CN111265586B - 一种治疗新型冠状病毒肺炎的中药组合物及其应用 - Google Patents
一种治疗新型冠状病毒肺炎的中药组合物及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗新型冠状病毒肺炎的中药组合物及其应用，通过采用蜜麻黄、生石膏、金银花、蜜桑白皮、葶苈子、黄芩、升麻、玄参、牡丹皮、生地黄、麸炒白术、党参、柴胡、荆芥、炙甘草等药物组合物并临床应用，其功效宣肺透邪、解毒凉血，兼顾护脾胃，能够截断逆转，阻断新冠肺炎病势进展，用于治疗新型冠状病毒肺炎疫毒犯(闭)肺证。临床应用发现其能缩短发热时间，并对患者的咳嗽、乏力等症状及肺部炎症的吸收表现出更优的疗效。
Description
技术领域
本发明涉及中药组合物领域，具体涉及一种用于治疗新型冠状病毒肺炎的中药组合物及其应用。
背景技术
新型冠状病毒肺炎是一种新发突发传染病，传染性强，人群普遍易感，部分患者感染后病情危重，可危及生命。新型冠状病毒肺炎主要临床表现为发热、咳嗽、咽痛、头痛、周身肌肉酸痛、困倦乏力、食欲不振、胸闷气促，大便溏薄或便秘、腹泻较少见，舌质淡红、暗，舌苔薄白、薄黄、厚腻不一，但以舌偏红、苔薄黄较多见。目前尚没有针对新冠病毒的特效抗病毒药物，治疗以对症支持治疗为主。
发明内容
申请人经研究发现疫毒犯(闭)肺是其核心病机，制定宣肺透邪、解毒凉血的治疗原则，并通过不断总结优化治疗方案，形成了针对COVID-19核心病机的院内协定处方-银丹解毒方，治疗病例包括普通型、重型和危重型，临床取得了较好疗效。
研究团队观察到发热、咳嗽和气促为最主要表现，Lancet在线发文的新冠肺炎数据也证实83％的患者出现了发热，82％的患者有咳嗽症状，31％的患者有气短症状。有些患者早期病情并不凶险，但可突然加重，快速进展至多脏器功能衰竭状态。我院收治的新冠肺炎患者胸部CT显示均有肺炎表现，可以说“病情轻重有不同，病位无不在肺中”，符合“温邪上受，首先犯肺，逆传心包”这一温病发病特点和传变规律。
新型冠状病毒不同于一般外感六淫之邪，也不同于一般病毒性肺炎，无论起病急缓，一定走向肺部，疫毒之邪稽留肺部。新冠肺炎病因为感受疫毒之邪，病位在肺，疫毒犯(闭)肺是核心病机。该病临床分型分为轻型、普通型(最常见的类型)、重型、危重型一样，中医临证若能以轻重区分，则有提纲挈领、执简驭繁的作用。轻症者系疫毒犯肺，表现为发热、咳嗽，肺部炎症尚属轻浅，病在卫分和气分；重症者则疫毒闭肺，肺部炎症进展，伴有低氧血症，表现为发热、喘憋，甚至发绀神昏，此时病势深重，波及营血，若不能及时截断逆转，肺炎进展甚至呈“大白肺”，表现为急性呼吸窘迫综合征(acute respiratory distresssyndrome，ARDS)，甚至多脏器衰竭、脓毒症等，即危重症的内闭外脱表现。基于团队对疫毒犯(闭)肺是基本核心病机的认识，治疗采用宣肺透邪、解毒凉血之法，力求截断逆转，阻断病势进展。具体而言，发现如下中药配方非常有效。
一种治疗新型冠状病毒肺炎的中药组合物，它由以下重量份的成分组成：
蜜麻黄4-8份、生石膏28-32份、金银花13-17份、蜜桑白皮13-17份、葶苈子18-22份、黄芩13-17份、升麻8-12份、玄参13-17份、牡丹皮13-17份、生地黄13-17份、麸炒白术13-17份、党参13-17份、柴胡8-12份、荆芥8-12份、炙甘草8-12份。
作为优选方案，以上所述的治疗新型冠状病毒肺炎的中药组合物，它由以下重量份的成分组成：
蜜麻黄5-7份、生石膏29-31份、金银花14-16份、蜜桑白皮14-16份、葶苈子19-21份、黄芩14-16份、升麻9-11份、玄参14-16份、牡丹皮14-16份、生地黄14-16份、麸炒白术14-16份、党参14-16份、柴胡9-11份、荆芥9-11份、炙甘草9-11份。
作为优选方案，以上所述的治疗新型冠状病毒肺炎的中药组合物，它由以下重量份的成分组成：
蜜麻黄6份、生石膏30份、金银花15份、蜜桑白皮15份、葶苈子20份、黄芩15份、升麻10份、玄参15份、牡丹皮15份、生地黄15份、麸炒白术15份、党参15份、柴胡10份、荆芥10份、炙甘草10份。
