| Objecctive To explore the clinical Features in Patients with somatization disorde and the clinical efficacy and safety of duloxetine in combination with small-dosage paliperidone in the treatment of somatization disorder.Methods Subjects were73patients,who should meet DSM-IV diagnostic criteria of somatization disorder. The subjects were assessed by self-made General Data Questionnaire,Screening for Somatoform Symptoms-7(SOMS-7),Hamilton Anxiety Scale (HAMA),Hamilton Depression Rating Scale (HAMD) and Self-report Symptom Checklist-90(SCL-90). All the patients with somatization disorder were randomly divided into a study group and a control group treated with duloxetine in combination with paliperidone and duloxetine alone, respectively, for8weeks. The clinical efficacy was evaluated at the ends of2,4,6and8weeks, using SOMS-7, HAMD, HAMA and SCL-90. And the side effects were evaluated at the ends of2,4,6and8weeks, using TESS. When the whole treatment was finished, there were66patients who’s data was fully collected,34patients from study group,32patients from control group.Using SPSS17.0to analysis the database by frequency analysis,correlation analysis, T-test, Chi-square test and Ridit analysis.When P<0.05confirmed significantly.Results1. The demography characteristic of somatization showed that:The number of female patients were more than male ones significantly, male/female=1/1.92;76.7%of the patients were married, more than the patients who were unmarried or divorced; Ural patients were more than urban ones significantly (P<0.01), Ural/urban=2.48/1. Most of the patients had low level of education,69.9%of the patients had no more than junior middile school education. The patients were main physical workers (68.5%), like farmers and workers, and the family economic status was at the middle level. 2. The pathogenetic background feature of somatization showed that:Average age of the patients is (27.84±3.07), they were main slow-moving onset, its course was (14.19±9.83) years on average. In the past one year, the average number of the patients with somatization disorder went to see doctors was (8.14±5.11). Most patients denied their true inducement or thought that the body disease caused it, very few patients admitted that it was related to the psychological factor.3. The symptoms of somatization disorder are mulriple, and multi-system is involved. Depression and anxiety are frequently present. The correlation analysis showed that:The total scores on SOMS-7were positively correlated with the total scores on HAMA and HAMD.4. The clinical effect of somatization showed that:For both the study group and control group, the total scores on SOMS-7, HAMA and HAMD were degraded to varying degrees after treatment than before treatment. Early in the treatment of second weekend,the total score of SOMS-7,HAMD anxiety/somatization factor and SCL-90somatization factor score were significantly lower than those before treament in the study group (P<0.01). While it is in the treatment of fourth weekend,these scores were significantly lower after treament than before in the control group(P<0.01). After second weeks treament,the number of SOMS-7somatization symptoms, the total score of SOMS-7,HAMD-SOM scores,the total score of HAMD,HAMD anxiety/somatization factor score, HAMD sleep factor score, SCL-90somatization and depression factor score were significantly lower in the study group than control group (P<0.05or P<0.01). After eighth weeks treament,the number of SOMS-7somatization symptoms, the total score of SOMS-7,HAMA total score and each factor score, HAMD total score and each factor score(except weight factor score), SCL-90somatization, obsess-compulsion,depression,anxiety and paranoid factor score were significantly lower than that of control group (P<0.05or P<0.01). By the end of the treatment, in the study group, there were4patients invalid,10patients progressive,16patients significantly progressive and4patients healing; in the control group, there were9patients invalid,12patients progressive,10patients significantly progressive and1patient healing. The result of Ridit analysis between control group and study group showed that the difference is significant(u=2.327, P<0.05).5. Safety analysis:The side effects of all the patients include thirst, nausea and throw up, dizzy and swoon, drowsiness, constipation, anorexia, tachycardia, insomnia and sweat. The side effect’s degrees of both groups were slight, and most of the side effects spontaneous remission with time or can be tolerate by the patients. There were no significant differences between the two groups in ADR rates (P>0.05).Conclusions1. Patients with somatization disorder are main female patients, and majority patients are from the countryside, married,low-education,physical workers and the family economic status was at the middle level.2. Onset of the disease is slow,the course is long and persisting and very few patients admitted that the disease was related to the psychological factor.3. The symptoms of somatization disorder are more,and the systems involved are wide; Depression,anxiety are frequently present,and the severity of somatic symptoms were positively correlated with the severity of depression and anxious symptoms.4. Duloxetine combined with paliperidone can effectively reduce the somatic, depression and anxious symptoms of patients with somatization disorder, meanwhile it worked better and faster than duloxetine alone.5. Duloxetine combined with paliperidone in the treatment of patients with somatization disorder is safe, and do not increase the side effects compared with duloxetine alone. |
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