MPS is a high-tech product of Sankyo Pharma""s advanced glycochemistry engineering. The starting material for MPS is obtained from organic tissue. In a multiple-step procedure, the extracted mucopolysaccharide is esterified to mucopolysaccharide polysulfate. The pharmacological properties are thus optimized.

多磺酸粘多糖（MPS)是通过三共制药先进的糖化工程技术生产的高科技产品。生产多磺酸粘多糖（MPS)的原料是从组织器官中提取的。经过一系列多步骤的程序，萃取的粘多糖被酯化成多磺酸粘多糖（MPS)。由此产生了最优化的药物有效成分。

 

 

 

 

 

The purified active substance is composed of alternating disaccharide units (glucuronic acid and N-acetyl galactosamine). The sulfate content is 14% by weight.  Each disaccharide unit contains on average 3 sulfate groups at varying binding sites.

MPS is structurally closely related to the constituents of the connective tissue, the acid  mucopolysaccharides, which are mainly responsible for the viscosity, permeability and water-binding capacity of tissues.

单纯的活性药物成分由若干交互的二糖单元（葡萄糖醛酸和N－乙酰－半乳糖胺）连结而成。硫酸盐的重量占 14%。每个二糖单位在不同的连接位点平均含有3个硫酸盐基团。多磺酸粘多糖（MPS)与结缔组织的主要成分－粘多糖酸在结构上非常类似。粘多糖酸的主要功能是维持组织的粘性、渗透性和保持水分的能力。

 

The polyvalent efficacy of MPS has been established in a large number of experimental and clinical studies. MPS has antithrombotic and anti-inflammatory actions, accelerates the resorption of haematomas and infiltrates and promotes the regeneration of connective tissue.

多磺酸粘多糖（MPS)的多种药效已经被大量的实验室和临床研究所证实。MPS具有抗血栓和抗炎作用，能加速血肿的吸收，并有渗透和促进结缔组织的再生作用。

 

MPS的规格:

 

Mean molecular weight:    9700 Dalton (polymolecularity index < 1.5)

Uronic acid content:         1.00-1.26 mmol/g

pH:                                     6.4 7.6

Optical rotation:                     10.0 to 15.0 degrees

平均分子量:          9700 道尔顿 ( 多分子性指数<1.5)

糖醛酸含量:           1.00-1.26 mmol/g

pH:                   6.4 7.6

旋光性:               10.0 到 15.0 度

 

 

MPS is a white/off-white powder without any smell, easily soluble in water. MPS can be dissolved without problems in the water-phase of water-in-oil or oil-in-water emulsions, as well as in most common water based gel systems.

MPS(多磺酸粘多糖）是没有任何气味的白色粉末,易溶于水。MPS(多磺酸粘多糖）不但能轻易地溶解于水包油的水相态或油包水的乳液态, 而且能轻易地溶解于以水为基质的凝胶系统。

 

 

 

 

 

The permeation of MPS into superficial tissue was demonstrated using a radioactive labeled substance as well as chemical-analytical and histochemical methods. Quantitative investigations have shown that MPS penetrates into deeper tissue layers and that therapeutic effective concentrations are achieved.

用放射活性标记物质、化学分析和组织化学法证实MPS(多磺酸粘多糖）能渗透入浅表组织。定量的观察还显示MPS(多磺酸粘多糖）不但能渗透入更深的组织层而且能达到有效的治疗浓度。

 

Stuttgen et al. reported the results of a highly interesting pharmacological study in human skin: The penetration rates of tritium-labeled MPS and tritium-labeled heparin were measured quantitatively and compared. In a perfusion chamber the creams were applied to freshly excised human skin.

Stuttgen等人报导了一项非常有趣的在人类皮肤表面进行的药理学研究的结论。这项研究定量地测定了氚标记的MPS（多磺酸粘多糖）和氚标记的肝素的透皮吸收率并进行了比较。在一灌注室，药膏被涂抹于新鲜的离体人类皮肤。

 

The results not only confirmed the absorption of MPS but also showed that the active ingredient reaches the individual dermal layers in therapeutic effective concentrations. The penetration rates of MPS were between 6 and 50 times of those of heparin. Repeated administration of MPS cream resulted in markedly enhanced levels.

