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【medical-news】老药新用：利福喷丁可治疗结核

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Potent Treatment For Tuberculosis Found To Be Older Rarely-Used Antibiotic

Although Rifapentine is already approved for use in humans, it has no current market, not even a prescription price. Its makers stopped commercial production years ago, because demand was so low. But an antibiotic long abandoned as a weak, low-dose treatment for tuberculosis (TB) may have found renewed purpose, this time as a potent, high-dose fighter against the most common and actively contagious form of the lung disease.

"Rifapentine is back," says Johns Hopkins infectious disease specialist Eric Nuermberger, M.D., whose studies in mice, to be published in the Public Library of Science journal PLoS Medicine online Dec. 17, have found it so promising as an initial treatment for active TB that clinical trials are scheduled to begin next year in at least eight countries.

The mouse studies showed that substituting higher and daily doses of rifapentine for another antibiotic, rifampin, cured mice two to three times faster than the much older, standard regimen of drugs that includes rifampin. Researchers say if tests in people confirm the findings in mice, the average time to clear the potentially fatal bacterial infection could be reduced from six months to three or less.

"People infected with TB are desperate for better therapies to combat the infection, therapies that can work more quickly and thus limit its chances to spread," says Nuermberger, who headed the team of researchers from Hopkins and elsewhere. "And having the ability to more effectively treat the most common form of the disease, so-called drug-susceptible TB, is a key step in holding off multidrug-resistant strains from developing, too."

"It's a huge advantage to have a drug that's already government approved and an equally great surprise to know that it was there all the while," says Nuermberger, an assistant professor at The Johns Hopkins University School of Medicine. He says that phase II clinical trials will begin as quickly as possible by mid-2008 to gauge the effectiveness of rifapentine as a key component to daily, anti-TB drug regimens.

The nonprofit Global Alliance for TB Drug Development (GATB) estimates that worldwide, more than 9 million people are infected with the highly contagious and active form of TB, caused by Mycobacterium tuberculosis; experts say another 424,000 are infected with the more dangerous, multidrug-resistant form of the disease.

Most of the antibiotics currently used to treat TB, Nuermberger notes, were developed in the 1950s or 1960s, and few new medications have appeared since.

Rifapentine, approved by the U.S. Food and Drug Administration in 1998 for treating widespread, drug-susceptible TB, was initially developed as a less cumbersome, once-weekly tablet. But the drug "was never really considered effective in low doses when compared to the gold standard, daily, high-dose regimens with rifampin," says Nuermberger. Rifampin (sold as Rifadin and Rimactane) was F.D.A. approved in 1968.

The potential for shortened treatment times follows an advance by the team's top scientist, Richard Chaisson, M.D., director of Hopkins' Center for TB Research, in October. Chaisson and his group showed that moxifloxacin (Avelox), another antibiotic, when substituted for ethambutol (Myambutol), may cut treatment times from six months to four.

Nuermberger and his team investigated the high-dose potential of rifapentine because the drug was in the same class of drugs as rifampin, which is part of the standard antibiotic cocktail of rifampin, pyrazinamide, and isoniazid, a triple drug combo sold as Rifater, or with moxifloxacin in place of isoniazid.

Given as part of Directly Observed Therapy Short-Course, or DOTS for short, because the drugs are usually given in direct view of a caregiver to ensure compliance, the regimen requires several daily doses for six to nine months. DOTS cures 95 percent of those treated, but the lengthy treatment period has proven a problem for patients, who sometimes miss taking their drugs on time, minimizing the therapy's effectiveness.

In the new study, Nuermberger and his team tested seven different combinations of antibiotic drugs in hundreds of mice infected with active TB. Some were treated with the standard DOTS regimen, daily Rifater, while others took rifapentine in place of rifampin. Rifapentine, in daily amounts similar to what an adult human would take (600 milligrams), was also tested separately in combination with moxifloxacin- or isoniazid-based DOTS regimens.

Blood and tissue testing were done over a six month period to see how quickly each drug combination rid the body of active TB. Treated mice were also tested three months later to check against any potential for relapse.

After 10 weeks of drug therapy, mice taking rifapentine and moxifloxacin tested negative for active TB and remained so when retested three months later. Those treated with rifapentine and isoniazid also tested clear of the bacterium by 10 weeks, but were at least 10 percent more likely to relapse unless treatment persisted for another month. Meanwhile, the traditional DOTS regimen mostly took the full six months to work.

Results showed a distinct advantage in using rifapentine over rifampin, with rifapentine having remained in the blood in three times higher concentrations throughout treatment, indicating the drug's "longer-lasting action," says Nuermberger.

