CN104127550A - Medicine for treating chemoradiotherapy-induced thrombocytopenia and preparation method thereof - Google Patents
Medicine for treating chemoradiotherapy-induced thrombocytopenia and preparation method thereof Download PDFInfo
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Abstract
Description
技术领域technical field
本发明涉及一种治疗血小板减少的药物,尤其是一种治疗放化疗所致血小板减少的药物。The invention relates to a medicine for treating thrombocytopenia, especially a medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy.
背景技术Background technique
恶性肿瘤发病率和病死率逐年升高,目前放化疗仍是恶性肿瘤综合治疗的重要手段。放化疗常使正常的骨髓造血干细胞、骨髓造血微环境受到损伤,造成骨髓抑制,外周血象减少,尤其是中性粒细胞和血小板减少,严重者可导致感染或出血,影响患者进一步治疗。The morbidity and mortality of malignant tumors are increasing year by year. At present, radiotherapy and chemotherapy are still an important means of comprehensive treatment of malignant tumors. Chemoradiation and chemotherapy often damage the normal bone marrow hematopoietic stem cells and the bone marrow hematopoietic microenvironment, resulting in myelosuppression and peripheral blood count reduction, especially neutrophil and thrombocytopenia, which can lead to infection or bleeding in severe cases, affecting further treatment of patients.
近年来随着粒细胞集落刺激因子的广泛应用,中性粒细胞减少得到有效控制。对于放化疗所致的血小板减少症的治疗,西医主要是输注血小板,但存在保存时间短、供血来源缺乏、花费较高且可能发生血源性感染、输血反应及产生血小板抗体等问题;近年上市的重组白细胞介素-11及血小板生成素虽有较好疗效,但价格昂贵,并且安全性有待于进一步研究。In recent years, with the widespread application of granulocyte colony-stimulating factor, neutropenia has been effectively controlled. For the treatment of thrombocytopenia caused by radiotherapy and chemotherapy, Western medicine mainly transfuses platelets, but there are problems such as short storage time, lack of blood supply sources, high cost, and possible blood-borne infections, blood transfusion reactions, and platelet antibody production; in recent years Although the commercially available recombinant interleukin-11 and thrombopoietin have good curative effects, they are expensive and their safety needs further study.
中医认为肿瘤形成时间较长,患者存在多脏腑气机失调,或又感邪毒,导致气滞血瘀痰湿互结,形成肿瘤,多属于本虚标实之证。放化疗治疗为攻伐治疗,热毒之邪,可伤气耗阴,更加重了脾肾亏损,气血损伤,出现骨髓抑制,血小板减少,常伴有白细胞下降及贫血。临床常表现为身体虚弱,乏力,疲倦,头晕,面色苍白,纳差,腰酸腿软,畏寒发热,皮下及牙龈出血等。脾为后天之本,气血生化之源,脾虚日久必损及肾;肾为先天之本,主骨生髓藏精,血为精所化,肾虚则髓不得满,血不能化,故放化疗导致脾肾损伤,致使气血生化无源,出现气虚血少,气虚不能摄血而见出血。因此本发明药物组合物治疗重点是补肾填精,温阳健脾,益气养血,止血散瘀。Traditional Chinese medicine believes that the tumor takes a long time to form, and the patient has multiple visceral qi disorders, or suffers from pathogenic toxins, resulting in stagnation of qi, blood stasis, phlegm and dampness, and the formation of tumors. Radiation and chemotherapy treatment is attacking treatment. The evil of heat and toxin can injure Qi and consume Yin, aggravate the loss of spleen and kidney, damage of Qi and blood, bone marrow suppression, thrombocytopenia, often accompanied by leukopenia and anemia. The clinical manifestations are weakness, fatigue, fatigue, dizziness, pale complexion, poor appetite, sore waist and legs, chills and fever, subcutaneous and gingival bleeding, etc. The spleen is the foundation of the acquired constitution, the source of qi and blood biochemistry, and the kidney is bound to be damaged if the spleen is deficient for a long time; Radiotherapy and chemotherapy lead to spleen and kidney damage, resulting in passive biochemistry of qi and blood, resulting in deficiency of qi and less blood, and bleeding due to inability to absorb blood due to qi deficiency. Therefore the therapeutic focus of the pharmaceutical composition of the present invention is to invigorate the kidney and essence, warm yang and invigorate the spleen, replenish qi and nourish blood, stop bleeding and remove blood stasis.
发明内容Contents of the invention
为获得新型高效安全的可适用于治疗放化疗所致血小板减少的药物及其制备方法,本发明人对此经过大量的深入研究,在付出了充分的创造性劳动后,完成了本发明。In order to obtain a new efficient and safe drug applicable to the treatment of thrombocytopenia caused by radiotherapy and chemotherapy and its preparation method, the present inventor has completed the present invention after a lot of in-depth research and sufficient creative work.
本发明涉及一种治疗放化疗所致血小板减少的药物,包括红景天、西洋参、鹿角胶、淫羊藿、菟丝子、陈皮、白术、黄芪、当归、龙眼肉、仙鹤草、肿节风。The invention relates to a medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy, which comprises rhodiola rosea, American ginseng, antler glue, epimedium, dodder, tangerine peel, atractylodes macrocephala, astragalus, angelica, longan meat, agrimony and sarcocarpus.
