【摘要】：目的:以隨機(jī)雙盲、平行對(duì)照方法評(píng)價(jià)小兒芩馬顆粒治療小兒急性咽炎(肺胃蘊(yùn)熱證)的臨床有效性及安全性。方法:收集湖北省中醫(yī)院兒科門診中3歲至14歲之間的急性咽炎(屬肺胃蘊(yùn)熱證)患兒病例,采用隨機(jī)雙盲、平行對(duì)照方法,試驗(yàn)組和對(duì)照組按1:1比例分配,其中試驗(yàn)組24例,對(duì)照組24例,總共48例。試驗(yàn)組予小兒芩馬顆粒,對(duì)照組予小兒芩馬顆粒模擬劑,兩組均以5天時(shí)間為一個(gè)療程進(jìn)行治療。采集患兒的人口學(xué)資料,分別記錄治療前后的癥狀和體征,并按要求填寫《癥狀體征分級(jí)量化標(biāo)準(zhǔn)表》。將患兒的性別、年齡的情況,治療前主癥、體征及次癥積分,小兒急性咽炎疾病療效,肺胃蘊(yùn)熱證癥候療效,單項(xiàng)主癥及體征療效,治療前后總積以及治療后主癥、體征及次癥積分,運(yùn)用SPSS 19.0軟件進(jìn)行統(tǒng)計(jì)分析,評(píng)價(jià)小兒芩馬顆粒的有效性。觀察并記錄入組患兒用藥前后的生命體征、心電圖、實(shí)驗(yàn)室檢查及出現(xiàn)的不良事件以評(píng)價(jià)其安全性。結(jié)果:1、對(duì)患兒的性別,年齡,治療前主癥、體征及次癥積分進(jìn)行統(tǒng)計(jì)分析,均無(wú)顯著差異,具有可比性。2、試驗(yàn)組與對(duì)照組肺胃蘊(yùn)熱證癥候療效比較,P值0.05,具有統(tǒng)計(jì)學(xué)意義;試驗(yàn)組愈顯率為79%,總有效率為100%;對(duì)照組愈顯率為0%,總有效率為92%。3、試驗(yàn)組與對(duì)照組治療前后咽喉疼痛、咽喉充血、咽喉腫脹的療效比較,P值均0.05,具有統(tǒng)計(jì)學(xué)意義。其中,咽喉疼痛試驗(yàn)組愈顯率、總有效率均為100%,對(duì)照組愈顯率、總有效率分別為54%、66.7%;咽喉充血試驗(yàn)組愈顯率、總有效率均為100%,對(duì)照組愈顯率、總有效率分別為8.3%、41.7%;咽喉腫脹試驗(yàn)組愈顯率、總有效率分別為83.3%、95.8%,對(duì)照組愈顯率、總有效率分別為37.5%、54.2%。4、試驗(yàn)組與對(duì)照組治療后總積分、主癥、體征及次癥積分進(jìn)行統(tǒng)計(jì),除發(fā)熱的積分比較,P值0.05,無(wú)統(tǒng)計(jì)學(xué)意義,其余項(xiàng)P值均0.05,具有統(tǒng)計(jì)學(xué)意義。5、試驗(yàn)過程中,患兒一般體檢項(xiàng)目、血常規(guī)、尿常規(guī)、糞常規(guī)、心電圖、肝功能和腎功能均未出現(xiàn)異常,且未出現(xiàn)不良反應(yīng),說(shuō)明小兒芩馬顆粒具有較好的安全性。結(jié)論:在小兒急性咽炎(肺胃蘊(yùn)熱證)的臨床治療中,使用小兒芩馬顆粒連續(xù)治療5天,試驗(yàn)結(jié)果顯示小兒芩馬顆粒明顯的治愈或緩解了患兒的臨床癥狀,且未出現(xiàn)不良事件,具有顯著的臨床有效性及安全性。表明小兒芩馬顆粒是具有較好的臨床應(yīng)用價(jià)值的新藥,值得在臨床上推廣使用。
[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.
【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R276.1

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