进口与国产罗红霉素分散片儿科临床应用比较

Clinical applications of domestic versus import roxithromycin dispersible tablets

目的比较国产和进口罗红霉素分散片治疗儿科细菌感染性疾病的临床有效性、安全性和依从性疗效。方法选择2004年7月～9月同期广东省妇幼保健院诊断为“细菌感染性疾病”的患儿共70例,随机分成试验药组和对照药组各35例,两组各项临床资料均具有可比性,经t和χ2检验,无明显差异(P>0.05);试验组口服国产罗红霉素分散片,按每天5～10mg/kg计算,连续服药时间平均(7.2±0.6)d(5～12d);对照组全部口服进口罗红霉素分散片,按每天5～10mg/kg计算,连续服药时间平均(7.1±0.8)d(5～12d)。用药期间不联合应用其它中、西抗菌药物,但可以给予补液等对症处理。所有病例在用药前及停药后d1做血、尿常规,肝、肾功能(ALT、ALP、TB、DB、BUN、Cr)测定,细菌培养和药敏试验。试验期间逐日详细观察并记录患者症状、体征变化及药物不良反应。下呼吸道感染患者用药前及停药后各作1次胸部x片检查。结果两组临床疗效及细菌学疗效比较治疗总有效率无显著性差异。两组退热时间、病程(d)、细菌清除率经t检验无显著差异(P>0.05);试验组不良反应发生率为17.14%(6/35);对照组不良反应发生率为14.28%(5/35)。经t检验两组间比较统计学上无显著差异(P>0.05)。两组病例监测血、尿常规,肝、肾功能均未见异常。本组病例为依从性良好(88.3%),无一例患儿退出临床观察。结论国产和进口罗红霉素分散片均能有效地治疗儿科呼吸道细菌感染性疾病,两者在治疗有效率、退热时间、病程、细菌清除率及不良反应等方面均基本接近,统计学上无显著差异,是治疗儿科院外获得性呼吸道细菌感染性疾病有效、安全的药物。

Objective To compare the clinical effectiveness, safety and compliance of import and domestic roxithromycin dispersible tablets in the treatment of bacterial infectious diseases of children. Method From July to September 2004, seventy children with bacterial infectious diseases were enrolled and randomly divided into test group （n = 35） and control group （n = 35）. Through t-test and X^2-test,there was no significant difference in clinical data of two groups （P〉0.05）. The test group were administered with 5 - 10mg/kg domestic roxithromycin dispersible tablets daily for 5 - 12 days, mean （7.2 ± 0. 6） days. The control group were treated with 5 -10mg/kg import roxithromycin daily for 5 - 12 days, mean （7. 1 ± 0. 8） days. During the therapy period, no other antibiotics were given for the two groups except fluid replacement. Blood routine, urine routine, hepatic function, renal function, bacteria cultivation and drug susceptibility were tested before administration and after withdrawal. During the experiment, symptom, sign and drug adverse reaction were observed and recorded. Children with lower respiratory tract infections were checked x-ray before and after the treatment. Results There was no statistically significant difference between the total clinical efficacy and bacteria effectiveness of the two groups. The time of reducing fever, course （day） and the bacterial clearance rate were not significantly different between the two groups （ P〉0.05）; incidence of side effects was 17.14% （6/35） and 14. 28% （5/35） with no statistical differences （P〉0.05）. There was no abnormality inblood routine, urine, routine, hepatic function and renal function of the two groups. Patients had good （88.3%） and no patient withdrew during the test. Conclusions Domestic and import roxithromycin tablets are both effective and safe for the treatment of community-acquired respiratory tract infections.