桑沙颗粒治疗小儿急性气管—支气管炎风燥伤肺型的临床研究及安全性初步评价

发布时间：2018-03-10 19:20

本文选题：桑沙颗粒　切入点：小儿急性气管-支气管炎　出处：《云南中医学院》2017年硕士论文　论文类型：学位论文

【摘要】：目的:对桑沙颗粒治疗小儿急性气管-支气管炎风燥伤肺型的临床疗效进行客观评价,并初步评估其安全性,为该药的临床应用提供依据。方法:(1)临床研究:将符合标准的患儿分为观察组(桑沙颗粒组)和对照组(桑菊感冒颗粒组),每组最终有效病例各30例,6天为一疗程,治疗1个疗程,观察记录并比较两组治疗前后的证候量化评分,对桑沙颗粒的临床疗效进行科学客观地评估。(2)急性毒性实验:在预实验测不出半数致死量(LD50)的情况下,以最大给药量法设计正式实验初步评估桑沙颗粒的安全性。结果:(1)临床研究:桑沙颗粒能消除或缓解小儿急性气管-支气管炎风燥伤肺型所表现的咳嗽、咯痰、咽痒症状,且能明显的改善患儿咽部充血、扁桃体肿大、饮食减少等情况。(1)两组治疗均能有效消除或减轻小儿急性气管-支气管炎风燥伤肺型所引起的多种症状、体征(P0.05);(2)观察组和对照组治疗小儿急性气管-支气管炎风燥伤肺型的总有效率分别为90%、86.7%,差别无统计学意义(P0.05);(3)观察组在改善小儿急性气管-支气管炎风燥伤肺型主要证候方面优于对照组,差别有统计学意义(P0.05),而在改善小儿急性气管-支气管炎风燥伤肺型总体证候、次要证候方面,两组疗效相当,差别无统计学意义(P0.05);(4)两组在改善小儿急性气管-支气管炎风燥伤肺型所引起的咽痛、肺部体征、鼻塞、流涕、舌象、大便干结方面疗效相当,差别无统计学意义(P0.05);(5)观察组在改善小儿急性气管-支气管炎风燥伤肺型所引起的咳嗽、咯痰、咽痒、咽部充血、扁桃体肿大、饮食减少方面疗效优于对照组,差别有统计学意义(P0.05);(6)两组在改善患儿血细胞分析异常方面疗效相当,差别无统计学意义(P0.05);(7)两组患儿治疗过程中均未发生不良反应。(2)急性毒性实验:实验小鼠均未出现死亡,给药后一般情况好,实验完成后对其进行解剖,肉眼大致观察其主要脏器均未见明显异常。根据实验药物(桑沙颗粒)的小鼠1日最大给药量法进行估算,等同于临床上成人1日临床用量的120.08倍,实验中均未见小鼠经口单次给药毒性反应。结论:通过对桑沙颗粒的临床研究及急性毒性实验,表明桑沙颗粒是治疗小儿急性气管-支气管炎风燥伤肺型的有效方,并且安全,值得临床使用和推广。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of Sansha granule in the treatment of acute tracheobronchial wind dryness in children. Methods: the children who met the standard were divided into observation group (Sansha granule group) and control group (mulberry chrysanthemum cold granule group). Each group had 30 effective cases for 6 days as a course of treatment. After one course of treatment, the quantitative syndromes scores before and after treatment were observed and compared between the two groups. The clinical efficacy of Sansha granules was evaluated scientifically and objectively. To evaluate the safety of Sangsha granules by the method of maximum dose. Results: Sangsha granule can eliminate or relieve the symptoms of cough, sputum and pharyngoitch in children with acute trachea bronchitis wind dryness injury. And can obviously improve the pharynx hyperemia, tonsillar enlargement, diet decrease and so on.) both groups can effectively eliminate or alleviate many symptoms caused by acute trachea bronchitis wind dryness injury lung type. The total effective rate of treatment of acute trachea bronchitis wind dryness injury in children in observation group and control group was 900.86. 7, respectively. There was no significant difference between observation group and control group in improving the lung type of acute tracheo-bronchitis wind dryness injury. Syndromes were superior to those in the control group. The difference was statistically significant (P 0.05), but in improving the overall syndrome and secondary syndromes of acute trachea bronchitis wind dryness injury in children, the two groups had the same curative effect. There was no significant difference between the two groups (P 0.05). The two groups had the same effect in improving pharynx pain, lung signs, nasal congestion, runny nose, tongue picture and stool dry knot caused by acute trachea bronchitis wind dryness injury in children. The effect of observation group on improving cough, sputum, pharynx itch, pharynx congestion, tonsil enlargement and diet reduction caused by acute trachea bronchitis wind dryness injury in children was better than that in the control group. The difference was statistically significant (P 0.05) the two groups had the same effect in improving the abnormal blood cell analysis in children, but there was no significant difference in the difference between the two groups (P 0. 05) there was no adverse reaction. 2) the acute toxicity test: no death was found in all the experimental mice, but there was no significant difference between the two groups in the course of treatment (P 0. 05 and P 0. 05, P < 0. 05, P < 0. 05). After administration, the mice were dissected and their main organs were observed by naked eye without obvious abnormality. According to the method of maximum dose of the experimental drug (Sangsha granules) on 1st, It is equal to 120.08 times of the clinical dosage of adult in 1st. No single oral toxicity reaction was found in mice. Conclusion: the clinical study and acute toxicity test of Sangsha granules were carried out. The results indicate that Sansha granule is an effective prescription for the treatment of acute trachea-bronchitis wind dryness in children, and it is safe and worthy of clinical use and popularization.
【学位授予单位】：云南中医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R272

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