A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Episodic Migraine

In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections.
Trial details include:
* Trial duration: 52 to 55 weeks;
* Screening period: 4 to 5 weeks;
* Treatment duration: 4 treatments, each about 12 weeks apart; and
* Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.

开始日期2025-08-01

申办/合作机构

Merz Therapeutics GmbH

NCT07018713

/ Recruiting临床3期

In this clinical trial, participants with chronic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections.
Trial details include:
* Trial duration: 52 to 55 weeks;
* Screening period: 4 to 5 weeks;
* Treatment duration: 4 treatments, each about 12 weeks apart; and
* Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.

开始日期2025-08-01

申办/合作机构

Merz Therapeutics GmbH

NCT06995287

/ Not yet recruiting临床3期IIT

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study

The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.

开始日期2025-06-01

申办/合作机构

Nantes University Hospital

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100 项与 A型肉毒毒素 (Biotecon) 相关的临床结果

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100 项与 A型肉毒毒素 (Biotecon) 相关的专利（医药）

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项与 A型肉毒毒素 (Biotecon) 相关的文献（医药）

2025-12-01·Techniques in Coloproctology

Urge fecal incontinence: are intramural rectal injections of botulinum toxin a long-term treatment option?

Article

作者: Baumstarck, Karine ; Vitton, Véronique ; Onana Ndong, Philippe

BACKGROUND AND AIMS:

Unsuccessful first-line conservative treatments for managing fecal incontinence (FI) lead to considering predominantly invasive options, posing challenges in terms of cost and patient acceptance of benefit/risk ratio. Recent data from a prospective randomized study have highlighted intramural rectal botulinum toxin (BoNT/A) injection as a promising minimally invasive alternative for urge FI, demonstrating efficacy at 3 months but lacking long-term evidence. This study aimed to evaluate the sustained efficacy and injection frequency of intramural rectal BoNT/A injection in the treatment of urge FI.

METHODS:

This retrospective monocentric study enrolled all patients who underwent intramural rectal BoNT/A injection for urge FI after failed conservative therapy or sacral neuromodulation (SNM). Injections were administered during sigmoidoscopy, delivering 200 U of BoNT/A at 10 circumferentially distributed sites. Treatment effectiveness was assessed using the Cleveland clinic incontinence score (CCS) and a visual analog scale (VAS) to measure the severity of discomfort related to episodes of fecal urgency, with reinjection performed upon symptom recurrence.

RESULTS:

In total, 41 patients (34 females) were included, with a median follow-up of 24.9 (range 3.2-70.3) months. Overall, 11 patients had previously failed sacral nerve stimulation. Significant reductions were observed in the CCS (median 11 versus 7, p = 0.001) and VAS symptoms (median 4, range 0-5 versus median 2, range 0-5, p = 0.001). In total, 22 patients (53%) experienced a reduction in the CCS by over 50%. The median interval between intramural rectal BoNT/A injections was 9.8 months (range 5.3-47.9 months).

CONCLUSIONS:

This study provides the first evidence of the sustained efficacy of intramural rectal BoNT/A injection for urge FI. Further investigations are warranted to refine patient selection and reinjection criteria, evaluate socioeconomic impacts, and compare rectal BoNT/A injection with other therapeutic modalities.

2025-08-01·EUROPEAN JOURNAL OF NEUROLOGY

Systematic Review and Meta-Analysis of Secondary Treatment Failure and Immunogenicity With Botulinum Neurotoxin A in Multiple Indications.

Review

作者: Albrecht, Phillipp ; Carr, Warner ; Walter, Uwe ; Hefter, Harald

BACKGROUND:

Botulinum neurotoxin A (BoNT-A) is recommended for the treatment of cervical dystonia (CD), spasticity, and blepharospasm. Some patients treated with BoNT-A have been reported to develop neutralizing antibodies (NAbs) against BoNT-A, which may result in reduced efficacy and, in some cases, secondary treatment failure (STF). Our aim was to investigate the incidence of STF and NAb positivity after treatment with one of three commercially-available BoNT-A formulations.

METHODS:

A systematic review and meta-analysis of STF and/or NAb positivity after treatment with abobotulinumtoxinA, incobotulinumtoxinA, or onabotulinumtoxinA in patients with CD, spasticity, or blepharospasm was conducted using PubMed, Embase, and Google Scholar.

RESULTS:

Twenty-nine unique studies reported in 29 publications assessed NAb positivity and were included. The meta-analysis showed that the proportions of patients developing STF were significantly higher after treatment with abobotulinumtoxinA or onabotulinumtoxinA than with incobotulinumtoxinA for CD or spasticity. Depending on the antibody test used, the proportions of patients developing NAbs were also significantly higher after treatment with abobotulinumtoxinA or onabotulinumtoxinA than with incobotulinumtoxinA for CD or spasticity. When data for all indications were pooled, proportions of NAb-positive patients were numerically higher with increasing mean doses of abobotulinumtoxinA or onabotulinumtoxinA. No patients treated exclusively with incobotulinumtoxinA were found to have developed immunogenic STF or persistent NAbs.

