复方福尔可定联合头孢克洛治疗小儿急性呼吸道感染的临床研究

Clinical trial of compound pholcodine combined with cefaclor in treating acute respiratory tract infection in children

目的 分析复方福尔可定联合头孢克洛治疗小儿急性呼吸道感染的疗效及对炎症指标的影响。方法 将急性呼吸道感染患儿随机分为对照组和试验组。对照组给予头孢克洛干混悬剂治疗,20 mg·kg^(-1)·d^(-1),q8 h,加水冲服,连续治疗7 d;试验组在对照组之上另给予复方福尔可定口服溶液治疗,6月~<2岁,每次2.5 mL,tid;2~6岁,每次5 mL,tid;>6岁,每次10 mL,tid,连续治疗7 d。比较2组临床疗效、临床症状消失时间、炎症指标[白细胞计数(WBC)、C-反应蛋白(CRP)、血清淀粉样蛋白A(SAA)、降钙素原(PCT)]水平以及治疗过程中发生的药物不良反应。结果 试验过程中共脱落30例,最终试验组和对照组分别纳入50例。治疗后,试验组和对照组总有效率分别为96.00%(48例/50例)和82.00%(41例/50例),在统计学上差异有统计学意义(P<0.05)。试验组和对照组发热消失时间分别为(1.49±0.23)和(2.55±0.57)d,咽喉肿痛消失时间分别为(3.03±0.52)和(4.28±0.71)d,流涕鼻塞消失时间分别为(2.46±0.50)和(3.76±0.84)d,咳嗽消失时间分别为(3.51±0.38)和(4.59±0.46)d,WBC水平分别为(7.25±1.41)和(8.49±1.60)×10^(9)·L^(-1),CRP水平分别为(2.55±0.63)和(4.09±0.78)mg·L^(-1),SAA水平分别为(29.42±4.88)和(37.15±6.24)mg·L^(-1),PCT水平分别为(0.81±0.15)和(0.93±0.18)ng·mL^(-1),试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头晕1例、呕吐1例、轻微嗜睡1例,对照组的药物不良反应主要有腹泻1例、呕吐1例,试验组和对照组的总药物不良反应发生率分别为6.00%(3例/50例)和4.00%(2例/50例),在统计学上差异无统计学意义(P>0.05)。结论 复方福尔可定联合头孢克洛治疗小儿急性呼吸道感染疗效显著,可降低炎症指标水平,安全可靠。

Objective To analyze the efficacy of compound pholcodine combined with cefaclor in the treatment of acute respiratory tract infection in children and its influence on inflammatory indicators.Methods The children with acute respiratory tract infection were randomly divided into control group and treatment group.The control group was given cefaclor treatment(20 mg·kg^(-1)·d^(-1),q8 h,with water,for 7 days),and the treatment group was also given compound pholcodine on the basis of the control group(6 months-2 years old,2.5 mL·time^(-1),tid;2-6 years old,5 mL·time^(-1),tid;> 6 years old,10 mL·time^(-1),tid,for 7days).The clinical efficacy,clinical symptom disappearance time,inflammatory indicators [white blood cell count(WBC),C-reactive protein(CRP),serum amyloid A(SAA),procalcitonin(PCT)] and occurrence of adverse drug reactions during treatment were compared between the two groups.Results 30 cases were dropped out during treatment,and 50 cases were finally included in treatment group and control group respectively.After treatment,the total effective rates in treatment group and control group were96.00%(48 cases/50 cases) and 82.00%(41 cases/50 cases) respectively,and the difference was statistically significant(P <0.05).The fever disappearance times were(1.49±0.23) and(2.55±0.57) d;the disappearance times of sore throat were(3.03±0.52) and(4.28±0.71) d;the disappearance times of runny nose and nasal obstruction were(2.46±0.50) and(3.76±0.84) d;the disappearance times of cough were(3.51±0.38) and(4.59±0.46) d;WBC levels were(7.25±1.41) and(8.49±1.60) × 10^(9)·L^(-1);CRP levels were(2.55±0.63) and(4.09±0.78) mg · L^(-1);SAA levels were(29.42±4.88) and(37.15±6.24) mg·L^(-1);PCT levels were(0.81±0.15) and(0.93±0.18) ng · mL^(-1),respectively(all P <0.05).The main adverse drug reactions in treatment group were dizziness(1 case),vomiting(1 case) and mild drowsiness(1 case),and the main adverse drug reactions in control group were diarrhea(1 case) and vomiting(1 case).The total incidence rates of adverse drug reactions in treatment group and control group were 6.00%(3 cases/50 cases) and 4.00%(2 cases/50cases)(P>0.05).Conclusion Compound pholcodine combined with cefaclor has a significant efficacy in the treatment of acute respiratory tract infection in children,and it can reduce the levels of inflammatory indicators.