ABSTRACT
Objective: To evaluate the efficacy and safety of different dosages of Pudilan Xiaoyan Oral Liquid (PXOL) in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome. Methods: A randomized controlled, double-blind, positive drug parallel controlled, and multi-center clinical trial was conducted. Totally 324 children from seven research centers were included, 108 cases in experimental high dose group (A Group), 108 cases in experimental low dose group (B Group), 54 cases in positive medicine group (Xiaoer yanbian Granula, C Group), and 54 cases in placebo group (D Group), with the ratios of 2:2:1:1.5 in a course. Results: (1) Totally 317 cases were in full analysis set (FAS), 284 cases in per-protocol set (PPS) and 324 cases in Safety Set (SS). (2) Evaluation on effectiveness: There was significant difference (P<0.001) between each two groups in the total effective rate of pharyngalgia and pharyngeal swelling. A Group and B Group were both superior to D Group, and were non-inferior to C Group. B Group was non-inferior to A Group. There was significant difference (P<0.001) between each two groups in total effective rate of syndrome of traditional Chinese medicine. There was significant difference (P<0.05) between each two groups in the median time of improving pharyngalgia syndrome. There was significant difference (P<0.001) between each two groups in the median time of pharyngalgia syndrome disappearing. There were significant differences (P<0.05) between each two groups in total effective rate of halitosis, cough, thirst, deep-colored urine, and dry stool. The analysis on PPS agrees with that of FAS. (3) Evaluation on safety: No adverse reactions in clinical significant laboratory examination were found during the trial. Conclusion: High and low dosages of PXOL show advantages over placebo and are non-inferior to the positive medicine Xiaoer Yanbian Granula. High dose group does not show advantage comparing with low dose group. No adverse reactions are found during the trial. Low dose therapy is recommended.
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the efficacy and mechanism of Fangchuan Mixture (FCM) in treating children with mild continuous asthma.</p><p><b>METHODS</b>One hundred and seventy-five patients in the three groups were treated with FCM (A), Flixotide (B), and the combination of FCM and Flixotide (C), respectively for 12 weeks. Their condition of asthma and TCM syndrome were observed, peak expiratory flow (PEF) and serum levels of immunoglobulin (Ig), interleukin-4 (IL-4) and interferon-gamma (IFN-gamma) were determined.</p><p><b>RESULTS</b>All the indexes determined were improved significantly in the three groups after treatment (P <0.05). Paired comparison among groups showed that the improvements in non-asthma time, time required beta-receptor activator, expectoration, complexion, appetite, and increasing serum IFN-gamma after treatment were superior in Group C than in Group A and B (P <0.05); the improvements in hidrosis, faint pulse and decreasing serum IL-4 level in Group A and C were better than those in Group B (P <0.05), and the effect for alleviating symptoms of rhinitis such as nasal obstruction and nasal discharge in Group C was more significant than that in Group B (P <0.05).</p><p><b>CONCLUSION</b>FCM could attenuate the allergic inflammation of bronchi to improve its hypersensitive state in children with asthma, and shows a cooperative action with Flixotide.</p>