Dickman R, Emmons S, Cui H, Sewell J, Hernández D, Esquivel R F, Fass R
The Neuro-Enteric Clinical Research Group, Section of Gastroenterology, Department of Medicine, Southern Arizona VA Health Care System, Tucson, AZ 85723, USA.
Aliment Pharmacol Ther. 2005 Sep 15;22(6):547-55. doi: 10.1111/j.1365-2036.2005.02620.x.
Therapeutic trials with high-dose lansoprazole and omeprazole have been shown to be sensitive clinical tools for diagnosing patients with gastro-oesophageal reflux disease-related non-cardiac chest pain.
To determine the clinical value of a therapeutic trial of high-dose rabeprazole over 7 days in detecting patients with gastro-oesophageal reflux disease-related non-cardiac chest pain.
Double-blind, randomized, placebo-controlled, crossover study. Patients referred by a cardiologist after a comprehensive cardiac work-up were enrolled into the study. Oesophageal mucosal disease was determined by upper endoscopy and 24-h oesophageal pH monitoring assessed acid exposure. Patients were then randomized to either placebo or rabeprazole 20 mg am and 20 mg pm for 7 days. After a washout period of 1 week, patients crossed over to the other arm of the study for an additional 7 days. Patients completed a daily diary assessing severity and frequency of chest pain throughout the baseline, treatment and wash-out periods. The rabeprazole therapeutic trial was considered as a diagnostic tool, if chest pain scores improved > or =50% from baseline.
Of the 35 patients enrolled, 16 (46%) were diagnosed as gastro-oesophageal reflux disease-positive and 19 (54%) as gastro-oesophageal reflux disease-negative. Of the gastro-oesophageal reflux disease-positive patients, 12 of 16 (75%) had a significant symptom improvement on rabeprazole when compared with 3 of 16 (19%) on placebo (P = 0.029). Of the gastro-oesophageal reflux disease-negative group, only two of 19 (11%) improved significantly on the medication and four of 19 (21%) on placebo (P = 0.6599). The calculated sensitivity and specificity of the rabeprazole therapeutic trial was 75% and 90%, respectively.
A rabeprazole therapeutic trial is highly sensitive and specific for diagnosing gastro-oesophageal reflux disease-related non-cardiac chest pain patients.
高剂量兰索拉唑和奥美拉唑的治疗试验已被证明是诊断胃食管反流病相关非心源性胸痛患者的敏感临床工具。
确定为期7天的高剂量雷贝拉唑治疗试验在检测胃食管反流病相关非心源性胸痛患者中的临床价值。
双盲、随机、安慰剂对照、交叉研究。经心脏病专家全面心脏检查后转诊的患者纳入研究。通过上消化道内镜检查确定食管黏膜疾病，并通过24小时食管pH监测评估酸暴露情况。然后将患者随机分为安慰剂组或雷贝拉唑组，雷贝拉唑组每天上午和下午各服用20毫克，共7天。经过1周的洗脱期后，患者交叉至研究的另一组，再进行7天治疗。患者在整个基线期、治疗期和洗脱期完成每日日记，评估胸痛的严重程度和频率。如果胸痛评分较基线改善≥50%，则将雷贝拉唑治疗试验视为一种诊断工具。
在纳入的35例患者中，16例（46%）被诊断为胃食管反流病阳性，19例（54%）为胃食管反流病阴性。在胃食管反流病阳性患者中，16例中有12例（75%）服用雷贝拉唑后症状有显著改善，而安慰剂组16例中有3例（19%）有改善（P = 0.029）。在胃食管反流病阴性组中，19例中只有2例（11%）服药后有显著改善，安慰剂组19例中有4例（21%）有改善（P = 0.6599）。雷贝拉唑治疗试验计算出的敏感性和特异性分别为75%和90%。
雷贝拉唑治疗试验对诊断胃食管反流病相关非心源性胸痛患者具有高度敏感性和特异性。
