WO2019128511A1 - 片仔癀及其制剂在制备治疗带状疱疹后遗神经痛的药物中的用途 - Google Patents

片仔癀及其制剂在制备治疗带状疱疹后遗神经痛的药物中的用途 Download PDF

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WO2019128511A1
WO2019128511A1 PCT/CN2018/115530 CN2018115530W WO2019128511A1 WO 2019128511 A1 WO2019128511 A1 WO 2019128511A1 CN 2018115530 W CN2018115530 W CN 2018115530W WO 2019128511 A1 WO2019128511 A1 WO 2019128511A1
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tze huang
pien tze
preparation
postherpetic neuralgia
treatment
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黄进明
袁慧君
于娟
洪绯
罗志毅
殷婷婷
张栋梁
郑玉清
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漳州片仔癀药业股份有限公司
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  • the invention belongs to the field of traditional Chinese medicine, and particularly relates to a new use of Pien Tze Huang and its preparation in the treatment of postherpetic neuralgia.
  • Postherpetic neuralgia is a disease in which the localized lesions of acute herpes zoster are healed or regenerated in the sensory innervation area with paroxysmal severe pain. It is the most common complication of herpes zoster. Found in elderly and immunocompromised patients, the incidence increases with age. Postherpetic neuralgia is very common and stubborn in clinical practice. It is a major difficulty in clinical treatment. Patients have symptoms such as burning pain, tingling, tactile allodynia or paroxysmal tear-like pain. The pain is severe. It can last for months or even years and seriously interferes with the daily work and life of patients.
  • Western medicine is mainly based on the principles of anti-infection, anti-virus, nutritional nerve, anti-inflammatory and analgesic.
  • the clinical application of Western medicine should consider the effectiveness, safety and tolerability of the drug and the patient's Clinical conditions (such as body condition, complications, contraindications, etc.), refractory herpes zoster neuralgia also require a combination of drugs.
  • the first-line clinical use of postherpetic neuralgia in Western medicine includes calcium channel modulators (such as pregabalin and gabapentin) and tricyclic antidepressants, which are affected by factors such as individual differences and tolerance. These drugs do not necessarily play an effective role, and the above drugs have obvious adverse drug reactions, and other safer and more effective treatments are needed for elderly people with poor tolerance.
  • Pien Tze Huang is a national first-class Chinese medicine protection variety. It is made from precious Chinese herbal medicines such as natural musk, natural bezoar, snake gall, and Sanqi. It has the effects of clearing away heat and detoxifying, cooling blood and removing blood stasis, reducing swelling and relieving pain. It is commonly used in the treatment of acute and chronic viral hepatitis. , malignant tumors, acne, unknown swollen poison, bruises and various inflammations.
  • the present invention proposes a novel use of Pien Tze Huang and its preparation in the treatment of postherpetic neuralgia.
  • the present invention provides the use of Pien Tze Huang and its formulations for the treatment of neuralgia.
  • the use described above is for use in the treatment of postherpetic neuralgia.
  • the prunus meal is added to a conventional excipient, and a clinically acceptable preparation is prepared according to a conventional process.
  • the pharmaceutically acceptable excipients are: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, matrices, and the like.
  • Filling agents include: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.
  • disintegrating agents include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, Cross-linked polyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.
  • lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.
  • suspending agent Including: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.
  • binders include: starch syrup, polyvinylpyrroli
  • the preparation is selected from the group consisting of a tablet, a tablet, a capsule, a granule, a powder, a pill, an elixir, a wine, a ointment or a mixture.
  • the preparation for each administration of the Pien Tze Huang preparation contains 0.3-0.9 g of Pien Tze Huang.
  • Pien Tze Huang has a significant effect on the treatment of postherpetic neuralgia, and the improvement of the patient's syndrome is comparable to that of pregabalin, and the degree of relief of neuropathic pain is significantly better than that of pregabalin; High safety and suitable for clinical application.
  • Pien Tze Huang was produced by Zhangzhou Pien Trick Pharmaceutical Co., Ltd.
  • Pien Tze Huang is prepared into a clinically acceptable lozenge according to a conventional process by adding conventional excipients.
  • Pien Tze Huang is prepared into a clinically acceptable tablet according to a conventional process by adding conventional excipients.
  • Pien Tze Huang is prepared into a clinically acceptable capsule according to a conventional process by adding conventional excipients.
  • Pien Tze Huang is prepared into a clinically acceptable granule according to a conventional process by adding conventional excipients.
  • the pain site is the trunk (including the limbs);
  • Control group Oral pregabalin capsule (Lerika, produced by Pfizer Pharmaceutical Co., Ltd., specification: 75mg), one capsule at a time, twice a day, if the treatment effect is not satisfactory, the dosage will be increased to 2 capsules at a time.
  • Therapeutic group The tablets of Pien Tze Huang prepared by oral administration of Example 3 (produced by Zhangzhou Pien Trick Pharmaceutical Co., Ltd., 0.3 g/granule), 2 capsules at a time, 3 times/day.
  • VAS pain score before and after treatment 0 is painless; 3 points is mild pain and can be tolerated; 4-6 is divided into patient pain affects sleep, can still bear; 7-10 is divided into progressive pain The pain is unbearable, affecting appetite and affecting sleep;
  • Safety indicators including important signs, blood routine, urine routine + urine sediment microscopy, stool routine + OB, liver function, renal function, adverse events, etc.
  • the total effective rate of clinical treatment (healing + effective) / total number of cases ⁇ 100%.
  • Pien Tze Huang has a significant effect on the treatment of postherpetic neuralgia, and the improvement of the patient's syndrome is comparable to that of pregabalin, and the degree of relief of neuropathic pain is significantly better than that of pregabalin; High safety and suitable for clinical application.

