巴戟天寡糖胶囊治疗抑郁症的临床研究

Clinical trial of bajitian oligosaccharide capsules in the treatment of depression

目的观察巴戟天寡糖胶囊治疗抑郁症的临床疗效和安全性,及其对血清生化指标的影响。方法将86例抑郁症患者随机分为对照组43例和试验组43例。对照组予以口服草酸艾司西酞普兰片10 mg qd,1周后加量至20 mg qd;试验组予以口服巴戟天寡糖胶囊每次0.3 g bid。2组患者均治疗6周。比较2组患者的临床疗效、汉密尔顿抑郁量表(HAMD-17)评分、汉密尔顿焦虑量表(HAMA)评分、中医肾虚量表评分、血清生化指标,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为95.35%(41/43例)和81.40%(35/43例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的HAMD-17评分分别为(9.45±1.12),(14.25±1.25)分;HAMA评分分别为(7.68±1.04),(12.42±1.45)分;中医肾虚证量表评分分别为(15.32±2.12),(18.32±2.16)分;血清神经生长因子分别为(5.48±0.65),(6.37±1.28)ng·L^(-1);皮质醇分别为(387.62±152.41),(472.38±161.29)nmol·L^(-1);5-羟色胺分别为(3.68±1.50),(3.02±1.37)μmol·L^(-1);脑源性神经营养因子分别为(47.99±13.62),(42.03±12.15)ng·L^(-1),差异均有统计学意义(P<0.05)。2组患者的药物不良反应主要有恶心、口干、失眠、食欲不振、乏力,且试验组和对照组的药物不良反应发生率分别为16.28%和23.26%,差异无统计学意义(P>0.05)。结论巴戟天寡糖胶囊助于改善抑郁症患者临床症状,提高治疗效果,可能与降低血清神经生长因子和皮质醇含量,提高5-羟色胺水平及脑源性神经营养因子表达水平有关。

Objective To observe the clinical efficacy and safety of bajitian oligosaccharide capsules in the treatment of depression, and its effects on serum biochemical indexes. Methods A total of 86 patients with depression were randomly divided into control group and treatment group with 43 cases per group. Control group was given the escitalopram oxalate tablets 10 mg qd,after 1 week the dosage increased to 20 mg qd.Treatment group was given oral bajitian oligosaccharide capsule every 0. 3g bid. Two groups were treated for 6 weeks. The clinical efficacy,Hamilton depression scale（ HAMD- 17） score, Hamilton anxiety scale（ HAMA） score,and traditional Chinese medical（ TCM） kidney scale score, serum biochemical indexes, and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 95. 35%（ 41 /43 cases） and81. 40%（ 35 /43 cases） with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared：HAMD- 17 scores were（ 9. 45 ± 1. 12）,（ 14. 25 ± 1. 25） points; HAMA scores were（ 7. 68 ± 1. 04）,（ 12. 42 ± 1. 45） points; TCM kidney deficiency scores were（ 15. 32 ± 2. 12）,（ 18. 32 ± 2. 16） points; serum nerve growth factor were（ 5. 48 ± 0. 65）,（ 6. 37 ± 1. 28） ng·L^-1; cortisol were（ 387. 62 ± 152. 41）,（ 472. 38 ± 161. 29）nmol·L^-1; 5- hydroxytryptamine were（ 3. 68 ± 1. 50）,（ 3. 02 ± 1. 37） μmol·L^-1; brain derived neurotropic factor were（ 47. 99 ± 13. 62）,（ 42. 03 ± 12. 15） ng · L^-1,the differences were statistically significant（ P〈0. 05）. The adverse drug reactions in two groups were based on nausea,dry mouth,insomnia,loss of appetite,fatigue. And the incidences of adverse drug reactions were 16. 28% and 23. 26% without significant difference（ P〈0. 05）.Conclusion Bajitian oligosaccharide capsule helps to improve the clinical symptoms of depression patients and the therapeutic effect,which may be related to the decrease of nerve growth factor and serum cortisol levels and the increase of 5- HT levels of serotonin and brain- derived neurotropic factor expression.