作为一种示例性例举,在所述药物组合物中,以重量份计,其具体组分含量如下:As an exemplary example, in the pharmaceutical composition, the content of specific components is as follows in parts by weight:
红景天5-12份、西洋参3-12份、鹿角胶3-10份、淫羊藿5-15份、菟丝子5-20份、陈皮3-8份、白术5-10份、黄芪15-50份、当归5-15份、龙眼肉5-20份、仙鹤草10-30份、肿节风5-15份。Rhodiola 5-12 parts, American ginseng 3-12 parts, antler glue 3-10 parts, epimedium 5-15 parts, dodder seed 5-20 parts, tangerine peel 3-8 parts, Atractylodes macrocephala 5-10 parts, astragalus 15- 50 parts, angelica 5-15 parts, longan meat 5-20 parts, agrimony 10-30 parts, swollen joint wind 5-15 parts.
本发明所述药物有优选配比为:Medicine of the present invention has preferred proportioning as:
优选的,红景天6份、西洋参5份、鹿角胶4份、淫羊藿8份、菟丝子6份、陈皮4份、白术6份、黄芪15份、当归5份、龙眼肉12份、仙鹤草12份、肿节风6份。Preferably, 6 parts of rhodiola, 5 parts of American ginseng, 4 parts of antler gum, 8 parts of epimedium, 6 parts of dodder, 4 parts of tangerine peel, 6 parts of Atractylodes macrocephala, 15 parts of astragalus, 5 parts of angelica, 12 parts of longan meat, crane 12 parts of grass, 6 parts of sarcophagus.
如上所述的一种治疗放化疗所致血小板减少的药物,其制备方法为:1)、按照所述重量份称取淫羊藿、菟丝子、陈皮、白术、黄芪、当归、龙眼肉、仙鹤草、肿节风,加13~17倍重量的水煎2.5~3.5小时,过滤离心去渣,浓缩成清膏;2)、称取相应重量份的红景天、西洋参,碎成细粉;3)、称取相应重量份的鹿角胶用黄酒加温烊化;4)、将步骤2)、3)所得产物与步骤1)所述清膏混合均匀,得所述药物。A kind of medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy as described above, its preparation method is: 1), according to the weight parts, take Epimedium, Cuscuta, Tangerine Peel, Atractylodes Rhizome, Radix Astragali, Angelica, Longan Meat, Agrimony , swollen joint wind, add 13 to 17 times the weight of decocting in water for 2.5 to 3.5 hours, filter and centrifuge to remove slag, and concentrate into a clear paste; 2), take the Rhodiola rosea and American ginseng in corresponding weight parts, and break into fine powder; 3 ), weighing corresponding parts by weight of deer horn gum and heating and curing with rice wine; 4), mixing the product obtained in steps 2) and 3) with the ointment described in step 1) to obtain the medicine.
优选的,步骤1)中为加15倍重量的水煎3小时。Preferably, in step 1), add 15 times the weight of water and decoct for 3 hours.
所述药物可以加入常规辅料,按照常规工艺,制成片剂、胶囊剂、散剂、丸剂、颗粒剂、膏剂或口服液体制剂。The medicine can be prepared into tablets, capsules, powders, pills, granules, ointments or oral liquid preparations by adding conventional auxiliary materials and according to conventional techniques.
其中,主要药物成分的作用功效为:Among them, the main medicinal ingredients have the following effects:
红景天:苦,甘,平,归肺、心经。益气活血,通脉平喘。藏医《四部医典》载:性平,清热,滋补元气,利气养血,能补肾,主周身乏力。现代药理研究证明具有抗氧化、抗衰老,抗辐射,抗病毒,抗缺氧,改善心血管功能,保肝等作用,而且安全无毒。Rhodiola rosea: bitter, sweet, flat, returns lung, heart meridian. Invigorating qi and activating blood circulation, dredging the pulse and relieving asthma. Tibetan medicine "Four Medical Codes" contains: flat nature, heat-clearing, nourishing vital energy, benefiting qi and nourishing blood, nourishing kidney, and treating fatigue all over the body. Modern pharmacological studies have proved that it has anti-oxidation, anti-aging, anti-radiation, anti-virus, anti-hypoxia, improvement of cardiovascular function, liver protection, etc., and it is safe and non-toxic.
西洋参:苦,微甘,寒。归心、肺、肾经。补气养阴,清火生津。American ginseng: bitter, slightly sweet, cold. Guixin, lung, kidney channel. Invigorating qi and nourishing yin, clearing fire and promoting body fluid.
鹿角胶:甘,咸,温。归肝、肾经。补肝肾,益精血,并能止血。Deer horn gum: sweet, salty, warm. Return liver, kidney channel. Invigorate the liver and kidney, benefit essence and blood, and stop bleeding.
淫羊藿:辛,甘,温。归肝、肾经。补肾阳,强筋骨,祛风除湿。Epimedium: pungent, sweet, warm. Return liver, kidney channel. Tonify kidney yang, strengthen muscles and bones, dispel wind and dampness.
