國家經營方向的分歧點

要經濟成長還是要國民幸福？ (自由時報社論 2011-4-25)

馬英九總統日前表態，「不會支持國光石化開發案在彰化縣繼續進行。」但也向石化業信心喊話，強調政府絕對不會放棄，也絕對不能放棄石化業，因此國光石化是否仍在台灣設廠，顯然還有模糊空間，後續爭議猶未平息。其實，國光石化設廠爭議，不能視為石化業內部議題，只以產業發展的角度衡量，而是攸關台灣整體發展策略與核心價值的總檢討。亦即討論國光石化存廢，應該延伸至一個核心議題：何者是台灣正確的發展方向？到底台灣的進步是要聚焦於經濟成長，或者追求全體國民的幸福感？

事實上，追求經濟成長與物慾滿足，乃是工業革命以來的主流思潮。西方學者曾將蒸汽引擎與另一個「引擎」─經濟成長─並列為十八世紀的兩大發明。而衡量經濟成長的ＧＤＰ（國內生產毛額），更是從經濟指標變成國家地位的象徵，擁有高ＧＤＰ成長的國家，意味著擺脫貧窮走向富強，可以躋入先進國家之林，因此追求ＧＤＰ成長成為國家發展的硬道理。然而，ＧＤＰ是衡量一個國家或地區「經濟活動」的量度，卻不能衡量健康品質、教育程度、社會福利，以及一些經濟發展過程中衍生的社會成本。如果一個國家空有高經濟成長，但社福、健保制度不健全，貧富差距懸殊，環境污染嚴重，生活品質不佳，根本不能稱為進步國家。

事實上，只追求經濟成長，往往會帶來許多嚴重副作用。首先是自然資源逐漸耗竭，環境品質惡化，自然災變的發生愈頻繁。例如日本經濟高度成長，為滿足電力需求，在狹小的島嶼上密集興建核電廠，終於導致此次日本強震帶來核災危機。這是自然的大反撲。其次，經濟成長創造巨大財富，卻集中在少數人手中，分配問題愈來愈大，引發許多的動盪與革命，共產主義的崛起，造成人類的浩劫，即是此種經濟成長至上思維所釀成的禍端。於是人類開始省思，不丹王國國王提出國民幸福指數（Gross National Happiness），認為「政策應該關注幸福，並應以實現幸福為目標」，雖然只是供參考的一項指標，並非全球化的今天所能達成的烏托邦，但值得執政者思考如何在經濟增長、文化發展和環境保護上取得平衡發展。

檢視過去台灣的發展過程，很明顯的是以經濟成長為主，ＧＤＰ成長數字幾乎成為檢視政府能力的唯一指標，經濟成長變成台灣奇蹟的代名詞。數十年來台灣經濟幾乎都是正成長，但是，從分配正義、環境保護與社福制度加以檢討，追求ＧＤＰ成長顯然已經無法為台灣民眾帶來更多幸福感。創造一個充滿幸福感的社會，充分就業是先決條件，民眾基本生活無虞，才能充分發揮生命潛能。而台灣當前的失業問題相當嚴重，即使以官方美化過的約五％失業率而言，仍處於歷史高點。其次，就薪資所得而言，台灣這十年來經濟大約仍維持四、五％的成長動力，但平均薪資所得竟然停滯不前，回到十二、三年前的水準。經濟成長的利益為何無法反映到國民所得與就業上，顯然是因為企業外移，尤其是大舉西進，使就業機會外流所致，導致國人無法分享經濟果實。最後，財富分配愈來愈不公平，貧富懸殊加劇，這雖然是世界共同的趨勢，但台灣的問題卻已到了不容忽視的地步。根據財稅資料中心統計，將綜所稅申報戶分成二十等分，二○○九年最窮五％家庭平均年所得只有五．一萬元，最富有五％家庭平均年所得達三百八十二．二萬元，貧富差距飆升至近七十五倍，不僅續創歷史新高，更遠高於二○○八年的六十五倍。

失業、低所得與貧富懸殊加劇，加上環境遭到嚴重破壞，經濟開發的外部成本由多數人承擔，利益卻由少數人獨攬，在在成為社會動盪不安的火種。此刻若不再檢討經濟成長至上的政策與思維，注入人文、環保與社會正義的價值觀，以追求最多數人的最大幸福的幸福指數作為發展目標，台灣的內部危機恐將一觸即發。由此觀之，國光石化或核四議題，都不是獨立的個案，如何處理這些議題，意味台灣已看到過去發展的弊病，選擇走上一條為多數國民創造幸福的道路？

 

著名的國際法學家，彭明敏的精闢判讀

彭明敏︰併選更有利買票 全民必須嚴厲監督

（記者廖振輝攝）

■專訪︰記者鄒景雯

前言：中選會已經決定將於明年一月同時舉行立委與總統選舉，前總統府資政彭明敏受訪指出，選舉的遊戲已經開始了，卻在遊戲的過程中改變遊戲規則，這違反公平性原則。國民黨輸不起，因此無所不用其極。併選將更有利於買票，全民必須嚴厲監督。

記者問：中選會已經決定明年立委與總統大選將合併舉行，日期大概是一月十四日，農曆過年前一週，你有何看法？

執政黨就是怕輸 才無所不用其極

彭明敏：這件事情充分說明了國民黨已經輸不起這次選舉，為了要贏，什麼手段都要用。在理論上，選舉太過頻繁不太好，同時為了節省經費，盡量將選舉合併，這沒有錯；但是必須考慮選舉的遊戲已經開始了，參選人都在準備積極投入競選活動，民進黨的初選已經在進行，這等於是遊戲規則早就有了，卻在遊戲的當中突然又再改變規則，這涉及了公平性問題，是不對的。

同時，總統與立委兩個選舉的規則並不同，投票的選民也不見得相同，投票時間變動，甚至影響到數萬名第一次有投票權的首投族權益，有人因此提議若要合併應從下次選舉再開始，但顯然國民黨不為所動，決定不擇手段，仍然朝著他們認為有利的方式在做，至於是不是真的有利，我不知道。

總統大選提前到一月舉行，若發生政黨輪替，將有四個月的空檔，這是非常奇怪的，世界各國沒有這樣的情況。在這個空檔，政府如何運作？恐怕很有問題，特別是以國民黨過去的作風來說，實在不能令人放心。這點，非常不合理，但國民黨認為沒有關係，似乎以為一定贏，沒有想過國民黨萬一選輸時的狀況。

中選會理應獨立 卻成了傀儡單位

事實上，明年的總統與立委選舉結果，有四種可能，一個是總統由國民黨當選，立委國民黨也掌握多數，但是另外三種可能，要嘛國民黨輸總統、要嘛輸國會，要嘛兩個都輸，這些會不會發生？國民黨完全不敢或不願意面對。

