Roghani H S, Massarrat S, Pahlewanzadeh M R, Dashti M
Department of Internal Medicine, Yazd University of Medical Sciences, Iran.
Eur J Gastroenterol Hepatol. 1999 Jul;11(7):709-12. doi: 10.1097/00042737-199907000-00004.
Classic triple therapy with bismuth, tetracycline and metronidazole is one of the most economic and effective regimens for the eradication of Helicobacter pylori. The aim of the study was to assess the efficacy of two different doses of tetracycline (TET) and metronidazole (MET) on cure of H. pylori infection and its MET-resistant strains.
A total of 131 patients with duodenal ulcer were randomized into three groups and received the following medication for 2 weeks: group A, colloidal bismuth subcitrate (CBS) 3 x 120 mg + TET 3 x 500 mg + MET 3 x 250 mg/day; group B, CBS 3 x 120 mg + TET 3 x 500 mg + MET 3 x 125 mg/day; group C, CBS 3 x 120 mg + TET 3 x 250 mg + MET 3 x 125 mg/day. Control endoscopy was performed after 6 weeks. Two biopsy specimens from antral and three from corpus mucosa were taken for a urease test, histology and culture. Eradication was concluded if all three tests were negative for H. pylori. MET resistance was determined by the disc diffusion method.
In total, 121 patients completed the study. Only two of the 43 patients in group A discontinued the therapy due to intolerance. Cure of H. pylori infection was achieved by per protocol analysis in 33 of 43 patients in group A (76.7%), in 20 of 40 patients in group B (50%) and in 20 of 38 patients in group C (52.6%) (P < 0.05 for A versus B or C). Forty-two out of 112 patients had H. pylori strains resistant to MET (42%). In each group, the cure rate of infection was higher in patients with MET-sensitive H. pylori than in MET-resistant H. pylori (80.7% versus 64.2% in group A, 60% versus 38.8% in group B and 52.6% versus 40% in group C, respectively). Increase of MET dose from 375 mg (in groups B and C) to 750 mg/day (in group A) seems to augment the eradication of MET-sensitive as well as MET-resistant strains (up from 52% to 84% and from 39% to 64%, respectively; P < 0.05).
Cure rate of H. pylori infection under classic triple therapy remains unaffected by dose reduction of tetracycline but not of metronidazole. In countries with a high prevalence of metronidazole resistance, such as Iran, higher doses of metronidazole are probably needed to increase the cure rate of bismuth triple therapy.
铋剂、四环素和甲硝唑的经典三联疗法是根除幽门螺杆菌最经济有效的方案之一。本研究旨在评估两种不同剂量的四环素（TET）和甲硝唑（MET）对幽门螺杆菌感染及其耐MET菌株的根除效果。
131例十二指肠溃疡患者随机分为三组，接受以下药物治疗2周：A组，枸橼酸铋钾（CBS）3×120mg + TET 3×500mg + MET 3×250mg/天；B组，CBS 3×120mg + TET 3×500mg + MET 3×125mg/天；C组，CBS 3×120mg + TET 3×250mg + MET 3×125mg/天。6周后进行对照内镜检查。从胃窦取两份活检标本，从胃体黏膜取三份活检标本进行尿素酶试验、组织学检查和培养。如果所有三项检测幽门螺杆菌均为阴性，则判定为根除。采用纸片扩散法测定MET耐药性。
共有121例患者完成研究。A组43例患者中只有2例因不耐受而停止治疗。根据方案分析，A组43例患者中有33例（76.7%）实现了幽门螺杆菌感染的治愈，B组40例患者中有20例（50%），C组38例患者中有20例（52.6%）（A组与B组或C组相比，P<0.05）。112例患者中有42例（42%）幽门螺杆菌菌株对MET耐药。在每组中，MET敏感的幽门螺杆菌患者的感染治愈率高于MET耐药的患者（A组分别为80.7%和64.2%，B组分别为60%和38.8%，C组分别为52.6%和40%）。将MET剂量从375mg（B组和C组）增加到750mg/天（A组）似乎可增强对MET敏感及MET耐药菌株的根除效果（分别从52%提高到84%和从39%提高到64%；P<0.05）。
经典三联疗法下幽门螺杆菌感染的治愈率不受四环素剂量降低的影响，但受甲硝唑剂量降低的影响。在甲硝唑耐药率较高的国家，如伊朗，可能需要更高剂量的甲硝唑来提高铋剂三联疗法的治愈率。
