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Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia

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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 × 109/L ≤ platelet count ≤ 70 × 109/L) and positive C13-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 × 109/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.

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Acknowledgments

This work was supported by Priority Research Center Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology (2009–0094050). The authors are grateful to Jeil Pharmaceutical Co., Ltd. Korea for supplying lansoprazole. The authors thank Min Young Kang and CRA for data collection.

Conflict of interest

All authors have no conflict of interest to declare.

Author contribution

HJK designed study concept; HK, WSL, KHL, SHB, MKK, JCJ, JHL, JHL, DYK, SML, HMR, MSH and HJK performed study; HK wrote the manuscript; YDJ and HJK critically reviewed study. HK and WSL contributed equally to this work.

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Authors and Affiliations

  1. Division of Hematology and Hematological Malignancies, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunhwan-doro, Ulsan, 682-714, Republic of Korea

    Hawk Kim & Jae-Cheol Jo

  2. Department of Hematology/Oncology, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea

    Won-Sik Lee & Sang Min Lee

  3. Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Kyoo-Hyung Lee, Je-Hwan Lee, Jung-Hee Lee & Dae-Young Kim

  4. Department of Hematology-Oncology, Daegu Catholic University Medical Center, Catholic University of Daegu School of Medicine, Daegu, Republic of Korea

    Sung Hwa Bae & Hun-Mo Ryoo

  5. Department of Hematology-Oncology, Yeungnam University Medical Center, Yeungnam University School of Medicine, Daegu, Republic of Korea

    Min Kyoung Kim & Myung Soo Hyun

  6. Department of Hematology/Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea

    Young-Don Joo

  7. Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical Center, 896 Pyeongchondong, Dongangu, Anyang, Gyeonggido, Republic of Korea

    Dae Young Zang & Hyo Jung Kim

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  1. Hawk Kim
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  2. Won-Sik Lee
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  9. Sang Min Lee
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  15. Hyo Jung Kim
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Consortia

CoOperative Study Group A for Hematology (COSAH)

Corresponding author

Correspondence to Hyo Jung Kim.

Additional information

This trial was registered at www.ClinicalTrials.gov (NCT01255332)

Institutional IRB: (UUH2010-09-084, Approved on Sep 20th, 2010; e-mail:uuhirb@uuh.ulsan.kr)

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Kim, H., Lee, WS., Lee, KH. et al. Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia. Ann Hematol 94, 739–746 (2015). https://doi.org/10.1007/s00277-014-2268-9

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  • DOI: https://doi.org/10.1007/s00277-014-2268-9

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