總統說：尊重中選會的專業。這典型是馬英九的作風，他一向都是這種做法。這次中選會明顯是按照國民黨的意思辦事，上頭在後面操縱，一旦事情發生，爭議表面化，他就撇清，這不是正當的做法。

第二個讓我失望的是中選會，這個單位理應是獨立的，現在卻成了國民黨的傀儡，居然以民調做為藉口，稱多數人主張合併，這民調有多可靠？我不知道。中選會還說：一個月、兩個月、四個月沒差別，這完全是敷衍。

第三，針對外界的疑慮，總統府的發言人說：這些都是假設性的問題。但是，所有的法律都是假設性的，假使你殺人會怎麼樣？假使你欺騙又會怎麼樣？因此怎麼可以用假設性來迴避？

內政部長又說：這只不過是「看守期」，不會造成憲政空窗，這根本是廢話，都是不敢面對問題。假使連親近國民黨的媒體都主張要併選應該二○一六再議，可見他們也認為不妥當。

國民黨現在說要通過總統交接條例，我認為通不通過都不是重點，重點是國民黨這三年來毫無誠信，例如併選這件事，避開憲法，又避開修法，國民黨想做就做，下次可能看情形再決定要不要改，如果效果不好，下次可能又分開選，完全不守法，因此即使訂了交接條例又如何？

問：國民黨之所以認為合併有利馬英九，你以為關鍵何在？

彭：這次的立委選舉，從各種角度看，國民黨都會選得比過去差，席次一下滑，就會被外界視為是輸，因此國民黨怕立委如果先選，選舉結果會影響二個月之後舉行的總統選情，實際上如何，我不清楚。但無論如何，合併之後將更有利於買票，單獨一個買很敏感，兩個合起來買，是不是比較方便？這點令人十分不安。

問：萬一馬英九敗選，未來這四個月會怎樣？

彭：我們很擔心的是，國民黨完全沒有公平競爭的精神，以他們的心態，如果國民黨輸了，總統會做什麼事情？這是很危險的，不但全民要有警覺，必須共同嚴密監視這個事情，也要讓國際充分了解，使國民黨若失敗時，能具體感到壓力，意識到大家都高度關切他們的一舉一動，不能亂來。

國民黨一旦敗選 恐不願交出政權

問：能不能具體一點？

彭：我們最怕的是，如果民進黨當選總統，國民黨利用這四個月做出不可恢復的事情，例如與中國簽協議。民進黨若能在國會取得相當席次，多少還能夠發揮制衡的作用，如果沒有呢？

此外，這四個月，馬英九還是總統，國民黨會不會做出更激烈的事情？或者暴力的事情，然後找理由宣布戒嚴，不乖乖交出政權？這類的事，許多人在說，心中有所驚恐，我很不願意講，但也不是完全沒有可能。甚至有人憂慮，不必等到開票，在選舉的過程中，如果國民黨的勢頭不好，他們會不會就開始做一些事？我看，國民黨是什麼手段都會使出來。

為什麼我會這樣認為？因為國民黨是絕對不能失去政權的，若再一次放掉政權，國民黨就完了，至少他們的核心內部有此想法。所以我很不樂觀，我不樂觀國民黨會依照民主的常規做事情。

問：國民黨勢必會反駁：現在已是民主時代，馬英九也不是這樣的人，你仍堅持這樣看嗎？

彭：他是不是這樣的人，就算他說了，我也不會相信。事前，他當然會說他不是這種人，但等事情發生了，他會說這不是他做的。我之所以相信許多事情他是敢在背後做的，只要看看台灣的司法就好，他也總是說他不干涉司法，但是大家相信嗎？我不認為現在的不正常情況與他一點關係也沒有。

另外就拿這次總統與立委併選來講，併得這麼勉強，這是一般的民主國家根本做不出來的事，而他就是做了。如果說是要避免浪費，就從下屆開始，為什麼一定要現在弄？如果一定要從這屆開始，為什麼不三年前上任時就開始規劃？遊戲尚未開始時就該趕快做，我看是因為他們看到國民黨情勢不好，才會遊戲都已經開始了才改遊戲規則，無所不用其極的要讓國民黨有利。這麼做，社會如何建立信賴？

我想強調的是，要改，就公正的來做，並且盡早來改。這就好像奢侈稅，三年來早就該做了，怎麼現在才在做？究竟這三年都在幹什麼？所以我才會說，國民黨根本不在意什麼主權、人民的福祉，如何保證馬英九當選，才是他們最關心的。現在這只是一個例，未來在投票之前，類似的惡例可能還會層出不窮。

促朝野和諧溝通 馬從未做過努力

問：有人主張應該就併選問題聲請大法官解釋，你以為呢？

彭：大法官有多少公正性？我懷疑。這麼說，真是對不起，大法官我一個都不認識，但是司法是台灣非常糟糕的一環，這點社會可以公評。若要請他們解釋，我不反對，但是結果會如何？不只大法官，現在政府的官員又有多少的抗壓性？

問：馬總統上任到現在，是否曾經與你或過去的資政溝通？有沒有對促進朝野和諧、彌合藍綠做過努力？

彭：完全沒有

 

台灣七成民眾 反對終極統一

2011-04-21

〔記者黃宣弼／台北報導〕根據遠見雜誌最近民調，目前台灣民眾對兩岸的統獨立場，維持現狀佔五十三．五％、獨立佔二十七％、統一佔七．五％；至於民眾的「終極統獨觀」， 贊成台灣終極獨立的高達四十九．三％，不贊成的佔三十四．七％，贊成兩岸終極統一的佔十五．七％，不贊成的高達六十九．六％。

遠見的民調顯示，依照當前兩岸現況，有十七．一％的民眾贊成台灣應該儘快獨立、九．九％認為先維持現狀再走向獨立（急獨與緩獨合計為二十七％）；四十一．一％認為先維持現狀再看情形、十二．四％認為永遠維持現狀（狹義的維持現狀合計為五十三．五％）；三．八％認為先維持現狀再和大陸統一、三．七％表示台灣應該儘快和大陸統一（緩統與急統合計為七．五％）；另十二％沒有明確表態。

而在「民眾終極統獨觀」的調查中，如果兩岸在經濟、政治、社會各方面條件差不多時，六十七．一％的民眾認為「沒必要統一」，認為「可以統一」的則只有十二．八％，有二十％未明確表態，比起九十九年十二月所做調查，認為沒必要統一的減少○．七％，認為可以統一的增加○．七％，幾無變動。

當問及贊不贊成台灣與大陸最後應該統一時，十五．七％表示贊成、六十九．六％不贊成，若細分其中泛藍立場民眾，則有二十五．六％贊成、六十五．六％不贊成，而即使籍貫為大陸省市者，也有五十二．二％表示不贊成，顯示台灣民眾目前反對兩岸走向「終極統一」，維持高度且穩定的共識。

當詢問民眾台灣最後應否獨立成為新國家時，則有四十九．三％表示贊成、三十四．七％不贊成，若細分泛藍立場民眾有三十六．八％贊成、五十五．八％不贊成，泛綠立場民眾有七十六％贊成、十九．一％不贊成，顯示民眾對於台灣是否終究應該獨立，態度依舊分歧且持續拉鋸。

Treatment guidelines offered for painful diabetic neuropathy

New expert guidelines on treatment of painful diabetic neuropathy have evaluated the evidence base and identified some recommended medications.

