Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan.
J Gastroenterol. 2012 Mar;47(3):284-92. doi: 10.1007/s00535-011-0488-5. Epub 2011 Nov 15.
To seek a promising therapeutic regimen for proton pump inhibitor (PPI)-refractory patients with gastroesophageal reflux disease (GERD) after the standard PPI treatment, we compared the efficacies of rikkunshito (a Japanese traditional medication) combined with rabeprazole (RPZ) and a double dose of RPZ in a prospective randomized multicenter trial in Japanese PPI-refractory GERD patients.
One hundred and four patients with GERD symptoms remaining after 4-week treatment with RPZ (10 mg/day) were randomly assigned to 4 weeks of either combination therapy [rikkunshito (7.5 g/day) with a standard dose of RPZ (10 mg/day)] or a double dose of RPZ (20 mg/day). The primary endpoint was the improvement rate, calculated based on the frequency scale for the symptoms of GERD (FSSG) before and after treatment. Subgroup analysis was also performed with respect to each subject's background factors such as reflux esophagitis (RE)/non-erosive GERD (NERD), age, gender, and body mass index (BMI).
Four-week treatment with rikkunshito combined with RPZ significantly decreased the FSSG score from 17.6 ± 6.5 to 12.0 ± 6.9, similar to the decrease seen on treatment with a double dose of RPZ. Regarding the therapeutic improvement rate, there were also significant effects in both groups. However, in the subgroup analysis based on RE/NERD, the improvement rate of male NERD patients in the rikkunshito group was significantly greater than that of such patients in the other group (P < 0.05). In the rikkunshito group, the treatment was more effective in NERD patients with a low BMI than in those with a high BMI (P < 0.05).
Rikkunshito combined with standard-dose RPZ therapy may be a useful new strategy for PPI-refractory GERD patients.
为了寻求质子泵抑制剂（PPI）难治性胃食管反流病（GERD）患者在标准 PPI 治疗后的有前途的治疗方案，我们在一项前瞻性随机多中心试验中比较了 rikkunshito（一种日本传统药物）联合雷贝拉唑（RPZ）与双倍剂量 RPZ 在日本 PPI 难治性 GERD 患者中的疗效。
104 例在雷贝拉唑（10mg/天）治疗 4 周后仍有 GERD 症状的患者被随机分配接受 4 周的联合治疗[rikkunshito（7.5g/天）加标准剂量 RPZ（10mg/天）]或双倍剂量 RPZ（20mg/天）。主要终点是根据治疗前后 GERD 症状频率量表（FSSG）计算的改善率。还根据每个患者的反流性食管炎（RE）/非糜烂性 GERD（NERD）、年龄、性别和体重指数（BMI）等背景因素进行了亚组分析。
rikkunshito 联合 RPZ 治疗 4 周可显著降低 FSSG 评分，从 17.6±6.5 降至 12.0±6.9，与双倍剂量 RPZ 治疗的降低程度相似。在治疗改善率方面，两组均有显著效果。然而，在基于 RE/NERD 的亚组分析中，rikkunshito 组中男性 NERD 患者的改善率明显高于其他组（P<0.05）。在 rikunshito 组中，BMI 较低的 NERD 患者的治疗效果明显优于 BMI 较高的患者（P<0.05）。
rikkunshito 联合标准剂量 RPZ 治疗可能是 PPI 难治性 GERD 患者的一种有用的新策略。