研究结论证实MPS（多磺酸粘多糖）不但能透皮吸收，而且其活性成分能在各真皮亚层达到有效的治疗浓度。MPS（多磺酸粘多糖）的透皮吸率是肝素的6－50倍。反复涂抹MPS（多磺酸粘多糖）能显著提高吸收水平。

 

The percutaneous absorption of MPS was also shown histomorphologically in human skin (Elling).The use of special histochemical procedures in connection with the embedding of the samples in synthetic material make it possible to demonstrate the deposition and distribution of topically administered MPS.

MPS(多磺酸粘多糖)在人类皮肤的透皮吸收还在组织形态学方面得到了证实。在皮肤表面涂抹MPS(多磺酸粘多糖)后，药物在皮下的沉淀和扩散可以通过在局部埋置合成材料制成的采样物并应用特殊的组织化学法测量证实。

 

Excisions of human skin were treated with a cream containing MPS; the cream remained on these samples for 0.5-2 hours. The penetration of MPS becomes apparent by the pronounced metachromatic staining in corium and subcutis; i.e. cells, fibres and ground substance show an intense reddish-violet staining due to the deposition of MPS. The superficial epithelia cells do not bind the active ingredient and thus only serve as a transit area.

表皮切除后涂抹含有MPS(多磺酸粘多糖)的乳膏，药物在创面保持0.5-2小时。真皮和皮下组织的染色显示MPS(多磺酸粘多糖)制剂具有显著的渗透性；细胞、纤维组织和基质因MPS(多磺酸粘多糖)的沉淀而呈紫红色。浅表的上皮细胞并不与活性药物成分结合，因而只是运输区。

 

The untreated skin does not show any metachromatic staining. As this histochemical procedure does not show the endogenous mucopolysaccharides of the skin – in contrast to other organs such as the cornea – the detection of metachromasia in the corium and subcutis is a definite proof of the deposition of MPS in the skin.

其它未用药的皮肤区域无染色。由于这项组化反应并不显示皮肤的内源性MPS(多磺酸粘多糖)－这与角膜等其它组织不同－因此，在真皮和皮下组织检测到染色反应，明确地论证了MPS(多磺酸粘多糖)在皮肤的沉淀。

 

Chasseaud and Moore studied the absorption of MPS in rats after cutaneous application of MPS cream containing 40,000 U/100 g. The total absorption varied between 0.3 and approx. 4% in the first eight hours. After two to four days the absorption rates were between 1.7 and 4.6%. The examination of the urine specimens by gel chromatography and electrophoresis showed that the active ingredient excreted in the urine was partly unchanged and partly depolymerized to molecules of shorter chain lengths.

Chasseaud和Moore研究了MPS(多磺酸粘多糖)涂抹于大鼠皮肤后的吸收情况，所用的乳膏浓度为每100g含40,000U 多磺酸粘多糖。在用药后的8小时内总体吸收率在0.3％和约4％之间。用药后2到4天内，吸收率为1.7％至4.6％。用凝胶电泳色谱法检测尿液显示，尿液中的活性药物成分部分为原形，部分解聚成更短的分子链。

The reports presented above show that the polyanion MPS is able to penetrate the skin barrier and reach deeper tissue layers. MPS is stored in connective tissue cells, fibers, and the ground sub-stance of corium and subcutis, where, over longer periods of time, it reaches concentrations which must be considered biologically active. Metachromasia, electrophoresis, and gel chromatography have shown that the charge of MPS and its chain length remain unchanged.

上述研究报道显示，聚阴离子MPS(多磺酸粘多糖)能渗透皮肤屏障并能到达更深的组织层。MPS(多磺酸粘多糖)储存于结缔组织细胞、纤维组织以及真皮和皮下组织基质，并在经过更长一段时间后在该处达到具有生物活性的浓度。利用药物的变色反应性，电泳和凝胶色谱法显示MPS(多磺酸粘多糖)的电荷及其链长没有改变。

The question to what extent the results of experimental studies can be transferred to humans is always of particular interest. A number of pharmacological studies in humans as well as clinical studies are available, many of them with double-blind design, which tested Hirudoid / Hirudoid forte for their efficacy in a variety of disorders. The results in comparison to placebo strongly suggest that MPS is absorbed. Thus, these studies may also be interpreted as indirect proof of absorption.

