益气养血活血方治疗激素无效特发性血小板减少性紫癜初步临床探索
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摘要
特发性血小板减少性紫癜(idiopathic thrombocytopenic purpura, ITP)是血液系统常见多发疾病之一,其主要临床表现为皮肤黏膜或内脏出血。糖皮质激素是其一线治疗首选药物,但一部分患者经糖皮质激素治疗无效,另有部分患者长期使用产生激素依赖及激素抵抗,发生明显不良反应,导致病情迁延难愈,严重影响患者的生活质量。其他疗法诸如免疫抑制剂、脾脏切除等疗效有限,且临床应用受到一定程度的限制。
     ITP属于中医“血证”等范畴,临床以“脾气虚弱,气不摄血”为基本病机。我们通过临床观察发现,ITP患者以“气血两虚、气不摄血”型为多,结合兼有血瘀的证候特点,确立“益气养血活血法”为基本治疗原则,以“益气养血活血方”为治疗药物,观察治疗了40例应用激素治疗无效的ITP患者,初步总结了临床疗效。
     根据研究方案,将符合ITP诊断标准与中医“气血两虚、气不摄血”证型标准的45例患者纳入临床观察,疗程结束时,可供统计的有效病例40例。研究结果显示:①按ITP疾病总疗效标准,显效3例,占7.50%;良效16例,占40.00%;进步19例,占47.50%;无效2例,占5.00%;总显效率与总有效率分别为47.50%与95.00%。②按ITP证候疗效判定标准,临床痊愈1例,占2.50%;显效31例,占77.50%;有效8例,占20.00%;无效0例,占0.00%;证候改善总显效率与总有效率分别为80.00%,与100.00%。③临床症状总评分从治疗第8周起与治疗前比较差异有统计学意义,P<0.05;疗程结束后,临床症状总评分与治疗前比较,有显著性差异,P<0.01;神疲乏力、气短懒言、头晕目眩、面色苍白或萎黄、出血症状各单项症状评分改善与治疗前比较,均从治疗第6周开始,差异有统计学意义,P<0.05,至疗程结束后,各单项症状评分与治疗前比较,均有显著性差异,P<0.01。④血小板计数从治疗第2周开始升高,与治疗前比较,差异有统计学意义,P<0.01。至疗程结束后,血小板计数与治疗前比较,有显著性差异,P<0.01。⑤治疗后骨髓颗粒型、裸核巨核细胞数与治疗前比较有所降低,差异无统计学意义,P>0.05;治疗后骨髓产板型、幼稚型巨核细胞较治疗前有所升高,差异有统计学意义,P<0.01。⑥益气养血活血方对18-60岁患者临床症状改善作用优于<18岁、>60岁患者,对中度、重度病情患者临床症状改善作用优于轻度病情患者。除此以外,性别、年龄、病程和治疗前病情对血小板计数的变化均无明显影响,P>0.05。性别、年龄、病程和治疗前病情对最终临床疗效均无明显影响,P>0.05。⑦应用益气养血活血方治疗过程中,仅10.00%的患者出现咽痛、便秘等不良反应,治疗均未受影响。综上所述,我们认为,益气养血活血方治疗激素无效ITP具有一定的临床疗效,并且安全性好,但其确切的临床疗效及作用机制尚待后续试验进一步探讨。
ITP(idiopathic thrombocytopenic purpura) is a kind of Immune Mediated Thrombocytopenia Syndrome,, and is one of commonly and frequently encountered diseases in hematological system, and its main clinical manifestation is skin mucous membrane (tunica mucosa) or internal organs (viscera) bleeding. Glucocorticoids is the prefer drug in its clinical therapy, but a part of patients with ITP is refractory to Glucocorticoids,while to treat some other patients for ITP with Glucocorticoids for a long period of time causes hormone dependent and hormonal resistance, which seriously influence the patients'living quality. Other therapies, such as immunosuppressive agents and spleen-ectomy etc, have limited therapeutic effect, and their clinical application is restricted to some extent.
     ITP belongs to the category of "hemorrhagic symptom"of TCM(traditional Chinese medicine), its basic pathogenesis is "deficiency-weakness of spleen-QI or QI failing to control blood " clinically. Through clinical observation we discover that most of ITP patients are the type "qi-blood asthenia and QI failing to control blood". According to the "zheng hou"features combining blood stasis, we set up a basic therapy principle of "fundoscopic and activating blood circulation method" and the therapy drugs of "Yiai Yangxue Huoxue Fang" and treat40cases of patients with ITP which are relapsed or refractory to glucocorticoids, then sum up the curative effect preliminarily.
     According to the research scheme, we bring45cases of patients into our clinical observation, which accord with the ITP diagnostic criteria and TCM criteria of "qi-blood asthenia or QI failing to control blood" pattern of syndrome. When the treatment period ends, there are40cases available. The research results indicate:1) According to ITP curative effect criteria, excellence3cases,7.50%; good16cases,40.00%; advance19cases,47.50%; inefficiency2cases,5.00%; the total excellence rate and the total efficiency rate are47.50%and95.00%respectively.2) According to TCM symptom criteria, clinic healing1case,2.50%; excellence31cases,77.50%; efficiency8cases,20.00%; inefficiency0case,0.00%; the total excellence rate and the total efficiency rate of clinical symptoms are80.00%and100.00%respectively.3) To compare the total scores of clinical symptoms counted from the eighth week of treatment, the differences have a statistical significance, P<0.05; after the time of therapy ends, there is a significant difference in the total score of clinical symptoms compared with prior treatment P0.05; the infantile dwarf and profile megacaryocyte count are higer, the differeces have statistical significance, P<0.01.6) The amelioration effect of "fundoscopic and activating blood circulation prescription" to clinical symptoms of the patients at the age of18-60outstrips the one at the age<18and at the age>60, while the curative effect to clinical symptoms of the midrange patients and severe patients outstrip the one of the mild patients. Except for this, gender, age, pathogenesis, and pathogenetic condition of prior treatment have no obvious influence on the change of the BPC, P>0.05. Gender, age, pathogenesis, and pathogenetic condition of prior treatment have not obvious influence on ultimum clinic curative effect, P>0.05.7) In the application process of "fundoscopic and activating blood circulation prescription", only10.00%patients have pharyngodynia and/or constipation etc, and all of the adverse reactions have not influence the overall treatment. To sum up the above, we consider that using "fundoscopic and activating blood circulation prescription" to treat hormonal inefficient ITP has a definite clinic curative effect and good reliability, but its exact clinic curative effect and mechanism of action need to be researched and approached further.
引文
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