CN115317554B - 一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物及其制备方法 - Google Patents
一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明提出了一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物及其制备方法，属于中药组合物技术领域。包括以下原料：黄芪、党参、白术、陈皮、附子、前胡、生石膏、海浮石、胆南星、蝉蜕、细辛、柴胡、板蓝根、败酱草。本发明发明人在长期临床中发现在西医基础上配合自拟中药方—治疗化疗后中性粒细胞缺乏伴发热的中药组合物(温阳清热饮)治疗FN的患者效果满意，可以在短时间内改善病情、缩短治疗时间。
Description
技术领域
本发明涉及中药组合物技术领域，具体涉及一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物及其制备方法。
背景技术
化疗仍是目前恶性肿瘤治疗的重要手段，甚至在一定程度上具有不可替代的地位，化疗引起的一系列副作用是不可避免的。骨髓抑制是化疗最常见的限制性毒副反应，由骨髓抑制导致的中性粒细胞缺乏伴发热(Febrile Neutropenia FN)是化疗后的严重并发症也是肿瘤学第一急症，相关报道25％～40％的化疗初治患者出现中性粒细胞缺乏伴发。FN患者感染风险大，当中性粒细胞计数＜0.5×109/L感染风险近20％，中性粒细胞计数＜0.1×109/L感染风险近30％，FN患者死亡率高，在实体肿瘤与淋巴瘤中FN致死率分别为8％与8.9％,而在白血病中这一致死率高达14.3％。FN还会导致患者活质量下降、延长住院时间，还可导致此后的化疗剂量减少、化疗间隔延长、降低治疗的有效率，影响远期效果。
FN目前治疗主要包括尽早使用升白药物，抗感染等，但由于病原菌培养阳性率低，患者感染部位不易发现或明确，因此难以给予精准抗感染治疗，临床上多予经验性抗感染治疗配合升白等治疗。
发明内容
本发明的目的在于提出一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物及其制备方法，该中药方治疗FN的患者效果满意，可以在短时间内改善病情、缩短治疗时间。
本发明的技术方案是这样实现的：
本发明提供一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物，包括以下原料：黄芪、党参、白术、陈皮、附子、前胡、生石膏、海浮石、胆南星、蝉蜕、细辛、柴胡、板蓝根、败酱草。
作为本发明的进一步改进，由以下原料按重量份制备而成：黄芪20-40份、党参15-25份、白术5-15份、陈皮3-8份、附子5-15份、前胡3-8份、生石膏20-40份、海浮石5-15份、胆南星10-20份、蝉蜕5-15份、细辛3-6份、柴胡10-30份、板蓝根5-15份、败酱草5-15份。
作为本发明的进一步改进，由以下原料按重量份制备而成：黄芪30份、党参20份、白术10份、陈皮6份、附子10份、前胡6份、生石膏30份、海浮石10份、胆南星15份、蝉蜕10份、细辛6份、柴胡20份、板蓝根10份、败酱草10份。
本发明进一步保护一种上述的治疗化疗后中性粒细胞缺乏伴发热的中药组合物的制备方法，包括以下步骤：
S1.将黄芪、党参、白术、细辛、柴胡、板蓝根、败酱草、陈皮、前胡洗净、干燥、粉碎后混合均匀，加入第一比例的水，加热煮沸第一时间段，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S2.将附子加入第二比例的水，加热煮沸第二时间段后放凉，取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S3.将生石膏粉碎后加入第三比例的水，加热煮沸第三时间段，然后将海浮石、胆南星、蝉蜕粉粉碎后加入上述石膏溶液中，继续加热煮沸第四时间段，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S4.将步骤S1、S2、S3制得的浓缩液混合均匀，制得治疗化疗后中性粒细胞缺乏伴发热的中药组合物。
作为本发明的进一步改进，所述第一比例的固液比为1：3-5g/mL；第二比例的固液比为1：5-7g/mL；所述第三比例的固液比为1:4-6g/mL。
