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[摘要]
目的 评价小儿肺热清颗粒治疗小儿急性支气管炎痰热壅肺证的有效性和安全性。方法 采用区组随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法。208例患者进入符合方案数据集,治疗组102例,对照组106例。治疗组服用小儿肺热清颗粒和急支颗粒模拟药;对照组服用急支颗粒和小儿肺热清颗粒模拟药。所有药物均将每瓶用温开水冲至100 mL后分次服用,用量均为3次/d,1~2岁,每次10 mL;3~6岁,每次15 mL;7~11岁,每次20 mL;12~14岁,每次30 mL,疗程5 d。观察两组的临床疗效、中医证候疗效和单项证候疗效,并对其依从性和安全性进行评价。结果 治疗组和对照组临床疗效的愈显率分别为86.27%、74.53%,中医证候疗效的愈显率分别为90.2%、75.47%,且治疗组的疗效优于对照组,差异有统计学意义(P < 0.05)。两组治疗前后自身比较,各单项症状差异均具有统计学意义(P < 0.001);治疗前后两组咳嗽、舌苔积分的差值比较,治疗组优于对照组,差异有统计学意义(P < 0.05)。两组均未发现不良反应。结论 小儿肺热清颗粒对小儿急性支气管炎痰热壅肺证具有良好的疗效,且安全性良好。
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[Abstract]
Objective To evaluate the efficacy and safety of Xiao'er Feireqing Granules in treatment of lung phlegm heat syndrome in children with acute bronchitis bronchitis. Methods The stratified random, double blind, double dummy, parallel control of positive drugs, and multi- center clinical method was applied to this study. Patients (208 cases) were included into per protocol analysis of the data set, and there were 102 and 106 cases in treatment and control group. Patients in the treatment group were administered with Xiao'er Feireqing Granules and simulation of Jizhi Granules, while patients in control group were administered with Jizhi Granules and simulation of Xiao'er Feireqing Granules. Every bottle of all medicine was dissolved into 100 mL with warm water, and take divides. The dosage was 3 times/d, 1 — 2 years old patients: 10 mL/time; 3 — 6 years old patients: 15 mL/time; 7 — 11 years old patients: 20 mL/time; 12 — 14 years old patients: 20 mL/time. The patients in two groups were treated for 5 d. Clinical efficacy, traditional Chinese medicine syndrome, and single syndrome curative effect were observed. And the medication compliance and security were evaluated. Results The curative rates of treatment and control groups in clinical efficacy were 86.27% and 74.53%, and the clinical curative rates of both groups in traditional Chinese medicine syndrome effect were 90.2% and 75.47%. These of treatment group were better than those of control group, and there were significant differences between the two groups (P < 0.05). Compared with same group before treatment, there were significant differences between the two groups in single syndrome curative effect (P < 0.001). There were significant differences between the two groups in the difference value of cough and tongue fur integrals before and after treatment, and treatment group were better than control group with significant (P < 0.05). There was no side effect in both groups. Conclusion Xiao'er Feireqing Granules has a definite effect on lung phlegm heat syndrome in children with acute bronchitis with good safety.
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