Андрология и генитальная хирургия. 2023; 24: 91-99
Безопасность и потенциальная эффективность аутоплазмы, обогащенной тромбоцитарными факторами роста, и экстракорпоральной ударно-волновой терапии при лечении эректильной дисфункции у пациентов после нервосберегающей радикальной простатэктомии: пилотное исследование
https://doi.org/10.17650/2070-9781-2023-24-4-91-99Аннотация
Введение. Рак предстательной железы является наиболее распространенным видом рака у мужчин. Радикальная простатэктомия (РПЭ), в том числе нервосберегающая, часто приводит к эректильной дисфункции, значительному снижению качества жизни. Существующие методы лечения имеют ограниченную эффективность и/или не подходят пациентам.
Цель исследования – оценка безопасности и эффективности применения аутоплазмы, обогащенной тромбоцитарными факторами роста (АОТ), и экстракорпоральной ударно-волновой терапии (ЭУВТ) при лечении эректильной дисфункции у пациентов после нервосберегающей РПЭ.
Материалы и методы. В исследование включены 14 мужчин, перенесших одно- или двустороннюю робот-ассистированную нервосберегающую РПЭ более чем 3 мес назад. Уровень общего простатспецифического антигена у всех пациентов составил <0,2 нг/мл через 3 мес и более после операции. Возраст пациентов – 57,8 ± 6,2 (49–72) года, продолжительность эректильной дисфункции – 7,6 ± 3,9 (3–16) мес. Осуществлялось 2 визита в неделю на протяжении 6 нед: в 1-й визит выполняли ЭУВТ (Dornier Aries) на половой член (ПЧ) и инъекции АОТ в ПЧ и мышцы, участвующие в акте эрекции, в конце сеанса активировали АОТ с помощью ЭУВТ; во 2-й визит – ЭУВТ на ПЧ. Обследование проводили на 0-й и 60-й дни исследования с использованием опросников (международный индекс эректильной функции (МИЭФ-5), профиль половых отношений, шкала твердости эрекции, Global Assessment Questions (GAQ), International Prostate Symptom Score (IPSS), Quality of Life (QoL)), определением уровня общего тестостерона крови, выполнением фармакодопплерографии (ФДГ) сосудов ПЧ с аналогом простагландина Е1. Критерии включения в исследование: отсутствие метастазов в отдаленные органы, лимфатические узлы; стадия не более T3b; МИЭФ-5 <21 балла после РПЭ; PSV (пиковая систолическая скорость) <30 см/с и/или RI (индекс резистентности) <0,8 по данным ФДГ сосудов ПЧ с аналогом простагландина Е1 после РПЭ; наличие эрекций до РПЭ.
Результаты. Все пациенты переносили лечение удовлетворительно. Статистически значимое улучшение эректильной функции отмечено по данным МИЭФ-5 (р <0,05), профиля половых отношений (р = 0,002), шкалы твердости эрекции (р = 0,002). По опроснику GAQ 11 (78,5 %) пациентов отметили положительный эффект от лечения. Согласно результатам ФДГ сосудов ПЧ, показатели PSV и RI по обеим кавернозным артериям значимо возросли (р <0,05). Все пациенты отметили снижение дизурических явлений по опросникам IPSS (р = 0,007) и QoL (р = 0,58). Концентрация общего тестостерона крови – без значимой динамики (р = 0,192).
Заключение. Наблюдается положительная динамика в отношении значимого улучшения эректильной функции у всех пациентов по данным валидированных опросников и ФДГ сосудов ПЧ. Предложенное лечение является перспективным методом восстановления для данной категории пациентов. Продолжается исследование на большей выборке пациентов.
Список литературы
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2. EAU Guidelines. Edn. presented at the EAU Annual Congress Milan 2023.