这些试验研究的结论在多大程度上适用于人类始终是一非常有趣的问题。现有许多研究对象为人类的药理和临床研究，其中许多是双盲设计，用于观测喜疗妥/特强喜疗妥治疗各种疾病的有效性。这些结论与安慰剂对照，均提示MPS(多磺酸粘多糖)吸收非常良好。因此，这些研究还可以作为说明喜疗妥吸收性的间接证据。

 

MPS improves blood flow in the thrombophlebitic skin areas due to its antithromboric and fibrinolysis enhancing properties. It accelerates the dissolution of thrombi and improves the supply of the tissue with oxygen and nutrients.

由于其抗血栓和促纤溶作用，多磺酸粘多糖能提高血栓受累皮肤区域的血流量。它促进了血栓的溶解，并能增进组织氧气和营养的供给。

 

Infusion thrombophlebitis is a feasible condition to measure the antithrombotic and anti-inflammatory activities of a preparation. Several placebo-controlled studies in this indication provide objective evidence that topically applied Hirudoid and Hirudoid forte accelerate the regression of superficial thrombi and inflammation.

输注性血栓性静脉炎是一可用于检测制剂抗血栓和抗炎作用的切实可行的病理状态。几项安慰剂对照的临床研究，将喜疗妥和喜疗妥特强乳膏外用于输注性血栓性静脉炎，客观地论证了其能有效地治疗浅表血栓和炎症。

 

Mehta et al. conducted a placebo-controlled double-blind study in 100 patients with infusion thrombophlebitis. Treatment with Hirudoid or placebo was repeated daily for at least 5 days. Thrombus development was measured by means of the ¹²⁵I-fibrinogen test. In the Hirudoid group a significantly more rapid decline in radioactivity from the site of the thrombophlebitis was found compared to the placebo group (p < 0.001).

The decline in radioactivity probably represents lysis of thrombi and disappearance of radioactive fibrin/fibrinogen from locally accumulated inflammatory exudates. The more rapid regression of thrombosis under treatment with Hirudoid was associated with an accelerated relief of symptoms.

Mehta等人进行了一项安慰剂对照的双盲研究，试验对象为100例输注性血栓性静脉炎患者。每天反复使用喜疗妥或安慰剂，至少5天。血栓的变化用I¹²⁵标记的纤维蛋白原进行测量。喜疗妥组与安慰剂组对比，血栓性静脉炎部位的放射活性的下降要显著迅速得多(p < 0.001)。放射活性的下降提示了血栓的衰退和放射性纤维蛋白/蛋白原从炎症渗出局部消失。用喜疗妥治疗后，血栓衰退更迅速，这是与症状的加速改善相对应的。

 

 

 

 

 

 

 

 

 

A similar placebo-controlled double-blind study was performed with Hirudoid forte in 40 patients with infusion thrombophlebitis (Schedel et al.). Results of the 125l-fibrinogen test showed a continuous decrease in radioactivity in the Hirudoid forte group starting after the first day of treatment whereas in the placebo group an increase in radioactivity was measured up to the fifth day. The difference between both groups was statistically significant at all days. The faster elimination of radioactivity under treatment with Hirudoid forte corresponded with an earlier relief of clinical symptoms.

Schedel等人进行了一项相似的安慰剂对照双盲临床研究，用特强喜疗妥乳膏治疗40位输注性血栓性静脉炎患者。I¹²⁵纤维蛋白原测试显示在治疗开始后的第一天起特强喜疗妥组的放射活性就持续下降，而安慰剂组直至第五天仍可测量到增加的放射活性。两组间差异在治疗期间始终具有统计学意义。用特强喜疗妥治疗后伴随着放射活性的快速消退是临床症状的更早缓解。

 

Gorog et al. produced in vivo platelet thrombus formation by laser irradiation in the microvasculature of the hamster cheek pouche. The time required until occlusion of the venules and the duration of the occlusion were measured. Intravenously administered MPS prevented formation of thrombi and prolonged the time required until occlusion of the irradiated vessels. When MPS was applied topically as a 0.3 % cream, the time required until occlusion was also significantly increased and the "reperfusion" of the occluded vessel occurred much earlier than in the controls.

