CN1033208C - L-赖氨酸盐酸盐在制备止血药物中的应用 - Google Patents
L-赖氨酸盐酸盐在制备止血药物中的应用 Download PDFInfo
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Abstract
本发明公开了一种止血新药(健身素颗粒剂),这种止血新药的主要成份是L-赖氨酸盐,用这种止血药物能治疗人体某些器官出血,如子宫异常出血、手术后异常出血,咯血,尿血等,从而开拓了L-赖氨酸的新用途。
Description
本发明涉及一种止血新药—健身素颗粒剂,其主要成分是L-赖氨酸盐类,尤其是L-赖氨酸盐酸盐。
L-赖氨酸,化学名2,6-二氨基己酸,(C6H14O2N2),是人体必需又不能自身合成的八种氨基酸中最重要的一种。它是水溶性氨基酸和小分子多肽混合物,具有促进人体生长发育、增强人体免疫能力的功能,据有关文献报道,赖氨酸因其结构类似6-氨基己酸,具有抗纤溶药物的作用,能阻抑纤溶酶原吸附在纤维蛋白上,保护纤维蛋白不被纤溶酶所溶解。但长期以来,人们主要将L-赖氨酸用作营养品和与其它氨基酸混合做成复合氨基酸糖浆等,提供给营养不良或久病、身体衰弱的病人服用,以增强抵抗力,并没有将它作为治疗某些病种的专用药物,所以赖氨酸的应用还不广泛,许多赖氨酸厂的产量和经济效益不能提高。
本发明的目的在于提供用L-赖氨酸盐酸盐作为药物的新用途,使赖氨酸的应用更为广泛。
本发明人经过试验,发现L-赖氨酸除了如文献中介绍的那样具有促进人体生长发育,增强人体免疫功能外,还发现L-赖氨酸具有意料不到的治疗人体某些器官出血症状的结果。经临床试验,发现对纤维蛋白溶解亢进引起的各种出血,如功能性子宫出血、人流后出血、产后出血、各种手术后异常出血,紫癜病、支气管扩张、肺结核咯血、血尿、消化道出血等病用赖氨酸治疗均有明显疗效,甚至对血友病、血小板减少症、白血病等也有不同程度的好转。
为了进一步观察用L-赖氨酸作为止血的药物,本申请人(广西赖氨酸厂)首先将本厂出产的L-赖氨酸盐酸盐(药品级,含C6H14N2O2·HCl98.5%)和上海天平制药厂生产的维生素K用小白鼠及家兔进行凝血对比试验。试验单位:广西自治区药检所,试验数据如下:表1 L-赖氨酸盐酸盐对小白鼠凝血时间的影响与对照组比较*p >0.05,**p<0.01,***p<0.001
表2 L-赖氨酸盐酸盐(健身素)对家免凝血时间的影响
与对照组比较★★P<0.05
组别 | 兔号 | 凝血所需时间,分 | x±SD | |
第1管 | 第2管 | |||
对照组 | 1 | 11.5 | 10.5 | 8.8±1.9 |
2 | 8.0 | 8.5 | ||
3 | 7.0 | 7.0 | ||
健身素2.7g/kg×3 | 4 | 3.0 | 3.5 | ★★5.9±2.5(32.9%) |
5 | 9.0 | 8.5 | ||
6 | 5.5 | 6.0 | ||
健身素2.7g/kg×1 | 7 | 6.0 | 9.0 | ★★5.9±2.3(32.9%) |
8 | 4.0 | 6.5 | ||
9 | 3.0 | 3.0 | ||
10 | 7.5 | 8.0 | ||
维k43.5mg/kg×3 | 11 | 5.0 | 9.5 | ★★5.6±2.0(36.3%) |
12 | 4.0 | 4.0 | ||
13 | 5.5 | 5.5 |
括号内为凝血时间缩短百分率
表3健身素对家兔优球蛋白溶解时间的影响
组别 | 兔号 | 试管号 | 溶解时间(小时) | x±SD |
对照组 | 1 | 1 | 4.3 | .9±1.4 |
2 | 3.8 | |||
2 | 3 | 7.0 | ||
4 | 4.7 | |||
给药组2.7g/kg | 3 | 5 | 4.7 | .5±3.8★(53.0%) |
6 | 6.0 | |||
4 | 7 | 6.7 | ||
8 | 11.8 |
★括号内为溶解时间延长率
上述试验表明,L-赖氨酸具有显著的促进凝血作用,亦即表明了用L-赖氨酸能作为优异的止血药物。
以下是本发明L-赖氨酸作为止血药物的作用方案:
一.成份、含量及剂型
1.成份含量:L-赖氨酸盐酸盐(含C6H14N2O2·HCl80-99%)。
