Достижения в области фармакоэпидемиологии и безопасности лекарственных средств

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Second-line Anti-Tuberculosis Drugs and Risk of Alopecia: A Retrospective Cohort study

Russom M, Berhe A and Hagos L

Background 

Alopecia is not a well-known adverse effect of second-line anti-tuberculosis drugs. It is however, been frequently reported in Eritrea and 83% of the reports of alopecia associated with second-line anti-TB drugs in the global adverse drug reaction database, as of July 25, 2017, were submitted from Eritrea. It is wondering why this much variation is happening and this study is therefore aimed at quantifying the risk, identifying possible risk factors and elucidating the causal association between alopecia and the second-line anti-TB drugs in Eritrea.

Methods

This was a retrospective cohort study that included all patients with multi-drug resistant tuberculosis (MDR-TB) in Eritrea enrolled to Merhano MDR-TB referral hospital for treatment between June 2011 and December 2016.

Results

A total of 152 eligible MDR-TB patients on treatment were identified with a median observation time of 23 months. Historical longitudinal data of these patients was screened and found 35 cases of alopecia, possibly associated with MDR-TB treatment, with an incidence rate of about 13 cases per 1000 person-months. Majority of the cases (68.6%) developed alopecia after 18 months of exposure to MDR-TB treatment. Patients exposed to treatment for longer period of time (>23 months) were more likely to develop alopecia compared to those exposed for shorter time (p=0.001). Patients younger than 45 years of age reported higher rates of alopecia compared to the older age groups (adjusted OR=9.4; 95%CI: 2.41-36.86, p=0.001). Females were also more likely to develop alopecia compared to males (adjusted OR=3; 95%CI: 1.24 - 7.34, p=0.015).

Conclusion

Alopecia associated with MDR-TB treatment is frequent but its delayed time to onset might be a reason to be missed by several similar studies conducted elsewhere. Even though alopecia is not life-threatening and does not cause physical pain, the cosmetic effects of hair loss can be psychologically devastating.