CN1748692A - 治疗慢性鼻炎的阿苯达唑鼻腔凝胶剂 - Google Patents
治疗慢性鼻炎的阿苯达唑鼻腔凝胶剂 Download PDFInfo
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Abstract
本发明涉及使用阿苯达唑制备鼻腔凝胶剂,以及阿苯达唑的鼻腔凝胶剂在治疗慢性鼻炎中的应用。
Description
本发明涉及使用阿苯达唑制备鼻腔凝胶剂,以及阿苯达唑的鼻腔凝胶剂在治疗慢性鼻炎中的应用。
一、慢性鼻炎简介I
慢性鼻炎(chronic rh initis)是鼻腔粘膜和粘膜下层的慢性炎症。表现为鼻粘膜的慢性充血肿胀,称慢性单纯性鼻炎(chronic simple rhinitis)。若发展为鼻粘膜和鼻甲骨的增生肥厚,称慢性肥厚性鼻炎(chronic hypertrophic rhinitis)。
(一)病因
1.局部病因
(1)急性鼻炎反复发作或治疗不彻底而演变成慢性鼻炎。
(2)由于邻近的慢性炎症长期刺激或畸形,致鼻发生通气不畅或引流阻塞,如慢性鼻窦炎、鼻中隔偏曲、慢性扁桃体炎或腺样体肥大等。
(3)鼻腔用药不当或过量过久形成药物性鼻炎(rhinitis medicamentosa),常见于久用滴鼻净之后。
2.全身病因
(1)长期慢性疾病,如内分泌失调、长期便秘、肾脏病和心血管疾病等,而致鼻粘膜长期或屡发性充血或瘀血。
(2)维生素缺乏,如维生素A或C。
(3)烟酒过度可影响鼻粘膜血管舒缩而发生障碍。
(4)长期服用利血平等降压药物,可引起鼻腔血管扩张而产生似鼻炎的症状。
3.环境因素:在有水泥、烟草、煤尘、面粉或化学物质等环境中的工作者,鼻粘膜受到物理和化学因子的刺激与损害,可造成慢性鼻炎。温湿度急剧变化的环境,如炼钢、冷冻、烘熔等车间上人,也较易发生此病。
(二)治疗原则 消炎消肿,通气引流和尽量维护鼻粘膜的生理功能,同时要注意对病因的处理。
二、慢性单纯性鼻炎
(一)病理 粘膜深层血管慢性扩张,尤以下鼻甲海绵状血窦变化最明显。粘液腺功能活跃,分泌增多。鼻甲粘膜肿胀,但粘膜下组织无明显增生性改变。
(二)临床表现
1.鼻塞:间歇性或交替性。①间歇性鼻塞:一般表现为白天、劳动或运动时减轻,夜间、静坐或寒冷时加重。②交替性鼻塞:侧卧时位于下侧的鼻腔常阻塞加重:转卧另一侧后,刚才位于上侧没有鼻塞或鼻塞较轻的鼻腔,转到下侧后出现鼻塞或鼻塞加重;而刚才位于下侧的鼻腔鼻塞减轻。此外,嗅觉可有不同程度的减退,说话呈闭塞性鼻音。由于鼻涕长期流经鼻前庭和上唇部,可致皮炎或湿疹,多见于小孩。鼻涕向后可流入咽腔,出现咳嗽、多痰等症状。
2.多涕:常为粘液性或粘脓性,偶呈脓性。脓性者多于继发性感染后出现。
3.检查:鼻粘膜肿胀,表面光滑、湿润,一般呈暗红色。鼻甲粘膜柔软而富有弹性,探针轻压可现凹陷,但移开探针则凹陷很快复原,特别在下鼻甲为明显。若用1~2%麻黄素液作鼻粘膜收缩,则鼻甲迅速缩小。总鼻道或下鼻道有粘液性或脓性分泌物。
(三)治疗 治疗原则为恢复鼻腔通气功能,排除分泌物,根除病因。
1.1%麻黄素或呋喃西林麻黄素液、氯霉素麻黄素液滴鼻,每日3次,
