百乐眠联合坦度螺酮治疗高血压病伴焦虑障碍的疗效及安全性

目的：评价百乐眠联合坦度螺酮治疗高血压病伴焦虑障碍的疗效及安全性。方法将128例高血压病伴焦虑障碍患者随机分为A、B、C、D 4组，均给予氨氯地平5 m g／d ，A组仅常规降压治疗，B组加用百乐眠（1．08g，2次／d），C组加用坦度螺酮（10mg，3次／d），D组加用百乐眠（1．08g，2次／d）和坦度螺酮（10 mg ，3次／d），连续治疗12周。于治疗前及治疗后4，8，12周末监测血压，并采用HAMA及匹兹堡睡眠质量指数（PSQI）评定临床疗效，采用治疗不良反应量表（TESS）及实验室检查评价其安全性。结果从降压的有效率看，治疗后4周时，C、D组的有效率均高于A组，治疗后8周和12周时B、C、D组的有效率均高于A组；从HAMA的减分率看焦虑障碍改善的有效率，治疗后4周时B、C、D组的有效率均高于A组，治疗后8周和12周时B、C、D组有效率均高于A组，而且C、D组有效率均高于B组；从PSQI的减分率看睡眠障碍改善的有效率，治疗后4周、8周和12周时B、D组的有效率均高于A组，而且B、D组自身前后比较，发现治疗后12周时B、D组的有效率明显高于治疗后4周，治疗后8周和12周时C组有效率高于A组；治疗后12周时D组3项指标的有效率均高于A、B、C组，以上比较差异均有统计学意义（ P ＜0．05）。各组总的不良反应发生例数分别为A组15例、B组19例、C组16例、D组26例。结论百乐眠可以有效改善睡眠障碍，而且随着治疗时间的延长疗效更好；百乐眠可加强降压疗效并改善焦虑障碍；坦度螺酮可明显增强降压疗效并改善焦虑障碍；百乐眠联合坦度螺酮对高血压病伴焦虑障碍有很好的协同作用，联合使用比单用疗效高且起效快，而不良反应并无明显增加。

Effects and safety of Bailemian combined with tandospirone on hypertension patients with anxiety disorder

Objective To evaluate the efficacy and safety of Bailemian combined with tandospirone on hypertension patients with anxiety disorder .Methods Totals of 128 hypertension patients with anxiety disorder were randomly divided into 4 groups as A ,B ,C ,D .Every group received amlodipine 5 mg/d ,group A only received conventional anti -hypertension therapy ,group B received Bailemian 1 .08 g b .i .d ., group C received tandospirone 10 mg t .i .d .,group D received Bailemian 1 .08 g b .i .d .and tandospirone 10mg t .i .d .,all lasted for 12 weeks .Changes from baseline to 4 ,8 and 12 weeks in blood pressure , Hamilton Anxiety Scale (HAMA) and Pittsburgh Sleep Quality Index (PSQI) scores were measured to assess the effects .Treatment Emergent Symptom Scale (TESS) and laboratory tests were used to evalu‐ate the safety .Results The anti-hypertensive effective rates of group C and D were higher than group A at 4 weeks after treatment ,meanwhile which of group B ,C and D were higher than group A at 8 weeks and 12 weeks after treatment .Reduction rate of HAMA and PSQI reflected the improvement of anxiety disorder and dyssomnia separately .Reduction rates of HAMA scores of group B ,C and D were higher than group A at 4 weeks after treatment ,which of group B ,C and D were higher than group A , meanwhile ,which of group C、D were higher than group B .PSQI reduction rates of group B and D were higher than group A at 4 ,8 and 12 weeks after treatment ,which of group C were higher than group A at 8 and 12 weeks after treatment .It was found that the efficiency of treatment at 12 weeks was significant‐ly higher than that at 4 weeks after treatment in group B and D .Response rates for blood pressure ,HA‐MA and PSQI of group D was significantly higher than that of group A ,B and C at 12 weeks after treat‐ment .The differences in all comparison above were statistically significant (P< 0 .05) .The numbers of adverse recation were 15 in A group ,19 in B group ,16 in C group and 26 in D group .Conclusions Bail‐emian can effectively improve the sleep disorders and the curative effect is better with the extension of treatment .Bailemian can strengthen the anti -hypertensive efficacy and improve anxiety disorder ;tan‐dospirone can significantly enhance the anti -hypertensive effect and improvement of anxiety disorder ;synergistic effect of Bailemian with tandospirone is outstanding on hypertension patients with anxiety dis‐orders ,the efficiency and onset of combination is superior to that of anyone separately .No obviously in‐crease adverse reactions were found .