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序贯甲硝唑-呋喃唑酮或克拉霉素-呋喃唑酮与基于克拉霉素的四联方案治疗消化性溃疡中幽门螺杆菌的疗效比较:一项双盲随机对照试验。

Sequential metronidazole-furazolidone or clarithromycin-furazolidone compared to clarithromycin-based quadruple regimens for the eradication of Helicobacter pylori in peptic ulcer disease: a double-blind randomized controlled trial.

机构信息

Digestive Disease Research Center, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Helicobacter. 2010 Dec;15(6):497-504. doi: 10.1111/j.1523-5378.2010.00798.x.

DOI:10.1111/j.1523-5378.2010.00798.x
PMID:21073605
Abstract

BACKGROUND

Furazolidone is a much cheaper drug with a very low resistance against Helicobacter pylori compared to clarithromycin. We aim to evaluate safety and efficacy of a sequential furazolidone-based regimen versus clarithromycin-based therapy in H. pylori eradication for ulcer disease.

MATERIALS

Patients with proven peptic ulcer or duodenitis were randomized into three groups: OAB-M-F; metronidazole (M) (500 mg bid) for the first 5 days, followed by furazolidone (F) (200 mg bid) for the second 5 days; OAC-P; clarithromycin (C) (500 mg bid) for 10 days; and OAB-C-F; clarithromycin (500 mg bid) for the first 5 days and furazolidone (200 mg bid) for the second 5 days. All groups received omeprazole (O) (20 mg bid) and amoxicillin (A) (1 g bid). Groups OAB-M-F and OAB-C-F were also given bismuth subcitrate (B) (240 mg bid), whereas a placebo (P) was given to group OAC-P. Adverse events were scored and recorded. Two months after treatment, a C(13) -urea breath test was performed.

RESULTS

Three hundred and ten patients were enrolled and 92 (OAB-M-F), 95 (OAC-P), and 98 (OAB-C-F) completed the study. The intention-to-treat eradication rates were 78.5% (95% CI = 69-85), 81.1% (95% CI = 73-88), and 82% (95% CI = 74-89), and per-protocol eradication rates were 91.3% (95% CI = 83-96), 90.4% (95% CI = 82-95), and 88.7% (95% CI = 81-94), for group OAB-M-F, OAC-P, and OAB-C-F, respectively. Eradication rate differences did not reach statistical significance. The most common adverse event, bad taste, occurred in all groups, but more frequently in groups OAC-P (34%) and OAB-C-F (32%), than OAB-M-F (14%) (p < .05). Adverse symptoms score were 0.88 ± 2.05 in group OAB-M-F, 1.15 ± 1.40 in group OAC-P, and 1.87 ± 1.62 in group OAB-C-F.

CONCLUSION

Furazolidone can replace clarithromycin in H. pylori eradication regimens because of lack of development of resistance and very low cost.

摘要

背景

与克拉霉素相比,呋喃唑酮是一种更便宜的药物,对幽门螺杆菌的耐药性也低得多。我们旨在评估基于呋喃唑酮的序贯疗法与克拉霉素治疗消化性溃疡疾病的安全性和疗效。

材料

经证实患有消化性溃疡或十二指肠炎的患者被随机分为三组:OAB-M-F 组;甲硝唑(M)(500 mg,bid)治疗 5 天,然后呋喃唑酮(F)(200 mg,bid)治疗 5 天;OAC-P 组;克拉霉素(C)(500 mg,bid)治疗 10 天;OAB-C-F 组;克拉霉素(500 mg,bid)治疗 5 天,然后呋喃唑酮(200 mg,bid)治疗 5 天。所有组均接受奥美拉唑(O)(20 mg,bid)和阿莫西林(A)(1 g,bid)治疗。OAB-M-F 组和 OAB-C-F 组还接受枸橼酸铋钾(B)(240 mg,bid)治疗,而 OAC-P 组则接受安慰剂(P)治疗。记录不良事件并进行评分。治疗 2 个月后,进行 C(13)-尿素呼气试验。

结果

共纳入 310 例患者,92 例(OAB-M-F)、95 例(OAC-P)和 98 例(OAB-C-F)完成了研究。意向治疗根除率分别为 78.5%(95%CI=69-85)、81.1%(95%CI=73-88)和 82%(95%CI=74-89),按方案根除率分别为 91.3%(95%CI=83-96)、90.4%(95%CI=82-95)和 88.7%(95%CI=81-94),分别为 OAB-M-F 组、OAC-P 组和 OAB-C-F 组。根除率差异无统计学意义。最常见的不良事件味觉异常在所有组中均有发生,但在 OAC-P 组(34%)和 OAB-C-F 组(32%)比 OAB-M-F 组(14%)更为常见(p<.05)。OAB-M-F 组不良症状评分 0.88±2.05,OAC-P 组 1.15±1.40,OAB-C-F 组 1.87±1.62。

结论

由于缺乏耐药性的发展和非常低的成本,呋喃唑酮可以替代克拉霉素用于幽门螺杆菌的根除方案。

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