The guidelines were developed by a panel representing the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine and the American Academy of Physical Medicine and Rehabilitation and were published online by Neurology on April 11.

The strongest evidence (Level A) was found to support offering pregabalin for relief of painful diabetic neuropathy. The guidelines also listed a number of treatments that are supported by Level B recommendations, and are probably effective so should be considered, including gabapentin, sodium valproate, amitriptyline, venlafaxine, duloxetine, dextromethorphan, morphine sulfate, tramadol, oxycodone, capsaicin and isosorbide dinitrate spray. The guideline writers noted that there was not sufficient evidence to prefer any of the listed antidepressants or opioids over another. Level C recommendations were made for adding venlafaxine to gabapentin and considering the Lidoderm patch.

A review of nonpharmacologic treatments was also conducted, and the experts made a Level B recommendation in favor of considering percutaneous electrical nerve stimulation. There was insufficient evidence on amitriptyline plus electrotherapy, and the other studied treatments (electromagnetic field treatment, low-intensity lasers, and Reiki therapy) should probably not be considered, the guidelines said.

Insufficient evidence was also found for topiramate, desipramine, imipramine, fluoxetine, vitamins, α-lipoic acid and the combination of nortriptyline and fluphenazine. Drugs that should probably not be considered for treatment of painful diabetic neuropathy include oxcarbazepine, lamotrigine, lacosamide, clonidine, pentoxifylline and mexiletine, according to the guidelines. In their recommendations for future research, the guideline authors called for longer, head-to-head trials of treatments with greater focus on quality of life, physical function and cost-effectiveness. A formalized process for rating pain scales is also needed, they said.

Genital herpes: Asymptomatic herpes patients can spread virus

People with asymptomatic herpes simplex virus (HSV) shed the virus less often than those with symptomatic disease, but they still pose significant risk of transmission, according to a new study.

The study included 498 patients who were seropositive for HSV-2. The participants collected swabs of their genital secretions for at least 30 days. In the 410 patients who had symptomatic disease, the virus was detected in 20% of samples. In the 88 people with asymptomatic cases, virus was found in 10% of samples. Although patients with symptoms had more subclinical shedding of virus, the amount of virus detected during these episodes was similar in people with and without symptoms. The study authors concluded that asymptomatic patients shed virus less frequently, but that the difference is attributable to their having less frequent genital lesions.

The study highlights the risk of disease transmission by people with unrecognized infections, the researchers noted. Although this study categorized patients as symptomatic or asymptomatic, disease manifestations actually vary along a broad continuum. The majority of people found to be seropositive do not have a history of genital herpes, but a substantial proportion of apparently asymptomatic patients will recognize recurrences after they've been diagnosed and educated, the authors said. The results were published in the April 13 Journal of the American Medical Association.

One of the purposes of this study was to address uncertainty about proper management of asymptomatic patients. The authors concluded that best practices should include anticipatory guidance with regard to genital symptoms and education about transmission risk. Proven methods of reducing transmission include condom use, daily valacyclovir therapy and disclosure of positive status. However, the strategies are only effective in diagnosed patients, who are a minority of the HSV-2 positive population, noted the authors, who called for a rethinking of current testing and control programs.

名聲功績被抑壓的英國 Leonardo，Robert Hooke

 

圖 156

Robert Hooke (1635-1703) (英國哲學家、建築家、科學家；發現有關彈性力學的Hooke’s law；1666年倫敦大火之後重建都市致富；寫了顯微鏡觀察的Micrographia一書；發現細胞“cell”； 可能是英國當時最有成就的polymath，被譽為是 “英國的Leonardo”；他的成績有實驗的，有理論的，在科學革命中扮演很主要的角色。只因和當時很多學者為了誰先發現的問題交惡，而死後他的名聲功績都被壓抑，連肖像都沒有被保留 (！)，到二十世紀才再被人發現)。 [圖156是2004年的畫像。沒有人知道他真正長相！]

Robert Hooke生於Isle of Wight (英國南岸最大的島，風景優美，詩人Alfred Lord Tennyson也是生於此處，Queen Victoria也建立她的居處於此；1979年被愛爾蘭共和軍 IRA刺殺的Lord Mountbatten就是此處的Governor)。父親是牧師並負責一所學校，有一個哥哥、兩個姊姊。自幼身體虛弱，有時由父親在家教他。他從小就觀察仔細，喜歡機械、繪圖。父親於他十五歲時死亡。他到倫敦，不久入學Westminster School (The Royal College of St. Peter in Westminster，私立的學校，Oxford-Cambridge大學錄取率最高)。他很快學會拉丁文、希臘文、幾何學。

英國當時因為內戰註一，而國內人士分為兩派。Westminster校長Richard Busby是保王派 (Royalist)，堅持科學精神 (攝政派是遵從聖經的)。

圖 157

Hooke在英國Cromwell攝政時期 (Protectorate，1653-1659)，在Oxford大學的Wadham College 讀書，因而成為很忠誠的保王派成員，其中心人物就是John Wilkins註二。Hooke擔任Thomas Willis註三及Robert Boyle註四之助手。1655年他開始研究天文學，他改善鐘擺 (pendulum)，進而學習重力，以及時鐘。他又想出計算經度 (longitude) 之方法；也設計出時鐘的anchor escapement [圖157]，應用這種裝置才能有現在的口袋型鐘錶。       

1660年Royal Society成立，四年後被委任Mechanick Lecture，1665年被任命為執行並審議實驗的curator終身職。這職位使他可以看到所有呈上來審查的發明發現。

圖 158

1664年他接任Gresham Professor of Geometry。1691年他接受 “Doctor of physics”頭銜。 [當時要取得Doctor = 博士頭銜好不容易！！]

