Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders

Background:
Periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) is the most common periodic fever syndrome of childhood. Symptoms can include swelling of the glands in the throat, mouth ulcers, and tonsillitis. Removal of the tonsils can stop the periodic flareups. But researchers do not know how PFAPA develops. In this natural history study, researchers will collect specimens and data from people with PFAPA to see what they might have in common.
Objective:
To collect blood and other specimens from people with PFAPA to learn more about the illness.
Eligibility:
People aged 1 month or older with symptoms of PFAPA or another tonsil disorder.
Design:
Participants will be screened. Their medical records will be reviewed. Researchers will ask about a family history of PFAPA.
The following specimens may be collected:
Blood. Blood will be drawn either from a needle inserted into a vein or from a prick in the finger or heel.
Mucus and cells. A stick with soft padding on the tip may be rubbed inside the nostrils or mouth.
Stool.
Saliva.
Tissue samples may be taken if participants are having surgery to remove the tonsils or adenoids. Participants having surgery may also have a nasopharyngeal wash; salt water will be squirted into the back of the throat and then sucked back out with a syringe.
Most participants will provide specimens only once. They can do this in person at the clinic; they can also have their local health providers send specimens to the researchers. Some participants may have optional follow-up visits over 10 years.

开始日期2023-05-23

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与周期性发热综合征相关的临床结果

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100 项与周期性发热综合征相关的转化医学

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0 项与周期性发热综合征相关的专利（医药）

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项与周期性发热综合征相关的文献（医药）

2025-08-01·Journal of Allergy and Clinical Immunology: Global

A newly identified pathology of episodic angioedema with hypereosinophilia (Gleich syndrome) revealed by multiomics analysis

Article

作者: Sato, Yasunori ; Koreeda, Tatsuya ; Muraoka, Hirokazu

BackgroundEpisodic angioedema with eosinophilia (Gleich syndrome) is a rare disease marked by periodic angioedema, fever, and severe eosinophilia, with limited understanding of its pathogenesis.ObjectiveWe sought to identify pathogenic factors contributing to severe Gleich syndrome through a comprehensive multiomics approach, using whole-genome sequencing (WGS) and RNA sequencing (RNA-seq).MethodsA multiomics analysis was conducted on a 16- to 20-year-old female patient with severe Gleich syndrome, presenting with periodic high fever, extensive urticaria/eczema, and marked eosinophilia. The analysis included WGS and RNA-seq of blood samples.ResultsWGS revealed high-impact pathogenic mutations that have the potential to significantly alter gene function in 16 genes, including PR domain containing 16 (gene involved in transcriptional regulation). RNA-seq identified differentially expressed genes linked to immune response regulation and viral defense. Combined z-score analysis of WGS and RNA-seq highlighted angiotensin-converting enzyme as a key gene, with significant downregulation during disease progression that normalized with treatment. IFNG was also implicated.ConclusionsThe findings suggest that decreased angiotensin-converting enzyme expression, driven by PR domain containing 16 (gene involved in transcriptional regulation) mutations and altered IFNG expression, may contribute to increased bradykinin levels and activation of the arachidonic acid cascade, leading to the severe inflammation and angioedema characteristic of Gleich syndrome. This study underscores the utility of integrating WGS and RNA-seq data in elucidating the molecular basis of rare diseases and offers a foundation for developing therapeutic strategies for hypereosinophilic syndromes.

2025-07-01·The Journal of Pediatrics

Features Associated with Response to Tonsillectomy in Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis Syndrome in Children

Article

作者: Srinivasalu, Hemalatha ; Garguilo, Kathryn ; Edwards, Kathryn M ; Failla, Laura ; Ortega-Villa, Ana M ; Bowes, Mary ; Barron, Karyl ; Romeo, Tina ; Kastner, Daniel L ; Ombrello, Amanda ; Manthiram, Kalpana ; Lapidus, Sivia ; Mudd, Pamela