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Abstract

片仔癀及其制剂在制备治疗带状疱疹后遗神经痛的药物中的用途。临床研究结果显示，片仔癀对带状疱疹后遗神经痛的治疗效果显著，对于患者综合症状的改善程度与普瑞巴林相当，且对于患者神经痛的缓解程度显著优于普瑞巴林；此外，其安全性高，适于临床推广应用。

Description

[根据细则37.2由ISA制定的发明名称]　片仔癀及其制剂在制备治疗带状疱疹后遗神经痛的药物中的用途 技术领域
本发明属于中药领域，具体涉及片仔癀及其制剂在治疗带状疱疹后遗神经痛中的新用途。
背景技术
带状疱疹后遗神经痛是急性带状疱疹病人局部皮损愈合后，感觉神经支配区遗留或重新产生的隐痛伴发阵发性剧烈疼痛的疾病，是带状疱疹最常见的并发症，多见于老年人和免疫功能低下的各种病人，其发病率随着年龄增大而增加。带状疱疹后遗神经痛在临床上十分常见且顽固，是临床治疗的一大难点，患者有烧灼痛、刺痛、触觉性痛觉异常或阵发性撕裂样剧痛等症状，疼痛感剧烈，可持续数月甚至数年，严重干扰患者的日常工作和生活。
对带状疱疹后遗神经痛的治疗，西医以抗感染、抗病毒、营养神经、消炎止痛等原则为主，西医临床用药时应综合考量药物的有效性、安全性和耐受性以及患者的临床情况(如体况、并发症、禁忌症等)，顽固性带状疱疹后遗神经痛还需采用联合用药的方案。目前，西医中带状疱疹后遗神经痛的临床一线用药包括钙离子通道调节剂(如普瑞巴林和加巴喷丁)、三环类抗抑郁药，由于受患者个体差异、忍耐程度等因素的影响，上述药物并不一定能发挥有效的作用，且上述药物存在明显的药物不良反应，对于耐受性较差的老年人则需要考虑其他更为安全、有效的治疗手段。
尽管中医已有运用龙胆泻肝汤、身痛逐瘀汤治疗带状疱疹后遗神经痛的临床研究的报道，但是由于均是与西药或其他疗法联合应用、 临床研究样本量小、研究方案未能基于中药特点进行科学设计等，导致其在临床应用上仍存在较大难度。
片仔癀是国家一级中药保护品种，采用天然麝香、天然牛黄、蛇胆、三七等名贵中药精制而成，具有清热解毒、凉血化瘀、消肿止痛的功效，临床常用于治疗急慢性病毒性肝炎、恶性肿瘤、痈疽疔疮无名肿毒、跌打损伤及各种炎症等。
目前，尚未见片仔癀及其制剂用于制备治疗带状疱疹后遗神经痛的相关报道。
发明内容
为此，本发明提出片仔癀及其制剂在治疗带状疱疹后遗神经痛中的新用途。
为解决上述技术问题，本发明是通过以下技术方案来实现的：
本发明提供片仔癀及其制剂在治疗神经痛中的用途。
优选地，上述用途，所述用途为在治疗带状疱疹后遗神经痛中的用途。
进一步优选地，上述用途，片仔癀加入常规辅料，按照常规工艺，制成临床上可接受的制剂。
所述药学上可接受的辅料为：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素纳等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚 乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000、PEG4000、虫蜡等。
进一步优选地，上述用途，所述制剂选自锭剂、片剂、胶囊剂、颗粒剂、散剂、丸剂、酊剂、酒剂、煎膏剂或合剂。
进一步优选地，上述用途，片仔癀制剂的每次给药制剂中含片仔癀0.3-0.9g。
本发明的上述技术方案相比现有技术具有以下优点：
临床研究结果显示，片仔癀对带状疱疹后遗神经痛的治疗效果显著，对于患者综合症状的改善程度与普瑞巴林相当，且对于患者神经痛的缓解程度显著优于普瑞巴林；此外，其安全性高，适于临床推广应用。
具体实施方式
本发明以下实施例和实验例中，片仔癀由漳州片仔癀药业股份有限公司生产。
实施例1
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的锭剂。
实施例2
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的片剂。
实施例3
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的胶囊剂。
实施例4
片仔癀按照常规工艺，加入常规辅料制成临床上可接受的颗粒剂。
实验例1片仔癀对带状疱疹后遗神经痛的治疗效果的研究
1、实验目的
研究片仔癀对带状疱疹后遗神经痛的治疗效果。
2、实验方法
2.1一般资料
