據(jù)《讀賣新聞》17日報道,今年4月和7月在日本京都大學(xué)附屬醫(yī)院兩次接受胰島細(xì)胞移植的一名女性Ⅰ型糖尿病患者,16日被宣布完全康復(fù)。
據(jù)報道,該名女性患者34歲,14歲時被診斷患有Ⅰ型糖尿病。20年來,患者每日必須注射4次胰島素。
京都大學(xué)附屬醫(yī)院今年4月從一名心臟停止跳動的男性胰臟中分離出35萬個胰島細(xì)胞,移植到該女性患者體內(nèi)后,患者開始分泌胰島素。7月初,該患者又接受手術(shù),移植了從另外一名捐獻(xiàn)者的胰臟里分離出的40萬個胰島細(xì)胞。
之后的檢查結(jié)果顯示,該名女性患者已能正常分泌胰島素。
據(jù)悉,患者已于8月初出院,現(xiàn)在只需服用免疫抑制劑。
統(tǒng)計表明,利用從腦死亡者提供的胰臟中分離出的胰島細(xì)胞進(jìn)行移植,這樣的手術(shù)目前世界上已有約500例。
但根據(jù)日本的臟器移植法,腦死亡者不能作為臟器捐獻(xiàn)者,只能利用心臟停止跳動者捐獻(xiàn)的臟器,因此類似的胰島細(xì)胞移植術(shù)在日本僅有4例。
胰島細(xì)胞移植只需進(jìn)行30分鐘點滴,不必進(jìn)行開胸手術(shù),可以大大減輕患者的負(fù)擔(dān)。日本國內(nèi)Ⅰ型糖尿病患者約為14萬人,這次該名患者的成功治愈為Ⅰ型糖尿病患者帶來了希望。
Diabetes Treatment Disappoints in New Study
細(xì)胞移植法治療糖尿病遭遇尷尬
The cell transplants did free patients from insulin shots, but only temporarily: within two years, 86 percent needed insulin again, according to a report to be published Thursday in The New England Journal of Medicine.
星期四刊登在《新英格蘭醫(yī)學(xué)雜志》上的報告顯示,細(xì)胞移植的確免除了患者注射胰島素之苦,但是作用卻只是暫時的:86%的患者在2年以內(nèi)再次需要新的胰島素。
The patients had severe Type 1 diabetes, also called juvenile diabetes, in which the body lacks insulin and people must inject it several times a day to control blood sugar. They were given islet cells from the pancreas of a dead organ donor.
患有嚴(yán)重的I型糖尿病,也稱為青少年糖尿病的患者體內(nèi)缺少胰島素,為了控制血糖必須每天多次注射胰島素。他們被移植了死亡的器官捐獻(xiàn)者的胰臟細(xì)胞。
The transplants do not require major surgery, just a tube inserted into a vein in the abdomen so that the cells can be dripped into the liver, where they take up residence in tiny blood vessels. Because the transplanted cells come from someone else, recipients must take immune-suppressing drugs for life to prevent rejection.
移植手術(shù)不需要動大手術(shù),只需要在患者腹部的血管中插入一個導(dǎo)管把細(xì)胞倒入患者的肝臟,細(xì)胞就依附在肝臟細(xì)小的血管上。因為細(xì)胞來自于別人體內(nèi),接受移植的患者必須終生服用免疫抑制藥物,預(yù)防產(chǎn)生排異現(xiàn)象。
The study, involving 36 patients at nine centers in the United States, Canada and Europe, was inspired by a smaller trial published in 2000 that sparked excitement about a transplant technique called the Edmonton protocol, developed at the University of Alberta. In that initial test, none of the patients needed insulin shots-but when the report was published, none had been followed for more than 14 months. Later, many did need the shots again.
這項研究是在來自于美國、加拿大和歐洲9個中心的36名患者身上進(jìn)行的。研究受到2000年發(fā)布的一項小規(guī)模的試驗結(jié)果的啟發(fā),那一試驗提出了讓人興奮的移植技術(shù),即在埃爾伯塔大學(xué)發(fā)展起來的埃德蒙頓方案。在起初的試驗中,沒有一個患者需要注射胰島素。但是到試驗報告發(fā)布的時候,所有的病人跟蹤觀察還不到14個月。后來,許多患者還是需要接著注射胰島素。
In the newer study, the transplants failed completely within a year in 10 of the 36 patients; but 16 others were off insulin completely, and the remaining 10 needed less insulin than before. By two years, only five were still free of insulin shots. A quarter of the patients had to switch immune-suppressing drugs because of side effects, which sometimes included a drop in kidney function.
