International journal of clinical pharmacology and therapeutics最新文献

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Comparative pharmacokinetics of new curcumin preparations and evidence for increased bioavailability in healthy adult participants. 姜黄素新制剂的比较药代动力学和提高健康成人生物利用度的证据。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-12-01 DOI: 10.5414/CP204257
Akiko Hirose, Yoshitaka Kuwabara, Yoko Kanai, Chieko Kato, Yuji Makino, Fukumoto Yoshi, Kazumoto Sasaki
{"title":"Comparative pharmacokinetics of new curcumin preparations and evidence for increased bioavailability in healthy adult participants.","authors":"Akiko Hirose,&nbsp;Yoshitaka Kuwabara,&nbsp;Yoko Kanai,&nbsp;Chieko Kato,&nbsp;Yuji Makino,&nbsp;Fukumoto Yoshi,&nbsp;Kazumoto Sasaki","doi":"10.5414/CP204257","DOIUrl":"https://doi.org/10.5414/CP204257","url":null,"abstract":"<p><strong>Objective: </strong>Theracurmin, which contains the curcumin composition, CR-033P, has been demonstrated to be highly bioavailable. To compare the pharmacokinetics of the three compositions, CR-033P, CR-043P using modified starch as an alternative to the dispersant gum ghatti used in the CR-033P, and TS-P1 containing the newly developed amorphous curcumin, a randomized double-blind crossover study (3-way, 3-period) was conducted.</p><p><strong>Materials and methods: </strong>A single dose of the curcumin capsules (TS-P1 45 mg, CR-033P 90 mg, and CR-043P 90 mg) was administered to healthy adult participants. Blood sampling was performed 24 hours after capsule administration, and the plasma concentration of total curcumin was determined using high-performance liquid chromatography coupled with tandem mass spectrometry.</p><p><strong>Results: </strong>TS-P1 and CR-043P tended to have a slightly lower area under the concentration time curve (AUC) <sub>0-24h</sub> than CR-033P, while TS-P1 displayed bioequivalence to CR-043P. Further, TS-P1 displayed bioequivalence to CR-033P in terms of AUC<sub>0-12h</sub>, while that of CR-043P tended to be lower than that of CR-033P. TS-P1 had a higher AUC<sub>0-12h</sub> than CR-043P. A statistically significant difference (p < 0.001) was found between the preparations in terms of C<sub>max</sub>. TS-P1 tended to have a higher C<sub>max</sub> than CR-033P, CR-043P tended to have a slightly lower C<sub>max</sub> than CR-033P, and TS-P1 tended to have a higher C<sub>max</sub> than CR-043P.</p><p><strong>Conclusion: </strong>The newly developed TS-P1 composition seemed to display similar curcumin systemic exposure except for a higher plasma concentration than the CR-033P composition. Further, only a few significant differences were found between CR-043P and CR-033P.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 12","pages":"530-538"},"PeriodicalIF":0.8,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10426177","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: 1
Hepatic failure with fatal outcome during pregnancy following administration of a single therapeutic dose of acetominophen: Case report and literature review. 妊娠期间服用单剂量乙酰氨基酚后肝功能衰竭致死性结局:病例报告和文献回顾。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-11-01 DOI: 10.5414/CP204242
Yu Gao, Rui Zhang, Hua Liang, Yan Huang
{"title":"Hepatic failure with fatal outcome during pregnancy following administration of a single therapeutic dose of acetominophen: Case report and literature review.","authors":"Yu Gao,&nbsp;Rui Zhang,&nbsp;Hua Liang,&nbsp;Yan Huang","doi":"10.5414/CP204242","DOIUrl":"https://doi.org/10.5414/CP204242","url":null,"abstract":"<p><p>Acetaminophen is generally regarded as a safe antipyretic and analgetic agent and is widely used in cases of pregnancy. However, acetaminophen is also one of the most frequently reported medications in cases of drug overdose. On the other hand, in the few instances described in the literature, where normal doses of acetaminophen administered during pregnancy may have had a fatal outcome, evidence existed