控制不良之高血壓患者為期12週隨機雙盲附加於西藥之複方丹參血壓調控評估

A 12-week, Randomised, Double-blind, Placebo- controlled Study to Evaluate the Benifit and Tolerability of Fufang Dansen as Add-on anti-hypertensive trial in Taiwanese Patients with Uncontrolled Hypertension

楊宗元(Tsung-Yuan Yang)

指導教授 ： 翁國昌 ； 韓志平

中山醫學大學/醫學院/醫學研究所/碩士(2010年)

https://doi.org/10.6834/CSMU.2010.00141

摘要

摘要
高血壓患者通常需要使用多重之降血壓藥物才能良好的控制血壓，因此本研究收納了控制不良之高血壓患者，進行為期12週，隨機、雙盲，附加於西藥的複方丹參血壓調控評估。這些患者仍然繼續服用原來的降血壓藥物，然後隨機分為兩組。實驗組三十人，服用複方丹參膠囊(1000mg，一天兩次)，對照組二十五人，則服用安慰劑。期間兩組都有20%的患者退出(missing rate=20% for both arms)。經過12週之後評估主要效益指標，發現血壓有良好反應的(Responder)，在複方丹參組有45.6%，對照組38.2%，未達統計上之意義(P= 0.946)。而次要效益指標是血壓得到良好控制的，在複方丹參組有25.5%，對照組7.3%，具有統計上之有意義(P= 0.016)。另外還有四項次要效益指標，包括收縮壓、舒張壓、平均血壓與心跳的起始至最終之變化值，上述指標達統計上顯著差異者，為第十二週複方丹參組平均收縮壓為139.2 mmHg與平均血壓100.8 mmHg；對照組平均收縮壓為153.1 mmHg與平均血壓107.4 mmHg，在統計上達顯著差異 (p = 0.009、0.027)。但是舒張壓下降的趨勢，在該二組之間的差異並不明顯，複方丹參組平均舒張壓為81.6 mmHg，對照組平均舒張壓為84.6 mmHg，在統計上未達顯著差異 (p = 0.277)。
結論
本研究針對控制不良之高血壓患者，進行附加於西藥的複方丹參效益評估，因為樣本數不足，因此研究結果有待商確。但是複方丹參對於合併西藥服用，可能有加強血壓調控之趨向。

關鍵字

丹參 ； 高血壓

並列摘要

Abstract
Hypertension frequently requires combination therapy to attain satisfactory control of blood pressure. The double-blind, case- controlled, randomized, single-center study is designed to investigate the add-on benifit of fufang Danshen versus placebo in Taiwanese hypertensive patients with uncontrolled blood pressure. Patients with uncontrolled hypertension were enrolled under current conventional anti-hypertensive treatment. Then randomize allocation to receive fufang Danshen capsule 1000 mg twice-daily (n=30) or placebo capsule (n=25) for 12 weeks. At the end of the study, the response rate of the primary endpoint were 45.6% in fufang Danshen group and 38.2% in the placebo groups, P=0.946 (the responsed patient was defined as the proportion of subjects with a final sitting SBP < 140 mmHg and/or DBP < 90 mmHg，or if decrease in SBP ≧ 10mmHg and/or decrease in DBP ≧ 5mmHg). The control rate (defined as the proportion of subjects with a final sitting SBP < 140 mmHg and DBP < 90 mmHg) of the secondary endpoint were 25.5% in fufang Danshen group and 7.3% in the control group (P=0.016). Besides, the treatment difference of SBP, DBP, MBP, and heart rate were also calculated (P=0.032, 0.771, 0.027, 0.027). The missing rate was 20% in both arm.
Conclusion
These data demonstrate the inconlusive result for the benefit of fufang Danshen as an add-on effect because of the relative small sample size and high missing rate, but fufang Danshen might have the trend to modify the high blood pressure while maintaining an acceptable safety profile.

並列關鍵字

Danshen ； hypertension

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