摘要
目的：通过对本研究进行回顾性研究、临床疗效分析、实验研究等三部分，对多发性肌炎(Polymyositis，PM)及皮肌炎(Dermatomyositis，DM)的临床特点及治疗用药规律等进行分析与总结，观察加味四妙散对实验性多发性肌炎湿热证型的治疗作用与疗效，结合实验结果进一步阐明加味四妙散治多发性肌炎／皮肌炎的意义所在。以求探索其相对安全可靠的治疗新方法，为指导用药提供临床及实验依据。
方法：1．回顾性分析80例患者资料(35例DM，45例PM)。根据PM／DM患者的临床资料，纪录其初诊症状、体征、舌脉、处方用药、肌酶、肌电图、肌肉活检、首次主任医师或教授查房所开中药处方、住院期间主要用药情况等进行统计并加以研究。
2．严格按照纳入标准将40例PM／DM临床患者分为治疗组和对照组各20例，分别观察两组患者治疗前后的中医临床症状、肌力、肌肉压痛、血清酶学、激素用量及其副作用发生率、总疗效等指标。
3．动物实验是采用免疫注射的方法，结合湿热证造模的方法制作豚鼠多发性肌炎湿热证模型，并应用病理、电镜、肌电图、血清肌酶谱检测等手段，观察应用加味四妙散和强的松等药物治疗，进行分组干预对比其疗效。
结果：1．回顾性研究发现40～60岁患该病的患者占51.25％，男女之比为1：1.7。血清肌酶增高，以LDH最为敏感。肌肉病理阳性率高于肌电图。本病虚实夹杂，以脾虚为本，以湿热蕴结为标，DM是以湿热、气阴两虚为主，涉及肺脾肾三脏；PM是以湿热浸淫为主，涉及肝脾肾三脏。在中医治疗用药中，肺(大肠)、脾(胃)、肾(膀胱)三个系统出现频率最高占前三位，显示出此类疾病的治疗以肺脾肾为主。这与刘友章教授的观点相吻合，与近年大多数学者报道的结果相似。
2．临床研究结果表明：治疗组与对照组均能有效改善患者的肌力、肌肉压痛、血清酶学等，治疗组的中医临床症状较对照组明显改善且激素用量明显低于对照组，副作用少。加味四妙散结合激素治疗可显着改善患者的临床症状，较快地稳定病情，且中药可对抗激素的副作用，有利于顺利撤减激素，为临床治疗该病提供了一种新的分法。
3．实验研究结果显示：豚鼠致病后第4周起即出现血清CK、LDH、AST逐步而显着的升高，病变主要表现为散在分布的节段性肌纤维坏死，坏死区、肌间质肌纤维变性和大量炎细胞浸润、肝炎及间质性肺炎为主的病变。多发性肌炎湿热型动物模型造模成功。在第8周治疗一周后，治疗组各组(C-G组)能不同程度的改善豚鼠的电生理作用，减轻肌肉的肌原性损害，以加味四妙散高剂量组、强的松组及中西药组的疗效最佳，三组间比较无显著性差异，疗效相当；各治疗组豚鼠血清CK、LDH、AST有不同程度的控制，而以中西药组能更好的控制血清肌酶的升高，其次是加味四妙散高剂量组；骨骼肌的炎性改变以加味四妙散高剂量组的炎症消减和肌细胞修复最为显着，炎症明显局限化，中西药组的间质性肺炎情况的改善程度优于强的松组，肺炎呈局灶性，炎性细胞浸润少，而肝炎、肝脂肪样变以加味四妙散高剂量组的治疗效果最优。
结论：1．据此可知，若40～60岁年龄段的女性若出现皮疹伴肌痛、肌无力，应首先考虑炎性肌病。PM／DM的基本证型为脾气亏虚、湿热蕴结。以肺脾肾为主，兼顾他脏，需多脏同治。刘教授根据多年的临床经验提出加味妙散治疗脾虚湿热型PM／DM并应用岭南中药治疗该病屡获良效，值得进一步研究。
2．加味四妙散与激素同用的中西医结合方法，治疗脾虚湿热型PM／DM具有安全及稳定性的疗效，可减少激素、免疫抑制剂用量及毒副作用和并发症，可长期应用。中药复方结合激素治疗PM／DM符合中西医结合治疗自身免疫性疾病这一大趋势。
3．加味四妙散高剂量组对细胞免疫反应有显着的抑制作用，控制炎性细胞浸润，与调节机体的整体免疫状态有关。其对PM的治疗，不仅改善肌肉病变，亦有防治并发症发生的作用。
Purpose:
The thesis is divided into three parts: the reviewing analysis, the clinical curativeanalysis and the animal experimental study. It concludes the analysis and thesummary of clinical characteristic of Polymyositis (PM) and Dermatomyositis (DM),and the therapeutic use of medicine in observing the clinical cure of theJiaWeiSiMiaouSan on experimental dampness-heat animal model of PM.Furthermore, we can expound the treatment of JiaWeiSiMiaouSan on PM/DM incombining all the above treatments with the experimental results. It is also exploringa safe and new method of therapy in offering the use of clinical application for itsreliability.