pointing to a history of liver disease. It is therefore of interest that the patient in this report who died of liver failure after ingesting standard doses of acetaminophen also suffered from intrahepatic cholestasis during pregnancy although there was no history of liver disease. Other than these instances, there have been no previous reports in the literature of a normal, therapeutic dose of acetaminophen having a fatal outcome in pregnancy. This case emphasizes the need for caution when prescribing acetaminophen during pregnancy to patients with a history of liver disease, regardless of whether the liver function has returned to normal.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 11","pages":"486-491"},"PeriodicalIF":0.8,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33478272","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: 0
Changes in the first anti-seizure medication prescribed for children and adolescents with epilepsy in a tertiary clinical center in Serbia over two decades. 二十年来,塞尔维亚三级临床中心为患有癫痫的儿童和青少年开的第一批抗癫痫药物的变化。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-10-01 DOI: 10.5414/CP204236
Ksenija Gebauer-Bukurov, Slobodan Sekulić, Željko Živanović, Željka Nikolašević
{"title":"Changes in the first anti-seizure medication prescribed for children and adolescents with epilepsy in a tertiary clinical center in Serbia over two decades.","authors":"Ksenija Gebauer-Bukurov,&nbsp;Slobodan Sekulić,&nbsp;Željko Živanović,&nbsp;Željka Nikolašević","doi":"10.5414/CP204236","DOIUrl":"https://doi.org/10.5414/CP204236","url":null,"abstract":"<p><strong>Objectives: </strong>We assessed the prevalence of the use of new anti-seizure medications and valproate in the female population over two decades.</p><p><strong>Materials and methods: </strong>We conducted a retrospective observational cross-sectional study of medical records of children and adolescents (4 - 19 years old) with newly diagnosed epilepsy in a tertiary clinical center in Serbia from 1997 to 1999 and 2017 to 2019.</p><p><strong>Results: </strong>The statistical analysis revealed significant changes in the treatment of generalized and focal seizures and all etiologies of epilepsy. Valproate use in the adolescent girl population decreased significantly from 2017 to 2019.</p><p><strong>Conclusion: </strong>The prescription pattern of the initial anti-seizure medication changed significantly over the two decades. The results correspond to current guidelines and recommendations.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 10","pages":"417-421"},"PeriodicalIF":0.8,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40705665","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
Drug-drug interaction between remdesivir and immunosuppressant agents in a kidney transplant recipient. 肾移植受者中瑞德西韦与免疫抑制剂的药物-药物相互作用。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-10-01 DOI: 10.5414/CP204239
Toshinori Hirai, Akari Mizuta, Takeshi Sasaki, Kouhei Nishikawa, Takahiro Inoue, Takuya Iwamoto
{"title":"Drug-drug interaction between remdesivir and immunosuppressant agents in a kidney transplant recipient.","authors":"Toshinori Hirai,&nbsp;Akari Mizuta,&nbsp;Takeshi Sasaki,&nbsp;Kouhei Nishikawa,&nbsp;Takahiro Inoue,&nbsp;Takuya Iwamoto","doi":"10.5414/CP204239","DOIUrl":"https://doi.org/10.5414/CP204239","url":null,"abstract":"<p><p>A 60-year-old man was treated with a regimen of controlled-release tacrolimus (2 mg once daily), everolimus (0.5 mg twice daily), methylprednisolone (4 mg once daily), and mizoribine (100 mg twice daily) as an anti-rejection regimen following living-donor kidney transplantation. One year after transplantation, the recipient was admitted to Mie University Hospital (day X; admission date) to treat coronavirus disease 2019 pneumonia. The latest trough concentrations of tacrolimus and everolimus before admission (day X-65) were 4.5 ng/mL and 4.4 ng/mL, respectively. Since tacrolimus concentration