菟丝子:辛,甘,平。归肝、肾、脾经。补阳益阴,固精缩尿,补肝明目,补脾止泻。Semen Cuscuta: pungent, sweet, flat. Return liver, kidney, spleen channel. Tonifying yang and benefiting yin, solidifying essence and reducing urination, nourishing liver and improving eyesight, nourishing spleen and stopping diarrhea.
陈皮:辛,苦,温。归脾、肺经。理气健脾,燥湿化痰。Tangerine peel: pungent, bitter, warm. Return spleen, lung meridian. Regulating qi and invigorating the spleen, drying dampness and resolving phlegm.
白术:甘,苦,温。归脾、胃经。健脾益气,燥湿利水,固表止汗。Atractylodes macrocephala: sweet, bitter, warm. Return spleen, stomach warp. Invigorate the spleen and replenish qi, dry dampness and diuresis, solidify the surface and stop perspiration.
黄芪:甘,温,归脾、肺经。补气升阳,益卫固表,托毒生肌,利水退肿。Radix Astragali: sweet, warm, returns spleen, lung meridian. Invigorate qi and promote yang, benefit health and solidify the exterior, detoxify and promote granulation, promote diuresis and reduce swelling.
当归:甘,辛,温。归肝、心、脾经。补血,活血止痛,润肠通便。Angelica: sweet, pungent, warm. Return liver, heart, spleen channel. Enriching blood, promoting blood circulation and relieving pain, moistening bowel and laxative.
龙眼肉:甘,温。归心、脾经。补心脾,益气血。Longan meat: sweet, warm. GUIXIN, Spleen Channel. Invigorate the heart and spleen, benefit qi and blood.
仙鹤草:苦,涩,平。归肺、肝、脾经。收涩止血,止痢,补虚强壮。Agrimony: bitter, astringent, flat. Return lung, liver, spleen channel. Receiving astringent to stop bleeding, stop dysentery, tonic and strong.
肿节风:苦,辛,平。归心、肝经。清热凉血,活血消斑,祛风通络。Swollen joint wind: bitter, pungent, flat. GUIXIN, Liver Channel. Clearing away heat and cooling blood, promoting blood circulation and eliminating spots, expelling wind and dredging collaterals.
本发明的有益效果:Beneficial effects of the present invention:
结合上述原料药的药理及药性,经过大量的研究和反复的临床治疗试验,研制出本发明药物,具有补肾填精,温阳健脾,益气养血,止血散瘀作用。本发明药物能够达到对放化疗所致血小板减少标本兼治的效果,消除临床症状,最终达到治愈目的,并有助于改善肿瘤患者生活质量和预后。本发明药物组合物治疗放化疗所致血小板减少效果显著且无副作用。Combining the pharmacology and medicinal properties of the above raw materials, through a large number of studies and repeated clinical treatment trials, the drug of the present invention has been developed, which has the functions of nourishing kidney and essence, warming yang and invigorating spleen, nourishing qi and blood, and stopping bleeding and removing blood stasis. The medicine of the invention can achieve the effect of treating both symptoms and root causes of thrombocytopenia caused by radiotherapy and chemotherapy, eliminate clinical symptoms, finally achieve the purpose of curing, and help to improve the quality of life and prognosis of tumor patients. The pharmaceutical composition of the invention has remarkable effect on treating thrombocytopenia caused by radiotherapy and chemotherapy and has no side effect.
具体实施方式Detailed ways
下面通过具体的实施例对本发明进行详细说明,但这些例举性实施方式的用途和目的仅用来例举本发明,并非对本发明的实际保护范围构成任何形式的任何限定,更非将本发明的保护范围局限于此。The present invention will be described in detail below through specific examples, but the use and purpose of these exemplary embodiments are only used to exemplify the present invention, and do not constitute any form of any limitation to the actual protection scope of the present invention, nor will the present invention The scope of protection is limited to this.
实施例1Example 1
一种治疗放化疗所致血小板减少的药物,以重量份计,其具体组分含量如下:A medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy, in parts by weight, its specific component content is as follows:
红景天5份、西洋参3份、鹿角胶3份、淫羊藿5份、菟丝子5份、陈皮3份、白术5份、黄芪15份、当归5份、龙眼肉5份、仙鹤草10份、肿节风5份。5 parts of rhodiola rosea, 3 parts of American ginseng, 3 parts of deer horn glue, 5 parts of epimedium, 5 parts of dodder seed, 3 parts of tangerine peel, 5 parts of atractylodes rhizome, 15 parts of astragalus, 5 parts of angelica, 5 parts of longan meat, 10 parts of Agrimony , 5 parts of sarcomas.
