摘要
【目的】观察中药珍珠母丸(珍珠母、龙齿、沉香、茯神、当归、熟地、党参、酸枣仁、柏子仁、水牛角)对负性生活事件所致失眠疗效的影响。【方法】采用随机数字表随机将121例患者分为治疗组(63例)和对照组(58例)。两组均给予赛乐特治疗,治疗组在此基础上加服珍珠母丸汤剂,两组疗程均为90 d。采用睡眠障碍量表(SDRS)和汉密尔顿焦虑量表(HAMA)进行评分,评价两组临床疗效及不良反应情况。【结果】治疗组显效22例,好转35例,无效6例,对照组显效13例,好转28例,无效17例,治疗组疗效优于对照组(P<0.01)。两组在治疗30、60、90 d和停药后2周的SDRS评分均较治疗前减少(P<0.01),且治疗组在治疗60、90 d和停药后2周的SDRS评分低于对照组(P<0.05或P<0.01)。两组在治疗30、90 d的HAMA评分也均较治疗前减少(P<0.01),但两组比较,差异均无统计学意义(P>0.05)。另外,治疗组的恶心、头晕等不良反应发生率较对照组少(P<0.01)。【结论】中药珍珠母丸能提高西药赛乐特治疗负性生活事件所致失眠的疗效,并能减少不良事件的发生。
[Objective] To observe the effect of Zhenzhumu Pill （mainly composed of Concha Margaritifera Usta, Dens Draeonis, Lignum Aquilariae Resinatum, Poria eum Radix Pini, Radix Angelieae Sinensis, Radix Rehmanniae Preparata, Radix Codonopsis, Semen Ziziphi Spinosae, Semen Platycladi, etc. ） on insomnia induced by negative life events. [Methods] One hundred and twenty-one insomnia patients were randomized into two groups. Groups A （ n = 63） and B （ n = 58） received paroxetine hydrochloride Tablets, and group A received decoction of Zhenzhumu Pill additionally. The treatment lasted 90 days. After treatment, sleeping dysfunction rating scale （SDRS） and the Hamilton anxiety scale （HAMA） were used to evaluate the therapeutic effect and adverse reactions. [Results] In group A, 22 patients were markedly effective, 35 effective, and 6 ineffective. In group B, 13 patients were markedly effective, 28 effective, and 17 ineffective （ P 〈 0.01 as compared with group B）. After 30-day, 60-day and 90-day treatment and 2 weeks after suspension of medication, SDRS scores were lower in groups A and B as compared with those before treatment （P 〈 0.01 ）, and those in group A after 60-day and 90-day treatment and 2 weeks after suspension were lower than those in group B （ P 〈 0.05 or P 〈 0.01 ）. HAMA scores in the two groups decreased after 30-day and 90-day treatment （ P 〈 0.01 as compared with those before treatment）, but the difference of HAMA scores between the two groups was insignificant （ P 〉 0.05）. Meanwhile, the incidence of adverse reactions such as nausea and vertigo was less in group A than that in group B （P 〈 0.01）. [Conclusion] Zhenzhumu Pill has a synergistic effect on paroxetine hydrochloride Tablets for insomnia induced by negative life events, and can reduce the incidence of adverse reactions.
出处
《广州中医药大学学报》
CAS
2007年第2期113-115,共3页
Journal of Guangzhou University of Traditional Chinese Medicine
