- 期刊
香砂六君子湯改善逆流性食道炎症狀及預防復發的效果
The effects of Xiangsha-Liujunzi-Tang to Improve Symptoms and to Prevent the Recurrence of Reflux Esophagitis
摘要
本研究的目的乃探討中藥方劑砂六君子湯是否具有加強PPI藥物Rabeprazole對胃食道逆流（GERD）的療效，並預防GERD復發的效果。我們共招募123名臨床上具GERD症狀，且經胃鏡證實有逆流性食道炎（reflux esophagitis）的患者進入臨床試驗。他們在簽署受試同意書後，被隨機分成兩組。一組66人（治療組）每日一次口服PPI西藥Rabeprazole 20mg合併香砂六君子湯中藥粉末每日2次，一次3.5公克；另外一組57人（對照組）則每日一次口服西藥Rabeprazole 20mg合併安慰劑每日2次，一次3.5公克。治療期共16週，我們以症狀量表每4週一次，評估受試者症狀的變化。治療結束後，受試者繼續每8週一次接受追蹤達24週，觀察其復發率。我們以unpaired Student's t-test分析比較兩組治療期間症狀指數的差異，並以χ2-test分析兩組間24週復發率的差異及藥物副作用的差異。研究結果顯示，治療組與對照組分別有40人及37人完成治療，其性別及年齡並無統計學上的差異。治療至第16週時，治療組比對照組在胃食道逆流嚴重度上輕度但有統計學差異的降低（0.3 vs. 0.8; P=0.01），但在24週追蹤復發率上兩組之間卻沒有統計學上顯著的差異。在副作用方面，治療組比對照組在胃脹（0.0% vs. 21.6%; P=0.002）及胃悶（0.0% vs. 16.2%; P=0.009）兩症狀的出現率顯著減少。此研究結果顯示，香砂六君子湯可以輕度但統計學上有意義的增加Rabeprazole改善胃食道逆流的效果，同時可以顯著地減輕胃脹及胃悶的症狀。香砂六君子湯與Rabeprazole可能是安全的組合，可以應用於有合併胃脹或胃悶等症狀的胃食道逆流之治療。
並列摘要
The aim of this study was to observe the effectiveness of Xiangsha-liujunzi-tang (XSLZT) in augmenting the effect of PPI and to reduce the recurrence of GERD. We include 123 patients with clinical symptoms of GERD and endoscopic findings with reflux esophagitis. After signing informed consent, subjects were randomly divided into two groups. The subjects in treatment group were given one tablet of Rabeprazole 20mg per day combined with 3.5 grams of extracted powder of XSLZT after each meal twice per day. The subjects in other group (control group) were given the same dosage of rabeprazole and placebo. The therapeutic period was 16 weeks. During this period, we evaluated the severity of symptoms in subjects with a questionnaire form for GERD. After complement of therapy, subjects were followed-up every 8 weeks until relapse for 24 weeks. Finally we analyzed the differences in symptomatic severity and recurrent rates of GERD between two groups by unpaired Student's t-test or χ2- test. The results revealed that, 40 subjects in treatment group and 37 subjects in control group completed treatment for 16 weeks. After treatment for 16 weeks, the severity score of GERD was lower, mildly but significantly, in treatment group than in control group (0.3 vs. 0.8; P=0.01). However, no significant difference in relapse rate was found between two group under follow-up for 24 weeks. The analysis of side-effect showed that, treatment group had significant low rates of epigastric fullness (0.0% vs. 21.6%; P=0.002) and epigastric compression (0.0% vs. 16.2%; P=0.009) than control group. The above results suggest that, XSLZT can increase the effect of Rabeprazole in treatment of GERD mildly but significantly. It also can reduce complication rates of epigastric fullness and compression. The combination of Rabeplazole and XSLZT is safe, and suitable to be used in treatment of GERD combined with symptoms of epigastric fullness and epigastric flatulence.