热炎宁合剂治疗小儿急性上呼吸道感染多中心临床研究

[目的]观察热炎宁合剂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]将入选的144例患儿,随机分成试验组和对照组,每组各72例,研究中剔除4例患儿,最终试验组、对照组纳入分析的病例数分别为71例、69例。试验组给予热炎宁合剂与双黄连颗粒模拟剂,对照组给予双黄连颗粒与热炎宁合剂模拟剂。疗程5 d。观察两组主要症状(发热、咽红肿痛)消失时间、完全退热时间、中医证候疗效等。[结果]热炎宁合剂在主要症状(发热、咽红肿痛)消失时间、完全退热时间、中医证候及中医单项症状改善方面,与双黄连颗粒疗效相当,两组比较差异无统计学意义。数据显示,在中医证候愈显率,以及中医单项症状咽喉肿痛、流浊涕、喷嚏、小便赤黄、大便干结总有效率方面,热炎宁合剂高于双黄连颗粒。[结论]热炎宁合剂治疗小儿急性上呼吸道感染疗效确切,使用安全,具有较好的临床应用前景。

Multicenter clinical research to treat the acute upper respiratory tract infection in children with Reyanning Mixture

[Objective] To observe the effect and safety of Reyanning Mixture in treating the acute upper respiratory tract infection(influenza with wind heat) in children.[Methods] The 144 cases of children who conformed to the diagnosis were randomly to divide into two groups, treatment group and control group, with 72 in each. With 4 cases eliminated in the study, and the final cases in the treatment group was 71, the control group was 69. The treatment group treated with Reyanning Mixture placebo and Shuanghuanglian Particles, and the control group treated with Shuanghuanglian Particles and Reyanning Mixture placebo. Treatment course was 5 days. To observe the time when main symptoms(fever and swollen sore throat)disappeared, fever relieving completely and the TCM syndrome efficacy, etc.[Results] Reyanning Mixture had the same efficacy as Shuanghuanglian Particles in the time when main symptoms(fever and swollen sore throat)disappeared, fever relieving completely and the TCM syndrome. The two groups was no significant difference. But the datas showed that the markedly effective rate of Reyanning Mixture in the improvement in TCM syndrome and the total effective rate in single TCM symptom(swollen sore throat, runnyopaquenose, sneeze, deep-colored urine, constipation) were highter than the Shuanghuanglian Particles.[Conclusion] Reyanning Mixture has the clinical curative effect for the acute upper respiratory tract infection in children. It is safety in use and has a good clinical application prospect.