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　　導(dǎo)讀：來(lái)自夏威夷大學(xué)癌癥中心進(jìn)行的一項(xiàng)膀胱癌藥物臨床試驗(yàn)已經(jīng)越來(lái)越接近FDA的批準(zhǔn)標(biāo)準(zhǔn)了，這種名為白介素15超拮抗劑復(fù)合物（ALT-803）的新型藥物可以同卡介苗結(jié)合，有望有效治療非肌層浸潤(rùn)性的膀胱癌患者，而非肌層浸潤(rùn)性膀胱癌是目前最為常見(jiàn)的一種膀胱癌。

　　研究者Charles Rosser表示，上一次FDA批準(zhǔn)膀胱癌藥物還是幾乎20年前的事兒了，目前膀胱癌療法并沒(méi)有太大進(jìn)展，自從上世紀(jì)80年代以來(lái)卡介苗一直是用于治療膀胱癌的藥物，而如今科學(xué)研究領(lǐng)域改變?nèi)绱酥�大，我們最終或?qū)�尋找到真正可以有效治療膀胱癌患者的療法�?

　　近日II期臨床試驗(yàn)已經(jīng)得到了制度審核部門和FDA的批準(zhǔn)，進(jìn)行II期臨床試驗(yàn)的首批病人為2015年10月15日招募的，而該期臨床試驗(yàn)將包括124名參與者，其中大多數(shù)都來(lái)自夏威夷，該階段試驗(yàn)的目的是改善膀胱癌患者的預(yù)后情況。2015年夏季研究者們完成了對(duì)9名參與者的I期臨床試驗(yàn)，至少有20%的參與者預(yù)期將會(huì)出現(xiàn)膀胱癌復(fù)發(fā)的情況，然而截止到現(xiàn)在為止，并沒(méi)有病人出現(xiàn)癌癥復(fù)發(fā)情況，總的來(lái)講，膀胱癌是一種高復(fù)發(fā)的癌癥，復(fù)發(fā)率大于50%。

　　I其臨床試驗(yàn)的參與者Clark Morgan表示，我知道在實(shí)驗(yàn)室中該藥物具有明顯的積極性作用，但我并沒(méi)有猶豫進(jìn)行這項(xiàng)臨床試驗(yàn)，我患有膀胱癌，而且我妻子在7年前也被查出有膀胱癌，我們應(yīng)該參與這項(xiàng)臨床試驗(yàn)。據(jù)美國(guó)國(guó)家癌癥研究所數(shù)據(jù)顯示，每年在美國(guó)大約有7.4萬(wàn)膀胱癌新發(fā)病例，而且大約有1.6萬(wàn)人死于膀胱癌，而膀胱癌在美國(guó)已經(jīng)成為前5位的癌癥了，該病通常在男性中發(fā)病率要高于女性。

　　I期臨床試驗(yàn)表明該試驗(yàn)?zāi)褪苄粤己茫�同時(shí)研究者在II期臨床試驗(yàn)中檢測(cè)了推薦的藥物劑量；如今研究者希望這種名為ALT-803的藥物早日獲得FDA的批準(zhǔn)。

　　推薦的新聞閱讀：

　　Clinical trial could lead to new bladder cancer drug

　　A bladder cancer drug tested in a University of Hawai''i Cancer Center clinical trial is getting closer to Food and Drug Administration (FDA) approval. The new drug, an interleukin 15 superagonist complex (ALT-803), combined with Bacillus Calmette-Guerin (BCG) is expected to be more effective for patients with non-muscle invasive bladder cancer, the most common type of bladder cancer.

　　The last time the FDA approved a drug for bladder cancer was almost two decades ago, said Dr. Charles Rosser, director of the UH Cancer Center''s Clinical Trials Office. Bladder cancer treatment hasn''t advanced very much; BCG has been the main drug used to treat the disease since the ''80s. The science field has changed so much since then. We may finally be able to move the field forward and get better drugs to patients.

　　Phase II of the study was recently approved by the Institutional Review Board (IRB) and FDA. The first patient for Phase II was enrolled on October 15, 2015. The Phase II study will have about 124 participants, most of whom will be from Hawai''i. The goal of this phase is to show improved outcomes for cancer patients.

　　Said Dr. Rosser, At least five other academic centers on the mainland are opening this clinical trial because of encouraging preclinical studies in addition to the Phase I clinical trial results. It is exciting because it started here in Hawai''i and other patients across the country, even across the world, may see positive results as well.

　　Phase I of the study with about 9 participants was completed in summer 2015. At least 20 percent of the participants were expected to have a recurrence of bladder cancer by now but, so far, no patients have. Overall, bladder cancer has a high recurrence rate of more than 50 percent.

　　Said Kailua resident Clark Morgan, a Phase I clinical trial participant, I knew this drug had positive results in the lab, so I didn''t hesitate to be a part of this clinical trial. I thought, well, I have bladder cancer, and my wife had breast cancer about 7 years ago, so she said we have to do what we can. I thought it was convenient and that I could stay in Hawai''i to get this treatment. I don''t know if I would have gone if it was on the mainland.

　　Nationally there are 74,000 new cases of bladder cancer and an estimated 16,000 deaths every year, according to the National Cancer Institute. It is ranked in the top five cancers for men in the U.S. The disease occurs more often in men than women.

　　Phase I showed that the trial was well-tolerated, and also demonstrated the recommended dose to be tested in Phase II. Researchers aim to get the ALT-803 drug created by Altor BioScience Corporation (Miramar, Florida) FDA approved.

　　膀胱癌如何？膀胱癌的治療藥物可以選擇：泰勒寧、平消片、貞芪扶正膠囊等。

　　詳情請(qǐng)致電我們的客服垂詢：400-101-6868。如需購(gòu)買泰勒寧、平消片、貞芪扶正膠囊，可到臨近門店。廣西南寧分店地址為：南寧市青秀區(qū)雙擁路9-8號(hào)明湖花園B座一層7號(hào)（廣西醫(yī)科大學(xué)正門對(duì)面）。

　　腫瘤科藥師溫馨提醒：膀胱癌是泌尿系統(tǒng)高發(fā)腫瘤，很多患者是因?yàn)槌霈F(xiàn)血尿現(xiàn)象懷疑患膀胱癌而進(jìn)行檢查。

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