Journal of Clinical Pharmacology最新文献_第9页

Pharmacokinetics and pharmacodynamics of vincristine sulfate liposome injection (VSLI) in adults with acute lymphoblastic leukemia. 硫酸长春新碱脂质体注射液(VSLI)在成人急性淋巴细胞白血病中的药代动力学和药效学。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-11-01 Epub Date: 2013-08-17 DOI: 10.1002/jcph.155

Jeffrey A Silverman, Laurie Reynolds, Steven R Deitcher

{"title":"Pharmacokinetics and pharmacodynamics of vincristine sulfate liposome injection (VSLI) in adults with acute lymphoblastic leukemia.","authors":"Jeffrey A Silverman, Laurie Reynolds, Steven R Deitcher","doi":"10.1002/jcph.155","DOIUrl":"https://doi.org/10.1002/jcph.155","url":null,"abstract":"Vincristine sulfate liposome injection (VSLI,) is a sphingomyelin and cholesterol nanoparticle formulation of vincristine sulfate (VCR) that was designed to overcome the dosing and pharmacokinetic limitations of standard VCR. In contrast to the rapid CL and wide tissue distribution of non-liposomal VCR, VSLI circulates in plasma for a prolonged period of time, with a slow CL of 345 mL/h and relatively small Vd of 3,570 mL. This facilitates enhanced and prolonged tumor-tissue delivery of VCR. The maximum tolerated dose of VSLI, 2.25 mg/m(2) once per week without a dose cap, enables individual and cumulative VCR exposure unachievable with non-liposomal VCR at its labeled dose of 1.4 mg/m(2) . VSLI is associated with a dose-dependent peripheral neurotoxicity albeit at doses that are two to three times that of standard VCR. VCR dose intensification with VSLI correlated with an increased probability of overall response and a strong trend towards increased complete response in adults with relapsed and/or refractory acute lymphoblastic leukemia. Overall, VSLI improves the therapeutic index by facilitating increased dose intensification while maintaining a predictable and manageable safety profile. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 11","pages":"1139-45"},"PeriodicalIF":2.9,"publicationDate":"2013-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.155","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31626029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 35

Co-medication of pravastatin and paroxetine-a categorical study. 普伐他汀与帕罗西汀联合用药的分类研究。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-11-01 Epub Date: 2013-08-13 DOI: 10.1002/jcph.151

Li An, Priyadarshini P Ravindran, Swetha Renukunta, Srinivas Denduluri

{"title":"Co-medication of pravastatin and paroxetine-a categorical study.","authors":"Li An, Priyadarshini P Ravindran, Swetha Renukunta, Srinivas Denduluri","doi":"10.1002/jcph.151","DOIUrl":"https://doi.org/10.1002/jcph.151","url":null,"abstract":"Electronic Medical Records (EMRs) are wealthy storehouses of patient information, to which data mining techniques can be prudently applied to reveal clinically significant patterns. Detecting patterns in drug-drug interactions, leading to adverse drug reactions is a powerful application of EMR data mining. Adverse effects of drug treatments can be investigated by mining clinical laboratory tests data which are reliable indicators of abnormal physiological functions. We report here the co-medication effects of pravastatin (HMG-CoA reductase inhibitor) and paroxetine (selective serotonin reuptake inhibitor (SSRI) anti-depressant) on significant clinical parameters, identified through a data mining analysis conducted on the Allscripts data warehouse. We found that the concomitant drug treatments of pravastatin and paroxetine increased the mean values of glucose serum from 113.2 to 132.1 mg/dL and international normalized ratio (INR) from 2.18 to 2.52, respectively. It also decreased the mean values of estimated glomerular filtration rate (eGFR) from 43 to 37 mL/min/1.73 m(3) and blood CO2 levels from 24.8 to 23.9 mEq/L respectively. Our findings indicate that co-medication of pravastatin and paroxetine might have significant impact on blood anti-coagulation, kidney function, and glucose homeostasis. Our methodology can be applied to any EMR data set to reveal co-medication effects of any drug pairs. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 11","pages":"1212-9"},"PeriodicalIF":2.9,"publicationDate":"2013-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.151","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31626443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 11

Founding an adverse drug reaction (ADR) network: a method for improving doctors spontaneous ADR reporting in a general hospital. 建立药品不良反应(ADR)网络:提高综合医院医生自发上报ADR的方法。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-11-01 Epub Date: 2013-08-19 DOI: 10.1002/jcph.149