他在物理天文、醫學、生理各方面都有很重要的發明或發現：為氣體定律實驗 (Boyle’s law) 做了vacuum pumps；發現毛細管作用；製造早期的Gregorian telescope (利用光反射的望遠鏡)，看到Mars (火星) 及Jupiter (木星) 會自轉；又觀察化石，而成為生物演化論的早期支持者；研究光折射，而最早演繹出光波的理論；提出：物質加熱就會膨脹，空氣是由微小物質所組成，其間的距離很大；又率先做出土地測量用的地圖。他差一點演繹出物理學之重力 (gravity) 是遵照inverse square law (量和距離的兩次方成正比)，而這種定律控制宇宙間星球的運行 (這個理論後來由牛頓Isaac Newton提出)。他做的實驗有：地心引力、物體的墜落、在不同高度不同氣壓下的物體重量、兩百英尺長的鐘擺等等。製造出來的器具有測量炸藥威力的儀器、雕切鐘錶齒輪用的引擎。這些科學成果都是在當Boyle助手時以及Royal Society評審員 (1662年起) 時期完成的。他的很多新構想，都用anagram變成密碼隱藏，不讓人偷竊，又可以證明他已經在當時發現了。anagram也是Huygens或Galileo等人常用的方法。

圖 159 [圖片暫缺]

圖 160

圖 161

1665年他將顯微鏡下的觀察結果寫成一本Micrographia。這本刺激了Leewenhoek製造自己的高效能顯微鏡，導致微生物的發現。他也從顯微鏡觀察。看到木拴 (cork) 有很多洞室，最先使用Cell一字描寫 (僧侶靜坐冥思的一個個房間，稱為 “cell”。圖159)。
[圖160：館藏Hooke使用的顯微鏡；圖161：他畫的跳蚤及蝨子]

除了更多物理實驗，他還看出打開狗的胸腔後，只要繼續用幫普維持空氣進出肺臟，狗還能活；又觀察到靜脈血及動脈血之差異。

圖 162

1666倫敦大火之後，他和好友、當時最有名的建築家Christopher Wren (1632-1723，建築了五十一座教堂，包括有名的St. Paul’s Cathedral) 重建倫敦，也因此致富。他設計了Monument to the fire, the Royal Greenwich Observatory, Montagu House in Bloomsbury, Bethlem Royal Hospital (Bedlam)，及The Royal College of Physicians (1679) , Buckinghamshire等。Christopher Wren 建築的St Paul's Cathedral圓頂是依照Hooke的建議方法蓋起來的。 [圖162是由Hooke設計，在Willen, Milton Keynes的教堂]

天文學方面，他發現月球上的火山口、土星的圓環、double-star systems (雙星binary stars，是環繞共同重心的多數星球) 等。

這麼多成就，可是他死後兩百年來幾乎沒有人注意到他，也不知道他長相如何，原因在於他的人際關係。

他從小身體虛弱，一生忙著工作，擁有很多專利，沒有結婚。年老時性格變得很暴躁易怒、驕傲，和工作上有競爭關係的人常常爭執。為了鐘錶的anchor escape是誰先發明，和Christiaan Huygens (1629 – 1695，FRS，荷蘭物理學家，製作計時器具) 爭執多年，不過以後別人的記載是Hooke早了十五年發明。尤其和當時任Royal Society主席的Isaac Newton 註五，兩人為了有關重力、inverse square law的觀念是誰先發表一直爭執，而受Newton的多方抑壓，以致在Hooke死後他的論文被收藏，到最近才被發現；據說Hooke唯一的畫像也被銷毀，結果迄今都不知道他長得像什麼！有人猜測他面長瘡皰，或是駝背 (！！)。 [這種學界廝殺未免是太過分了！]

1705年Richard Waller寫第一篇Hooke的傳記The Posthumous Works of Robert Hooke, M.D. S.R.S.，描寫他的性格卑劣、多疑、嫉妒等等 (" but despicable"、"melancholy、 mistrustful、and jealous.")，以致以後兩百年有關他的性格脾氣都非常地負面，如：自私、不講道德、復仇心重，孤獨不和人來往；最友善的描寫也是說他「易怒、多疑、不易相處」。

其實他有不少同樣保王派的好朋友，例如Christopher Wren、古董商John Aubry、製造鐘錶的Thomas Tompion (1639–1713)。到死後一百三十多年，1935年他的自傳被發表，Robert Gunther及Margaret Espinosse等才開始糾正對他的一片負面的評語。Hooke的日記更記載他常常和Robert Boyle到咖啡店；會帶研究助理Harry Hunt去喝茶；也會帶姪女表弟們來家裡教她們數學。

Hooke死後有一行星命名為3514 Hooke (1971 UJ) ；月球及金星上的火山口有他名字命名的；有Robert Hooke Science center在倫敦Westminster School的St. John Smith Square；也有The Hooke Medal。

 

註一：英國內戰

從1642到1651之間英國王室Charles一世與二世，和議會之間有三次內戰，1642-1646, 1648-1649, 1649-1651；結果議會軍隊在1651年九月三日Battle of Worcester戰勝，Charles 一世被判死刑，二世放逐，王室改為共和國Commonwealth of England，由議會掌權 (1651-1653)，後來由軍人出身的Oliver Cromwell攝政 (1653-1659)。Cromwell攝政時堅固新教的勢力，殺害蘇格蘭、愛爾蘭天主教徒 (導致迄今英國與愛爾蘭之間不斷的衝突)。1658年他因瘧疾以及尿路感染敗血症死亡，葬於Westminster Abbey。1658-1659年由Cromwell之子Richard Cromwell執政，但1660年五月二十九日Charles二世又被請回來主政，Cromwell之屍體被挖出來斬首。

註二：John Wilkins (1614-1672)

是牧師、哲學家，當過Oxford, Cambridge兩大學校長，創立Royal Society，也是博學。

註三：Thomas Willis (1621-1675)

英國醫師，解剖、神經科、精神科，Royal Society創始會員，腦部循環circle of Willis是以他命名。

註四：Robert Boyle (1627-1691)

學通哲學、神學、物理化學，又是發明家，被認為創始現代化化學這一門學問，發現Boyle’s law，就是氣體的體積和壓力成反比。

註五：Isaac Newton：牛頓 (1643-1727)

圖 163

英國物理學家、數學家、天文學家、哲學家，1687年發表Philosophiæ Naturalis Principia Mathematica ("Mathematical Principles of Natural Philosophy"; 簡稱Principia)，可能是史上最重要的科學書籍，是古典力學的基礎；描寫地心引力及三個運動定律。 [圖163]

Prophylactic Antibiotics Lower Bacterial Resistance in ICU

 CME/CE

News Author: Laurie Barclay, MD
CME Author: Charles P. Vega, MD

CME/CE Released: 03/29/2011 ; Valid for credit through 03/29/2012

March 29, 2011 — Preventive antibiotic use significantly lowers the risk for infection with antibiotic-resistant bacteria in patients in the intensive care unit (ICU), according to the results of an open-label, clustered group-randomized, crossover study reported online first March 21 in The Lancet Infectious Diseases.

