Mason I, Millar L J, Sheikh R R, Evans W M, Todd P L, Turbitt M L, Taylor M D
The Surgery, The Old Orchard, Limekilns, Fife, UK.
Aliment Pharmacol Ther. 1998 Mar;12(3):263-71. doi: 10.1046/j.1365-2036.1998.00282.x.
There is need for an evidence-based comparison of clinical management strategies to provide the rationale for selection of a particular therapeutic approach to treatment. Ideal dyspepsia treatment should quickly and conveniently alleviate patient symptoms whilst also minimizing the use of healthcare resources.
To examine dyspepsia symptom relief over 16 weeks and compare an omeprazole clinical management strategy with a commonly used combination of antacid-alginate followed by H2-antagonist.
Seven hundred and twenty-five patients participated in this randomized, open, parallel group comparison over 16 weeks. Patients were randomized to receive either an omeprazole treatment strategy (363) consisting of omeprazole 10 mg stepping up to 20 mg and 40 mg as required, or an antacid-alginate/ranitidine treatment strategy (362) consisting of antacid-alginate 10 mL q.d.s. stepping up to ranitidine 150 mg b.d. and 150 mg q.d.s. as required.
A greater proportion of patients receiving the omeprazole clinical management strategy had achieved the stringent health target of complete symptom relief (61 vs. 40%, P < 0.0001) at 16 weeks. Forty-six per cent of omeprazole-treated patients were symptom free after the first 10 mg step compared to only 17% in the antacid-alginate treated group (P = 0.0001). Total relief of heartburn, the most common symptom at entry, was achieved by more patients in the omeprazole treatment group than the antacid-alginate/ranitidine treatment group, 62 vs. 36%, respectively, at 4 weeks, and 81 vs. 60% at 16 weeks (P = 0.0001).
Treatment with the omeprazole clinical management strategy was superior to the antacid-alginate/ranitidine management strategy in providing relief of acid-related dyspepsia symptoms after 16 weeks. In addition, the omeprazole treatment strategy involved fewer GP consultations and thus minimized the use of other healthcare resources.
需要对临床管理策略进行基于证据的比较，以便为选择特定的治疗方法提供依据。理想的消化不良治疗应能快速、方便地缓解患者症状，同时尽量减少医疗资源的使用。
研究16周内消化不良症状的缓解情况，并比较奥美拉唑临床管理策略与常用的抗酸剂-藻酸盐联合用药后再使用H2拮抗剂的治疗策略。
725名患者参与了这项为期16周的随机、开放、平行组比较研究。患者被随机分为接受奥美拉唑治疗策略组（363例），即根据需要给予奥美拉唑10mg，逐步增至20mg和40mg；或抗酸剂-藻酸盐/雷尼替丁治疗策略组（362例），即根据需要给予抗酸剂-藻酸盐10mL每日四次，逐步增至雷尼替丁150mg每日两次和150mg每日四次。
接受奥美拉唑临床管理策略的患者中，有更大比例在16周时达到了症状完全缓解这一严格的健康目标（61%对40%，P<0.0001）。在奥美拉唑治疗组中，46%的患者在首次服用10mg后症状消失，而抗酸剂-藻酸盐治疗组中这一比例仅为17%（P=0.0001）。在4周时，奥美拉唑治疗组中更多患者实现了烧心（入组时最常见的症状）的完全缓解，分别为62%和36%，在16周时分别为81%和60%（P=0.0001）。
在缓解16周后与酸相关的消化不良症状方面，奥美拉唑临床管理策略优于抗酸剂-藻酸盐/雷尼替丁管理策略。此外，奥美拉唑治疗策略涉及的全科医生会诊较少，从而尽量减少了其他医疗资源的使用。