Lee Hilary Goldstein, Maya Berlin, Walid Saliba, Mazen Elias, Matitiyahu Berkovitch

{"title":"Founding an adverse drug reaction (ADR) network: a method for improving doctors spontaneous ADR reporting in a general hospital.","authors":"Lee Hilary Goldstein, Maya Berlin, Walid Saliba, Mazen Elias, Matitiyahu Berkovitch","doi":"10.1002/jcph.149","DOIUrl":"https://doi.org/10.1002/jcph.149","url":null,"abstract":"Adverse drug reactions (ADR) are underreported by doctors despite numerous efforts. We aimed to determine if establishing an \"ADR reporting doctor's network\" within a hospital would increase the quantity of ADRs reported by hospital doctors. One hundred hospital doctors joined the network. Email reminders were sent to network members during the 1 year study period, conveying information about ADRs reported, amusingly and pleasantly reminding them to report ADRs in minimal detail, by phone, email, text message or mail to the Clinical Pharmacology Unit, who would further complete the report. A total of 114 ADRs were reported during the study period in comparison to 48, 26, and 17 in the previous 3 years (2008, 2009, 2010, respectively). In the 3 years prior, doctors reported 41.7% of the reported ADRs whereas in the study period, doctors reported 74.3% of ADRs (P < .001), reflecting an 80% increase in doctors reports. Ninety seven percent of doctors' reports were of ADR network members. Thirty-four (34%) network members reported an ADR during the study period and 31 of the 34 reporters had never reported ADRs before becoming network members. Establishing an ADR network of doctors substantially increases ADR reporting amongst its members. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 11","pages":"1220-5"},"PeriodicalIF":2.9,"publicationDate":"2013-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.149","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31579593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 25

Integration of biostatistics and pharmacometrics computing platforms for efficient and reproducible PK/PD analysis: a case study. 整合生物统计学和药物计量学计算平台，用于高效和可重复的PK/PD分析:一个案例研究。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-11-01 Epub Date: 2013-08-29 DOI: 10.1002/jcph.157

Ying C Ou, Arthur Lo, Brian Lee, Phillip Liu, Karen Kimura, Charisse Eary, Alan Hopkins

{"title":"Integration of biostatistics and pharmacometrics computing platforms for efficient and reproducible PK/PD analysis: a case study.","authors":"Ying C Ou, Arthur Lo, Brian Lee, Phillip Liu, Karen Kimura, Charisse Eary, Alan Hopkins","doi":"10.1002/jcph.157","DOIUrl":"https://doi.org/10.1002/jcph.157","url":null,"abstract":"Results of pharmacometric analyses influence high-level decisions such as clinical trial design, drug approval, and labeling. Key challenges for timely delivery of pharmacometric analyses are the data assembly process and tracking and documenting the modeling process and results. Since clinical efficacy and safety data typically reside in the biostatistics computing area, an integrated computing platform for pharmacometric and biostatistical analyses would be ideal. A case study is presented integrating a pharmacometric modeling platform into an existing statistical computing environment (SCE). The feasibility and specific configurations of running common PK/PD programs such as NONMEM and R inside of the SCE are provided. The case study provides an example of an integrated repository that facilitates efficient data assembly for pharmacometrics analyses. The proposed platform encourages a good pharmacometrics working practice to maintain transparency, traceability, and reproducibility of PK/PD models and associated data in supporting drug development and regulatory decisions. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 11","pages":"1112-20"},"PeriodicalIF":2.9,"publicationDate":"2013-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.157","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31630583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Safety, tolerability, and pharmacokinetics of oral and intravenous administration of GSK1322322, a peptide deformylase inhibitor. 肽去甲酰基酶抑制剂GSK1322322口服和静脉给药的安全性、耐受性和药代动力学

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-11-01 Epub Date: 2013-08-13 DOI: 10.1002/jcph.150