在新近的研究中,在細(xì)胞移植的36例患者中,1年以內(nèi)有10例移植完全失敗;但是另外16例患者完全不在需要胰島素注射,另外10例需要的胰島素的量也比以前減少了。到2年的時候,僅有5例依然不需要注射胰島素。由于副作用的原因,包括出現(xiàn)腎功能下降的情況,四分之一的患者不得不停止使用免疫抑制藥物。
For now, the cell transplants are not recommended for most patients.
所以現(xiàn)在絕大部分患者都沒有建議采用細(xì)胞移植法。
"I don't think this is ready for prime time," said Dr. Jonathan S. Bromberg, director of transplantation at Mount Sinai Hospital in Manhattan. He was not involved in the research, but wrote an editorial about it in the same journal.
“我認(rèn)為時機還不成熟,” 曼哈頓西奈山醫(yī)院器官移植主任喬納森·S·布隆伯格博士說。他沒有參與這次研究,但是他在同一期刊上撰寫了關(guān)于研究報告的社評。
But he also said the field was advancing so fast that the transplants may actually become a viable option in the not-so-distant future.
但是他說,這一領(lǐng)域發(fā)展很快,實際上移植可能在不遠(yuǎn)的將來成為可靠的治療方法。
"I think we've got every reason to believe there will be significant progress," Dr. Bromberg said.
他表示:“我認(rèn)為我們有足夠的理由相信這一技術(shù)將會取得重大的進(jìn)步?!?br>
In the meantime, even in their present form, the cell transplants may still help some people - approximately 10 percent of those with Type 1 diabetes, who frequently suffer from severe episodes of low blood sugar, or hypoglycemia, that strike without warning and can cause confusion, fainting or even seizures.
同時,即便是在他們現(xiàn)在的情形下,細(xì)胞移植對于大約10%的患有I型糖尿病的患者可能依然有用。這些患者經(jīng)常受到嚴(yán)重的低血糖癥狀或者低血糖癥的折磨,這些疾病會在沒有任何征兆的情況下發(fā)生,并能誘發(fā)神志不清、昏迷甚至驚厥。
This kind of hypoglycemia can be so severe that patients "can't function in society," said Dr. A.M. James Shapiro, who led the study and is director of the islet transplant program at the University of Alberta. His team developed the Edmonton protocol.
這種低血糖癥會非常嚴(yán)重,可以導(dǎo)致患者“不能正?;顒印?,領(lǐng)導(dǎo)這項研究的埃爾伯塔胰島移植項目主任A.M. 詹姆斯·夏皮羅博士表示。他領(lǐng)導(dǎo)的團隊開創(chuàng)了埃德蒙頓方案。
Patients in the study had the condition, but the transplants diminished their hypoglycemic attacks, even when the cells were only partly effective.
研究中的患者都有上述情況,但在細(xì)胞移植后,甚至即便在這些細(xì)胞只有部分發(fā)揮作用時,他們都免受了低血糖癥的困擾。
In the United States, the cell transplants are considered experimental and are available only in studies. They are more widely available in Canada, Dr. Shapiro said.
在美國,細(xì)胞移植還在試驗階段,只有在研究中可以使用。夏普羅博士介紹說,但在加拿大,細(xì)胞移植應(yīng)用更加廣泛。
Transplanting the entire pancreas can reverse Type 1 diabetes, but it is a major operation and in this country is usually done only when the diabetes is so severe that the patient needs a kidney transplant as well. About 1,500 pancreas transplants a year are performed in the United States. The transplants tend to work for 5 to 10 years, Dr. Bromberg said. Eventually most patients need insulin again.
完全移植整個胰臟可以徹底治療I型糖尿病,但是這是一項大手術(shù),而且在美國只有糖尿病已經(jīng)嚴(yán)重到需要腎移植的時候才通常會被采用。布隆伯格博士說,移植往往可以保證5到10年,但大多數(shù)患者最后還是需要注射胰島素。
But people with Type 1 do not really need a whole pancreas: they need just the islet cells, which make up only about 3 percent of the organ.
