目的探讨疏肝解郁胶囊联合文拉法辛治疗抑郁症合并功能性消化不良的临床疗效和安全性。方法选取2014年1月-2015年2月于新疆阿克苏地区第一人民医院接受治疗的160例抑郁症合并功能性消化不良患者作为研究对象,按随机数字表法分为两组,每组各80例。对照组常规治疗基础上给予文拉法辛(75 mg/次,口服,1次/d),观察组在对照组基础上联合应用疏肝解郁胶囊(4粒/次,口服,3次/d)。6周后,比较对照组和观察组患者功能性消化不良的临床疗效与不良反应、临床症状积分及血清IL-6水平。随访6个月,比较组间复发率。结果观察6周,观察组总有效率高于对照组(93.8%vs 81.2%,P<0.05),观察组患者腹胀、腹痛、早饱、恶心呕吐等症状积分较对照组降低[(1.0±0.3)分vs(1.7±0.6)分;(0.9±0.2)分vs(1.8±0.5)分;(0.8±0.2)分vs(1.5±0.4)分;(1.1±0.3)分vs(2.0±0.5)分],血清IL-6水平明显下降[(75.38±10.72)pg/ml vs(81.26±12.25)pg/ml],组间比较差异均有统计学意义(P<0.05)。随访6个月,观察组的复发率明显低于对照组(2.5%vs 17.5%,P<0.05)。治疗过程中,所有患者均未发生严重不良反应,且对照组和观察组不良反应的发生率大体相似(15.0%vs 10.0%,P>0.05)。结论疏肝解郁胶囊联合文拉法辛治疗抑郁症合并功能性消化不良,能降低患者血清IL-6水平,提高临床疗效和减少疾病复发率,不良反应轻微,值得临床应用。 Objective To investigate the clinical efficacy and safety of Shugan Jieyu capsule combined with venlafaxine in the treatment of depression and functional dyspepsia. Methods One hundred and sixty patients with functional dyspepsia who were treated in First People’s Hospital of Aksu, Xinjiang from January 2014 to February 2015 were selected as subjects and divided into two groups according to random number table example. The control group was given venlafaxine (75 mg / time, once a day, d) on the basis of conventional treatment. The observation group was given Shugan Jieyu Capsule (4 capsules / time, orally, 3 times / d). Six weeks later, the clinical efficacy and adverse reactions, clinical symptom scores and serum IL-6 levels in patients with functional dyspepsia were compared between the control group and the observation group. Followed up for 6 months, compared the recurrence rate between groups. Results The total effective rate in the observation group was significantly higher than that in the control group (93.8% vs 81.2%, P <0.05) after 6 weeks of observation. The scores of abdominal distension, abdominal pain, early satiety and nausea and vomiting in the observation group were lower than those in the control group [(1.0 ± 0.3 ) Vs (1.7 ± 0.6) vs (0.9 ± 0.2) vs (1.8 ± 0.5) vs (0.8 ± 0.2) vs (1.5 ± 0.4) vs (1.1 ± 0.3 vs 2.0 ± 0.5) (P <0.05). There was a significant difference between the two groups (P <0.05). The level of IL-6 in serum was significantly decreased [(75.38 ± 10.72) pg / ml vs (81.26 ± 12.25) pg / ml] The follow-up of 6 months showed that the recurrence rate of the observation group was significantly lower than that of the control group (2.5% vs 17.5%, P <0.05). During the course of treatment, no serious adverse reactions occurred in all patients, and the incidence of adverse reactions in the control group and observation group was similar (15.0% vs 10.0%, P> 0.05). Conclusion Shugan Jieyu capsule combined with venlafaxine in the treatment of depression combined with functional dyspepsia can reduce serum IL-6 level, improve clinical efficacy and reduce the incidence of disease recurrence, with mild adverse reactions, which is worthy of clinical application.