| Object:To evaluate the clinical efficacy and safety of PingFeng BiShu capsule in Allergic Rhinitis(AR)which is termed as lung-deficiency-related cold type and to explore its mechanisms by adjusting the nasal mucosa inflammatory reaction and histamine content in serum of the model rats of AR.Methods:1.Clinical research:This clinical research adopts randomized,double-blind,placebo parallel control,multiple-centered clinical study design.,Multiple-center:Seven research center which led by our hospital.Random allocation:216 patients which were randomly assigned in a 1:1:1 ratio by computer-generated randomization listed into A group(Taking a placebo capsules),B group(Taking a low dose capsules)and C group(Taking a high dose capsules).Each group had 72 cases.Double-blind methods:put the codes and therapeutic schedule with the random method into a sealed envelope,which was saved in double and only when data revealed blind unsealed.Intervention:A group with a placebo capsules,B group with a low dose capsules)and C group with a high dose capsules.Treatment cycle was 28 days.Evaluation index:The main clinical curative effect observation indexes was VAS,the main quantitative score,the treatment rate and effective rate.Secondary clinical curative effect observation index was secondary symptoms score.to take blood routine examination,liver and kidney functions,urinalysis,electrocardiogram as a safety observation index.Evaluation method:To analyze the date with SPSS20.0 software between groups and within the groups before Treatment,after 2 and 4 weeks(the end of the experiment).To evaluate the drug’s clinical effective and safety.Meanwhile,to record patients’ adverse reactions and the condition of drug combination during treatment.2.Animal experimentGroup:60 SD rats which were randomly assigned in a 1:1:1 ratio listed into A group(Blank group),B group(the control group of simple model),C group(Taking a low dose capsules)and D group(Taking a high dose capsules).Each group had 15 cases.Making model:after 2 weeks,The three groups of rats builded model by ovalbumin sensitization method,to establish the model rats with allergic rhinitis,group A was replaced equally by 0.9%NS.Intervention:Experimental group was gavaged with0.061g/kg,0.122g/kg capsules.Control groups was gavaged with0.9%normal saline about 28 days.Evaluation index:Behavior score of rats of AR;to observe nasal mucosa of nasal cavity mucosal after HE staining under morphology;Immunohistochemical staining with Serum levels of histamine;Through the comparison between groups,to analyze the adjustment of inflammatory state.Results:1.clinical research(1)The baselines of the three groups indemographic characters and vital signs showed statistical differences.(2)During the period of treatment and follow-up,3 patients in group A were out of experiment,the group B had 58patients out of experiment,and the group C had 6 patients out of experiment,the average expulsion rate was7.87%.The compliance analysis showed that they had no significantly difference.(p>0.05).(3)The VAS sores:In inter group comparison,Before the treatment,After two and four weeks of treatment,the VAS score of the single and the total symptom was lower than before,the difference was significant(P<0.05).Between the three groups,The experimental group was better than the control group after treating two weeks between B and C groups,but the difference was no statistically significant(P>0.05).after four weeks,The group C was better than the group B and C.The group B was better than the group A.there was significant differences(P<0.05).therefore,The group with the highest dose showed the best effect in all groups,the group witha placebo capsules showed the least effect.(4)Rimary symptom of quantitative score:In inter group comparison,Before the treatment,After two and four weeks of treatment,the VAS score of the single and the total symptom were lower than before,and the difference was significant(P<0.05).Between the three groups,The experimental group was better than the control group after treating two and four weeks.meanwhile.the difference was statistically significant(P<0.05).Significant differences were found between groups(P<0.05).The group C was better than the group B.(5)Symptoms of quantitative score:In inter group comparison,The score of the single and the total symptom were significantly decreased before treatment and after two or four weeks(P<0.05).Between the groups,there was no significant difference after two weeks(p>0.05).After four weeks,The group C was better than the group B and C in spontaneous perspiration,Short of breath,cold evil wind,but there was no significant difference in score of pale complexion(p>0.05).(6)Syndrome scores:In inter group comparison,The scores were significantly decreased between before treatment and after two or four weeks(P<0.05).Between the groups,The experimental group was better than the control group after treating two weeks,while.there was no significant difference(p>0.05).After four weeks,The group C was better than the group B and A.The group B was better than the group A,and there was significant difference(p<0.05).(7)Evaluation on treatment efficiency:after treatment ended.the cure rate between the three groups were 1.45%,4.69%,6.06%.The cure rate of three groups were low and had no significant difference.the total effective rate between the three groups were 46.67%87.5%,95.45%.The experimental group was better than the control group with taking a placebo capsules.The group with taking a high capsules had the best efficiency.(8)Security indicators:5 cases manifested abnormality.2 cases in blood routine,1 case in Liver and kidney function,1 case in urinary sediment,1 case in electrocar-diography.Their incidences were all 1.5%.no adverse events were evident between the three groups.2.Animal Experiments(1)After model and Intervention,There were no deaths in 4 groups SD rats.(2)behavioral score of AR rats:After model,the score of A group is lower than B,C,D groups,there was significant difference(p<0.05).After Intervention,In inter group comparison,behavior score of C and D groups decreased obviously.Group D can be basic to blank control group,there was no significant difference between A and B(p>0.05).Group C had a less decrease,there was no significant difference between B and C(P>0.05).(3)Nasal mucosa of nasal cavity mucosal after HE staining under morphology,Mucosal epithelium was damaged.Cilia fall off,submucosal gland hyperplasia of nasal mucosa,Gland blood capillary expansion,A large number of inflammatory cells infiltration.After Intervention.Mucosal inflammatory reaction was relieved.Between two groups,The group D restored to normal,but there was still a stove sexual inflammation.Inflammatory reaction of group was reduced,but mucosal epithelium was still destroyed.(4)Immunohistochemical staining with Serum levels of histamine:After Intervention,The expression level of histamine between C and D group was lower than the pure model group.In inter group comparison,the group D was better than group C,and they had significant difference(P<0.05),but they could not be basic to blank control group.Conclusion:1.clinical studiesPingfeng Bishu capsule can improve the score of VAS and measurement of TCM syndromes in(lung-deficiency-related cold type)patients of AR.The group of taking high dose group was better than the low dose group,both three groups all have highsecurity.2.animal experimentPingfeng Bishu capsule can improve the scores of rats in model group and therapeutic after modeling,can effectively improve nasal mucosal inflammatory reaction,reduce the expression level of histamine. |
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