| Objective:1.To observe the clinical effect of bagui zhitong cream on postherpetic neuralgia,2.optimize the matrix composition and dosage of bagui analgesic cream.Methods:1.According to the inclusion criteria,84 Patients with postherpetic neuralgia were included,they were randomly divided into three groups by sealed envelope lottery,with 28 Patients in each group.All Patients in the 3 groups were treated with traditional Chinese medicine(TCM)for 2 times/day,150ml/time.The experimental group was given bagui analgesic cream for external use on the basis of traditional Chinese medicine,control group(1)was given funtaline emulsion for external use,the control group(2)was not allowed to use drugs externally.The frequency of external drug use was 2 times/day,1 week was a course of treatment,a total of 4 courses of treatment.Numerical rating scale?Athens Insomnia Scale?Self-Rating Anxiety Scale and Self-Rating Depression Scale was applied at 0,1,2,3 and 4weeks of treatment.Blood,urine routine and liver and kidney function examination were conducted before and after treatment in each group.The total effective rate was calculated according to nimodipine method.One outpatient follow-up was conducted one month after treatment to calculate the recurrence rate.2.Single factor pre-experiment was used to determine the matrix components that affect the stability of the cream.Orthogonal test L9(3~4)was designed to screen out the best base cream composition by centrifugal test,cold and heat resistance test and the appearance and uniformity of the cream as evaluation indexes.Results:1.completion:Of the 84 Patients included in this study,76 were actually completed in the end,2 in the experimental group,3 in the control group and 2 in the control group.The total shedding rate was 9.52%.2.Clinical observation3.2.1.The general information:Before treatment,the general data scores of the three groups showed no statistical significance(P>.05),indicating comparability.2.2.Efficacy index NRS score:There was no significant difference in NRS score between the three groups before treatment(P=0.462>0.05),indicating comparability.NRS score in the three groups decreased after treatment compared with that before treatment(P<0.01).We conducted statistical analysis and comparison between the experimental group and the control group,and found that there was no significant statistical difference between the experimental group and the control group 1,but there was a significant statistical difference between the control group 2 and the other two groups.2.3.Secondary scoring indicators:Before treatment,the scores of AIS,SAS and SDS in the three groups showed no statistical significance.After treatment,the scores of AIS,SAS and SDS in the three groups decreased compared with those before treatment in the three groups,with statistical significance(P<0.01).For the above three secondary efficacy indicators,we respectively conducted statistical analysis and comparison between the experimental group and the control group for each of them,and found that there was no significant statistical difference between the experimental group and control group 1,but there was significant statistical difference between control group 2 and the other two groups.2.4.Adverse reactions:Among the three groups of Patients,only 1 Patient in the experimental group showed adverse reactions,and the treatment was not terminated due to timely treatment and mild symptoms.2.5.The recurrence rate:At 1 month after the end of treatment,17 patients in the experimental group were followed up,among whom,1 patient had relapse,with a probability of 5.89%.One of the 14 patients in the control group was followed up,and the disease was repeated in 1 patient,with a probability of 7.14%.A total of 12 patients in control group 2were followed up,and 3 patients had relapse,with a probability of 25%.2.6.Total effective rate:The total effective rate of the experimental group was 96.2%.Control group 1 total effective rate 92%;The total effective rate of control group 2 was 72%,The comparison probability of the total effective rate between the experimental group and the other two control groups was P=0.025<0.05.The comparison probability of the total effective rate between the experimental group and the other two control groups was P=0.025<0.05.3.Matrix optimization:Based on the characteristics of clinical medicine prescription of each single herbs properties,cream preparation choose oil-in-water(O/W)matrix,according to the water oil Phase,and the use of proportion,to determine 7 cream prescription,prescription,7of them are all prescription in appearance,smooth,coated best,determine Bagui analgesic cream matrix of oil Phase is:stearic acid,liquid Paraffin,lanolin.Aqueous Phase:glycerin,triethanolamine,hydroxybenzoate,Purified water,extract.The single factor pre-experiment showed that the components that had a great influence on the matrix were stearic acid,liquid Paraffin,triethanolamine and so on.Based on the results of single pretest,the related orthogonal test was designed to determine the composition of cream matrix and its preparation process.Conclusion:1.Bagui analgesic cream has curative effect in treating postherpetic neuralgia,which can reduce the Pain of Patients,improve the sleep quality of Patients,and reduce the anxiety and depression of Patients.2.The preparation Process was as follows:10g stearic acid,12g liquid Paraffin,1g lanolin were Placed in a 150ml beaker,heated in a water bath until melted,and further heated to 70?~80?.Will glycerin,10 g,5 g triethanolamine,hydroxyl ethyl benzene,Purified water,57.8g 0.2 g into another 150 ml beaker of water bath heating to dissolve,water Phase matrix completely dissolved after the condensate 14 g,stir well,continue to heated to 70?~80?,at the same temperature aqueous solution to trickle into the oil Phase in the solution,and while stirring(stirring speed is about:200 r.min-1),until the condensate to 40?or so stop stirring,allow it to cool to room temperature naturally for a quick Bagui analgesic cream.3.The optimum amount of matrix components for cream is 10g stearic acid,12g liquid Paraffin,1g lanolin,5g triethanolamine,10g glycerin,0.2g hydroxybenzoate. |
PDF Full Text Request