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【2007ESC年会】临床试验要确保妇女得到最佳治疗

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Large trials needed to ensure women get optimal treatment (OASIS)

Professor Eva Swahn

A CALL FOR WOMEN-ONLY trials to determine the best approach in non ST-elevation acute coronary syndromes (NTSE ACS) was made in a Hot Line Session yesterday. Behind the call were “alarming” new results suggesting that a routine invasive approach in NTSE ACS may be actively harmful in women.

Professor Eva Swahn, from the University Hospital in Linköping, Sweden, descibed a small randomised trial in women with NSTE ACS. The OASIS 5 women sub-study compared early routine coronary angiography (and, if appropriate, coronary revascularisation within seven days) with a wait-and-see approach in which coronary angiography was performed only when women had signs or symptoms of angina.

The study included 184 patients and was too small to provide conclusive evidence. However, the trends were worrying, said Swahn. There was no significant difference in rates of myocardial infarction (MI), worsening of angina, or stroke. But at one year, eight patients in the early invasive group had died (all cardiovascular deaths), compared with one patient (from bleeding) in the wait-and-see group. The difference persisted at two years.

This finding adds yet more confusion to determining the best strategy for women with NTSE ACS. The first suggestion of a problem with a routine invasive approach in women came from the FRISCII study in 2001, which was then backed by findings from RITA3 in 2002.

However, these results were contradicted by TACTICS, also in 2002, which found higher rates of MI deaths in the wait-and-see group.

“With such alarming results in our very small trial,” she said, “we need to conduct a large randomised trial to determine the safety and efficacy of an early invasive approach in women.”

This may be easier said than done. The current study was intended to include 1600 women, but far fewer were actually recruited. All but three subjects were in Sweden and Poland; six countries in the larger OASIS study did not recruit for the women sub-study at all.

Swahn said that many doctors were reluctant to include women specifically in the sub-study because they would receive different treatment from the standard approach in men. But she said: “Only large studies will show for certain that we are treating women in the best way for women, and men in the best way for men.”

Possible explanations for the gender difference include higher rates of bleeding among women, and differences in the optimal doses of medication. But, said Swahn, “we do not have the answer to these questions.”

http://www.escardio.org/congresses/esc_congress/esc2007/news/HLIIFinesseEllisVDWerf.htm

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2007-09-05 12:36 浏览 : 650 回复 : 3

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本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。

2007-09-26 14:16

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Large trials needed to ensure women get optimal treatment (OASIS)
开展大规模临床试验以确保女性获得最佳治疗

Professor Eva Swahn

A CALL FOR WOMEN-ONLY trials to determine the best approach in non ST-elevation acute coronary syndromes (NTSE ACS) was made in a Hot Line Session yesterday. Behind the call were “alarming” new results suggesting that a routine invasive approach in NTSE ACS may be actively harmful in women.
昨天一个电话会议中确定了一项女性临床试验，以确定治疗非st段抬高急性冠脉综合征（NTSE ACS）的最佳方法。这项决定源于一个令人震惊的新的研究结果：目前关于NTSE ACS的常规介入治疗可能对女性有很大副作用。

Professor Eva Swahn, from the University Hospital in Linköping, Sweden, descibed a small randomised trial in women with NSTE ACS. The OASIS 5 women sub-study compared early routine coronary angiography (and, if appropriate, coronary revascularisation within seven days) with a wait-and-see approach in which coronary angiography was performed only when women had signs or symptoms of angina.
瑞典Linköping医科大学的Eva Swahn教授开展了一项针对女性NTSE ACS患者的小规模临床随机试验。OASIS-５研究中，观测治疗对照组的女性出现心绞痛的症状或指征时，才实施冠状动脉造影术。从而与早期常规冠状动脉造影术（通常在7天内进行冠状动脉造影术）进行比较。

The study included 184 patients and was too small to provide conclusive evidence. However, the trends were worrying, said Swahn. There was no significant difference in rates of myocardial infarction (MI), worsening of angina, or stroke. But at one year, eight patients in the early invasive group had died (all cardiovascular deaths), compared with one patient (from bleeding) in the wait-and-see group. The difference persisted at two years.
Swahn认为该项研究包括了184名患者，虽然规模太小不能提供结论性的证据，但是这种潜在可能还是需要引起人们的注意。两组患者心肌梗死塞（MI）死亡率、心绞痛加重率以及卒中发生率差别无统计学意义。但是一年内，早期介入治疗组有8名患者死于心脏病，而观测治疗组有1名患者死于出血。这种差别持续2年。