OBJECTIVETo identify clinical features associated with response to tonsillectomy among children with periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis (PFAPA) syndrome and to determine optimal management of children with continued episodes after tonsillectomy.STUDY DESIGNPatients with PFAPA seen at Vanderbilt University Children's Hospital and the National Institutes of Health (NIH) who underwent tonsillectomy were enrolled and queried regarding symptoms before and after surgery.RESULTSNinety-seven subjects with PFAPA (43 Vanderbilt, 54 NIH) were followed for a median of 49 months following tonsillectomy. Nearly half of participants reported complete resolution of PFAPA episodes (65% at Vanderbilt and 35% at NIH), while 25% had less severe or frequent episodes, 23% had a period of remission with recurrence, and 4% had no change in episodes. By logistic regression, factors associated with a full response to tonsillectomy were episode resolution with glucocorticoid treatment, presence of exudative pharyngitis, absence of rash, and absence of arthralgia/myalgia during pre-tonsillectomy PFAPA flares. Among those requiring treatment for persistent flares post-tonsillectomy, 15/19 (79%) reported improvement with cimetidine or famotidine prophylaxis.CONCLUSIONTonsillectomy remains effective in improving PFAPA flares in most patients. However, unique episode features prior to tonsillectomy appear to be clinical predictors of response to tonsillectomy. Histamine receptor 2 antagonists like cimetidine were effective prophylactic agents for refractory cases post-tonsillectomy. Patients with incomplete response to tonsillectomy may represent a subset of PFAPA with unique factors affecting their pathogenesis.

2025-04-01·Jornal de Pediatria

Surgical management for periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis (PFAPA) syndrome: a systematic review and meta-analysis

Review

作者: Battistuta, Sophia Massafelli ; Yuamoto, Bruno ; Makabe, Pedro Faria ; Cavalcante, Luís Fernando Ferreira ; Bueno, Isadora Silva Fanucci ; Sáfadi, Marco Aurélio Palazzi ; Costa, Giovanna ; Vilela, Felipe Endrigo Gonçalves

OBJECTIVEThis systematic review and meta-analysis aimed to evaluate the efficacy of surgical management, specifically total and partial tonsillectomy, for Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) syndrome, focusing on symptom resolution and recurrence reduction.DATA SOURCESA systematic search of MEDLINE, Scopus, and Cochrane databases identified randomized controlled trials (RCTs) comparing surgical to non-surgical management in children with PFAPA. Data extraction and quality assessment adhered to Cochrane guidelines and PRISMA protocols. Risk ratios (RR) and confidence intervals (CI) were calculated using random-effects models.SUMMARY OF FINDINGSAfter the removal of duplicates, 31 studies were screened and 3 studies were included. Pooled analysis revealed a 72% reduction in persistent symptoms following surgical interventions compared to non-surgical management (RR: 0.28, 95% CI: 0.12-0.68, I² = 22%, p = 0.005).CONCLUSIONThe findings confirm that surgical management, including total and partial tonsillectomy, is an effective therapeutic option for PFAPA, with substantial benefits in symptom resolution and quality of life improvement. While surgery offers long-term benefits, its risks, and broader immunological implications require careful consideration. The study underscores the necessity for larger, multicenter trials to validate these findings across diverse populations and optimize treatment strategies.