2.剂型:用上述L-赖氨酸盐酸盐颗粒制得的粉剂、片剂、胶囊、口服液、注射液等。
3.也可用L-赖氨酸的其它盐类。
二.用法
患某些器官出血的病人,如子宫出血,人流后出血,产后出血,手术后异常出血,咯血,血尿,消化道出血等症状,每次服1-5克(重症病人可加大1-2倍),每日3-4次,不间断连用2周至一个月,如果显效可继续1-2个疗程。
三.临床应用
本申请人于1992年起与广西医科大学附属医院妇产科及广西南宁第一医院妇产科等医院合作用L-盐酸赖氨酸盐酸盐(含量:98%)对102例子宫出血的病例进行治疗,具体过程如下:
(一)、病例选择与分组:
选择住院或门诊的子宫出血患者,包括功能性子宫出血、月经过多、人流或放环后子宫出血不止等作为治疗对象。为便于观察,固定医生治疗,采用单盲法将病人随机分为二组,即健身素颗粒剂(L-赖氨酸盐酸盐)(广西赖氨酸厂生产)试验组102例。维生素K4(上海天平制药厂)对照组70例。在试验期间停止其他治疗药物。
(I)两组病年龄分布:(见表1)
表I 两组年龄分布
试验组年龄最大为53岁,最小11岁;对照组年龄最大54岁。最小16岁。由上表可见。两组病人的年龄以21岁至40岁(生育期)居多,分别为59例、51例,占各自总数57.84%,72.85%。其次是41岁(更年期)以上年龄组,分别为33例,18例,占各自总数的32.5%,25.71%。因此说明我们所选择观察的两组病人年龄分布接近。
组别 | 总例数 | <20 | 21~30 | 31~40 | 41~44 | 45~50 | >51 |
例 % | 例 % | 例 % | 例 % | 例 % | 例 % | ||
试验组 | 102 | 10 9.80 | 26 25.49 | 33 32.35 | 11 10.78 | 19 18.63 | 3 2.94 |
对照组 | 70 | 1 1.43 | 23 32.85 | 28 40.00 | 2 2.86 | 12 17.14 | 4 5.71 |
(2)两组病人治疗前病种分布:(见表2)
组别 | 总例数 | 功能性子宫出血 | 月经过多 | 放环或肌瘤引起出血 |
例 % | 例 % | 例 % | ||
试验组 | 102 | 56 54.90 | 29 28.43 | 17 16.67 |
对照组 | 70 | 30 42.86 | 21 30.00 | 192 27.14 |
由上表可知,两组的病种以功能性子宫出血和月经过多居多,分别为试验组56例,29例占各自总数的54.90%、28.43%;对照组30例、21例,占总数的42.86%、30.00%,表明所选择的两组病种分布接近。
(二)、诊断标准(对照新药(中药)临床研究指导原则中“西医诊断标准”。
1、功能失调性子宫出血:经妇检子宫内膜病理检查等无明显器质性病变、而性腺内分泌检查显示有功能失调者。
2、某些生殖器官器质性病变引起的月经失调:经妇检、B型超声显像,子宫腔碘油造影及子宫腔镜、腹腔镜等检查证实有生殖道炎症、子宫肌瘤,多束卵巢和子宫肥大症、盆腔瘀血症等病变。
3、宫内节育器或输卵管结扎术后引起的月经不调。
注:凡月经周期基本正常,而经量较以往明显增多,或经量超过100毫升者为月经过多。凡月经周期及经量基本正常,行经时间超过七天以上但少于两周者为经期延长。
(三)疗效评定
1、显效:用药二天后比原出血量减少1/2量。
2、有效:用药三天后比原出血量减少1/3量。
3、无效:用药三天后比原出血量无明显减少。
(四)、试验方法
试验组:每天口服健身素颗粒剂三次,每次3克。
对照组:每天口服维生素K4三次。每次4毫克。
(五)观察方法
1、治疗前后各进行一次妇科检查,未婚女子可进行肛检。询问自觉症状,并进行B超声显像检查。
2、随时观察病人的毒付反应。
(六)、治疗结果(见表3)
表3 近期疗效比较
组别 | 总例数 | 显效 | 有效 | 无效 | 有效率 |
例 % | 例 % | 例 % | 例 % | ||
试验组 | 功能性子宫出血56 | 24 42.86 | 22 39.29 | 10 17.86 | 46 82.14 |
月经过多29 | 18 62.07 | 8 27.59 | 3 10.34 | 26 89.66 | |