was 4.2 ng/mL on day X+3, the dose was adjusted to 1.5 mg once daily to reach the target concentration of 3.0 ng/mL due to the introduction of remdesivir. After starting remdesivir on day X+4, the increased trough concentrations of tacrolimus on day X+6 (6.9 ng/mL) and everolimus on day X+7 (9.2 ng/mL) were observed, which resulted in dose reduction of tacrolimus (0.5 mg once daily) and discontinuation of everolimus. After discontinuation of remdesivir on day X+9, dose titration of controlled-release tacrolimus and restart of everolimus (0.5 mg twice daily) were performed from day X+15. The dose of controlled-release tacrolimus was titrated and fixed to 2 mg once daily at discharge (day X+21). There was no toxicity due to immunosuppressive agents during hospitalization. This case report indicated that remdesivir might interact with cytochrome P450 3A4 substrates, such as tacrolimus and everolimus, and elevate their blood concentrations under high inflammatory conditions.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 10","pages":"439-444"},"PeriodicalIF":0.8,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40525087","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: 4
Lemborexant add-on further improves the effect of galantamine on sleep-wake disorder in Alzheimer's disease. Lemborexant添加物进一步改善了加兰他明对阿尔茨海默病睡眠-觉醒障碍的影响。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-10-01 DOI: 10.5414/CP204213
Tsukasa Murata, Mayumi Hamada
{"title":"Lemborexant add-on further improves the effect of galantamine on sleep-wake disorder in Alzheimer's disease.","authors":"Tsukasa Murata,&nbsp;Mayumi Hamada","doi":"10.5414/CP204213","DOIUrl":"https://doi.org/10.5414/CP204213","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 10","pages":"445-447"},"PeriodicalIF":0.8,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40600334","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: 0
Pharmacokinetic evaluation and relative bioavailability pilot study of fidaxomicin in healthy Chinese subjects: An open, randomized, single-dose, cross-over study. 非达霉素在中国健康受试者体内的药代动力学评价和相对生物利用度的初步研究:一项开放、随机、单剂量、交叉研究。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-10-01 DOI: 10.5414/CP204263
Yu-Ran Cao, Yu-Feng Li, Jing-Jing Wang, Hai-Jing Yang, Qiong Wei, Ji-Cheng Yu, Guo-Ying Cao, Jian Gao, Jing Zhang, Xiao-Na Li, Shu-Yan Yu
{"title":"Pharmacokinetic evaluation and relative bioavailability pilot study of fidaxomicin in healthy Chinese subjects: An open, randomized, single-dose, cross-over study.","authors":"Yu-Ran Cao,&nbsp;Yu-Feng Li,&nbsp;Jing-Jing Wang,&nbsp;Hai-Jing Yang,&nbsp;Qiong Wei,&nbsp;Ji-Cheng Yu,&nbsp;Guo-Ying Cao,&nbsp;Jian Gao,&nbsp;Jing Zhang,&nbsp;Xiao-Na Li,&nbsp;Shu-Yan Yu","doi":"10.5414/CP204263","DOIUrl":"https://doi.org/10.5414/CP204263","url":null,"abstract":"<p><strong>Objective: </strong>To compare the pharmacokinetic (PK) characteristics, investigate relative bioavailability, and provide data for potential additional bioequivalence trials between generic fidaxomicin (test (T) formulation) and the original brand (reference (R) formulation) in healthy Chinese subjects.</p><p><strong>Materials and methods: </strong>An open, randomized, single-dose, cross-over study was conducted in 18 healthy Chinese subjects. The subjects randomly received T or R formulations and the alternative formulations were received after a 14-day wash-out period. Blood and fecal samples were collected and tested by liquid chromatography-tandem mass spectrometry (LC-MS/MS). PK parameters were calculated using a non-compartmental model. Relative bioavailability considering commonly established bioequivalence criteria was assessed.