Předběžné modelování odchylky nákladů pro porovnání autologní intraovariální plazmy bohaté na trombocyty a standardní hormonální substituční terapie při menopauze
Authors:
Sills S. E. 1,2; Tan L. S. 3,4
Authors‘ workplace:
Montréal, Quebec, Canada
; Escondido, California, USA
; San Clemente, California, USA
; Reproductive Research Section, FertiGen/ CAG
1; Department of Obstetrics and Gynecology, Palomar Medical Center
2; OriginElle Fertility Clinic
3; Department of Obstetrics and Gynecology, McGill University Health Centre
4
Published in:
Ceska Gynekol 2022; 87(1): 28-34
Category:
Original Article
doi:
https://doi.org/10.48095/cccg202228
Overview
Úvod: Příznaky menopauzy a hormonální substituční terapie (HRT) patří mezi nejčastější důvody, proč pacientky přichází ke gynekologovi. Ačkoli ve vyspělých zemích v průběhu života HRT užívá nejméně polovina všech žen, s léčbou jsou spojena rizika a doporučené postupy se různí. Větší povědomí o rizicích HRT při dlouhodobém užívání vyvolalo zájem o „bezpečnější alternativy“. Do popředí se tak dostalo zmírnění příznaků menopauzy pomocí autologního intraovariálního podání plazmy bohaté na trombocyty (OPRP), jehož vhodnost a nákladovou efektivitu je však nutné prozkoumat. Metody: Kumulativní roční náklady na pacientku byly na základě údajů o HRT a OPRP z USA porovnány pomocí stochastického modelování metodou Monte Carlo. Výsledky: Střední hodnota ± SD nákladů na pacientku pro HRT, zahrnující úvodní konzultaci a opakované vydání v lékárně, byla odhadnuta jako 576 ± 246 USD za rok. Ačkoli OPRP nemá lékárenskou složku, odhadované 4 návštěvy v průběhu jednoho roku v rámci udržování OPRP zahrnují ultrazvuk, flebotomii / zpracování vzorku, chirurgické vybavení a náklady na inkubaci / laboratoř. Střední hodnota ± SD nákladů pro OPRP byla 8 719 ± 4 911 USD za rok (p < 0,0001 vs. HRT, T-test). Horní hranice odhadu pro roční náklady na HRT a OPRP byla 1 341 USD, resp. 22 232 USD. Závěr: Ačkoli jsou HRT a OPRP v léčbě menopauzy podobně účinné a bezpečné, výrazně se liší v nákladové efektivitě. Pro většinu pacientek by OPRP byla pravděpodobně příliš komplexní, invazivní a drahá na to, aby mohla konkurovat HRT. Ačkoli je OPRP pro vybrané pacientky s menopauzou, které se zdráhají podstoupit HRT, zajímavou a s opatrností i užitečnou metodou, širší použití této léčby neplodnosti se v porovnání se standardními možnostmi HRT, které jsou momentálně na trhu, nezdá být efektivní.
Klíčová slova:
menopauza – alternativní léčba – plazma bohatá na trombocyty – náklady na zdravotní péči
Sources
1. Marjoribanks J, Farquhar C, Roberts H et al. Long-term hormone therapy for perimenopausal and postmenopausal women. Cochrane Database Syst Rev 2017; 1 (1): CD004143. doi: 10.1002/14651858.CD004143.pub5.
2. Thaung Zaw JJ, Howe PR, Wong RH. Postmenopausal health interventions: time to move on from the Women’s Health Initiative? Ageing Res Rev 2018; 48: 79–86. doi: 10.1016/j.arr.2018.10.005.
3. Donovitz GS. Society position statements on bio-identical hormones-misinformation leads to a dilemma in women’s health. Healthcare (Basel) 2021; 9 (7): 782. doi: 10.3390/healthcare9070 782.
4. Majumdar SR, Almasi EA, Stafford RS. Promotion and prescribing of hormone therapy after report of harm by the Women’s Health Initiative. JAMA 2004; 292 (16): 1983–1988. doi: 10.1001/jama.292.16.1983.
5. Hing E, Brett KM. Changes in U.S. prescribing patterns of menopausal hormone therapy, 2001–2003. Obstet Gynecol 2006; 108 (1): 33–40. doi: 10.1097/01.AOG.0000220502.77153.5a.
6. Krzyżanowska M, Górecka K. Women‘s knowledge on the menopausal transition in relation to their socio-economic status. Prz Menopauzalny 2021; 20 (2): 81–87. doi: 10.5114/pm. 2021.106891.
7. Vance DA. Premarin: the intriguing history of a controversial drug. Int J Pharm Compd 2007; 11 (4): 282–286.
8. Santoro N, Liss J. Compounded bioidentical hormones: myths and realities. Clin Obstet Gynecol 2021; 64 (4): 793–802. doi: 10.1097/ GRF.0000000000000650.