CONCLUSIONS:

The risk of developing STF and NAbs appears to vary with indication and BoNT-A formulation. When the efficacy and safety of formulations are comparable, incobotulinumtoxinA may be recommended to avoid developing STF and immunogenicity, particularly for patients requiring higher doses and repeated treatments.

2025-07-01·CLINICAL NEUROLOGY AND NEUROSURGERY

The use of onabotulinum toxin type A and other neurotoxins for the treatment of chronic migraine: An American Headache Society survey study

Article

作者: Hamilton, Kendra ; Mathew, Paul G ; Ali, Ashhar ; Agarwal, Utkarsh

PURPOSE:

OnabotA is the only US Food and Drug Administration-approved neurotoxin for chronic migraine prevention; however, non-onabotA toxins may be equally effective. Few studies have explored clinician practices and patient outcomes with non-onabotA neurotoxins. Our study aimed to generate a statistical snapshot of clinician perspectives and treatment practices regarding onabotulinum toxin A (onabotA) and other neurotoxins for chronic migraine and comorbid conditions.

METHODS:

A 15-question survey was distributed online to clinician members of the American Headache Society (AHS) assessing clinical practices using onabotA and non-onabotA toxins for chronic migraine and comorbid conditions, and descriptive analysis was performed.

RESULTS:

168 respondents (162 from the United States and 6 from Canada) completed the survey (response rate 10.1 % [168/1665]). Of 48 respondents (28 % of total) using non-onabotA toxins for chronic migraine, 27 (16 %) used incobotulinum toxin A; 23 (14 %) used abobotulinum toxin A; and 12 (7 %) used rimabotulinum toxin B. Non-onabotA toxins were predominantly used due to administration/payor imposed issues (19/48; 40 %) and cost (18/48 [38 %]). Most clinicians using non-onabotA toxins reported similar efficacy to onabotA (32/48; 67 %), while fewer reported better efficacy (9/48 [19 %]) or worse efficacy (7/48 [15 %]) than onabotA. Many respondents (114/168 [68 %]) had used neurotoxins for chronic migraine in addition to other comorbid conditions, including temporomandibular joint disorders (95/114 [83 %]) and cervical dystonia (64/114 [56 %]).

CONCLUSION:

While non-onabotA toxins are used less frequently for chronic migraine, they may have similar efficacy as onabotA and are used off-label in clinical practice due to administrative/payor issues or cost.

