Mishra Kundan, Kumar Suman, Sandal Rajeev, Jandial Aditya, Sahu Kamal Kant, Singh Kanwaljeet, Ahuja Ankur, Somasundaram Venkatesan, Kumar Rajiv, Kapoor Rajan, Sharma Sanjeevan, Singh Jasjit, Yanamandra Uday, Das Satyaranjan, Chaterjee Tathagat, Sharma Ajay, Nair Velu
Department of Clinical Hematology and Stem Cell Transplant, Army Hospital (Research & Referral) Delhi, India.
Department of Radiotherapy and Oncology, IGMC Shimla Himachal Pradesh, India.
Am J Blood Res. 2021 Aug 15;11(4):361-372. eCollection 2021.
Immune Thrombocytopenia (ITP) is characterized by low platelet counts. Splenectomy has been in practice for the treatment of ITP since the early 20th century. We aimed to analyze the data of ITP patients from our hospital who underwent splenectomy and further present the long-term outcome and safety profile in these patients.
This study was a single-center, registry based study conducted at a tertiary care hospital in Northern India. Patients aged 18 years or more, who underwent splenectomy after at least one line of therapy, were included in the study. The primary outcome was the overall response rate (ORR) at one month after splenectomy. Secondary outcomes were sustained response, relapse-free survival, factors affecting the ORR, and adverse events after splenectomy.
Forty-five patients of ITP were included in the study. Thirty-six patients underwent splenectomy in the first half (2001-2010), of the study period. The median age of the patients was 38 (19-56) years. The median duration from diagnosis to splenectomy was 1.76 (0.47-2.58) years. The median number of therapy received before splenectomy was 3 (1-6). The overall response rate (ORR) post-splenectomy at day 30 was 89.2% with 61.8% complete response (CR). The ORR was 88.5% at 1-year, with 48.8% CR. The relapse-free survival (RFS) at 5-years was 57.38% (95% Confidence Interval 40.59-71.02%), There was no effect of duration of disease, age, gender, and prior therapy received, on the ORR at one-month. At one year, the platelet response was significantly better in patients who had a CR at one-month than patients who had a partial response at one month. The relapse-free survival was better in patients who achieved CR after 1-month of splenectomy. During the median follow-up of 5.02 (1 month-20 years) years, there were five cases of overwhelming post-splenectomy infection (OPSI). There was no recorded incidence of perioperative mortality, deep vein thrombosis, or mesenteric thrombosis.
Despite the variation in outcome from different studies, splenectomy gives the best possible long-term treatment-free remission amongst all the available second-line agents. It is also, one of the most financially affordable therapies. Despite advantages, the number of ITP patients undergoing splenectomy has been on the decline and largely attributable to the newer and more effective second-line therapies. There is no pre-surgery variable predicting the ORR after splenectomy.
Splenectomy in ITP offers a long-term sustained response at an economical cost.
免疫性血小板减少症(ITP)的特征是血小板计数低。自20世纪初以来,脾切除术一直用于治疗ITP。我们旨在分析我院接受脾切除术的ITP患者的数据,并进一步呈现这些患者的长期结局和安全性概况。
本研究是在印度北部一家三级医疗中心进行的单中心、基于登记的研究。纳入年龄在18岁及以上、至少经过一线治疗后接受脾切除术的患者。主要结局是脾切除术后1个月的总缓解率(ORR)。次要结局包括持续缓解、无复发生存率、影响ORR的因素以及脾切除术后的不良事件。
45例ITP患者纳入本研究。36例患者在研究期间的前半段(2001 - 2010年)接受了脾切除术。患者的中位年龄为38(范围19 - 56)岁。从诊断到脾切除术的中位时间为1.76(范围0.47 - 2.58)年。脾切除术前接受治疗的中位次数为3(范围1 - 6)次。脾切除术后30天的总缓解率(ORR)为89.2%,完全缓解(CR)率为61.8%。1年时的ORR为88.5%,CR率为48.8%。5年无复发生存率(RFS)为57.38%(95%置信区间40.59 - 71.02%)。疾病持续时间、年龄、性别以及之前接受的治疗对1个月时的ORR均无影响。1年时,1个月时达到CR的患者血小板反应明显优于1个月时部分缓解的患者。脾切除术后1个月达到CR的患者无复发生存情况更好。在中位随访5.02(范围1个月 - 20年)年期间,有5例发生暴发性脾切除术后感染(OPSI)。围手术期死亡率、深静脉血栓形成或肠系膜血栓形成均无记录。
尽管不同研究的结果存在差异,但在所有可用的二线治疗药物中,脾切除术能带来最佳的长期无治疗缓解。它也是最经济实惠的治疗方法之一。尽管有这些优点,但接受脾切除术的ITP患者数量一直在下降,这在很大程度上归因于更新的、更有效的二线治疗方法。没有术前变量可以预测脾切除术后的ORR。
ITP患者的脾切除术能以经济的成本提供长期持续缓解。