Objectives:To compare the efficacy of trigeminal nerve block(via pterygopalatine fossa block)combined with stellate ganglion block and trigeminal nerve block alone in the treatment of Primary Trigeminal Neuralgia(V2,V3),and to explore the efficacy and safety of the combined therapy.Methods:A total of 46 patients with Primary Trigeminal Neuralgia(PTN)and regional pain in the V2 and V3 branches of the First Affiliated Hospital of Kunming Medical University from October 2019 to October 2020 were selected and randomly divided into the control group C and test group M,23 cases in each group;patients in group C underwent three consecutive trigeminal nerve blocks with an interval of 5 days,totaling 3 times,group M combined with trigeminal nerve block,once a day for a total of 5 times bilateral Stellate Ganglion Block(SGB),during the treatment period,all patients maintain the original dose of Carbamazepine(CBZ)treatment,and adjust the dose according to the patient’s pain relief after treatment.Follow-up 3 Months;Visual Analogue Scale(VAS)was used to evaluate the pain relief of patients before and after treatment,and the daily dose of CBZ was recorded;Hamilton Anxiety Scale(HAMA)was used to evaluate patients before and after treatment changes in anxiety of patients;Pittsburgh Sleep Quality Index(PSQI)was used to evaluate the changes in sleep quality before and after treatment;Barrow Neurological Institute(BNI)was used to evaluate the recurrence of patients after treatment;VAS score and CBZ dose changes after treatment were used as the co-primary endpoints,and HAMA score,PSQI score and BNI grading after treatment were used as secondary endpoints to compare the overall efficacy and complication rates of the two groups.Results:(1)A total of 46 patients were included in the study.At the end of the study,5 patients dropped out.A total of 41 patients completed the experimental study,including 21 in the M group and 20 in the C group.There was no statistical difference between the two groups of patients normal information before treatment(P>0.05).(2)Co-primary endpoints:①Compared within the group,the VAS scores of the M group and the C group at 1 week,4 weeks and 3 months after treatment decreased compared with that before treatment,the difference was statistically significant(P<0.001);comparison between groups,the VAS of the M group were lower than the corresponding C group at different time points,and the difference was statistically significant(P<0.05).②Compared within the group,the CBZ dose of patients in the M group and the C group at I week and 3 months after treatment decreased compared with that before treatment,and the difference was statistically significant(P<0.001);comparison between groups,after treatment at 1 weeks,the mean CBZ doses of the M group and the C group were 175±116.416 mg and 185±118.210 mg,respectively.There was no significant difference between the two groups(P>0.05).At 3 months after treatment,the CBZ doses of the M group and the C group were 200±91.760 mg and 275±125.132 mg,respectively.The difference between the two groups was statistically significant(P<0.05).③One week after treatment,the total effective rates of the M group and the C group were 95%and 90%,respectively,and there was no statistically significant difference between the groups(P>0.05);3 months after the treatment,the total effective rates of the M group and the C group were 90%and 65%,respectively,the difference between the groups was statistically significant(P<0.05).(3)Secondary endpoints:①Compared within the group,the HAMA scores of the M group and the C group at 1 week,4 weeks and 3 months after treatment decreased compared with that before treatment,and the difference was statistically significant(P<0.001);Comparing between groups,the HAMA score of the M group was lower than the corresponding C group at all time points after treatment,and the difference was statistically significant(P<0.05).②Compared within the group,the PSQI scores of the M group and the C group decreased in 1 month and 3 months after treatment,and the difference was statistically significant(P<0.001);comparison between the groups,the PSQI score of the M group was lower than the corresponding control group,the difference was statistically significant(P<0.05).(4)Comparison of recurrence:3 months after treatment,2 cases(10%)and 5 case(25%)of the M group and the C group had recurrences,respectively.There was no significant difference in the recurrence rate between the two groups(P>0.05).(5)Comparison of adverse reactions and complications:After the treatment,16 cases(86%)and 16 cases(80%)in the M group and the C group respectively had facial numbness and hypoesthesia on the affected side.These symptoms was within the acceptable range of the patients and was gradually relieved in 2 weeks after treatment.There were 4 cases(19%)and 3 cases(15%)in the M group and the C group,respectively,who experienced mild dizziness and instability after treatment,and all resolved spontaneously after resting.In the M group,2 patients(10%)experienced hoarseness after treatment,which resolved spontaneously after 3 hours without special treatment.No other serious adverse reactions and complications occurred in the enrolled cases.Conclusions:Trigeminal nerve block via pterypalatine fossa combined with SGB is safe and effective in the treatment of PTN(V2,V3),and compared with Trigeminal nerve block via pterypalatine fossa alone,the combined therapy is more effective in alleviating the pain of PTN(V2,V3)patients,improving the patient’s anxiety inhibition state and improving sleep disorders.It has reference and application value in clinical treatment of PTN. |