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目的:探讨复方参芪软胶囊与颗粒剂治疗气虚证、儿童脾气虚证的疗效,同时对两种剂型制剂使用的安全性、不良反应及禁忌做出评价。方法:采用分层随机平行组对照设计,非盲。将中医诊断为气虚、脾气虚者,按年龄及诊断分层后随机入组。试验组给予复方参芪软胶囊,成人每次4粒,tid;3岁以上儿童,1次2粒,tid。对照组给予复方参芪颗粒,温开水冲服,成人每次2袋,tid;3岁以下儿童,一次半袋,3岁以上儿童,一次1袋,tid。1个月为一疗程。结果:复方参芪两种剂型的制剂均能明显提高成人及儿童气虚患者的免疫指标,改善气虚患者的临床症状和体征。对于儿童脾气虚的治疗,软胶囊剂治疗后证候积分与颗粒剂比较有显著性差异。结论:复方参芪两种剂型的制剂治疗气虚证、脾气虚证疗效满意,不良反应少见,适合临床推广应用。
Objective: To investigate the curative effect of compound Shenqi soft capsule and granule on qi deficiency syndrome and spleen qi deficiency syndrome in children, and to evaluate the safety, adverse reactions and contraindications of the two formulations. Methods: Stratified randomized parallel group control design, non-blind. Chinese medicine diagnosis of qi deficiency, spleen Qi, according to age and diagnosis stratified randomized into the group. The experimental group given compound Shenqi soft capsule, adult each 4, tid; children over 3 years old, 1 2, tid. Control group given compound Shenqi particles, warm boiled water, adults each 2 bags, tid; children under 3 years old, a half bag, children over 3 years old, a bag. 1 month for a course of treatment. Results: The preparation of compound Shenqi both formulations can significantly improve the immunological parameters of adults and children with Qi deficiency, improve the clinical symptoms and signs of Qi deficiency patients. For the treatment of children’s spleen Qi, soft capsule points after treatment syndrome scores and granules were significantly different. Conclusion: The two prescriptions of compound prescription of Shenqi can treat the qi deficiency syndrome and spleen qi deficiency syndrome with satisfactory curative effect and rare adverse reactions, which is suitable for clinical popularization and application.