Two clinical trials are scheduled to study high-dose and daily combinations with rifapentine. The first is being spearheaded by Chaisson and will take place in Brazil. The second will be led by Hopkins researcher Susan Dorman, M.D., and scientists from the U.S. Centers for Disease Control and Prevention, and will study those infected in 40 cities in six countries around the world.

http://www.medicalnewstoday.com/articles/92151.php

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2007-12-19 12:44

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Potent Treatment For Tuberculosis Found To Be Older Rarely-Used Antibiotic
治疗肺结核的潜在药是很少使用的老抗生素
Although Rifapentine is already approved for use in humans, it has no current market, not even a prescription price. Its makers stopped commercial production years ago, because demand was so low. But an antibiotic long abandoned as a weak, low-dose treatment for tuberculosis (T may have found renewed purpose, this time as a potent, high-dose fighter against the most common and actively contagious form of the lung disease.
尽管利福喷丁被认可用于治疗，它现在没有市场，甚至没有一个合适的价格。因为它的需求很少，所以它的生产者已经在数年前停止商业生产了。但是这个长时间不被关注的抗生素被发现以较低的剂量可以用于治疗肺结核，现在可以作为一个潜在的高剂量的治疗药用于这种最常见且传染性强的肺病。
"Rifapentine is back," says Johns Hopkins infectious disease specialist Eric Nuermberger, M.D., whose studies in mice, to be published in the Public Library of Science journal PLoS Medicine online Dec. 17, have found it so promising as an initial treatment for active TB that clinical trials are scheduled to begin next year in at least eight countries.
“利福喷丁回来了，” Eric Nuermberger医学博士、传染病专家Johns Hopkins这么说，他在小鼠的实验发现它很有希望成为肺结核的有利治疗药物，而临床实验将计划于明年在至少八个国家进行，他的研究结果将在12.17的the Public Library of Science journal PLoS Medicine在线发表。
The mouse studies showed that substituting higher and daily doses of rifapentine for another antibiotic, rifampin, cured mice two to three times faster than the much older, standard regimen of drugs that includes rifampin. Researchers say if tests in people confirm the findings in mice, the average time to clear the potentially fatal bacterial infection could be reduced from six months to three or less.
小鼠实验显示每日服用更高剂量的利福喷丁以代替另一种抗生素利福平，可以比标准服用药物包括利福平在内，治愈率高了两到三倍。研究者说如果在人身上的实验结果证实了在小鼠上的发现，那么清除潜在的细菌感染将从六个月减少到三个月甚至更短。
"People infected with TB are desperate for better therapies to combat the infection, therapies that can work more quickly and thus limit its chances to spread," says Nuermberger, who headed the team of researchers from Hopkins and elsewhere. "And having the ability to more effectively treat the most common form of the disease, so-called drug-susceptible TB, is a key step in holding off multidrug-resistant strains from developing, too."
“感染肺结核的病人会不顾一切的治疗来克服感染，较快起效的治疗从而限制其扩散的速度，” Nuermberger说，他是Hopkins和其他地方研究小组的组长，“对这种最常见形式的疾病，所谓的药物敏感性的肺结核的最有效治疗方式，其关键步骤是延迟其发病过程中的多重耐药性。”
"It's a huge advantage to have a drug that's already government approved and an equally great surprise to know that it was there all the while," says Nuermberger, an assistant professor at The Johns Hopkins University School of Medicine. He says that phase II clinical trials will begin as quickly as possible by mid-2008 to gauge the effectiveness of rifapentine as a key component to daily, anti-TB drug regimens.
“这是一个很大的优势，有一个政府已经批准的药物，同时我们恨惊讶地发现它一直在这里，”Nuermberger说，他是Johns Hopkins University School of Medicine的副教授。他说二期临床试验将在2008年中期开展，从而评价利福喷丁作为一个治疗肺结核的关键成分的有效性。
The nonprofit Global Alliance for TB Drug Development (GAT) estimates that worldwide, more than 9 million people are infected with the highly contagious and active form of TB, caused by Mycobacterium tuberculosis; experts say another 424,000 are infected with the more dangerous, multidrug-resistant form of the disease.
非盈利的全球肺结核药物研发联盟估计全世界有超过9百万的病人感染了这种高传染性和激活型的肺结核，是由结核分枝杆菌引起的，专家说还有424,000的人感染感染了更危险的多重耐药型肺结核。
Most of the antibiotics currently used to treat TB, Nuermberger notes, were developed in the 1950s or 1960s, and few new medications have appeared since.
大多数治疗肺结核的抗生素药物是在19世纪50，60年代研发出来的，近年来没有什么新药，Nuermberger说。
