Objectives Trichloroethylene (TCE) -induced hypersensitivity syndrome (TIHS) is a potentially life-threatening disease. Several genetic susceptibility biomarkers have been found to be associated with TIHS, and this systematic prospective study has been conducted to evaluate the utility of these genetic susceptibility biomarkers in preventing the disease.
Methods The newly hired TCE-exposed workers were recruited from March 2009 to October 2010. HLA-B*13:01 genotyping and 3-month follow-up procedure were conducted. All workers were monitored for adverse reaction by telephone interview every week. The workers with early symptoms of TIHS were asked to go to the hospital immediately for further examination, diagnosis and treatment. The medical expense record data of patients with TIHS were collected for cost-effectiveness analysis in 2018.
Results Among 1651 workers, 158 (9.57%) were found to carry the HLA-B*13:01 allele and 16 (0.97%) were diagnosed with TIHS. HLA-B*13:01 allele was significantly associated with an increased TIHS risk (relative risk=28.4, 95% CI 9.2 to 86.8). As a risk predictor of TIHS, HLA-B*13:01 testing had a sensitivity of 75%, a specificity of 91.1% and an area under curve of 0.83 (95% CI 0.705 to 0.955), the positive and negative predictive values were 7.6% and 99.7%, respectively. The incidence of TIHS was significantly decreased in HLA-B*13:01 non-carriers (0.27%) compared with all workers (0.97%, p=0.014). Cost-effectiveness analysis showed that HLA-B*13:01 screening could produce an economic saving of $4604 per TIHS avoided.
Conclusions Prospective HLA-B*13:01 screening may significantly reduce the incidence of TIHS and could be a cost effective option for preventing the disease in TCE-exposed workers.
- hypersensitivity syndrome
- prospective cohort study
- cost-effectiveness analysis
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YD and WZ contributed equally.
Contributors YD, XH and YZ designed the study. YD and YZ obtained the financial support and conducted the study. WZ, JH, YX, HH and YS undertook participants recruitment and TCE exposure assessment and collected personal data. WZ, JY and XH collected the information of patients and medical expense record data. HyD, YN, HwD, MY, PB and MS undertook related data handling and calculation, managed recruitment and obtained biological samples. HyD and QJ performed the genotyping of all samples and undertook data checking and statistical analysis. YD and QJ wrote the first draft. YZ and XH revised the draft. All authors contributed to the final manuscript.
Funding This project was supported by grants from the National Natural Science Foundation of China (81773477, 30872089) and National Key Technology R&D Program in the 11th and 12th Five Year Plan of China（2006BAI06B02, 2014BAI12B02).
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. Please contact with Yufei Dai (firstname.lastname@example.org) for requesting data of genotyping protocol and genotyping data.
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