CN104491039B - 一种用于治疗痛风急性发作的药物组合物及其制备方法和应用 - Google Patents
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Abstract
本发明涉及一种用于治疗痛风急性发作的药物组合物及其制备方法和应用，其药物组合物的组分为：新癀片、黄马酊、槐花蜂蜜。经临床实验证实新癀片联合黄马酊和槐花蜂蜜外敷治疗痛风急性发作的效果佳，明显优于单用一种药物。
Description
技术领域
人类生活必需 本产品属于药物用途发明领域。
背景技术
痛风是由于嘌呤代谢紊乱导致血尿酸增加，伴有结缔组织内尿酸结晶沉着为特征的疾病。临床上以高尿酸血症、特征性急性关节炎反复发作和痛风结石形成为特点，严重者可致关节畸形、活动障碍，肾尿酸结石或痛风肾病。痛风急性发作起病急骤，躲在夜间突发，以第一跖趾关节多见，发作时关节红肿热痛，疼痛剧烈难忍，给病人带来很大痛苦。近年来，随着经济的发展和生活水平的提高，高蛋白、高嘌呤食物摄入量的增加，痛风的发病率不断上升。正确积极的治疗可缩短发作期，减轻患者痛苦。
目前临床上用于治疗痛风急性发作的药物主要分为三种：1、秋水仙碱：是治疗急性痛风性关节炎的特效药物，能抑制嗜中性粒细胞活性，抑制络氨酸磷酸化减轻尿酸结晶沉积，止痛效果快。但副作用多，毒性大：肾功能欠佳者易中毒。与他汀类降脂药引起急性肌病。严重的胃肠道反应。2、非甾体抗炎药：其共同作用机制为抑制花生四烯酸代谢中的环氧化酶活性，进而抑制前列腺素的合成而达到消炎镇痛的作用。应用时需注意活动性消化性溃疡、消化道出血等禁忌症。3、糖皮质激素：该类药物特点是起效快，缓解率高，但容易出血症状的“反跳”现象。以上药物用于痛风急性发作的治疗安全性和耐受性相对较差。虽然随着中药的发展，许多口服中药方剂或中成药给缓解痛风带来了希望，但具有治疗时间长，操作不方便，价格成本高等缺点。因此研究出更高效而毒副作用更小的药物，已成为临床医师和医药界的共同愿望。
本发明通过临床实验发现新癀片联合黄马酊和槐花蜂蜜持续外敷患处，能快速消肿止痛、缓解症状，未发现明显毒副作用，搽涂操作简便，价格低廉。这一研究成果在国内外还未见报道，应用于临床，必将产生巨大的社会和经济效益。
发明内容
本发明对急性痛风患者在常规治疗的基础之上，采用新癀片联合黄马酊和槐花蜂蜜外敷患处辅助治疗，解决了目前临床上口服药物毒副作用大，耐受性差的缺点，给急性痛风性关节炎的治疗提供了一条全新的有效途径。
本发明内容包括新癀片、黄马酊和槐花蜂蜜这一药物组合物的制备方法，及其治疗痛风急性发作的临床观察。黄马酊由75%酒精加黄连、圣马前子（碎）制成，具有清热解毒、燥湿泻火，活血化瘀，消肿止痛等功效。患者在常规治疗的基础上，加用新癀片和黄马酊及槐花蜂蜜持续外敷患处，局部红肿消退天数明显缩短，疼痛显著减轻，住院天数减少，治疗效果佳。
具体实施方式：
本发明通过临床观察，将我院2012年2月-2013年8月的30例急性痛风患者，采用新癀片联合黄马酊和槐花蜂蜜外敷辅助治疗，证实患者关节红肿疼痛明显减轻，疗效佳。具体实施方案如下：
1.临床资料：
1.1一般资料：选择上述时期本院收治的痛风患者90例，年龄31-80岁，均符合美国风湿病协会1997年制订的急性痛风性关节炎诊断标准；有21例为第1次发作，其他均为2次以上发作。单侧跖趾关节红肿热痛54例，累计踝关节34例，累及膝关节12例。随机分为对照组，新癀片治疗组和新黄蜂治疗组各30例，3组一般情况具有可比性。
