国产亚胺培南／西司他丁钠治疗重症吸入性肺炎疗效观察

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

目的评价国产亚胺培南／西司他丁钠（速能）治疗重症吸入性肺炎的疗效和安全性。方法采用随机开放、平行对照试验设计，将68例重症吸入性肺炎患者按照随机数字表分配法分为试验组（36例）和对照组（32例），试验组静脉滴注（静滴）国产亚胺培南／西司他丁钠1．0g，6。8h1次，用药7～14d；对照组静滴进口亚胺培南／西司他丁钠（泰能）1．0g，6～8h1次，用药7—14d。观察记录两组患者的每日最高体温（T）、心率（HR）、呼吸频率（RR）、脉搏血氧饱和度（SpO2）、动脉血氧分压（PaO2）、吸入氧浓度（FiO2）、氧合指数（Pa02／FiO2）、气道峰压（Paw）、分钟通气量（MV）及治疗前和治疗1、3、7d白细胞计数（WBC）、降钙素原（PCT）、超敏c-反应蛋白（hs—CRP）等指标，定期检查肝肾功能、x线胸片，以及痰培养＋药敏试验；并按疗效及安全性标准判定治疗效果。结果两组治疗后各指标均有明显改善，T、HR、RR、Paw、MV、WBC、PCT、CRP均逐渐下降，PaO2／FiO2均逐渐升高，试验组和对照组治疗3d即与治疗前比较差异有统计学意义[T（℃）：37．35±0．91比38．43±1．06，37．28±0．88比38．35±1．11；HR（次／min）：90．25±10．60比118．94±15．46，89．31±11．17比124．34±17．87；RR（次／min）：25．14±3．17比32．28±4．49，24．81±2．43比33．13±4．17：Paw（cmH2O，1cmH，0=0．098kPa）：23．03±3．04比33．22±4．59，22．75±3．22比33．63±4．79；MV（L／min）：8．67±1．26比11．80±2．01．8．88±1．45比13．21±2．90；WBC（×10^9／L）：11．26±1．96比14．57±3．10，12．28±3．38比15．25±4．93：PCT（μg/L）：6．90±5．46比16．97±7．93，6．17±6．13比21．26±11．54；hs—CRP（mg/L）：85．50±37．91比120．17±45．47，94．31±38．51比142．34±53．57；PaO2／FiO2（mmHg，1mmHg=0．133kPa）：182．06±40．88比98．67±20．62，184．09±43．78比96．22±22．59，均P〈0．05]；而两组治疗前后SpO2无明显改变。试验组与对照组临床总有效率分别为83．4％和81．2％，不良反应发生率分别为13．9％和9．4％，细菌清除率为90．3％和87．0％，两组比较差异均无统计学意义（均P〉0．05）。结论国产亚胺培南／西司他丁钠可有效控制重症吸入性肺炎，是安全有效的广谱抗菌药物。

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 （SpO2）, blood oxygen partial pressure （PaO2）, inhaled oxygen concentration （FiO2）, oxygenation index （PaO2/FiO2）, airway peak pressure （Paw）, minute ventilation （ MV ） and white blood count （WBC）, pro ealeitonin （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, PaO2/FiO2 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 vs. 38.43 ± 1.06, 37.28±0.88 vs. 38.35 ± 1.11 ; HR （bpm） ： 90.25 ± 10.60 vs. 118.94 ± 15.46, 89.31 ± 11.17 vs. 124.34 ± 17.87; RR （bpm） ： 25.14 ± 3.17 vs. 32.28 ± 4.49, 24.81 ± 2.43 vs. 33.13 ±4.17; Paw （cm H2O, 1 cm H2O=0.098 kPa）： 23.03 ± 3.04 vs. 33.22 ±4.59, 22.75 ± 3.22 vs. 33.63 ± 4.79; MV （L/min）： 8.67±1.26 vs. 11.80 ± 2.01, 8.88 ± 1.45 vs. 13.21 ±2.90; WBC （ × 10^9/L）： 11.26 ± 1.96 vs. 14.57 ±3.10, 12.28 ±3.38 vs. 15.25 ±4.93; PCT （lAg/L）： 6.90±5.46 vs. 16.97 ±7.93, 6.17 ±6.13 vs. 21.26 ± 11.54; CRP （mg/L） ： 85.50 ± 37.91 vs. 120.17± 45.47, 94.31 ± 38.51 vs. 142.34 ± 53.57; PaO2/FiO2 （mm Hg, 1 mm Hg=0.133 kPa）： 182.06 ± 40.88 vs. 98.67 ± 20.62, 184.09 ± 43.78 vs. 96.22 ± 22.59, all P〈0.05） There was no significant change in Sp02 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 betv？een the two groups （all/9〉0.05）. Conclusion Domestic imipenem eilastatin sodium can effectively control severe aspiration pneumonia, and it is safe and effective antibiotics.