| Objective: This study sought to evaluate the clinical effectiveness and safety of Corydalis decumbens(CD)injection in the treatment of postherpetic neuralgia(PHN).The concentrations of pain causing medium SP,CGRP,NO and analgesic substance β-EP in fasting blood of patients in the morning were measured pre treatment and in different treatment periods,and dynamic observation and analysis of the changes of concentrations in patients in different periods,to explore the possible mechanism of CD in treatment of PHN in order to provide a new idea and basis for clinical treatment of PHN.Methods:1.Using a randomized controlled study:60 patients with postherpetic neuralgia who were hospitalized in our department from March2019 to December 2019 were selected according to the case inclusion criteria.They were randomly divided into general treatment group(group G)and adjunct treatment group(group A),30 cases in each group.All patients did not take antiepileptic drugs,opioids,acupuncture,nerve block,interventional treatments and other invasive treatment.2.therapeutic method:The patients in group A were treated with antiepileptics(gabapentin),antidepressants(amitriptyline)and analgesics(paracetamol and oxycodone),The patients in group B received intramuscular injection with injection of corydalis decimbens(ICD)(2ml,twice a day)on the basis of oral drugs in group A.Both groups were treated for 2weeks;After discharge,the two groups continued to take conventional drugs for2 weeks according to the method and dose on the day of discharge and were followed up.3.Observation index:(1)on the 1st day(T0)before treatment,on the day of 1 week during the treatment(T1),on the day of 2 weeks during the treatment(T2)and on the day of 2 weeks after treatment(T3),NRS was used to evaluate the severity of pain;(2)on T0,T2 and T3,self-rating depression scale(SDS)was used to evaluate the change of depression degree,self-rating anxiety scale(SAS)was used to evaluate the change of anxiety state;(3)on T0 and T3,pit burgh sleep quality index(PSQI)was used to evaluate the sleep quality of patients,the MOS 36-item short from health survey(SF-36)was used to evaluate the quality of life of the two groups;(4)on T0,T2 and T3,fasting blood samples were collected in the early morning to detect the concentrations of SP,CGRP,NO and β-EP in the plasma of the patients,and observe that if there is effect on the content of the four before and after the treatment;(5)on T0,T2 and T3,fasting blood samples were collected in the early morning to detect the serum liver function indexes(ALT,AST),renal function indexes(URE,CREA,CCR),and to evaluate the liver and renal function at each time point before and after treatment;(6)on T0～T3,adverse reactions such as drug allergy,gastrointestinal bleeding,nausea and vomiting were observed in two groups of patients.4.Statistical analysis: spss22.0 was used for statistical analysis,P<0.05,the difference was statistically significant.Results:1.Comparison of general conditions between two groups of patients.In group A,there were 16 males and 14 females with an average age of(60.2±12.3)years.The course of disease was(8.2±3.1)months.The location of the disease was left chest in 15 cases and right chest in 15 cases.In group B,there were 15 males and 15 females with an average age of(60.7±11.4)years.The course of disease was(8.3±2.6)months.The location of the disease was left chest in 14 cases and right chest in 16 cases.There was no significant difference between the two groups in gender,age,course of disease and location of disease(P>0.05).2.Comparison of the NRS,SDS,SAS,PSQI and SF-36 scores between the two groups on admission.30 patients in group A received NRS(7.2±1.4),SDS(62.93±5.50),SAS(55.36±5.13),PSQI(14.9±3.6),SF-36[PCS(61.33±4.65),MCS(60.67±6.78)] on admission.30 patients in group B received NRS score(7.3±0.9),SDS score(62.89±5.60),SAS score(54.67±4.73),PSQI score(13.8±3.4),SF-36 score [PCS(60.83±5.16),MCS(61.73±6.08)] on admission.There was no significant difference in NRS,SDS,SAS,PSQI and SF-36 scores between the two groups(P>0.05).3.Comparison of NRS scores between the two groups at different time points.Compared with t0 time point,the NRS scores of T1,T2 and T3 in the two groups were significantly lower(P< 0.05);Compared with T2 time point,the NRS scores of of T3 time point in group A had no significant difference(P > 0.05),the NRS scores of T3 time point in group B were significantly higher(P < 0.05);Compared with group A,NRS scores of T2 and T3 time points in group B were significantly lower(P <0.05).4.Comparison of SDS scores and SAS scores between the two groups at different time points.Compared with t0 time point,the SDS score and SAS score of T2 and T3 in the two groups were significantly lower than those of T0(P < 0.05);Compared with T2 time point,the SDS score and SAS score of T3 in group A had no significant difference(P > 0.05),the SDS score and SAS score of T3 time point in group B were significantly higher(P < 0.05);compared with group A,SDS score and SAS score of T2 and T3 in group B were significantly lower(P < 0.05).5.Comparison of PSQI scores、SF-36 scores between two groups at different time points.Compared with T0,the PSQI scores at T3 in the two groups were significantly lower(P < 0.05),the SF-36 scores(PCs,MCS)of T3 in the two groups were significantly higher(P < 0.05);compared with group A,the PSQI scores at T3 in group B were significantly lower(P < 0.05),the SF-36 scores(PCS,MCS)at T3 in group B were significantly higher(P<0.05).6.Comparison of the concentration of SP、CGRP、NO、β-EP between the two groups at different time points.Compared with T0,the concentration of SP、CGRP、NO in plasma of the two groups at T2 and T3 decreased significantly(P<0.05),the concentration of β-EP increased significantly(P<0.05);Compared with T2,there was no significant difference in the concentration of SP、CGRP、NO、β-EP in plasma in group A at T3,the concentration of SP、CGRP、NO in plasma of group B at T3 increased significantly,the concentration ofβ-endorphin decreased significantly(P < 0.05);Compared with group G,the concentration of substance P in group A decreased significantly at T2 and T3,the concentration of β-endorphin increased significantly(P<0.05).7.Comparison of liver and kidney function indexes between the two groups at different time points.Compared with T0,there was no significant difference in serum ALT,AST,URE,CREA and Ccr between the two groups at T2 and T3(P>0.05).8.Comparison of the adverse events of the two groups.Up to T3 time point,no adverse reactions such as drug allergy,gastrointestinal bleeding,nausea and vomiting were observed in the two groups.Conclusions: Injection of corydalis decumbens in the adjuvant treatment of PHN has obvious effect and high safety,it can significantly reduce the plasma SP,CGRP,NO concentration and increase the β-EP concentration.The therapeutic mechanism may be related to the inhibition of SP,CGRP,NO release and the promotion of β-EP release. |
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