1.2方法：对照组采用常规方法治疗，包括：要求卧床休息；禁食嘌呤类含量高的食物；戒烟酒，多饮水，小苏打碱化尿液；根据辩证给服中成药痛风定片。新癀片治疗组在对照组治疗基础上单用新癀片外敷，先用生理盐水把新癀片4-6片软化，调成糊状，再用棉棒均匀涂于患处，每日1次，7-14日后观察疗效。新黄蜂治疗组在对照组治疗基础上，再用新黄蜂外敷，将新癀片、黄马酊和槐花蜂蜜按一定比例调成糊状后，均匀涂于患处，每日1次，7-14日后观察疗效。
1.3 治疗前后检测血尿酸，评定VAS疼痛评分；比较三组临床总疗效。
1.4疗效评价标准：根据《中医病症诊断疗效标准》有关“痛风”的疗效标准评定，治愈：关节发作次数为0，肿胀、疼痛消失，活动正常，尿酸降至正常范围。有效：关节发作次数<3次，关节肿胀、疼痛缓解，关节活动基本恢复，尿酸接近正常。无效：关节发作次数>3次，肿胀、疼痛症状改变不明显，活动仍受影响，尿酸水平未下降。
1.5统计方法：应用 SPSS13.0软件包进行统计分析，计量资料以±s表示，采用X2检验和t检验。
2.结果：
2.1 总疗效比较：随访1年，结果显示新黄蜂治疗组治愈病例24例，无效1例；新癀片治疗组治愈病例21例，无效4例；对照组治愈病例16例，无效7例。三组差异有统计学意义（P <0.05）。
表1.三组总疗效比较 （n）
| 组别 | n | 治愈 | 有效 | 无效 | 总有效率（%） |
| 对照组 | 30 | 16 | 7 | 7 | 76.67 |
| 新癀片治疗组 | 30 | 21* | 5* | 4* | 86.67 |
| 新黄蜂治疗组 | 30 | 24*# | 5*# | 1*# | 96.67 |
注：与对照组比* P <0.05,与新癀片治疗组比 # P <0.05
2.2 治愈病例的相关比较 新黄蜂治疗组治愈24例，住院时间4-7天，局部红肿消退天数2-4天，VAS评分降至0分天数2-5天；新癀片治疗组治愈21例；住院时间5-9天，局部红肿消退天数3-7天，VAS评分降至0分天数3-7天；对照治愈16例，住院时间7-12天，局部红肿消退天数3-9天，VAS评分降至0分天数4-10天 （P <0.05）。
表2.三组治愈病例相关比较 （±s，d）
| 组别 | n | 住院天数 | 红肿消退时间 | VAS 0分时间 |
| 对照组 | 30 | 3.82±1.16 | 2.84±1.02 | 2.82±2.03 |
| 新癀片治疗组 | 30 | 5.77±1.73* | 3.41±2.12* | 4.37±1.69* |
| 新黄蜂治疗组 | 30 | 8.40±3.15*# | 5.85±2.56*# | 6.14±2.83*# |
注：与对照组比* P <0.05,与新癀片治疗组比 # P <0.05
本发明的优点在于：
1、首次发现新癀片联合黄马酊和槐花蜂蜜外敷治疗痛风急性发作疗效好，优于单一用药。
2、此药物组合物价格低廉，治疗方式简便，有助于解决目前临床上口服别嘌醇、秋水仙碱副作用大等缺点，给痛风急性发作的治疗提供了一条全新的有效途径。
Claims (1)
1.一种治疗痛风急性发作的药物组合物，其特征在于，由以下药物组成：新癀片，黄马酊，槐花蜂蜜；
所述新癀片、黄马酊、槐花蜂蜜的重量比为10：40-60：20-40。
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