项与 A型肉毒毒素 (Biotecon) 相关的新闻（医药）

2025-08-07

·EINPresswire

DermAlign Medical Aesthetics Removes Wrinkles with Ease

DermAlign Medical Aesthetics now uses this minimally non-surgical cosmetic treatment called PDO Thread Lift as an alternative to the standard Surgical Facelift. LANGHORNE , PA, UNITED STATES, August 7, 2025 / EINPresswire.com / -- DermAlign Medical Aesthetics Removes Wrinkles with Ease August 7, 2025 DermAlign Medical Aesthetics based in Langhorne, Pa, would like to reach out to residents who may be in search of anti-aging medical spa treatments. This Med Spa offers a wide range of medical spa treatments with a special emphasis on wrinkle removal techniques. DermAlign Medical Aesthetics is a boutique med spa committed to providing exceptional cosmetic care using the latest non-surgical technologies. With a strong emphasis on natural beauty, safety, and personalized service, so whether you’re looking for Injectables, Micro-Needling, PDO Thread Lifting, Sexual Wellness, Medical Grade Weight Loss, Hair Restoration, PRP or the latest Hollywood Salmon Sperm PDRN DermAlign Medical Aesthetics has you covered. The Medical Staff at DermAlign Medical Aesthetics invests in over 100 Continuing Education hours per year ensuring that their patients receive the most advance & update treatments and thus allowing DermAlign Medical Aesthetic to be a leader in medical aesthetics field. Ekata Rushi PA-C, Founder of DermAlign Medical Aesthetics looks forward to providing quality, effective treatments to her patients. While DermAlign Medical Aesthetics mainly services the Mainline, Bryn Mawar, Bluebell, King of Prussia, New Hope, Bucks, Montgomery County PA. & Mercer & Hunterdon County NJ. “Men and women throughout the country as far as Alabama to Miami Fl. fly in to see Ekata Rushi PA-C. Patients can finally look and feel their best with the help of DermAlign Medical Aesthetics. Ekata Rushi PA-C at DermAlign Medical Aesthetics is a leading Aesthetic Medicine Physician Associate who offers her patients the latest in Wellness and Aesthetic solutions. Ekata specializes in the “30 minute nonsurgical face lift” using PDO Threads. Using the most advance Facelift techniques that she learned from the world leading plastic surgeons. So even if you’re looking for the best wrinkle removal treatments, DermAlign Med Spa utilizes many non-invasive techniques and treatments that can help remove wrinkles from the faces of our patients. One very popular option that is offered at the Med spa is the insertion of dermal fillers, which can help smooth out one’s skin and minimize the appearance of moderate to deep grooves and wrinkles. The spa uses clinically tested and proven dermal fillers from dependable producers like JUVÉDERM ® to fill in areas where the patient may have lost volume. The advanced dermal fillers used by Ekata Rushi PA-C are made to last a long time, and one can expect the effects to last up to years. While dermal fillers can boost the appearance of one’s skin on an immediate basis, it is still important to take care of one’s skin and protect it in order to lessen the effects of aging. DermAlign Medical Aesthetics offers its own Medical Grade Skin line solutions to help patients maintain the appearance of their skin. Ekata Rushi PA-C also offers her patients advice on how to avoid wrinkles. “Once Ekata Rushi PA-C gets you started on your custom anti-aging regimen you will begin to notice the benefits of injectables and Medical grade Skin products, you need to start looking at preventive skincare,” says Ekata. “Granted, you’re still going to age, so you can’t stop all wrinkles from forming. However, you can certainly work to lessen your risk of deep wrinkles and other signs of aging. The best way to prevent wrinkles is to minimize sun exposure and wear sunscreen daily. DermAlign Medical Aesthetics has an entire line of protective products that offer SPF protection. Some products are even tinted and blend in perfectly underneath your makeup. Schedule your anti-aging consultation at DermAlign Medical Aesthetics and take control of your wrinkles.” Ekata Rushi PA-C has over 14 years of Neurosurgical & Weight loss surgical and Emergency Medicine Experience. After over a decade of high-intensity medical & surgical care, she turned her attention to aesthetics, pursuing her passion for artistry and long-term patient care. Ekata lives in Newtown with her husband and two daughters and is deeply involved in the local community. At DermAlign, her mission is simple: to educate, empower, and enhance every patient’s natural beauty with safe, effective, and proven treatments. and is considered a leader in the cosmetic medicine industry. A number of Ekata patients have left excellent reviews of her work. One review on the DermAlign Medical Aesthetics GMB listing, from a patient named Edina “Omg I can’t say enough she is absolutely wonderful, check out my before and after pictures- also she called me in the evening and left me message to remind me of the aftercare needed, and the next day also to see how I was doing, you do not find anyone who will care enough to call and check on you anywhere !!! She is an amazing artist with her work; I will definitely be back also check her out on Instagram! " Another patient, Melissa “New Botox/Xeomin patient appointment today. The staff was very friendly & knowledgeable. Took their time to explain everything in detail. Didn’t feel rushed. I definitely will be returning.” Contact Information • DermAlign Medical Aesthetics • 320 Middletown Blvd, Ste 300, Langhorne, PA 19047, USA • info@dermalignmedspa.com • www.Dermalignmedspa.com EKATA RUSHI PA-C DERMALIGN MEDICAL ANESTHETICS INFO@DERMALIGNMEDSPA.COM Visit us on social media: Instagram Facebook YouTube TikTok Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

