左卡尼汀注射液联合阿托伐他汀钙片治疗慢性心力衰竭的临床研究

Clinical trial of levocarnitine injection combined with atorvastatin calcium tablets in the treatment of chronic heart failure

目的观察左卡尼汀注射液联合阿托伐他汀钙片治疗慢性心力衰竭的临床疗效及安全性。方法将72例慢性心力衰竭患者随机分为对照组36例与试验组36例。对照组予以阿托伐他汀钙10 mg,qd,口服;试验组在对照组治疗的基础上,予以20 mg·kg^(-1)左卡尼汀注射液,qd,静脉推注。2组患者一个周期均为21 d,共治疗2个周期。比较2组患者的临床疗效、核转录因子-κB、白细胞介素^(-1)β、C反应蛋白、血浆脑利钠肽、左心室内径、左心室射血分数、6 min步行试验最大距离,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为83.33%(30/36例)和61.11%(22/36例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的核转录因子-κB分别为(34.44±3.50),(49.57±5.17)pg·L^(-1);白细胞介素^(-1)β分别为(0.42±0.05),(0.59±0.07)μg·L^(-1);C反应蛋白分别为(10.04±1.11),(13.29±1.44)ng·L^(-1);血浆脑利钠肽分别为(241.63±25.77),(340.92±35.16)pg·L^(-1);左心室内径分别为(49.19±5.12),(52.11±5.44)mm;左心室射血分数分别为(49.39±5.12)%,(41.02±4.15)%;6 min步行试验最大距离分别为(376.09±40.15),(262.98±28.71)m,差异均有统计学意义(P<0.05)。试验组的药物不良反应主要有胃肠道不适和口干,对照组的药物不良反应主要有胃肠道不适、视觉模糊和皮疹。试验组和对照组的药物不良反应发生率分别为5.56%和11.11%,差异无统计学意义(P>0.05)。结论左卡尼汀注射液联合阿托伐他汀钙片治疗慢性心力衰竭的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of levocarnitine injection combined with atorvastatin calcium tablets in the treatment of chronic heart failure. Methods A total of 72 patients with chronic heart failure were randomly divided into control group and treatment group with 36 cases per group. Control group was treated with atorvastatin calcium 10 mg qd oral. Treatment group was given levocarnitine injection 20 mg · kg-1qd by intravenous injection,on the basis of the control group. Two groups were treated for 2 cycles with 21 d per cycle.The clinical efficacy,nuclear transcription factor kappa B（ NF-κB）,interleukin 1β（ IL-1β）,C reactive protein（ CRP）,plasma brain natriuretic peptide（ BNP）, left ventricular diameter（ LVID）, leftventricular ejection fraction（ LVEF）,the maximum distance of 6 min walking test（ 6-MWT）,and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates in treatment and control groups were 83. 33%（ 30/36 cases） and 61. 11%（ 22/36 cases）,with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： NF-κB were（ 34. 44 ± 3. 50）,（ 49. 57 ± 5. 17） pg·L-1; IL-1β were（ 0. 42 ± 0. 05）,（ 0. 59 ± 0. 07） μg·L-1; CRP were（ 10. 04 ± 1. 11）,（ 13. 29 ± 1. 44） ng·L-1; BNP were（ 241. 63 ± 25. 77）,（ 340. 92 ± 35. 16） pg·L-1; LVID were（ 49. 19 ± 5. 12）,（ 52. 11 ± 5. 44） mm; LVEF were（ 49. 39 ± 5. 12） %,（ 41. 02 ± 4. 15） %; 6-MWT were（ 376. 09 ± 40. 15）,（ 262. 98 ± 28. 71） m,with statistically significant difference（ P〈0. 05）. The adverse drug reactions in treatment group were gastrointestinal discomfort and dry,which in control group were gastrointestinal discomfort,blurred vision and rash. The incidence of treatment and control groups were 5. 56% and 11. 11% without significant difference（ P〉0. 05）. Conclusion Levocarnitine injection combine with atorvastatin calcium tablets has a definitive clinical efficacy in the treatment of chronic heart failure,without increasing the incidence of adverse drug reactions.