金莲清热泡腾片治疗手足口病（普通型）临床研究

发布时间：2018-04-11 07:34

本文选题：手足口病 + 金莲清热泡腾片　；参考：《成都中医药大学》2012年硕士论文

【摘要】：目的：初步评价金莲清热泡腾片治疗手足口病普通型患儿的临床疗效和安全性,并观察了解手足口病合并心肌受损的发生情况。方法：将72例符合纳入标准的患儿随机分为治疗组与对照组,治疗组36例,对照组36例。两组在相同基础治疗方案的同时,治疗组口服金莲清热泡腾片,对照组口服金莲清热泡腾片模拟剂。治疗时间为3-7天,随访3天。研究过程中观察并记录两组患儿临床症状和体征变化情况、中医证候改善情况、不良反应等情况,并观察分析心肌酶学指标改变情况,采用SPSS17.0统计软件进行疗效分析。结果：1.疗效分析：(1)两组退热起效时间、体温恢复正常时间、皮疹/疱疹、口腔溃疡消退时间比较,经Log-rank检验,差异有统计学意义(P0.0001),提示治疗组临床疗效明显优于对照组。(2)不同时间访视时临床合并症状和体征完全消失时间比较,在病程的不同时间均出现治疗组优于对照组,差异有统计学意义(P0.05)。(3)退热剂使用情况比较,治疗组用量少于对照组,差异有统计学意义(P0.05)。(4)两组治疗结局比较无差异,同时无病例转为重症。(5)两组中医证候疗效比较,差异有统计学意义(P0.05),治疗组改善中医证候疗效明显优于对照组。2.安全性分析：安全性指标观测未发现明显毒副作用,提示安全性良好。3.心肌受损发生情况：手足口病病程中可出现不同程度的心肌酶谱增高。结论：金莲清热泡腾片治疗手足口病普通型疗效肯定,未发现药物引起的不良反应及毒副作用,值得临床进一步推广应用。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of Jinlian Qingre effervescent tablet in treating children with hand foot and mouth disease and to observe the occurrence of hand foot mouth disease complicated with myocardial injury.Methods: 72 cases were randomly divided into treatment group (n = 36) and control group (n = 36).The two groups were given Jinlian Qingre effervescent tablet while the control group was treated with Jinlian Qingre effervescent tablet at the same time.The treatment time was 3-7 days and follow-up was 3 days.In the course of the study, the changes of clinical symptoms and signs, the improvement of TCM syndromes and adverse reactions were observed and recorded in the two groups. The changes of myocardial enzymes were observed and analyzed, and the curative effect was analyzed by SPSS17.0 statistical software.The result is 1: 1.Effective time of antipyretic effect, recovery time of body temperature, rash / herpes, extinction time of oral ulcer were compared between the two groups by Log-rank test.The difference was statistically significant (P 0.0001), which suggested that the clinical efficacy of the treatment group was significantly better than that of the control group. (2) the time of complete disappearance of clinical symptoms and signs at different time of visit was better in the treatment group than in the control group, and it was better in the treatment group than in the control group at different time of course of disease.The use of antipyretic agents in the treatment group was less than that in the control group, and there was no difference in the outcome of treatment between the two groups, and there was no difference in the outcome of treatment between the two groups. At the same time, there was no case turned to severe syndrome, and the curative effect of TCM syndrome was compared between the two groups.The difference was statistically significant (P 0.05). The curative effect of improving TCM syndrome in the treatment group was obviously better than that in the control group. 2. 2.Safety analysis: safety index observation did not find obvious side effects, indicating good safety. 3.Myocardial damage: increased myocardial enzymes were observed in the course of HFMD.Conclusion: Jinlian Qingre effervescent tablet is effective in the treatment of hand, foot and mouth disease, no adverse reactions and side effects caused by drugs have been found, which is worthy of further clinical application.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R272

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