| 1.Objectives1.1 To evaluate the clinical superiority of pterygopalatine fossa puncture with one acupuncture needle compared to verum acupuncture for moderate-severe persistent allergic rhinitis.1.2 To evaluate the safety of the two treatments.1.3 To evaluate the economics of the two treatments.1.4 To investigate the mechanism of the two treatments for moderate-severe persistent allergic rhinitis.1.5 To clarify the following questions by anatomical research which based on the clinical operation procedure of pterygopalatine fossa puncture with one acupuncture needle:A.Whether the sphenopalatine ganglion can be touched by acupuncture needle which will be inserted from infratemporal fossa to pterygopalatine fossa.B.The reasons of bruise in palpebra inferior at the next day after intervention.C.Whether there is the correlation between the width of facial cranium and the depth of puncture.If has,what is the correlation.2.Methods2.1 Clinical researchIn the trial,60 patients previously diagnosed with moderate-severe persistent allergic rhinitis and meeting all inclusion criteria will be allocated to one of two equal therapeutic groups by using a computer-generated randomization list.The interventional group will receive pterygopalatine fossa puncture with one acupuncture needle for 4 weeks(once or twice weekly,total 4-8 sessions);attending physicians will decide whether the second session is required in a week by examining signs and symptoms.The control group will receive individualized verum acupuncture for 4 weeks(twice weekly,total 8 sessions).Follow-up evaluations will be performed 1 month later.The primary outcome measure is the change in the total nasal symptom score(TNSS)from the baseline to week 4.The secondary outcome measures include the change of total non nasal symptom score(TNNSS)and nasal symptom score(2004 version)from the baseline to week 4,the onset time and duration of effectiveness in every session,change in number of days with moderate-severe persistent allergic rhinitis from the baseline to week 8,change in total immunoglobulin E level and eosinophil count in venous blood from the baseline to week 4,change in Rhinoconjunctivitis Quality of Life Questionnaire score from the baseline to week 4,and clinical waiting time.2.2 Anatomical researchSix adult male cadaveric heads,which brian should be taken first,were inserted by one acupuncture needle from infratemporal fossa to pterygopalatine fossa,and then the posterior walls of pterygopalatine fossa were opened,and then the sphenopalatine ganglions were carefully separated,the pterygopalatine parts of internal maxillary arterys were exposed and stayed at the normal position.After the anatomical operation,the researchers would observe whether the acupuncture needles have been inserted into the pterygopalatine fossas.The following datas would be meseaured:the puncture depth,the distance between the two sides of the hollow below the arcus superciliaris,the distance between the acupuncture needle and the sphenopalatine ganglion,the distance between the the acupuncture needle and the pterygopalatine part of internal maxillary artery,the distance between the pterygopalatine part of internal maxillary artery and the maxillary nerve which passes through the pterygopalatine fossa.3.Results3.1 Clinical research3.1.1 Primary outcome(TNSS)There are no statistical significances in both intition to treat and per-protocol analysis datasets for the mean of TNSS between two groups(P>0.05),the mean of TNSS in each time-point have statistical significances compared with that at baseline in each group(P<0.01).3.1.2 Second outcomesA.There are no statistical significances in both intition to treat and per-protocol analysis datasets for the mean of TNNSS between two groups(P>0.05),the mean of TNNSS in each time-point have statistical significances compared with that at baseline in each group(P<0.05).B.There are no statistical significances in both intition to treat and per-protocol analysis datasets for the mean of nasal symptom score(2004 version)between two groups(P>0.05),the mean of nasal symptom score(2004 version)in each time-point have statistical significances compared with that at baseline in each group(P<0.05).C.There are no statistical significances in both intition to treat and per-protocol analysis datasets for the mean of Rhinoconjunctivitis Quality of Life Questionnaire score between two groups(P>0.05),the mean of Rhinoconjunctivitis Quality of Life Questionnaire score in each time-point have statistical significances compared with that at baseline in each group(P<0.05).D.IN each group,the days with moderath-severe rhinitis in the follow-up are less than that at baseline in both intition to treat and per-protocol analysis datasets,there is no statistical significance between two groups(P>0.05).E.There has statistical significance in both intition to treat