3. Avulova S., Zhao Z., Lee D. et al. The effect of nerve sparing status on sexual and urinary function: 3-year results from the CEASAR study. J Urol 2018;199(5):1202–9. DOI: 10.1016/j.juro.2017.12.037
4. Ko Y.H., Coelho R.F., Sivaraman A. et al. Retrograde versus antegrade nerve sparing during robot-assisted radical prostatectomy: which is better for achieving early functional recovery? Eur Urol 2013;63(1):169–77. DOI: 10.1016/j.eururo.2012.09.051
5. Alemozaffar M., Duclos A., Hevelone N.D. et al. Technical refinement and learning curve for attenuating neurapraxia during robotic-assisted radical prostatectomy to improve sexual function. Eur Urol 2012;61(6):1222–8. DOI: 10.1016/j.eururo.2012.02.053
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7. Emanu J.C., Avildsen I.K., Nelson C.J. Erectile dysfunction after radical prostatectomy: prevalence, medical treatments, and psychosocial interventions. Curr Opin Support Palliat Care 2016;10(1):102–7. DOI: 10.1097/SPC.0000000000000195
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9. Gentile P., Di Pasquali C., Bocchini I. et al. Breast reconstruction with autologous fat graft mixed with platelet-rich plasma. Surg Innovat 2013;20(4):370–6. DOI: 10.1177/1553350612458544
10. Spartalis E.D., Tomos P., Dimitroulis D., Kouraklis G. Platelet-rich plasma in surgical oncology. Surg Innov 2014;21(4):441. DOI: 10.1177/1553350613520516
11. Spartalis E.D., Tomos P., Konofaos P. et al. Breast reconstruction with autologous fat graft; does plateletrich plasma affect patient’s survival? Int J Clin Exp Med 2014;7(1):329–30. PMID: 24482728.
12. Guo X., Wu Y., Hathaway H.J., Hartley R.S. Microenvironmental control of the breast cancer cell cycle. Anat Rec (Hoboken) 2012;295(4):553–62. DOI: 10.1002/ar.22417
13. Levva S., Kotoula V., Kostopoulos I. et al. Prognostic evaluation of epidermal growth factor receptor (EGFR) genotype and phenotype parameters in triple-negative breast cancers. Cancer Genom Proteom 2017;14(3):181–95. DOI: 10.21873/cgp.20030
14. Spartalis E., Tsilimigras D.I., Charalampoudis P. et al. The “Yin and Yang” of platelet-rich plasma in breast reconstruction after mastectomy or lumpectomy for breast cancer. Anticancer Res 2017;37(12):6557–62. DOI: 10.1016/j.gene.2019.04.025
15. Luzo A.C.M., Fávaro W.J., Seabra A.B., Durán N. What is the potential use of platelet-rich-plasma (PRP) in cancer treatment? A mini review. Heliyon 2020;6(3):e03660. DOI: 10.1016/j.heliyon.2020.e03660
16. Eichler C., Baucks C., Üner J. et al. Platelet-rich plasma (PRP) in breast cancer patients: an application analysis of 163 sentinel lymph node biopsies. Biomed Res Int 2020;2020:3432987. DOI: 10.1155/2020/3432987
17. Ding X.G., Li S.W., Zheng X.M. et al. The effect of platelet-rich plasma on cavernous nerve regeneration in a rat model. Asian J Androl 2009;11(2):215–21. DOI: 10.1038/aja.2008.37
18. Wu C.C., Wu Y.N., Ho H.O. et al. The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. J Sex Med 2012;9(11):2838–48. DOI: 10.1111/j.1743-6109.2012.02881.x
19. Wu Y.N., Wu C.C., Sheu M.T. et al. Optimization of platelet-rich plasma and its effects on the recovery of erectile function after bilateral cavernous nerve injury in a rat model. J Tissue Eng Regen Med 2016;10(10):E294–E304. DOI: 10.1002/term.1806
20. Wu Y.N., Liao C.H., Chen K.C., Chiang H.S. Dual effect of chitosan activated platelet rich plasma (cPRP) improved erectile function after cavernous nerve injury. J Formos Med Assoc 2022;121(1Pt1):14–24. DOI: 10.1016/j.jfma.2021.01.019
