CN116421693A - 参苓白术在治疗新型冠状病毒感染患者愈后精神神经症状中的应用 - Google Patents
参苓白术在治疗新型冠状病毒感染患者愈后精神神经症状中的应用 Download PDFInfo
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Abstract
本发明提供参苓白术在制备治疗新型冠状病毒感染患者愈后的精神神经症状的药物中的应用。
Description
技术领域
本发明属于医学和中医学领域，具体涉及参苓白术在治疗新型冠状病毒感染患者预后精神神经症状中的应用。
背景技术
参苓白术散出自宋朝《太平惠民和剂局方》，是“培土生金”的代表方，方中人参、白术及茯苓健脾益肺燥湿，为君药；山药、莲子、白扁豆并薏苡仁健脾渗湿止泻，为臣药；砂仁醒脾化湿，桔梗宣肺利气、载药上行，均为佐药；炒甘草健脾和中为使，全方补脾益肺、渗湿止泻，常用于肺系及脾胃系疾病，症见体倦乏力，食少便溏等。临床上应用的参苓白术制剂包括丸剂、散剂、颗粒剂和胶囊剂。
新型冠状病毒感染(Corona Virus Disease 2019,COVID-19，以下亦可简称“新冠感染”)。绝大多数感染者虽然能够达到临床治愈的标准，但是在急性感染期过后，尽管病毒核酸检测已经转阴，却持续出现一系列后遗症状，包括乏力、咳嗽、气短、纳呆、低热、盗汗、便秘或腹泻、胸闷、心悸、慢性出血、失眠、焦虑或抑郁状态、感觉障碍、运动障碍等；其中，超过20％的人在急性感染6个月后处于焦虑或抑郁的状态，26％的人出现失眠(Huang C,etal.6-month consequences of COVID-19in patients discharged from hospital:acohort study[J].Lancet.2021；397(10270):220-232)。上述后遗症状极大地影响新冠感染愈后患者的生活质量，尤其是失眠、焦虑、抑郁等精神神经症状，使新冠感染带来的心理伤害长期滞留。因此，为临床治愈的新冠感染患者提供缓解、改善其精神神经症状的药物，将帮助其尽快回归正常的生活和生产活动。
发明内容
针对现有技术的不足，本发明提供传统中医名方参苓白术的新的医药用途。
为实现上述技术效果，本发明采用了如下的技术方案：
参苓白术在制备治疗新型冠状病毒感染患者愈后的精神神经症状的药物中的应用；所述参苓白术的原料组成为：人参、麸炒白术、茯苓、山药、莲子、炒白扁豆、薏苡仁、砂仁、桔梗和甘草
优选地，所述新型冠状病毒感染患者愈后的精神神经症状包括失眠、焦虑和抑郁中的至少一种。
优选地，所述药物为临床上可以接受的制剂。
更优选地，所述药物选自汤剂、丸剂、散剂、颗粒剂、片剂或胶囊剂。
所述参苓白术的原料中，各药材的重量份为：
人参100份，麸炒白术100份，茯苓100份，山药100份，莲子50份，炒白扁豆75份，麸炒薏苡仁50份，砂仁50份，桔梗50份，甘草100份。
本说明书中，所述“重量份”或“份”不是重量或质量单位，其仅表示各组分之间的相对重量(质量)配比关系。根据实际情况，1重量份可以是1g，4g，5g，10g，1kg，或其它任意的重量(质量)。
通过临床观察，参苓白术颗粒能够有效治疗新冠感染患者愈后的精神神经症状，使患者尽快回归正常的生活和生产活动。
附图说明
下面结合附图，对本发明做进一步说明。
图1示出的是焦虑自评量表(SAS)的样表。
图2示出的是抑郁自评量表(SDS)的样表。
具体实施方式
2019新型冠状病毒(2019-nCoV)不仅仅给感染期患者呼吸系统造成严重损伤，还对患者的全身生物系统造成巨大影响，给患者带来了延续、长期的后遗症，使患者的身体健康和生存质量都收到极大影响。发明人在湖北省内通山县人民医院、国药东风总医院、咸宁市中心医院和阳新县人民医院四家医院开展了参苓白术制剂对改善新冠感染患者愈后精神神经症状的临床观察试验。经过近一个月的干预治疗，令人惊喜地发现患者的焦虑、抑郁等精神神经系统方面的后遗症状明显减轻。
以下参照具体的实施例来说明本发明。本领域技术人员能够理解，这些实施例仅用于说明本发明，其不以任何方式限制本发明的范围。
下述实施例中的实验方法，如无特殊说明，均为常规方法。下述实施例中所用的药材原料、试剂材料等，如无特殊说明，均为市售购买产品。
实施例1参苓白术颗粒对新冠感染患者愈后精神神经症状的干预作用
本实施例于2021年9月至2022年7月湖北省内的通山县人民医院、国药东风总医院、咸宁市中心医院和阳新县人民医院进行。
1.病例分布情况
研究共入组受试者313例，完成313例，占入组例数的100％，剔除8例年龄超出18-80岁范围的病例，进入分析集305例。
2.病例一般资料
男性166人(54.43％)，女性139人(45.57％)；汉族303人(99.34％)；平均年龄46.34±14.09岁，年龄最小者2岁，最大者84岁。平均体重63.41±7.51(kg)。
3.生命体征
入组时体温、呼吸、血压、心率各项体征基本正常，研究期间各项体征未见明显异常。
4.给药方案
研究期间平均服药天数28.09±0.88天，最短服药天数25天，最长服药天数32天，中位服药天数28天。受试者开始服药的前1天记为0天，开始服药的当天记为1天，以此类推，直至28天。
