Hamada Yohhei, Kontsevaya Irina, Surkova Elena, Wang Ting Ting, Wan-Hsin Liu, Matveev Aleksandr, Ziganshina Liliya Eugenevna, Denkinger Claudia M, Korobitsyn Alexei, Ismail Nazir, Abubakar Ibrahim, Rangaka Molebogeng X
Institute for Global Health, University College London, London, United Kingdom.
Division of Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center, Borstel, Germany.
Open Forum Infect Dis. 2023 May 2;10(5):ofad228. doi: 10.1093/ofid/ofad228. eCollection 2023 May.
A systematic review showed that the accuracy of antigen-based skin tests (TBSTs) for tuberculosis is similar to that of interferon γ release assay, but the safety of TBSTs has not been systematically reviewed.
We searched for studies reporting injection site reactions (ISRs) and systemic adverse events associated with TBSTs. We searched Medline, Embase, e-library, the Chinese Biomedical Literature Database, and the China National Knowledge Infrastructure database for studies through 30 July 2021, and the database search was updated until 22 November 2022.
We identified 7 studies for Cy-Tb (Serum Institute of India), 7 (including 2 found through the updated search) for C-TST (Anhui Zhifei Longcom), and 11 for Diaskintest (Generium). The pooled risk of any injection site reactions (ISRs) due to Cy-Tb (n = 2931; 5 studies) did not differ significantly from that for tuberculin skin tests (TSTs; risk ratio, 1.05 [95% confidence interval, .70-1.58]). More than 95% of ISRs were reported as mild or moderate; common ISRs included pain, itching, and rash. In 1 randomized controlled study, 49 of 153 participants (37.6%) given Cy-Tb experience any systemic adverse event (eg, fever and headache), compared with 56 of 149 participants (37.6%) given TST (risk ratio, 0.85 [95% confidence interval, .6-1.2]). In a randomized controlled study in China (n = 14 579), the frequency of systemic adverse events in participants given C-TST was similar to that for TST, and the frequency of ISRs was similar to or lower than that for TST. Reporting of the safety data on Diaskintest was not standardized, precluding meta-analysis.
The safety profile of TBSTs appears similar to that of TSTs and is associated with mostly mild ISRs.
一项系统评价表明，基于抗原的结核菌素皮肤试验（TBSTs）对结核病的诊断准确性与干扰素γ释放试验相似，但TBSTs的安全性尚未得到系统评价。
我们检索了报告与TBSTs相关的注射部位反应（ISRs）和全身不良事件的研究。我们检索了Medline、Embase、电子图书馆、中国生物医学文献数据库和中国知网数据库，检索截至2021年7月30日的研究，并将数据库检索更新至2022年11月22日。
我们确定了7项关于Cy-Tb（印度血清研究所）的研究、7项关于C-TST（安徽智飞龙科马）的研究（包括通过更新检索找到的2项）和11项关于Diaskintest（Generium）的研究。Cy-Tb导致的任何注射部位反应（ISRs）的合并风险（n = 2931；5项研究）与结核菌素皮肤试验（TSTs）相比无显著差异（风险比为1.05 [95%置信区间为0.70 - 1.58]）。超过95% 的ISRs报告为轻度或中度；常见的ISRs包括疼痛、瘙痒和皮疹。在一项随机对照研究中，153名接受Cy-Tb的参与者中有49名（37.6%）出现任何全身不良事件（如发热和头痛），而149名接受TST的参与者中有56名（37.6%）出现（风险比为0.85 [95%置信区间为0.6 - 1.2]）。在中国的一项随机对照研究（n = 14,579）中，接受C-TST的参与者全身不良事件的发生率与接受TST的参与者相似，ISRs的发生率与TST相似或更低。关于Diaskintest安全性数据的报告不规范，无法进行荟萃分析。
TBSTs的安全性似乎与TSTs相似，且大多与轻度ISRs相关。
