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題名 | 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 |
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作者姓名(中文) | 陳明豐; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(86)1-(86)21 |
分類號 | 414.5 |
關鍵詞 | 香砂六君子湯; 逆流性食道炎; 胃食道逆流症狀量表; Xiangsha-liujunzi-tang; Reflux esophagitis; Quantitative questionnaire for symptoms of gastroesophageal reflux; |
語文 | 中文(Chinese) |
中文摘要 | 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。我們已於民國 101年共招募 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或 χ2-test,分析比較兩組治療期間症狀指數的差異及 24週復發率的差異。 在 102年度我們已完成受試者的治療、追蹤及統計分析。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不多。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。 |
英文摘要 | 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. In 2012, we included 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. In 2013, we completed the treatment and follow-up for subjects and performed statistics. 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 may be safe, and suitable to be used in treatment of GERD combined with symptoms of epigastric fullness and epigastric flatulence. |
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