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24. Banno J.J., Kinnick T.R., Roy L. et al. 146 the efficacy of platelet-rich plasma (PRP) as a supplemental therapy for the treatment of erectile dysfunction (ED): initial outcomes. J Sex Med 2017;14:e59–60. DOI: 10.1016/j.jsxm.2016.12.134
25. Matz E.L., Pearlman A.M., Terlecki R.P. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol 2018;59(1):61–5. DOI: 10.4111/icu.2018.59.1.61
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27. Zaghloul A.S., Mahmoud ElNashar A.E.R, GamalEl Din S.F. et al. Smoking status and the baseline international index of erectile function score can predict satisfactory response to platelet-rich plasma in patients with erectile dysfunction: a prospective pilot study. Andrologia 2021;53(9):e14162. DOI: 10.1111/and.14162
28. Taş T., Çakıroğlu B., Arda E. et al. Early clinical results of the tolerability, safety, and efficacy of autologous platelet-rich plasma administration in erectile dysfunction. Sex Med 2021;9(2):100313. DOI: 10.1016/j.esxm.2020.100313
29. Poulios E., Mykoniatis I., Pyrgidis N. et al. Platelet-rich plasma (PRP) improves erectile function: a double-blind, randomized, placebo-controlled clinical trial. J Sex Med 2021;18(5):926–35. DOI: 10.1016/j.jsxm.2021.03.008
30. Masterson T.A., Molina M., Ledesma B. et al. Platelet-rich plasma for the treatment of erectile dysfunction: a prospective, randomized, double-blind, placebo-controlled clinical trial. J Urol 2023;210(1):154–61. DOI: 10.1097/JU.0000000000003481
31. Geyik S. Comparison of the efficacy of low-intensity shock wave therapy and its combination with platelet-rich plasma in patients with erectile dysfunction. Andrologia 2021;53(10):e14197. DOI: 10.1111/and.14197
32. Ruffo A., Stanojevic N., Romeo G. et al. PS-5-3 Management of erectile dysfunction using a combination treatment of low-intensity shock waves (LISW) and platelet rich plasma (PRP) intracavernosal injections. J Sex Med 2020;17:S133–4. DOI: 10.1016/j.jsxm.2020.04.048
33. Ruffo A., Franco M., Illiano E., Stanojević N. Effectiveness and safety of Platelet rich Plasma (PrP) cavernosal injections plus external shock wave treatment for penile erectile dysfunction: first results from a prospective, randomized, controlled, interventional study. Eur Urol Suppl 2019;18(1):e1622–3. DOI: 10.1016/S1569-9056(19) 31175-3
34. Gettman M. A study evaluating intraoperative application of platelet-rich plasma to the neurovascular bundles during nerve-sparing radical prostatectomy: initial technical description and prospective early postoperative outcomes analysis. Available at: https://clinicaltrials.gov/ct2/show/NCT02957149
35. Rho B.Y., Kim S.H., Ryu J.K. et al. Efficacy of low-intensity extra-corporeal shock wave treatment in erectile dysfunction following radical prostatectomy: a systematic review and meta-analysis. J Clin Med 2022;11(10):2775. DOI: 10.3390/jcm11102775
Andrology and Genital Surgery. 2023; 24: 91-99
Safety and potential effectiveness of platelet-rich plasma and extracorporeal shock wave therapy in the treatment of erectile dysfunction after nerve-sparing radical prostatectomy in patients: pilot study
https://doi.org/10.17650/2070-9781-2023-24-4-91-99Abstract
Background. Prostate cancer is the most common type of cancer in men. Radical prostatectomy (RPE), including nerve-sparing, often leads to erectile dysfunction and a significant decrease in the quality of life. The available treatments are limited in effectiveness and/or are not suitable for patients.
Aim. The aim of the study was to evaluate the safety and effectiveness of platelet-rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) in the treatment of erectile dysfunction in patients after nerve-sparing RPE.
