桔梗白虎颗粒治疗小儿急性化脓性扁桃体炎胃火炽盛证的临床观察及安全性初步评价
发布时间：2019-04-10 18:29
【摘要】：目的:对桔梗白虎颗粒治疗小儿急性化脓性扁桃体炎胃火炽盛证的临床疗效进行客观研究分析,并通过药物急性毒性实验初步评估其安全性,为临床应用提供依据。方法:(1)临床研究:将符合纳入标准的患儿随机分为观察组(桔梗白虎颗粒)和对照组(阿莫西林克拉维酸钾分散片(7:1)),每组30例,临床观察1~2疗程(3天一疗程),观察记录并比较两组治疗前后的证候量化评分,对桔梗白虎颗粒的临床疗效进行科学客观的分析。(2)药物急性毒性实验:通过预实验测定小鼠半数致死量(LD50),再通过正式实验测定小鼠的1日最大耐受量,以初步评估桔梗白虎颗粒的安全性。结果:(1)临床研究:桔梗白虎颗粒能有效促进患儿扁桃体脓性分泌物的吸收、咽部充血的消退,并能改善饮食减少、大便干结的临床症状。(1)治疗后,两组证候积分均低于治疗前,差异有统计学意义(P0.05),提示观察组与对照组治疗均有效。(2)观察组与对照组治疗后的总有效率分别为93.3%、86.7%,差异有统计学意义(P0.05),提示观察组治疗本病优于对照组;(3)治疗后证候总积分、主积分对比,观察组均低于对照组,差异有统计学意义(P0.05),提示观察组在改善总体证候、主要证候方面,临床疗效均优于对照组;(4)治疗后,两组患儿扁桃体脓性分泌物、咽部充血的消退时间对比,观察组低于对照组,差异有统计学意义(P0.05),可认为观察组在扁桃体脓性分泌物吸收、咽部充血消退时间上优于对照组;(5)治疗后,两组患儿扁桃体外观、饮食、大便单项积分比较,观察组均低于对照组,差异有统计学意义(P0.05),可认为观察组在改善扁桃体外观、饮食、大便症状方面,临床疗效优于对照组;(6)治疗后两组证候次积分对比,差异无统计学意义(P0.05),在改善次要证候方面两组治疗效果相当;(7)治疗后,两组患儿咽痛、吞咽困难程度、面色、唇色、口渴程度等单项积分比较,差异无统计学意义(P0.05),提示在改善这些证候方面,两组疗效相当。(8)治疗前后两组患儿血细胞分析结果组间对比,差异无统计学意义(P0.05)。(9)观察组和对照组患儿治疗前后血细胞分析结果自身对比,差异有统计学意义(P0.05),提示两组在改善血细胞分析结果异常方面均有效。(10)观察组在治疗期间未出现不良反应,对照组在治疗期间出现3例轻度大便稀溏、恶心、饮食减少反应,两组例数相比,差异无统计学意义(P0.05),可认为两组在是否会引起不良反应方面无可比性。(2)急性毒性实验:预实验未测得半数致死量(LD50),故通过正式实验测得桔梗白虎颗粒小鼠1日最大耐受量为78.0g/kg,相当于成人(60kg)每日用量的200.0倍,可以初步认为桔梗白虎颗粒临床用药安全。结论:通过对桔梗白虎颗粒的临床疗效观察及急性毒性实验,表明桔梗白虎颗粒为治疗小儿急性化脓性扁桃体炎胃火炽盛证的有效方药,且该药无明显毒副作用及不良反应,临床应用安全有效,值得临床推广。
[Abstract]:Aim: to study and analyze the clinical efficacy of Platycodon grandiflorum Baihu granule in treating acute suppurative tonsillitis in children with incandescent stomach fire syndrome, and to evaluate its safety through acute toxicity test of drugs, so as to provide evidence for clinical application. Methods: (1) Clinical study: the children who met the inclusion criteria were randomly divided into two groups: observation group (Platycodon grandiflorum granule) and control group (amoxicillin-clavulanate potassium dispersible tablet (7:1),) with 30 cases in each group. We observed 1-2 courses of treatment (3 days a course of treatment), observed and compared the quantitative scores of syndrome before and after treatment between the two groups. Objective and scientific analysis was carried out on the clinical efficacy of Platycodon grandiflorum White Tiger granules. (2) Acute toxicity test: half lethal dose (LD50) of mice was determined by pre-test, and then the maximum tolerance dose of 1 day was measured by formal experiment. To evaluate the safety of Platycodon grandiflorum White Tiger granules. Results: (1) Clinical study: Platycodon grandiflorum white tiger granule can effectively promote the absorption of purulent secretion of tonsillar, dissipate the congestion of pharynx, and improve the clinical symptoms of diet reduction and stool dry knot. (1) after treatment, it can promote the absorption of suppurative secretion of tonsil and the regression of pharynx congestion. The scores of the two groups were significantly lower than those before treatment (P0.05), suggesting that the treatment of the observation group and the control group were effective. (2) the total effective rates of the observation group and the control group after treatment were 93.3% and 86.7%, respectively. The difference was statistically significant (P0.05), suggesting that the observation group is better than the control group in the treatment of this disease; (3) after treatment, the total integral and main integral of the syndrome in the observation group were lower than those in the control group, the difference was statistically significant (P0.05), suggesting that the observation group is superior to the control group in improving the overall syndrome and the main syndrome aspects; (4) after treatment, the regression time of tonsillar purulent secretion and pharyngeal congestion in the two groups was significantly lower than that in the control group (P0.05), and it could be considered that the observation group was absorbed in tonsillar purulent secretion. The