The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
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Effect of 2.5 hr-interval single oral combination treatment of Gamisoyo-san with Tamoxifen on the pharmacokinetics profiles of Tamoxifen in rats

  • Kim, Joo-Ik (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Ku, Sae-Kwang (Department of Anatomy and Histology, College of Korean Medicine, Daegu Haany University) ;
  • Lee, Young-Joon (Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University)
  • Received : 2020.09.15
  • Accepted : 2020.11.15
  • Published : 2020.12.01
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Abstract

Objectives: Objectives: The object of this study was to elucidate the possible effects on the pharmacokinetics of tamoxifen after single oral co-administration of Gamisoyo-san (GMSYS) with 2.5 hr-intervals combination therapy of tamoxifen with GMSYS. Methods: After 2.5 hr of 50 mg/kg of tamoxifen treatment, GMSYS 100 mg/kg was administered. The plasma was collected at 30 min before administration, 30 min, 1, 2, 3, 4, 6, 8 and 24 hrs after end of GMSYS treatment, and plasma concentrations of tamoxifen were analyzed using LC-MS/MS methods. PK parameters of tamoxifen were analysis as compared with tamoxifen single administered rats. Results: Although single co-administration with GMSYS with 2.5 hr-interval induced increased trends of plasma tamoxifen concentrations, there are no significant changes on the plasma concentrations of tamoxifen were demonstrated in tamoxifen and GMSYS 100 mg/kg co-administrated rats with 2.5 hr-intervals as compared to those of tamoxifen single 50 mg/kg treated rats, and also GMSYS co-administrated rats did not showed any significant changes on the all pharmacokinetic parameters as compared to those of tamoxifen single formula treated rats. Conclusions: According to the this study, single co-administration of GMSYS with 2.5 hr-intervals did not critically influenced on the oral bioavailability of tamoxifen, suggesting GMSYS did not critically influenced on the absorption and excretion of tamoxifen, the oral bioavailability, when they were co-administered with 2.5 hr-intervals, at the dose levels of tamoxifen 50 mg/kg and GMSYS 100 mg/kg.

Keywords

Acknowledgement

This work was supported by grant of Korea of Health & Welfare, Republic of Korea (Project No: 20-11-0-090-091-3000-3033-320).