Odin J Naderer, Lori S Jones, John Zhu, Milena Kurtinecz, Etienne Dumont

{"title":"Safety, tolerability, and pharmacokinetics of oral and intravenous administration of GSK1322322, a peptide deformylase inhibitor.","authors":"Odin J Naderer, Lori S Jones, John Zhu, Milena Kurtinecz, Etienne Dumont","doi":"10.1002/jcph.150","DOIUrl":"https://doi.org/10.1002/jcph.150","url":null,"abstract":"GSK1322322 is the first in a new class of antibiotics that targets peptide deformylase (PDF), an essential bacterial enzyme required for protein maturation. This randomized, double-blind, placebo-controlled, eight-cohort phase I trial enrolled 62 healthy volunteers to assess safety, tolerability, and pharmacokinetic profiles of GSK1322322. GSK1322322 was administered as a single oral or intravenous (IV) dose, escalating from 500 to 3,000 mg or repeat IV doses escalating from 500 to 1,500 mg twice daily. Upon repeat IV administration, GSK1322322 exhibits linear pharmacokinetics over time upon repeat doses as shown by time-invariant pharmacokinetics. A dose-proportional increase in area under concentration-time curve was observed after single or repeat IV dosing, whereas clearance at steady state remained generally unchanged across doses. There was minimal accumulation of GSK1322322 after repeat IV twice-daily administration. After oral tablet doses of GSK1322322 1,000 and 1,500 mg, absolute bioavailability was 69% and 56%, respectively. GSK1322322 administration at single and repeat IV doses and at supratherapeutic single IV doses of 2,000 and 3,000 mg was associated with mild-to-moderate drug-related adverse events. On the basis of the pharmacokinetics and tolerability demonstrated in this study, GSK1322322 has the potential to become the first-in-class PDF inhibitor for clinical use. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 11","pages":"1168-76"},"PeriodicalIF":2.9,"publicationDate":"2013-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.150","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31625712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 15

CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies. cyp3a介导的药物-药物相互作用潜力和brentuximab vedotin(一种抗体-药物偶联物)在cd30阳性血液恶性肿瘤患者中的排泄

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-08-01 Epub Date: 2013-06-10 DOI: 10.1002/jcph.116

Tae H Han, Ajay K Gopal, Radhakrishnan Ramchandren, Andre Goy, Robert Chen, Jeffrey V Matous, Maureen Cooper, Laurie E Grove, Stephen C Alley, Carmel M Lynch, Owen A O'Connor

{"title":"CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies.","authors":"Tae H Han, Ajay K Gopal, Radhakrishnan Ramchandren, Andre Goy, Robert Chen, Jeffrey V Matous, Maureen Cooper, Laurie E Grove, Stephen C Alley, Carmel M Lynch, Owen A O'Connor","doi":"10.1002/jcph.116","DOIUrl":"https://doi.org/10.1002/jcph.116","url":null,"abstract":"Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E (MMAE) into CD30-expressing cells. This study evaluated the CYP3A-mediated drug-drug interaction potential of brentuximab vedotin and the excretion of MMAE. Two 21-day cycles of brentuximab vedotin (1.2 or 1.8 mg/kg intravenously) were administered to 56 patients with CD30-positive hematologic malignancies. Each patient also received either a sensitive CYP3A substrate (midazolam), an effective inducer (rifampin), or a strong inhibitor (ketoconazole). Brentuximab vedotin did not affect midazolam exposures. ADC exposures were unaffected by concomitant rifampin or ketoconazole; however, MMAE exposures were lower with rifampin and higher with ketoconazole. The short-term safety profile of brentuximab vedotin in this study was generally consistent with historic clinical observations. The most common adverse events were nausea, fatigue, diarrhea, headache, pyrexia, and neutropenia. Over a 1-week period, ∼23.5% of intact MMAE was recovered after administration of brentuximab vedotin; all other species were below the limit of quantitation. The primary excretion route is via feces (median 72% of the recovered MMAE). These results suggest that brentuximab vedotin (1.8 mg/kg) and MMAE are neither inhibitors nor inducers of CYP3A; however, MMAE is a substrate of CYP3A.","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 8","pages":"866-77"},"PeriodicalIF":2.9,"publicationDate":"2013-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.116","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31496077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 59

Cancer cachexia raises the plasma concentration of oxymorphone through the reduction of CYP3A but not CYP2D6 in oxycodone-treated patients. 在羟考酮治疗的患者中，癌症恶病质通过降低CYP3A而不是CYP2D6来提高氧吗啡酮的血浆浓度。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-08-01 Epub Date: 2013-06-03 DOI: 10.1002/jcph.112