作为本发明的进一步改进，所述第一时间段为30-40min；所述第二时间段为0.5-1h；所述第三时间段为20-25min；所述第四时间段为30-40min。
本发明进一步保护一种上述治疗化疗后中性粒细胞缺乏伴发热的中药组合物在制备治疗或辅助治疗化疗后中性粒细胞缺乏伴发热症状的产品中的应用。
本发明具有如下有益效果：本发明发明人在长期临床中发现在西医基础上配合自拟中药方—治疗化疗后中性粒细胞缺乏伴发热的中药组合物(温阳清热饮)治疗FN的患者效果满意，可以在短时间内改善病情、缩短治疗时间。
方中黄芪补中益气，固表升阳；附子温壮元阳，大补先天，使先天之阳升，则一身之阳升；党参、白术健脾益气，使元气旺盛，清阳得升，其热自退；陈皮理气调中，补气而不滞气；柴胡解表退热，升阳气助君药。因此本方中黄芪、附子、党参、白术、陈皮、柴胡合用具有温阳补虚，甘温除热之功效。另外本方中细辛辛散走窜，善于通窍，温肺散寒解表，对于外感发热有良好的治疗作用；石膏泻火解毒，解肌退热；海浮石化痰清肺火；胆南星清热化痰；蝉蜕疏风，凉散风热；板蓝根、败酱草清热解毒，上七味配合有清解表里邪实之功效，且效速而不伤正。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
原料组成(重量份)：黄芪20份、党参15份、白术5份、陈皮3份、附子5份、前胡3份、生石膏20份、海浮石5份、胆南星10份、蝉蜕5份、细辛3份、柴胡10份、板蓝根5份、败酱草5份。
制备方法包括以下步骤：
S1.将黄芪、党参、白术、细辛、柴胡、板蓝根、败酱草、陈皮、前胡洗净、干燥、粉碎后混合均匀，按照固液比为1：3g/mL加入水，加热煮沸30min，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩，备用；
S2.将附子加入按照固液比为1：5g/mL加入水，加热煮沸0.5h后放凉，取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S3.将生石膏粉碎后按照固液比为1:4g/mL加入水，加热煮沸20min，然后将海浮石、胆南星、蝉蜕粉粉碎后加入上述石膏溶液中，继续加热煮沸30min，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S4.将步骤S1、S2、S3制得的浓缩液混合均匀，制得治疗化疗后中性粒细胞缺乏伴发热的中药组合物。
实施例2
原料组成(重量份)：黄芪40份、党参25份、白术15份、陈皮8份、附子15份、前胡8份、生石膏40份、海浮石15份、胆南星20份、蝉蜕15份、细辛6份、柴胡30份、板蓝根15份、败酱草15份。
制备方法包括以下步骤：
S1.将黄芪、党参、白术、细辛、柴胡、板蓝根、败酱草、陈皮、前胡洗净、干燥、粉碎后混合均匀，按照固液比为1：4g/mL加入水，加热煮沸25min，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S2.将附子加入按照固液比为1：6g/mL加入水，加热煮沸1h后放凉，取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S3.将生石膏粉碎后按照固液比为1:5g/mL加入水，加热煮沸第三时间段，然后将海浮石、胆南星、蝉蜕粉粉碎后加入上述石膏溶液中，继续加热煮沸35min，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S4.将步骤S1、S2、S3制得的浓缩液混合均匀，制得治疗化疗后中性粒细胞缺乏伴发热的中药组合物。
实施例3
原料组成(重量份)：黄芪30份、党参20份、白术10份、陈皮6份、附子10份、前胡6份、生石膏30份、海浮石10份、胆南星15份、蝉蜕10份、细辛6份、柴胡20份、板蓝根10份、败酱草10份。
制备方法包括以下步骤：