Methods:
1. It consists of eighty reviewing analytical cases, thirty-five cases of DM andforty-five cases of PM. According to PM/DM patients' clinical information, wenote down the first visit symptom, solicit the body, tongue, pulse-taking,prescription, serum of muscle enzyme, the electric picture of skin, live-muscleexamine, the first time traditional Chinese medicine (TCM) prescription byprofessor, and the mainly used medicine during in hospital.
2. Clinical analysis: of 40 PM/DM patients, they are divided into two groups, thetreating group and the contrasting group, twenty patients for each group.Observing the symptom of two groups before and after being treated byJiaWeiSiMiaouSan, they are muscular strength, muscle tenderness, the serumenzyme, hormone consumption, side effects and curative effects.
3. The experiment adopts the immunity inject method in combining dampness-heatanimal PM model of cavy. The thesis uses pathology, electric mirror, theelectric picture of skin and the serum skin enzyme table to measure etc. Thesemethods are to observe the treated difference of TCM (JiaWeiSiMiaouSan) andprednisone.
Result:
1. The reviews show that the patients who suffer from this disease accounts for51.25% around the ages of forty to sixty years old, and the ratio of men towomen are 1: 1.7. The serum of muscle enzyme increases, specially sensitivein LDH. Pathological positive rates of the muscle are more obvious than theelectric picture of skin. The disease, itself to TCM, is the mixture of excessivefunction and hypo function in which the spleen asthenia occurs to be the primaryfactor and the dampness-heat appears to be the secondary. There are two mainfactors of DM, the dampness-heat and the deficiency of qi and ying, involvingthree zang-viscera: lung, spleen and kidney. PM is mainly with accumulationof dampness and heat, involving three zang-viscera: liver, spleen and kidney. Inthe therapy of Chinese Traditional Medicine (TCM), lung (large intestine),spleen (stomach) and kidney (bladder) systems rank to be the top three fortreating the disease. This means that the core of treating this kind of disease islung, spleen and kidney systems. This is identical with the point-view ofprofessor Liu You Zhang in treating the disease, and also similar with the scholarreports of recent years.
2. The clinical study shows that the treating group and the contrasting group bothcan improve the patient's muscular strength, muscle tenderness, serum enzymeetc. Effectively, the clinical symptom of TCM treated group improves muchmore obvious than the contrasting group. The hormone consumption of theTCM treated group is obviously lower than the contrasting group with fewer sideeffects. JiaWeiSiMiaouSan can obviously improve patients' symptom andstabilize the disease. It can also oppose the side effects of the hormone, thishelps patients to reduce and dismiss from the hormone smoothly, and can alsooffer a new way of treatment for treating the disease.
3. The experiment shows that the serum of the cavies, the fourth week after thecavies being ill, appears promptly rising progressively in serum's CK, LDH andAST. The pathological change is shown as mainly the segment muscle fiberdistributed and necrosis, necrotizing area, the quality among the skin big musclefiber changes, and also a large number of inflammation cells soak into liver, lungand muscle. After the eighth week, being treated for one week, treating groupsC-G had various changes in electrical physiological function, lightens the muscledamages, especially in group C, F group and G group. There are no significantdifferences among three groups. Each treating group has its CK, LDH and ASTunder control in various degrees. G group shows the best control in serumenzyme; secondly is group C. The skeleton of skin change subdue withinflammation in C group with the best cell repair apparently. The inflammationis limited. The improvement degree of the pneumonia situation of G group is better than group F. The pneumonia presents as limited with fewer soakedinflammation cells. Group C shows the best result in treating hepatitis and fattyliver.
Conclusion:
1. Accordingly, if women, at the age of forty to sixty, happen to have rash withmuscle aches and muscle weakness, PM/DM should first be considered. Thebasic type of PM/DM is spleen asthenia and accumulation dampness and heat.Treatment involves multi-viscera, treating lung, spleen and kidney as primary,and other viscera should be considered as well. Professor Liu You Zhang,according to years of experience in treating the disease, JiaWeiSiMiaouSan withTCM of south of the Five Ridges in treating the dampness-heat type of PM/DMhas repeatedly won a good result. It is worth to study in depth.
2. The therapy, JiaWeiSiMiaouSan with hormone, is the combination of TCM andwestern medicine. It shows the security and the stability in treating spleen asthenia-dampness-heat kind of PM/DM. It can reduce the hormone, the immune inhibitorconsumption, the poisonous side effect and complication. Therefore, the therapycan be applied for the long run in'treating the disease. Moreover, the therapy, TCMcombines with hormone, will be the main trend of treating PM/DM in the therapyfield of combining TCM and western medicine.
3. The high dosage group of JiaWeiSiMiaouSan shows the inhibition to cells'immune response. It can control the soaked inflammation cells, and alsoregulate the immune system. JiaWeiSiMiaouSan not only can improve themuscle pathological change, but also have the function of preventing and curingthe disease.
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