2.0.25~0.5%普鲁卡因作鼻丘封闭或下鼻甲粘膜下封闭,每次1~1.5ml,隔日1次,或每周2次,5次为一疗程。
3.超短波或红外线理疗,可改善局部血循环以减轻症状。
4.经上述疗法无效时,可选用硬化剂作下鼻甲注射治疗。
5.找出与疾病有关的病因并及时治疗。锻炼身体增强机体抵抗力。
三、慢性肥厚性鼻炎
慢性肥厚性鼻炎(chronic hypertrophic rhinitis)为鼻粘膜、粘膜下层及鼻甲骨的增生肥厚性改变,一般由慢性单纯性鼻炎发展而来。
(一)病理 粘膜上皮纤毛脱落,变为复层立方上皮,粘膜下层由水肿继而发生纤维组织增生而使粘膜肥厚,久之,可呈桑椹状或息肉样变,骨膜及骨组织增生,鼻甲骨骨质也可呈肥大改变。
(二)临床表现
1.鼻塞较重,多为持续性、常张口呼吸,嗅觉多减退。
2.鼻涕稠厚,多呈粘液性或粘脓性。由于鼻涕后流,刺激咽喉致有咳嗽、多痰。
3.当肥大的中鼻甲压迫鼻中隔时,可引起三叉神经眼支所分出的筛前神经受压或炎症,出现不定期发作性额部疼痛,并向鼻梁和眼眶放射,称筛前神经痛,又称筛前神经综合症。
4.检查:①下鼻甲明显肥大,或下鼻甲与中鼻甲均肥大,常致鼻腔堵塞。鼻腔底部或下鼻道有粘液性或粘脓性分泌物。②粘膜肿胀,呈粉红色或紫红色,表面不平,或呈结节状或桑椹状,尤以下鼻甲前端及其游离缘为明显。探针轻压凹陷不明显,触之有硬实感。③局部用血管收缩剂后粘膜收缩不明显。
(三)治疗
1.血管收缩剂滴鼻液的应用,限于轻型病例。
2.下鼻甲粘膜下硬化剂注射,其作用机理为硬化剂注射后,可使局部发生化学性炎性反应,产生疤痕组织,缩小鼻甲体积,改善通气。常用50%葡萄糖液加15%氯化钠溶液、5%鱼肝油酸钠或80%甘油等。鼻甲表面麻醉后,用22~23号细长针头从下鼻甲下缘前端平行向后刺入,勿刺通粘膜,边退针边注射硬化剂,直至针头拔出为止。亦可于下鼻甲前端、中部、后端分3次注射,每侧注射0.5ml,每10天1次,以3~5次为一疗程。
3.下鼻甲粘膜下电凝固肥厚的粘膜组织,使产生疤痕收缩。在表面麻醉后,电针头从下鼻甲前端刺入,凝固20~30秒钟后拔出,电流为10~30毫安。
4.冷冻手术,是将特制的冷冻头置于下鼻甲表面做冷冻,每次1~2分钟,使病变粘膜坏死脱落而再生粘膜。
5.手术疗法,一般治疗无效,或粘膜显著肥厚,或肥厚部分位于下鼻甲后端或下缘,可行下鼻甲部分切除术或中鼻甲部分切除术。下鼻甲切除不宜过多,原则上不超过下鼻甲的1/3,以免影响鼻粘膜功能或继发萎缩性鼻炎。骨性肥大者,宜行下鼻甲粘-骨膜下切除术,既可改善鼻腔的通气引流,又无损于鼻粘膜的生理功能。
6.对全身慢性疾病或邻近病灶如鼻中隔偏曲或鼻窦炎等,亦给予适当治疗。
四、阿苯达唑简介