Rifapentine, approved by the U.S. Food and Drug Administration in 1998 for treating widespread, drug-susceptible TB, was initially developed as a less cumbersome, once-weekly tablet. But the drug "was never really considered effective in low doses when compared to the gold standard, daily, high-dose regimens with rifampin," says Nuermberger. Rifampin (sold as Rifadin and Rimactane) was F.D.A. approved in 1968.
利福喷丁是1998年由美国FDA批准的治疗广布的，药物敏感性的肺结核药物，最初是作为不太累赘的，一周一次的药剂。但是这个药“与金标准，每日一次的高剂量的治疗药物利福平相比，低剂量的利福喷丁未显示出疗效。”
The potential for shortened treatment times follows an advance by the team's top scientist, Richard Chaisson, M.D., director of Hopkins' Center for TB Research, in October. Chaisson and his group showed that moxifloxacin (Avelox), another antibiotic, when substituted for ethambutol (Myambutol), may cut treatment times from six months to four.
在研究组的首席科学家， Hopkins肺结核研究中心的负责人Richard Chaisson博士提出缩短治疗时间的潜在性后，Chaisson和他的研究组提出莫西沙星，另一个抗生素，在代替乙胺丁醇后可以将治疗时间从六个月缩短至四个月。
Nuermberger and his team investigated the high-dose potential of rifapentine because the drug was in the same class of drugs as rifampin, which is part of the standard antibiotic cocktail of rifampin, pyrazinamide, and isoniazid, a triple drug combo sold as Rifater, or with moxifloxacin in place of isoniazid.
Nuermberger和他的小组研究了高剂量的利福喷丁的治疗可能性，因为这个药与利福平是同一类药物，它是标准抗生素组合利福平，异烟酰胺和异烟肼的一部分，这三种药以卫非特为名字销售，或者用莫西沙星代替异烟肼。
Given as part of Directly Observed Therapy Short-Course, or DOTS for short, because the drugs are usually given in direct view of a caregiver to ensure compliance, the regimen requires several daily doses for six to nine months. DOTS cures 95 percent of those treated, but the lengthy treatment period has proven a problem for patients, who sometimes miss taking their drugs on time, minimizing the therapy's effectiveness.
作为直接观察的治疗短期课程的一部分，或者简称为DOTS，因为这个药通常以一个caregiver来保证顺应性，这个用药法要求很多每日剂量持续六到九个月。DOTS可以治愈95％的病人，但是治疗时间对患者来说是一个问题，患者有时候会忘记服药，而使治疗效果受影响。
In the new study, Nuermberger and his team tested seven different combinations of antibiotic drugs in hundreds of mice infected with active TB. Some were treated with the standard DOTS regimen, daily Rifater, while others took rifapentine in place of rifampin. Rifapentine, in daily amounts similar to what an adult human would take (600 milligrams), was also tested separately in combination with moxifloxacin- or isoniazid-based DOTS regimens.
在最新的研究中，Nuermberger和他的组员用上百只感染肺结核的小鼠试验了七种不同的抗生素组合。有些用标准DOTS疗法，每日的卫非特，而其他的用利福喷丁替代利福平。利福喷丁，每日量与成年人服用量相似（600mg），也单独在以莫西沙星或异烟肼为基础的DOTS疗法中试验了。
Blood and tissue testing were done over a six month period to see how quickly each drug combination rid the body of active TB. Treated mice were also tested three months later to check against any potential for relapse.
血样和组织试验也进行了六个月去观察每个药物组合可以多快地除去体内的活性肺结核。被处理的小鼠也试验了三个月，之后去检查任何复发的可能性。
After 10 weeks of drug therapy, mice taking rifapentine and moxifloxacin tested negative for active TB and remained so when retested three months later. Those treated with rifapentine and isoniazid also tested clear of the bacterium by 10 weeks, but were at least 10 percent more likely to relapse unless treatment persisted for another month. Meanwhile, the traditional DOTS regimen mostly took the full six months to work.
药物治疗10周后，服用利福喷丁和莫西沙星的小鼠对肺结核显示阴性结果，三个月之后显示同样的结果。服用利福喷丁和异烟肼在10周后显示清除了细菌，但是至少10％恨可能复发除非持续治疗一周。同时，传统的DOTS疗法大概需要六个月才起效。
Results showed a distinct advantage in using rifapentine over rifampin, with rifapentine having remained in the blood in three times higher concentrations throughout treatment, indicating the drug's "longer-lasting action," says Nuermberger.
结果显示使用利福喷丁替代利福平有一个直接的优势，因为治疗过程中血浆里的利福喷丁保持三倍的高浓度，显示该药的持久作用，Nuermberger说。
Two clinical trials are scheduled to study high-dose and daily combinations with rifapentine. The first is being spearheaded by Chaisson and will take place in Brazil. The second will be led by Hopkins researcher Susan Dorman, M.D., and scientists from the U.S. Centers for Disease Control and Prevention, and will study those infected in 40 cities in six countries around the world.
两个临床试验正准备进行去研究高剂量和每日组合用利福喷丁。第一个由Chaisson组织将在巴西进行，第二个有Hopkins研究员Susan Dorman博士组织，来自美国疾病控制和预防中心的科学家将研究全世界6个国家的40
个城市的感染者。

