Re: [討論] 修改捐血者健康標準
Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products
http://tinyurl.com/zf4zdcb
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidance/Blood/UCM446580.pdf
※ 引述《RayBoku (一任階前點滴到天明)》之銘言:
: 然根據美國食品藥物管理局去年公布的《減少血品傳播人類免疫缺乏病毒之修正建議》,
: 其中承認:禁止男性間性行為者捐血是一種歧視;而隨著醫療進步,此防堵策略的好處也
原文是 the indefinite policy is perceived by some as discriminatory
有些人覺得和FDA認為好像是兩回事...
1.MSM危險性多高?
原文第4頁
MSM ... a small percentage of... U.S. male...(approximately 7% of men ...
ever...MSM, approximately 4% ...MSM activity...in...last 5 years)
Among persons...with HIV...2012, ...56% were MSM.
In 2010, majority of new HIV attributed to male-to-male sexual...
63% among all adults and 78% among men,
新HIV感染者中MSM過半,但MSM只佔人口7%,估計危險性應該遠遠遠高於多重異性伴侶者?
2.美國MSM捐血者有效自我篩選
第6頁
prevalence...HIV infection in male blood donors...reported...MSM...0.25%,
...much lower than...11-12% HIV prevalence in ...regular MSM behavior
This indicates...considerable self-selection likely took place in individuals
who presented to donate.
3.澳洲比較從終身改成1年限制前後5年資料
第6頁
During the five years before and five years after a change from a lifetime
deferral to a one-year deferral in Australia, there was no change in
risk to the blood supply, defined by the number of HIV positive donations
per year and the proportion of HIV-positive donors with male-to-male sex
as a risk factor.
https://www.ncbi.nlm.nih.gov/pubmed/20663106
The proportion of HIV-positive donors with male-to-male sex as a risk factor
in Period 1 was 2 in 15 (13.3%), which was not significantly different from
the proportion in Period 2, 5 in 16 (31.25%; p=0.22).
從13.3%變成31.2%,然後說統計上沒有顯著差異...
要是一個新糖尿病藥物做個100人trial然後發現兩組沒統計差異,FDA會放他過嗎?
從那個數字來看odds ratio(OR)=(5/11)/(2/13)=2.95, RR=(5/16)/(2/15)=2.34
不管是OR還是RR都遠大於1.3,不可能通過non-inferiority標準
(至少要落在1.3以下才有可能通過1.3的non-inferiority ratio檢定)
所以如果美國用這個數據來說一定不會增加基本上是錯誤的,只能說沒證據顯示會增加
話說回來,所謂實證的舉證責任到底該歸於哪一方?
是要由贊成終生禁止者來證明只禁止1年會增加風險才該繼續禁止?
還是由反對終生禁止者來做non-inferiority trial來證明絕對不會增加風險才能解禁?
美國FDA在糖尿病藥物上是要求藥商負舉證責任做心血管風險trial來證明
之前的食安事件多數人也會選擇讓食品商負舉證責任,而非沒實證證明有害就放行...
而不同文化因素也可能影響結果,美國MSM有效自我選擇才沒有釀成大禍,
若放在酒駕盛行的台灣島上,不知結果是否還能一樣?
當然還有一種方法就是做完整"血品履歷",然後健保卡中加一格血品傾向欄位,
願意接受各種高風險捐血者的受血人填書面意願書給健保署登錄,
然後當需要輸血時,這些人優先使用其選定的高風險族群血品使用...
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11/04 14:23, , 1F
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具體時程可以是等到登記願意接受高風險族群的比率達一定門檻後
再開始接受高風險族群捐血並開始血品履歷制度,
如果那些人真的有意願也有空去聯署,相信應該也有空去登錄血品傾向 XD
當然我是不太看好啦,所以還是認為應該維持現行終身禁捐制度,
至於那些不順從捐血者,就修法提高刑責,至少要高於公共危險罪和酒駕的刑責,
實際造成受血者感染者課以殺人未遂罪同等刑責,
受血者感染而死亡者,課以故意殺人罪同等刑責
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prospective比較難,retrospective比較容易,而多數司法手段也都是retrospective的
一旦血品驗出MSM相關傳染病,一律移送檢調偵辦...
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既然沒獲利,受血者也不想接受,何苦來哉? XDD
話說回來酒駕也沒獲利.....
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請問酒駕撞到人和疲勞駕駛撞到人有什麼區別?
msm和多重異性伴侶最大的差異在於msm一方把性器放入另一方單層柱狀上皮結構中摩擦,
造成感染率遠遠高於異性放入對方的多層鱗狀上皮結構(陰道)
簡言之,異性性行為是天然符合生理結構的,msm不是,
而如果回到遠古時代擺脫一切禮教束縛,究竟是單一異性伴侶較天然?
還是多重異性伴侶較天然則未可知 XD
既然是醫學生版,不妨來看看組織學
https://en.wikipedia.org/wiki/Epithelium
https://upload.wikimedia.org/wikipedia/commons/8/8f/Illu_epithelium.jpg
![](https://upload.wikimedia.org/wikipedia/commons/8/8f/Illu_epithelium.jpg)
裡面何者物理防禦率最高應該顯而易見
(口腔和陰道同屬非角質化鱗狀上皮...)
肛門的anatomy與squamocolumnar junction
http://analcancerinfo.ucsf.edu/anatomy-anus
anorectal junction的histology
http://tinyurl.com/zxqgkml
https://www.google.com.tw/search?tbm=isch&q=anorectal+junction+histology
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這就像我國健保DRG為何不願意像國外醫療保險分非常細一樣,
分越細當然越能按風險分級,但是行政成本也越高,
MSM風險確定是遠高於多重性伴侶,這是一個高效且具因果相關的合理歧視分類
MSM暫緩一年的風險可能還是高於多重性伴侶暫緩一年?
醫學上永遠有false positive與false negative的問題,
什麼樣的頭痛病人該排CT? 所謂的低風險群裡面就沒有腦出血嗎? 每個人都排CT好不好?
每個急診醫師都有空在那邊算腦出血風險score嗎?
從醫療經濟的角度,找出相關性最高又相對簡便的分類,可以減少醫療失誤,達到最高效率
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如果多數人持相同看法,捐血中心當初可能就不是這樣訂了 XD
話說回來,MSM風險既然比多重性伴侶高,一個退學一個留校查勘尚符比例原則...
當然隨著IT技術進步,uber和網路電商市佔逐漸擴大,
血品履歷與受血者自主血品選擇未來幾十年內應該會水到渠成
多數人可以得到滿足,除了那些連署卻又不想申報血品傾向的之外(如果存在的話)
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※ 編輯: hahawow (123.192.234.22), 11/04/2016 17:12:22
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※ 編輯: hahawow (123.192.175.105), 11/05/2016 11:15:10
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