Effectiveness of polyvalent bacterial lysate for pediatric asthma control: a retrospective propensity score-matched cohort study.

Abstract

Previous studies showed bacterial lysates were effective for pediatric asthma. However, evidence of polyvalent bacterial lysate Qipian is lacking. In this real-world retrospective cohort study, data of children with asthma, aged six months to 14 years old, attending to Jiangxi Provincial Children's Hospital from January 2021 to April 2022, prescribed routine treatment for asthma plus Qipian (Qipian group) or not (control group) were extracted. To minimize the impact of confounders on the outcomes, baseline characteristics were utilized to perform propensity score matching through a multivariable logistic regression model. After matching, asthma control, exacerbation, etc. were compared. Totally, 795 patients were included (337 in the Qipian group and 458 in the control group), with 278 pairs (556 patients) matched. Most baseline characteristics were well-balanced. The proportion of males were 68.3% and 70.1% in the two groups. The Qipian group favored better asthma control, with more "controlled" [3-month: 257 (92.4%) vs. 240 (86.3%); 6-month: 246 (88.5%) vs. 235 (84.5%)], and fewer "poorly/very poorly controlled" patients, compared with the control group (P=0.004 and 0.025, respectively). Patients in the Qipian group had lower risks of exacerbation. Incidence rate ratios (IRR) for any exacerbation were 0.56 [95% confidence interval (CI): 0.33 to 0.93] in the 3-month period and 0.83 (95% CI: 0.55 to 1.26) in the 6-month period. IRR for severe exacerbations were 0.09 (95% CI: 0.01 to 0.71) in the 3-month period and 0.20 (95% CI: 0.06 to 0.70) in the 6-month period (compared to the control group). Qipian significantly reduced the cumulative dose of short-acting beta-agonist (3-month: 3.22±10.37 vs. 8.08±16.71 mg; P<0.001; 6-month: 6.56±16.23 vs. 11.81±24.41 mg; P=0.002). There was no difference in incidences of respiratory tract infection or fever due to respiratory tract infection between the two groups. Numbers of antibacterial agent prescription were fewer in the Qipian group compared to the control group (3-month: 0.67±1.16 vs. 1.04±1.45; P=0.001; 6-month: 1.14±1.69 vs. 1.51±2.12; P=0.023). According to this retrospective study, Qipian may be effective for improved pediatric asthma control. Safety profile and mechanisms of action of Qipian need further investigation. Further randomized controlled trials are warranted to confirm our results.