Gorog等人用激光辐射在鼠脸颊袋部的微脉管部位造成了血小板栓塞。测量了小静脉闭塞所需要的时间和闭塞的持续期。静脉应用多磺酸粘多糖预防了血栓的形成，并延长了受照射静脉闭塞所需的时间。当外用0.3%的多磺酸粘多糖乳膏时，闭塞所需要的时间也显著增加了，闭塞静脉的再灌注也比对照组早得多。

 

Walther et al. documented the antithrombotic efficacy of Hirudoid in a comparative animal study. After the administration of Hirudoid thrombi induced in the ear vein of the mouse were dissolved within a few days and the affected vascular systems were rechannelled. When compared to the reference group, treated with cream base, a clear shortening of the mean thrombus length was seen after the administration of Hirudoid.

在另一相当的动物研究中，Walther等人同样论证了喜疗妥的抗血栓作用。涂抹喜疗妥后，小鼠耳静脉的人造栓塞在很短的几天内很快分解了。而与用软膏基质的对照组相比，应用喜疗妥后平均血栓长度明显缩短。

 

 

 

 

 

 

 

 

 

 

According to Campos et al., the administration of MPS cream leads to an improvement of blood flow in transplants. This effect can be considered to be a result of the activation of endogenous fibrinolysis. The blood flow in myocutaneous lobes that were re-implanted in rats after injection of ¹³¹iodine improved statistically significantly on the third day after the operation during a treatment with MPS cream in comparison to the control group. The clinical control on the 18^th day after the operation showed that the necrotizing tendency of the tissue was clearly decreased under the treatment with MPS and that at the same time hydration was increased. The improved oxygen supply to the tissue is of functional importance.

据Campos等人的研究，应用多磺酸粘多糖乳膏可使被移植物的血流量增加。这一作用可以看成是内源性纤维蛋白溶解被激活的结果。与对照组相比较，用喜疗妥乳膏治疗组在术后第三天，大鼠被移植物内I¹³¹显著提高了，并具有统计学差异。术后第18天，用多磺酸粘多糖治疗组组织的坏死倾向显著降低了，而水合作用增加了。同时，氧供的增加对组织的功能相当重要。

 

 

In addition to the antithrombotic and fibrinolysis enhancing effects, MPS possesses antiphlogistic properties. The anti-inflammatory action of MPS is based on its capacity to interfere with several phlogistic pathways. It inhibits lysosomal enzymes in the catabolic phase of inflammation. An inhibition of prostaglandins by MPS was also found. In recent studies an activation of the tissue factor pathway inhibitor (TFPI) could be shown after cutaneous application of MPS. TFPI inhibits the effect of tissue factor, which is released during inflammation and acts as a mediator of inflammation. It is assumed that the ability of topically applied MPS to activate TFPI is one of the modes of action which contributes to the anti-inflammatory effects of the drug.

除了抗血栓和促纤溶作用，多磺酸粘多糖MPS还有抗炎作用。多磺酸粘多糖MPS的抗炎作用是基于其能干扰不同的炎症通路。它能抑制参与炎症分解代谢的酶。多磺酸粘多糖还能抑制前列腺素。最近的研究显示，皮肤涂抹喜疗妥后还能激活组织因子旁路抑制因子（TFPI）。组织因子旁路抑制因子（TFPI）抑制了组织因子的作用，组织因子是在炎症过程中释放的一种炎症介质。因而假设，外用多磺酸粘多糖激活了组织因子旁路抑制因子（TFPI），是药物具有抗炎作用的机制之一。

 

Mathies / Gabler investigated the influence of MPS on the increase in tissue permeability caused by hyaluronidase. In the dyestuff spreading test in rats, the authors found a statistically significant inhibition of the hyaluronidase activity, which means that the spreading of inflammation was prevented.

