| Objective: To explore the therapeutic effect and improvement of milnacipran in depressive patients with different degrees of somatic pain,and to analyze its safety.Further exploration and observation on the changes of clinical efficacy of milnacipran associated with r TMS.It was expected that this study will provide new ideas and methods to treat depressive disorder with different degrees of somatic pain.Methods: 276 depressive patients with different degrees of somatic pain,who have already visited the Mental Health Department of the Second Hospital of Lanzhou University from January 2020 to February 2021,have been enrolled.However,4 patients choosed to withdraw from the clinical study due to their own reasons or adverse reactions,and a total of 272 patients were finally incorporated into the FAS set.First of all,visual analogue scale（VAS）was used to divide research subjects into three large groups: group A was the mild pain group（1 point≤VAS≤3points）,group B was the moderate pain group（4 points≤VAS≤6 points）,and group C was the severe pain group（7 points≤VAS≤10 points）.Then group A was randomly divided into three subgroups: subgroup A1,A2 and A3.Group B was randomly divided into three subgroups: subgroup B1,B2 and B3.And group C was randomly divided into three subgroups: subgroup C1,C2 and C3.Among them,group A1,B1 and C1 were given paroxetine hydrochloride tablets,group A2,B2 and C2 were given milnacipran hydrochloride tablets,and group A3,B3 and C3 were given milnacipran hydrochloride tablets in combination with the high frequency r TMS.HAMD-24 and HAMA-14 scales applied to evaluating psychological state of the nine subgroups of patients at the baseline,the second weekend,the fourth weekend and the sixth weekend of treatment.Meanwhile,the main clinical efficacy evaluation indexes contained change in the scores of HAMD and HAMA,and the reduction rate was as much part of them.Before treatment and at the sixth weekend,use VAS to assess the degree of somatic pain for patients,and the reduction rate served as the secondary evaluation index of clinical efficacy.Additionally,evaluation of the safety of dissimilar regiments was conducted by TESS.Finally,SPSS 26.0 software was employed as statistical analysis and data processing of FAS data.Results: The total number of patients included in the FAS was 272: 31 cases in subgroup A1,30 cases in subgroup A2,30 cases in subgroup A3,31 cases in subgroup B1,30 cases in subgroup B2,30 cases in subgroup B3,30 cases in subgroup C1,30 cases in subgroup C2,and 30 cases in subgroup C3.Based on the collected research data,the analysis results were as follows: 1.There was no remarkable difference in the general clinical data（sex,age and duration）and baseline conditions（HAMD-24 and HAMA-14 scores）of the nine subgroups before treatment（P>0.05）.2.Compared with the scores before treatment,the total scores of HAMD and HAMA at each observation point（the 2nd,4th and 6th weekend）after treatment were markedly decreased in the nine subgroups（P<0.05）,especially in the first fourteen days of treating process.Additionally,the VAS scores of the total nine subgroups after treatment were dramatically lower than those before treatment,with a statistically significant difference（P<0.05）.3.For patients in the mild pain group,after comparing subgroup A1 and subgroup A2,there was no significant dissimilarity in the total scores of HAMD at the 2nd weekend and the HAMA scores at any treatment period between the two subgroups（P>0.05）,while the HAMD scores of subgroup A2 at the4 th and 6th weekend of treatment were remarkably lower than those of subgroup A1（P<0.05）,and the VAS showed that the effective number of subgroup A2 at the 6th weekend was markedly higher than that of subgroup A1（P<0.05）.After comparing subgroup A2 and subgroup A3,there was no significant distinction in the effective and recovery number of depressive and anxious mood at the 2nd weekend between the two subgroups（P>0.05）,while the HAMA scores and the total scores of HAMD scale at the 4th and 6th weekend in subgroup A3 were dramatically lower than those in subgroup A2（P<0.05）,and the VAS showed that the effective number of subgroup A3 at the 6th weekend of treatment was obviously higher than that of subgroup A2（P<0.05）.4.For patients in the moderate pain group,after comparing subgroup B1 and subgroup B2,there was no significant dissimilarity in the total scores of HAMA at any observation stage and the HAMD scores at the 2nd and 4th weekend between the two subgroups（P>0.05）,while the HAMD scores of subgroup B2 at the 6th weekend after treatment significantly decreased than subgroup B1（P<0.05）,and the VAS scores of subgroup B2 at the 6th weekend were remarkably lower than those of subgroup B1,at the same time,the effective number of clinical treatment in subgroup B2 was also greater than that in subgroup B1（P<0.05）.After comparing subgroup B2 and subgroup B3,the total scores of HAMD and HAMA scales at the 4th and 6th weekend in subgroup B3 were lower and there was a significant difference（P<0.05）,while at early stage of treatment（the 2nd weekend）,there was no obvious difference between the effective and recovery number of depressive and anxious mood for the two subgroups of patients（P>0.05）,and the VAS showed that the effective number of subgroup B3 at the end of the 6th week was markedly higher than that of subgroup B2（P<0.05）.5.For patients in the severe pain group,after comparing subgroup C1 and subgroup C2,the total scores of HAMA at the 2nd weekend and the HAMD scores at the 4th and 6th weekend after treatment in subgroup C1 strikingly increased than subgroup C2,with a statistically significant difference（P<0.05）,while there was no significant distinction in the HAMD scores at the 2nd weekend and the HAMA scores at the 4th and 6th weekend between the two subgroups（P>0.05）,and the total scores of VAS at the 6th weekend of treatment in subgroup C2 were remarkably less than those in subgroup C1,meanwhile the effective number of subgroup C2 was more than that of subgroup C1（P<0.05）.After comparing subgroup C2 and subgroup C3,the total scores of HAMA at the 2nd weekend between the two subgroups were similar（P>0.05）,while the HAMA scores at the 4th and 6th weekend and the total scores of HAMD at different time of observation in subgroup C3 obviously reduced than subgroup C2（P<0.05）,and the VAS scores of subgroup C3 at the 6th weekend after treatment was significantly lower than those of subgroup C2（P<0.05）.6.At the 6th weekend after treatment,no statistically significant difference in the total number of patients developing side effects or adverse reactions and the total scores of TESS scale for the nine subgroups was found（P>0.05）.Conclusions: 1.For depressive patients with different degrees of somatic pain,the antidepressant effects of milnacipran after the entire treatment period is better than that of paroxetine,which is the representative drug of SSRIs,while both of them have equivalent effects on anxiety symptoms.2.Milnacipran can relieve different degrees of somatic pain in patients with depressive disorder.3.In a short period of time（≤2weeks）,milnacipran in combination with r TMS has the same therapeutic effects on depressive disorder and anxiety as milnacipran,while the former in improving depressive and anxious symptoms is gradually more effective than the latter after 4weeks,and the former is much better than the latter in improving different degrees of somatic pain in patients with depressive disorder.4.The safety of milnacipran has no obvious difference with paroxetine,and milnacipran is well tolerated,meanwhile,medication period,attention should be paid to the changes of patients’ heart rate and blood pressure. |
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