References

  1. Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, et al., Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. Journal of the National Cancer Institute, 1998;90(18):1371-1388. https://doi.org/10.1093/jnci/90.18.1371
  2. Lerner HJ, Band PR, Israel L, Leung BS, Phase II study of tamoxifen: report of 74 patients with stage IV breast cancer. Cancer treatment reports, 1976;60(10):1431-1435.
  3. Zeneca Pharmaceuticals, Nolvadex (tamoxifen citrate) prescribing information. 1998.
  4. Braems G, Denys H, De Wever O, Cocquyt V, Van den Broecke R, Use of tamoxifen before and during pregnancy. The oncologist, 2011;16(11):1547-1551. https://doi.org/10.1634/theoncologist.2011-0121
  5. Karn A, Jha AK, Shrestha S, Acharya B, Poudel S, Bhandari RB, Tamoxifen for breast cancer. JNMA; journal of the Nepal Medical Association, 2010;49(177):62-67.
  6. Notley LM, Crewe KH, Taylor PJ, Lennard MS, Gillam EM, Characterization of the human cytochrome P450 forms involved in metabolism of tamoxifen to its α-hydroxy and α,4-dihydroxy derivatives. Chemical research in toxicology, 2005;18(10):1611-1618. https://doi.org/10.1021/tx050140s
  7. Lien EA, Anker G, Lonning PE, Solheim E, Ueland PM, Decreased serum concentrations of tamoxifen and its metabolites induced by aminoglutethimide. Cancer research, 1990;50(18):5851-5857.
  8. Ritchie LD, Grant SM, Tamoxifen-warfarin interaction: the Aberdeen hospitals drug file. BMJ (Clinical research ed.), 1989;298(6682):1253. https://doi.org/10.1136/bmj.298.6682.1253
  9. Lamberts SW, Verleun T, Hofland L, Oosterom R, Differences in the interaction between dopamine and estradiol on prolactin release by cultured normal and tumorous human pituitary cells. The Journal of clinical endocrinology and metabolism, 1986;63(6):1342-1347. https://doi.org/10.1210/jcem-63-6-1342
  10. Dowsett M, Pfister C, Johnston SR, Miles DW, Houston SJ, Verbeek JA, et al., Impact of tamoxifen on the pharmacokinetics and endocrine effects of the aromatase inhibitor letrozole in postmenopausal women with breast cancer. Clinical cancer research : an official journal of the American Association for Cancer Research, 1999;5(9):2338-2343.
  11. Reid AD, Horobin JM, Newman EL, Preece PE, Tamoxifen metabolism is altered by simultaneous administration of medroxyprogesterone acetate in breast cancer patients. Breast cancer research and treatment, 1992;22(2):153-156. https://doi.org/10.1007/bf01833345
  12. Dehal SS, Brodie AM, Kupfer D, The aromatase inactivator 4-hydroxyandrostenedione (4-OH-A) inhibits tamoxifen metabolism by rat hepatic cytochrome P-450 3A: potential for drug-drug interaction of tamoxifen and 4-OH-A in combined anti-breast cancer therapy. Drug metabolism and disposition: the biological fate of chemicals, 1999;27(3):389-394.
  13. West CM, Reeves SJ, Brough W, Additive interaction between tamoxifen and rifampicin in human biliary tract carcinoma cells. Cancer letters, 1990;55(2):159-163. https://doi.org/10.1016/0304-3835(90)90027-U
  14. Williams JA, Ring BJ, Cantrell VE, Jones DR, Eckstein J, Ruterbories K, et al., Comparative metabolic capabilities of CYP3A4, CYP3A5, and CYP3A7. Drug metabolism and disposition: the biological fate of chemicals, 2002;30(8):883-891. https://doi.org/10.1124/dmd.30.8.883
  15. Terauchi M, Hiramitsu S, Akiyoshi M, Owa Y, Kato K, Obayashi S, et al., Effects of three Kampo formulae: Tokishakuyakusan (TJ-23), Kamishoyosan (TJ-24), and Keishibukuryogan (TJ-25) on Japanese peri- and postmenopausal women with sleep disturbances. Archives of gynecology and obstetrics, 2011;284(4):913-921. https://doi.org/10.1007/s00404-010-1779-4
  16. Hidaka T, Yonezawa R, Saito S, Kami-shoyo-san, Kampo (Japanese traditional medicine), is effective for climacteric syndrome, especially in hormone-replacement-therapy-resistant patients who strongly complain of psychological symptoms. The journal of obstetrics and gynaecology research, 2013; 39(1):223-228. https://doi.org/10.1111/j.1447-0756.2012.01936.x
  17. Kimura Y, Takamatsu K, Fujii A, Suzuki M, Chikada N, Tanada R, et al., Kampo therapy for premenstrual syndrome: efficacy of Kamishoyosan quantified using the second derivative of the fingertip photoplethysmogram. The journal of obstetrics and gynaecology research, 2007;33(3):325-332. https://doi.org/10.1111/j.1447-0756.2007.00531.x
  18. Qu Y, Gan HQ, Mei QB, Liu L, Study on the effect of Jia-Wei-Xiao-Yao-San decoction on patients with functional dyspepsia. Phytotherapy research : PTR, 2010;24(2): 245-248. https://doi.org/10.1002/ptr.2920
  19. Ishikawa T, Funahashi T, Kudo J, Effectiveness of the Kampo kami-shoyo-san (TJ-24) for tremor of antipsychotic-induced parkinsonism. Psychiatry and clinical neurosciences, 2000;54(5):579-582. https://doi.org/10.1046/j.1440-1819.2000.00756.x