具体制备方法如下:The specific preparation method is as follows:
1)、按照所述重量份称取淫羊藿、菟丝子、陈皮、白术、黄芪、当归、龙眼肉、仙鹤草、肿节风,加13~17倍重量的水煎2.5~3.5小时,过滤离心去渣,浓缩成清膏;2)、称取相应重量份的红景天、西洋参,碎成细粉;3)、称取相应重量份的鹿角胶用黄酒加温烊化;4)、将步骤2)、3)所得产物与步骤1)所述清膏混合均匀,得所述药物。1), take epimedium, dodder seed, tangerine peel, Atractylodes macrocephala, astragalus, angelica, longan meat, agrimony, and sarcocarpus according to the weight parts, add 13 to 17 times the weight of water and decoct for 2.5 to 3.5 hours, filter and centrifuge Remove slag, concentrate into clear paste; 2), take the Rhodiola rosea and American ginseng of corresponding weight parts, and break into fine powder; 3), take the deer horn glue of corresponding weight parts and heat and melt with rice wine; 4), put The product obtained in steps 2), 3) is uniformly mixed with the ointment described in step 1) to obtain the drug.
实施例2Example 2
一种治疗放化疗所致血小板减少的药物,在所述药物组合物中,以重量份计,其具体组分含量如下:A medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy. In the pharmaceutical composition, the content of its specific components is as follows in parts by weight:
红景天12份、西洋参12份、鹿角胶10份、淫羊藿15份、菟丝子20份、陈皮8份、白术10份、黄芪50份、当归15份、龙眼肉20份、仙鹤草30份、肿节风15份。12 parts of rhodiola, 12 parts of American ginseng, 10 parts of deer horn glue, 15 parts of epimedium, 20 parts of dodder, 8 parts of tangerine peel, 10 parts of Atractylodes macrocephala, 50 parts of astragalus, 15 parts of angelica, 20 parts of longan meat, 30 parts of Agrimony , 15 parts of sarcomas.
具体制备方法如下:The specific preparation method is as follows:
同实施例1。With embodiment 1.
实施例3Example 3
一种治疗放化疗所致血小板减少的药物,在所述药物组合物中,以重量份计,其具体组分含量如下:A medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy. In the pharmaceutical composition, the content of its specific components is as follows in parts by weight:
红景天8份、西洋参6份、鹿角胶6份、淫羊藿8份、菟丝子8份、陈皮4份、白术8份、黄芪20份、当归10份、龙眼肉8份、仙鹤草15份、肿节风10份。8 parts of rhodiola rosea, 6 parts of American ginseng, 6 parts of deer horn glue, 8 parts of epimedium, 8 parts of dodder seed, 4 parts of tangerine peel, 8 parts of Atractylodes macrocephala, 20 parts of astragalus, 10 parts of angelica, 8 parts of longan meat, 15 parts of Agrimony , 10 parts of sarcomas.
具体制备方法如下:The specific preparation method is as follows:
同实施例1。With embodiment 1.
实施例4Example 4
一种治疗放化疗所致血小板减少的药物,在所述药物组合物中,以重量份计,其具体组分含量如下:A medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy. In the pharmaceutical composition, the content of its specific components is as follows in parts by weight:
红景天10份、西洋参9份、鹿角胶9份、淫羊藿12份、菟丝子12份、陈皮5份、白术10份、黄芪25份、当归10份、龙眼肉12份、仙鹤草20份、肿节风10份。10 parts of rhodiola rosea, 9 parts of American ginseng, 9 parts of deer horn glue, 12 parts of epimedium, 12 parts of dodder, 5 parts of tangerine peel, 10 parts of Atractylodes macrocephala, 25 parts of astragalus, 10 parts of angelica, 12 parts of longan meat, 20 parts of Agrimony , 10 parts of sarcomas.
具体制备方法如下:The specific preparation method is as follows:
同实施例1。With embodiment 1.
实施例5Example 5
一种治疗放化疗所致血小板减少的药物,在所述药物组合物中,以重量份计,其具体组分含量如下:A medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy. In the pharmaceutical composition, the content of its specific components is as follows in parts by weight:
红景天12份、西洋参10份、鹿角胶10份、淫羊藿15份、菟丝子15份、陈皮6份、白术10份、黄芪40份、当归15份、龙眼肉18份、仙鹤草25份、肿节风15份。12 parts of rhodiola rosea, 10 parts of American ginseng, 10 parts of deer horn glue, 15 parts of epimedium, 15 parts of dodder, 6 parts of tangerine peel, 10 parts of Atractylodes macrocephala, 40 parts of astragalus, 15 parts of angelica, 18 parts of longan meat, 25 parts of Agrimony , 15 parts of sarcomas.
具体制备方法如下:The specific preparation method is as follows:
同实施例1。With embodiment 1.
实施例6Example 6
一种治疗放化疗所致血小板减少的药物,在所述药物组合物中,以重量份计,其具体组分含量如下:A medicine for treating thrombocytopenia caused by radiotherapy and chemotherapy. In the pharmaceutical composition, the content of its specific components is as follows in parts by weight:
红景天6份、西洋参5份、鹿角胶4份、淫羊藿8份、菟丝子6份、陈皮4份、白术6份、黄芪15份、当归5份、龙眼肉12份、仙鹤草12份、肿节风6份。6 parts of rhodiola, 5 parts of American ginseng, 4 parts of deer horn glue, 8 parts of epimedium, 6 parts of dodder, 4 parts of tangerine peel, 6 parts of Atractylodes macrocephala, 15 parts of astragalus, 5 parts of angelica, 12 parts of longan meat, 12 parts of Agrimony , 6 parts of sarcomas.