S1.将黄芪、党参、白术、细辛、柴胡、板蓝根、败酱草、陈皮、前胡洗净、干燥、粉碎后混合均匀，按照固液比为1：35g/mL加入水，加热煮沸30min，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S2.将附子加入按照固液比为1：7g/mL加入水，加热煮沸0.5h后放凉，取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S3.将生石膏粉碎后按照固液比为1:6g/mL加入水，加热煮沸第三时间段，然后将海浮石、胆南星、蝉蜕粉粉碎后加入上述石膏溶液中，继续加热煮沸40min，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S4.将步骤S1、S2、S3制得的浓缩液混合均匀，制得治疗化疗后中性粒细胞缺乏伴发热的中药组合物。
测试例1
(1)诊断、纳入与排除标准
化疗后FN的诊断标准：⑴所有患者均由病理确诊为恶性肿瘤，⑵化疗后中性粒细胞绝对值(absolute neutrophil count，ANC)<1.0×109/L且预计在48小时内降至≤0.5×109/L，并且单次温度≥38.3℃或者温度≥38.0℃超过1小时。纳入病例标准：⑴符合西医恶性肿瘤诊断标准，⑵化疗方案均为FN中度风险(风险在10％-20％)如：结直肠癌FOLFOX(氟尿嘧啶+亚叶酸钙+奥沙利铂)，食管癌和胃癌(表柔比星+顺铂/卡铂+5-氟尿嘧啶)，非小细胞肺癌(多西他赛+卡铂/顺铂)，⑶年龄18-80岁，⑷化疗前血常规正常，体温正常，无感染性疾病。1.4排除标准：⑴不符合西医诊断标准，包括恶性肿瘤诊断标准及FN诊断标准，⑵化疗方案为非FN中度风险，⑶不能配合服用中药或中途放弃使用中药的患者。
(2)临床资料与分组方法
自2019年1月至2022年6月笔者主管使用温阳清热饮治疗的FN患者共12人，列为观察组，年龄40-75岁。同期在我院治疗未使用中药治疗的FN患者共46人，列为对照组，年龄35-79岁。所有病例均来源于我院HIS系统。观察组非小细胞肺癌5例，结直肠癌4例，食管癌2例胃癌1例。对照组非小细胞肺癌21例，结直肠癌15例，食管癌7例，胃癌3例。两组患者临床资料比较见表1，差异无统计学意义，有可比性。
(3)治疗方法
1)对照组：抗生素治疗，在无病原菌培养结果时采用经验用药，包括左氧氟沙星、莫西沙星、头孢哌酮他唑巴坦钠、头孢哌酮舒巴坦钠、哌拉西林等抗生素，病原菌培养阳性时按药敏试验结果选用抗生素。升白治疗：使用粒细胞集落刺激因子G-CSF治疗，每日1次皮下或静脉注射给药5μg/kg(取整至最接近药瓶规格)，持续用药直至ANC从最低点后恢复至正常水平。退热治疗：物理降温、布洛芬等。
2)观察组：在对照组基础上服用中药汤剂——温阳清热饮。该方由黄芪30g党参20g白术10g陈皮6g附子10细辛6g前胡6生石膏30g海浮石10g胆南星15g蝉蜕10g柴胡20g板蓝根10g败酱草10g组成，煎煮时上方以水没过药渣2cm为度，先武火沸腾后改小火煎煮15分钟，连续两次煎煮取汁混合代茶饮，30分钟一次，每日一剂。连续3日。
(4)观察项目与方法
⑴观察两组发热持续时间，⑵两组ANC恢复正常所用时间，⑶两组患者住院时间，⑷两组ANC恢复正常后再次降至正常水平以下的人数。
(5)统计学处理
采用SPSS 21.0统计软件进行统计学分析处理，年龄等定量资料用均数±标准差
表示，时间统计采用定量资料的t检验，患者性别、肿瘤、ANC恢复正常后再次降低的人数比较为定性资料，采用x2检验。以P＜0.05为差异有统计学意义。
表1两组患者临床资料比较
2、结果
(1)两组患者发热持续时间比较
两组患者发热持续时间比较见表2，治疗组持续发热时间为7.21±2.33对照组持续发热时间为11.30±4.24治疗组较对照组持续发热时间缩短，差异具有统计学意义，P＜0.05。
(2)两组ANC恢复正常所用时间比较
两组ANC恢复正常所用时间比较见表2，治疗组ANC恢复正常所用时间减少约4天左右，具有明显差异，P＜0.05。
(3)两组患者住院时间比较
两组患者住院时间比较见表2，治疗组住院时间为10.40±3.73，对照组住院时间为14.23±5.12治疗组较对照明显缩短了住院时间，P＜0.05。
表2两组患者发热持续时间、ANC恢复正常所用时间、住院时间比较
(4)两组ANC恢复正常后再次降至正常水平以下的人数比较
两组ANC恢复正常后再次降至正常水平以下的人数见表3，对照组ANC再次再次降至正常水平以下的人数多于治疗组，但差异无统计学差异。
表3两组ANC恢复正常后再次降至正常水平以下的人数比较