项与周期性发热综合征相关的新闻（医药）

2023-10-20

·药时代

药时代BD需求-009项目 | 知名中国上市企业寻找IL-1β抗体

秉承着“聚焦新药研发，荟萃行业精华。分享交流合作，共筑健康天下”的宗旨，药时代一直努力捕捉医药圈发生的各种新闻动态，也致力于为新药研发的英雄们及时提供有价值的信息，协助做药的英雄们做好药。为了达到这一目标，药时代举办了系列BD论坛、项目路演的活动，持续改进BD投融资业务以帮助好的项目早日找到合作伙伴，顺利推进到临床甚至上市阶段。在药时代BD团队的努力下，已经有一批项目处于TS探讨阶段，若干项目进入合同签署阶段。近日我们又得到一家知名中国上市药企的委托，帮助其寻找一个靶向IL-1β的项目。如您有IL-1β的项目，且有对外合作的意向，欢迎与我们联系！我们将高效地推进您与需求方的合作！项目需求项目代号：DTD20231009-009项目名称：IL-1β药物类型：单抗或者双抗适应症：痛风、骨关节炎、罕见病系列（包括周期性发热综合征等）产品阶段：临床I期或者 PCC阶段（体内初步药效）专利：PCT专利（拟申请或已经申请）合作需求：中国权益如果您对该项目感兴趣，欢迎与我们联系！请注明项目代号：DTD20231009-009我们将与您详细探讨。谢谢！联系人：Richard电话：17821449819微信：DrugTimes_BD邮箱：qi.yang@drugtimes.cn其他BD项目药时代BD-087项目 | 高安全性、高选择性第三代非共价BTK抑制剂寻求合作药时代BD-029-002项目 | 临床阶段大瘤种BIC潜质HER2HER2双靶点ADC寻求合作药时代BD-092项目 | 高活性，低风险THRβ靶向NASH新药寻求合作药时代BD-093项目 | 全球首创治疗r/r T-ALL/LBL及AML的自体CD7-CAR-T寻求合作药时代BD-095项目 | 广谱抗结核药物增敏剂寻求合作药时代BD-091项目 | 高效、低毒MerTK靶向肝癌、乳腺癌项目寻求合作药时代独家代理！卡塔尔制剂药厂寻找买家！德国设计建造，去年5月份刚刚投产药时代BD-089项目 | 高选择性线粒体复合物I抑制剂血液瘤临床前项目寻求合作药时代BD-090项目 | DprE1靶向高活性、低毒性抗结核病新药寻求合作药时代BD-067项目 | 美国实体瘤I期GD2xCD3双抗寻求合作药时代BD-066项目 | 抑郁症领域每日一次口服缓释剂寻求中国合作伙伴药时代BD-065项目 | 潜在Best-In-Class腹膜透析液海外II期项目寻求合作药时代BD-036项目 | DNA-PK靶向潜在FIC级别肿瘤小分子寻求合作药时代BD-035项目 | 高选择性、长半衰期PDE-5口服小分子I/II期项目寻求合作药时代BD-063项目 | NY-ESO-1靶点安全、有效TCR-T项目寻求合作药时代BD-052项目 | FLT3靶向临床III期口服小分子寻求合作药时代BD-053项目 | 与奥贝胆酸同靶点临床II期NASH口服小分子寻求合作药时代BD-056项目 | 美国临床阶段生物公司寻找投资及AD项目合作药时代BD-045项目 | 临床II期阶段LAT1靶向治疗脑部肿瘤及多种实体瘤的全球首创小分子药物药时代BD-043项目 | 安全、高效PD-1xTGF-β双抗肿瘤项目寻求合作药时代BD-041项目 | 高结合力、高效能PD-1xPD-L1双抗I期项目药时代BD-026项目 | IBS领域FIC/BIC潜质I期 5-HT3部分激动剂寻求合作药时代BD-040项目 | HER2靶向FIC潜力乳腺癌一/二线疗法药时代BD-033项目 | FXR靶向安全有效潜在BIC小分子 NASH I期项目药时代BD-034项目 | KHK靶向安全、有效BIC潜质口服小分子 NASH I期项目药时代BD-038项目 | VEGF靶向单抗III期眼病蓝海项目药时代BD-039项目 | III期抗EGFR单抗周制剂寻求合作药时代BD-044项目 | 第三代linker技术ADC新药靶向Claudin18.2 海外公司寻求中国合作伙伴药时代BD-029-001项目 | BIC潜质HER2/HER2双靶点抗体药时代BD-012项目 | 高亲和力、高效能CD24靶向单克隆抗体药时代BD-007项目 | 潜在FIC KRas靶向的TCR项目寻求合作，转让国内/全球权益药时代BD-021项目 | 国外癌症疫苗公司寻求国内授权或合作研发药时代BD-009项目 | 具有独特MOA且安全、有效的美国IIb期NASH项目寻求中国权益转让药时代BD直播间第1期 | CDMO企业带产品出售药时代BD-004项目 | 高效、高选择性，靶向CXCR4口服小分子拮抗剂转让国外权益药时代BD-002项目 | 肿瘤领域潜在FIC项目寻找全球权益合作药时代BD-001项目 | 潜在更优THR-β激动剂，目标适应症：NASH和血脂异常。寻找全球或中国权益合作伙伴了解更多好项目，请点击阅读原文

