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目的观察小儿双清颗粒治疗小儿急性上呼吸道感染表里俱热证的疗效和安全性。方法收集急性上呼吸道感染表里俱热证患儿420例,随机分为试验组315例,对照组105例。治疗组给予小儿双清颗粒,对照组给予小儿热速清颗粒,两组均1岁以内每次1g,1～3岁每次2g,4+～6岁每次3g,6岁以上每次4g,每天3次。治疗3天后比较两组疾病疗效、中医证候疗效、单项中医症状疗效、体温完全恢复正常所需时间,并观察治疗过程中的不良反应。结果疾病疗效总有效率试验组为83.23%、对照组为60.95%;中医证候疗效总有效率试验组为94.41%、对照组为74.29%,两组比较差异均有统计学意义(P<0.05);两组各单项中医症状有效率试验组均明显高于对照组(P<0.05)。试验组体温完全恢复正常所需时间明显短于对照组(P<0.05)。两组均未发现明显不良反应。结论小儿双清颗粒治疗急性上呼吸道感染表里俱热证患儿疗效确切,临床应用安全。
Objective To observe the efficacy and safety of pediatric double-clear granule in treating children with acute upper respiratory tract infection. Methods A total of 420 children with acute upper respiratory tract infection (ADR) were enrolled in this study. They were randomly divided into experimental group (315 cases) and control group (105 cases). The treatment group was given Shuangqing granule, while the control group was given Pyrex granules. Both groups were given 1g each within 1 year old, 2g each from 1 to 3 years old, 3g each from 4 to 6 years old, 4g each above 6 years old, , 3 times a day. After 3 days of treatment, the curative effect of TCM, the efficacy of TCM syndrome, the curative effect of single TCM symptoms, the time required for the body temperature to completely recover to normal, and the adverse reactions during the treatment were observed. Results The total effective rate of the disease was 83.23% in the trial group and 60.95% in the control group. The total effective rate of the TCM syndromes was 94.41% in the trial group and 74.29% in the control group, with significant difference between the two groups (P <0.05 ). The effective rate of TCM symptom in both groups was significantly higher than that of the control group (P <0.05). Test group body temperature completely return to normal time required was significantly shorter than the control group (P <0.05). No obvious adverse reactions were found in both groups. Conclusion Pediatric Shuangqing Granules in Treating Acute Upper Respiratory Tract Infection in Children and Babies is effective and safe in clinical application.