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纯化蛋白衍生物皮肤试验反应与接受诱导性卡介苗治疗的非肌层浸润性膀胱癌患者的临床结局相关。

Purified protein derivative skin test reactions are associated with clinical outcomes of patients with nonmuscle invasive bladder cancer treated with induction bacillus Calmette-Guérin therapy.

作者信息

Niwa Naoya, Kikuchi Eiji, Matsumoto Kazuhiro, Kosaka Takeo, Mizuno Ryuichi, Oya Mototsugu

机构信息

Department of Urology, Keio University School of Medicine, Tokyo, Japan.

Department of Urology, Keio University School of Medicine, Tokyo, Japan.

出版信息

Urol Oncol. 2018 Feb;36(2):77.e15-77.e21. doi: 10.1016/j.urolonc.2017.10.005. Epub 2017 Oct 31.

Abstract

OBJECTIVES

To investigate the relationship between purified protein derivative (PPD) skin test reactions before bacillus Calmette-Guérin (BCG) therapy and the clinical outcomes of BCG-naïve nonmuscle invasive bladder cancer patients treated with adjuvant BCG therapy.

MATERIALS AND METHODS

A total of 288 nonmuscle invasive bladder cancer patients subjected to the PPD skin test before BCG therapy were included. PPD skin test reactions were categorized into 3 groups: positive, slightly positive, and negative. The presence of an induration was positive. If an induration was absent, erythema of 10mm or more and less than 10mm corresponded to slightly positive and negative, respectively.

RESULTS

A total of 66 (22.9%), 149 (51.7%), and 73 (25.3%) patients exhibited a positive, slightly positive, and negative to PPD skin test, respectively. The 5-year recurrence-free survival rate of patients with positive PPD skin test reactions was 89.4 ± 4.1%, which was significantly higher than those of patients with slightly positive (65.5 ± 4.2%, P = 0.001) and negative reactions (56.4 ± 6.6%, P<0.001). A multivariate Cox regression analysis revealed that a positive PPD skin test reaction was independently associated with tumor recurrence (hazard ratio of 0.233, P<0.001), but not with stage progression. The incidence of fever persisting for more than 2 days or fever of ≥38°C was significantly higher in patients with a positive PPD skin test reaction (18.2%) than in patients with slightly positive (8.7%) and negative PPD skin test reactions (4.1%).

CONCLUSIONS

The PPD skin test reactions before BCG therapy may predict clinical outcomes following BCG therapy and help clinicians counsel patients exhibiting strong therapeutic effects with BCG therapy and potentially major BCG-related side effects.

摘要

目的

探讨卡介苗(BCG)治疗前纯化蛋白衍生物(PPD)皮肤试验反应与初治非肌层浸润性膀胱癌患者接受辅助性BCG治疗的临床结局之间的关系。

材料与方法

纳入288例在BCG治疗前接受PPD皮肤试验的非肌层浸润性膀胱癌患者。PPD皮肤试验反应分为3组:阳性、弱阳性和阴性。出现硬结为阳性。若无硬结,红斑直径≥10mm和<10mm分别对应弱阳性和阴性。

结果

分别有66例(22.9%)、149例(51.7%)和73例(25.3%)患者的PPD皮肤试验呈阳性、弱阳性和阴性。PPD皮肤试验反应阳性患者的5年无复发生存率为89.4±4.1%,显著高于弱阳性患者(65.5±4.2%,P=0.001)和阴性反应患者(56.4±6.6%,P<0.001)。多因素Cox回归分析显示,PPD皮肤试验反应阳性与肿瘤复发独立相关(风险比为0.233,P<0.001),但与分期进展无关。PPD皮肤试验反应阳性患者持续发热超过2天或体温≥38°C的发生率(18.2%)显著高于弱阳性患者(8.7%)和PPD皮肤试验反应阴性患者(4.1%)。

结论

BCG治疗前的PPD皮肤试验反应可能预测BCG治疗后的临床结局,并有助于临床医生为BCG治疗显示出强烈治疗效果且可能出现重大BCG相关副作用的患者提供咨询。

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