Mathies 和Gabler观察了多磺酸粘多糖对由透明质酸引起的组织渗透性增加的影响。对大鼠进行染色试验，作者发现多磺酸粘多糖能显著抑制透明质酸酶的活性，从而能预防炎症的扩散。

 

Egg reported on an inhibition of the prostaglandin synthesis caused by MPS.The inhibition of prostaglandin E2 synthesis by MPS is of particular importance as this specific prostaglandin plays an important role in the course of inflammation and in the development of pain.

Egg报道多磺酸粘多糖能抑制前列腺素的合成。多磺酸粘多糖对于前列腺素E2合成的抑制具有特别重要的意义，因为这种特殊物质在炎症和疼痛发展中具有非常重要的作用。

 

In vitro studies have shown that MPS, in concentrations achieved therapeutically, effectively interferes with the formation of phlogistic mediators by inhibiting complement activation and release of leukotriene B4 (Schmer). A distinct inhibition of complement factor CIq can already be reached by very low concentrations of MPS (Heinz/Loos). The complement system intervenes in several phases of the inflammatory process.

研究显示，多磺酸粘多糖在治疗浓度能通过抑制补体的激活和白介素B4的释放而有效地干扰炎症介质的形成（Schmer）。多磺酸粘多糖在很低的浓度就能直接抑制补体CIq(Heinz/Loos)。补体系统干预了炎症过程的数条途径。

 

Hoppensteadt et al. investigated the ability of topically applied MPS to release tissue factor pathway inhibitor (TFPI).TFPI is known for its local anti-inflammatory effect. During an inflammatory process cells become activated and several mediators including tissue factor (TF) are released. The TFPI is capable of binding to the TF thereby inhibiting its effects.

Hoppensteadt等人研究了外用多磺酸粘多糖后对组织因子旁路抑制因子（TFPI）释放的影响。TFPI是用于局部抗炎的。在炎症过程中，细胞被激活，同时数种炎症介质被释放包括组织因子（TF）。TFPI能通过其与组织因子的结合而抑制其作用。

 

In a period of 10 days 3% MPS and placebo cream were administered cutaneously to non-human primates on days 1,2,5,7 and 10. Citrated blood samples were drawn at ba seline, 2, 4, 8 and 24 hours after the application of MPS on all days. Platelet counts, APTT, thrombin time (TT), Heptest and total and free TFPI levels were measured on the plasma samples.

为期10天的研究中，3％的多磺酸粘多糖和安慰剂软膏在第1、2、5、7和10天被反复涂抹于灵长类。每天，在用药前及外用多磺酸粘多糖后第2、4、8和24小时抽取血样，溶于柠檬酸盐溶液中。并且对血样进行有关检测，包括血小板计数、部分凝血酶原时间，凝血酶时间，Heptest和总的及游离的组织因子旁路抑制因子水平。

 

 

 

 

 

 

In contrast to the placebo group a progressive increase of total and free TFPI was determined after the administration of the MPS cream. In the placebo group no increase of TFPI could be measured. The difference in TFPI values became significant on days 7 and 10 (p < 0,05).

与安慰剂组不同的是，多磺酸粘多糖乳膏组，总的和游离的组织因子旁路抑制因子（TFPI）水平持续增加。而，安慰剂组TFPI无增加。第7和10天两组的TFPI值有统计学差异(p < 0,05)。

 

The parameters of coagulation remained unchanged during the whole observation period. There was no accumulation effect detected in either group.

两组血凝参数在整个观测期间均无改变，亦无累积效应。

 

These results lead to the conclusion that after cutaneous application MPS reaches capillary vascular sites where the substance acts as an anti-inflammatory and anticoagulant agent without influencing the systemic coagulation.

从这些结论我们可以得知，持续应用多磺酸粘多糖后其能达到毛细血管水平，并具有抗炎和抗凝作用，但不影响系统凝血。

 

Sunburn is an inflammation of the superficial layers of the skin. Since the anti-inflammatory potential of MPS is well documented, the investigation of the efficacy of MPS cream in the treatment of solar dermatitis is of interest.

