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　　6月14日，歐洲藥品管理局（EMA）發(fā)布聲明指出，藥品風(fēng)險評估委員會（PRAC）建議將羥乙基淀粉退市。

　　PRAC對于羥乙基淀粉的裁決是基于發(fā)表在NEJM上的三項重要研究，這些研究對比了HES以及其他液體復(fù)蘇液對危重癥患者的療效和安全性。

　　第一項研究表明，6%HES用于液體復(fù)蘇并不優(yōu)于生理鹽水，而且HES還與患者腎臟損傷的高風(fēng)險率有關(guān)。（NEJM：Hydroxyethyl starch or saline for fluid resuscitation in intensive care.)

　　第二項研究表明，使用羥乙基淀粉的危重癥患者與使用乳酸林格液的患者相比有更高的死亡風(fēng)險。（NEJM：通過羥乙基淀粉進行復(fù)蘇治療的ICU患者存在更高的腎臟損傷風(fēng)險）

　　第三項研究表明，HES對于嚴重毒血癥患者“有害并且毒副作用會隨著累積劑量增加而升高”。（NEJM：羥乙基淀粉130/0.4治療嚴重膿血癥效果不佳）

　　基于以上研究結(jié)果，EMA授權(quán) PRAC對這些研究結(jié)果進行評估，并評估羥乙基淀粉在低血容量性患者中的風(fēng)險收益比。PRAC指出，羥乙基淀粉臨床受益不比高于臨床風(fēng)險，建議羥乙基淀粉在歐洲退市。

　　EMA指出，除非有權(quán)威部門有足夠的證據(jù)可以證明羥乙基淀粉對一些患者群體的臨床受益高于風(fēng)險，否則退市的裁決應(yīng)該不會改變。

　　歐盟下屬的協(xié)調(diào)機構(gòu)（the Coordination Mutual Recognition and Decentralised Procedures–Human）將酌情考慮EMA的這一建議，并作出最終裁決。

　　針對近來關(guān)于羥乙基淀粉的報道，以及發(fā)表在NEJM上面的研究。我們對NEJM：羥乙基淀粉130/0.4治療嚴重膿血癥效果不佳 這項研究的通訊作者Dr. Perner進行了采訪：

　　DXY: Recently, several famous medical journals (such as NEJM, BMJ, JAMA) have pointed out that HES has many adverse reactions. However, HES has been used in clinical for a long time. My question is, does this indicate the end of HES in the treatment of all its indications?

　　DXY: 近期，多家頂級期刊（如NEJM, BMJ, JAMA) 發(fā)表了對HES不利的研究結(jié)果。這是否意味著HES的終結(jié)。

　　Dr. Perner: Maybe, depending on the postion taken by EMA, see the attachment.

　　Dr. Perner:有可能，這取決于的歐洲藥品管理局實施的地域。詳見附件。

　　DXY: To get a general understanding of Chinese doctor's usage and attitudes towards HES, we have done a survey among professional members of our DXY.CN. More than seven thousand doctors participated in this survey, and the result shows that large numbers of Chinese doctors use HES normally in their medical orders, especially in ICU and Anesthesiology. Many doctors think HES has a good clinical effect and the adverse reaction is slim, and this is obviously contrary to the results of many researches. What's your opinion on such a difference between the clinic practice and research results？

　　DXY: 為了了解中國醫(yī)生對羥乙基淀粉的臨床使用情況和態(tài)度，我們做了一項調(diào)查。這份調(diào)查有7000余名醫(yī)生參與。調(diào)查結(jié)果表明，非常多的中國醫(yī)生在臨床中經(jīng)常使 用羥乙基淀粉，ICU醫(yī)生和麻醉科醫(yī)生甚至常規(guī)使用。而且，很多醫(yī)生認為羥乙基淀粉臨床效果尚可，且不良反應(yīng)輕微。這與研究結(jié)果并不一致，您怎么看待臨床 醫(yī)生實踐與研究結(jié)果之間的差異？

　　Dr. Perner: For HES, high quality data have only been published in the last year. These data indicate that the effects of HES is only marginally better than crystalloid solutions, if at all, and that the side effects results in overall harm at least in critically ill patients. Now clinicians, guideline committee members and policy-makers should adopt these results and translate them into a change in clinical practice to ensure patient safety.

　　Dr. Perner:關(guān)于羥乙基淀粉的高質(zhì)量數(shù)據(jù)僅在去年發(fā)表過，這些數(shù)據(jù)表明，羥乙基淀粉與晶體溶液相比，沒有優(yōu)勢，而且在危重癥病人中副作用明顯?，F(xiàn)在，臨床醫(yī)師、指南委員會成員以及策略制定者應(yīng)吸納這些研究結(jié)果，并使其在臨床應(yīng)用的轉(zhuǎn)變中有所體現(xiàn)，以確保患者的安全。

　　DXY: HES holds large proportion of the market in China, and such bad news may be fatal to this medicine . I wonder what's the size of HES's market in Europe and what difference has this result made in the medical circle of Europe?

　　DXY: 羥乙基淀粉在中國市場份額巨大，這種消息對于羥乙基淀粉無疑是致命一擊。羥乙基在歐洲的市場份額有多大，這將會對歐洲醫(yī)藥界產(chǎn)生多大的影響？

　　Dr. Perner: Here in Europe my impression is that HES use has declined dramatically; in some countries sale no. are down to 30% of what they were prior to the publications of the large trials.

