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皮肤瘙痒是终末期肾脏病(end-stage renal disease, ESRD)腹膜透析病人常见的并发症之一,导致焦虑、抑郁、睡眠障碍等,严重影响病人生活质量,研究[1]表明伴有瘙痒的ESRD病人死亡率明显升高。随着透析充分性的提高,ESRD病人瘙痒发生率有所下降,但仍维持在40%~50%[2]。针对ESRD病人瘙痒的治疗包括抗组胺药物、润肤液、止痒剂乳液、理疗等,也有研究[3]发现血液灌流能够改善ESRD病人瘙痒症状。氯雷他定是一种新型抗组胺药物,能够缓解瘙痒症状,安全性较高[4],统计发现一半以上的临床医生选择氯雷他定作为慢性瘙痒的一线用药,但疗效欠佳[5],也有研究[6]认为组胺水平在瘙痒发病机制中作用较小。加巴喷丁是一种新型抗癫痫药物,被用于神经痛的辅助治疗,瘙痒和神经痛有类似的发病机制,已有研究[7]发现加巴喷丁用于治疗血液透析病人皮肤瘙痒有较好的疗效,但在腹膜透析病人中相关研究较少,本研究评估加巴喷丁治疗腹膜透析病人皮肤瘙痒的疗效及安全性。现作报道。
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选取2018年7月至2020年7月我院腹膜透析中心明确诊断为ESRD并行维持性腹膜透析的病人,所有病人治疗>3个月,合并皮肤瘙痒[视觉模拟量表评分(visual analog scale, VAS)>4分],外用药、理疗无效。排除标准:除肾功能衰竭外导致皮肤瘙痒的系统性疾病。入选病人常规行腹膜透析治疗,研究开始前48 h所有病人停止应用缓解瘙痒药物。研究经我院医学伦理委员会审查批准。研究方案细节均向纳入对象告知,所有纳入对象表示理解并同意参加本研究。采用随机数字表法将病人随机分为观察组和对照组,观察组每日睡前口服加巴喷丁100 mg,对照组每晚睡前口服抗组胺药物氯雷他定10 mg。试验时间共计4周。入选病人50例,观察组和对照组各25例,对照组2例失访,实际完成观察组25例,对照组23例。2组性别、年龄、体质量以及透析时间差异无统计学意义(P>0.05)(见表 1),均具有可比性。
分组 n 男 女 年龄/岁 体质量/kg 透析时间/月 对照组 23 18 5 51.7±9.63 65.14±12.75 41.57±23.48 观察组 25 19 6 52.4±8.24 70.26±14.82 37.61±20.41 t — 0.54 0.27 1.28 0.62 P — >0.05 >0.05 >0.05 >0.05 *示χ2值 表 1 2组病人一般资料比较(x ±s)
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收集治疗前后病人血尿素氮、血肌酐、血红蛋白、Kt/V、血钙、血磷、甲状旁腺激素等实验室资料。瘙痒的严重程度由VAS、5-D瘙痒量表评价[8]。分别于0周、4周测量。VAS由10 cm标记0~10的水平直线组成,无瘙痒记为0,轻度瘙痒记为1~3分(间断性局部瘙痒,不影响工作和睡眠),中度瘙痒记为4~7分(持续大范围瘙痒,无睡眠障碍),重度瘙痒8~10分(持续大范围瘙痒,影响睡眠)。5-D瘙痒量表包含5方面:瘙痒程度、瘙痒持续时间、瘙痒变化趋势、瘙痒致功能障碍(包括睡眠、社交、工作、家务)、瘙痒部位。评分将5个维度的分数得出,相加得到总分,5分代表无瘙痒,25分代表最严重的瘙痒。分别记录药物不良反应。
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采用χ2检验和t检验。
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2组病人治疗前后血尿素氮、血肌酐、血红蛋白、Kt/V、血钙、血磷、甲状旁腺激素水平比较差异均无统计学意义(P>0.05)(见表 2)。观察组中24 h尿量>400 mL 4例,100~400 mL 12例, < 100 mL 9例。
分组 n 血尿素氮/ (mmol/L) 血肌酐/ (μmol/L) 血红蛋白/ (g/L) Kt/V 血钙/ (mmol/L) 血磷/ (mmol/L) 甲状旁腺激素/ (pg/mL) 治疗前 对照组 23 20.37±4.57 1 048.54±298.57 105.28±20.59 1.35±0.21 2.12±0.23 1.56±0.24 322.59±98.47 观察组 25 19.24±5.78 1 023.79±351.81 101.39±18.47 1.24±0.19 2.21±0.19 1.62±0.18 319.48±108.91 t — 0.75 0.26 0.69 1.91 1.48 0.99 0.10 P — >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 治疗后 对照组 23 20.74±3.65 1 026.20±161.55 100.40±6.19 1.35±0.11 2.18±0.21 1.58±0.22 395.80±64.33 观察组 25 21.68±3.43 962.20±90.98 99.20±10.18 1.34±0.13 2.16±0.11 1.60±0.09 389.20±53.20 t — 0.42 0.77 0.23 0.06 0.19 0.17 0.18 P — >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 表 2 对照组和观察组病人治疗前后实验室指标比较(x ±s)
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2组治疗前VAS评分及5-D瘙痒量表评分比较差异无统计学意义(P>0.05),治疗后观察组VAS评分及5-D瘙痒量表评分均低于对照组(P < 0.05)(见表 3)。
分组 n VAS评分 5-D瘙痒量表评分 治疗前 对照组 23 7.30±1.84 17.40±6.50 观察组 25 7.10±1.90 21.60±2.51 t — 0.37 0.55 P — >0.05 >0.05 治疗后 对照组 23 6.80±2.07 21.18±1.76 观察组 25 2.20±1.10 10.00±1.22 t — 5.19 9.29 P — < 0.05 < 0.05 表 3 治疗前后2组VAS及5-D瘙痒量表评分比较(x ±s;分)
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对照组4例出现嗜睡,观察组6例病人出现乏力和嗜睡,均未作处理症状自行缓解,无一人出现中止治疗。观察组中24 h尿量>400 mL、100~400 mL、 < 100 mL病人分别有1例、3例、2例出现乏力和嗜睡,亚组间不良反应发生率差异无统计学意义(χ2=0.02,P>0.05)。
加巴喷丁治疗腹膜透析病人皮肤瘙痒的疗效及安全性观察
Efficacy and safety of gabapentin in the treatment of pruritus in peritoneal dialysis patients
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摘要:
目的 观察加巴喷丁治疗腹膜透析病人皮肤瘙痒的疗效及安全性。 方法 采用随机对照研究,选取腹膜透析伴瘙痒病人,随机分为对照组和观察组。对照组23例,每晚睡前口服抗组胺药物氯雷他定10 mg,观察组25例,每日睡前口服加巴喷丁100 mg。4周后根据视觉模拟评分(VAS)、5-D瘙痒量表评分观察疗效,记录不良反应。收集治疗前后病人血尿素氮、血肌酐、血红蛋白、Kt/V、血钙、血磷、甲状旁腺激素等实验室检查结果。 结果 治疗后观察组VAS评分及5-D瘙痒量表评分较对照组下降(P < 0.05)。对照组4例出现嗜睡,观察组6例出现乏力和嗜睡,均未作处理症状自行缓解,无一例出现严重并发症而中止治疗。观察组中24 h尿量>400 mL、100~400 mL、 < 100 mL病人组间不良反应发生率差异均无统计学意义(P>0.05)。 结论 加巴喷丁对于腹膜透析伴瘙痒病人改善瘙痒症状有较好的疗效,小剂量每日应用是一种较安全的给药方式。 Abstract:Objective To observe the efficacy and safety of gabapentin in the treatment of pruritus in peritoneal dialysis patients. Methods A randomized controlled trial was performed. Peritoneal dialysis patients with pruritus were selected and randomly divided into experimental group and control group. Twenty-three patients in the control group received loratadine 10 mg orally before sleep every night, while 25 patients in the experimental group received gabapentin 100 mg orally before sleep every day. After 4 weeks, efficacy was observed according to visual analog score(VAS) and 5-D pruritus scale score, and adverse reactions were recorded. Laboratory data such as blood urea nitrogen, blood creatinine, hemoglobin, Kt/V, blood calcium, blood phosphorus and parathyroid hormone of patients before and after treatment were collected. Results After treatment, VAS score and 5-D pruritoneal scale score in the experimental group decreased compared with the control group, and the differences were statistically significant(P < 0.05). Four cases in the control group showed drowsiness and 6 cases in the experimental group showed fatigue and drowsiness, all of which were relieved without any treatment, and none of them developed serious complications that led to discontinuation of treatment. There was no significant difference in the incidence of adverse reactions among patients with 24 h urine volume >400 mL, 100-400 mL and < 100 mL in the observation group(P>0.05). Conclusions Gabapentin is effective in improving pruritus in patients with peritoneal dialysis complicated with pruritus and small-dose daily administration is a safe way for using. -
Key words:
- peritoneal dialysis /
- gabapentin /
- pruritus
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表 1 2组病人一般资料比较(x ±s)
分组 n 男 女 年龄/岁 体质量/kg 透析时间/月 对照组 23 18 5 51.7±9.63 65.14±12.75 41.57±23.48 观察组 25 19 6 52.4±8.24 70.26±14.82 37.61±20.41 t — 0.54 0.27 1.28 0.62 P — >0.05 >0.05 >0.05 >0.05 *示χ2值 表 2 对照组和观察组病人治疗前后实验室指标比较(x ±s)
分组 n 血尿素氮/ (mmol/L) 血肌酐/ (μmol/L) 血红蛋白/ (g/L) Kt/V 血钙/ (mmol/L) 血磷/ (mmol/L) 甲状旁腺激素/ (pg/mL) 治疗前 对照组 23 20.37±4.57 1 048.54±298.57 105.28±20.59 1.35±0.21 2.12±0.23 1.56±0.24 322.59±98.47 观察组 25 19.24±5.78 1 023.79±351.81 101.39±18.47 1.24±0.19 2.21±0.19 1.62±0.18 319.48±108.91 t — 0.75 0.26 0.69 1.91 1.48 0.99 0.10 P — >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 治疗后 对照组 23 20.74±3.65 1 026.20±161.55 100.40±6.19 1.35±0.11 2.18±0.21 1.58±0.22 395.80±64.33 观察组 25 21.68±3.43 962.20±90.98 99.20±10.18 1.34±0.13 2.16±0.11 1.60±0.09 389.20±53.20 t — 0.42 0.77 0.23 0.06 0.19 0.17 0.18 P — >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 >0.05 表 3 治疗前后2组VAS及5-D瘙痒量表评分比较(x ±s;分)
分组 n VAS评分 5-D瘙痒量表评分 治疗前 对照组 23 7.30±1.84 17.40±6.50 观察组 25 7.10±1.90 21.60±2.51 t — 0.37 0.55 P — >0.05 >0.05 治疗后 对照组 23 6.80±2.07 21.18±1.76 观察组 25 2.20±1.10 10.00±1.22 t — 5.19 9.29 P — < 0.05 < 0.05 -
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