2025-03-21

·乐威医药

仿制药vs原研药！FDA罕见发文打破行业认知盲区

关于品牌药与仿制药之间的安全性和有效性差异是最近热点讨论话题之一，而FDA日前的一封罕见训诫信又为这一话题增加了更多的谈资，这封训诫信针对的是制药公司宣传材料中的不实结论。 FDA的处方药推广办公室（OPDP, the Office of Prescription Drug Promotion）日前向Edenbridge Pharmaceuticals发出了一封训诫信（图1），指出后者在一次会议展位上展示了一个关于其 Hemady 多发性骨髓瘤治疗的宣传面板（图2）。FDA称，该面板的内容不仅缺乏重要的风险信息，而且还宣称相对于仿制药而言，患者对Hemady的依从性更高。FDA指出，Edenbridge引用的研究并不支持这一结论，因为研究设计和方法存在问题。例如，尚不清楚服用仿制药的患者是新诊断的还是复发性多发性骨髓瘤，这两个患者群体截然不同，需要不同的治疗方案。值得注意的是，这次训诫是OPDP的首次提及此类问题。图1. FDA针对Hemady签署的训诫信部分内容。（图片来源：FDA） Hemady的活性成分是dexamethasone（地塞米松），其20 mg 片剂于2019 年 10 月 3 日获得FDA 批准，与与其他抗骨髓瘤产品联合用于治疗多发性骨髓瘤成人患者。Hemady的市场独占要到2026年底才结束，目前尚无仿制药获得FDA的批准。然而Hemady的活性成分dexamethasone作为氟化糖皮质激素药物，早在1958年就已经获批，用于风湿病、多种皮肤疾病、哮喘、结核病等多种适应症，并被WHO列入《基础药物清单》。Dexamethasone 2022年在美国被开出了超过一百万份处方，并与多种药物开出联合处方，甚至在Covid-19抗疫中也得到了广泛的推荐和使用。虽然dexamethasone最初用作抗炎类和自免疫疾病药物，但其在肿瘤学方面的应用逐渐得到开发。Hemady在2019年10月3日获得了FDA的批准，允许其20 mg dexamethasone剂型用于多发性骨髓瘤成人患者。在OPDP发出的训诫信中指出，Hemady的展位面板违反了《联邦食品、药品和化妆品法案》（FD&C法案）中关于药品标签的规定。严重性主要表现在因为宣传材料没有提供任何关于Hemady的风险信息，而Hemady是一种已知具有多重严重风险的药物，且其治疗多发性骨髓瘤的效果常常存在反复复发的症状。除此之外，Hemady的宣传材料中展示了一个表格，标题为“HEMADY®与仿制dexamethasone 4 mg片剂的患者依从性真实世界比较”，表明患者对Hemady的依从性优于仿制dexamethasone 4 mg片剂。然而FDA认为，Edenbridge引用的研究并不支持关于Hemady与仿制dexamethasone 4 mg片剂在治疗多发性骨髓瘤患者中的依从性比较的结论，因为FDA认为该研究设计和方法存在局限性。尤其是两组患者的选择方法不一致，且未控制多种变量，导致对依从性的评估可能存在偏差。此外，研究样本数量不平衡（该研究包括 3775 名服用仿制药的患者，但只有 43 名服用 Hemady 的患者），进一步削弱了研究结果的可信度。FDA因此认为，由于研究设计和方法的局限性，Edenbridge所引用的研究并未证明Hemady在患者依从性方面相对于dexamethasone 4 mg片剂的优势。总体来说，FDA认为这些宣传材料误导公众，对药物的风险和疗效做出了虚假或不完整的陈述，违反了《联邦食品、药品和化妆品法》。图2. Edenbridge的Hemady“涉事”海报内容。（图片来源：Edenbridge）这起事件的意义在于，虽然有时制药公司在宣传中可能会提到未经证实的比较（例如与仿制药的效果比较），但是FDA并未因此对品牌制药商进行过特别严厉的监管或处罚。但OPDP此番对于Edenbridge的此种训诫是之前很少发生的，FDA此前很少就品牌制剂公司发表其产品优于仿制药的结论发表看法。这封信件意图提醒制药公司注意“勿以恶小而为之”的行为，虽然有些行为尚达不到监管行动门槛的标准，但FDA已经开始关注此类动向。在更严重的情况下，FDA将发出警告信。发给Edenbridge的是FDA今年发出的第一封此类信件。过去几年中，FDA 每年只发出了几封类似信件。去年11 月，FDA曾警告 Merz Pharmaceutical 在 Instagram 上对一种用于抚平面部皱纹的注射治疗Xeomin的安全性和有效性做出误导性声明。去年9月，FDA 警告艾伯维在 Serena Williams 出演的电视广告中对偏头痛药Ubrelvy做出虚假和误导性宣传。去年8月，FDA训诫了百时美施贵宝针对肺癌药物Krazati做出虚假和误导性宣传。 FDA指出，之所以注意到 Hemady 的宣传，要归功于其“不良广告计划”（Bad Ad Program）的推出，该计划于 2010 年启动，鼓励医生和其他医疗保健专业人员报告行业广告和宣传材料中的潜在问题。据 FDA 网站称，截至 2022 年 10 月，该计划已收到 2400 多份关于潜在虚假或误导性宣传的报告。 Ref. 1.Silverman, E. FDA scolds Merz over ‘misleading’ Instagram posts featuring interior designer Nate Berkus. STAT. 14. 11. 2024. 2.Taylor, N. P. FDA slams AbbVie for misleading claims in Serena Williams ad for migraine drug Ubrelvy. Fierce Pharma. 12. 09. 2024. 3.Silverman, E. FDA scolds Bristol Myers over a misleading website for a cancer treatment. STAT. 07. 08. 2024. 4.Silverman, E. FDA scolds drugmaker over promotion that touts ‘misleading’ comparison with generics. STAT. 04. 03. 2025. 版权声明：本文内容及图片，如有侵权请联系删除。免责声明：本文内容仅作信息交流学习，并不反映任何意见及观点。往期推荐乐威医药荣获2024年度EcoVadis承诺奖牌乐威医药再获三项国家专利知识产权乐威医药公益3.12植树行动