time of regression of pharynx congestion was better than that of control group. (5) after treatment, the scores of tonsillar appearance, diet and stool in the two groups were significantly lower than those in the control group (P0.05), and the observation group could be regarded as improving tonsillar appearance and diet. In the aspect of stool symptoms, the clinical efficacy was better than that in the control group. (6) after treatment, there was no significant difference between the two groups in the scores of syndrome scores (P0.05), and the therapeutic effect of the two groups was the same in improving secondary syndrome; (7) after treatment, there was no significant difference in the scores of dysphagia, facial color, lip color and thirst degree between the two groups (P0.05). (8) there was no significant difference in the results of blood cell analysis between the two groups before and after treatment (P0.05). (- 9). The results of blood cell analysis in the observation group and the control group were self-comparison before and after treatment. The difference was statistically significant (P0.05), suggesting that the two groups were effective in improving the abnormal results of blood cell analysis. (10) the observation group had no adverse reaction during the treatment, while the control group had 3 cases of mild loose stool and nausea during the treatment period. There was no significant difference in the number of cases between the two groups (P0.05). There was no significant difference between the two groups in terms of whether they would cause adverse reactions. (2) Acute toxicity experiment: no half lethal dose (LD50) was measured in the pre-test, but no significant difference was found between the two groups in terms of whether or not they would cause adverse reactions. It is concluded that the maximum tolerance of Platycodon grandiflorum White Tiger granule is 78.0 g / kg, which is 200.0 times that of adult (60kg) daily. It can be concluded that Platycodon grandiflorum White Tiger granule is safe for clinical use. Conclusion: through the observation of clinical curative effect and acute toxicity experiment of Platycodon grandiflorum White Tiger granule, it is shown that Platycodon grandiflorum White Tiger granule is an effective prescription for treating acute suppurative tonsillitis in children, and it has no obvious side effects and adverse reactions. The clinical application is safe and effective and worthy of clinical 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】：R276.1
本文编号：2456024
[Abstract]:Aim: to study and analyze the clinical efficacy of Platycodon grandiflorum Baihu granule in treating acute suppurative tonsillitis in children with incandescent stomach fire syndrome, and to evaluate its safety through acute toxicity test of drugs, so as to provide evidence for clinical application. Methods: (1) Clinical study: the children who met the inclusion criteria were randomly divided into two groups: observation group (Platycodon grandiflorum granule) and control group (amoxicillin-clavulanate potassium dispersible tablet (7:1),) with 30 cases in each group. We observed 1-2 courses of treatment (3 days a course of treatment), observed and compared the quantitative scores of syndrome before and after treatment between the two groups. Objective and scientific analysis was carried out on the clinical efficacy of Platycodon grandiflorum White Tiger granules. (2) Acute toxicity test: half lethal dose (LD50) of mice was determined by pre-test, and then the maximum tolerance dose of 1 day was measured by formal experiment. To evaluate the safety of Platycodon grandiflorum White Tiger granules. Results: (1) Clinical study: Platycodon grandiflorum white tiger granule can effectively promote the absorption of purulent secretion of tonsillar, dissipate the congestion of pharynx, and