S-1化疗,定期随访。按照RECIST的疗效标准评价病情进展。传统上,GC被认为是尿路上皮细胞癌的一线化疗方案。在本研究中,我们研究了GC + S-1联合化疗在研究中的疗效。
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引用次数: 6
Developmental Expression of Calcium Activated Chloride Ion Channels Anoctamin 5 in Mouse Skeletal Muscle 钙激活氯离子通道-氨基辛胺5在小鼠骨骼肌中的发育表达
Pub Date : 2015-04-01 DOI: 10.4172/2167-1052.1000179
Hai-yan Song, Yi-Min Zhang, Hui Lian, Li Zhou, Yue-Min Tian, Jin-Xia Zhu
Anoctamin 5 (Ano5), also named TMEM16E, belongs to the Anoctamin gene family. The mutations in the Ano5 gene cause Limb-girdle muscular dystrophy (LGMD) 2L type and Miyoshi muscular dystrophy (MMD3). Both patients showed sarcolemmal lesions. The studies showed that TMEM16E mRNA expressed in the somites during embryogenesis, particularly in the myotomal cells, and also in the muscle myotome-derived progenitor cells. However, no report has been done to examine Ano5 expression during mouse skeletal muscle development. In the present study, we investigated the distribution and quantification of Ano5 in the skeletal muscles of mice during their development, with the methods of immunofluorescence, Reverse transcription-polymerase chain reaction (RT-PCR) and Western blot analyses. The results indicated that Ano5 mRNA and protein are expressed in skeletal muscle of the mouse from 1 day to 6 months, but with development and aging, the expression of Ano5 reduced gradually. Taken together, our results demonstrate that Ano5 expression level decreased throughout development and aging, and this may explain why the musculardystrophy syndrome of Ano5 mutant patients only starts during the later stage of their lives.
Anoctamin 5 (Ano5)也被命名为TMEM16E,属于Anoctamin基因家族。Ano5基因的突变导致肢体带状肌营养不良(LGMD) 2L型和三良肌营养不良(MMD3)。两例患者均有肌上皮病变。研究表明,TMEM16E mRNA在胚胎发生过程中在体体中表达,特别是在肌瘤细胞中,也在肌瘤源性祖细胞中表达。然而,没有关于Ano5在小鼠骨骼肌发育过程中的表达的报道。本研究采用免疫荧光、逆转录聚合酶链反应(RT-PCR)和Western blot等方法研究了Ano5在小鼠发育过程中骨骼肌中的分布和定量。结果表明,Ano5 mRNA和蛋白在小鼠1 ~ 6月龄骨骼肌中有表达,但随着发育和衰老,Ano5的表达逐渐降低。综上所述,我们的研究结果表明,Ano5的表达水平在发育和衰老过程中下降,这可能解释了为什么Ano5突变患者的肌肉营养不良综合征只在他们生命的后期才开始。
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引用次数: 2
Drug-Induced Pulmonary Edema and Acute Respiratory Distress Syndrome in Children 儿童药物性肺水肿和急性呼吸窘迫综合征
Pub Date : 2015-03-02 DOI: 10.4172/2167-1052.1000178
P. Magon
Non-cardiogenic pulmonary edema, and to a lesser extent, Acute Respiratory Distress Syndrome (ARDS) are common clinical manifestations of drug-induced lung diseases. Clinical features and radiographic appearances are generally indistinguishable from other causes of pulmonary edema and ARDS. Typical manifestations include dyspnoea, chest discomfort, tachypnoea, and hypoxemia. Chest radiographs commonly reveal interstitial and alveolar filling infiltrates without cardiomegaly. The laboratory results are usually nonspecific. We illustrate potential aetiologies relating to ARDS and the recognition of mucolytic drug use as one of the pathophysiologic factors of ARDS.
非心源性肺水肿,以及较小程度的急性呼吸窘迫综合征(Acute Respiratory Distress Syndrome, ARDS)是药物性肺部疾病的常见临床表现。临床特征和影像学表现通常与其他原因肺水肿和ARDS难以区分。典型表现为呼吸困难、胸部不适、呼吸急促和低氧血症。胸片通常显示间质和肺泡充盈浸润,但无心脏增大。实验室结果通常是非特异性的。我们阐明了与ARDS相关的潜在病因,并认识到溶黏液药物的使用是ARDS的病理生理因素之一。
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引用次数: 2
期刊
Advances in Pharmacoepidemiology and Drug Safety
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