以科學的研究方式來評估三伏貼臨床使用之效用

中醫三伏貼用藥療效之探討

Drug utilization evaluation:Efficacy of Sang-Fu-Teh,a traditional

Chinese topical prescription

中文摘要

中醫認為天人是合一的「三伏天」是一年中最炎熱(夏至後第三個庚日為初伏天、第四個庚日為中伏天、立秋後第一個庚日為末伏天),陽氣最旺的日子,加上人體陽氣最為旺盛,運用藥物由皮膚滲入穴位經絡直達病處,能達到扶正祛邪的最佳效果。雖中醫臨床自古沿用至今,但目前仍缺乏客觀的科學研究資料驗證其效用,為此本研究期以科學的研究方式來評估三伏貼臨床使用之效用。

本研究採前瞻式,對照的研究設計。收案來源為臺北市立聯合醫院中醫院區,選定年齡介於 3-60 歲以下的孩童及成年人,對象為氣喘、患過敏及皮膚過敏症者。

實驗組 77 人:有使用三伏貼穴位敷貼及併用西藥吸入劑,三伏貼穴位敷貼係經由皮膚滲入穴位經絡。對照組 69 人:無使用三伏貼穴位敷貼,僅服用中藥及併用西藥吸入劑。

本研究運用自行設計之三伏貼藥物紀錄表,於患者完成敷貼療程之 30 天後回診,在完成三伏貼穴位敷貼療程之患者中,其臨床療效:1.氣喘發作次數之比率。

2.鼻子過敏之狀況改善比率。3.過敏體質或其他過敏反應之狀況獲得改善比率。

4.感冒次數減少之比率。5.睡眠狀況改善程度之比率等,明顯改善皆已達

92.21%。由混合模式可知尖峰呼氣流速計最佳值(%)與心跳數(下/分)與時間及是否有使用三伏貼有很大的關聯,以未使用三伏貼及未開立處方前的尖峰呼氣流速計最佳值(%)為基準,貼初伏後之尖峰呼氣流速計最佳值較未使用的病人多 14.28%,貼中伏後之尖峰呼氣流速計最佳值較未使用的病人多 20.66 %,貼末伏後之尖峰呼氣流速計最佳值較未使用的病人多 34.84 %;若以未使用三伏貼及未開立處方前的心跳數為基準,貼初伏後之心跳數較未使用的病人少 5.69 次,貼中伏後之心跳數較未使用的病人少 6.68 次,貼末伏後之心跳數較未使用的病人少12.51 次,整體而論,三伏貼穴位敷貼在中醫臨床上的療效,具有統計上的顯著意義。

驗證現代研究認為三伏貼穴位敷貼的功用一方面可以刺激穴位、誘發經氣,達到發揮經絡穴位本身的:理血氣、調陰陽、補虛損之作用;另一方面,經藥物透過皮膚吸收,到達臟腑經氣失調之處,發揮其藥理作用。

關鍵字: 不良反應、氣喘、過敏、三伏貼

英文摘要

In Chinese medicine, human body is believed synchronizing with heavens. Yearly,

"Dog Days" (the Initial Fu Day is the third Age Day after the summer solstice, the Mid Fu Day is the fourth Age Day; and the Last Fu Day is the first Age Day in Liqiu.)

is the hottest period. Yang-chi reaches the top of the year. Coupled with the most

robust human yang-chi, the use of topical drugs by infiltrating through the meridian

points is considered that it may uphold to achieve the best results. Sang-Fu-Teh, a

topical prescription of traditional Chinese medicine, has been clinically used since

ancient times, but it is still lacking of objective scientific information to verify its

effectiveness. This study tries to scientifically evaluate the clinical effects of

Sang-Fu-Teh.

The research design of this study was by prospective and control group method. Case

sources were from the Chinese Medicine Branch of Taipei city Hospital. The selected

populations include children and adults, age of 3-60 years old, who have asthma, nose

allergy, or other allergic diseases. In experimental group, there are 77 patients that

receive the use of Sang-Fu-The for topical paste application on acupoints and western

medication inhalation. The acupoints on the back are: Tientu, Dazhui, Dingchuan (2

points), Feiyu (2 points), Shenyu (2 points), and Fongmen (2 points). In control group,

there are total 69 patients who only take Chinese medicine and western medicine

inhalation, but without Sang-Fu-Teh.

A self-designed Sang-Fu-Teh application form was used for record. Patients were

invited to return for assessment in thirty days when completing the application

treatment. The clinical efficacy used for assessment included: 1. The ratio of asthma

attack. 2. The improving ratio of nose allergies. 3. The improving ratio of atopic skin

or other allergic reactions. 4. The reduction rate in the number of catching cold. 5. The

status of sleep quality improvement. Totally, it indicated 92.21% symptomatic

improvement. By mixed-mode study, peak expiratory flow rate (%), heart rate (bits

per min.), and timing of Sang-Fu-Teh usage were used as benchmark to evaluate the

patients before and after Sang-Fu-Teh application. In Initial Fu Day, the peak

expiratory flow rate increased 14.28% after Sang-Fu-Teh application. In Mid Fu Day,

the peak expiratory flow rate increased 20.66% after Sang-Fu-Teh application. In Last

Fu Day, the peak expiratory flow rate increased 34.84% after Sang-Fu-Teh application.

By assessing heart bpm (beat per min.), there was 5.69 bpm reduction on the group

after Sang-Fu-Teh application in Initial Fu Day, 6.68 bpm reduction in Mid Fu Day,

and 12.51 bpm reduction in Last Fu Day as well. Overall, the clinical effect of

Sang-Fu-Teh is statistically significant.

Validation studies suggest that the function of Sang-Fu-The application on acupoints

can stimulate the acupuncture points, induce chi to reach the meridian points to

regulate blood and chi, adjust yin and yang, and make up for the necessary body

requirement. On the other hand, the absorption of drugs through the skin may reach

the internal organs of the disorder sites to play its pharmacological effects. Keywords:Side effects, Asthma, Allergy, Sang-Fu-Teh

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