Clinical Research Based On The Treatment Of Pediatric Acute Bronchitis (Wind-heat Cough) With Shi Sang Granules

Objective: By therapeutic effect of Shi Sang Granules for pediatric acute bronchitis(wind-heat cough) with clinical and safety observation, to explore the mechanism ofaction and advanced therapy, and to provide the primary evidence for Shi SangGranules by an acute toxicity test.Methods:(1) Clinical observation: Collected60standard clinical children whosuffered from pediatric acute bronchitis (wind-heat cough) and randomly dividedthem into observation group (Shi Sang Granules) and control group (Ji Zhi Syrup)with30cases, repectively. Checked the symptoms, signs and examination, andestimated therapeutic effect after one course of treatment (5days). It was required thatrecorded the details about adverse reaction, if happened.(2) The acute toxicity test:According to a recondition that was no obtaining LD50, feeded test mice one timewith Shi Sang Granules by the maximum concertration and volume, then calculatedthe maximum dose for per mouse per day in order to preliminarily evaluate the safety.Results:(1) Clinical observation: Shi Sang Granules can effectively relieve or curethe cough and expectoration,etc. It had obvious superiorities in regulation of thespleen and stomach, and in amelioration of orexia.①The total effective rate inobservation group and control group was separately96.7%and83.3%, and thedifference was statistically significant. It indicated that total clinical efficacy ofobservation group was better than the control group.②The efficacy of observation group treating cough, congestion of throat, antiadoncus and auscultation in lung wasequal to of control group, no significant difference(P>0.05).③The efficacy ofobservation group treating expectoration, nose running, nasal obstruction,constipation and anorexia was better than of control group, and the difference wasstatistically significant(P<0.05).④The comparasion regarding the change of bloodroutine before and after medications between two groups had no statisticalsignificance(P>0.05), showing that they had the same clinical efficacy.⑤The twogroups did not have any adverse reaction.(2)The acute toxicity test: All test mice ofthe observation group (Shi Sang Granules) and control group (Ji Zhi Syrup) werealive and nomal in action and activities. The comparasion regarding the change ofweight and food-intake between two groups had no statistical significance(P>0.05);The maximum dose of Shi Sang Granules for per mouse per day one time was256.08g(crude drug)/kg, which was equivalent to114.8times of nomal dose for oneadult one day. It demonstrated that the toxicity of Shi Sang Granules for mice onetime was low. Combined with the results of clinic observation, it could testify theclinical safety of Shi Sang Granules.Conclusion: By the clinical research and the acute toxicity test, it could confirm thatShi Sang Granules is an effective therapy and safe. Therefore, it is deserved to bepopularized and apply.