具体制备方法同实施例1。Concrete preparation method is with embodiment 1.
病例及临床效果:Cases and clinical effects:
病例:case:
王某,男,72岁。2013年9月8日初诊。Wang, male, 72 years old. First visit on September 8, 2013.
患者因咳嗽憋气,痰中带血4月,诊断为右肺癌,胸腔积液,病理为中分化腺癌。已经行化疗(泰索帝+顺铂)4周期,并行放射治疗10次。今化验血常规示白细胞2.20×109/L,血小板计数72×109/L,血红蛋白102g/L。KPS评分40分。现症见干咳,乏力、气短,头晕,怕冷,纳差,便溏,小便黄,无明显皮下及牙龈出血。舌胖,舌质淡红,苔薄白,脉弱。诊断为肺癌化放疗后,血小板减少。The patient was holding his breath due to coughing and had bloody sputum for 4 months. He was diagnosed with right lung cancer and pleural effusion. The pathology was moderately differentiated adenocarcinoma. Chemotherapy (taxotere + cisplatin) has been performed for 4 cycles, and radiation therapy has been performed 10 times. Today's routine blood test showed white blood cells 2.20×10 9 /L, platelet count 72×10 9 /L, and hemoglobin 102g/L. The KPS score is 40 points. Symptoms include dry cough, fatigue, shortness of breath, dizziness, fear of cold, poor appetite, loose stools, yellow urine, no obvious subcutaneous and gingival bleeding. Fat tongue, pale red tongue, thin white fur, weak pulse. Thrombocytopenia was diagnosed after chemoradiotherapy for lung cancer.
辩证:脾肾虚损,气血两虚。Dialectical: Deficiency of the spleen and kidney, deficiency of both qi and blood.
治法:补肾填精,益气养血。Governing law: tonify the kidney and essence, replenish qi and nourish blood.
处方:红景天10g、西洋参6g、鹿角胶6g、淫羊藿15g、菟丝子20g、陈皮6g、炒白术12g、黄芪40g、当归10g、龙眼肉20g、仙鹤草20g、肿节风10g。以上为每日的剂量。Prescription: Rhodiola rosea 10g, American ginseng 6g, deer horn glue 6g, epimedium 15g, dodder seed 20g, tangerine peel 6g, fried Atractylodes macrocephala 12g, astragalus 40g, angelica 10g, longan meat 20g, agrimony 20g, sarcophagus 10g. The above is the daily dosage.
上述处方按照实施例1制成颗粒剂。每日3次,每次1袋,开水冲服。Above-mentioned prescription is made granule according to embodiment 1. 3 times a day, 1 bag each time, take with boiling water.
二诊:9月14日,患者服药后咳嗽减轻,乏力、气短明显减轻,无头晕及低热,饮食增加,二便正常,舌淡红略胖,苔薄白,脉弱,复查血常规示白细胞4.12×109/L,血小板计数103×109/L,血红蛋白102g/L,予上药继服7天。Second visit: On September 14, after taking the medicine, the patient’s cough was relieved, fatigue and shortness of breath were significantly relieved, no dizziness and low-grade fever, diet increased, stools were normal, the tongue was light red and slightly fat, the fur was thin and white, and the pulse was weak. The blood test showed white blood cells 4.12×10 9 /L, platelet count 103×10 9 /L, hemoglobin 102g/L, and continued to take medicine for 7 days.
三诊:9月21日,患者轻微咳嗽乏力,活动时气短,饮食睡眠正常,大小便正常。KPS评分60分,化验血常规示白细胞5.22×109/L,血小板计数121×109/L,血红蛋白106g/L,血象恢复正常。Third visit: On September 21, the patient had a slight cough and fatigue, shortness of breath during activities, normal diet and sleep, and normal bowel movements. The KPS score was 60 points, the routine blood test showed white blood cells 5.22×10 9 /L, platelet count 121×10 9 /L, hemoglobin 106g/L, and the blood picture returned to normal.
张某,男,25岁。2014年4月27初诊。Zhang, male, 25 years old. First visit on April 27, 2014.
患者因左上腹部疼痛不适,消瘦半年,查胃镜诊断为胃癌,术后诊断:胃低分化腺癌IV期(T3N3M0),已经化疗4周期(替吉奥+奥沙利铂),目前仍服用替吉奥。化验血常规示白细胞2.40×109/L,血小板计数68×109/L,血红蛋白96g/L,KPS评分40分,现证见刷牙时牙龈出血,周身乏力,四肢酸软,活动时心悸,恶心,纳差,嗳气,恶寒,体重下降,大便略干,2日一次,舌略胖,边有齿痕,舌质淡红有瘀点,苔薄白,脉细弱。诊断为胃癌术后化疗后,血小板减少。The patient suffered from pain and discomfort in the left upper abdomen and lost weight for half a year. Gastric cancer was diagnosed by gastroscopy. Postoperative diagnosis: gastric poorly differentiated adenocarcinoma stage IV (T 3 N 3 M 0 ), and 4 cycles of chemotherapy (S-1 + Oxaliplatin) , still taking S-1. Routine blood test showed white blood cells 2.40×10 9 /L, platelet count 68×10 9 /L, hemoglobin 96g/L, KPS score 40 points, bleeding gums when brushing teeth, general fatigue, limp limbs, palpitations and nausea during activities , anorexia, belching, aversion to cold, weight loss, slightly dry stool, once every 2 days, a slightly fat tongue with tooth marks on the sides, pale red tongue with petechiae, thin white fur, thready and weak pulse. Thrombocytopenia was diagnosed after postoperative chemotherapy for gastric cancer.