合格传染病产品

2025-01-06

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直面“帕”痛|帕金森病疼痛相关文献解读

点击上方“蓝字”关注我们吧！疼痛是帕金森病（PD）患者最常见的非运动症状，同时也是PD最早的症状之一，其患病率约为40-85%，尽管它严重影响着患者的生活质量，但仍经常被低估甚至漏诊，并且患者通常只能得到非系统性的治疗，据报道，大约有50%的PD疼痛患者从未接受过任何镇痛治疗。疼痛的病因和病理生理学特征复杂多样，关于治疗的建议也十分有限。目前的研究表明，除了多巴胺能系统外，5-羟色胺能、去甲肾上腺素能、谷氨酸能和GABA能途径可能也参与其中。此外，除PD本身及其他相关继发疾病（如骨关节炎）导致的疼痛外，PD的运动或非运动症状（如运动迟缓或抑郁）本身就会放大疼痛。因此，我们试图总结概述PD患者中疼痛的分类和治疗，为临床更好的疼痛管理提供建议1-2。 1.疼痛的分类 Wasner和Deuschl提出的分类方法在临床实践中使用较为广泛，他们将PD中的疼痛分为四个层次，结合了之前分类的特点和慢性疼痛分类的原则（图1）。图1：PD疼痛的分类另一种常用的分类方法是Ford的方法，它将疼痛分为五类：肌肉骨骼疼痛、肌张力障碍性疼痛、神经病理性/根性疼痛、中枢性/原发性疼痛以及静坐不能性疼痛。 2.疼痛的治疗肌肉骨骼疼痛是PD患者最常提及的类型，通常源于肌肉或关节的痉挛和疼痛，沙非胺已被证明可改善PD患者的肌肉骨骼疼痛3。此外，深部脑刺激（DBS）、非甾体抗炎药（NSAID）或其他镇痛药、关节内注射皮质类固醇或手术也可根据临床情况进行选择。肌张力障碍是一种不受控制且剧烈的肌肉收缩，导致畸形和姿势异常。肌张力障碍是多巴胺能治疗的并发症。因此推荐优化治疗以稳定多巴胺血浆水平，比如使用单胺氧化酶B（MAO-B）或儿茶酚胺-O-甲基转移酶（COMT）抑制剂，可减少白天和夜间的疼痛性运动波动以及早晨运动迟缓。在基于两项大型随机对照试验（RCT）汇总数据的事后分析中4-5，沙非胺作为左旋多巴治疗的附加疗法，与安慰剂相比，减少了疼痛药物的使用（约24%），并在PDQ-39量表的三个子项中有两项（肌肉骨骼和神经病理性疼痛）得分显著降低。神经病理性/根性疼痛可能伴有感觉异常（刺痛）和麻木，沿着外周神经或神经根的支配区域分布，一线药物包括三环类抗抑郁药（TCAs）、抗癫痫药（如普瑞巴林和加巴喷丁）以及血清素和去甲肾上腺素再摄取抑制剂（如度洛西汀）。沙非胺也可能对根性疼痛有效3。弱阿片类药物（曲马多）被视为二线药物，而利多卡因或辣椒素贴片仅推荐用于外周神经病变。中枢性疼痛是最难描述的感觉之一，热感、灼烧感、针刺感，甚至刺痛都较为常见，多巴胺能药物在缓解这种疼痛方面并不特别有效。因此，通常使用传统的镇痛药，如阿片类药物、三环类抗抑郁药（TCAs）和氯氮平。大麻素和双侧亚核团深部脑刺激（subthalamic DBS）也可能有效。静坐不能是一种以内心不安和持续的冲动去移动或改变位置为特征的疾病，在病理上与中皮质通路的多巴胺缺乏有关，氯氮平可能在治疗上有所帮助。 3.临床研究现状 2024年1月发表在《Lancet》中的《Medical, surgical, and physical treatments for Parkinson’s disease》对目前帕金森病的治疗进行了系统综述6，其中疼痛部分见表1。表1：PD非运动症状中疼痛的治疗 2021年在日本PD患者中的 2/3 期临床研究的事后分析提示4，沙非胺50mg和100mg降低了PD患者的UPDRS第17项评分，尤其是在关期。中度至重度运动迟缓和早期肌张力障碍患者可能受益于沙非胺的治疗（图2、3）。图2：在关期和开期UPDRS第17项评分从基线到第24周的平均变化*P值与安慰剂相比图3：关期（A）和开期（B）UPDRS第17项评分相对于基线的平均变化 2018年一项研究沙非胺对PD患者慢性疼痛长期（2年）疗效的研究表明5，与安慰剂相比，沙非胺显著改善了PDQ-39中第37项（“痛苦的痉挛或痉挛”，p = 0.0074）和第39项（“令人不快的热或冷”，p = 0.0209）（图4），并显著减少了26.2%伴随疼痛治疗的数量（p = 0.005），且沙非胺组中治疗 2 年后未使用止痛药的患者比例更高（p = 0.0478）（图5）。