扶正化淤胶囊要放冰箱吗？

liver_for_life

原帖由 特深沉 于 2009-8-18 12:10 发表
没有经过临床试验就卖的，就可判定是骗人的假药。

深沉版主，我引用的正是你的贴，不好意思。
没有经过美国临床，当然不能在美国卖。但经过了中国药监局批准，当然可以在中国卖，至于药监局的认定程序，老百姓不懂。

liver411

实际上中国记者报道的这个新闻缺欠精确度。事实上上海的“扶正化淤胶囊”和“扶正化淤片”都刚刚通过第一期临床被容许在美国几家医院进行第二期试药了（参看下面的英文报道）。本来2007年7月24日《健康报网》报道了《扶正化瘀胶囊在美进入二期临床》，将于2009年完成 。（请注意，中国已经作了5万人。），结果因为有问题没有那么预期，耽搁到今年才批准。没办法，FDA比SFDA要求严格啊，不过上个月才两个（胶囊和片剂都容许进入II期。

有人想这是不是很伟大了啊？

FDA接受其做临床一期试验，那又算得了什么呢？一期临床只不过是检验该药是否有毒性和安全性，
二期临床才是检验该药的疗效。很多药物在FDA过了第一关，却再也过不了第二关。FDA往往是宽进严出，只要材料齐全，都可以做临床试验。做完之后该药命运如何，要看结果而定。 不过，老百姓和某些人的期望值太高，总认为中药有很多灵丹妙药，有很多奇迹般的东西可以出现。很多厂家为了追求商业利益，必然想方设法抓住病人过度迷信中医药的这种心理，以此误导病人。复方丹参滴丸不也进入过FDA的II期...后来没消息了。做事，仍然需要实事求是，按部就班，正确数据和可重复性...统计等才能证明。旌旗，奖状=空气。

II期试药预计需要一千万美金，5家医院双盲，正常对照，100个病人...。

耽搁后，这下要2011年才能揭晓，期间别瞎诈唬了。祈祷吧。

liver411

Liver pills get the nod after US drug trial

A traditional Chinese medicine has passed the United States Food and Drug Administration's primary examination and will now begin clinical tests.
The medicine, the Fuzhenghuayu pill, is expected to become the first traditional medicine used to treat patients with liver fibrosis and liver cirrhosis.
The US has no effective medication in the field, and experts say about 16 percent of chronic hepatitis B patients and 20 percent of hepatitis C patients can develop liver cirrhosis.
"There are 25 million people with liver diseases in the US, and 20,000 die every year. About 300,000 people are hospitalized for liver cirrhosis annually," said Dr Tarek Hassanein from the medical center of University of California at San Diego (UCSD).
US experts will launch a two-year second phase clinical test on 120 patients in the UCSD medical center later this year. The third phase with a bigger number of patients will run over another three years. --(7/24)

http://www.shme.com/today/2007/july.htm

liver411

TCM liver drug in US breakthrough
2009-08-18 07:41

A traditional Chinese medicine developed in Shanghai has received a permit from the United States Food and Drug Administration to conduct clinical tests on American hepatitis C patients who have developed fibrosis of the liver.

The development was seen as a primary step toward entering the North American market, experts told a medical forum in the city yesterday.

If it passes all clinical tests, the Fuzheng Huayu capsule developed by Shanghai University of Traditional Chinese Medicine will become China's first TCM to be officially recognized by the US FDA.

No drug in the US has so far been successful in treating liver fibrosis. About 20 to 30 percent of patients with chronic hepatitis C develop liver fibrosis, which can lead to cirrhosis, the sixth leading cause of deaths in the world.

Fuzheng Huayu, a compound containing six herbs, was formulated after long-term Chinese research in treating liver fibrosis and was approved by China's FDA for public use in 2002.

Domestic clinical tests have shown the medicine can protect liver cells and slow down or even reverse liver fibrosis in more than 52 percent of patients.

"The medicine is widely available in the nation and has received a national scientific award," said Dr Liu Chenghai from Shuguang Traditional Chinese Medicine Hospital, who is also a Fuzheng Huayu researcher.

"The clinical tests in the US are to study the effects on Americans, a different race with a different cultural background and different metabolism."

It was approved for Phase II clinical tests last month.

Five US hospitals will be involved in the tests, with 100 patients participating.

"Phase II is expected to be completed in 2011 and then we will apply for Phase III, the last step for drug approval, and finish it in 2016," said Bian Huashi, director of Shanghai Sundise Chinese Medicine Technology Development Co, the producer.

He said the medicine was in a TCM globalization project under the Ministry of Science and Technology and received ministry sponsorship.

The Phase II tests would cost US$10 million and the Phase III tests US$70 million for a 1,000-patient coverage, he said.

"The success of Fuzheng Huayu also can better TCM's position in international medical field," Bian said.
Source:Shanghai Daily

liver411

这里可以查到FDA试验变化和更正等
http://clinicaltrials.gov/ct2/show/NCT00854087

liver411

西药的乙克， 干细胞移植，体细胞移植...也是一丘之貉。没有通过试药一样对待。

「十把火」

411老师英文果然了得！中国是不是让你们这些老师都有些失望了呢？

liver_for_life

411老大，英文意思不懂，能否简单说下意思，不一定要翻译。谢谢！
另外，至少扶正有勇气去申请美国FDA认定，俺认为还是要鼓励的，恐怕有些国药连这个信心也没有，至少说明扶正不是属于那种骗人的东西，能否通过美国FDA那要看它是否符合美国的标准。