辩证:脾肾两虚,气血不足。Dialectical: Deficiency of spleen and kidney, deficiency of qi and blood.
治法:补肾健脾,益气养血。Governing method: tonify the kidney and spleen, replenish qi and nourish blood.
处方:红景天10g、西洋参12g、鹿角胶6g、淫羊藿12g、菟丝子20g、陈皮8g、白术15g、黄芪30g、当归10g、龙眼肉20g、仙鹤草20g、肿节风10g。以上为每日的剂量。Prescription: Rhodiola 10g, American ginseng 12g, antler gum 6g, epimedium 12g, dodder 20g, tangerine peel 8g, Atractylodes macrocephala 15g, astragalus 30g, angelica 10g, longan meat 20g, agrimony 20g, sarcophagus 10g. The above is the daily dosage.
上述处方按照实施例1制成浓缩丸剂服用,每日3次,每次1袋,开水送服。服用7天后诸症好转,复查白细胞4.10×109/L,血小板计数103×109/L,血红蛋白105g/L;服药14天后临床症状消失,复查血常规示白细胞5.90×109/L,血小板计数133×109/L,血红蛋白112g/L,KPS评分70分。以后继续服上药,又化疗2周期,无明显不适,复查血常规均正常,未再复发。Above-mentioned prescription is made into concentrated pill and taken according to embodiment 1, every day 3 times, each 1 bag, boiled water delivery service. After taking the medicine for 7 days, all the symptoms improved. The white blood cell count was 4.10×10 9 /L, the platelet count was 103× 10 9 /L, and the hemoglobin was 105g/L. After taking the medicine for 14 days, the clinical symptoms disappeared. The count was 133×10 9 /L, the hemoglobin was 112g/L, and the KPS score was 70 points. Continue to take the medicine in the future, and chemotherapy for 2 cycles, no obvious discomfort, reexamination blood routine is normal, no recurrence.
林某,男,58岁。2013年6月18日初诊。患者2月前查体发现胸部占位病变,经查胸部CT及PET-CT诊断为胸腺恶性肿瘤,双肺内转移,纵膈淋巴结转移,锁骨上淋巴结转移,穿刺活检病理示鳞状细胞癌,考虑原发为胸腺癌。已经于5月10日及6月2开始予GP+恩度方案化疗2周期。化疗反应明显。现症见头晕、乏力、活动时气短,食少,畏寒喜暖,腰膝酸软,双下肢见较多皮下出血点,有些融合成片,刷牙或吸吮时可见牙龈出血。舌体胖大边有齿痕,舌质淡,舌苔薄白,脉细弱。查血常规白细胞2.30×109/L,血小板计数36×109/L,血红蛋白106g/L。KPS评分40分。Lin, male, 58 years old. First visit on June 18, 2013. The patient had a chest mass-occupying lesion found in a physical examination two months ago. Chest CT and PET-CT were diagnosed as a thymic malignant tumor with metastases in both lungs, mediastinal lymph nodes, and supraclavicular lymph nodes. Squamous cell carcinoma was found in biopsy pathology. Consider primary thymic carcinoma. On May 10 and June 2, 2 cycles of chemotherapy with GP+Endostar regimen have been started. Chemotherapy response was obvious. Symptoms include dizziness, fatigue, shortness of breath during activities, lack of food, chills and warmth, weakness of the waist and knees, many subcutaneous hemorrhages in the lower limbs, some fused into flakes, and bleeding gums can be seen when brushing teeth or sucking. The tongue is fat and big with tooth marks on the sides, the tongue is pale, the tongue coating is thin and white, and the pulse is thready and weak. The blood routine white blood cell count was 2.30×10 9 /L, the platelet count was 36×10 9 /L, and the hemoglobin was 106g/L. The KPS score is 40 points.
辨证:脾肾阳虚,气血不足,气不摄血Syndrome differentiation: Deficiency of spleen and kidney yang, deficiency of qi and blood, failure of qi to absorb blood
治法:温阳补肾,益气摄血补血Therapeutic method: warming the yang and tonifying the kidney, replenishing qi and nourishing the blood
处方:红景天15g、西洋参10g、鹿角胶10g、淫羊藿15g、菟丝子12g、陈皮6g、白术10g、黄芪50g、当归10g、龙眼肉20g、仙鹤草30g、肿节风15g。以上为每日的剂量。Prescription: Rhodiola rosea 15g, American ginseng 10g, antler glue 10g, epimedium 15g, dodder seed 12g, tangerine peel 6g, Atractylodes macrocephala 10g, astragalus 50g, angelica 10g, longan meat 20g, agrimony 30g, sarcophagus 15g. The above is the daily dosage.
上述药物按照实施例1制成胶囊剂。每日3次,每次4粒,开水送服。Above-mentioned medicine is made capsule according to embodiment 1. 3 times a day, 4 capsules each time, take with boiled water.