所述治疗新型冠状病毒肺炎的中药组合物的功能是宣肺透邪，解毒凉血。用于新型冠状病毒肺炎疫毒犯(闭)肺证，症见发热，咳嗽痰少，或有黄痰，胸闷气促，甚则紫绀，倦怠乏力，食欲不振，大便不畅或便溏。
所述治疗新型冠状病毒肺炎的中药组合物的用法用量：水煎服，每日一剂，每剂煎至300-400ml，分2-3次口服。
本处方中不含有法定标准中标识有毒性及现代毒理学证明有毒性的药材，不含有十八反、十九畏配伍禁忌。
上述15味药物用量经多次优化，与一般用药相比，能够针对新冠肺炎病例特点，增强泻肺平喘、清热解毒凉血功效，兼顾护脾胃，治愈率大幅提高。
所述的治疗新型冠状病毒肺炎的中药组合物，可制备成汤剂、颗粒、胶囊或丸剂等，参照上述煎服等同剂量。
所述中药组合物在制备治疗肺炎疾病的药物中的应用。
所述肺炎由病毒感染所致。
所述肺炎是新型冠状病毒肺炎COVID-19。
附图说明
图1为本发明倾向匹配评分前后银丹组和抗病毒组患者的总体治愈出院率；
图2为银丹组和抗病毒组患者的体温复常时间；
图3为银丹组和抗病毒组患者的症状缓解率；
图4为银丹组和抗病毒组患者的肺部炎症吸收率；
图5为银丹组和抗病毒组患者的病毒核酸转阴率。
具体实施方式
实施例1
以以下成分组成配方临床适用为例：蜜麻黄6g、生石膏30g、金银花15g、蜜桑白皮15g、葶苈子20g、黄芩15g、升麻10g、玄参15g、牡丹皮15g、生地黄15g、麸炒白术15g、党参15g、柴胡10g、荆芥10g、炙甘草10g。水煎服，每日一剂，每剂煎至300-400ml，分2-3次口服。效果如下：
(一)两组患者基线特征
课题组对北京地坛医院收治的98例COVID-19患者，进行了前瞻性队列研究，以评价银丹解毒方的疗效。服用银丹解毒方的患者为39例(银丹组)，应用抗病毒药物治疗的患者为59例(抗病毒组)。银丹组患者全部接受银丹解毒方口服，抗病毒组患者全部接受口服抗病毒药物(包括洛匹那韦利托那韦、奥司他韦、帕拉米韦、磷酸氯喹)，两组均辅以对症支持治疗。
银丹组患者平均年龄51.8岁，其中男性18(46.2％)例，女性21(53.8％)例；抗病毒组为46.5岁，其中男性38(64.4％)例，女性21(35.6％)例。银丹组临床分型中轻型0(0.0％)例，普通型30(76.9％)例，重型5(12.8％)例，危重型4(10.3％)例；抗病毒组中轻型2(3.4％)例，普通型39(66.1％)例，重型13(22％)例，危重型5(8.5％)例。上述基线指标年龄、性别、临床分型在两组无统计学差异(p>0.05)。实验室检查结果表明银丹组和抗病毒组在淋巴细胞计数、粒细胞淋巴细胞比例无统计学差异(p>0.05)，但是抗病毒组患者的白细胞计数、中性粒细胞计数、丙氨酸氨基转移酶均较银丹组患者明显升高(p<0.05)。(表1)。
为削弱两组之间产生系统性的偏差，将银丹组与抗病毒组基线不齐的特征变量纳入倾向评分匹配分析，匹配后两组的各基线特征无明显差异(p>0.05)，具体参见表1。
表1.COVID-19患者基线特征
年龄用中位数±标准差表示，计数资料用数量(百分比)表示，计量资料用中位数(四分位数间距)表示；
统计学方法:a)独立样本t检验，b)卡方检验，c)独立样本非参数检验。
(二)疗效分析
1、总体治愈出院率
至随访45天，银丹组的总体治愈出院率为82.1％，抗病毒组为44.1％，两组具有显著的统计学差异(p＝0.0002)。应用倾向评分匹配分析方法，纳入两组的基线差异因素白细胞计数、中性粒细胞计数和丙氨酸氨基转移酶纳入分析，银丹组和抗病毒组患者进行1:1倾向匹配，匹配后银丹组的总体治愈出院率(81.1％)较抗病毒组明显升高(59.5％)，两组具有显著的统计学差异(p＝0.0109)，具体参见图1。
2、症状、肺部炎症和病毒核酸的转归
(1)银丹组发热患者体温恢复正常的平均时间(四分位数间距)为5.7(4.0-7.0)天，明显短于抗病毒组患者8.4(5.8-9.0)天(p＝0.026)。(图2)。