临床1期临床2期抗体药物偶联物引进/卖出免疫疗法

2022-10-25

·生物制品圈

五大失败临床案例：幸运总是少数，不幸则各有各的不幸

本次直播免费参加，点击上方链接马上报名！临床试验失败是制药研发中最严酷的现实之一，可能会使公司的资金“打水漂”，也可能会影响到管线在其他适应症的开拓，但最为重要的是让患者感到“走投无路”。通常，在临床后期和接近试验终点时，药物失败的影响最大。尽管新药在后期已经相对稳定，但没有药物可以保证是绝对可以通过安全通过临床并上市的。Contemporary Clinical trials Communications曾发表过一个针对640项试验的评估，结果发现，54%的新疗法在III期试验中失败了，其中57%是因为疗效不足。过去几个月里，令人失望的试验数据涵盖了从早期到后期开发阶段的产品，且针对一系列不同的疾病。以下是影响最大的五个试验失败案例。1阿斯利康/牛津COVID-19鼻喷疫苗失败药物开发人员一直在积极寻找新一代COVID-19疫苗，以克服疫苗的一些限制，而鼻腔喷雾剂无疑提供了新思路。鼻喷剂不仅可以让免疫系统在病毒进入人体的地方攻击病毒，且用法更便捷。至少有12种鼻喷COVID-19疫苗正处于研发阶段，其中4种候选疫苗正在进行III期试验。有几项研究报告了积极结果，其中两项获得了监管机构的批准：一项在中国，另一项在印度。但本月，阿斯利康和牛津大学表示，他们研发的ChAdOx1腺病毒载体疫苗的鼻喷剂在小型I期试验中“未能诱导一致的粘膜抗体反应或强烈的全身反应”。据研究人员称，这项研究被认为是首次发表有关使用“简单鼻喷剂”的腺病毒载体疫苗数据，这种鼻喷剂比中国批准的需要复杂喷雾装置的喷雾剂更容易使用。此前，24个国家报告了该疫苗和罕见的血凝块有关，疫苗因而暂停使用。尽管如此，去年阿斯利康在COVID相关产品上仍然赚了40亿美元，但该公司预计，其2022年的销售额将下降至少20%。阿斯利康希望通过鼻喷疫苗重振其市场地位的希望渺茫。当然，行业内使用其他技术研发鼻喷剂的工作正在进行中。总部位于纽约的Codagenix公司表示，其拥有的COVI-VAC鼻喷疫苗最早可能在明年获得批准。2Biohaven的ALS药物II期试验折戟9月29日，Amylyx Pharmaceuticals的ALS药物Relyvrio获FDA批准。Amylyx的部分资金来自2014年网上走红的“冰桶挑战”。Relyvrio是第三款获批治疗ALS的药物。但就在同一天，来自Biohaven的ALS药物Verdiperstat却宣布III期试验失败。Verdiperstat于2018年从阿斯利康引进，当时正在马萨诸塞州总医院与多种实验性ALS药物进行研究。但与安慰剂相比，该药物未能在疾病进展或生存率方面取得进展。今年5月，Biohaven与辉瑞达成了一项重大交易，后者以116亿美元的价格收购了Biohaven的偏头痛产品。Biohaven尚未透露是否会继续开发Verdiperstat用于其他适应症，但目前只有一种进入III期临床，这是一种强迫症治疗药物，计划在今年晚些时候报告数据。就在Biohaven的消息公布几天后，Clene Nanomedicine也报告称，其研发的ALS药物在II期试验中未能达到主要和次要终点。目前，Clene Nanomedicine正在为该产品寻找战略合作伙伴，推进在不同剂量下该药物的疗效试验。3诺华抗炎药物第三次在III期“跌倒”诺华在肿瘤领域有一个远大目标，开发可以防止高危人群罹患癌症的治疗方法，尤其是开发调节炎症的免疫靶向药物。诺华认为这可能是治疗癌症的“下一个前沿产品”。然而，其名为Canakinumab的抗炎罕见病药物用于癌症治疗的努力未能达到预期效果。