放环或肌瘤出血17 | 9 52.94 | 6 35.29 | 2 11.76 | 15 88.24 | |
合计 102 | 51 50.00 | 36 35.39 | 15 14.71 | 87 85.29 | |
对照组 | 功能性子宫出血30 | 2 6.6 | 9 30.00 | 19 63.33 | 11 36.67 |
月经过多21 | 5 23.81 | 11 52.38 | 5 23.81 | 16 76.19 | |
放环或肌瘤出血19 | 3 15.79 | 8 42.11 | 8 42.11 | 11 57.89 | |
合计 70 | 10 14.29 | 28 40.00 | 32 45.71 | 38 54.29 |
由上表可知,试验组和对照组的疗效比较。无论从各病种的显效率或有效率均有明显的差别,经X检验得X2=20.1,p值<0.001,两组总疗效有显著差异,说明试验组优于对照组。
(七)、疗效分析
经过一年的疗效观察,102例妇科子宫出血的初步总结(功血56例),认为本药止血与调经作用显著,对功血及月经过多效果较好,能便使月经周期延长、月经不规则、经期延长、月经量增多的患者的月经周期、经期、经量恢复正常。对功血的显效率为42.86%(24例)、有效为39.29%(22例)、无效为17.86%(10例),总有效率为82.14%。对月经过多29例患者,显效为62.07%(18例)、有效为27.59%(8例)、无效10.34%(3例),总有效率为89.66%(26例)。对放环、人流或肌瘤引起的子宫出血的17例患者也有较好的疗效。显著为52.94%(9例)、有效35.29%(6例)、无血快、疗效高、无明显副作用等优点。56例功血患者中,有部分患者曾用激素、止血药(如维生素K、安络血)及中成药(如珍珠精母、益母草、妇康片)等药物治疗效果明显,改用本药治疗效果较好。
从上述102例子宫出血治疗的病例中,证明L-赖氨酸完全可以作为单一止血良药。经分析,我们认为:
1、功能性子宫出血是因女性生殖器中枢神经体液障碍引起,中枢神经系统因体外与体内环境的失调,产生刺激,因而功能改变。与卵巢功能失调有关,激素形成紊乱,出现月经周期紊乱,血量增多。而L-赖氨酸盐酸盐的作用在于调节中枢神经功能,及调节神经内分泌于卵巢,调节激素平衡而起到止血调经作用,因为L-赖氨酸可在人体内代谢生成乙酰辅酶A,乙酰辅酶A是体内合成Ach(乙酰胆碱)的重要条件,当体内缺少乙酰辅酶A,则神经组织中的Ach合成势必受到明显限制,而Ach对大脑皮层主要起调节、兴奋的作用,在中枢神经组织中广泛存在,是中枢神经系的递质,特别是上行网状系统和边缘系统即关于皮层唤醒体系更为明显。因此利用L-赖氨酸在人体内代谢物乙酰辅酶A合成Ach的作用,可以调节神经功能,从而达到治疗功能性子宫出血及其它器官出血的目的。
2、子宫内膜血管内皮细胞介导的解溶作用受解溶酶系激活物,P和解溶酶原激活物抑制剂(PAI)的调控,当这种关系受到破坏,血中的PAI显著升高,激活解溶酶原(pg),造成局部解溶状态,导致宫腔出血,L-赖氨酸除保护解维蛋白不被解溶酶所降解外,可能有调整PA与PAI的比值,从而起到调节体内解溶活性,达到止血目的。
所以,L-赖氨酸除了可作营养保健品外,用作止血药物也是十分有效的。
四、病例:
1、滕××,女,44岁,因阴道流血20多天未净,到广西医科大学治疗,诊断为无排卵型功能性子宫出血,曾用过妇康片治疗无效,但用药物L-赖氨酸盐酸盐颗粒剂治疗,每次3克,每日3次,治疗二天血量减少1/2,三天即止血,而且精神大为好转、出院后继续用药,月经量均正常。
2、瘳××,38岁,月经过多半年余,诊断为月经过多,诉每次月经持续10天未净,服用L-赖氨酸盐酸盐胶囊,月经6天干净,以后均正常。
3、张振一,男,87岁,因呕血于92年11月10日收治北京天坛医院,精神烦噪,呕血约200ml,测血红蛋白5.6克%,此病人还患有动脉硬化等症,入院第二天用L-赖氨酸治疗,精神好转,一周后血红蛋白升至9.89%,继续服用一个月,症状已消失。
Claims (1)
1. L-赖氨酸盐酸盐在制备止血药物中的应用。
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