This finding adds yet more confusion to determining the best strategy for women with NTSE ACS. The first suggestion of a problem with a routine invasive approach in women came from the FRISCII study in 2001, which was then backed by findings from RITA3 in 2002.
然而这项研究给如何确定NTSE ACS的最佳治疗方案带来了更多的困惑。关于对女性采用常规介入治疗问题的第一个建议来源于2001年的FRISCII研究，2002年的RITA3研究也支持了这一建议。

However, these results were contradicted by TACTICS, also in 2002, which found higher rates of MI deaths in the wait-and-see group.
但是这些结果和2002年的TACTICS相矛盾，TACTICS发现等待治疗组有更高的心肌梗塞死亡率。

“With such alarming results in our very small trial,” she said, “we need to conduct a large randomised trial to determine the safety and efficacy of an early invasive approach in women.”
Swahn说：“我们这次小规模的临床试验获得令人担忧的结果，我们需要进行一次大规模的随机试验以确定对女性开展早期介入治疗的安全性和有效性。”

This may be easier said than done. The current study was intended to include 1600 women, but far fewer were actually recruited. All but three subjects were in Sweden and Poland; six countries in the larger OASIS study did not recruit for the women sub-study at all.
但是说起来容易做起来难。目前的研究预计包含1600名女性患者，但极少数是实际招募的。仅有的3个受试中心在瑞典和波兰。大规模的OASIS研究中有6个国家根本没有招募对照组的女性患者。

Swahn said that many doctors were reluctant to include women specifically in the sub-study because they would receive different treatment from the standard approach in men. But she said: “Only large studies will show for certain that we are treating women in the best way for women, and men in the best way for men.”
Swahn认为许多医生不愿意将女性患者列入对照组，因为她们接受的治疗不同于男性患者采用的常规治疗方法。但是她认为只有大规模的研究才能够正确揭示我们分别治疗女性和男性患者的最佳疗法。

Possible explanations for the gender difference include higher rates of bleeding among women, and differences in the optimal doses of medication. But, said Swahn, “we do not have the answer to these questions.”
性别差异的可能解释包括女性更高的出血率、药物适合剂量的差别。但是Swahn也承认目前对这些问题还没有答案。

2007-09-27 15:41

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叮当痒痒编辑于 2007-09-28 11:32

• 腹痛数日

叮当痒痒

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编译：【2007ESC年会】临床试验要确保妇女得到最佳治疗

　　2007ESC年会的一个电话会议中确定了一项女性临床试验，用以确定治疗非st段抬高急性冠脉综合征（NTSE ACS）的最佳方法。

　　这项决定源于瑞典Linköping医科大学的Eva Swahn教授所做的研究。Swahn教授开展了一项针对女性NTSE ACS患者的小规模临床随机试验，得出一个令人震惊的研究结果：目前关于NTSE ACS的常规介入治疗可能对女性有很大副作用。

　　OASIS-5研究中，只有当观测治疗对照组的女性出现心绞痛的症状或指征时，才实施冠状动脉造影术。从而与早期常规冠状动脉造影术（通常在7天内进行冠状动脉造影术）患者进行比较。

　　研究共包括184名患者，虽然规模太小不能提供结论性的证据，但是这种潜在可能还是需要引起人们的注意。两组患者心肌梗死塞（MI）死亡率、心绞痛加重率以及卒中发生率差别无统计学意义。但是一年内，早期介入治疗组有8名患者死于心脏病，而观测治疗组有1名患者死于出血。这种差别持续2年。

　　然而这项研究给如何确定NTSE ACS的最佳治疗方案带来了更多的困惑。关于对女性采用常规介入治疗问题的第一个建议来源于2001年的FRISCII研究，2002年的RITA3研究也支持了这一建议。但是这些结果和2002年的TACTICS相矛盾，TACTICS发现等待治疗组有更高的心肌梗塞死亡率。

　　Swahn说：“我们这次小规模的临床试验获得令人担忧的结果，我们需要进行一次大规模的随机试验以确定对女性开展早期介入治疗的安全性和有效性。”

　　但是说起来容易做起来难。目前的研究预计包含1600名女性患者，但极少数是实际招募的。仅有的3个受试中心在瑞典和波兰。大规模的OASIS研究中有6个国家根本没有招募对照组的女性患者。

　　Swahn认为许多医生不愿意将女性患者列入对照组，因为她们接受的治疗不同于男性患者采用的常规治疗方法。但是她认为只有大规模的研究才能够正确揭示我们分别治疗女性和男性患者的最佳疗法。性别差异的可能解释包括女性更高的出血率、药物适合剂量的差别。但是Swahn也承认目前对这些问题还没有答案。

2007-09-27 15:42

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叮当痒痒编辑于 2007-09-28 11:34

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