二诊:7月5日,患者服药7天,头晕乏力减轻,气短好转,饮食增加,睡眠好转,畏寒减轻,无新的皮下出血点,刷牙时可见少许牙龈出血。复查血常规白细胞3.70×109/L,血小板计数62×109/L,血红蛋白108g/L,KPS评分60分,予继续服上药。Second visit: On July 5, the patient took the medicine for 7 days. The dizziness and fatigue were relieved, the shortness of breath was improved, the diet was increased, the sleep was improved, the chills were relieved, no new subcutaneous bleeding points, and a little gum bleeding was seen when brushing teeth. Recheck blood routine white blood cell 3.70×10 9 /L, platelet count 62×10 9 /L, hemoglobin 108g/L, KPS score 60 points, continue to take medicine.
三诊:7月12日,患者无明显头晕,轻度乏力,活动时气短较前明显减轻,饮食睡眠正常,无皮下出血点,无刷牙时牙龈出血。KPS评分70分。复查血常规白细胞4.2×109/L,血小板计数98×109/L,血红蛋白113g/L。后随访瞩继续服本药,又继续化疗2周期,病情好转,未再出现血小板及白细胞减少。Third visit: On July 12, the patient had no obvious dizziness, mild fatigue, shortness of breath during activities was significantly reduced compared with before, normal diet and sleep, no subcutaneous bleeding points, and no bleeding gums when brushing teeth. The KPS score is 70 points. Check blood routine white blood cell 4.2×10 9 /L, platelet count 98×10 9 /L, hemoglobin 113g/L. Follow up a case by regular visits to after and continue to take this medicine, continue chemotherapy for 2 cycles again, the state of an illness takes a turn for the better, and thrombocytopenia and leukopenia do not occur again.
马某,男,59岁。2014年3月13日初诊。Ma, male, 59 years old. First visit on March 13, 2014.
患者2月前因反复腹痛,腰部疼痛,查CEA及CA-199明显升高,经CT检查及PET-CT检查诊断为胰腺癌,腹膜后淋巴结转移。已予GP方案化疗(吉西他滨1000mg/m2,静滴q1,q8;顺铂25mg/m2,静滴,q1-3)共2周期。现患者乏力,头晕,腰痛,困倦,恶心,食欲差,饮食少,大便稀,睡眠差,下肢皮下见针尖样出血点,刷牙时牙龈出血。舌淡嫩胖,舌边有齿痕,苔薄白,脉细弱。查血常规白细胞3.30×109/L,血小板计数56×109/L,血红蛋白108g/L。KPS评分50分。The patient had repeated abdominal pain and low back pain two months ago, and the CEA and CA-199 levels were significantly increased. He was diagnosed with pancreatic cancer and retroperitoneal lymph node metastasis by CT examination and PET-CT examination. GP regimen chemotherapy (gemcitabine 1000mg/m 2 , intravenous infusion q1, q8; cisplatin 25mg/m 2 , intravenous infusion, q1-3) has been given for 2 cycles. The present patient is fatigued, dizzy, lumbago, drowsy, nausea, poor appetite, lack of diet, loose stool, poor sleep, pinpoint-like bleeding points under the skin of the lower limbs, and bleeding gums when brushing teeth. The tongue is pale and tender, with tooth marks on the edge of the tongue, thin white fur, thready and weak pulse. The blood routine white blood cell count was 3.30×10 9 /L, the platelet count was 56×10 9 /L, and the hemoglobin was 108g/L. The KPS score is 50 points.
辨证:脾肾亏虚,气不摄血Syndrome differentiation: Deficiency of the spleen and kidney, Qi does not absorb blood
治法:健脾补肾,益气摄血Treatment method: invigorate the spleen and kidney, replenish qi and absorb blood
治疗:予实施例6的药物组合制成片剂,每日3次口服治疗,每次剂量相当于生药9g。Treatment: the medicine combination of Example 6 is made into tablet, and it is orally treated 3 times a day, and each dose is equivalent to crude drug 9g.
二诊:3月20日,患者服药7天,乏力头晕减轻,困倦好转,无恶心,饮食增加,大便略稀,畏寒减轻,睡眠好转,皮下出血点已消散,刷牙时可见少许牙龈出血。复查血常规白细胞3.90×109/L,血小板计数78×109/L,血红蛋白108g/L,KPS评分60分,予继续服上药。三诊:7月12日,患者无明显头晕,轻度乏力,活动时气短较前明显减轻,饮食睡眠正常,大小便正常,无皮下出血点,无刷牙时牙龈出血。KPS评分70分。复查血常规白细胞4.2×109/L,血小板计数106×109/L,血红蛋白111g/L。予继续服药治疗,准备继续化疗。Second visit: On March 20, the patient took the medicine for 7 days, the fatigue and dizziness were relieved, the drowsiness improved, no nausea, the diet increased, the stool was slightly loose, the chills were relieved, the sleep improved, the subcutaneous bleeding spots had dissipated, and a little gum bleeding could be seen when brushing teeth. Recheck blood routine white blood cell 3.90×10 9 /L, platelet count 78×10 9 /L, hemoglobin 108g/L, KPS score 60 points, continue to take medicine. Third visit: On July 12, the patient had no obvious dizziness, mild fatigue, shortness of breath during activities was significantly reduced compared with before, normal diet and sleep, normal bowel movements, no subcutaneous bleeding points, and no bleeding gums when brushing teeth. The KPS score is 70 points. Check blood routine white blood cell 4.2×10 9 /L, platelet count 106×10 9 /L, hemoglobin 111g/L. I continued to take medication and prepared to continue chemotherapy.