"Previously, we assessed selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SOD) on survival and prevention of bacteraemia in patients in intensive-care units," write Anne Marie G. A. de Smet, MD, from University Medical Center in Utrecht , the Netherlands , and colleagues. "In this analysis, we aimed to assess effectiveness of these interventions for prevention of respiratory tract colonisation and bacteraemia with highly resistant microorganisms acquired in intensive-care units."

Between May 2004 and July 2006, participants admitted to 13 ICUs in the Netherlands with an expected duration of mechanical ventilation of more than 48 hours or an expected duration of stay of more than 72 hours were randomly assigned to receive SOD, SDD, or standard care. SOD consisted of topical tobramycin, colistin, and amphotericin B in the oropharynx, and SDD consisted of SOD antibiotics in the oropharynx and stomach plus 4 days of intravenous cefotaxime.

An independent clinical pharmacist blinded to ICU identity applied the computer-randomized order of study regimens. To assess acquired infection among patients with ICU stay of more than 3 days, the investigators calculated crude odds ratios (ORs) for rates of bacteremia or respiratory tract colonization with highly resistant microorganisms.

Of 5939 eligible patients, 5927 (> 99%) had available data, and 5463 (92%) were in the ICU for more than 3 days. Bacteremia developed after 3 days in 239 (13%) of 1837 patients in standard care, 158 (9%) of 1758 patients in SOD (OR, 0.66; 95% confidence interval [CI], 0.53 - 0.82), and 124 (7%) of 1868 patients in SDD (OR, 0.48; 95% CI, 0.38 - 0.60). Bacteremia with highly resistant microorganisms developed in 8 patients during SDD vs 18 patients (with 19 episodes) during standard care (OR, 0.41; 95% CI, 0.18 - 0.94; rate reduction [RR], 59%; absolute risk reduction [ARR], 0.6%) and 20 patients during SOD (OR, 0.37; 95% CI, 0.16 - 0.85; RR, 63%; ARR, 0.7%).

Endotracheal aspirate cultures were obtained in approximately half of the patients staying in ICUs for more than 3 days: 881 (49%) receiving standard care, 886 (50%) receiving SOD, and 828 (44%) receiving SDD.

Respiratory tract colonization with highly resistant microorganisms occurred in 128 (15%) of patients during standard care, in 74 (8%) during SDD (OR, 0.58; 95% CI, 0.43 - 0.78; RR, 38%; ARR, 5.5%), and in 88 (10%) during SOD (OR, 0.65; 95% CI, 0.49 - 0.87; RR, 32%; ARR, 4.6%). The lowest rates of acquired respiratory tract colonization with gram-negative bacteria or cefotaxime-resistant and colistin-resistant pathogens occurred during SDD.

"The beneficial effects of SDD and SOD on outcomes, together with the favourable results for infection and colonisation with antibiotic-resistant pathogens reported in this study, justify the extended use of these interventions in settings with low rates of antibiotic resistance," the study authors write.

Study Limitations

Limitations of this study include slight differences in the baseline characteristics among the study groups, suggesting that patients receiving SDD or SOD were more severely ill than were those receiving standard care. In addition, surveillance of digestive tract colonization was done only in the SDD group, and respiratory tract samples were obtained twice every week during SDD and SOD but not during standard care.

"The benefits of prophylactic antibiotic use need to be balanced against the inevitable risks of selection of antibiotic-resistant bacteria," the study authors conclude. "As such, widespread use of topical antimicrobial prophylaxis in patients in intensive-care units has been the subject of debate for years."

In an accompanying comment, Jean-Louis Vincent and Frédérique Jacobs, from Erasme Hospital in Brussels , Belgium , further discuss the study limitations.

"In summary, the interesting findings are mitigated by a lack of effect on problematic organisms, the study setting, and the length of observation," Drs. Vincent and Jacobs write. "We believe that the data provided by our Dutch colleagues will not convince the world to use SDD or SOD."

This study received no external funding. Two of the study authors have disclosed various financial relationships with 3M, Destiny Pharma, Cepheid, Phico Therapeutics, Pfizer, Aventis, Novartis, and/or Kimberly Clark. The other study authors have disclosed no relevant financial relationships. Drs. Vincent and Jacobs have disclosed no relevant financial relationships.

Lancet Infect Dis. Published online March 21, 2011. Abstract

The Infectious Diseases Society of America provides a number of guidelines for the prevention of infection in the acute care setting on its Web site.

Clinical Context

SDD and SOD can improve mortality outcomes among patients in the ICU, according to a previous study by the authors of the current research. This study, which was published in the January 1, 2009, issue of the New England Journal of Medicine, did not demonstrate a significant difference in the gross mortality rates in comparing participants receiving usual care, SDD, or SOD. However, on adjusted analyses, the ORs for death associated with the use of both SDD and SOD were significantly reduced vs usual care (0.83 and 0.86, respectively).

An important concern regarding the use of SDD and SOD is the emergence of resistant organisms. The current study addresses this issue.

Study Highlights

• The study used an open-label, clustered group-randomized controlled crossover design. It was conducted in 13 ICUs between 2004 and 2006.


• Patients eligible for study participation were expected to require mechanical ventilation for at least 48 hours or have an expected ICU stay of at least 72 hours.


• Participants were randomly selected to receive SDD, SOD, or usual care. SDD consisted of 4 days of intravenous cefotaxime plus topical application of an oral paste of tobramycin, colistin, and amphotericin B in the oropharynx and stomach. SOD consisted of application of the oral paste only.


• Patients receiving SDD and SOD were tested with oropharyngeal swabs to analyze bacterial colonization and antimicrobial resistance on admission and twice per week. Patients receiving SDD also had surveillance cultures of endotracheal aspirates performed twice weekly. All participants received blood cultures as part of the study protocol.


• The main study outcome was the effect of SDD and SOD vs usual care on rates of bacterial colonization of endotracheal aspirates, antimicrobial resistance, and rates of bacteremia.


• 5927 patients had data for study analysis. Patients receiving SDD and SOD were more seriously ill vs patients receiving usual care.


• The rates of bacteremia were 13%, 9%, and 7% in the usual care, SOD, and SDD groups, respectively. These differences yielded ORs of 0.66 (95% CI, 0.53 - 0.82) for SOD and 0.48 (95% CI, 0.38 - 0.60) for SDD.


• Researchers obtained 19,404 microbiological cultures from endotracheal aspirates. The rate of cultures was approximately 30% lower in the usual care group vs the SOD and SDD groups.


