盐酸文拉法辛对慢性紧张性头痛患者生活质量的影响

Influence of venlafaxine hydrochloride on the quality of life in patients with chronic tension headache

目的:用萘普生作为对照评价盐酸文拉法辛对慢性紧张性头痛患者生活质量的影响。方法:选择2002-11/2004-08四川大学华西医院、昆明医学院第一附属医院和重庆医科大学附属第一医院就诊的慢性紧张性头痛患者123例,随机分为试验组61例或对照组62例,试验组服用盐酸文拉法辛胶囊25mg/次,2次/d,对照组服用萘普生片,2片/次,2次/d,服药时间均为14d。服药前及服药后第2,5,7,10,14天观察并记录生活质量评分(日常生活、日常工作、睡眠、情绪),试验结束后比较生活质量改善情况,改善率(%)=(治疗前总分-治疗后总分)/治疗前总分×100%。疗效判定:临床控制:改善率≥90%。显效:改善率≥50%,<90%。进步:改善率≥20%,<50%。无效:改善率<20%或无改变或较疗前更差。显效与有效合计为有效。结果:试验组失访1例,对照组失访3例,进入结果分析患者119例,试验组60例,对照组59例。①试验组临床控制率为38%、总有效率为70%,获益率为90%;对照组临床控制率为31%、总有效率为59%,获益率为81%。两组有效率比较,差异无显著性意义(QCMH=1.7230,P=0.1893),两组获益率比较,差异无显著性意义(QCMH=1.8298,P=0.1762),按意向性分析,治疗后两组生活质量改善方面差异有显著性意义(Z=-4.6268,P<0.0001)。②各时点两组间生活质量积分比较差异均无显著性。③治疗后第14天试验组与对照组比较在睡眠控制方面差异有显著性(1.17±1.70,1.95±2.25,t=-2.14,P=0.0344);在治疗后的第10天情绪控制方面,两组差异有显著性(1.73±1.73,2.53±2.04,t=-2.29,P=0.0238)。说明试验组在睡眠和情绪控制上疗效明显优于对照组,但在其他各时点治疗后日常生活、日常工作、睡眠及情绪评分比较两组间差异无显著性。结论:盐酸文拉法辛对慢性紧张性头痛患者的生活质量有一定的改善作用,总的结果与萘普生相似。

AIM： To evaluate the effec, t of venlafaxine hydrochloride on the quality of life （QOL） in patients with chronic tension headache by taking naproxen as a control. METHODS： Totally 123 cases of chronic tensiun headache patients, who were treated respectively in the West China Hospital of Sichuan University, the First Affiliated Hospital of Kunming Medical College and the First Affiliated Hospital of Chongqing University of Medical Sciences form November 2002 to August 2004, were randomly divided into the test group （n=61） and control group （n=62）. Patients in the test group look venlafaxine hydrochloride capsules, 25 mg for each time arid twice a day, while those in the control group took naproxen pills, 2 pills for each time （0.2 g） and twice a day, the medication lasted for 14 days in both groups. The scores of QOL （daily life, daily work, sleep and mood） of both groups were observed, recorded and evaluated before medication and on the 2^th, 5^th, 7^th, 10^th and 14^th days after medication, and the life quality improvcmeat ratios were compared .after the test. The improvement ratio （%） = （pre-treatment total score - post-treatment total score）/pre-treatment total score ×100%. Therapeutic effect identification： improvement ratio ≥90% as clinical control; 90% 〉 improvement ratio ≥ 50% as obvious eftect; 50% 〉 improvement ratio ≥ 20% as progressed effect; improvement ratio 〈 20% or no change or worse as ineffective. The obvious effect and effective were considered as effective together. RESULTS： One case in the test group and 3 cases in the control group lost to the tollow-up. Finally 119 patients entered the analysis of results with 60 cases in the test group and 59 cases in the coatrol group. （1） In the test group, the clinical control ratio was 38%, the total effective ratio was 70%, arid the beneficial ratio was 90%; in the control gronp, the clinical control ratio was 31%, the total effective ratio was 59%, and the beneficial ratio was 81%. The effective ratio and beneficial ratio were insignifieandy different between the two groups （QCMH =1.723 0, P=0.1893; QCMH=1.829 8, P=0.176 2）. According to the inteution-to-treat analysis, there was significant difference in the improvement of post treatment QOL between tire two groups （Z=-4.626 8, P 〈 0.000 1）. C23 There were no significant differences in the QOL scores at each time point between the two groups. （3） On thc 14th day after treatment, the score of sleep control was significantly different between the test group and control group （1.17±1.70, 1.95±2.25, t=-2.14, P=0.034 4）; on the 10^th day after treatment, the score of mood control was also significantly different between the test group and control group （1.73±1.73, 2.53±2.04, t=-2.29, P=0.023 8）. It was indicated that, the curative effects on sleep and mood control in the test group were obviously better than those in the control group, but the scores of daily life, daily work, sleep and mood at other time points had insignificant differences between the twit groups. CONCLUSION： Venlafaxine hydrochloride has a certain improving effect on the QOL of patients with chronic tension headache, and the total results are similar to those of naproxen.