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

Abstract

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.