中藥企業尋求通過臨牀試驗證明中藥療效

Traditional Chinese medicine needs to prove its worth through rigorous clinical trials, according to the head of one of China’s largest herbal remedy companies, as a contentious new law to boost the $40bn sector comes into effect.

在引發爭議的《中醫藥法》正式施行之際，中國最大中藥企業之一的負責人表示，中藥需要通過嚴格的臨牀試驗證明其價值。這部新法旨在提振400億美元的中藥行業。

Traditional Chinese medicine is estimated by analysts to account for a third of sales in China’s $117bn pharmaceutical market, the world’s second largest.

分析師估計，中藥在中國1170億美元的醫藥市場中佔銷售額的三分之一。中國是全球第二大醫藥市場。

But most of those sales are of relatively cheap over-the-counter drugs, with many Chinese hospital doctors reluctant to prescribe TCM remedies because of the lack of evidence for their effectiveness.

但中藥銷售大多數都是相對廉價的非處方藥，許多中國醫生不願開中藥處方，因爲缺乏證據證明這些中藥的療效。

China’s first law promising equal status for TCM and western medicine in the country’s state-dominated healthcare system comes into effect this weekend. Provisions include encouragement for hospitals to set up TCM centres, and a licensing system for practitioners.

上週末，中國首部承諾在國家主導的醫療體系中給予中藥和西藥平等地位的法律開始生效。條款包括鼓勵醫院設立中醫藥科室，以及中醫醫師執業註冊制度。

“This law is very important for securing the status of TCM,” said Wu Yiling, chairman of Yiling Pharmaceutical, a company that makes herbal remedies based on traditional recipes in the northern province of Hebei.

“這部法律對於確保中藥的地位非常重要，”以嶺藥業(Yiling Pharmaceutical)董事長吳以嶺說。位於中國河北省的以嶺藥業是一家基於傳統配方生產中藥的企業。

Listed in Shenzhen, Yiling has a market capitalisation of Rmb20.7bn ($3bn). Mr Wu, the son of a herbal practitioner, controls a family fortune of $1.6bn, according to the Hurun rich list.

深圳上市的以嶺藥業市值達207億元人民幣（合30億美元）。胡潤(Hurun)富豪榜顯示，出身中醫世家的吳以嶺控制着16億美元的家族財富。

Mr Wu is both a proponent of the nature of Qi — the mystical energy force that provides the basis for much of TCM theory — and the clinical trials crucial to western pharmaceutical companies. “TCM needs to develop?.?.?.?using modern research methods,” he said.

吳以嶺既重視中醫所謂的“氣”（爲大部分中醫藥理論提供基礎的神祕能量），也倡導對西方製藥公司來說至關重要的臨牀試驗。“中藥需要發展……要利用現代研究方法，”他說。

For instance, researchers from Peking and Cardiff Universities tested the health benefits of Yiling’s herbal medicine Yangzheng Xiaoji, publishing papers in the International Journal of Oncology that showed the drug can slow the growth of cancer tumours.

例如，來自北京大學和卡迪夫大學(Cardiff University)的研究人員測試了以嶺藥業的中藥“養正消積膠囊”的治療效果，他們在《國際腫瘤學期刊》(International Journal of Oncology)上發表的論文顯示這種藥可以減緩癌症腫瘤的生長。

“The theory and recipe is TCM, but in practice the evaluation of our medicines is carried out according to western evidence-based methods,” Mr Wu said.

“理論和配方是中醫藥的，但在實踐中，我們對藥物的評估是根據西方以證據爲基礎的方法進行的，”吳以嶺說。

Yiling and other TCM companies are attempting to gain credibility in the domestic market through pursuing overseas approvals. The company increased sales of its flagship anti-cold drug by a quarter last year after it reached the second phase of clinical trials with the US Food and Drug Administration.

以嶺藥業及其他中藥企業正嘗試通過尋求海外認證的方式在國內市場獲得信譽。在進入美國食品藥品監督管理局(FDA)第二期臨牀試驗後，該公司的旗艦抗感冒藥去年的銷量提高了四分之一。

A compound made by Shanghai-listed Tasly Pharmaceutical in December became the first Chinese herbal drug to pass the FDA’s phase-three clinical trials, causing a spike in the company’s share price.

去年12月，上海上市的天士力製藥(Tasly Pharmaceutical)生產的一種複方藥，成爲首個完成FDA三期臨牀試驗的複方中藥，引發該公司股價飆漲。

Analysts say such tests can help win over sceptical hospital doctors and boost prescriptions. “Doctors need strong evidence that drugs definitely work,” said Serena Shao, healthcare analyst at brokerage CLSA.

分析師表示，此類試驗有助於說服持懷疑態度的醫生增加中藥處方。里昂證券(CLSA)醫療衛生分析師邵瑩(Serena Shao)說：“醫師需要強有力的證據證明藥物確實有效。”

“Some of these companies are currently doing clinical trials, and getting proof that their drugs have the same efficacy as chemical drugs. That’s the way to go,” she added.

“一些中藥企業目前正在進行臨牀試驗，而且正在獲得證據證明自己的藥品與化學藥品具有相同療效。這是正途，”她補充說。

The TCM law has been greeted with scepticism from China’s western-schooled medical establishment, which points to a lack of rigorous training for TCM doctors, and a recent series of scandals involving herbal injections alleged to have been harmful.

這部《中醫藥法》受到中國接受西式培訓的醫療人士的質疑，他們提到了中醫醫師缺乏嚴格培訓，以及近期一系列涉及據稱對健康有害的中藥注射劑的醜聞。

Officials “will try and encourage TCM, but also will be very cautious about what kinds of TCM they use in hospitals”, added Ms Shao.

邵瑩還表示，官員們“將嘗試並鼓勵中藥，但也會對醫院使用何種中藥非常謹慎。”