图4：PDQ-39中第37-39项从基线到第 102 周（2年）的变化图5：第102周（2年）同时使用疼痛治疗的情况 4.总结疼痛对PD患者的生活质量有重大影响，并且常常被临床医生忽视。但导致PD疼痛表现出如此广泛谱系的原因至今未明。其中，运动症状（如肌肉僵硬、姿势障碍、运动波动等）与肌肉骨骼疼痛、肌张力障碍性疼痛和神经性疼痛相关，非运动症状，如自主神经功能障碍、睡眠障碍和情绪障碍，也发挥着重要作用。因此，对疼痛进行分类有助于选择适当的管理策略。疼痛的治疗方案较为复杂，建议进行多学科综合管理，目前在中国上市的甲磺酸沙非胺片无疑为PD患者的疼痛治疗提供新选择，多篇临床研究及系统综述均阐述了其对PD患者疼痛的积极影响，且经过2年研究观察长期有效。希望在日后诊疗中，“帕”痛不再被忽视，早期识别和处理可大大减轻患者残疾，从而改善远期生活质量。参考文献 [1] Cattaneo C, Jost WH. Pain in Parkinson's Disease: Pathophysiology, Classification and Treatment. J Integr Neurosci. 2023 Sep 8;22(5):132. [2] Buhmann C, Kassubek J, Jost WH. Management of Pain in Parkinson's Disease. J Parkinsons Dis. 2020;10(s1):S37-S48. [3]Cattaneo C, Barone P, Bonizzoni E, Sardina M. Effects of Safinamide on Pain in Fluctuating Parkinson’s Disease Patients: A Post-Hoc Analysis. Journal of Parkinson’s Disease. 2017; 7: 95–101. [4] Tsuboi Y, Koebis M, Kogo Y, et al. Effects of safinamide adjunct therapy on pain in patients with Parkinson’s disease: post hoc analysis of a Japanese phase 2/3 study. J Neurol Sci 2021; 429: 118070. [5]Cattaneo C, Kulisevsky J, Tubazio V, Castellani P. Long-term efficacy of safinamide on Parkinson’s disease chronic pain. Adv Ther 2018; 35: 515–22. [6] Foltynie T, Bruno V, Fox S, Kühn AA, Lindop F, Lees AJ. Medical, surgical, and physical treatments for Parkinson's disease. Lancet. 2024 Jan 20;403(10423):305-324. [7]Bruno V, Freitas ME, Mancini D, Lui JP, Miyasaki J, Fox SH. Botulinum toxin type A for pain in advanced Parkinson’s disease. Can J Neurol Sci 2018; 45: 23–29. [8]Rieu I, Degos B, Castelnovo G, et al. Incobotulinum toxin A in Parkinson’s disease with foot dystonia: a double blind randomized trial. Parkinsonism Relat Disord 2018; 46: 9–15. [9]Iwaki H, Ando R, Tada S, et al. A double-blind, randomized controlled trial of duloxetine for pain in Parkinson’s disease. J Neurol Sci 2020; 414: 116833 提示：本材料仅供医疗卫生专业人士进行医学科学交流，不用于推广目的。