临床:clinical:
本发明药物组合物经临床治疗肿瘤放化疗所致血小板减少患者62例,所有患者均经细胞学、病理组织学或影像学检查确诊为恶性肿瘤,经化疗引起血小板减少,伴有白细胞或血红蛋白下降。其中男41例,女21例,年龄25-75岁,平均59岁;肺癌21例,胰腺癌12例,乳腺癌8例,胃癌13例,大肠癌8例。所用化疗药物包括吉西他滨、培美曲塞、环磷酰胺、顺铂、替吉奥、多西他赛、奥沙利铂等,已经化疗2~4个疗程,有些患者同时或先后进行放射治疗。The pharmaceutical composition of the present invention has been used to clinically treat 62 patients with thrombocytopenia caused by tumor radiotherapy and chemotherapy. All patients were diagnosed as malignant tumors by cytology, histopathology or imaging examination. . Among them, there were 41 males and 21 females, aged 25-75 years, with an average of 59 years old; 21 cases of lung cancer, 12 cases of pancreatic cancer, 8 cases of breast cancer, 13 cases of gastric cancer, and 8 cases of colorectal cancer. The chemotherapeutic drugs used include gemcitabine, pemetrexed, cyclophosphamide, cisplatin, S-1, docetaxel, oxaliplatin, etc. 2 to 4 courses of chemotherapy have been given, and some patients have received radiation therapy simultaneously or successively.
诊疗方案:使用本发明所述药物,根据患者症状选择实施例1-6的药物配比方案,进行服用。Diagnosis and treatment scheme: use the medicine described in the present invention, select the medicine proportioning scheme of Embodiment 1-6 according to the patient's symptoms, and take it.
血小板减少诊断及疗效标准:放化疗所致血小板减少按照世界卫生组织抗肿瘤药物毒副反应的分级标准(WHO,1979)诊断,并参考有关文献疗效标准判断疗效。Thrombocytopenia diagnosis and curative effect standard: The thrombocytopenia caused by radiotherapy and chemotherapy is diagnosed according to the grading standard of antineoplastic drug toxicity (WHO, 1979), and the curative effect is judged by referring to the curative effect standard of relevant literature.
显效:血小板升至100×109/L以上;Significantly effective: platelets rise above 100×10 9 /L;
有效:血小板已回升到2倍或以上但仍未至100×109/L;Effective: platelets have recovered to 2 times or more but still not to 100×10 9 /L;
无效:达不到显效及有效评定标准者。Invalid: Those who fail to meet the markedly effective and effective evaluation standards.
治疗结果见下表(表1,表2):Treatment results are shown in the following table (Table 1, Table 2):
表1.治疗后血小板疗效 例(%)Table 1. Platelet curative effect after treatment Cases (%)
表2.治疗前后血小板减少严重程度的分布例数 例Table 2. Number of cases distributed by severity of thrombocytopenia before and after treatment
患者症状变化评定采用5分度计量,治疗后下降≥1度为好转,增加≥1度为恶化,下降或增加不足1度为稳定。生活质量评定参照KPS评分,提高≥10分为好转,减少≥10分为恶化,提高或减少不足10分为稳定。结果见下表(表3)。The change of symptoms in patients is evaluated on a 5-point scale. After treatment, a decrease of ≥1 degree is considered improvement, an increase of ≥1 degree is defined as deterioration, and a decrease or increase of less than 1 degree is considered stable. The quality of life was evaluated with reference to the KPS score. An improvement of ≥10 points was considered improvement, a decrease of ≥10 points was considered deterioration, and an increase or decrease of less than 10 points was considered stable. The results are shown in the table below (Table 3).
表3治疗后患者症状及KPS评分好转率 例(%)Table 3 The improvement rate of patients' symptoms and KPS score after treatment Cases (%)
上述临床研究表明:本发明药物组合物临床治疗的62例放化疗所致血小板减少患者,治疗2周后显效49例,有效10例,无效3例,总有效率达到95.2%。经治疗患者各项临床症状也明显改善,生活质量提高,未出现症状恶化者。The above clinical research shows that: 62 cases of patients with thrombocytopenia caused by radiotherapy and chemotherapy were clinically treated with the pharmaceutical composition of the present invention. After 2 weeks of treatment, 49 cases were markedly effective, 10 cases were effective, and 3 cases were ineffective. The total effective rate reached 95.2%. After treatment, the clinical symptoms of the patients were also significantly improved, and the quality of life was improved, and no symptoms worsened.
同时经临床观察本发明药物组合物未见毒副作用。Simultaneously, the pharmaceutical composition of the present invention has no toxic and side effects through clinical observation.
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