舒肝解郁胶囊治疗寻常型银屑病的临床研究

Clinical trial of Shuganjieyu capsules in the treatment of psoriasis vulgaris

目的观察舒肝解郁胶囊治疗寻常型银屑病的临床疗效及安全性。方法将60例进展期寻常型银屑病患者随机分成对照组30例和试验组30例,另取健康志愿者30例作为健康对照组。对照组予以口服复方甘草酸苷片每次50 mg tid,外用卤米松/三氯生乳膏和卡泊三醇软膏涂擦于患处,bid。试验组在对照组治疗的基础上,予以口服舒肝解郁胶囊每次0.72 g tid。2组患者1个疗程均为4周,共治疗4个疗程。比较2组患者的临床疗效和药物不良反应的发生情况。并比较3组患者的汉密尔顿抑郁量表(HAMD)评分、汉密尔顿焦虑量表(HAMA)评分、血清中去甲肾上腺素(NE)、多巴胺(DA)及5-羟色胺(5-HT)的含量。结果治疗后,试验组和对照组的总有效率分别为96.67%(29/30例)和66.67%(20/30例),差异有统计学意义(P<0.01)。治疗前,试验组、对照组和健康对照组的HAMD评分分别为(21.55±5.62),(20.93±5.57),(8.18±1.98)分;HAMA评分分别为(17.69±4.78),(18.04±4.14),(7.44±2.12)分;NE分别为(6.95±2.31),(6.78±2.26),(2.09±1.11)μg·g^(-1);DA分别为(8.02±2.22),(8.16±2.31),(4.68±1.34)μg·g^(-1);5-HT分别为(62.67±21.18),(61.88±21.55),(21.15±8.66)μg·g^(-1),试验组、对照组的上述指标与健康对照组比较差异均有统计学意义(P<0.01)。治疗后,试验组和对照组的HAMD评分分别为(13.46±3.65),(18.89±3.86)分;HAMA评分分别为(10.75±2.83),(16.64±3.59)分;NE分别为(3.25±2.16),(4.78±1.32)μg·g^(-1);DA分别为(4.65±1.42),(6.88±2.19)μg·g^(-1);5-HT分别为(32.34±10.95),(46.65±20.26)μg·g^(-1),差异均有统计学意义(P<0.01)。试验组和对照组治疗期间未发生药物不良反应。结论舒肝解郁胶囊治疗寻常型银屑病的临床疗效显著,能有效改善患者的精神状态,调节外周血单胺类神经递质水平,且安全性较高。

Objective To observe the clinical efficacy and safety of Shuganjieyu capsules in the treatment of psoriasis vulgaris. Methods Sixty patients with progressive psoriasis vulgaris were randomly divided into control group and treatment group with 30 cases per group,and 30 healthy volunteers as healthy control group. The control group was given orally compound glycyrrhizin tablets 50 mg tid,halogen topical betamethasone /triclosan cream and calcipotriol ointment rubbed on the affected area bid.Treatment group was treated with Shuganjieyu capsules 0. 72 g tid oral,on the basis of control group. Two groups were treated for 4 courses with4 weeks per course. The clinical efficacy and adverse drug reactions were compared between two groups. The Hamilton Depression Scale（ HAMD） score,Hamilton Anxiety Scale（ HAMA） score and the levels of serum norepinephrine（ NE）,dopamine（ DA） and 5- hydroxytryptamine（ 5- HT） were compared between three groups. Results After treatment,the total effective rates in treatment and control groups were 96. 67%（ 29 /30 cases） and 66. 67%（ 20 /30 cases） with statistically significant difference（ P〈0. 01）. Before treatment,the main indexes in treatment,control and health control groups were compared： HAMD scores were（ 21. 55 ± 5. 62）,（ 20. 93 ± 5. 57）,（ 8. 18 ± 1. 98） points; HAMA scores were（ 17. 69 ±4. 78）,（ 18. 04 ± 4. 14）,（ 7. 44 ± 2. 12） points; NE were（ 6. 95 ± 2. 31）,（ 6. 78 ± 2. 26）,（ 2. 09 ± 1. 11）μg·g^-1; DA were（ 8. 02 ± 2. 22）,（ 8. 16 ± 2. 31）,（ 4. 68 ± 1. 34） μg · g^-1; 5- HT were（ 62. 67 ± 21. 18）,（ 61. 88 ±21. 55）,（ 21. 15 ±8. 66） μg·g^-1,with significant difference（ P〈0. 01）. After treatment,the main indexes in treatment and control groups were compared： HAMD scores were（ 13. 46 ± 3. 65）,（ 18. 89 ± 3. 86） points; HAMA scores were（ 10. 75 ± 2. 83）,（ 16. 64 ± 3. 59） points; NE were（ 3. 25 ± 2. 16）,（ 4. 78 ± 1. 32） μg · g^-1; DA were（ 4. 65 ±1. 42）,（ 6. 88 ±2. 19） μg·g^-1; 5- HT were（ 32. 34 ± 10. 95）,（ 46. 65 ± 20. 26） μg·g^-1,with statistically significant difference（ P〈0. 01）. There was no adverse drug reactions occurred in treatment and control groups.Conclusion Shuganjieyu capsule has a definitive clinical efficacy and safety for the treatment of psoriasis vulgaris,which can improve the patient＇s mental state,and improve peripheral monoamine neurotransmitter levels.