9. Pantos K, Nitsos N, Kokkali G et al. Ovarian rejuvenation and folliculogenesis reactivation in peri-menopausal women after autologous platelet-rich plasma treatment [abstract]. Hum Reprod 2016; Suppl: P401. Available from: https: //sa1s3.patientpop.com/ assets/docs/111052.pdf.
10. Sfakianoudis K, Simopoulou M, Nitsos N et al. Autologous platelet-rich plasma treatment enables pregnancy for a woman in premature menopause. J Clin Med 2018; 8 (1): 1. doi: 10.3390/jcm8010001.
11. Farimani M, Heshmati S, Poorolajal J et al. A report on three live births in women with poor ovarian response following intra-ovarian injection of platelet-rich plasma (PRP). Mol Biol Rep 2019; 46 (2): 1611–1616. doi: 10.1007/s11033-019-04609-w.
12. Pantos K, Simopoulou M, Pantou A et al. A case series on natural conceptions resulting in ongoing pregnancies in menopausal and prematurely menopausal women following platelet-rich plasma treatment. Cell Transplant 2019; 28 (9–10): 1333–1340. doi: 10.1177/0963689719859539.
13. Morris E, Currie H. UK HRT shortages, how can this be good for anybody? Post Reprod Health 2020; 26 (1): 3–4. doi: 10.1177/2053 369120910693.
14. Chalouhi S. Menopause: a complex and controversial journey. Post Reprod Health 2017; 23 (3): 128–131. doi: 10.1177/2053369117711346.
15. Cumming GP, Currie H, Morris E et al. The need to do better – are we still letting our patients down and at what cost? Post Reproductive Health 2015; 21 (2): 56–62. doi: 10.1177/2053369115586122.
16. Latalski M, Walczyk A, Fatyga M et al. Allergic reaction to platelet-rich plasma (PRP): case report. Medicine (Baltimore) 2019; 98 (10): e14702. doi: 10.1097/MD.0000000000014702.
17. McPherson T, Fontane P, Bilger R. Patient experiences with compounded medications. J Am Pharm Assoc (2003) 2019; 59 (5): 670.e2–677.e2. doi: 10.1016/j.japh.2019.05.005.
18. Huntley AL. Compounded or confused? Bioidentical hormones and menopausal health. Menopause Int 2011; 17 (1): 16–18. doi: 10.1258/mi.2011.011009.
19. Atkinson L, Martin F, Sturmey RG. Intraovarian injection of platelet-rich plasma in assisted reproduction: too much too soon? Hum Reprod 2021; 36 (7): 1737–1750. doi: 10.1093/ humrep/deab106.
20. Sills ES, Rickers NS, Petersen JL et al. Regenerative effect of intraovarian injection of autologous platelet rich plasma: serum anti-Mullerian hormone levels measured among poor-prognosis in vitro fertilization patients. Int J Regenerative Med 2020; 3: 1–5. doi: 10.31487/j.RGM.2020.01.02.
21. Ahmadian S, Sheshpari S, Pazhang M et al. Intra-ovarian injection of platelet-rich plasma into ovarian tissue promoted rejuvenation in the rat model of premature ovarian insufficiency and restored ovulation rate via angiogenesis modulation. Reprod Biol Endocrinol 2020; 18 (1): 78. doi: 10.1186/s12958-020-00638-4.
22. Cagnacci A, Venier M. The controversial history of hormone replacement therapy. Medicina (Kaunas) 2019; 55 (9): 602. doi: 10.3390/medicina55090602.
23. Rozenberg S, Al-Daghri N, Aubertin-Leheudre M et al. Is there a role for menopausal hormone therapy in the management of postmenopausal osteoporosis? Osteoporosis Int 2020; 31 (12): 2271–2286. doi: 10.1007/s00198-020-05 497-8.
24. Sills ES, Li X, Rickers NS et al. Metabolic and neurobehavioral response following intraovarian administration of autologous activated platelet rich plasma: first qualitative data. Neuro Endocrinol Lett 2019; 39 (6): 427–433. Available from: https: //www.nel.edu/userfiles/articlesnew/1553033179_39_6_sills_427-pdf.pdf.
25. Allied Market Research. HRT market analysis. 2021 [online]. Available from: https: //www.alliedmarketresearch.com/hormone-replacement-therapy-market-A09508.
26. Sills ES, Wood SH. Progress in human ovarian rejuvenation: current platelet-rich plasma and condensed cytokine research activity by scope and international origin. Clin Exp Reprod Med 2021; 48 (4): 311–315. doi: 10.5653/cerm.2021.04651.
27. Masler S, Strickland RR. The role of management in an in vitro fertilization practice. Semin Reprod Med 2013; 31 (3): 204–210. doi: 10.1055/s-0033-1336601.
28. Sheyn D, Mahajan S, Billow M et al. Geographic variance of cost associated with hysterectomy. Obstet Gynecol 2017; 129 (5): 844–853. doi: 10.1097/AOG.0000000000001966.