and per-protocol analysis datasets for the onset time between two groups(P<0.001),the onset time is shorter in the intervention group.F.There has statistical significance in both intition to treat and per-protocol analysis datasets for the duration of effectiveness between two groups(P<0.001),the duration of effectiveness is longer in the intervention group.G.There is no statistical significance for the eosinophil count in venous blood compared between baseline and after treatment in each group(P>0.05),there is no statistical significance for the that at baseline and after treatment between two groups(P>0.05).H.There is no statistical significance for the total immunoglobulin E level compared between baseline and after treatment in each group(P>0.05),there is no statistical significance for that at baseline and after treatment between two groups(P>0.05).1.The mean of clinical waiting time in the intervention group is 6.640±3.035mins,that in the control group is 31.19±1 0.216mins,there has statistical significance between groups.3.1.3 Adversary eventsIn the control group,the total session is 215,5 times of mild bruising are witnessed,no patients withdrew the study due to that.In the intervention group,the total session is 116,2 times of mild bruising,1 time of local hematoma happened in the course of intervention and 1 time of bruise in palpebra inferior at the next day after intervention are witnessed,the patients who experienced whether local hematoma or bruise in palpebra inferior withdrew the study.The volume of the hematoma is far less after instant cold compression,in the next day the hematoma is disappeared.For patient with bruise in palpebra inferior,cefuroxime 0.5g was orally taken twice a day for three days to prevent the secondary infection.The bruise was also disappeared in the next day after Cefuroxime was taken.3.2 Anatomical researchThe researcher applied 12 times of acupuncture(12 needles),all needles entered into the pterygopalatine fossa.The mean of puncture depth(mm)is 55.89±1.87 for the left side and 55.26±1.59 for the right side.The ratio scale between the puncture depth and the two sides of the hollow below the arcus superciliaris is 44%to 54%.Only 2 times of 12 intervention,the pinpoint touched the sphenopalatine ganglion.The mean distance between the acupuncture needle and the sphenopalatine ganglion(mm)is 5.88±3.70 for the left side and 6.43±5.54 for the right side,the rate of sphenopalatine ganglion approaching(the distance is less than 10mm)is 75%.The mean of distance between the the acupuncture needle and the pterygopalatine part of internal maxillary artery(mm)is 2.77±3.99 for the left side and 5.67±4.95 for the right side.The rate of pterygopalatine part of internal maxillary artery touched by the needle is 58.88%.The mean of distance between the pterygopalatine part of internal maxillary artery and the maxillary nerve which passes through the pterygopalatine fossa(mm)is 2.83±4.05 for the left side and 5.67±4.95 for the right side.The rate of the two anatomical structure which are touched each other is 41.67%.There is no statistical significances in the above data between two sides.4.ConclusionA.The clinical superiority of pterygopalatine fossa puncture with one acupuncture needle compared to verum acupuncture for moderate-severe persistent allergic rhinitis are that the onset time is shorter,the duration of effectiveness is longer and the clinical waiting time is less.B.There is no differences for the symptoms alleviation,the days with moderate-severe rhinitis and life quality improvement between the pterygopalatine fossa puncture with one acupuncture needle and verum acupuncture.C.The safety of the pterygopalatine fossa puncture with one acupuncture needle and verum acupuncture are satisfied,however,although the rates of local hematoma and bruise in palpebra inferior are low,those adversary events will influence the compliance,so that the researchers advice that doctors must passed the strict training before applying the intervention method in the trial.D.There are no evidences to support that the eosinophil count in venous blood and the total immunoglobulin E level can be decreased by the two acupuncture technics.E.The acupuncture needle can be inserted into pterygopalatine fossa from infratemporal fossa,however,the rate of sphenopalatine ganglion touched by pinpoint is low.F.The reasons of the bruise in palpebra inferior at the next day after intervention are that the pterygopalatine part of internal maxillary artery or it’s forward branch----infra-orbital artery were punctured by acupuncture needle.G.The depth of puncture(a)and the width of facial cranium(b)has correlation which is that the rate scale of a/b is 44%-54%.The researchers advice 44%will be applied after fully consideration of safety and clinical effectiveness. |
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