2007-12-20 22:16

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治疗肺结核的潜在药是很少使用的老抗生素
尽管利福喷丁被认可用于治疗，它现在没有市场，甚至没有一个合适的价格。因为它的需求很少，所以它的生产者已经在数年前停止商业生产了。但是这个长时间不被关注的抗生素被发现以较低的剂量可以用于治疗肺结核，现在可以作为一个潜在的高剂量的治疗药用于这种最常见且传染性强的肺病。

“利福喷丁回来了，” Eric Nuermberger医学博士、传染病专家Johns Hopkins这么说，他在小鼠的实验发现它很有希望成为肺结核的有利治疗药物，而临床实验将计划于明年在至少八个国家进行，他的研究结果将在12.17的the Public Library of Science journal PLoS Medicine在线发表。

小鼠实验显示每日服用更高剂量的利福喷丁以代替另一种抗生素利福平，可以比标准服用药物包括利福平在内，治愈率高了两到三倍。研究者说如果在人身上的实验结果证实了在小鼠上的发现，那么清除潜在的细菌感染将从六个月减少到三个月甚至更短。

“感染肺结核的病人会不顾一切的治疗来克服感染，较快起效的治疗从而限制其扩散的速度，” Nuermberger说，他是Hopkins和其他地方研究小组的组长，“对这种最常见形式的疾病，所谓的药物敏感性的肺结核的最有效治疗方式，其关键步骤是延迟其发病过程中的多重耐药性。”

“这是一个很大的优势，有一个政府已经批准的药物，同时我们恨惊讶地发现它一直在这里，”Nuermberger说，他是Johns Hopkins University School of Medicine的副教授。他说二期临床试验将在2008年中期开展，从而评价利福喷丁作为一个治疗肺结核的关键成分的有效性。

非盈利的全球肺结核药物研发联盟估计全世界有超过9百万的病人感染了这种高传染性和激活型的肺结核，是由结核分枝杆菌引起的，专家说还有424,000的人感染感染了更危险的多重耐药型肺结核。

大多数治疗肺结核的抗生素药物是在19世纪50，60年代研发出来的，近年来没有什么新药，Nuermberger说。利福喷丁是1998年由美国FDA批准的治疗广布的，药物敏感性的肺结核药物，最初是作为不太累赘的，一周一次的药剂。但是这个药“与金标准，每日一次的高剂量的治疗药物利福平相比，低剂量的利福喷丁未显示出疗效。”

在研究组的首席科学家， Hopkins肺结核研究中心的负责人Richard Chaisson博士提出缩短治疗时间的潜在性后，Chaisson和他的研究组提出莫西沙星，另一个抗生素，在代替乙胺丁醇后可以将治疗时间从六个月缩短至四个月。Nuermberger和他的小组研究了高剂量的利福喷丁的治疗可能性，因为这个药与利福平是同一类药物，它是标准抗生素组合利福平，异烟酰胺和异烟肼的一部分，这三种药以卫非特为名字销售，或者用莫西沙星代替异烟肼。

作为直接观察的治疗短期课程的一部分，或者简称为DOTS，因为这个药通常以一个caregiver来保证顺应性，这个用药法要求很多每日剂量持续六到九个月。DOTS可以治愈95％的病人，但是治疗时间对患者来说是一个问题，患者有时候会忘记服药，而使治疗效果受影响。

在最新的研究中，Nuermberger和他的组员用上百只感染肺结核的小鼠试验了七种不同的抗生素组合。有些用标准DOTS疗法，每日的卫非特，而其他的用利福喷丁替代利福平。利福喷丁，每日量与成年人服用量相似（600mg），也单独在以莫西沙星或异烟肼为基础的DOTS疗法中试验了。

血样和组织试验也进行了六个月去观察每个药物组合可以多快地除去体内的活性肺结核。被处理的小鼠也试验了三个月，之后去检查任何复发的可能性。

药物治疗10周后，服用利福喷丁和莫西沙星的小鼠对肺结核显示阴性结果，三个月之后显示同样的结果。服用利福喷丁和异烟肼在10周后显示清除了细菌，但是至少10％恨可能复发除非持续治疗一周。同时，传统的DOTS疗法大概需要六个月才起效。

结果显示使用利福喷丁替代利福平有一个直接的优势，因为治疗过程中血浆里的利福喷丁保持三倍的高浓度，显示该药的持久作用，Nuermberger说。

两个临床试验正准备进行去研究高剂量和每日组合用利福喷丁。第一个由Chaisson组织将在巴西进行，第二个有Hopkins研究员Susan Dorman博士组织，来自美国疾病控制和预防中心的科学家将研究全世界6个国家的40个城市的感染者。

2007-12-20 22:19

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lily_d617 编辑于 2007-12-20 22:23

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