論「韓國真珠草治B 型肝炎」之廣告疑異：從中醫理論與專利申請觀點分析

Questionable Advertising Claims of “Treating Hepatitis B with Phyllanthus Urinaria Koreana”: Analyzing from the Viewpoints of Chinese Medicine Theories and the Patent Application Process

「韓國真珠草」治療肝病的報導儼然成為媒體新寵兒。然而販賣此產品的香港某藥業網站資訊中，存在許多問題。1.「韓國真珠草」治療B型肝炎的概念實為西藥利用單一藥物治療某一病名的思路，非中醫治療模式。因接受測試的病人並沒有按中醫辨證，只要有「B型肝炎」即可，且只以「韓國真珠草」萃取物來進行治療，而非完整植株。然而網路文宣，卻拿誤用之中醫觀念為其背書。2. 該藥業宣稱只有韓國的品種有療效，然而網站所引用之1996年專利申請書，其中僅作珍珠草與蜜甘草之比對，並無任何各地區亞種間效力差異之描述。另外專利申請書及藥業網頁所列研究內容也有需要檢視之處。專利申請書部分：在未列出臨床副作用測試下宣稱此產品低毒性且無副作用；雖然對大鼠進行毒性測試，卻只注重肝臟功能，忽略整體機能是否受影響；臨床實驗沒有對照組。藥業網頁部分：臨床測試病人條件不明確（沒有標出未服用藥物時體內病毒數、年齡、性別、有無其他重大傷病等等）；臨床實驗的病人數不足（第二期人體臨床試驗30 人；第三期人體臨床試驗治療組：80 位病人、比較組：40 位病人）。由本研究結果了解，藥業網站和專利申請書中，存在許多不專業的論述和設計。

Recently the herb “Phyllanthus Urinaria Koreana” has became popular in the press for treatment of liver diseases. A brief look at the Hong Kong based pharmaceutical company website, however, revealed many issues.Firstly, The concept of using “Phyllanthus Urinaria Koreana” to treating hepatitis B is the western pharmaceutical approach of using a single drug therapy for one disease, which does not involve traditional Chinese medicine treatment modalities. The patients were not categorized by Chinese medicine criteria, but simply by having “Hepatitis B” or not. The patients were only treated with “Phyllanthus Urinaria Koreana” extract, instead of the complete herb. However, the seller’s website took mistaken concepts of traditional Chinese medicine and used it for its endorsement. Secondly, The document cited by the website is just a patent application in 1993, which is not a patent certificate. In this document there is only a simple comparison between P. urinaria and P. ussurinensis, without any description of differences in effectiveness between subspecies. The content of the patent application and research on website also contain aspects that requires a closer look: such as claiming the product to be low in toxicity and non side effects without listing results of clinical side effect tests. In addition, although rats are used in toxicity tests, only liver function is investigated, without attention to potential effects on overall function. There is no control group for clinical experiments. Patient information in the clinical trials is not clearly enough (without marking the amount of virus at the time of drug administration, age, sex, and whether other major traumas or illnesses are present, etc.). The number of patients in clinical trials are insufficient (second stage clinical trial has only 30 patients, third stage human clinical trials has only 80 patients in the treatment group, with 40 patients in the comparison group). The results of this study shows that both the website of the pharmaceutical company and the patent application documents included many unprofessional statements and designs.