晒伤是皮肤表皮的一种炎症。因为多磺酸粘多糖的抗炎作用已有了很好的论证，对于多磺酸粘多糖乳膏治疗日光性皮炎的疗效观测是非常有趣的。

 

The UV erythema is an inflammation model in which the inhibition of skin reddening by pharmaceutical agents is assessed as a parameter for their anti-inflammatory effect.

紫外线红斑是一炎症模型，而药物制剂对于其皮肤充血的抑制则作为观测抗炎作用的参数。

 

Raake investigated the extent of the antiphogistic effect of MPS ointment on the ultraviolet erythema test in guinea pigs. To ensure reproducible results, the untreated control animals had to develop erythemas of grade 2.5-3.0. The grade of erythema was classified 0-4 by the method of Ther. Immediately after the irradiation, creams containing MPS or heparin were lightly massaged into the treated areas.

Raake等人通过紫外线红斑试验，观测了多磺酸粘多糖在该方面的作用，试验对象为豚鼠。为了保证结论的可靠性，对照组动物亦人为造成2.5-3.0级红斑。红斑通过Ther方法分为0－4级。放射后立即用含有多磺酸粘多糖或肝素的乳膏轻轻地按摩入受损区域。

 

All the ointments tested led to an inhibition of the UV-induced erythema, but there were great differences in the extent of inhibition.

所有的受试软膏均对紫外线诱导的红斑有抑制作用，但抑制程度有很大的不同。

 

 

The most effective product was MPS ointment with an inhibition of 69%.The effects of heparin ointments varied widely. The ointment bases, the different excipients and the varying properties of heparins are being discussed as possible reasons for the different effects of ointments containing heparin.

最有效的产品是多磺酸粘多糖软膏，其抑制率为69％。而肝素软膏的作用差异很大，差异的原因可能是软膏基质、赋形剂和所含肝素浓度的不同。

 

The antiedemic, antiexudative and absorption promoting action of MPS is a result of its inhibiting effect on hyaluronidase and its ability to increase local blood flow.

多磺酸粘多糖由于能抑制透明质酸酶并能增加局部血供而能促进水肿吸收。

 

Tronnier et al. investigated the promotion of absorption by MPS in volunteers after cutaneous administration, using the so called weal absorption test.

Tronnier等人通过伤痕吸收试验，观测了连续应用多磺酸粘多糖于志愿者后对水肿吸收的促进作用。

 

He compared intra-individually the effect of six different topical products (Hirudoid cream, various heparin and heparinoid creams) on experimentally induced superficial weals in healthy volunteers. Treatment with cream base and untreated volunteers served as controls. The preparations were administered 2 hours before the weal was produced by intracutaneous injection of 0.2 mi saline. The height was measured over 20 minutes every 2 to 3 minutes.

他比较了六种不同外用药物（喜疗妥乳膏，各种肝素和类肝素乳膏）对试验人为造成的浅表伤痕的疗效，受试者为健康志愿者。用乳膏基质和未治疗的志愿者为对照。在皮内注射0.2ml盐水造成局部伤痕前2小时应用各种制剂。20分钟后每2到3分钟测量伤痕的高度。

 

Hirudoid proved to be superior to all other comparison products and to placebo in regard to the regression of weals, with the difference being statistically significant.

试验证实喜疗妥对于伤痕的减轻作用要优于所有其它对照药物和安慰剂，并具有统计学差异。

 

Using an identical study design, the same author compared the effect of Hirudoid gel to placebo and to the untreated control group.

应用同样的研究设计，该作者还以未治疗的对照组和安慰剂为对比，观测了特强喜疗妥凝胶的作用。

 

 

 

 

 

Dosage of the gels and methods were the same as with the creams. Again in this experiment, the weals were reduced more rapidly after administration of Hirudoid gel compared to gel base or untreated controls.

凝胶的剂量和试验方法与乳膏相同。在这个试验中，再一次验证了对于伤痕的减轻，喜疗妥凝胶组比凝胶基质组或未治疗的对照组要迅速得多。

 

 

Superficial subcutaneous haematomas are particularly suitable for the verification of the absorption promoting effect of cutaneously administered compounds on corpuscular components and fibrin deposits of extravasates. The enhancing effect of MPS on the absorption of superficial haematomas was demonstrated in human volunteers and animals.

