title: Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia.
abstract: The practical usefulness of Helicobacter pylori eradication for immune thrombocytopenia (ITP) patients is still controversial. However, some ITP patients respond to H. pylori eradication. We conducted a multi-center, open label, prospective phase II study to define the efficacy and toxicities of H. pylori eradication as the first line treatment for persistent or chronic ITP patients with moderate thrombocytopenia. Patients with persistent or chronic ITP showing moderate thrombocytopenia (30 × 10(9)/L ≤ platelet count ≤ 70 × 10(9)/L) and positive C(13)-urea breath test (UBT) were selected. Medication consisted of lansoprazole 30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg orally twice daily for a week. Complete response (CR) rate at 4 weeks, 3 months, 6 months, 12 months, and maximal response was 19.2, 50.0, 50.0, 26.9, and 65.4%, respectively. Overall response rate (ORR) at 4 weeks, 3 months, 6 months, 12 months, and maximal response was 19.2, 57.7, 65.4, 30.8, and 69.2%, respectively. Median maximal platelet count during the first 3 months was 110 × 10(9)/L (range, 40-274). Median time to CR was 8 weeks (95% CI = 5.429-10.571). Median time to ORR was 4 weeks (95% CI = 1.228-6.772). Only per-protocol population was a response predictor for ORR at 3 months (70.0%, p = 0.054) and maximal ORR (80.0%, p = 0.051), but not for CR at 3 months (60.0%, p = 0.160). Therefore, eradication of H. pylori is an effective and durable first line treatment for persistent or chronic ITP with moderate thrombocytopenia with high ORR and rapid onset in this study.
authors.affiliation: Division of Hematology and Hematological Malignancies, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunhwan-doro, Ulsan, 682-714, Republic of Korea.
authors.forename: Hawk
authors.initials: H
authors.lastname: Kim
authors.forename: Won-Sik
authors.initials: WS
authors.lastname: Lee
authors.forename: Kyoo-Hyung
authors.initials: KH
authors.lastname: Lee
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.forename: Min Kyoung
authors.initials: MK
authors.lastname: Kim
authors.forename: Young-Don
authors.initials: YD
authors.lastname: Joo
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.forename: Jae-Cheol
authors.initials: JC
authors.lastname: Jo
authors.forename: Sang Min
authors.initials: SM
authors.lastname: Lee
authors.forename: Je-Hwan
authors.initials: JH
authors.lastname: Lee
authors.forename: Jung-Hee
authors.initials: JH
authors.lastname: Lee
authors.forename: Dae-Young
authors.initials: DY
authors.lastname: Kim
authors.forename: Hun-Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Myung Soo
authors.initials: MS
authors.lastname: Hyun
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000472:pathogenicity*; D006801:Humans; D064747:Lansoprazole / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D013921:Thrombocytopenia / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D064747:Lansoprazole; D000658:Amoxicillin; D017291:Clarithromycin