(2)经上述治疗1周后，银丹组的咳嗽、乏力等症状缓解率89.7％，抗病毒组61.0％，两组间具有统计学差异(p＝0.002)；经治疗2周后，银丹组的咳嗽、乏力等症状缓解率97.4％，抗病毒组84.7％；随访4周时，银丹组的咳嗽、乏力等症状缓解率97.4％，抗病毒组94.9％。(图3)。
(3)影像学动态观察显示，治疗1周时银丹组患者肺部炎症吸收率33.3％，抗病毒组15.3％，两组间具有统计学差异(p＝0.036)；治疗2周时，银丹组患者肺部炎症吸收率89.7％，抗病毒组67.8％，两组间亦具有统计学差异(p＝0.012)；随访4周时，银丹组患者肺部炎症吸收率94.9％，抗病毒组88.1％。
(图4)。
(4)病毒核酸监测提示，治疗1周时银丹组及抗病毒组的病毒核酸转阴率分别为25.6％和42.4％，2周时分别为89.7％和79.7％，组间均无明显统计学差异(p＝0.091和p＝0.186)；随访4周时，银丹组及抗病毒组的病毒核酸转阴率均为100％。(图5)。
3、疗效总结
COVID-19患者入院后，在对症支持治疗的基础上分别应用了银丹解毒方或口服抗病毒药物，对两种治疗方式的疗效进行了归纳分析。结果表明，随访20天时就出现了银丹解毒方总体治愈出院率明显优于抗病毒药物的现象，银丹组治愈出院率为53.8％，抗病毒组为28.8％，两组间具有统计学差异(p＝0.013)；而到随访45天，银丹组的治愈出院率高达82.1％，而抗病毒组仅为44.1％，两组间具有显著统计学差异(p<0.0001)。这在倾向匹配前后均得到了相似的结果，说明银丹解毒方可明显缩短患者的住院时间，提高治愈率。
基于上述疗效判断主要指标的分析，我们进一步对发热、呼吸道症状、肺部炎症和病毒核酸等次要指标进行分析。结果表明，银丹解毒方能较对照组缩短发热时间2.7天，在疗程1周时，银丹解毒方较抗病毒药物对患者的咳嗽、乏力等症状及肺部炎症的吸收就表现出更优的疗效。银丹解毒方具有较好的退热作用，能够改善咳嗽、乏力等症状、促进肺部炎症吸收，进而缩短患者病程。
4、银丹解毒方安全性评价
所有患者在治疗期间均进行了安全性评估，包括血常规、尿常规、肝肾功能、心电图等，未见明显不良反应。1例患者出现腹泻每天5-6次，停药后恢复正常。
以上只通过说明的方式描述了本发明的某些示范性实施例，毋庸置疑，对于本领域的普通技术人员，在不偏离本发明的精神和范围的情况下，可以用各种不同的方式对所描述的实施例进行修正。因此，上述附图和描述在本质上是说明性的，不应理解为对本发明权利要求保护范围的限制。
Claims (5)
1.一种治疗新型冠状病毒肺炎的中药组合物，其特征在于，其由以下重量份的成分组成：蜜麻黄4-8份、生石膏28-32份、金银花13-17份、蜜桑白皮13-17份、葶苈子18-22份、黄芩13-17份、升麻8-12份、玄参13-17份、牡丹皮13-17份、生地黄13-17份、麸炒白术13-17份、党参13-17份、柴胡8-12份、荆芥8-12份、炙甘草8-12份。
2.根据权利要求1所述的治疗新型冠状病毒肺炎的中药组合物，其特征在于，其由以下重量份的成分组成：蜜麻黄5-7份、生石膏29-31份、金银花14-16份、蜜桑白皮14-16份、葶苈子19-21份、黄芩14-16份、升麻9-11份、玄参14-16份、牡丹皮14-16份、生地黄14-16份、麸炒白术14-16份、党参14-16份、柴胡9-11份、荆芥9-11份、炙甘草9-11份。
3.根据权利要求2所述的治疗新型冠状病毒肺炎的中药组合物，其特征在于，其由以下重量份的成分组成：蜜麻黄6份、生石膏30份、金银花15份、蜜桑白皮15份、葶苈子20份、黄芩15份、升麻10份、玄参15份、牡丹皮15份、生地黄15份、麸炒白术15份、党参15份、柴胡10份、荆芥10份、炙甘草10份。
4.根据权利要求1-3任一项所述的治疗新型冠状病毒肺炎的中药组合物，其特征在于，制备成汤剂、颗粒、胶囊或丸剂。
5.权利要求1-4任一项所述中药组合物在制备治疗新型冠状病毒肺炎COVID-19的药物中的应用。
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