浅表皮下血肿特别适合用于验证连续应用化合物后，其对渗出物中细胞成分及纤维沉淀物的吸收促进作用。多磺酸粘多糖对于浅表血肿的吸收促进作用无论在人类志愿者还是动物都得到了验证。

 

In a placebo-controlled double-blind study in 10 healthy volunteers standardized subcutaneous haematomas were induced in both thighs by injection of autologous blood with an addition of 125l-fibrinogen (Larsson et al.). The haematoma on one side was treated with Hirudoid cream and that of the contralateral side with placebo. The absorption of haematomas was assessed quantitatively by daily measurement of the radioactivity and compared intraindividually.

在一安慰剂对照的双盲研究中，将加有1251标记的纤维蛋白原的自体血液注射入10位健康志愿者的双腿部，造成标准皮下血肿（Larsson等人）。一侧的血肿用喜疗妥软膏治疗，对侧则用安慰剂。血肿的吸收通过每日定量地测定放射活性进行比较。

 

There was a significant faster dissolution of haematomas under the treatment with Hirudoid in comparison to placebo. The time until 50% absorption of the haematomas decreased from about 4 days under treatment with placebo to about 2 days under Hirudoid, i.e. it was reduced by half.

血肿的分解，喜疗妥组要显著快于安慰剂组。血肿吸收50％所需要的时间，安慰剂组为4天，而喜疗妥组只需2天。

 

The difference determined was statistically significant at all times of investigation.

在整个观测期间，所有差异均具有统计学意义。

 

 

 

 

 

Fianu et al. studied the effect of MPS cream on experimentally induced haematomas in rabbits. Haematomas of comparable size were produced by subcutaneous injection of blood into both ear lobes of the animals followed by compression. One ear was treated with Hirudoid cream, while the other ear was either left untreated or treated with the cream base only.

Fianu等人研究了多磺酸粘多糖软膏对于实验人造血肿的作用，受试对象为兔。通过在兔双耳垂注射血液后挤压而造成相同大小的血肿。一只耳朵用喜疗妥软膏治疗，而另一只耳朵则不治疗或只用软膏基质治疗。

 

The results show a significantly faster absorption of haematomas treated with Hirudoid cream compared with placebo-treated and totally untreated controls. The size of the haematomas treated with Hirudoid was reduced after 24 hours, while the haematomas which remained untreated or were treated with cream base required 24-36 hours to show a distinct improvement. The mean time required for the complete absorption was 5.2 days for the haematomas treated with Hirudoid, 8.1 days for those treated with placebo and 10 days for the untreated ones. The differences were statistically significant (p < 0.001).

实验结果显示，血肿的吸收喜疗妥组比安慰剂组和完全不治疗组要快得多。血肿的大小在喜疗妥组用药24小时后即减小了，而未治疗组或软膏基质组则需要24－36小时才有明显的改善。血肿完全吸收所需要的平均时间，喜疗妥组为5.2天，安慰剂组为8.1天，而未治疗组为10天。这些差异均具有统计学意义(p < 0.001)。

 

Zeiller and Sensch tested the effect of several concentrations of MPS solution on experimental haematomas in rabbits. The haematomas were produced by intracutaneous injection of autologous blood on the back of the animals. MPS solution or saline were applied twice daily.

Zeiller 和Sensch测试了不同浓度多磺酸粘多糖溶液对于兔实验血肿的作用。血肿是通过在动物背部皮内注射自体血液造成的。多磺酸粘多糖溶液或盐水一天应用两次。

 

The effect of cutaneously applied MPS and its action on the distribution and regression of haematomas are demonstrated photographically. The photographs were evaluated quantitatively by planimetry and by serial comparison of the color intensity of the haematomas.

连续应用多磺酸粘多糖的作用及其对血肿分解和吸收通过照片记录得到了论证。通过这些照片进行了定量的评估，包括测面积法和连续的血肿色泽深度比较。

 

The results showed a statistically significant therapeutic effect of MPS on the development and distribution of haematomas compared with the controls.