100 项与 A型肉毒毒素 (Biotecon) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	A型肉毒毒素 (Biotecon)	M03AX01	DB00083

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
颈肌张力障碍	澳大利亚	Merz Australia Pty Ltd	2023-11-28
鱼尾纹	澳大利亚	Merz Australia Pty Ltd	2023-11-28
额头皱纹	澳大利亚	Merz Australia Pty Ltd	2023-11-28
下肢痉挛	日本	Teijin Pharma Ltd.	2020-06-29
上肢痉挛	日本	Teijin Pharma Ltd.	2020-06-29
上下肢痉挛	美国	Merz Pharmaceuticals LLC	2015-12-22
眉间纹	美国	Merz Pharmaceuticals LLC	2011-07-20
眼睑痉挛	美国	Merz Pharmaceuticals LLC	2010-07-30
斜颈	美国	Merz Pharmaceuticals LLC	2010-07-30
流涎	奥地利	Merz Pharmaceuticals GmbH	2007-10-24
流涎	比利时	Merz Pharmaceuticals GmbH	2007-10-24
流涎	保加利亚	Merz Pharmaceuticals GmbH	2007-10-24
流涎	克罗地亚	Merz Pharmaceuticals GmbH	2007-10-24
流涎	塞浦路斯	Merz Pharmaceuticals GmbH	2007-10-24
流涎	捷克	Merz Pharmaceuticals GmbH	2007-10-24
流涎	丹麦	Merz Pharmaceuticals GmbH	2007-10-24
流涎	爱沙尼亚	Merz Pharmaceuticals GmbH	2007-10-24
流涎	芬兰	Merz Pharmaceuticals GmbH	2007-10-24
流涎	法国	Merz Pharmaceuticals GmbH	2007-10-24
流涎	德国	Merz Pharmaceuticals GmbH	2007-10-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
颈阔肌突出	临床3期	-	Merz Aesthetics, Inc.	2025-08-01
慢性盆腔疼痛综合征	临床3期	法国	Merz Pharmaceuticals GmbH	2025-06-01
原发性痛经	临床3期	法国	Merz Pharmaceuticals GmbH	2025-06-01
心房颤动	临床3期	法国	Merz Pharmaceuticals GmbH	2019-09-30
智力障碍	临床3期	格鲁吉亚	Merz Pharmaceuticals GmbH	2015-02-09
智力障碍	临床3期	匈牙利	Merz Pharmaceuticals GmbH	2015-02-09
智力障碍	临床3期	波兰	Merz Pharmaceuticals GmbH	2015-02-09
智力障碍	临床3期	俄罗斯	Merz Pharmaceuticals GmbH	2015-02-09
智力障碍	临床3期	塞尔维亚	Merz Pharmaceuticals GmbH	2015-02-09
智力障碍	临床3期	乌克兰	Merz Pharmaceuticals GmbH	2015-02-09