2016年1月至12月收治的带状疱疹后遗神经痛患者108例，其中男性52例，女性56例，年龄35-67岁，平均49.2岁。所有患者均符合带状疱疹后遗神经痛西医诊断标准(参照《临床诊疗指南(疼痛学分册)》，2007年，人民卫生出版社)。所有患者随机分为2组，分别为治疗组和对照组，每组54例。两组患者在年龄、性别、病程、VAS疼痛评分等基线资料均无显著差异(P＞0.05)。
2.2纳入标准
(1)年龄：18-75岁；
(2)符合西医诊断标准；
(3)疼痛部位为躯干部(包括四肢)；
(4)入组前1周内未服用或外用过相关治疗药物；
(5)认知功能完整，签署知情同意书。
2.3排除标准
(1)排除疼痛部位为头面部、四肢、臀部、肛周部位；
(2)入组前一周内使用过对带状疱疹有治疗作用的药物，或使用糖皮质激素和免疫抑制剂者；
(3)过敏体质者，患有癌症、艾滋病等其他严重疾病患者；
(4)妊娠期、哺乳期妇女；
(5)入组前3个月内参加过其他药物临床试验者。
2.4治疗方法
对照组：口服普瑞巴林胶囊(乐瑞卡，辉瑞制药有限公司生产，规格75mg)，一次1粒，2次/天，如治疗效果不理想，将服用量增加到一次2粒。
治疗组：口服实施例3制备的片仔癀胶囊剂(漳州片仔癀药业股份有限公司生产，0.3g/粒)，一次2粒，3次/天。
以上两组疗程均为7天，疗程结束后观察结果，评定疗效。
2.5观察指标
(1)临床治疗总有效率；
(2)治疗前后VAS疼痛评分：0分为无痛；3分以下为有轻微的疼痛、能忍受；4-6分为患者疼痛影响睡眠、尚能忍受；7-10分为有渐进性疼痛，疼痛难忍，影响食欲，影响睡眠；
(3)安全性指标：包括重要体征，血常规、尿常规+尿沉渣镜检、大便常规+OB，肝功能、肾功能、不良事件等。
2.6疗效判定标准
痊愈：患者神经疼痛症状消失，饮食、睡眠及日常生活状态完全恢复正常；
有效：患者神经疼痛症状减轻，受凉、劳累后仍存在阵发性阵痛，饮食、睡眠和日常生活状态改善；
无效：患者神经疼痛症状毫无变化，饮食、睡眠及日常生活状态较
差。临床治疗总有效率＝(痊愈+有效)/总例数×100％。
2.7统计分析
实验结束时，同时对各项观察指标进行评价和分析，将P＜0.05作为所检验的差别有统计学意义的标准。
3、实验结果
3.1两组患者疗效比较
两组患者疗效的实验结果如表1所示。
表1 两组疗效比较
组别 n 痊愈 有效 无效 总有效率(％)
治疗组 54 27 22 5 90.7
对照组 54 25 20 9 83.3
由表1可知，治疗组与对照组两组患者的临床治疗后总有效率相当(差异无统计学意义)。
3.2两组患者VAS疼痛评分比较
两组患者VAS疼痛评分的实验结果如表2所示。
表2 两组前后疼痛程度比较
组别 n 治疗前 治疗后
治疗组 30 7.2±1.7 1.6±0.8*
对照组 30 7.3±1.5 2.1±1.2
注：与对照组相比，*P＜0.05
由表2可知，治疗前，两组VAS疼痛评分差异无统计学意义(P＞0.05)；治疗后，治疗组VAS疼痛评分显著低于对照组VAS疼痛评分(P＜0.05)。
3.3不良反应
治疗组均未发现不良反应，对照组有16例患者在治疗期间出现嗜睡、头晕、水肿、胃部不适等不良反应。
4.结论
临床研究结果显示，片仔癀对带状疱疹后遗神经痛的治疗效果显著，对于患者综合症状的改善程度与普瑞巴林相当，且对于患者神经痛的缓解程度显著优于普瑞巴林；此外，其安全性高，适于临床推广应用。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。

Claims (5)

  1. 片仔癀及其制剂在治疗神经痛中的用途。
  2. 根据权利要求1所述的用途，其特征在于，所述用途为在治疗带状疱疹后遗神经痛中的用途。
  3. 根据权利要求1或2所述的用途，其特征在于，片仔癀加入常规辅料，按照常规工艺，制成临床上可接受的制剂。
  4. 根据权利要求1-3任一项所述的用途，其特征在于，所述制剂选自锭剂、片剂、胶囊剂、颗粒剂、散剂、丸剂、酊剂、酒剂、煎膏剂或合剂。
  5. 根据权利要求1-4任一项所述的用途，其特征在于，所述的片仔癀制剂的每次给药制剂中含片仔癀0.3-0.9g。
PCT/CN2018/115530 2017-12-28 2018-11-15 片仔癀及其制剂在制备治疗带状疱疹后遗神经痛的药物中的用途 WO2019128511A1 (zh)

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