普瑞巴林胶囊联合甲钴胺注射剂治疗尿毒症透析致皮肤瘙痒的临床研究

Clinical trial of pregabalin capsules combined with mecobalamin injection in the treatment of itchy shin caused by uremia dialysis

目的观察普瑞巴林胶囊联合甲钴胺注射剂治疗尿毒症透析致皮肤瘙痒的临床疗效及安全性。方法将64例尿毒症透析致皮肤瘙痒患者随机分为对照组32例和试验组32例。对照组予以甲钴胺每次0.5 mg,qd,静脉注射;试验组在对照组治疗的基础上,予以普瑞巴林每次75 mg,于透析当晚口服。2组患者均治疗8周。比较2组患者的临床疗效、血清全段甲状旁腺激素(iPTH)、血磷和β2-微球蛋白(β_2-MG)水平、视觉模拟评分法(VAS)评分,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为90.63%(29例/32例)和75.00%(24例/32例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的iPTH分别为(113.18±7.36)和(216.21±26.65)ng·L^(-1),血磷分别为(1.89±0.18)和(2.33±0.25)mmol·L^(-1),β_2-MG分别为(6.80±0.73)和(11.28±1.07)mg·L^(-1),VAS评分分别为(3.22±2.55)和(5.59±1.78)分,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有嗜睡、视力模糊、头晕、体重增加、血小板减少和便秘,对照组的药物不良反应主要有便秘和嗜睡。试验组和对照组的总药物不良反应发生率分别为25.00%和9.37%,差异无统计学意义(P>0.05)。结论普瑞巴林胶囊联合甲钴胺注射剂治疗尿毒症透析致皮肤瘙痒的临床疗效确切,其能显著降低患者的iPTH、血磷及β_2-MG水平,且不增加药物不良反应的发生率。

Objective To observe clinical efficacy and safety of pregabalin capsules combined with mecobalamin injection in the treatment of itchy shin caused by uremia dialysis. Methods Sixty-four patients with uremia dialysis caused itchy shin were randomly divided into control group and treatment group with 32 cases per group. Control group was treated with mecobalamine 0. 5 mg per time,qd,intravenous infusion.Treatment group was treated with pregabalin 75 mg per time,oral administration on dialysis night,on the basis of control group. Two groups were treated for 8 weeks. The clinical efficacy,serum intact parathyroid hormone（ iPTH）,blood phosphorus and β2-microglobulin（ β_2-MG）,visual analogue scale（ VAS） score and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 90. 63%（ 29 cases/32 cases）and 75. 00%（ 24 cases/32 cases） with significant difference（ P 〈0. 05）.After treatment,the main indexes in treatment and control groups were compared： iPTH were（ 113. 18 ± 7. 36） and（ 216. 21 ± 26. 65） ng·L^（-1）,blood phosphorus were（ 1. 89 ± 0. 18） and（ 2. 33 ± 0. 25） mmol·L^（-1）,β_2-MG were（ 6. 80 ± 0. 73） and（ 11. 28 ± 1. 07） mg·L^（-1）,VAS scores were（ 3. 22 ± 2. 55） and（ 5. 59 ± 1. 78） points,the differences were statistically significant（ all P〈 0. 05）. The adverse drug reactions in treatment group were lethargy,blurred vision,dizziness,weight gain,thrombocytopenia and constipation,which in control group were constipation and lethargy. The incidences of adverse drug reactions in treatment and control groups were 25. 00% and 9. 37%without significant difference（ P〉 0. 05）. Conclusion Pregabalin capsules combined with mecobalamin injection have a definitive clinical efficacy in treatment of uremia dialysis caused itchy shin,which can significantly reduce the levels of iPTH,blood phosphorus and β_2-MG,without increasing the incidence of adverse drug reaction.