| ObjectiveThe purpose of this study is to evaluate the efficacy and safetyof Vitex oil capsules on acute stage and chronic stage chronicbronchitis(phlegm blocking the lung) patients’ cough andexpectoration through a research on296outpatients. We furtherlyprovide evidence-based basis for the clinical application of Vitexoil capsules.MethodThe296outpatients were choosed from different Chinese medicinehospital from February2012to February2013.Among the296cases,148outpatients wsa diagnosed as acute stage of chronicbronchitis(phlegm blocking the lung), the other148cases chronicstage of chronic bronchitis(phlegm blocking the lung). Usingmulticenter, randomized and double-blind controlled clinical trialmethods, we divided all of the outpatients into experimental groupand control group.The experimental group were given Vitex oilemulsion, and the control group Vitex oil capsules.We evaluate theefficacy and safety of Vitex oil capsules according to thepatients’ cough, expectoration,other TCM symptoms and laboratoryexamination. ResultThe comparative analysis of expectorant total score at each timepoint comparison demostrated that group comparison aftermedications, group difference comparison after4days medicationsand group difference comparison after medications hadstatistically significance (P <0.05).However, group comparisonbefore incoming group and group comparison after4days medicationshad no statistically significance(P>0.05).According to Expectorant integral curve (AUC) group comparison,the mean of A group is34.722±12.308,and B group31.447±9.843.Corrected t-test inspection found that the difference between thegroups was statistically significant (P <0.05)After treatment, the expectorant total score difference beforeand after analysis of covariance found that Centre factors, factorsbetween the two groups and before treatment factors were allstatistically significant (P <0.05)Cough integral comparative analysis of each time pointdemostrated that group comparison after medications, groupdifference comparison after medications had statisticallysignificance (P <0.05). However, group comparison before incominggroup, group comparison after4days medications and groupdifference comparison after4days medications had no statisticallysignificance (P>0.05).The area the cough integral under the curve (AUC) groupcomparison revealed that the mean of A group is16.714±4.451,andB group16.379±3.953.The t-test inspection found nostatistically significance(P>0.05). ConclusionVitex oil emulsion can ease patients’ cough, expectorationsymptoms and TCM syndrome.Its possible mechanisms may includemuscle relaxation, relieving the spasmodic smooth muscle,anti-inflammatory, anti-histamine,anti-acetylcholine, alkalizingmucus, reducing mucus viscosity, beta-sympathomimetic effect,accelerating mucus forwarding, enhancing mucociliaryclearance.The safty of Vitex oil emulsion is good. |