</p><p><strong>Results: </strong>C<sub>max</sub> were 3.58 ± 2.74 ng/mL and 6.01 ± 3.93 ng/mL, and AUC<sub>0-∞</sub> were 35.71 ± 18.68 h×ng/mL and 52.15 ± 31.31 h×ng/mL for the T and R formulations, respectively. The t<sub>max</sub> of both formulations was 5.00 hours. The cumulative fecal excretion rate (Fe<sub>0-96h</sub>/F) of fidaxomicin and its main active metabolite OP-1118 were similar for both formulations. The geometric mean ratios and 90% confidence intervals (CI) of AUC<sub>0-t</sub>, AUC<sub>0-∞</sub>, and C<sub>max</sub> were not completely within the range of 80.00 - 125.00%. Significant within-subject and inter-subject coefficients of variation (> 30%) were found.</p><p><strong>Conclusion: </strong>Despite the differences in exposure, PK characteristics and fecal recovery of the two formulations were similar, suggesting that an effective concentration of the generic fidaxomicin could be achieved locally in the gastrointestinal tract. Fidaxomicin was a highly viable drug, thus providing reference for future clinical study design.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 10","pages":"448-458"},"PeriodicalIF":0.8,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40705666","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: 0
Search for nutritional and inflammatory marker ratios to predict neutropenia in FEC therapy for breast cancer: A retrospective observational study. 寻找营养和炎症标志物比率来预测FEC治疗乳腺癌中性粒细胞减少:一项回顾性观察研究。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-10-01 DOI: 10.5414/CP204264
Toshiki Nakamura, Hajime Matsubara
{"title":"Search for nutritional and inflammatory marker ratios to predict neutropenia in FEC therapy for breast cancer: A retrospective observational study.","authors":"Toshiki Nakamura,&nbsp;Hajime Matsubara","doi":"10.5414/CP204264","DOIUrl":"https://doi.org/10.5414/CP204264","url":null,"abstract":"<p><strong>Objective: </strong>Nutritional and inflammatory marker ratios are known to predict response to chemotherapy in breast cancer, but whether they predict adverse effects caused by chemotherapy remains unclear. We investigated whether nutritional and inflammatory marker ratios before starting FEC therapy (5-fluorouracil, epirubicin, and cyclophosphamide) predict grade 4 neutropenia as a serious adverse effect.</p><p><strong>Materials and methods: </strong>61 patients with breast cancer who started FEC therapy for the first time as preoperative or postoperative chemotherapy were studied. Relevant nutritional and inflammatory marker ratios were compared between patients who developed grade 4 neutropenia (n = 44) and those who did not (n = 17).</p><p><strong>Results: </strong>In univariate analysis, occurrence of neutropenia was related significantly (p < 0.05) to pre-FEC-therapy white blood cell count, platelet count, neutrophil count, lymphocyte-to-monocyte ratio (LMR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and modified Glasgow prognostic score. Analysis using cutoff values obtained from receiver operating characteristic curves showed that LMR, NLR, and PLR predicted grade 4 neutropenia. However, multivariate logistic regression analysis identified no independent factor associated with grade 4 neutropenia. A post-hoc power analysis revealed an inadequate sample size.</p><p><strong>Conclusion: </strong>Inflammatory marker ratios, especially PLR, may predict grade 4 neutropenia caused by FEC therapy for breast cancer. Although multivariate analysis identified no independent predictive markers in this study due to inadequate sample size, further prospective large-scale research is needed to examine the usefulness of nutritional and inflammatory marker ratios for predicting adverse effects.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 10","pages":"422-429"},"PeriodicalIF":0.8,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40600337","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: 0
Randomized, open-label, crossover trial comparing the pharmacokinetic profile of a novel oral aspirin solution and a chewed aspirin tablet. 比较新型阿司匹林口服溶液和阿司匹林咀嚼片药代动力学特征的随机、开放标签、交叉试验。
IF 0.9 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-10-01 DOI: 10.5414/CP204271
