RESUMEN
ObjectiveTo evaluate the efficacy and safety of An'erning granules in the treatment of community-acquired pneumonia in children. MethodA randomized， double-blind， single-simulation， placebo-controlled trial was designed in this study. The children were randomly assigned into an observation group （An'erning granules combined with ceftriaxone sodium） and a control group （An'erning granules placebo combined with ceftriaxone sodium） according to the ratio of 2∶1. The disease cure rate was taken as the main indicator of efficacy， and the safety of An'erning granules was observed. ResultA total of 206 children （137 in the observation group and 69 in the control group） were included in this study. Before treatment， the age， sex， body height， body weight， diagnosis time of pneumonia， and symptom and sign scores had no significant differences between the two groups. After 8 days of continuous medication， the observation group［70.80%（97/137）］ had higher cure rate than the control group［56.52%（39/69）］（χ2=4.17，P<0.05） and total effective rate of chest X-ray ［97.98%（97/99）］ than the control group［86.27%（44/51）］ （χ2=12.98，P<0.01）. The observation group was superior to the control group in the alleviation of TCM syndrome under the condition of 0-3 g dose stratification on day 3 of medication （P<0.01）. The recovery time， time to complete fever abatement， time to fever abatement and expectoration alleviation， rate of conversion to severe case， and reduction in the frequency of antibiotic use showed no significant differences between the two groups. In terms of safety， 13 and 7 adverse events occurred in the observation group and control group， respectively， which were relieved or disappeared after drug withdrawal or symptomatic treatment and showed no significant difference between the two groups. ConclusionIntravenous drip of ceftriaxone sodium combined with An'erning granules is effective in the treatment of community-acquired pneumonia in children. It can accelerate the absorption of pulmonary inflammation， alleviate the clinical symptoms in a short time for young children or the children with mild symptoms， and is safe in clinical application.
RESUMEN
ObjectiveTo evaluate the efficacy and safety of An'erning granules in the treatment of community-acquired pneumonia in children. MethodA randomized， double-blind， single-simulation， placebo-controlled trial was designed in this study. The children were randomly assigned into an observation group （An'erning granules combined with ceftriaxone sodium） and a control group （An'erning granules placebo combined with ceftriaxone sodium） according to the ratio of 2∶1. The disease cure rate was taken as the main indicator of efficacy， and the safety of An'erning granules was observed. ResultA total of 206 children （137 in the observation group and 69 in the control group） were included in this study. Before treatment， the age， sex， body height， body weight， diagnosis time of pneumonia， and symptom and sign scores had no significant differences between the two groups. After 8 days of continuous medication， the observation group［70.80%（97/137）］ had higher cure rate than the control group［56.52%（39/69）］（χ2=4.17，P<0.05） and total effective rate of chest X-ray ［97.98%（97/99）］ than the control group［86.27%（44/51）］ （χ2=12.98，P<0.01）. The observation group was superior to the control group in the alleviation of TCM syndrome under the condition of 0-3 g dose stratification on day 3 of medication （P<0.01）. The recovery time， time to complete fever abatement， time to fever abatement and expectoration alleviation， rate of conversion to severe case， and reduction in the frequency of antibiotic use showed no significant differences between the two groups. In terms of safety， 13 and 7 adverse events occurred in the observation group and control group， respectively， which were relieved or disappeared after drug withdrawal or symptomatic treatment and showed no significant difference between the two groups. ConclusionIntravenous drip of ceftriaxone sodium combined with An'erning granules is effective in the treatment of community-acquired pneumonia in children. It can accelerate the absorption of pulmonary inflammation， alleviate the clinical symptoms in a short time for young children or the children with mild symptoms， and is safe in clinical application.
RESUMEN
OBJECTIVE:To establish a method for the quality control of Jiuweiniuhuang pills.METHODS:TLC was applied for the quantitative identification of Bostaurus domesticus,Carthamus tinctorius and Aucklandia lappa in this prescription as well as the testing of the limit of Aristolochic acid A. RP-HPLC method was established for determination of Costunolide and Dehydrocostuslactone.RESULTS: The TLC spots were clear,well-separated,specific and free from interference of negative sample. The content of Aristolochic acid A which stood at less than 2.5 ?g?6 g-1 was up to the standard.Costunolide showed a linear relationship at the concentration range of 0.26～1.3 ?g with an average recovery of 99.8% (RSD=1.1%,n=6); and Dehydrocostuslactone showed a linear relationship at the concentration range of 0.258～1.29 ?g with an average recovery of 98.2%(RSD=1.7%,n=6).CONCLUSION: The method is suitable for the quality control of Jiuweiniuhuang pills.