I型糖尿病患者并不是一定需要整個胰臟的移植,他們只需要相當(dāng)于整個器官3%的胰島細(xì)胞。
Researchers have been experimenting with islet transplants since the 1970's. But the cells never survived for long in humans - not until the study reported in 2000 by Dr. Shapiro and his colleagues. His team succeeded because they suspected that the immune-suppressing drugs were killing off the islet cells, and they switched to a less toxic regimen. It worked.
研究人員從20世紀(jì)70年就開始試驗胰島細(xì)胞移植。但是直到2000年夏普羅博士和他的同事發(fā)表的研究報告,這些細(xì)胞在人體內(nèi)從來就沒有存活過。他的研究小組的成功是由于他們懷疑抑制免疫的藥物同時也殺死了胰島細(xì)胞,所以他們成功地使用了一種毒性更小的療法。
Even so, too many cells die - half to three quarters, Dr. Shapiro said. If more could survive, patients might be able to go much longer without insulin. Researchers are testing different drug combinations and other refinements to improve their results.
夏普羅博士說,即便如此,太多的細(xì)胞-大約有一半島3/4,還是死亡了。如果更多的細(xì)胞能夠存活,患者不需要使用胰島素的時間就可能會延長。研究人員正在試驗不同的藥物組合和其他的更加精細(xì)的方法來提高細(xì)胞的成活率。
"I would be first to admit that it has a long way to go before it matches whole pancreas transplantation," Dr. Shapiro said, but he added that he still expected the cell infusions to catch up with whole organ transplants in a few years. The shortage of organ donors will be a limiting factor, however.
“首先我得承認(rèn),要達(dá)到整個胰臟移植的效果還有很長的路要走,”夏普羅博士承認(rèn),但是他接著說,他依然期待在幾年的時間里細(xì)胞灌輸可以趕上整個胰臟器官移植的效果。然而,缺少胰臟捐獻(xiàn)者將是一個不利因素。
Dr. Bromberg said that for most diabetics, new forms of insulin, insulin pumps and glucose monitors were improving control of the disease so much that it would be hard to justify the risks of a transplant and lifelong immune-suppressing drugs.
布隆伯格博士說,對于大多數(shù)糖尿病患者,新的合成胰島素、胰島素泵和血糖監(jiān)測儀大量使用,用來改善對疾病的監(jiān)控,但這也使得判斷細(xì)胞移植和終生使用免疫抑制藥物的風(fēng)險變得困難。
Cell transplants are being studied primarily in people with Type 1 diabetes, which affects about a million people in the United States. It occurs when a person's immune system, for unknown reasons, attacks the pancreas cells that make insulin.
細(xì)胞移植的研究首先是在I型糖尿病患者身上進(jìn)行的,患這種疾病的人在美國大約有100萬人。這一疾病是由于某種不確知的原因致使免疫系統(tǒng)損害產(chǎn)生胰島素的胰島細(xì)胞所致。
Type 2 diabetes is different, and far more common, affecting about 20 million in the United States. Patients produce insulin, but their bodies cannot use it properly. The disease is genetic, but often develops only when someone who has the genes for it also becomes overweight. Type 2 is increasing in many countries as obesity rises. (Type 1 is not linked to obesity.)
II型糖尿病則不同,也更加普遍,在美國大約有2000萬患者?;颊吣軌蚍置谝葝u素,但卻不能正常地使用這些胰島素。這種疾病是遺傳所致,但是通常只在帶有致病遺傳基因同時也體重超標(biāo)的人才會患這種疾病。II型糖尿病隨著肥胖癥的增加在很多國家也有所增加。I型糖尿病與肥胖癥無關(guān)。
Both forms of the disease can have devastating consequences, including blindness, kidney failure and circulatory problems that can lead to amputations.