improve the clinical symptoms of diet reduction and stool dry knot. (1) after treatment, it can promote the absorption of suppurative secretion of tonsil and the regression of pharynx congestion. The scores of the two groups were significantly lower than those before treatment (P0.05), suggesting that the treatment of the observation group and the control group were effective. (2) the total effective rates of the observation group and the control group after treatment were 93.3% and 86.7%, respectively. The difference was statistically significant (P0.05), suggesting that the observation group is better than the control group in the treatment of this disease; (3) after treatment, the total integral and main integral of the syndrome in the observation group were lower than those in the control group, the difference was statistically significant (P0.05), suggesting that the observation group is superior to the control group in improving the overall syndrome and the main syndrome aspects; (4) after treatment, the regression time of tonsillar purulent secretion and pharyngeal congestion in the two groups was significantly lower than that in the control group (P0.05), and it could be considered that the observation group was absorbed in tonsillar purulent secretion. The time of regression of pharynx congestion was better than that of control group. (5) after treatment, the scores of tonsillar appearance, diet and stool in the two groups were significantly lower than those in the control group (P0.05), and the observation group could be regarded as improving tonsillar appearance and diet. In the aspect of stool symptoms, the clinical efficacy was better than that in the control group. (6) after treatment, there was no significant difference between the two groups in the scores of syndrome scores (P0.05), and the therapeutic effect of the two groups was the same in improving secondary syndrome; (7) after treatment, there was no significant difference in the scores of dysphagia, facial color, lip color and thirst degree between the two groups (P0.05). (8) there was no significant difference in the results of blood cell analysis between the two groups before and after treatment (P0.05). (- 9). The results of blood cell analysis in the observation group and the control group were self-comparison before and after treatment. The difference was statistically significant (P0.05), suggesting that the two groups were effective in improving the abnormal results of blood cell analysis. (10) the observation group had no adverse reaction during the treatment, while the control group had 3 cases of mild loose stool and nausea during the treatment period. There was no significant difference in the number of cases between the two groups (P0.05). There was no significant difference between the two groups in terms of whether they would cause adverse reactions. (2) Acute toxicity experiment: no half lethal dose (LD50) was measured in the pre-test, but no significant difference was found between the two groups in terms of whether or not they would cause adverse reactions. It is concluded that the maximum tolerance of Platycodon grandiflorum White Tiger granule is 78.0 g / kg, which is 200.0 times that of adult (60kg) daily. It can be concluded that Platycodon grandiflorum White Tiger granule is safe for clinical use. Conclusion: through the observation of clinical curative effect and acute toxicity experiment of Platycodon grandiflorum White Tiger granule, it is shown that Platycodon grandiflorum White Tiger granule is an effective prescription for treating acute suppurative tonsillitis in children, and it has no obvious side effects and adverse reactions. The clinical application is safe and effective and worthy of clinical 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】：R276.1
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