Gyógyszerészet 2021. november

A CMV fertőzés az egyik leggyakoribb allogén vérképző sejt-transzplantációt (hematopoietic cell transplantation, HCT) követő fertőzés típus. Míg intakt immunrendszerrel rendelkező betegnél a CMV fertőzés tünetmentesen vagy enyhe tünetekkel zajlik, a sugár- illetve kemoterápiával kezelt betegek esetében megnövekedett a fertőzés következményeként kialakuló súlyos betegség kockázata. A letermovir egy innovatív támadásponttal rendelkező, kizárólag CMV specificitású antivirális vegyület, amely gátolja az utódvírus DNS hasításához és csomagolásához szükséges CMV DNS termináz komplexet. A letermovir a világ első és idáig egyetlen gyógyszere, amely megakadályozza a csontvelő-átültetésben részt vevő betegek fertőzését egy gyakori vírussal, ami paradigmaváltást idéz elő a transzplantáció ezen területén, mivel bizonyítottan csökkenti a reinfekciók előfordulását, és a betegek mortalitását. A letermovir a klinikai és valós életbeli tapasztalatok alapján is jól tolerálható és hatékony. A 2017-es Európai irányelv a legerősebb, AI-es ajánlással látta el a letermovirt a CMV profilaxisában allogén HSCT-n átesett betegeknél.

Irodalom

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Barótfi Sz, Ács A: Prevymis (letermovir) – A breakthrough in preventing CMV infection in hematopoietic stem cell transplant recipients

In 2021 the Hungarian Experimental and Clinical Pharmacological Society has awarded the “Drug of the year” title to a drug (Prevymis/letermovir – MSD) that brought significant breakthrough in the prevention of CMV infection in patients who underwent hematopoietic stem cell transplantation. In hematopoietic stem cell transplant (HSCT) recipients there are a number of virus infections has to be considered,  including cytomegalovirus (CMV), which is a beta-herpesvirus that remains dormant in the human body after infection for life. Although CMV is benign in patients with intact immune function, patients with compromised immune systems such as those treated with radiation or chemotherapy before HSCT are at significantly increased risk of CMV infection, which can lead to direct and indirect clinical complications associated with increased morbidity and mortality. Letermovir is a novel antiviral agent which targets the DNA terminal transferase complex of the cytomegalovirus (CMV), which is required for viral DNA processing and packaging, and which is used to prevent CMV reactivation in immunocompromised patients. This mechanism of action differs from that of previously available agents and does not lead to the development of cross resistance. According to the phase III study results, the drug is well tolerated, without side effects previously seen with anti-CMV agents, such as myelosuppression and nephrotoxicities. Letermovir was associated with a statistically significant reduction when compared with placebo for the prevention of clinically significant CMV infection through week 24 post-transplant. Currenty letermovir is the only CMV-specific prophylactic agent, that has clinical and real-life evidence supporting it’s effectiveness and tolerability. The ECIL-7 guidelines recommend the letermovir for the prevention of CMV in adult seropositive allogeneic HSCT patients, which is really a shift in the standard of care for these medically complex patients.

Az elhízás népegészségügyi jelentőségű probléma hazánkban. A testtömegkontrollt segítheti a gyógyszeres kezelés, a folyékony étkezéshelyettesítők és az étrend-kiegészítők alkalmazása, amelyek közül az utóbbiak nagy számban és változatos hatóanyag-tartalommal kerülnek forgalomba. A jelen tanulmány keretében áttkintetésre kerül a jelenleg forgalmazott, súlycsökkenést ígérő gyógyhatású-, illetve gyógynövénykészítmények hatékonysága és biztonságossága. Az eddigi vizsgálatok eredményei nem támasztották alá minden kétséget kizáróan a vizsgált természetes eredetű és szintetikusan előállított, étrend-kiegészítőként forgalmazott testsúlycsökkentést célzó szerek hatásosságát és biztonságosságát: ahol a vizsgálatokban statisztikailag szignifikáns hatást találtak (pl. króm, L-karnitin), ott a hatás nagysága nem volt jelentős, vagy súlyos mellékhatások jelentkeztek (ephedra, Hoodia gordonii). Klinikailag szignifikáns, vagyis legalább 5%-os testsúlycsökkenést egyik hatóanyag esetében sem tapasztaltak. További, longitudinális kutatások szükségesek a fogyást támogató hatóanyagok tekintetében. Mindezen ismeretek elősegítik az ilyen készítmények alkalmazása iránt érdeklődő páciensek hiteles tájékoztatását.

Irodalom

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Kalecz RD, Czeglédi E: Supporting weight control in the pharmacy

Obesity is a public health problem in Hungary. Weight control can be supported by medication, liquid meal replacements, and dietary supplements. The latter are marketed in large numbers and with a variety of active ingredient contents. In the present study, the efficacy and safety of currently marketed weight loss and herbal preparations are reviewed. Results of studies to date have not conclusively substantiated the efficacy and safety of the natural and synthetically produced weight loss agents tested as dietary supplements. Where studies found a statistically significant effect (eg. chromium, L-carnitine), the magnitude of the effect was not significant or severe side effects occurred (ephedra, Hoodia gordonii). No clinically significant weight loss of at least 5%, was observed with either active substance. Further longitudinal research is needed on weight loss agents. Knowledge of all this information will help to provide credible information to patients interested in using such products.