骨髓抑制几乎是每一例恶性肿瘤患者化疗后的必经之路，由骨髓抑制导致的中性粒细胞缺乏伴发热不仅会导致活质量下降、延长住院时间，还可导致此后的化疗剂量减少、化疗间隔延长、降低治疗的有效率，甚至死亡。自从CSF用于临床，中性粒细胞缺乏这一问题得到了较好的解决，但对一部分人效果不佳，特别是多程化疗或药物剂量较大时患者起效慢，仍有高感染率及死亡风险。
粒细胞缺乏患者临床常表现为头晕、周身乏力、四肢酸软、厌食恶心、脉弱等症状，属于中医气虚范畴，当机体正气亏虚，六淫外邪易乘虚而入，正邪相争而发热，临床可表现为壮热，有汗不解，烦躁不安，这与FN极为相似。有学者认为化疗后发热治疗应滋阴潜阳以制虚火。也有学者认为要养阴清热，阴精复则阳亢渐消。在临床中笔者以滋阴潜阳，养阴清热等方法治疗FN症状改善并不理想，笔者认为阴虚非一朝一夕所成，亦非一朝一夕可补，而FN发病关键在气虚，气虚邪实而发热。临床中气虚发热病因有多种，发明人认为气虚—卫外不固—正邪相争—发热为是FN最主要及最常见发病轴，因此治疗应重视益气温阳，同时兼顾清热以治标。笔者根据FN临床特征自拟温阳清热饮，治疗FN效果满意，方中黄芪补中益气，固表升阳；附子温壮元阳，大补先天，使先天之阳升，则一身之阳升；党参、白术健脾益气，使元气旺盛，清阳得升，其热自退；陈皮理气调中，补气而不滞气；柴胡解表退热，升阳气助君药。因此本方中黄芪、附子、党参、白术、陈皮、柴胡合用具有温阳补虚，甘温除热之功效。另外本方中细辛辛散走窜，善于通窍，温肺散寒解表，对于外感发热有良好的治疗作用；石膏泻火解毒，解肌退热；海浮石化痰清肺火；胆南星清热化痰；蝉蜕疏风，凉散风热；板蓝根、败酱草清热解毒，上七味配合有清解表里邪实之功效，且效速而不伤正。本研究结果显示温阳清热饮可以在短时间内改善发热症状，较少ANC恢复正常所用时间，缩短住院治疗时间。
目前市场上应用比较广泛的升白中成药有芪胶升白胶囊、十一味参芪片，两者均以为扶正温阳，但无清解热邪之功，FN临床表现除了气虚、阳虚还有热邪，基于温阳清热饮治疗FN的疗效，该方有进一步研究价值。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (6)
1.一种治疗化疗后中性粒细胞缺乏伴发热的中药组合物，其特征在于，由以下原料按重量份制备而成：黄芪20-40份、党参15-25份、白术5-15份、陈皮3-8份、附子5-15份、前胡3-8份、生石膏20-40份、海浮石5-15份、胆南星10-20份、蝉蜕5-15份、细辛3-6份、柴胡10-30份、板蓝根5-15份、败酱草5-15份。
2.根据权利要求1所述的治疗化疗后中性粒细胞缺乏伴发热的中药组合物，其特征在于，由以下原料按重量份制备而成：黄芪30份、党参20份、白术10份、陈皮6份、附子10份、前胡6份、生石膏30份、海浮石10份、胆南星15份、蝉蜕10份、细辛6份、柴胡20份、板蓝根10份、败酱草10份。
3.一种如权利要求1或2所述的治疗化疗后中性粒细胞缺乏伴发热的中药组合物的制备方法，其特征在于，包括以下步骤：
S1.将黄芪、党参、白术、细辛、柴胡、板蓝根、败酱草、陈皮、前胡洗净、干燥、粉碎后混合均匀，加入第一比例的水，加热煮沸第一时间段，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S2.将附子加入第二比例的水，加热煮沸第二时间段后放凉，取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩溶液，备用；
S3.将生石膏粉碎后加入第三比例的水，加热煮沸第三时间段，然后将海浮石、胆南星、蝉蜕粉粉碎后加入上述石膏溶液中，继续加热煮沸第四时间段，冷却后取浸液；药渣重复操作一次；合并两次所得浸液，加热、蒸发浓缩备用；
S4.将步骤S1、S2、S3制得的浓缩液混合均匀，制得治疗化疗后中性粒细胞缺乏伴发热的中药组合物。
4.根据权利要求3所述的制备方法，其特征在于，所述第一比例的固液比为1：3-5g/mL；第二比例的固液比为1：5-7g/mL；所述第三比例的固液比为1:4-6g/mL。
5.根据权利要求3所述的制备方法，其特征在于，所述第一时间段为30-40min；所述第二时间段为0.5-1h；所述第三时间段为20-25min；所述第四时间段为30-40min。
6.一种如权利要求1或2所述治疗化疗后中性粒细胞缺乏伴发热的中药组合物在制备治疗或辅助治疗化疗后中性粒细胞缺乏伴发热症状的产品中的应用。
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