Abstract:

Objective　To explore the effect of Tiaoren Tongdu acupuncture combined with Shugan Jieyu decoction for patients with insomnia and anxiety disorder. Methods　A total of 168 patients with insomnia and anxiety disorder (heart kidney disharmony) treated at Hanzhong Hospital of Traditional Chinese Medicine from January 2021 to June 2024 were selected for the randomized controlled trial, and were divided into groups A, B, C, and D by the random number table method, with 42 cases in each group. In group A, there were 18 males and 24 females; they were (55.12±9.63) years old; the duration of anxiety disorder was 22 (14, 31) months; the duration of insomnia was 34 (20, 48) months. In group B, there were 16 males and 26 females; they were (56.55±10.98) years old; the duration of anxiety disorder was 25 (14, 33) months; the duration of insomnia was 36 (21, 50) months. In group C, there were 15 males and 27 females; they were (54.64±9.27) years old; the duration of anxiety disorder was 24 (12, 32) months; the duration of insomnia was 34 (21, 51) months. In group D, there were 16 males and 26 females; they were (54.83±10.02) years old; the duration of anxiety disorder was 23 (15, 30) months; the duration of insomnia was 32 (20, 47) months. Group A were treated with conventional western medicine, group B with conventional western medicine and Shugan Jieyu decoction, group C with conventional western medicine and Tiaoren Tongdu acupuncture, and group D with conventional western medicine, Tiaoren Tongdu acupuncture, and Shugan Jieyu decoction. The scores of traditional Chinese medicine symptoms, Hamilton Anxiety Scale (HAMA), and Pittsburgh Sleep Quality Index (PSQI) and serum levels of 5-hydroxytryptamine (5-HT), norepinephrine (NE), and dopamine (DA) before and after the treatment, clinical efficacies, and occurrence of adverse reactions were compared between the two groups. Statistical analyses were performed using the χ² test, rank sum test, t test, one-way analysis of variance, SNK-q test, Kruskal-Wallis H test, and Mann-Whitney U test. Results　Six cases were excluded, and 162 were included, including 39 in group A, 41 in group B, 40 in group C, and 42 in group D. After the treatment, the scores of traditional Chinese medicine main symptoms, secondary symptoms, and tongue and pulse, total score of traditional Chinese medicine symptoms, scores of HAMA and PSQI, and serum levels of 5-HT, NE, and DA in group A were 7.92±1.25, 7.38±1.17 points, 2 (0, 2), 16.36±3.36, 9.62±1.42, 8.33±1.54, (133.06±18.74) g/L, (25.31±4.82) μg/L, and (394.49±72.32) mmol/L; those in group B were 7.02±1.06, 6.80±1.06, 1 (0, 2), 14.80±2.81, 8.76±1.31, 7.37±1.41, (145.11±20.36) g/L, (19.99±3.96) μg/L, and (343.19±59.63) mmol/L; those in group C were 6.95±1.03, 6.70±1.01, 1(0, 2), 14.60±2.75, 8.53±1.27, 7.45±1.36, (148.13±20.17) g/L, (20.05±4.03) μg/L, and (340.13±58.49) mmol/L; those in group D were 5.83±0.98, 5.74±0.96, 0(0, 1), 12.38±2.44, 7.02±1.12, 6.79±1.24, (162.74±22.55) g/L, (15.98±3.36) μg/L, and (318.53±50.17) mmol/L; after the treatment, the traditional Chinese medicine main symptom score, secondary symptom score, tongue and pulse score, total score, HAMA score, PSQI score, and serum levels of NE and DA were lower than those before the treatment in all the groups; those in groups B,C, and D were higher than those in group A (all P<0.05); those in group D were higher than those in groups B and C (all P<0.05). The total effective rates of groups A, B, C, and D were 76.92% (30/39), 85.37% (35/41), 87.50% (35/40), and 97.62% (41/42), respectively, and the total effective rate of group D was higher than that of group A (P<0.05). There was no statistical difference in the total incidence rate of adverse reactions between the 4 groups (P>0.05). Conclusion　On the basis of conventional western medicine, the effect and safety of applying Tiaoren Tongdu acupuncture and Shugan Jieyu decoction in the treatment of patients with insomnia and anxiety disorder (heart kidney disharmony) can relieve their symptoms and anxiety, improve their sleep quality, and regulate the serum levels of neurotransmitters.