　　Dr. Perner:在我看來，羥乙基淀粉在歐洲的應(yīng)用已經(jīng)急劇下降，在一些國家的消瘦量相比該大型試驗結(jié)果發(fā)表之前下降到僅剩三成。

　　DXY: Some studies showed that HES is related to increased risk of kidney injuries. And I have noticed that the primary outcome in your study was “either death or end-stage kidney failure”. Does the death rate here mean “all-cause mortality”? If we do a “kidney-related mortaliy” subgroup analysis, would it make a difference on the results?

　　DXY: 不少研究表明羥乙基淀粉對腎臟有一定毒性，我注意到您在研究中的首要終點為死亡率和90天后末期腎功能衰竭，這里的死亡率應(yīng)該是全因死亡率吧？如果對腎臟引起的死亡率進行單獨的分析，結(jié)果會有所不同么？

　　Dr. Perner: The mortality rates are all cause mortality. We have not assessed ‘kidney-related mortality’, but those patients that received dialysis had markedly increased mortality compared to those who did not.

　　Dr. Perner:該死亡率指的是全因死亡率。我們并沒有評估“腎臟相關(guān)死亡率”，但接受透析病人的死亡率比未接受透析病人的死亡率有明顯的升高。

　　DXY: In this study, you chose “Modified Intention-to-treat (ITT) population” for analysis, which means the analysis was based on patients’ assigned treatment, regardless of what treatment they really got. I was wondering why chose Modified ITT over pre-protocol analysis, which was based on the actual treatment patients got?

　　DXY: 您在研究中選擇了“改良后意向治療（Modified Intention-to-treat, ITT）人群”，也就是基于最初的治療意愿進行分析的方法，不考慮患者在試驗中實際接受的治療。您為何會選擇意向治療人群呢？如果按“符合方案集（Pre-protocol, PP）分析”進行研究對結(jié)果會有怎樣的影響呢？

　　Dr. Perner: ITT analyses are preferred in general because the risk of bias is lower than with per-protocol analyses. We did two per-protocol analyses and found results comparable to the ITT analysis.

　　Dr. Perner:我們一般首選ITT分析，因為它的偏倚風(fēng)險率藥低于其他符合方案分析。我們進行了兩種符合方案分析，其結(jié)果與ITT分析結(jié)果相符。

　　DXY: Are there any explanations or mechanism studies about the impaired kidney function related to HES?

　　DXY: 目前學(xué)術(shù)界對羥乙基淀粉引起腎臟損傷風(fēng)險有沒有什么解釋？其機制大致如何呢？

　　Dr. Perner: In our data, we have no mechanistic explanations, but others have found HES in kidney and other biopsies, so it may be that HES is deposited in tissues where it cannot be metabolised or excreted and therefore act as a foreign body.

　　Dr. Perner:在我們的研究數(shù)據(jù)中并沒有解釋其機制，但其他研究有在腎臟及其他組織中發(fā)現(xiàn)羥乙基淀粉，這可能是由于羥乙基淀粉進入到不能被代謝或排除的組織中，成為了體內(nèi)異物。

　　DXY: In the article published in NEJM, you mentioned that “if (the trial fluid) doses higher than the maximum daily dose were required, unmasked Ringer’s acetate was used, regardless of the treatment assignment”. My question is, should these patients use HES and Ringer’s acetate together to achieve the required dose, or should they only take Ringer’s acetate without assigned treatment? If it’s the former situation, could there be any interaction between HES and Ringer’s acetate? Have you done a subgroup analysis of “HES+ Ringer’s acetate” combined therapy?

　　DXY: 您在文章中提到，不論患者最初應(yīng)接受HES還是醋酸鈉林格，一旦患者需要的劑量超出了最大劑量，直接給予患者醋酸鈉林格溶液。我的問題是，是在患者分配到的藥的基礎(chǔ)上聯(lián)合醋酸鈉林格溶液，還是直接換用醋酸鈉林格，不接受分配的藥？如果是前一種情況，HES和醋酸鈉林格之間有沒有什么相互影響，研究有沒有進行“HES+Ringer”亞組分析？

　　Dr. Perner: The patients recieved either masked HES or Ringers to the maximum dose (33 ml/kg/d). If they then needed more on that day they received Ringers.

　　Dr. Perner:患者被給予最大劑量（33ml/kg/d）的羥乙基淀粉或林格溶液，如果一天內(nèi)他們還需要更大劑量，則繼續(xù)給予林格溶液。

　　DXY: What kind of plasma volume expander would you recommend in the condition of severe sepsis?

　　DXY: 在如今嚴重膿血癥的治療中，您推薦哪種血容量擴張藥？

　　Dr. Perner: Based on the results of the high quality trials and systematic reviews, I recommend to use crystalloids (saline or Ringers) as the Surviving Sepsis Campaign do.

　　Dr. Perner:這要依據(jù)高質(zhì)量試驗結(jié)果和系統(tǒng)回顧，我推薦使用晶體溶液（生理鹽水或林格溶液）作為膿血癥的搶救措施。