氟哌噻吨美利曲辛片联合甲磺酸倍他司汀片治疗脑梗死后焦虑抑郁患者头晕症状的临床研究

Clinical trial of flupentixol/melitracen tablet in combination with betahistine mesylate tablet on dizziness in post-stroke patients with anxiety and depression

目的观察氟哌噻吨美利曲辛片联合甲磺酸倍他司汀片治疗脑梗后焦虑抑郁患者头晕症状的临床疗效和安全性。方法将72例脑梗后焦虑抑郁患者随机分为对照组36例和试验组36例。对照组予以甲磺酸倍他司汀片12 mg,口服,每日1次,共4周;试验组在对照组的基础上加用氟哌噻吨美利曲辛片10.5mg,口服,早、午各1次,共4周。比较2组患者头晕评定量表(DHI)、汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)评分差异,以及药物不良反应发生率。结果治疗后,试验组和对照组总有效率分别为80.56%(29例/36例)和16.67%(6例/36例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的DHI评分分别为(34.50±15.54),(44.72±20.92)分;HAMA评分分别为(11.89±3.75),(16.83±5.70)分;HAMD评分分别为(13.50±4.70),(19.14±6.45)分,差异均有统计学意义(均P<0.05)。试验组出现头晕加重1例,口干2例,药物不良反应发生率8.33%(3例/36例);对照组出现恶心2例,头痛1例,便秘1例,药物不良反应发生率11.11%(4例/36例)。2组药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论氟哌噻吨美利曲辛片联合甲磺酸倍他司汀片对脑梗后焦虑抑郁患者的头晕症状疗效显著,且安全性高。

Objective To observe the clinical efficacy and safety profile of flupentixol/melitracen tablet in combination with betahistine mesylate tablet in the treatment of on dizziness in post-stroke patients with anxiety and depression. Methods A total of 72 post-stroke patients with anxiety and depression were randomly divided into the control group（ n =36 cases） and the treatment group（ n = 36 cases）. The control group was given oral administration of 12 mg of betahistine mesylate tablet once daily. The treatment group received 10. 5 mg of flupentixol/melitracen tablet in the morning and at noon,respectively,on the basis of the control group. Both groups were treated for 4 weeks. The clinical efficacy,the scores of dizziness handicap inventory（ DHI）,Hamilton anxiety scale（ HAMA）,Hamilton depression scale（ HAMD） and adverse drug reactions were compared between the two groups. Results After treatment,the total effective rates of the treatment group and the control group were 80. 56%（ 29 cases/36 cases） and 16. 67%（ 6 cases/36 cases）,respectively,and significant difference was found between the two groups（ P 〈0. 05）. After treatment,there were significant differences between the treatment group and the control group in DHI score（ 34. 50 ± 15. 54 vs44. 72 ± 20. 92）,HAMA score（ 11. 89 ± 3. 75 vs 16. 83 ± 5. 70）,and HAMD score（ 13. 50 ± 4. 70 vs 19. 14 ± 6. 45）（ P 〈0. 05）. The main adverse drug reactions of the treatment group were aggravated dizziness and dry mouth,while those of the control group were nausea,headache and constipation. The incidences of adverse drug reactions in the treatment group and the control group were 8. 33%（ 3 cases/36 cases） and 11. 11%（ 4 cases/36 cases）,without statistical significant difference（ P〉 0. 05）. Conclusion Flupentixol/melitracen tablet in combination with betahistine mesylate tablet exerted significant efficacy and high safety profile on dizziness in post-stroke patients with anxiety and depression.