29. Samsioe G, Dvorak V, Genazzani AR et al. One-year endometrial safety evaluation of a continuous combined transdermal matrix patch delivering low-dose estradiol-norethisterone acetate in postmenopausal women. Maturitas 2007; 57 (2): 171–181. doi: 10.1016/j.maturitas.2007.01.001.
30. Chang CY, Tsai FJ, Chiou JS et al. Timing and dosage of and adherence to hormone replacement therapy and fracture risk in women with menopausal syndrome in Taiwan: a nested case-control study. Maturitas 2021; 146: 1–8. doi: 10.1016/j.maturitas.2020.12.010.
31. Storrs C. Is platelet-rich plasma an effective healing therapy? Sci Am 2009 [online]. Available from: https: //www.scientificamerican.com/article/platelet-rich-plasma-therapy-dennis-cardone-sports-medicine-injury/.
32. U.S. inflation calculator. 2021 [online]. Available from: https: //www.usinflationcalculator.com/.
33. Sourouni M, Zangger M, Honermann L et al. Assessment of the climacteric syndrome: a narrative review. Arch Gynecol Obstet 2021; 304 (4): 855–862. doi: 10.1007/s00404-021-06139-y.
34. Marino JM. Genitourinary syndrome of menopause. J Midwifery Womens Health 2021; 66 (6): 729–739. doi: 10.1111/jmwh.13277.
35. Kalmbach DA, Cheng P, Arnedt, JT et al. Improving daytime functioning, work performance, and quality of life in postmenopausal women with insomnia: comparing cognitive behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. J Clin Sleep Med 2019; 15 (7): 999–1010. doi: 10.5664/jcsm.7882.
36. Chiu HH, Tsao LI, Liu CY et al. The perimenopausal fatigue self-management scale is suitable for evaluating perimenopausal Taiwanese women’s vulnerability to fatigue syndrome. Healthcare (Basel) 2021; 9 (3): 336. doi: 10.3390/healthcare9030336.
37. Birkhäuser M. Climacteric depression and anxiety. Ther Umsch 2021; 78 (8): 427–434. doi: 10.1024/0040-5930/a001293.
38. Stute P, Wienges J, Koller AS et al. Cognitive health after menopause: does menopausal hormone therapy affect it? Best Pract Res Clin Endocrinol Metab 2021; 35 (6): 101565. doi: 10.1016/j.beem.2021.101565.
39. Conde DM, Verdade RC, Valadares AL et al. Menopause and cognitive impairment: a narrative review of current knowledge. World J Psychiatry 2021; 11 (8): 412–428. doi: 10.5498/wjp.v11.i8.412.
40. Kagan R, Shiozawa A, Epstein AJ et al. Impact of sleep disturbances on employment and work productivity among midlife women in the US SWAN database: a brief report. Menopause 2021; 28 (10): 1176–1180. doi: 10.1097/GME. 0000000000001834.
41. Sfakianoudis K, Simopoulou M, Grigoriadis S et al. Reactivating ovarian function through autologous platelet-rich plasma intraovarian infusion: pilot data on premature ovarian insufficiency, perimenopausal, menopausal, and poor responder women. J Clin Med 2020; 9 (6): 1809. doi: 10.3390/jcm9061809.
42. Merhi Z, Seckin S, Mouanness M. Intraovarian PRP injection improved hot flashes in a woman with very low ovarian reserve. Reprod Sci 2021; 29 (2): 614–619. doi: 10.1007/ s43032-021-00655-7.
43. Hormone replacement therapy cost. Cost Helper Health 2021 [online]. Available from: https: //health.costhelper.com/hormone-replacement-therapy.html#extres2.
44. Sills ES, Rickers NS, Wood SH. Intraovarian insertion of autologous platelet growth factors as cell-free concentrate: fertility recovery and first unassisted conception with term delivery at age over 40. Int J Reprod Biomed 2020; 18 (12): 1081–1086. doi: 10.18502/ijrm.v18i12.8030.
45. Petryk N, Petryk M. Ovarian rejuvenation through platelet-rich autologous plasma (PRP) – a chance to have a baby without donor eggs, improving the life quality of women suffering from early menopause without synthetic hormonal treatment. Reprod Sci 2020; 27 (11): 1975–1982. doi: 10.1007/s43032-020-00266-8.
Labels
Paediatric gynaecology Gynaecology and obstetrics Reproduction medicineArticle was published in
Czech Gynaecology
2022 Issue 1
Most read in this issue
- Pregnancy outcome prediction after embryo transfer based on serum human chorionic gonadotrophin concentrations
- Hand-foot-mouth disease in puerperium
- Accuracy of the Edinburgh Postnatal Depression Scale in screening for major depressive disorder and other psychiatric disorders in women towards the end of their puerperium
- Indocyanine green as a new trend in sentinel lymphatic node detection in oncogynecology