To observe the clinical efficacy and safety of caffeine citrate injection combined with poractant alfa injection in the treatment of respiratory distress syndrome (RDS) in premature infants.

RDS premature infants were divided into control group and treatment group according to the cohort method. The control group was given 100-200 mg·kg^-1 of poractant alfa injection by endotracheal tube injection and added 100 mg·kg^-1 after 12 h, whereas the treatment group received intravenous injection of caffeine citrate injection on the basis of the control group (with the initial loading dose of 20 mg·kg^-1 for 30 min, followed by an additional maintenance dose of 5 mg·kg^-1 for 10 min every 24 h). Both groups were treated continuously for 7 days. The clinical efficacy, treatment-related indicators, blood gas indicators, serological indicators and complications were compared between groups, and the safety evaluation was performed.

There were 57 cases in treatment group and 51 cases in control group. After treatment, the total effective rates in treatment group and control group were 94.74% (54 cases/57 cases) and 78.43% (40 cases/51 cases), respectively (P<0.05). After treatment, the mechanical ventilation time in treatment group and control group was (101.29±22.24) and (113.57±27.55) h; oxygen therapy time was (199.21±43.28) and (238.72±44.01) h; the hospitalization time was (25.63±3.37) and (29.98±4.90) d; the partial pressure of arterial blood oxygen (PaO₂) values were (79.55±7.27) and (74.83±6.16) mmHg; the arterial partial pressure of carbon dioxide (PaCO₂) values were (40.65±3.94) and (45.72±4.46) mmHg; blood pH values were 7.40±0.05 and 7.34±0.05; adrenocorticotropic hormone (ACTH) levels were (30.71±6.92) and (36.80±7.04) pg·mL^-1; cortisol (Cor) levels were (272.90±34.51) and (306.47±30.11) ng·mL^-1; interleukin-6 (IL-6) levels were (35.10±8.49) and (42.55±9.72) pg·mL^-1, and compared with control group, the above indicators in treatment group were statistically different (all P<0.05). During treatment, the incidence rates of complications in treatment group and control group were 3.51% (2 cases/57 cases) and 5.88% (3 cases/51 cases), respectively (P>0.05). There were no adverse drug reactions such as hypotension, bradycardia and irritability in both groups during treatment.

Caffeine citrate injection combined with poractant alfa injection in the treatment of RDS in premature infants can improve the efficacy, shorten the mechanical ventilation time, oxygen therapy time and hospitalization time, improve the blood gas and serum oxidative stress and inflammatory indicators, and the safety is good.