運用中藥方劑（MB-6）在轉移性大腸直腸癌接受化學治療的患者身 上，以期達到輔助治療降低化學治療藥物毒副作用，提升患者生活品質 的目標，在目前的臨床研究已經有了部份初步正面的收獲和意義。初步 結果在血液學、肝腎功能以及電解質等項目,初步並沒有統計學上顯著 的差異性。可以確定的是對患者的心理健康與心理層面功能都有正向顯 著的提升。
臨床上雖然無法證實能降低化學治療藥物毒副作用，但是提升了患 者的心理健康與心理層面功能，使患者能更正向的接受治療，延長治療 的次數及更能忍受化學治療所帶來的不適，對整體治療無疑的是一大利 多，也達到中藥方劑輔助化學治療的目的。
但是 MB-6 屬於複方中藥方劑，因此其中含有的成分種類繁多，而且 真正有效的藥理機轉也尚未釐清，假以時日將其中的成份純化，進行更 多更大型嚴謹的臨床試驗來，方能更確實的證明其功效。
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附錄一 彰化基督教醫院人體試驗委員會同意臨床試驗證明書
附錄二 彰化基督教醫院臨床試驗受試者同意書
附錄三
附錄四 患者毒副作用評估表
Toxicity Grade 1 Grade 2 Grade 3 Grade 4 or mild increase
in ostomy
Loss of appetite Oral intake decreased without body weight loss or dehydration or
malnutrition
Inadequate oral intake, need IV fluid and tube feedings or TPN
Life-threatening consequences
Vomiting
1episode in 24
hrs
2~5 episodes in
24 hrs
es, bleeding with trauma complete loss of
nail
－ －
Blood/Bone marrow
Leukopenia <3.0 x <3.0~2.0 x <2.0~1.0 x <1.0x Neutropenia <1500 <1500~1000 <1000~500 <500 Thrombocytopenia <75000 <75000~50000 <50000~25000 <25000
Hemoglobin <10.0/ g/dL <10.0~8.0 / g/dL <8.0~6.5 / g/dL <6.5/ g/dL
Other Adverse
Skin necrosis or ulceration of
Intervention indicated
of stairs without stopping
Dyspnea on exertion, but unable to walk
1 fight of stairs
附錄五 SF-36 臺灣版身心健康狀況評估表
b.中等程度活動，例如搬桌子、
完全沒有妨礙...1
可以讓您高興起來？
d.您覺得心情平靜？ 1 2 3 4 5 6
e.您精力充沛？ 1 2 3 4 5 6
f.您覺得悶悶不樂和憂鬱？ 1 2 3 4 5 6
g.您覺得筋疲力竭？ 1 2 3 4 5 6
h.您是一個快樂的人？ 1 2 3 4 5 6
i.您覺得累？ 1 2 3 4 5 6
10. 在過去一個月內，您的身體健康或情緒問題有多少時候會妨礙您的社交活動（如 拜訪親友等）？ 請僅圈選一項答案) 一直都會...1
大部分時間會...2
有時候會...3
很少會...4
從不會...5
11.下列各個陳述對您來說有多正確？(每行請僅圈選一項答案) 完全正確 大部分正確 不知道 大部分不正確 完全不正確 a.我好像比別人較容易生病 1 2 3 4 5
b.和任何一個我認識的人來 比, 我和他們一樣健康。 1 2 3 4 5
c.我想我的健康會越來越壞 1 2 3 4 5
d.我的健康狀況好得很 1 2 3 4 5
英文摘要 Topic：
Randomized control double-blind trial on the alternative effects of
Chinese herbal formula (MB-6) in metastatic colorectal cancer patients treated with chemotherapy
Background:
The prevalence of colorectal cancer is increasing yearly in Taiwan. It has been the first of cancer incidence and the third of cancer mortality rate according to the statistic of 2009 of bureau of national health insurance , department of health. The most effective treatment of colorectal cancer is surgical resection. For those patients with pathologic stage III, stage IV, and some high risk groups in stage II , adjuvant chemotherapy is indicated. But the selective specificity of chemotherapy is not high. It destroys not only the cancer cells but the normal cells at the same time. That causes lots of side effects. Those side effects include decreased human immune function , gastrointestinal discomfort and poor life quality.
To reduce those problems caused by chemotherapy , some Chinese herbal formulas were used to improve the human immune function by many researches and they do show some benefits. The purpose of our study is to evaluate the alternative treatment of the Chinese herbal formula in metastatic
colorectal cancer patients treated with chemotherapy. Hoping those patients can benefit from the complementary and alternative treatment and can decrease the side effects caused by chemotherapy.
Methods：
Metastatic colorectal cancer patients treated with chemotherapy were enrolled in this study,, and double-blindly randomized into two groups:
Chinese herbal formula group and placebo group. Chinese herbal formula (MB-6) and placebo were taken during the chemotherapy period of time.
Those patients were evaluated every two weeks, using the “Common Terminology Criteria for Adverse Events” which designed by National Cancer Institutes (NCI) for the toxicity evaluation and laboratory data( including: blood cell counts, liver function and renal function) were recorded. Metastatic lesions were measured by computer tomography. All data were recorded and analyzed.
Results：
In each group, 6 patients were randomly enrolled. But only 5 patients completed the study. For the evaluation of the toxicity of chemotherapy, the number of patients who suffered with the Grade 3~4 side effects decreased
phenomenon was not found in placebo group. To evaluate the patient’s life, the SF-36 questionnaire was used, the mental health score increased, and there was significant statistically difference（p=0.011）, while the score in the Mental Component Scale was also increased（p=0.018）.
Conclusions：
By using the Chinese herbal formula (MB-6) in metastatic colorectal cancer patients accepting chemotherapy, the toxicity of chemotherapy decreased, and the life quality of those patients were promoted. It shows that Chinese herbal formula (MB-6) offers an alternative way to alleviate the side effects of cancer treatment. However, due to the large varieties of chemotherapy agents and the accurate mechanism and effective ingredients are not totally clear. More clinical trials are necessary to confirm our theory.
Key words：Chinese herbal formula、MB-6、Metastatic colorectal cancer、
Chemotherapy
個人簡歷 陳宏彰
生日： 西元 1967 年 02 月 14 日
學歷： 中國醫藥大學畢業(September 1986-June 1993)
中國醫藥大學中西醫研究所碩士班(September 2007-June 2011)
醫學訓練：
財團法人彰化基督教醫院 外科住院醫師 (July 1995- June 1999) 財團法人彰化基督教醫院 外科住院總醫師、
大腸直腸外科住院醫師、總醫師 (July 1999- June2000)
財團法人彰化基督教醫院 大腸直腸外科主治醫師 (July 2000-) 美國克里夫蘭醫學中心大腸直腸外科研究醫師 (July 2001- December
2001)
現任：
中華民國大腸直腸外科醫學會會員 中華民國外科醫學會專科醫師 中華民國超音波醫學會會員 中華民國癌症醫學會會員
中華民國消化系外科醫學會會員 中華民國內視鏡外科專科醫師 彰化基督教醫院大腸直腸外科主任