Takafumi Naito, Masaki Tashiro, Takuya Ishida, Kazunori Ohnishi, Junichi Kawakami

{"title":"Cancer cachexia raises the plasma concentration of oxymorphone through the reduction of CYP3A but not CYP2D6 in oxycodone-treated patients.","authors":"Takafumi Naito, Masaki Tashiro, Takuya Ishida, Kazunori Ohnishi, Junichi Kawakami","doi":"10.1002/jcph.112","DOIUrl":"https://doi.org/10.1002/jcph.112","url":null,"abstract":"This study evaluated the plasma concentrations of oxycodone and its demethylates and opioid-induced adverse effects based on cachexia stage in cancer patients receiving oxycodone. Seventy patients receiving oxycodone for cancer pain were enrolled. Cachexia was evaluated using the Glasgow Prognostic Score (GPS). Predose plasma concentrations of oxycodone, oxymorphone, and noroxycodone were determined at the titration dose. Opioid-induced adverse effects were monitored for 2 weeks after the titration. Plasma concentrations of oxycodone and oxymorphone but not noroxycodone in patients with a GPS of 2 were significantly higher than that with a GPS of 0. The metabolic ratios of noroxycodone but not oxymorphone to oxycodone in patients with a GPS of 1 and 2 were significantly lower than in those with a GPS of 0. A higher GPS was associated with a higher incidence of somnolence, while the GPS did not affect the incidence of vomiting. Plasma concentrations of oxycodone and oxymorphone were not associated with the incidence of adverse effects. In conclusion, cancer cachexia raised the plasma exposures of oxycodone and oxymorphone through the reduction of CYP3A but not CYP2D6. Although the cachexia elevated the incidence of somnolence, alterations in their pharmacokinetics were not associated with the incidence. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 8","pages":"812-8"},"PeriodicalIF":2.9,"publicationDate":"2013-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.112","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31480079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 17

Impact of food and different meal types on the pharmacokinetics of rilpivirine. 食物及不同膳食类型对利匹韦林药代动力学的影响。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-08-01 Epub Date: 2013-05-30 DOI: 10.1002/jcph.107

Herta M Crauwels, Rolf P G van Heeswijk, Annemie Buelens, Marita Stevens, Katia Boven, Richard M W Hoetelmans

{"title":"Impact of food and different meal types on the pharmacokinetics of rilpivirine.","authors":"Herta M Crauwels, Rolf P G van Heeswijk, Annemie Buelens, Marita Stevens, Katia Boven, Richard M W Hoetelmans","doi":"10.1002/jcph.107","DOIUrl":"https://doi.org/10.1002/jcph.107","url":null,"abstract":"The objective of the study was to determine the impact of food and different meal types on the pharmacokinetics of rilpivirine, a nonnucleoside reverse transcriptase inhibitor. In this open-label, randomized, crossover study, healthy volunteers received a single, oral 75 mg dose of rilpivirine either with a normal-fat breakfast (reference), under fasting conditions, with a high-fat breakfast, or with a protein-rich nutritional drink. Pharmacokinetic parameters were determined by non-compartmental methods and analyzed using a linear mixed-effects model. Safety was assessed throughout. The least-squares mean ratio for area under the plasma concentration-time curve to last timepoint was 0.57 (90% confidence interval [CI]: 0.46-0.72) under fasting conditions compared to dosing with a normal-fat breakfast. With a high-fat breakfast or only a protein-rich nutritional drink, the corresponding values were 0.92 (90% CI: 0.80-1.07) and 0.50 (90% CI: 0.41-0.61), respectively, compared to dosing with a normal-fat breakfast. Under all conditions, rilpivirine was generally safe and well tolerated. Administration of rilpivirine under fasting conditions or with only a protein-rich nutritional drink substantially lowered the oral bioavailability when compared to administration with a normal-fat breakfast. Rilpivirine bioavailability was similar when administered with a high-fat or normal-fat breakfast. Rilpivirine should always be taken with a meal to ensure adequate bioavailability.","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 8","pages":"834-40"},"PeriodicalIF":2.9,"publicationDate":"2013-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.107","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31467269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 46

Functional G1199A ABCB1 polymorphism may have an effect on cyclosporine blood concentration in renal transplanted patients. 功能性G1199A ABCB1多态性可能对肾移植患者环孢素血药浓度有影响。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-08-01 Epub Date: 2013-05-30 DOI: 10.1002/jcph.105