  20. Kim JI, Ku SK, Lee YJ, Effect of the Single Oral Combination Treatment of Tamoxifen with Gamisoyo-san on the Pharmacokinetics Profiles of Tamoxifen. J Physiol & Pathol Korean Med, 2020;34(4):201-208. https://doi.org/10.15188/kjopp.2020.08.34.4.201
  21. Gibaldi M, Perrier D, Pharmacokinetics. 2nd ed. Taylor & Francis. 1982.
  22. Chiou WL, Critical evaluation of the potential error in pharmacokinetic studies of using the linear trapezoidal rule method for the calculation of the area under the plasma level-time curve. Journal of pharmacokinetics and biopharmaceutics, 1978;6(6):539-546. https://doi.org/10.1007/BF01062108
  23. Adam HK, Patterson JS, Kemp JV, Studies on the metabolism and pharmacokinetics of tamoxifen in normal volunteers. Cancer treatment reports, 1980;64(6-7):761-764.
  24. Murphy C, Fotsis T, Pantzar P, Adlercreutz H, Martin F, Analysis of tamoxifen and its metabolites in human plasma by gas chromatography-mass spectrometry (GC-MS) using selected ion monitoring (SIM). Journal of steroid biochemistry, 1987;26(5):547-555. https://doi.org/10.1016/0022-4731(87)90006-9
  25. Jordan VC, Metabolites of tamoxifen in animals and man: identification, pharmacology, and significance. Breast cancer research and treatment, 1982;2(2):123-138. https://doi.org/10.1007/BF01806449
  26. Sun D, Sharma AK, Dellinger RW, Blevins -Primeau AS, Balliet RM, Chen G, et al., Glucuronidation of active tamoxifen metabolites by the human UDP glucuronosyltransferases. Drug metabolism and disposition: the biological fate of chemicals, 2007;35(11):2006-2014. https://doi.org/10.1124/dmd.107.017145
  27. AstraZeneca Pharmaceuticals, Nolvadex (tamoxifen citrate) prescribing information. 2003.
  28. Vehmanen L, Elomaa I, Blomqvist C, Saarto T, Tamoxifen treatment after adjuvant chemotherapy has opposite effects on bone mineral density in premenopausal patients depending on menstrual status. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006;24(4):675-680. https://doi.org/10.1200/JCO.2005.02.3515
  29. Grilli S, Tamoxifen (TAM): the dispute goes on. Annali dell'Istituto superiore di sanita, 2006;42(2):170-173.
  30. Decensi A, Maisonneuve P, Rotmensz N, Bettega D, Costa A, Sacchini V, et al., Effect of tamoxifen on venous thromboembolic events in a breast cancer prevention trial. Circulation, 2005;111(5):650-656. https://doi.org/10.1161/01.CIR.0000154545.84124.AC
  31. Osman KA, Osman MM, Ahmed MH, Tamoxifen-induced non-alcoholic steatohepatitis: where are we now and where are we going? Expert opinion on drug safety, 2007;6(1):1-4. https://doi.org/10.1517/14740338.6.1.1
  32. Paganini-Hill A, Clark LJ, Preliminary assessment of cognitive function in breast cancer patients treated with tamoxifen. Breast cancer research and treatment, 2000;64(2):165-176. https://doi.org/10.1023/A:1006426132338
  33. Eberling JL, Wu C, Tong-Turnbeaugh R, Jagust WJ, Estrogen- and tamoxifen-associated effects on brain structure and function. NeuroImage, 2004;21(1):364-371. https://doi.org/10.1016/j.neuroimage.2003.08.037
  34. Cella D, Fallowfield L, Barker P, Cuzick J, Locker G, Howell A, et al., Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast cancer research and treatment, 2006;100(3):273-284. https://doi.org/10.1007/s10549-006-9260-6
  35. Karimian E, Chagin AS, Gjerde J, Heino T, Lien EA, Ohlsson C, et al., Tamoxifen impairs both longitudinal and cortical bone growth in young male rats. Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2008;23(8):1267-1277. https://doi.org/10.1359/jbmr.080319
  36. Nalbandian G, Paharkova-Vatchkova V, Mao A, Nale S, Kovats S, The selective estrogen receptor modulators, tamoxifen and raloxifene, impair dendritic cell differentiation and activation. Journal of immunology (Baltimore, Md. : 1950), 2005;175(4):2666-2675. https://doi.org/10.4049/jimmunol.175.4.2666
  37. Rousset-Jablonski C, Thalabard JC, Gompel A, Tamoxifen contraindicated in women with hereditary angioedema? Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, 2009;20(7):1281-1282. https://doi.org/10.1093/annonc/mdp295
  38. Kwak MA, Park SJ, Park SH, Lee YJ, Ku SK, Effect of Jaeumkanghwatang (JEKHT), a Polyherbal Formula on the Pharmacokinetics Profiles of Tamoxifen in Male SD Rats (1) - Single Oral Combination Treatment of Tamoxifen 50 mg/kg with JEKHT 100 mg/kg within 5 min -. J Korean Med, 2016;37(2):1-11. https://doi.org/10.13048/jkm.16016
  39. Park SJ, Kwak MA, Park SH, Lee YJ, Ku SK, Effect of Jaeumkanghwatang (JEKHT), a Polyherbal Formula on the Pharmacokinetics Profiles of Tamoxifen in Male SD Rats (2) - Oral Combination Treatment of Tamoxifen 50 mg/kg with JEKHT 100 mg/kg on JEKHT 6-day Repeated Pretreated Rats with 8-day Repeated. J Soc Prev Korean Med, 2016;20(2):97-109.