兩種疾病都可能導(dǎo)致災(zāi)難性的后果,包括失明、腎衰竭和導(dǎo)致的截肢的循環(huán)系統(tǒng)疾病。
?干細(xì)胞移植目前屬于臨床研究階段還不能用于治療,如果是一型糖尿病,胰島素是最好的治療方案。 糖尿病病人盡早實施胰島素治療,可使血糖長期嚴(yán)格控制達(dá)標(biāo),大大減少糖尿病慢性并發(fā)癥(尤其是微血管并發(fā)癥)的發(fā)生率。而且,給予適量的胰島素治療,有利于維持正常的糖代謝和脂代謝,改善胰島素抵抗,對心血管具有保護作用。 借助特定類型的干細(xì)胞可調(diào)節(jié)機體的免疫功能,因而嘗試使用干細(xì)胞治療免疫系統(tǒng)疾病已成熱門,其中就包括1型糖尿病。 有胰島素還不夠 1型糖尿病為兒童及青少年最常見的內(nèi)分泌疾病之一,隨病程進(jìn)展,患者胰島β細(xì)胞數(shù)目進(jìn)行性減少甚至完全喪失,功能隨之殆盡。臨床上主要通過外源胰島素的替代治療來維持患者體內(nèi)正常的血糖水平。但是長期皮下注射胰島素在一定程度上可以延長或維持生命,卻不能阻止并發(fā)癥發(fā)生,還會帶來較嚴(yán)重的身心問題,降低其生活質(zhì)量。因此,醫(yī)生仍在探求新方案,以期實現(xiàn)或接近理想化目標(biāo),即擺脫外源性胰島素的替代治療。 借干細(xì)胞調(diào)節(jié)免疫 現(xiàn)已認(rèn)同1型糖尿病是T淋巴細(xì)胞介導(dǎo)的自身免疫性疾病,其發(fā)生與自身反應(yīng)性T細(xì)胞激活并增殖,選擇性破壞胰島β細(xì)胞有關(guān)。因此消除異常的免疫反應(yīng),重建一個正常的免疫系統(tǒng),才可能治愈1型糖尿病。目前可選的思路一方面是阻止胰島β細(xì)胞繼續(xù)破壞,保護殘留胰島β細(xì)胞;另一方面是促進(jìn)胰島β細(xì)胞增殖。 干細(xì)胞作為人體各種組織細(xì)胞的初始來源,其最顯著的生物學(xué)特征是既有自我更新和不斷增生的能力,又有多向分化的潛能。而特定類型的干細(xì)胞還可同時調(diào)節(jié)機體的免疫功能。目前,臨床干細(xì)胞移植在治療其他自身免疫性疾病,如系統(tǒng)性紅斑狼瘡、多發(fā)性硬化等方面均取得了良好效果。而探索干細(xì)胞移植技術(shù)已成為全球糖尿病治療領(lǐng)域的一個新亮點,也引起了前所未有的關(guān)注。 臨床嘗試確有效果 自體外周造血干細(xì)胞移植治療1型糖尿病的可能機制,是在免疫病理細(xì)胞清除的基礎(chǔ)上重建相對正常的免疫系統(tǒng),并可能形成新的免疫耐受;同時通過不同途徑促使胰島β細(xì)胞增殖,使胰島素水平達(dá)到或接近正常的分泌狀態(tài)。 基于這種治療機理,國外學(xué)者Voharelli等采用自體外周造血干細(xì)胞移植的方法治療了新診斷的1型糖尿病患者,并在不同時期內(nèi)停用外源性胰島素,證實造血干細(xì)胞移植治療1型糖尿病具有良好效果,且移植距發(fā)病的時間對于移植后病情的改善有重要影響。 大規(guī)模推廣還太早 需要指出的是,無論是自體造血干細(xì)胞還是間充質(zhì)干細(xì)胞移植治療糖尿病,都僅是初步探索。盡管取得了一些令人鼓舞的結(jié)果,但其中也存在不少問題仍待進(jìn)一步探索和確定。因此,目前干細(xì)胞移植治療糖尿病仍處于臨床探索階段,不宜大規(guī)模推廣使用,前述一些研究僅僅是短期療效評估,而且樣本量相對較少,其確切療效尚需大樣本、長期隨訪進(jìn)一步確定。然而,國內(nèi)一些醫(yī)院卻盲目夸大干細(xì)胞移植治療糖尿病的療效,或由于經(jīng)濟利益的驅(qū)使,對可能并不適合移植的患者采用了這種方法,有??茖W(xué)原理,顯然不應(yīng)提倡。 干細(xì)胞移植可以治療糖尿病目前雖然有些進(jìn)展,但還遠(yuǎn)未成熟。建議能在有經(jīng)驗的醫(yī)生指導(dǎo)下找到適合自己病情的胰島素的劑型劑量和用法,祝您健康! 相關(guān)閱讀:干細(xì)胞治療肝硬化及糖尿病問題與回答 糖尿病
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