Gomaa Mostafa-Hedeab, Maha M Saber-Ayad, Inas A Latif, Sahier O Elkashab, Tarek H Elshaboney, Magdy Ibrahim Mostafa, Sanaa Abd El-Shafy, Magda M Zaki

{"title":"Functional G1199A ABCB1 polymorphism may have an effect on cyclosporine blood concentration in renal transplanted patients.","authors":"Gomaa Mostafa-Hedeab, Maha M Saber-Ayad, Inas A Latif, Sahier O Elkashab, Tarek H Elshaboney, Magdy Ibrahim Mostafa, Sanaa Abd El-Shafy, Magda M Zaki","doi":"10.1002/jcph.105","DOIUrl":"https://doi.org/10.1002/jcph.105","url":null,"abstract":"Cyclosporine A (CsA) shows significant inter-individual variability in its pharmacokinetics, which may be due to polymorphisms in ABCB-1 genes coding for P-glycoprotein. The aim of this study was to explore the role of genetic polymorphisms of ABCB-1 in affecting the CsA blood concentrations in renal transplanted patients over the first 3 months after transplantation. Renal transplanted patients receiving CsA (n = 40) were genotyped for ABCB -1 C3435T (I1145I) and G1199A (S400N) polymorphisms. CsA blood concentrations were measured on Day 7, 30, and 90 after transplantation. G1199A variant showed higher CsA blood concentrations in stable patients, that was significant for trough levels (198 vs. 136 ng/mL on Day 7, P = .004, 196 vs. 125 ng/mL on Day 30, P = .007, 194 vs. 121 ng/mL on Day 90, P = .005 for stable vs. unstable groups). Polymorphisms of ABCB-1 have only a minor effect on CsA blood concentrations. The functional G1199A polymorphism can affect the drug levels more than non-functional C3435T. This polymorphism might be of a potential prognostic value in renal transplanted patients. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 8","pages":"827-33"},"PeriodicalIF":2.9,"publicationDate":"2013-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.105","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31560157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 8

Radix Puerariae: an overview of its chemistry, pharmacology, pharmacokinetics, and clinical use. 葛根化学、药理学、药代动力学及临床应用综述。

IF 2.9 4区医学

Journal of Clinical Pharmacology Pub Date : 2013-08-01 Epub Date: 2013-05-16 DOI: 10.1002/jcph.96

Zhen Zhang, Tai-Ning Lam, Zhong Zuo

{"title":"Radix Puerariae: an overview of its chemistry, pharmacology, pharmacokinetics, and clinical use.","authors":"Zhen Zhang, Tai-Ning Lam, Zhong Zuo","doi":"10.1002/jcph.96","DOIUrl":"https://doi.org/10.1002/jcph.96","url":null,"abstract":"Radix Puerariae has been traditionally used for the treatment of diarrhea, acute dysentery, deafness and cardiovascular diseases. Yege (Gegen or Radix Puerariae lobatae), the dried root of Pueraria lobata (Wild.) Ohwi, has been widely used in China and, to a lesser extent, in Japan, Korea, and the United States. Although they have been classified into different categories in Chinese Pharmacopoeia, Yege is often used interchangeably in practice with Fenge (Radix Puerariae thomsonii), which is the dried root of Pueraria thomsonii Benth. Among various commercially available products of Radix Puerariae, injection of puerarin, the major isoflavone from Radix Puerariae, has been most widely used as a vasodilator for the treatment of angina and myocardial infarction. Considering the extensive clinical usage and recent alert of fatal herb-drug interaction of Radix Puerariae, the current review is proposed to cover its traditional applications, pharmacological activities, pharmacokinetics, clinical efficacy, and potential herb-drug interactions aiming to fill in the information gaps of this herb for frontline practitioners. Although various small, poorly designed clinical trials have demonstrated the safety, efficacy, and significant clinical benefits of Radix Puerariae, prospective randomized controlled clinical trials are needed to further establish its effective and safe use. ","PeriodicalId":48908,"journal":{"name":"Journal of Clinical Pharmacology","volume":"53 8","pages":"787-811"},"PeriodicalIF":2.9,"publicationDate":"2013-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/jcph.96","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31433868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 169