Materials and methods. 14 men were included in the study after unilateral or bilateral nerve-sparing RPE more than 3 months ago. The total prostate-specific antigen in all patients was less than 0.2 ng/ml 3 months or more after surgery. Age – 57.8 ± 6.2 (49–72) years, duration of erectile dysfunction – 7.6 ± 3.9 (3–16) months. Two visits per week were out for 6 weeks: in visit 1, the ESWT (Dornier Aries) was performed on penis and injections of PRP into the penis, the muscles involved in the erection were activated at the end of the session by ESWT, in visit 2, ESWT on penis. The examinations were performed on the 0 and 60 days of the study: International Index of Erectile Function (IIEF-5), Sexual Encounter Profile (SEP), Erection Hardness Score (EHS), Global Assessment Questionnaire (GAQ), International Prostate Symptom Score (IPSS), Quality of Life (QoL), total blood testosterone, to penile duplex Doppler ultrasonography (PDDU) with prostaglandin E1 analog. Inclusion criteria were absence of metastases to distant organs and lymph nodes; stage no more than T3b; IIEF-5 less than 21 points after RPE; PSV less than 30 cm/s and/or RI less than 0.8 according to the PDDU after RPE; the presence of erections before RPE.
Results. Treatment was tolerated satisfactorily for all patients. Significant improvement of erectile function was noted according to IIEF-5 (p <0.05), SEP (p = 0.002), EHS (p = 0.002). According to GAQ, 11 patients (78.5 %) noted a positive effect of treatment. PSV and RI in both cavernous arteries increased significantly (p <0.05) according PDDU. All patients noted a dysuria decrease based on IPSS (p = 0.007) and QoL (p = 0.58). The concentration of total testosterone in the blood without significant dynamics (p = 0.192).
Conclusion. There are positive effects in relation to a significant improvement in erectile function in all patients according to validated questionnaires and PDDU. The proposed treatment is a promising method of restoring patient data. The study continues on a larger sample of patients.
References
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24. Banno J.J., Kinnick T.R., Roy L. et al. 146 the efficacy of platelet-rich plasma (PRP) as a supplemental therapy for the treatment of erectile dysfunction (ED): initial outcomes. J Sex Med 2017;14:e59–60. DOI: 10.1016/j.jsxm.2016.12.134
25. Matz E.L., Pearlman A.M., Terlecki R.P. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol 2018;59(1):61–5. DOI: 10.4111/icu.2018.59.1.61
26. Shin-Mei W., Bing-Juin C., Hui-Chun C. et al. Short term follow up for intracavernosal injection of platelet rich plasma for the treatment of erectile dysfunction. Urol Sci 2021;32(4):171–6. DOI: 10.4103/UROS.UROS_22_21
27. Zaghloul A.S., Mahmoud ElNashar A.E.R, GamalEl Din S.F. et al. Smoking status and the baseline international index of erectile function score can predict satisfactory response to platelet-rich plasma in patients with erectile dysfunction: a prospective pilot study. Andrologia 2021;53(9):e14162. DOI: 10.1111/and.14162
28. Taş T., Çakıroğlu B., Arda E. et al. Early clinical results of the tolerability, safety, and efficacy of autologous platelet-rich plasma administration in erectile dysfunction. Sex Med 2021;9(2):100313. DOI: 10.1016/j.esxm.2020.100313
29. Poulios E., Mykoniatis I., Pyrgidis N. et al. Platelet-rich plasma (PRP) improves erectile function: a double-blind, randomized, placebo-controlled clinical trial. J Sex Med 2021;18(5):926–35. DOI: 10.1016/j.jsxm.2021.03.008
30. Masterson T.A., Molina M., Ledesma B. et al. Platelet-rich plasma for the treatment of erectile dysfunction: a prospective, randomized, double-blind, placebo-controlled clinical trial. J Urol 2023;210(1):154–61. DOI: 10.1097/JU.0000000000003481
31. Geyik S. Comparison of the efficacy of low-intensity shock wave therapy and its combination with platelet-rich plasma in patients with erectile dysfunction. Andrologia 2021;53(10):e14197. DOI: 10.1111/and.14197
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34. Gettman M. A study evaluating intraoperative application of platelet-rich plasma to the neurovascular bundles during nerve-sparing radical prostatectomy: initial technical description and prospective early postoperative outcomes analysis. Available at: https://clinicaltrials.gov/ct2/show/NCT02957149
35. Rho B.Y., Kim S.H., Ryu J.K. et al. Efficacy of low-intensity extra-corporeal shock wave treatment in erectile dysfunction following radical prostatectomy: a systematic review and meta-analysis. J Clin Med 2022;11(10):2775. DOI: 10.3390/jcm11102775
