OncohematologyOncohematologyОнкогематология1818-83462413-4023Publishing House ABV Press754PHARMACOTHERAPYФАРМАКОТЕРАПИЯOsteodestruction markers and quality of life parameters at pomegara (pamidronate) treatment in multiple myeloma patients with lytic bone lesionsМаркеры остеодеструкции и показатели качества жизни при применении помегары (памидронат) у больных множественной миеломой с литическими костными поражениямиLuninV. V.ЛунинВ. В.
Russian Federation

Moscow

Москва

YurovaYe. V.ЮроваЕ. В.
Russian Federation

Moscow

Москва

KudryavtsevaO. A.КудрявцеваО. А.
Russian Federation

Moscow

Москва

MinenkoS. V.МиненкоС. В.
Russian Federation

Moscow

Светлана Владимировна Миненко

отдел подростковой и возрастной гематологии и онкологии ФГУ Федеральный научно-клинический центр детской гематологии, онкологии и иммунологии

Москва

svetlanaminenko@yandex.ruPtushkinV. V.ПтушкинВ. В.
Russian Federation

Moscow

отдел подростковой и возрастной гематологии и онкологии ФГУ Федеральный научно-клинический центр детской гематологии, онкологии и иммунологии

Москва

Botkin Municipal Clinical HospitalГКБ им. С. П. БоткинаFederal Research Center of Pediatric Hematology, Oncology and ImmunologyМинздравсоцразвития России260820103525826112022261120222010https://oncohematology.abvpress.ru/ongm/article/view/754

   The aim of the given study is investigation of influence onosteodestruction markers and quality of life parameters of therapy with generic preparation of pamidronic acid (pomegara) in patients with multiple myeloma (MM) and lytic bone lesions.

   For this purpose prior to the beginning of the study and every 4 week after pomegara injection throughout 16 weeks blood СТХ (terminal crosslinking telopeptide of type I collagene) concentration and urine DPD (deoxypyridinoline) were detected. In addition monitoring of tumor symptoms intensity using MDASI (M.D. Anderson Symptom Inventory) and FACT (Functional Assessment of Cancer Therapy) questionnaires was conducted and pain intensity was also investigated using analogue scale. Study is finished in eighteen patients. Bone resorbtion markers (serum СТХ and urine DPD) have essential decreased after fourth pomegara injection to 33 % of median initial value for CTX (р < 0.05) and to 73 % – for DPD (р=ns). Statistically significant increasing of integrated quality of life parameter in comparison with initial value is registered by 12th week of treatment (р < 0.05). The majority of pomegara side effects were mild and moderate severity and preparation cancelling has not necessary. The frequency and spectrum of complications (fever, skeletal and muscular pain, etc.) corresponded to the similar parameters revealed in large controlled studies of bisphosphonate treatment in MM. Careful monitoring of renal function during pomegara treatment has not shown significant negative effect, including patients with initial renal involvement. According to data received in this restricted volume study we can conclude that pomegara treatment in patients with MM and lytic bone lesions result in decrease of bone destruction, quality of life improvement and decrease severity of pain. Drug acceptability did not principally differ from original pamidronate shown in controlled studies.

   Данное исследование проводилось с целью выявления влияния дженерического препарата памидроновой кислоты (помегара) на маркеры остеодеструкции и показатели качества жизни у пациентов с множественной миеломой и литическими поражениями костей.

   Для этого до начала исследования и через каждые 4 недели после введения помегары на протяжении 16 недель определялась концентрация СТХ крови и деоксипиридинолина мочи. Кроме этого у пациентов мониторировалась интенсивность симптоматики опухоли по опросникам MDASI и FACT и исследовалась выраженность болевого синдрома по аналоговой шкале. Восемнадцать пациентов закончили исследование. Показатели маркеров костной резорбции (СТХ в сыворотке крови и ДПИД в моче) существенно снизились после четвертой инъекции помегары, составив для СТХ 33 % от медианы его исходного значения (р < 0,05) и для ДПИД – 73 % (р = NS). Статистически значимое улучшение интегрального показателя качества жизни в сравнении с исходными показателями зарегистрировано к 12-й неделе лечения (р < 0,05). Большинство выявленных в исследовании побочных действий были легкой и промежуточной степени тяжести и не потребовали отмены препарата. Общая частота и спектр осложнений (лихорадка, скелетно-мышечные боли и др.) соответствовали аналогичным показателям, выявленным в крупных контролируемых исследованиях по применению бисфосфонатов при множественной миеломе. Тщательный мониторинг функции почек при терапии помегарой не показал существенного отрицательного влияния на почечную функцию, в том числе у больных с исходным ее поражением. Полученные в данном, ограниченном по объему, исследовании результаты позволяют сделать вывод о том, что применение помегары у пациентов с множественной миеломой и остеолитическими поражениями костей сопровождается снижением интенсивности остеодеструкции, улучшением качества жизни и снижением выраженности болевого синдрома. Переносимость препарата принципиально не отличалась от переносимости оригинального памидроната, показанного в контролируемых исследованиях.

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