【摘要】 目的评价抗感颗粒治疗小儿流行性感冒的疗效及安全性。方法采用随机、双盲双模拟、平行对照、多中心临床试验方法,将240例患儿分为治疗组和对照组各120例,治疗组口服抗感颗粒及利巴韦林颗粒模拟剂,对照组口服抗感颗粒模拟剂及利巴韦林颗粒,两组疗程均为7天,疗程中临床痊愈者,随时停药,按完成病例处理。观察两组患儿完全退热时间、临床痊愈时间、主要症状(发热、头痛、鼻塞、流涕、咽痛)的曲线下面积(AUC)以及中医证候疗效与安全性,同时采用全分析集分析(FAS)与符合方案分析集分析(PDS)。结果完全退热时间FAS治疗组中位时间为32.00 h,对照组为72.00 h(P<0.01)。临床痊愈时间FAS治疗组中位时间为56.00 h,对照组为80.00 h,PPS与FAS结果相近,两组比较差异有统计学意义(P<0.01)。治疗组患儿发热、咽痛AUC面积治疗组小于对照组(P<0.01)。PPS与FAS结果一致。两组患儿中医证候疗效比较:FAS治疗组总有效率100%,愈显率92.50%。对照组分别为91.67%及72.50%。PPS治疗组总有效率100%,愈显率93.40%;对照组分别为91.26%及73.79%。治疗组总有效率及愈显率均高于对照组(P<0.01)。PPS与FAS结果一致。两组患儿均未出现不良反应。结论抗感颗粒治疗小儿流行性感冒疗效优于利巴韦林颗粒,且安全性好。更多还原

【Abstract】 Objective To evaluate the curative effect and safety of Kanggan Keli in treating infantile influenza.Methods A multicenter randomized,double-blind,double simulation,parallel control clinical trial was designed.Two hundred and forty children with influenza were divided into a treatment group( 120 cases) and a control group( 120 cases). The treatment group was given oral Kanggan Keli and ribavirin particle analogue; while the control group was given oral Kanggan Keli analogue and ribavirin particle. The course in both groups was 7 days. During the course,medication was stopped at any time once the patient was recover,which was processed as the completed case.It was examined in both groups that time for body temperature return normal,time for clinical recovery,area under curve( AUC) of main symptoms( fever,headache,nasal obstruction,nasal discharge and sore throat),and Chinese medicine syndrome effect and safety. Meanwhile,full analysis set( FAS) and per protocol set( PPS) analysis was adopted. Results The median time for body temperature return to normal by FAS was 32. 00 h in the treatment group,and 72. 00 h in the control group( P < 0. 01). The median time for clinical recovery by FAS was 56. 00 h in the treatment group,and 80. 00 h in the control group. The result of PPS was similar to that of FAS. There was significant difference between the two groups( P < 0. 01). AUC of fever and sore throat in the treatment group was smaller than that in the control group( P < 0. 01). The result of PPS and FAS was similar. For Chinese medicine syndrome effect,the total effective rate and the cured and markedly effective rate by FAS was 100% and 92. 50%,respectively in the treatment group,and 91. 67% and 72. 50% respectively in the control group; the total effective rate and the cured and markedly effective rate by PPS was 100% and 93. 40%,respectively in the treatment group,and 91. 26% and73. 79% respectively in the control group. The total effective rate and the cured and markedly effective rate in the treatment group were both higher than those in the control group( P < 0. 01). The result of PPS and FAS was similar.No side effect was found in both groups. Conclusion The effect of Kanggan Keli in treating infantile influenza seems better than ribavirin particle,with good safety.更多还原