疏清颗粒治疗小儿急性上呼吸道感染的上市后再评价

Post-marketing evaluation of Shuqing Granules in treatment of pediatric acute upper respiratory infection

目的评价疏清颗粒治疗小儿急性上呼吸道感染(风热感冒证)的有效性和安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心临床研究方法,从11个研究中心共入选急性上呼吸道感染患儿240例,随机分为试验组(120例)和对照组(120例),分别口服疏清颗粒+双黄连颗粒模拟剂、双黄连颗粒+疏清颗粒模拟剂,疗程均5 d。结果两组疾病痊愈的中位时间均为72 h,组间比较差异无统计学意义。试验组、对照组的疾病痊愈率分别为95.33%、90.52%,率差95%置信区间(95%CI)为5.67%(-1.21%,12.55%),提示试验组痊愈率不劣于对照组。试验组、对照组48 h完全退热率分别为79.44%、65.52%(PPS),率差95%CI为13.92%(2.15%,25.69%),组间差异有统计学意义,试验组优于对照组。中医证候疗效(愈显率)、主要症状消失率(除咽红肿痛外)的组间比较,差异均无统计学意义。报道临床不良事件7例,两组临床不良事件发生率分别为3.33%、2.50%,差异无统计学意义,判断为不良反应的共0例。结论疏清颗粒治疗小儿急性上呼吸道感染(风热感冒证)的疾病疗效、证候疗效均不劣于双黄连颗粒,48 h完全退热率优于双黄连颗粒,且安全性好,有较好的临床应用价值。

Objective To evaluate the clinical efficacy and safety of Shuqing Granules in the treatment of pediatric acute upper respiratory infection （anemopyretic cold）. Methods A random, double-blind and double-dummy, positive-drug parallel control, and multi-centered observational clinical approach were used. A total of 240 patients from 11 centers were randomly divided into experimental group （120 patients） and control group （120 patients）, which were took Shuqing Granules plus simulant Shuanghuanglian Granules and Shuanghuanglian Granules plus simulant Shuqing Granules, respectively, each cause of treatment for 5 d. Results The median time of recovery of twogroups was both at 72 hours, with no statistical significance. The total cure rate of the experimental and control group were 95.33% and 90.52%, respectively, the 95%CI of rate difference between groups was 5.67% （-1.21%, 12.55%）, which indicated that the total cure rate of the experimental group was no lower than that of the control group. The complete rate of the abatement of fever of the experimental group and control group after 48 h were 79.44% and 65.52% （PPS）, respectively, The differences between groups were of statistical significance, the 95%CI of rate difference of the two groups is 13.92% （2.15%, 25.69%） and the experimental group was superior to the control group. The group differences of TCM syndrome curative effect （obvious curative rate） and cardinal symptom disappearing rate （except red and swollen throat） were of no statistical significance. Seven clinic adverse drug cases were reported and the occurrence rate of adverse drug cases of each group were 3.33% and 2.50%, respectively, with no statistical significance, among which no case was judged to be untoward reaction. Conclusion The curative effect and syndrome effect of Shuqing Granules in the treatment of pediatric acute upper respiratory infection is no worse than Shuanghuanglian Granules, the complete rate of which for the abatement of fever is superior to the Shuanghuanglian Granules within 48 h, and it is safer and has a better clinical application value.