小儿芩马颗粒治疗小儿急性咽炎（肺胃蕴热证）的临床研究

发布时间：2019-06-20 09:15

【摘要】：目的:以随机双盲、平行对照方法评价小儿芩马颗粒治疗小儿急性咽炎(肺胃蕴热证)的临床有效性及安全性。方法:收集湖北省中医院儿科门诊中3岁至14岁之间的急性咽炎(属肺胃蕴热证)患儿病例,采用随机双盲、平行对照方法,试验组和对照组按1:1比例分配,其中试验组24例,对照组24例,总共48例。试验组予小儿芩马颗粒,对照组予小儿芩马颗粒模拟剂,两组均以5天时间为一个疗程进行治疗。采集患儿的人口学资料,分别记录治疗前后的症状和体征,并按要求填写《症状体征分级量化标准表》。将患儿的性别、年龄的情况,治疗前主症、体征及次症积分,小儿急性咽炎疾病疗效,肺胃蕴热证症候疗效,单项主症及体征疗效,治疗前后总积以及治疗后主症、体征及次症积分,运用SPSS 19.0软件进行统计分析,评价小儿芩马颗粒的有效性。观察并记录入组患儿用药前后的生命体征、心电图、实验室检查及出现的不良事件以评价其安全性。结果:1、对患儿的性别,年龄,治疗前主症、体征及次症积分进行统计分析,均无显著差异,具有可比性。2、试验组与对照组肺胃蕴热证症候疗效比较,P值0.05,具有统计学意义;试验组愈显率为79%,总有效率为100%;对照组愈显率为0%,总有效率为92%。3、试验组与对照组治疗前后咽喉疼痛、咽喉充血、咽喉肿胀的疗效比较,P值均0.05,具有统计学意义。其中,咽喉疼痛试验组愈显率、总有效率均为100%,对照组愈显率、总有效率分别为54%、66.7%;咽喉充血试验组愈显率、总有效率均为100%,对照组愈显率、总有效率分别为8.3%、41.7%;咽喉肿胀试验组愈显率、总有效率分别为83.3%、95.8%,对照组愈显率、总有效率分别为37.5%、54.2%。4、试验组与对照组治疗后总积分、主症、体征及次症积分进行统计,除发热的积分比较,P值0.05,无统计学意义,其余项P值均0.05,具有统计学意义。5、试验过程中,患儿一般体检项目、血常规、尿常规、粪常规、心电图、肝功能和肾功能均未出现异常,且未出现不良反应,说明小儿芩马颗粒具有较好的安全性。结论:在小儿急性咽炎(肺胃蕴热证)的临床治疗中,使用小儿芩马颗粒连续治疗5天,试验结果显示小儿芩马颗粒明显的治愈或缓解了患儿的临床症状,且未出现不良事件,具有显著的临床有效性及安全性。表明小儿芩马颗粒是具有较好的临床应用价值的新药,值得在临床上推广使用。
[Abstract]:Objective: To evaluate the clinical efficacy and safety of the treatment of children's acute pharyngitis (lung-stomach heat syndrome) with a randomized, double-blind, parallel-control method. Methods: The cases of acute pharyngitis (the lung-stomach heat syndrome) between the ages of 3 and 14 in the department of pediatrics in Hubei Province were collected. The randomized, double-blind, parallel-control method was used. The test group and the control group were assigned according to the ratio of 1:1, of which 24 cases were in the test group and 24 in the control group, and the total was 48 cases. The experimental group was used for the treatment of the children, and the control group was treated with a 5-day treatment course. The demographic data of the children were collected and the symptoms and signs before and after treatment were recorded separately, and the criteria for grading of the symptoms and signs were filled in as required. The method comprises the following steps of: integrating the sex and the age of the child, the main symptoms, the signs and the secondary symptoms, the curative effect of the children's acute pharyngitis, the curative effect of the lung-stomach heat syndrome, the curative effect of the individual main and the sign, the total product before and after the treatment, and the integral of the main symptoms, the signs and the secondary symptoms before and after the treatment, SPSS 19.0 software was used to carry out statistical analysis to evaluate the effectiveness of the children. Vital signs, electrocardiogram, laboratory tests, and adverse events before and after use of the enrolled children were observed and recorded to evaluate their safety. Results:1. There was no significant difference in the sex, age, main symptoms, signs and secondary symptoms of the children. The total effective rate was 100%, the higher the control group was 0%, the total effective rate was 92%. The more effective rate and total effective rate of the throat pain test group were 100%, the higher the control group and the total effective rate of the control group were 54% and 66.7%, respectively. The higher the total effective rate and the total effective rate of the control group were 100%, the higher the control group, the total effective rate was 8.3% and 41.7%, respectively. The higher the total effective rate was 83.3%, 95.8% and the higher the control group, the total effective rate was 37.5% and 54.2% respectively. There is no statistical significance, and the rest of the P-value is 0.05, which is of statistical significance.5. In the test, the general physical examination items, blood routine, urine routine, and feces routine, electrocardiogram, liver function and renal function of the child are not abnormal, and no adverse reaction occurs. It is a good safety for the children to be treated with horse-like particles. Conclusion: In the treatment of children's acute pharyngitis (lung-stomach heat syndrome), the treatment of children's acute pharyngitis (lung-stomach heat syndrome) for 5 days, the test results show that the children's baby-like particles can obviously cure or relieve the clinical symptoms of the child and have no adverse events. And has remarkable clinical efficacy and safety. It is shown that the drug is a new drug with good clinical application value, and it is worth to be popularized and used in clinic.
【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R276.1

【相似文献】