具体给药方案为：参苓白术颗粒1日3次，每次1袋(3g/袋)，连服28天。其中，参苓白术颗粒由北京汉典制药有限公司生产，批号为211032、211134、211232。
5.疗效评价指标
SAS评分(焦虑自评量表，见图1)、SDS评分(抑郁自评量表，见图2)测定。
6.数据采集
所有入组受试者分别在0天、14天和28天进行就诊，以收集症状和赋分记录，其中0天的数据记为“访视1”，14天的数据记为“访视2”，28天的数据记为“访视3”，三组数据进行统计和分析。
7.统计和分析
统计分析将采用SAS 9.4(或以上版本)统计分析软件。
所有的统计检验均采用双侧检验，给出检验统计量及其对应的P值，P<0.05可认为差异有统计学意义。
定量数据，描述其例数、均数、标准差、最小值、中位数、最大值、上四分位数(Q1)、下四分位数(Q3)、95％置信区间(95％CI)。各处理组间的比较，采用t检验。若考虑协变量的影响，用协方差分析。时序资料，描述其中位生存时间并绘制其Kaplan-Meier曲线，采用Log-rank检验比较两组中位生存时间的组间差异。若考虑到中心或其他因素的影响，采用Cox回归分析。
定性数据，描述各种类的例数及其所占百分比。计数资料各处理组组间的比较，用卡方检验、Fisher精确概率法；等级资料各处理组间比较，采用Wilcoxon秩和检验。若考虑到中心或其他因素的影响，采用CMH卡方检验或Logistic回归。
8.干预疗效
8.1SAS量表(焦虑自评量表)评分结果
结果见表1和表2。
表1SAS量表评分实测值
表2SAS量表评分差值
通过干预治疗，研究期间访视2相对于基线评分平均降低了17.21±12.45分，访视3相对于基线评分平均降低了27.44±15.94分，通过混合效应模型和配对秩检验分析，发现差异均有统计学意义(p<0.05)，说明SAS量表评分通过治疗较基线显著下降。
8.2SDS量表(抑郁自评量表)评分结果
结果见表3和表4。
表3量表评分实测值
表4SDS量表评分差值
通过干预治疗，研究期间访视2相对于基线评分平均降低了17.63±11.56分，访视3相对于基线评分平均降低了28.34±15.58分，通过混合效应模型和配对秩检验分析，发现差异均有统计学意义(p<0.05)，说明SDS量表评分通过治疗较基线显著下降。
9.结论
参苓白术可以治疗新冠感染患者愈后出现的焦虑、抑郁、失眠等精神神经症状。
Claims (4)
1.参苓白术在制备治疗新型冠状病毒感染患者愈后的精神神经症状的药物中的应用；所述参苓白术的原料组成为：人参、麸炒白术、茯苓、山药、莲子、炒白扁豆、薏苡仁、砂仁、桔梗和甘草。
2.根据权利要求1所述的应用，其特征在于，所述新型冠状病毒感染患者愈后的精神神经症状包括失眠、焦虑和抑郁中的至少一种。
3.根据权利要求1或2所述的应用，其特征在于，所述药物为临床上可以接受的制剂。
4.根据权利要求3所述的应用，其特征在于，所述药物选自汤剂、丸剂、散剂、颗粒剂、片剂或胶囊剂。
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| CN109045201A (zh) * | 2018-10-26 | 2018-12-21 | 上海市中医医院 | 用于治疗慢性消化道疾病伴焦虑抑郁状态的中药组合物 |
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| CN109045201A (zh) * | 2018-10-26 | 2018-12-21 | 上海市中医医院 | 用于治疗慢性消化道疾病伴焦虑抑郁状态的中药组合物 |
Non-Patent Citations (3)
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| 王红霞;朱永钦;付凯;: "参苓白术散治疗肠易激综合征脾虚湿盛证的临床研究", 黑龙江中医药, no. 02, 15 March 2018 (2018-03-15), pages 27 - 29 * |
| 阎博华;唐健元;丁红;卢云;曾芳;曾洁萍;李明权;夏结来;黄青松;由凤鸣;温川飙;谢春光: "中医药促进新型冠状病毒肺炎恢复期康复临床研究方案", 成都中医药大学学报, vol. 43, no. 01, 15 March 2020 (2020-03-15), pages 1 - 6 * |
| 陈辉;杨伟兴;肖国辉;王天刚;冯雯;王科闯;: "参苓白术散论治失眠症思路探讨", 中医临床研究, vol. 11, no. 32, 20 November 2019 (2019-11-20), pages 64 - 66 * |
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| WO2024131315A1 (zh) * | 2022-12-21 | 2024-06-27 | 北京红太阳药业有限公司 | 参苓白术在制备治疗新型冠状病毒感染患者愈后精神神经症状的药物中应用 |
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