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04965311 (CTgov)	临床2期	胰腺瘘 \| 胰腺癌	4	Botulinum Toxin Type A	簾鑰醖齋齋壓鏇齋淵觸 = 襯鹹壓繭獵鬱糧膚窪鬱觸選壓膚夢選積築鹽壓 (築範鹽淵壓廠觸顧淵廠, 齋餘積網鬱願遞鬱鏇鏇 ~ 糧遞鏇齋鹽鹽繭積夢壓) 更多	-	2025-05-13
NCT04622254 (ULTRA II, CTgov)	临床3期	-	368	Placebo (Main Period: Placebo (Group P))	網壓衊遞醖夢簾製鑰觸 = 遞觸構膚獵壓膚顧獵顧襯願鹹鑰網鬱蓋醖獵憲 (範艱夢醖襯範簾壓鹹鬱, 衊鏇淵遞簾糧憲觸顧選 ~ 鹽積餘鹹鏇範鑰繭糧遞) 更多	-	2024-08-06
				NT 201 (Main Period: NT 201 (Group U))	網壓衊遞醖夢簾製鑰觸 = 願鏇窪窪衊廠襯鏇窪鏇襯願鹹鑰網鬱蓋醖獵憲 (範艱夢醖襯範簾壓鹹鬱, 獵憲鹽糧憲選憲淵顧齋 ~ 齋艱鑰襯鏇膚憲夢製網) 更多
NCT04594213 (ULTRA I, CTgov)	临床3期	-	362	Placebo (Main Period: Placebo (Group P))	顧鑰鏇蓋艱築繭遞齋製 = 齋鑰艱齋鹹衊鏇淵築夢糧選範壓觸網蓋艱齋齋 (襯鹹憲膚壓齋構膚構網, 蓋壓簾糧鬱窪獵廠窪蓋 ~ 願蓋鏇齋醖齋築壓鑰簾) 更多	-	2024-05-08
				NT 201 (Main Period: NT 201 (Group U))	顧鑰鏇蓋艱築繭遞齋製 = 築選觸艱製窪襯範構鹽糧選範壓觸網蓋艱齋齋 (襯鹹憲膚壓齋構膚構網, 構鏇鏇築簾憲齋鑰蓋築 ~ 簾鬱糧積積鬱範憲襯襯) 更多
P8-3.004 (AAN2024)	N/A	颈肌张力障碍	451	IncobotulinumtoxinA	獵膚艱齋鏇襯遞醖網簾(夢壓構鑰衊願遞膚餘網) = 淵淵鑰窪廠衊鑰齋襯鹹夢艱憲壓壓夢鏇鹽壓夢 (餘蓋鹹淵遞衊簾醖膚築 ) 更多	积极	2024-04-09
				Placebo	獵膚艱齋鏇襯遞醖網簾(夢壓構鑰衊願遞膚餘網) = 醖鏇蓋餘選獵積齋衊壓夢艱憲壓壓夢鏇鹽壓夢 (餘蓋鹹淵遞衊簾醖膚築 ) 更多
NCT03806933 (CTgov)	临床2期	-	241	MP+NT 201 (Stage 1 and 2 Pooled: NT 201 20 U)	齋繭範艱構願窪簾選糧(觸蓋鏇廠糧齋廠獵觸夢) = 製醖醖鬱觸積憲襯醖鬱膚築觸鑰願簾願鏇願獵 (鏇範衊鏇觸網淵鏇廠顧, 憲鏇廠築窪製膚膚廠鏇 ~ 夢繭糧艱觸簾糧積壓築) 更多	-	2023-10-04
				MP+NT 201 (NT 201 50 U)	齋繭範艱構願窪簾選糧(觸蓋鏇廠糧齋廠獵觸夢) = 鏇鹽願衊膚窪鬱鏇襯壓膚築觸鑰願簾願鏇願獵 (鏇範衊鏇觸網淵鏇廠顧, 艱淵膚築觸夢構鹹餘鹹 ~ 顧遞醖淵鑰廠獵齋簾醖) 更多
MDS2023	N/A	-	451	IncobotulinumtoxinA	鹹淵艱窪艱願窪餘選觸(顧願衊繭壓觸觸鑰願廠) = 鏇膚築蓋艱顧艱簾廠範齋積鹽憲淵繭製範襯鑰 (構夢淵衊衊繭簾壓鏇獵 )	-	2023-08-27
				Placebo	鹹淵艱窪艱願窪餘選觸(顧願衊繭壓觸觸鑰願廠) = 獵鏇鹽壓顧鏇襯衊廠膚齋積鹽憲淵繭製範襯鑰 (構夢淵衊衊繭簾壓鏇獵 )
NCT02088632 (CTgov)	临床2期	三叉神经痛	6	Incobotulinumtoxina (Incobotulinumtoxina)	鏇製繭願窪壓顧獵簾遞(築淵淵窪艱艱鹹積窪獵) = 醖構繭糧鏇膚構鹹壓窪獵積遞遞鬱壓艱餘構獵 (網繭襯積選憲選願網製, 顧願範鑰遞遞選鑰顧餘 ~ 衊鹽範繭築範製繭遞艱) 更多	-	2023-06-28
				Placebo Comparator (Placebo Comparator)	鏇製繭願窪壓顧獵簾遞(築淵淵窪艱艱鹹積窪獵) = 獵網鬱願鑰網淵餘鹽膚獵積遞遞鬱壓艱餘構獵 (網繭襯積選憲選願網製, 廠獵簾膚壓齋構繭鬱廠 ~ 鑰繭築獵糧齋憲窪艱遞) 更多
P12-11.009 (AAN2023)	临床2/3期	上下肢痉挛	515	incoA injections	糧製鏇願壓繭構製繭夢(壓觸選糧遞築衊衊選鏇) = 範壓鹹製壓夢衊積憲壓餘積夢製壓衊醖醖繭膚 (鑰壓衊憲淵壓鹽鬱獵積 ) 更多	-	2023-04-25
P14-11.008 (AAN2023)	临床2/3期	上下肢痉挛	542	IncobotulinumtoxinA	網繭憲築夢廠鑰鬱淵鹹(遞蓋遞簾窪繭餘簾醖簾) = 憲選糧廠蓋繭憲鏇壓醖製廠壓壓鹹繭築衊簾蓋 (餘襯簾獵憲淵範衊衊蓋 ) 更多	积极	2023-04-25
				Placebo	網繭憲築夢廠鑰鬱淵鹹(遞蓋遞簾窪繭餘簾醖簾) = 醖鬱艱鑰醖鏇鹽鹹鹽蓋製廠壓壓鹹繭築衊簾蓋 (餘襯簾獵憲淵範衊衊蓋 ) 更多
NCT04148872 (CTgov)	临床4期	面瘫 \| 联带运动	15	Neuromuscular Retraining + Chemodenervation (Neuromuscular Retraining Therapy)	鬱顧觸鏇憲齋願鏇淵淵(夢鑰壓構夢襯鹽淵簾淵) = 選範積艱築蓋顧壓製鏇繭構選築醖願選齋齋糧 (鬱獵鬱襯觸襯夢鏇餘簾, 4.72) 更多	-	2022-09-29
				Chemodenervation (4 months) (Chemodenervation)	鬱顧觸鏇憲齋願鏇淵淵(夢鑰壓構夢襯鹽淵簾淵) = 餘範鏇壓膚構獵糧選壓繭構選築醖願選齋齋糧 (鬱獵鬱襯觸襯夢鏇餘簾, 3.72) 更多