阿苯达唑,英文通用名称为Albendazole;一般名称为:阿苯哒唑、阿丙条、5-丙硫-2-苯并咪唑氨甲酸甲酯、丙硫达唑、丙巯咪唑、丙硫咪唑等。为广谱驱虫药。可影响虫体多种生化代谢途径。本药可以抑制肠道寄生虫对葡萄糖的摄取,导致虫体内的糖原耗竭;也可与虫体微管蛋白结合抑制微管聚集,从而抑制分泌颗粒转运和其它亚细胞器运动;还可抑制虫体线粒体延胡索酸还原酶系统,减少ATP生成,从而干扰虫体生存和繁殖而导致其死亡。本药为高效广谱驱虫药,系苯并咪唑类药物中杀虫作用最强的一种。口服吸收缓慢。口服后2.5-3小时血药浓度达峰值,一日15mg/kg分两次或分三次口服所达到的曲线下面积(AUC)相同。本药生物利用度小于5%,在体内分布于肝、肾、肌肉且可透过血-脑脊液屏障,故脑组织内也有一定浓度。本药在肝脏内转化为丙硫苯咪唑-亚砜与丙硫苯咪唑-砜,前者为杀虫成分。原药与砜衍生物在血中的浓度极低,不能测出,而丙硫苯咪唑-亚砜的浓度变化很大,自0.04μg/mL至0.55μg/mL不等,平均0.16μg/mL。原药及其代谢产物在24小时内有87%随尿排泄,肾脏清除率为0.16-0.81L/h,13%经消化道排泄。半衰期为8.5-10.5小时。药物在体内无积蓄作用。不被血液透析清除。。
五、迄今,国内外都尚未见任何将阿苯达唑用于治疗慢性鼻炎的报道或文献记载。
本发明将阿苯达唑作为单独的有效成分或与其它药物一起配成复方,制成鼻腔凝胶剂。
本发明所述的用阿苯达唑或用含阿苯达唑的复方制成的鼻腔凝胶剂的适应症,包括,但不限于以下病症:鼻息肉或鼻息肉病、鼻炎、咽炎、气管炎和支气管炎。
使用本发明所述的用阿苯达唑或用含阿苯达唑的复方制成的鼻腔凝胶剂,对于鼻息肉或鼻息肉病患者,直接鼻腔给药,可有效地使大的鼻息肉缩小,使小的鼻息肉消失;或于鼻息肉切除术后给药,可阻止鼻息肉的复发:对于鼻炎、咽炎、气管炎和支气管炎,可以缓解炎症症状。
本发明所述的鼻腔凝胶剂,为喷鼻剂的一中,系指在喷鼻剂中加入能增加药液粘度的辅料,使药液能更好地粘附于鼻粘膜上,从而使有药物能从药液中缓慢或持续释放。所述的能增加药液粘度的辅料,包括,但不限于:各种规格或类型的卡泊普(Carbopol)、各种规格或类型的羟甲基纤维素、各种规格或类型的羟乙基纤维素、各种规格或类型的羟丙甲纤维素等。
本发明所述的慢性鼻炎,是本领域的技术人员所熟知的,现代的医学书籍中有其准确的定义。本发明所述的过敏性鼻炎、咽炎、气管炎和支气管炎,也是本领域的技术技术人员所熟知的,现代的医学书籍中有其准确的定义。
通过以下实施例对本发明的阿苯达唑鼻腔凝胶剂的制备,及其在治疗慢性鼻炎中的应用进行描述。需说明的是,下述实施例只是用来说明而非限制本发明,本领域技术人员所熟知的通过其他给药途径将阿苯达唑用于治疗过敏性鼻炎、慢性鼻炎、咽炎、气管炎和支气管炎的技术均在本发明的范围内。
实施例1采用卡泊普制备阿苯达唑鼻腔凝胶剂
称取卡泊普940(Carbopol940)2g;取100ml 80℃左右的无菌蒸馏水;边搅拌边向热水中加入卡泊普,全部加入卡泊普后,持续搅拌12h。待温度降低后,加入100mg阿苯达唑,再加入适量防腐剂,再搅拌30min后,及得阿苯达唑凝胶,分装到鼻腔喷雾剂瓶中或滴鼻剂瓶中,即得阿苯达唑鼻腔凝胶剂。
实施例2采用羟甲基纤维素制备阿苯达唑鼻腔凝胶剂
称取羟甲基纤维素2g;取100ml 80℃左右的无菌蒸馏水;边搅拌边向热水中加入卡泊普,全部加入卡泊普后,持续搅拌12h。待温度降低后,加入l00mg阿苯达唑,再加入适量防腐剂,再搅拌30min后,及得阿苯达唑凝胶,分装到鼻腔喷雾剂瓶中或滴鼻剂瓶中,即得阿苯达唑鼻腔凝胶剂。