Canakinumab曾被批准用于治疗3种罕见和独特类型的周期性发热综合征。今年8月，诺华称，Canakinumab在其针对非小细胞肺癌（NSCLC）的第三次试验中失败，该药物最近正在进行预防术后肿瘤复发的试验。这是Canakinumab第三次III期试验失败。2018年，FDA拒绝批准Canakinumab作为某些心脏疾病的预防性治疗的新适应症申请，现在诺华扩大该药物在NSCLC中的应用似乎也陷入僵局。Jefferies的分析师曾预测，扩大批准可能会将Canakinumab的销售额提高到20亿美元。该公司正在进行该药物针对肺癌的另一项试验，一位肿瘤学专家最近告诉彭博社，Canakinumab的抗炎特性仍可能使其成为针对适当患者群体进行癌症预防“很好的模式”。4Intercept针对NASH管线再受挫非酒精性脂肪性肝炎（NASH）被认为是“药物开发的坟场”，长期以来未能有明显进展。这个拥有约350亿美元的巨大市场促使人们竞相开发首个获批药物。NASH是一种代谢疾病，通常源于肥胖（而非酒精摄入），会引发疤痕、肝硬化甚至肝脏功能衰竭。Intercept Pharmaceuticals的奥贝胆酸药物Ocaliva正在针对几种与NASH相关的适应症开展试验，该药此前已获批用于胆汁性肝硬化。一年多来，Intercept一直在与FDA就推动Ocaliva获批用于NASH导致的肝纤维化患者进行沟通。最近，该公司一项针对NASH导致代偿性肝硬化患者的试验失败，更使该领域药物发展复杂化。Intercept的研发总裁、首席医疗官M. Michelle Berrey表示：“在临床试验中，NASH导致的代偿性肝硬化的组织学终点达到统计学意义是一个非常高的门槛。”9月30日，Intercept宣布Ocaliva在Reverse试验中未能达到主要终点。该公司在一份声明中称，该结果不会影响Ocaliva用于肝纤维化的NDA计划，该部分III期结果积极。Intercept计划在今年年底前提交NDA。包括诺和诺德、Alnylam及其合作伙伴Regeneron、Akero Therapeutics在内的其他几家公司也有NASH在研项目。5Relmada抑郁症药物未达主要终点近年来，以迷幻药为基础的抑郁症新药研发领域重新焕发了活力，如强生的氯胺酮鼻喷雾剂Spravato和Axsome Therapeutics的Auvelity，后者在8月获批，成为首个治疗重度抑郁症的速效口服药物。Relmada Therapeutics也一直致力于REL-1017的适应症。新型NMDA受体（NMDAR）拮抗剂REL-1017（右美沙酮）可阻断“过度活跃的NDMAR通道”。如果该药能够成功，Relmada认为这种“新方法”可以提供另一种快速治疗抑郁症的选择。然而，Relmada本月宣布，在为期四周的疗程结束后，由于安慰剂反应高于预期，REL-1017治疗重度抑郁症（MDD）的III期研究未能达到其主要终点。试验失败的消息导致该公司股价暴跌近80%。Relmada现在将希望寄托在REL-1017的表现上，这是该公司唯一的重要产品，在另外两个III期试验中，REL-1017将与其他抑郁症药物一起进行测试。Relmada表示，这些研究的积极结果可能足以向FDA提交申请。然而，任何失败都可能给Relmada带来厄运，该公司其他开发项目包括通过收购获得的“裸头草碱（psilocybin）及其衍生物”。有望治疗抑郁症的候选药物仍然不多。去年年底的一项分析显示，对抑郁症有积极效果的II期或III期试验疗效的候选药物只有9种，该领域仍需要创新。参考文献：1、5 impactful drug trial failures from the last year；pharmavoice