• Rates of endotracheal colonization with nonfermenting gram-negative rods, such as Pseudomonas aeruginosa and Acinetobacter spp, were similar in the SOD and SDD groups. However, colonization with Enterobacteriaceae was more common with SOD vs SDD.


• Colonization with enterococci occurred more frequently among participants receiving SDD vs SOD and usual care.


• Overall, the rates of respiratory tract colonization with highly resistant organisms were 15%, 10%, and 8% in the usual care, SOD, and SDD groups, respectively. These differences yielded ORs of 0.65 (95% CI, 0.49 - 0.87) for SOD and 0.58 (95% CI, 0.43 - 0.78) for SDD. Gram-negative bacteria accounted for 98% of all highly resistant microorganisms.


• Rates of resistance to the specific antibiotics used in SOD and SDD did not exceed 3%.

Clinical Implications

• Both SDD and SOD were associated with significant decreases in the risk for death vs usual care in a previous study of patients in ICU.


• In the current study, SOD and SDD among patients in ICU reduced the risk for bacteremia and also the risk for acquisition of highly resistant microorganisms on endotracheal aspirates.

 

台灣紅十字會應該公佈詳細營運內情!!!

只能說真可怕。 可能是世界級的醜聞! 都是KMT在搞鬼!  無恥無品到極點。

                ＊＊＊

別搞垮台灣的愛心

◎ 林德正

昨天在網路上看到一篇「搞垮捐款信心 欺善 紅十字會憂讒畏譏」的報導，新聞中提到立委潘孟安的質疑。他表示，台灣紅十字會說撥給日本一千五百萬美元是「慣例」，因為其他國家也採相同作法，例如美國紅十字會至今也只提供一千萬美元。但潘立委查證到美國已撥款六千萬美元給日本的紅十字會支部。如果潘立委資料確實，那麼就是台灣紅十字會說謊！這還了得？這比「零時差」的謊言更嚴重，陳長文是否該出面澄清？

另外，有人為紅十字會講話，說收取十五趴的「行政作業費用」是「依法有據」，法源是「公益勸募條例」。昨天陳長文在報章發表長篇大論辯解，都沒有提到十五趴的問題。我的想法是：以這次捐助日本而言，台灣紅十字會總會共募得十八億七千萬元，十五趴就是二億八千萬元。新台幣二億八千萬元的「行政作業費用」？太多了吧？紅十字會是不是應該巨細靡遺、拿出最周全的表單、收據、帳冊等等，毫無保留地一次解釋清楚？如果只是嘴巴說說，如何取信捐款人？

最後，為什麼是十五趴？潘孟安說，美國紅十字會是每一百塊捐款，有九塊錢是用在薪水、管理和籌資等行政成本，其餘九十一塊到災區。也就是說：台灣紅十字會十五趴，物價比台灣高很多的美國紅十字會只九趴。

老實說，我覺得司法機關應該調查清楚，該辦的辦，該還人家清白的就還。否則，辛苦賺錢的小老百姓的愛心，會受到很大很大的影響。（作者任大學教職，桃園縣民）

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利息呢？ ◎ 林碧珠 據報導，紅十字會收到日本地震善款約十七億元，只送出四億多元；紅十字會人員召開記者會，說他們會分批地送出善款。 九二一經驗中，紅十字會的善款也是分批送出。紅十字會，是一個世界知名的團體，每次所收到的捐款都非常的龐大，這些善款中有許多是很多人省吃儉用的辛苦錢。想請問紅十字會，每次分批而尚未送出的善款，利息你們如何處理？ 我曾在報上，看到有人質疑紅十字會的會長、秘書長等領取高薪，是真的嗎？那麼，是不是有動用到利息收入？ 我合理地懷疑，紅十字會不把善款有效率地處理好，是圖利自己的高層人員？還是，你們的執行人員效率不彰？ 我參與慈善會志工多年，據我了解，一般慈善會的所有理事、監事等，都是無薪職；參與慈善會的運作，就是準備出錢出力，所有的工作人員，只有「奉獻」的理念。 紅十字會難道不也是個慈善機構嗎？請問，你們的利息收入怎麼處理？ （作者為台中市春暉慈善會志工）   郝龍斌的12萬 ◎ 郭川珍 在此不得不檢視紅會過往的作為與背景。首先，據報載郝龍斌過去擔任秘書長任內月薪高達十二萬元，而非陳長文所言的十萬元以內。據悉，郝龍斌坦承並認為一切合法。現今，也許調降到十萬元以內，但報載過去紅會分會曾用「業務津貼」等方式自肥員工的情事，而今都不復發生了嗎？過去曾有議員質疑九二一地震的捐款用到中國川震的重建上，以及行政費用比率過高、佣金高達十五％等事，得到的答案都是「一切合法」。而今紅會，是否都照舊進行著「一切合法」的模式呢？ 若果如此，民眾真該「教育」，不能今非昨是，過去「愚善」是可以心安理得，因為沒有人「教育」我們；而今，要更專業地發揮善心、善舉，徹底監督善款的運用與流向。否則，捐款還要被嫌「教育」不夠啊！ （作者為教師，嘉義縣民） 傲慢！ ◎ 李文凱 前幾天看完紅十字會陳會長的記者會，我覺得基本上，錢怎麼應用，本來就有互相討論溝通的空間。但我不欣賞陳大律師在記者會上的態度，把一切質疑都推向教育出了問題。大家出自一片善意捐錢，稍有點質疑，就是教育不夠，只有你是高級知識份子，質疑你就是教育不足。在陳先生身上，我看不到身為慈善工作者應有的悲天憫人、感同身受的胸懷，卻只看到滿滿的傲慢。 馬政府執政團隊何嘗不是如此，標榜菁英治國，卻屢屢與民意背道而馳，把你當人看，已經是很瞧得起你。看不到對黎民社稷的真心關懷，骨子裡充滿了傲慢，以為只要下下鄉、握握手，就是跟你博感情。以至於出現了種種離譜的作為，最近恐龍法官一案亦是如此。若不能卸下專業的傲慢，放下身段傾聽人民真正的聲音，那最近的事只是冰山一角，必將層出不窮，我們拭目以待之。 （作者為醫師，台北市民）

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零時差？日本的「赤十字」VS. 陳長文的「紅十字」

◎ 楊斯棓

回顧歷史，日本的紅十字會（赤十字社）於一八九九年十一月二十六日在台北市設台灣支部（分會）。支部長由民政長官後藤新平兼任，支部副長是醫學校校長山口秀高。日本赤十字社台灣支部為了長期在台灣經營公益事業，與台灣總督府合作興建醫院，一九○五年「日本赤十字社台灣支部病院」由當時總督府醫學校校長高木友枝兼任院長，赤十字病院成為醫學校教學醫院。一九三六年三月，赤十字病院建築物由台北帝國大學醫學部收購，由東門町原址（今台大醫院新院區）遷移至泉町（今鄭州路上之中興醫院）。

