Logan R P, Gummett P A, Schaufelberger H D, Greaves R R, Mendelson G M, Walker M M, Thomas P H, Baron J H, Misiewicz J J
Parkside Helicobacter Study Group, Central Middlesex Hospital, London.
Gut. 1994 Mar;35(3):323-6. doi: 10.1136/gut.35.3.323.
Clarithromycin, a new and well tolerated, acid stable macrolide antibiotic, has a similar antimicrobial spectrum to erythromycin but a better in vitro MIC90 (0.03 microgram/l-1) against Helicobacter pylori (H pylori). This study aimed at determining the eradication rate using clarithromycin 500 mg thrice daily and omeprazole 40 mg daily for two weeks. Patients were given an endoscopy and H pylori status assessed by antral culture (microaerobic conditions, for up to 10 days), antral and corpus histology tests (haematoxylin and eosin/Gimenez stains), and 13C-urea breath test (13C-UBT, European standard protocol, positive result = excess delta 13CO2 excretion > 5 per mil). Compliance was assessed by returned tablet counts. H pylori clearance at the end of treatment and eradication four weeks after finishing treatment were assessed by the 13C-UBT. Seventy three patients (54 men, median age 45 years) with duodenal ulcers (n = 42) or duodenitis/non-ulcer dyspepsia (n = 31) all with a positive 13C-UBT (mean (SEM) excess delta-13CO2 excretion = 26.6 (4.9) per mil) and either positive antral histology (n = 72) or positive antral culture (n = 35) were studied. Before treatment 2/27 (7%) isolates of H pylori were resistant to clarithromycin and five isolates were resistant to metronidazole. In 70/73 (96%) the 13C-UBT was negative immediately after finishing treatment. Four weeks later the 13C-UBT was negative in 57/73 (mean (SEM) excess delta 13CO2 excretion = 1.2 (0.3) per mil, eradication rate = 78%). Forty eight (66%) patients experienced a metallic taste while taking the tablets. Although four (5%) patients, however, could not complete the course of treatment, in only one of these four was H pylori not eradicated. These results show that duel therapy with clarithromycin and omeprazole is well tolerated. With an eradication rate of 78% it is an effective treatment for metronidazole resistant H pylori and may be an alternative to standard triple therapy.
克拉霉素是一种新型且耐受性良好、酸稳定的大环内酯类抗生素,其抗菌谱与红霉素相似,但对幽门螺杆菌(H pylori)的体外最低抑菌浓度(MIC90)更佳(0.03微克/升)。本研究旨在确定每日三次服用500毫克克拉霉素及每日服用40毫克奥美拉唑,持续两周的根除率。对患者进行了内镜检查,并通过胃窦培养(微需氧条件,最长10天)、胃窦和胃体组织学检查(苏木精和伊红/吉姆萨染色)以及13C - 尿素呼气试验(13C - UBT,欧洲标准方案,阳性结果 = 过量δ13CO2排泄>5‰)评估幽门螺杆菌状况。通过回收的药片计数评估依从性。治疗结束时的幽门螺杆菌清除情况以及完成治疗四周后的根除情况通过13C - UBT进行评估。研究了73例患者(54名男性,中位年龄45岁),他们患有十二指肠溃疡(n = 42)或十二指肠炎/非溃疡性消化不良(n = 31),所有患者的13C - UBT均为阳性(平均(标准误)过量δ - 13CO2排泄 = 26.6(4.9)‰),且胃窦组织学检查阳性(n = 72)或胃窦培养阳性(n = 35)。治疗前,2/27(7%)的幽门螺杆菌分离株对克拉霉素耐药,5株对甲硝唑耐药。70/73(96%)的患者在治疗结束后立即进行的13C - UBT为阴性。四周后,57/73的患者13C - UBT为阴性(平均(标准误)过量δ13CO2排泄 = 1.2(0.3)‰,根除率 = 78%)。48例(66%)患者在服药期间出现金属味。然而,尽管有4例(5%)患者未能完成疗程,但这4例中只有1例的幽门螺杆菌未被根除。这些结果表明,克拉霉素和奥美拉唑联合治疗耐受性良好。根除率为78%,它是治疗甲硝唑耐药幽门螺杆菌的有效疗法,可能是标准三联疗法的替代方案。