Dan Atar, Sougat Sarkar, Emil Kolev, Carla Mura, Frank Brosstad, Lotte Theodorsen, Geir Ivar Westen, Per Erik Stribolt-Halvorsen
{"title":"Randomized, open-label, crossover trial comparing the pharmacokinetic profile of a novel oral aspirin solution and a chewed aspirin tablet.","authors":"Dan Atar, Sougat Sarkar, Emil Kolev, Carla Mura, Frank Brosstad, Lotte Theodorsen, Geir Ivar Westen, Per Erik Stribolt-Halvorsen","doi":"10.5414/CP204271","DOIUrl":"10.5414/CP204271","url":null,"abstract":"<p><strong>Objectives: </strong>The primary objective of this study was to assess the pharmacokinetic profiles of acetylsalicylic acid (ASA) and salicylic acid (SA) after administration of two different formulations of aspirin under fasting and fed conditions.</p><p><strong>Materials and methods: </strong>The study was a randomized, open-label, parallel-group, 2-arm crossover study conducted at a single center. Healthy subjects were randomized to receive 300 mg of aspirin in either a 15-mL oral solution (pre-packaged vial containing powder and solvent that are combined at the time of administration) or a single solid tablet to be chewed and swallowed with 150 mL of water. Treatment visits were separated by a 10-day wash-out period.</p><p><strong>Results: </strong>At 3 minutes, ASA concentrations for the oral solution fed state and fasting state arms exceeded those for the chewed tablet (fed 299 vs. 139 ng/mL; fasting 356 vs. 204 ng/mL). Compared to the chewed tablet, the mean plasma ASA concentration was 74% greater with the oral solution under fasting conditions, and 115% greater under fed conditions. Similarly, at 3 minutes, the mean SA plasma concentration with the oral solution under fed and fasting conditions exceeded those for the chewed tablet (fed 310 vs. 160 ng/mL; fasting 330 vs. 185 ng/mL). Under fasting conditions, the mean plasma ASA AUC<sub>0-last</sub>, with the oral solutions was 168,076.8 min.ng/mL compared to 163,726.3 min.ng/mL with the chewed tablet. Under fed conditions, the mean plasma ASA AUC<sub>0-last</sub>, with the oral solutions was 179,116.7 min.ng/mL compared to 164,704.3 min.ng/mL with the chewed tablet.</p><p><strong>Conclusion: </strong>This phase 1 study showed that use of an aspirin oral solution provided more rapid exposure to higher plasma concentration levels of ASA and SA than chewing a solid tablet.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 10","pages":"430-438"},"PeriodicalIF":0.9,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9494154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40706104","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: 0
Effect of vitamin C on immune reconstitution after bone marrow transplantation. 维生素C对骨髓移植后免疫重建的影响。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-06-17 DOI: 10.5414/CP204182
Víctor Itaí Urbalejo-Ceniceros, H. Rocha-González, B. Acosta-Maldonado, L. M. Valero-Saldaña, Areli E Hernández-Alcántara, D. Pérez-Camargo
{"title":"Effect of vitamin C on immune reconstitution after bone marrow transplantation.","authors":"Víctor Itaí Urbalejo-Ceniceros, H. Rocha-González, B. Acosta-Maldonado, L. M. Valero-Saldaña, Areli E Hernández-Alcántara, D. Pérez-Camargo","doi":"10.5414/CP204182","DOIUrl":"https://doi.org/10.5414/CP204182","url":null,"abstract":"BACKGROUND\u0000Vitamin C is an essential nutrient for the adequate function and maturation of the immune system. In vitro studies show that the development, proliferation, and functioning of T cells requires vitamin C, especially for natural killer (NK) cells. Their deficiency during the acute phase post-transplantation could cause greater morbidity and mortality in these patients. A prospective clinical trial using high-dose vitamin C was performed to determine if vitamin C supplementation improves reconstitution of NK lymphocytes after hematopoietic stem cell transplantation (HSCT).