实施例3采用羟乙基纤维素制备阿苯达唑鼻腔凝胶剂
称取羟乙基纤维素2g;取100ml 80℃左右的无菌蒸馏水;边搅拌边向热水中加入卡泊普,全部加入卡泊普后,持续搅拌12h。待温度降低后,加入100mg阿苯达唑,再加入适量防腐剂,再搅拌30min后,及得阿苯达唑凝胶,分装到鼻腔喷雾剂瓶中或滴鼻剂瓶中,即得阿苯达唑鼻腔凝胶剂。
实施例4采用羟丙甲纤维素制备阿苯达唑鼻腔凝胶剂
称取羟丙甲纤维素2g;取100ml 80℃左右的无菌蒸馏水;边搅拌边向热水中加入卡泊普,全部加入卡泊普后,持续搅拌12h。待温度降低后,加入100mg阿苯达唑,再加入适量防腐剂,再搅拌30min后,及得阿苯达唑凝胶,分装到鼻腔喷雾剂瓶中或滴鼻剂瓶中,即得阿苯达唑鼻腔凝胶剂。
实施例5阿苯达唑鼻腔凝胶剂治疗慢性鼻炎
阿苯达唑鼻腔凝胶剂治疗慢性鼻炎15例,取得了显著的临床效果。
一般资料 门诊病例25例,其中男12例,女13例;年龄21~54岁,平均32岁。患者病程13个月至5年。慢性单纯性鼻炎9例,慢性肥厚性鼻炎16例。所有病例均曾接受其他药物治疗。
治疗方法 患者随机分为阿苯达唑治疗组(15例,其中慢性单纯性鼻炎5例,慢性肥厚性鼻炎10例)和对照组(10例,其中慢性单纯性鼻炎4例,慢性肥厚性鼻炎6例)。阿苯达唑治疗组,采用阿苯达唑鼻腔凝胶剂治疗,每天鼻腔给药喷二次,剂量为100ug/0.1ml每喷。对照组用0.25%氯霉素麻黄素液,滴鼻或喷入鼻腔,每日三次,每次3~5滴。两组疗程均为4周,期间禁用其他抗炎药物及其他类型的滴鼻剂。
疗效评价标准 以末次随访时检查情况为标准。痊愈:鼻塞症状完全消失,鼻腔完全恢复通气,鼻分泌物及嗅觉亦有改善,下鼻甲明显缩小。好转:鼻塞明显改善,仅在上呼吸道感染或侧卧时有轻微鼻塞现象,下鼻甲较治疗前有不同程度缩小。无效:随访时间内鼻塞无改善,下鼻甲无改变。
结果 两组治疗后1周、2周、1个月及3个月分别随访4次,以后不定期随访。随访时间长者9个月,最短者1个月,平均随访4个月。
阿苯达唑治疗组15例患者中,有慢性单纯性鼻炎5例(痊愈3例,好转2例,总有效率100%);有慢性肥厚性鼻炎10例(痊愈4例,好转5例,无效1例,总有效率90%)。
0.25%氯霉素麻黄素液对照组112例患者中,有慢性单纯性鼻炎4例(痊愈1例,好转1例,无效2例,总有效率50%);有慢性肥厚性鼻炎6例(痊愈0例,好转4例,无效2例,总有效率66.7%)。
因此,阿苯达唑治疗慢性鼻炎的有效率高,疗效高于0.25%氯霉素麻黄素液。
实施例6阿苯达唑鼻腔凝胶剂治疗慢性鼻炎个案
某男,40岁,患慢性鼻炎12年,头痛、头晕、鼻塞,使用阿苯达唑鼻腔凝胶剂行鼻局部吸入治疗,15天后症状消失。随访观察30天,未见复发。以后除感冒时再无鼻炎症状。
Claims (2)
1.将阿苯达唑作为有效成分或有效成分之一制成的鼻腔凝胶剂。
2.阿苯达唑在用于治疗慢性鼻炎的鼻腔凝胶剂的生产中的应用。
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