Key words: Insomnia,  , Anxiety disorder,  , Tiaoren Tongdu , acupuncture,  , Shugan Jieyu , decoction,  , Neurotransmitters

摘要：

目的　探讨调任通督法针刺与疏肝解郁汤在失眠伴焦虑症中的应用效果。方法　采用前瞻性随机对照试验。选取2021年1月至2024年6月汉中市中医医院168例失眠伴焦虑症（心肾不交证）患者，随机数字表法分为A、B、C、D组，各42例。A组男18例、女24例，年龄（55.12±9.63）岁，焦虑症病程22（14，31）个月，失眠病程34（20，48）个月；B组男16例、女26例，年龄（56.55±10.98）岁，焦虑症病程25（14，33）个月，失眠病程36（21，50）个月；C组男15例、女27例，年龄（54.64±9.27）岁，焦虑症病程24（12，32）个月，失眠病程34（21，51）个月；D组男16例、女26例，年龄（54.83±10.02）岁，焦虑症病程23（15，30）个月，失眠病程32（20，47）个月。A组采用常规西医治疗，B组采用常规西医联合疏肝解郁汤治疗，C组采用常规西医联合调任通督法针刺治疗，D组采用常规西医、调任通督法针刺联合疏肝解郁汤治疗。比较各组治疗前后中医症状评分、汉密尔顿焦虑量表（HAMA）评分、匹兹堡睡眠质量指数（PSQI）评分、血清5-羟色胺（5-HT）、去甲肾上腺素（NE）、多巴胺（DA）水平；统计各组临床疗效及不良反应。采用χ²检验、秩和检验、t检验、单因素方差分析、SNK-q检验、Kruskal-Wallis H和Mann-Whitney U检验进行统计分析。结果　共排除6例患者，纳入162例，包括A组39例，B组41例，C组40例，D组42例。治疗后，A组中医症状主症评分、次症评分、舌脉象评分、总分、HAMA评分、PSQI评分和血清5-HT、NE、DA水平分别为（7.92±1.25）分、（7.38±1.17）分、2（0，2）分、（16.36±3.36）分、（9.62±1.42）分、（8.33±1.54）分、（133.06±18.74）g/L、（25.31±4.82）μg/L、（394.49±72.32）mmol/L，B组分别为（7.02±1.06）分、（6.80±1.06）分、1（0，2）分、（14.80±2.81）分、（8.76±1.31）分、（7.37±1.41）分、（145.11±20.36）g/L、（19.99±3.96）μg/L、（343.19±59.63）mmol/L，C组分别为（6.95±1.03）分、（6.70±1.01）分、1（0，2）分、（14.60±2.75）分、（8.53±1.27）分、（7.45±1.36）分、（148.13±20.17）g/L、（20.05±4.03）μg/L、（340.13±58.49）mmol/L，D组分别为（5.83±0.98）分、（5.74±0.96）分、0（0，1）分、（12.38±2.44）分、（7.02±1.12）分、（6.79±1.24）分、（162.74±22.55）g/L、（15.98±3.36）μg/L、（318.53±50.17）mmol/L；治疗后各组中医症状主症评分、次症评分、舌脉象评分、总分及HAMA评分、PSQI评分和血清NE、DA水平均低于治疗前，B、C、D组低于A组（均P<0.05），D组低于B、C组（均P<0.05）；血清5-HT水平高于治疗前，B、C、D组高于A组（均P<0.05），D组高于B、C组（均P<0.05）。A、B、C、D组总有效率分别为76.92%（30/39）、85.37%（35/41）、87.50%（35/40）、97.62%（41/42），D组总有效率高于A组（P<0.05）；A、B、C、D组不良反应总发生率比较，差异无统计学意义（P>0.05）。结论　在常规西医基础上应用调任通督法针刺与疏肝解郁汤治疗失眠伴焦虑症（心肾不交证）均可缓解症状，减轻焦虑情绪，改善睡眠质量，调节血清神经递质水平。

关键词: 失眠, 焦虑症, 调任通督法针刺, 疏肝解郁汤, 神经递质