疫苗抗体并购合作信使RNA

2022-08-22

·BioSpace

Clinical Catch-Up: Anixa, Palisade and Genexine Launch New Trials

Novartis' canakinumab failed again in non-small cell lung cancer (NSCLC), and Anixa Biosciences, Palisade Bio and Genexine kicked off new trials. For that and more clinical news, keep reading. Novartis reported that its Phase III CANOPY-A trial of canakinumab for adults with NSCLC failed to hit its primary efficacy endpoint. The drug is a human monoclonal antibody targeting interleukin-1ß. The trial evaluated almost 1,400 patients with stage II-IIIA and IIIB NSCLC whose tumors had been completely resected. The primary endpoint was disease-free survival (DFS). Marketed as Ilaris, the drug is indicated for cryopyrin-associated autoinflammatory syndromes in children and adults, systemic juvenile idiopathic arthritis and three other periodic fever syndromes. It is also approved to treat adult-onset Still's disease. Anixa Biosciences treated the first patient at the H. Lee Moffitt Cancer Center & Research Institute with its CAR-T therapy for ovarian cancer. The Phase I dose-escalation study will include 48 patients. The treatment leverages Anixa's chimeric endocrine receptor T-cell (CER-T) because the engineered T-cells target an endocrine receptor. The endocrine receptor target is a follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells in healthy adult females. Palatin Technologies announced a planned interim analysis of its Phase III MELODY-1 trial of PL9643 for dry eye disease. The interim analysis included the independent Data Monitoring Committee (DMC) evaluation of the first 120 patients who completed the treatment. The DMC recommended the trial continue with a study sample size target of 350 patients. No safety concerns were identified. PL9643 is a melanocortin agonist. Palisade Bio dosed the first patient in a Phase III trial of LB1148, which aims to accelerate the return of bowel function in adults undergoing gastrointestinal surgery. The drug is a novel oral liquid formulation of the digestive enzyme inhibitor tranexamic acid. Palisade believes it has the potential to decrease abdominal adhesions and help restore bowel function after surgery. It neutralizes the activity of potent digestive proteases released from the gut during surgery. Genexine dosed the first patient in a Phase II trial of triple combination therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The treatment consists of two of Genexine's drugs, GX-188E and GX-17. GX-188E is a first-in-class DNA vaccine, while GX-17 is a first-in-class long-acting interleukin 7. The third drug is Bristol Myers Squibb's anti-PD-1 checkpoint inhibitor Opdivo (nivolumab). The study is being run in South Korea and will evaluate the combination in 21 patients with HPV-16 or 18-positive recurrent/metastatic head and neck squamous cell carcinoma. PharmaJet and the University of Adelaide launched a human clinical trial of a DNA-based COVID-19 vaccine booster using the PharmaJet Tropis Needle-free Injection System (NFIS). The vaccine targets the Omicron variant and, as a DNA vaccine, can be modified easily to future variants. The partners chose the PharmaJet Tropis NFIS based on preclinical and clinical data showing improved immunogenicity when administering DNA vaccines. CSL announced positive topline results for its Phase III trial of garadacimab for hereditary angioedema (HAE). The drug is a first-in-class monoclonal antibody inhibiting Factor XIIa. The trial hit the primary and secondary efficacy endpoints and demonstrated a favorable safety profile. HAE is a rare, genetic and potentially life-threatening disease that causes painful, debilitating and unpredictable swelling of the abdomen, larynx, face and extremities. Valo Health dosed the first patient in its Phase II trial of oral OPL-0401 in patients with mild, moderate and severe non-proliferative diabetic retinopathy. OPL-0401 is a small molecule Rho kinase 1/2 inhibitor and a potential first-in-class oral option compared to current intravitreal injections, surgery, or laser treatment options. The study was designed using the company's Opal Computational Platform, allowing real-world data analyses to identify patient populations that might benefit from early treatment. Lundbeck reported that Vyepti (eptinezumab) failed to show statistical superiority over placebo at reducing the number of monthly migraine days. The drug was approved in the United States in 2020 as a preventive measure against migraine. The Phase III Sunlight trial was designed to set the drug up for accelerated approval in China. Sorrento Therapeutics received clearance from the Chinese regulatory authority to initiate a Phase I trial of its oral main viral protease inhibitor, STI-1558, in COVID-19 patients. A single ascending dose (SAD) portion of the trial was completed in Australia with no serious adverse events or severe treatment-emergent adverse events. Pharmacokinetics were dose proportional. In the China trial, the drug will be given to patients with COVID-19 in multiple ascending doses with three dose cohorts.

抗体First in Class疫苗小分子药物加速审批