| 摘要: | 研究背景:
大腸直腸癌是一重要的疾病。在台灣，從1994年起大腸直腸癌已成為癌病發生率及死亡原因中第三位。大腸直腸癌的主要治療方式以手術為主，術後再針對第三期、第四期、以及部分第二期高復發率的危險族群患者投與輔助性化學治療（adjuvant chemotherapy）。但是目前的化學治療藥物缺乏特異性選擇作用，在殺傷癌細胞同時也殺傷正常細胞，會對正常的人體組織細胞產生一定程度的傷害，使機體免疫功能下降，影響患者生活品質。本計劃的目的是要利用中醫藥的觀點，在不影響正常癌症治療的原則下，給予患者輔助中藥方劑，藉由中藥調理的功能，減輕大腸直腸癌患者因為接受化學治療藥物毒副作用引發的一連串身體不適症狀。
研究方法：
研究將大腸直腸癌術後接受化學治療患者，使用隨機雙盲的方式分為實驗組（四君子湯組）和對照組（Placebo），在服用藥物前、第二週、第四週做患者評估，評估項目包括血球檢驗、肝腎功能、化學治療藥物毒性副作用等級（Common Terminology Criteria for Adverse Events），並利用生活質量表（SF-36台灣版）在服藥前後一個月的時間做問卷評估，將所得結果做統計分析。
研究結果：
最後確定實驗組有10位患者、對照組有7位患者完成此臨床試驗。在患者服用中藥方劑前後血球數的變化方面：實驗組和對照組的白血球數、血色素、血小板在服用中藥方劑前後並無顯著統計學上的意義。在服用藥前後肝腎功能的變化部份，在實驗組以及對照組本身服用藥物前後肝腎功能都無顯著變化。在針對化學治療產生的毒副作用評估部分，可以看到實驗組與對照組在Grade 3~4患者個數有減少的情形，實驗組在Grade 1~2的毒副作用患者有減少但對照組則無，但二者無統計學上差異。在生活品質方面評估部分，使用台灣版SF-36問卷計算出來8 個面向得分，實驗組可以見到心理健康前後測得分進步約16分，達到統計上意義（p=0.012），整體心理層面得分進步幅度亦達到統計上的意義（p=0.017）。
結論：
運用中藥方劑四君子湯在接受大腸直腸癌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，達到提升患者生活品質，提供醫師及患者在現代正規癌症治療學外的另一個治療方向。但是因為化學治療藥物種類繁多，以及患者的接受度與配合度不同，我們需要更多更大型嚴謹的臨床試驗來佐證功效。
Topic：
Clinical randomized double-blind study on the complementary effects of Chinese herbal formula (SHY JIUN TZYY TANG) in colorectal cancer patients treated with chemotherapy.
Background:
Colorectal cancer is an important disease. In Taiwan, it has been the third of cancer incidence and mortality rate since 1994, and the numbers of cancer patients has been increasing year by year. The main treatment of colorectal cancer is surgery. Then, patients with pathologic stage III, stage IV, and some high risk groups in stage II are treated with adjuvant chemotherapy. But these drugs do not have high selective specificity. These drugs damage the normal cells and cause injuries at the same time when destroy the cancer cells. The pharmacological reactions decreased the human immune function and affected the life quality of these patients.
Some Chinese herbal formulas, such as the Chinese herbal formula (SHY JIUN TZYY TANG ) have improvement of the human immune function were confirmed by many researches. The purpose of our study is to evaluate the alternative treatment by using the Chinese herbal formula in colorectal cancer patients treated with chemotherapy. We hope patients can benefit from the complementary and alternative treatment and can decrease the side effects caused by chemotherapy.
Methods：
In the study, colorectal cancer patients post-operatively treated with chemotherapy was enrolled, and double-blindly divided to two groups: Chinese herbal formula group and placebo group. Chinese herbal formula (SHY JIUN TZYY TANG) and placebo were taken for 1 month. We evaluated these patients 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. SF-36 questionnaire was used to evaluate the quality of life. All data were recorded and analyzed .
Results：
There were 10 patients in the Chinese herbal formula group and 7 in the placebo group. In the aspect of blood cell counts（including white blood cell counts, hemoglobin, and platelet）variation, there was no significant statistically difference in both groups. In the aspect of hepatic and renal function, there was also no significant statistically difference in both groups. For the evaluation of the toxicity of chemotherapy, the number of patient decreased in the Grade 3~4 in both groups; however, in Grade 1~2, the number only decreased in the Chinese herbal formula group, but the phenomenon was not found in placebo group. In the life quality of patient, using the SF-36 questionnaire, the mental health score increased, and there was significant statistically difference（p=0.012）, while the score in the Mental Component Scale was also increased（p=0.017）.
Conclusions：
Using of Chinese herbal formula (SHY JIUN TZYY TANG ) in treating colorectal cancer patients accepting chemotherapy decreased the toxicity of chemotherapy, promoted patient’s quality of life and offered an alternative way in cancer treatment. However, due to various kinds of chemotherapy drug and patient’s cooperation and acceptance, we need more, large and serious clinical trial to confirm our theory. |
