Polaprezinc for prevention of oral mucositis in patients receiving chemotherapy followed by hematopoietic stem cell transplantation: A multi‐institutional randomized controlled trial
Polaprezinc for prevention of oral mucositis in patients receiving chemotherapy followed by hematopoietic stem cell transplantation: A multi‐institutional randomized controlled trial
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聚普锌用于预防化疗后造血干细胞移植患者的口腔粘膜炎：一项多机构随机对照试验
DOI：
10.1002/ijc.33316
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发表时间：
2020
影响因子：
6.4
通讯作者：
Suzuki Akio
中科院分区：
文献类型：
--
作者：
Kitagawa Junichi;Kobayashi Ryo;Nagata Yasuyuki;Kasahara Senji;Ono Takaaki;Sawada Michio;Ohata Koichi;Kato‐Hayashi Hiroko;Hayashi Hideki;Shimizu Masahito;Itoh Yoshinori;Tsurumi Hisashi;Suzuki Akio
口腔粘膜炎是接受大剂量化疗后接受造血干细胞移植（HSCT）的患者常见且令人痛苦的并发症。我们之前在一项单中心回顾性分析中报告，L-肌肽锌（Polaprezinc [PZ]）降低了HSCT相关口腔粘膜炎的发生率。为了验证PZ对口腔粘膜炎预防作用的准确性，我们进行了一项多机构前瞻性随机对照研究。患者被随机分配到预防组（在化疗前开始PZ锭剂治疗）或对照组（在2级口腔粘膜炎发作后立即开始PZ锭剂给药）。从化疗开始到移植后35天，每天评估口腔粘膜炎。共入组91例患者，88例患者（对照组47例，预防组41例）符合数据分析条件。与对照组相比，预防组中≥2级但不≥3级口腔粘膜炎的发生率显著降低（对照组为44.7%，预防组为22.0%，P= 0.025）。两组间其他不良事件的发生率或植入率无显著差异（95.6%vs97.2%，P = 0.693）。这些结果表明，PZ含片可有效预防接受HSCT的患者中与化疗相关的≥2级口腔粘膜炎，对HSCT结局无任何影响。
Oral mucositis is a common and distressing complication in patients receiving high‐dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT). We reported previously in a single‐center retrospective analysis that zinc‐L‐carnosine (polaprezinc [PZ]) reduced the incidence of oral mucositis associated with HSCT. To verify the accuracy of the prophylactic effect of PZ against oral mucositis, we carried out a multi‐institutional prospective randomized controlled study. Patients were randomly allocated to either the prevention group, in which PZ lozenge treatment was started before chemotherapy, or the control group, in which administration of PZ lozenges was initiated immediately after the onset of Grade 2 oral mucositis. Oral mucositis was evaluated daily from the start of chemotherapy to 35 days after transplantation. A total of 91 patients were enrolled, and 88 patients (47 in the control group and 41 in the prevention group) were eligible for data analysis. The incidence of Grade ≥2 but not Grade ≥3 oral mucositis was significantly reduced in the prevention group compared to the control group (44.7% in control group vs 22.0% in the prevention group,P= .025). There were no significant differences in the incidence rates of other adverse events or the rate of engraftment (95.6% vs 97.2%,P= .693) between the two groups. These findings suggest that PZ lozenge is effective for prophylaxis against Grade ≥2 oral mucositis associated with chemotherapy in patients undergoing HSCT without any influence on the HSCT outcome.
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帕利弗明预防和治疗急性淋巴细胞白血病患者口腔粘膜炎的可靠性和有效性：一项随机、双盲对照临床试验。
影响因子：
--
作者：
A. Lucchese;G. Matarese;M. Manuelli;C. Ciuffreda;L. Bassani;G. Isola;G. Cordasco;E. Gherlone
通讯作者：
E. Gherlone
影响因子：
2.1
作者：
Lauria Silva, Geisa Badauy;Sacono, Nancy Tomoko;Batista, Aline Carvalho
通讯作者：
Batista, Aline Carvalho
影响因子：
45.3
作者：
Blijlevens, Nicole;Schwenkglenks, Matthias;McCann, Shaun
通讯作者：
McCann, Shaun
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DOI：
--
发表时间：
2001
期刊：
Medical science monitor : international medical journal of experimental and clinical research
影响因子：
--
作者：
S. Kato;A. Tanaka;Y. Ogawa;K. Kanatsu;K. Seto;Tomoyuki Yoneda;K. Takeuchi
通讯作者：
K. Takeuchi
影响因子：
2.7
作者：
Sung L;Robinson P;Treister N;Baggott T;Gibson P;Tissing W;Wiernikowski J;Brinklow J;Dupuis LL
通讯作者：
Dupuis LL