实验结果显示，多磺酸粘多糖的对于血肿发展和分解的疗效，与对照组相比具有显著的统计学差异。

 

 

 

MPS inhibits various aggressive lysosomal enzymes that degrade important constituents of connective tissue, such as elastase (degradation of elastin), collagenase (degradation of collagen) and hyaluronidase (degradation of hyaluronic acid). As these lysosomal enzymes cause progressive damage of the connective tissue, the inhibiting effect of MPS leads to an improvement of tissue regeneration (Baici/Fehr).

MPS抑制了各种参与分解代谢的酶，这些酶用于降解结缔组织的重要组成元素，如弹性蛋白酶（降解弹性蛋白），胶原酶（降解胶原）和透明质酸酶（降解透明质酸）。这些降解酶会造成结缔组织的进一步损害，因而MPS对其的抑制作用有利于促进组织再生(Baici/Fehr)。

 

Tissue regeneration of the skin and improvement of viscoelasticity is important for revitalisation of hypotrophic and damaged skin. Regulation of viscosity, permeability and water binding capacity of the intercellular substance are leading to normal diffusion conditions.

皮肤组织再生和粘性的改善对于受损皮肤的复原非常重要。细胞间质的粘性、渗透性和水合能力是细胞间物质传递的重要环境。

 

Stimulation of the cell metabolism by MPS leads to an increased formation of important constituents of connective tissue, thus resulting in an increased skin moisture and elasticity of the skin.

MPS通过促进结缔组织重要组成要素的形成刺激了细胞代谢，从而增加了皮肤的水分和弹性。

 

The stimulating effect of MPS on the rate of synthesis of connective tissue cells has been documented in various investigations. A pronounced increase in the rate of synthesis of the proteoglycan and collagen metabolism as direct result of the administration of MPS was shown both, in animal studies and in human and animal cell cultures.

许多调查研究记录了MPS能促进结缔组织细胞的合成。应用MPS后蛋白多糖和胶原代谢显著增加，这一结论无论在动物研究还是在人类和动物细胞培养均得到了直接的论证。

 

Hyaluronic acid, as acid mucopolysaccharide, fulfils important tasks in the connective tissue; it plays an essential role in the regulation of water binding capacity, supports the regulation of the distribution of plasma proteins and promotes wound healing.

透明质酸，作为一种粘多糖酸，在结缔组织中有着非常重要的作用，它是调节组织水合能力的关键，同时改善血浆蛋白的运输和促进伤口愈合。

 

 

 

 

MPS shows an excellent moisturizing capacity by the stimulation of the synthesis of endogenous hyaluronate in the skin and through its accumulation in tissue with reduced levels of hyaluronate. Thus, the viscosity, permeability and water binding capacity of the intercellular substance are normalized and diffusion conditions and ion exchange regulated (Dettmer).

MPS通过促进皮肤内源性透明质酸的合成及其在缺乏组织部位的积聚从而能非常显著地增加皮肤保持水分的能力。从而，恢复了细胞间质的粘性、渗透性和保持水分的能力，改善了细胞间物质和离子传递的微环境(Dettmer)。

MPS stimulates the metabolic activity of human dermal fibrocytes. In particular, the production of hyaluronate, the most important skin glyosaminoglycan, is promoted. The synthesis of heparin sulfate, dermatan sulfate and chondroitin sulfate also increases under the influence of MPS (Mitsuyama et al.).

MPS刺激了人类皮肤纤维细胞的代谢活动。特别是促进了透明质酸，皮肤最重要的葡萄糖醛酸粘多糖的合成。MPS还促进了肝磷脂硫酸盐、dermatan硫酸盐和软骨素硫酸炎的合成(Mitsuyama 等人)。

 

Verbruggen/Veys observed a considerably higher synthesis rate of hyaluronate in tissue cultures of synovial membrane cells after the administration of MPS than after that of heparin or chondroitin sulfate.

Verbruggen/Veys观察到，在滑膜组织培养液中，透明质酸酶的合成在应用MPS组比肝磷脂或软骨素硫酸盐组要高得多。