台灣今日醫療有此水準，日本赤十字社功不可沒。但今天日本有難，台灣的紅十字會如何「作為」？

早在日人有難之前，媒體人范立達就曾為文《紅十字會檔案，一度淪喪的公益團體》，提及：「以前，我們購買紅十字會郵票的款項，以及民間人士慷慨解囊捐助紅十字會的經費，竟然有絕大部分被會裡的幹部挪用、中飽私囊。」紅十字會總會秘書長陳長文感受到壓力，卻也不過發表了：「承認紅十字會各分會、支會的經費運用情形，可能確有不當之處。」風頭一過，紅十字會似乎又變成社會捐款的頭號選項。

先前王偉忠處理一雙中田英壽的義賣球鞋不當，被網友罵「幹鞋哥」而頻為自己抱屈，沒錯，場子正是紅十字會的。那場名為「相信希望Fight & Smile賑災募款晚會」官方網站上清楚寫著：「將台灣民眾的愛心，透過中華民國紅十字會總會零時差地轉達到日本災民手中送到日本。」「零時差」這三個字，似乎是自取其辱般地相映陳長文近日辯駁的：「紅十字會如果只是把募來的錢『順手』捐出，實在沒有存在必要。」

陳長文先生，百姓相信你們「零時差」地會捐款給日本，所以選擇你們這個平台；今天你竟然把「零時差」扭曲成「順手」，然後貶低「順手」之意，合理化你們的「過一手」。

這次部落客酥餅以及妙子等人緊盯紅十字會，出招「呼籲中華民國紅十字會總會立刻把錢全數交給日本紅十字會！」真是打蛇打七寸，但我認為追回善款只是次要目標，讓整個台灣社會對紅十字會高度警戒，才是部落客努力的終極目的。

（完整版請見http://ybonbon.blogspot.com/，作者為部落客醫師）

這篇文章寫得正中標靶，讀來真暢快!!! 好文章，留存在部落格內。

總統是玩家

當權三年，以耍賴皮見長，把 「我不知道」、「我看報才知道」當口頭禪的人，根本不配當總統；要用「苦肉計」轉移注意力，換取同情；用「置入行銷」騙自己的人，早就該下台。

但台灣就有如此總統，不但不下台，還要尋求連任，而國民黨竟然也沒有人敢於異議，反而是幾個聽他使喚的「中常委」，搬出唬人的「全國」大旗，組織「挺馬興台聯盟」。其他非正統的國民黨走卒只能「無力勿言」，暗爭老二自爽。

這種異象只反映馬英九個人德行與才具不足，和國民黨在台灣，坐轎與抬轎階級分明的文化 。

馬被吹捧有潘安之貌，迷倒婦女眾生，喜歡當花蝴蝶，上鏡頭，作作秀，但演技也不過是童星的裝無辜可愛和出場賣臉蛋，言行不符的耍嘴皮。

並不是說總統要當宅男，但他承擔的第一責任是台灣這個國家二千三百萬人民的幸福生活，不能以拋頭露面當玩家，每天以競選為業。看他每天的行程，盡是一些上鏡頭的紀念儀式、廟宇慶典、神明「起轎」，接見訪客，追悼會，參訪廠商，八成屬縣市長職掌。

一個自稱天主教徒的人，已把天主教義置之度外，每天參拜眾神，還依主人之命，穿起道袍哈腰上香，真不知置「總統」體統於何地！

提名大法官的正經事，卻荒腔走板。國民黨權力分配，台灣人與女性都是陪襯；馬英九二○○八年以乖寶寶造型大贏婦女票，這次怕婦女票大流失，急於找女性填補大位，結果「看報才知道」提了一個會讓更多婦女票流失的恐龍法官。

他御駕親征去挑戰反國光石化示威，媒體指為「苦肉計」，果真如此，那已是黔驢技窮，無計可施，把領導人最重要的尊嚴付之一搏。國民黨出了一個玩家總統，它的陪襯階級卻是眾士諾諾，以爭備胎為最高目標，那真是「精彩百年」的恐龍政黨。

（作者王景弘，資深新聞工作者）

實在寫得好!!!!!

 

Gabapentin可用於paresthesia-dysesthesia；FDA新批准，可用於RLS

Gabapentin (Neurontin)是用於治療seizure disorder (癲癇)、神經病變引起的疼痛(neuropathic pain、post-herpetic pain等)、major depressive disorder (憂鬱症)等的藥物。劑量通常是300 mg，一天四次左右。它是GABA之類，抑制腦細胞間聯繫(synaptic impulse)的化合物質。(下面引用的文章是討論長效型藥物，新批准使用於restless leg syndrome=RLS，服用法不一樣)

Gabapentin還有改善皮膚刺癢(paresthesia-dysesthesia，俗稱pins-and-needles)症狀的作用。劑量不必要高，100-200 mg，一天兩三次就可能有效。這是少有人討論的藥效，不過，對有此症狀的病患是很重要。

皮膚刺癢是真性多血症(polycythemia vera，PV)病患常見(40%)的症狀。因為這是非致命的症狀，很少研究。但是症狀非常惱人，可以使病人極為難受，無法工作、無法入眠。因為PV病人不知道 "刺癢" 和 "癢" 不一樣，常常稱為是皮膚癢(pruritus)，而使用antihistamine治療(無效) [我相信教科書上描寫PV的皮膚症狀為 pruritus是錯誤，應該是paresthesia-dysesthesia。兩者發生機轉不一樣: Paresthesia-dysesthesia是neuropathic pain的一種，撫擦皮膚就會舒服。Pruritus的機轉尚不明，有可能是和pain不同的神經傳導，會引起反射性搔抓，一般使用antihistamine可以抑制pruritus]。

真性多血症的皮膚刺癢一般典型的是熱水澡之後出現，不過很有可能開始時是由某些食物刺激引起(food intolerance: http://tw.myblog.yahoo.com/ccshsu-clement/article?mid=5982)，以後PV病情可能有某些變化，而成為常態性症狀。[這是筆者的疾病自身觀察的結果，因此會有後續情報。]

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April 11, 2011 — The US Food and Drug Administration (FDA) has approved gabapentin enacarbil extended-release tablets (Horizant; GlaxoSmithKline and XenoPort Inc) for the treatment of moderate-to-severe primary restless legs syndrome (RLS) in adults.

Gabapentin is the first medication in its class to be approved for the treatment of moderate-to-severe primary RLS, a statement from the companies notes. The drug's efficacy in the treatment of moderate-to-severe primary RLS was confirmed in two 12-week clinical trials in adults.