\u0000\u0000\u0000MATERIALS AND METHODS\u0000We enrolled 24 patients who underwent autologous HSCT for multiple myeloma and lymphoma. Patients were randomized to receive standard treatment or standard treatment plus 20 g vitamin C once daily (1 - 10 days) and 500 mg twice daily (11 - 100 days) after transplantation.\u0000\u0000\u0000RESULTS\u0000NK and CD3+ lymphocytes showed an increase from days +30 to +100 only in the vitamin C-treated group. Patients in the vitamin C group had a lower frequency of infections. No severe adverse events were reported.\u0000\u0000\u0000CONCLUSION\u0000Our results suggest that high-dose vitamin C supplementation is an effective and safe therapeutic option to decrease the frequency of infections and enhance immune reconstitution after HSCT.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48212662","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
Adverse reaction profile of sulfasalazine and its persistence in chronic therapy of rheumatoid arthritis and spondyloarthritis: A multicentric observational study. 磺胺吡啶在类风湿性关节炎和脊椎关节炎慢性治疗中的不良反应及其持续性:一项多中心观察性研究。
IF 0.8 4区 医学
International journal of clinical pharmacology and therapeutics Pub Date : 2022-06-17 DOI: 10.5414/CP204120
Mamatha Jayachandran, V. Koshy, Rosme David, Vanditha Santhakumari, D. Padmanabhan, S. Surendran, ArunKr. Tiwari, C. Mithun, S. Singh, Saroj Kumar Suman, P. Yadav, A. Singhal, A. Nair, V. Marwaha, P. Palatty
{"title":"Adverse reaction profile of sulfasalazine and its persistence in chronic therapy of rheumatoid arthritis and spondyloarthritis: A multicentric observational study.","authors":"Mamatha Jayachandran, V. Koshy, Rosme David, Vanditha Santhakumari, D. Padmanabhan, S. Surendran, ArunKr. Tiwari, C. Mithun, S. Singh, Saroj Kumar Suman, P. Yadav, A. Singhal, A. Nair, V. Marwaha, P. Palatty","doi":"10.5414/CP204120","DOIUrl":"https://doi.org/10.5414/CP204120","url":null,"abstract":"OBJECTIVES\u0000Sulfasalazine has been widely used in treatment of rheumatoid arthritis and spondyloarthritis. This study aims to assess persistence with sulfasalazine and also frequency and severity of adverse drug reactions (ADRs) encountered with this very well-established disease-modifying anti-rheumatoid drug.\u0000\u0000\u0000MATERIALS AND METHODS\u0000This retrospective study was done in 1,114 patients from medicine and rheumatology outpatient departments of six centers across India. The inclusion criteria was patients taking sulfasalazine. Patients receiving sulfasalazine for rheumatoid arthritis or spondyloarthritis were selected and details on drugs used, duration of taking sulfasalazine, ADRs to sulfasalazine and whether sulfasalazine had to be stopped due to ADRs were analyzed.\u0000\u0000\u0000RESULTS\u0000Of the total of patients included in the study, 10.1% had ADRs with sulfasalazine, and stopped the drug. Gastritis, deranged liver enzymes, hepatitis, skin rashes were the most commonly encountered ADRs. Of the total number of patients recruited for the study, 11% were lost to follow-up, as most of the centers were army hospitals and the officers and staff were posted to other places. Sulfasalazine was taken for less than 1 month by 3.8% patients while 12.5% had taken the drug for less than 6 months. Of the study patients, 28.6% had taken the drug for 24 - 60 months and 4.6% (51 patients) had taken it for more than 5 years. It was found that ADRs were most commonly encountered within the first year of using the drug, and persistence was seen in patients on long-term therapy.\u0000\u0000\u0000CONCLUSION\u0000Sulfasalazine is a safe option in chronic therapy of rheumatoid arthritis and spondyloarthritis. Although frequency of ADRs with patients taking sulfasalazine is minimal, it did necessitate the stoppage of drug. If not well tolerated, sulfasalazine would not have been continued for more than 12 months as evidenced from this study.","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47517682","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: 2
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