[Domestic imipenem cilastatin sodium for the treatment of severe aspiration pneumonia, a curative effect observation].

Objective: To evaluate the efficacy and safety of domestic imipenem cilastatin sodium for the treatments of severe aspiration pneumonia.

Methods: A randomize, open, parallel-controlled trial was conducted. Sixty-eight patients with severe aspiration pneumonia were divided into trial group (n=36) and control group (n=32) by random distribution method. The application of trial group domestic imipenem cilastatin sodium was 1.0 g intravenous drip, every 6-8 hours for 7-14 days. The control group application with imported injection imipenem cilastatin sodium was 1.0 g intravenous drip, every 6-8 hours for 7-14 days. The highest daily temperature (T), heart rate (HR), breathing rate (RR), pulse blood oxygen saturation (SpO(2)), blood oxygen partial pressure (PaO(2)), inhaled oxygen concentration (FiO(2)), oxygenation index (PaO(2)/FiO(2)), airway peak pressure (Paw), minute ventilation (MV) and white blood count (WBC), pro calcitonin (PCT), high-sensitivity C-reactive protein (hs-CRP) index before and 1, 3, 7 days after treatment, and liver and kidney function, chest X-rays, and sputum cultures of drug sensitive test were conducted. And the effectiveness and safety were determined according to the standards.

Results: After treatment indexes of the two groups were obviously improved, i. e. T, HR, RR, Paw, MV, the WBC, PCT, CRP were gradually declined, PaO(2)/FiO(2) was gradually raised. There were statistical significance before and 3 days after treatment in the trial and the control group [T: 37.35±0.91 centigrade vs. 38.43±1.06 centigrade, 37.28±0.88 centigrade vs. 38.35±1.11 centigrade; HR: 90.25±10.60 bpm vs. 118.94±15.46 bpm, 89.31±11.17 bpm vs. 124.34±17.87 bpm; RR: 25.14±3.17 bpm vs. 32.28±4.49 bpm, 24.81±2.43 bpm vs. 33.13±4.17 bpm; Paw: 23.03±3.04 cm H(2)O vs. 33.22±4.59 cm H(2)O, 22.75±3.22 cm H(2)O vs. 33.63±4.79 cm H(2)O; MV: 8.67±1.26 L/min vs. 11.80±2.01 L/min, 8.88±1.45 L/min vs. 13.21±2.90 L/min; WBC: 11.26±1.96 ×10(9)/L vs. 14.57±3.10 ×10(9)/L, 12.28±3.38 ×10(9)/L vs. 15.25±4.93 ×10(9)/L; PCT: 6.90±5.46 μg/L vs. 16.97±7.93 μg/L, 6.17±6.13 μg/L vs. 21.26±11.54 μg/L; CRP: 85.50±37.91 mg/L vs. 120.17±45.47 mg/L, 94.31±38.51 mg/L vs. 142.34±53.57 mg/L; PaO(2)/ FiO(2): 182.06±40.88 mm Hg vs. 98.67±20.62 mm Hg, 184.09±43.78 mm Hg vs. 96.22±22.59 mm Hg, all P<0.05]. There was no significant change in SpO(2) before and after treatment in two groups. And the total clinical effective rate in trial and control group were 83.4% and 81.2%, adverse reaction rate were 13.9% and 9.4%, bacterial removal rate were 90.3% and 87.0% respectively, and there was no significant difference between the two groups (all P>0.05).

Conclusion: Domestic imipenem cilastatin sodium can effectively control severe aspiration pneumonia, and it is safe and effective antibiotics.