"Our experience has shown that patients with moderate-to-severe primary RLS can suffer from a range of disruptive symptoms and may benefit from a new treatment option," said Richard K. Bogan, MD, chairman and chief medical officer of SleepMed of South Carolina in Columbia, a clinical trial investigator, in the company release.

Gabapentin enacarbil extended-release tablets are absorbed via the body's nutrient transport mechanisms. The drug is then converted into gabapentin, which binds to a specific type of calcium channel receptor, with no known affinity for other receptors. However, the exact mechanism of action of this agent in treating RLS is unknown.

Gabapentin enacarbil extended-release tablets are not interchangeable with other forms of gabapentin because of differing pharmacokinetics. The same doses of this and other gabapentin products result in different plasma concentrations of gabapentin.

The newly approved drug may cause significant driving impairment, the statement notes. In three 12-week clinical trials, the 2 most commonly observed adverse reactions for the 600 mg per day (n = 163) and 1200 mg per day (n = 269) doses were lethargy (20%, 27%) and dizziness (13%, 22%), compared with 6% and 4%, respectively, with placebo (n = 245).

The recommended dosage is 600 mg once daily taken with food at about 5:00 pm. In addition, the new formulation is contraindicated for patients who need to sleep during the day and remain awake at night.

Gabapentin is an antiepileptic drug. This class of drugs has been associated with an increased risk for suicidal thoughts, depression, and mood changes.

The prevalence for RLS in adults with medically significant symptoms ranges from 1.5% to 2.7% in the United States and/or Western Europe. Diagnostic criteria for RLS include an urge to move the legs usually accompanied or caused by uncomfortable leg sensations, symptoms begin or worsen during periods of inactivity and are partially or totally relieved by movement at least as long as the activity continues, and symptoms are worse or occur only in the evening or night. Potential genetic variants of RLS may exist.

Full prescribing information is available on the GlaxoSmithKline Web site.

 

ICU病床及環境必須要徹底消毒，以減少抗藥菌持續感染

April 5, 2011 — Enhanced intensive care unit (ICU) cleaning involving disinfectant-saturated cleaning cloths, an educational campaign, and targeted feedback may reduce methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE) transmission. The risk for MRSA acquisition may also be eliminated from an MRSA-positive room occupant, according to the findings of a recent cohort study.

Rupak Datta, MPH, with the University of California Irvine School of Medicine and colleagues reported their findings in the March 28, 2011, issue of the Archives of Internal Medicine.

According to the researchers, contamination with multidrug-resistant bacteria is particularly important in ICUs, as patients are at high risk for infection from comorbidities, wounds, and the use of medical devices.

Previous studies have shown that an intervention including repeated immersion of cleaning cloths into disinfectant-filled containers, cleaning efficiency feedback, and an educational campaign reduced MRSA and VRE room contamination. The current retrospective cohort study was designed to assess the effect of this cleaning intervention on the risk for MRSA and VRE acquisition from prior room occupants.

A total of 9449 patients admitted to 10 ICUs at a 750-bed academic medical center from September 1, 2006, through April 30, 2008, during the enhanced cleaning intervention, were compared vs a baseline of 8203 patients admitted from September 1, 2003, through April 30, 2005.

The enhanced cleaning intervention resulted in a reduction in MRSA and VRE vs baseline. MRSA was reduced from 3.0% to 1.5% (P < .001), and VRE was reduced from 3.0% to 2.2% (P < .001). Patients in rooms previously occupied by carriers showed increased contamination in the baseline group (3.9% vs 2.9%; P = .03) but not in the intervention group (1.5% vs 1.5%; P = .79) for MRSA. However, for VRE, an increased risk was seen at baseline (4.5% vs 2.8%; P = .001) and during intervention (3.5% vs 2.0%; P < .001).

Additional studies to evaluate the differential effect of enhanced cleaning on MRSA and VRE are needed. This may be especially applicable to healthcare settings with a high prevalence of VRE where rigorous cleaning methods may be indicated.

The study was supported by the National Institutes of Health. The study authors have disclosed no relevant financial relationships.

Arch Intern Med. 2011;171:491-494. Abstract

 

治療 C. difficile: 使用Fidaxomycin 比 vancomycin 好!

April 5, 2011 — The experimental antibiotic fidaxomicin (Optimer Pharmaceuticals Inc) has won a hearty endorsement from the US Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee for the treatment of life-threatening Clostridium difficile–associated diarrhea.

The committee unanimously agreed that fidaxomicin was safe and effective, although a few panel members voiced concerns about safety in pregnant women, the elderly, and people with a compromised immune system in the discussion that followed the vote. Some of the panel were also concerned about gastrointestinal bleeding, which occurred more often with fidaxomicin than with vancomycin.

The positive reception was forecast last week when FDA reviewers released documents stating that fidaxomicin worked as well as its comparator, the older antibiotic vancomycin, in fighting C difficile infections.

According to FDA documents, fidaxomicin, which Optimer plans to market as Dificid, is a macrolide antibacterial with an 18-membered ring that is microbiologically active against C difficile. It has a narrow-spectrum antibacterial profile, has bactericidal activity against C difficile, is poorly absorbed, and exerts its activity in the gastrointestinal tract.

The panel thought the 2 studies presented by Optimer were very well done.

"I voted yes because the trials were rigorously done," said Yu Shyr, PhD, from Vanderbilt University School of Medicine, Nashville, Tennessee, who was one of the statisticians on the panel.

William Hasler, MD, professor of internal medicine at the University of Michigan, Ann Arbor, said the data were strong. "In fact," he said, "I think the data suggests this drug is superior to vancomycin." He added that he had some minor concerns about the risks of gastrointestinal bleeding and leukopenia, "but I believe these are relatively minor and can be followed postmarketing."

The acting chair of the committee, Matthew Goetz, MD, professor at the David Geffen School of Medicine at the University of California, Los Angeles, added that he too was concerned about leukopenia. Although this concern did not prevent him from voting for approval, leukopenia is something that warrants further observation, he said.

Several panel members were pleased that Optimer had considered the pediatric age group. "Undoubtedly it will be used in that population, and I applaud the company for having a plan in place for looking at pediatric patients," said Sheldon L. Kaplan, MD, professor at Baylor College of Medicine in Houston, Texas.

Archana Chatterjee, MD, PhD, professor of pediatrics at Creighton University School of Medicine in Omaha, Nebraska, noted that C difficile–associated diarrhea, although clearly a significant problem in adults (especially the elderly), is increasingly becoming a concern in children.

"These are the patients I care for," she said. "For the first time I have come to this committee meeting and I do not have to plead for a plan for a formulation for children, so I congratulate that company for having a plan for them."

FDA Anti-Infective Drugs Advisory Committee; Hilton Washington, DC; Silver Spring, Maryland; April 5, 2011.