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台湾合一生技重磅新药「速必一」(研发代号:ON101)三期试验数据与药物作用机制，9月3日于国际知名SCI医学期刊JAMA Network Open发表。
糖尿病患与高龄人口逐年攀升，衍生之并发症亦随之增加，其中，严重的糖尿病足溃疡患者，因缺乏有效治疗药物被迫截肢而致残、致死，造成个人、家庭与社会的巨大医疗负担。台湾合一生技历经13年持续不懈的努力，研发成功的「速必一」新药，具有独特的药物作用机制，可调控慢性伤口因高血糖而失衡的巨噬细胞，进而改善发炎、促进组织修复，达到伤口完全愈合的效用。在国际多中心三期临床试验中，「速必一」展现了远优于目前标准治疗照护的临床疗效，可大幅降低糖足伤口溃疡照护成本以及减少截肢风险。
JAMA Network Open为国际知名医学期刊美国医学会杂志JAMA出版发行之网路开放版(Open Access)，透过线上公开方式向全球提供学术性科学资讯，为Science Citation Index (SCI)医学领域开放性期刊中，影响因子分数最高的期刊。期刊网站流量一年超过840万人次，文章阅览数与下载数量超过1560万，具有极大学术影响力及流通性。「速必一」的三期临床结果与药物作用机制在JAMA Network Open发表，不仅是国际权威期刊对于「速必一」临床科学实证的肯定，更可透过网络的公开，增加国际糖足溃疡专业医护人士对于「速必一」疗效的了解，增强「速必一」新药的全球知名度，进而帮助全球广大的糖足溃疡病患，能经由「速必一」的推广而为健康重建带来新曙光。
「调节巨噬细胞创新药物治疗糖尿病足溃疡患者伤口的疗效：一项三期国际多中心随机临床试验」请于后台回复文献，可下载论文，论文主要内容：
约80%的下肢截肢手术源于慢性糖尿病足溃疡（DFU），造成医疗照护和医疗支出重担。临床上迫切需要创新有效的方式来治疗这种致残和危及生命的疾病。
高血糖会增高促炎M1和促再生M2巨噬细胞间的比例，导致创面难以愈合，因此靶向巨噬细胞表型可为潜在有效的DFU治疗方法。创新药ON101（台湾合一生技股份有限公司研发/生产）通过调节M1/M2巨噬细胞间的平衡达到治疗效果。
ON101由两种原料药:PA-F4到手香提取物及S1积雪草提取物组成，许多文献皆显示这两种药材对创面愈合有显著的药理活性。ON101 的48项药理学研究显示这两种原料药的协同效果，有助于调节M1/M2巨噬细胞比例，以乳膏基剂成为专利配方。PA-F4通过抑制NLRP3介导的炎症小体信息路径和下游炎症细胞因子如白介素（IL）-1ß和IL-6的产生，显着降低M1巨噬细胞，从而抑制炎症期。而S1通过增加胶原合成、刺激成纤维细胞增殖和角质形成细胞的迁移来激活M2型巨噬细胞 。
临床药代动力学研究针对12例DFU患者以单剂量和重复剂量方式，每天2次涂抹ON101，第1天和第14天的最大机体浓度相似，药物在体内没有明显蓄积，亦无治疗相关不良事件。在一项24例Wagner3级的慢性DFU患者临床试验中，ON101治疗2周后，创面大小减少约20%，未有严重不良事件。其中21例可评估患者中，基线时的平均创面大小为359 mm2（范围20-2352 mm2），经过2周的药物治疗后降至293 mm2。
先前的数据充分支持ON101的安全性，并且明确显现其促进创面愈合的治疗潜力。本项三期试验旨在通过与标准治疗的伤口护理亲水纤维敷料进行比较，评估ON101治疗DFU的效果。
本项试验遵循美国食品药品管理局的“充分和良好对照的研究”，设计了一项随机、对照、评估者设盲的三期研究，以亲水纤维敷料为对照，评估每天2次局部使用ON101治疗DFU的疗效。试验经机构审查委员会的批准，于三个地区的21家伤口护理专科医学/临床中心执行。本试验亦遵循国际协调会议指南（https://www.ich.org），与Consolidated Standards of Reporting Trials声明 。
依据（CONSORT）统一标准的报告指南，本试验于2012年11月23日至2020年5月11日间入组了年龄介于20-80岁、筛选期中或随机分组前3个月内测量的基线HbA1c < 12%的I型或II型糖尿病（根据世界卫生组织标准的定义）门诊患者。入组患者的目标溃疡必须是Wagner 1或2级（脚踝以下）、清创术后的面积需要达到1-25 cm2、无活动性感染，且随机分组前已进行标准治疗（依据国际糖尿病足指南工作组；https://iwgdfguidelines.org 定义）但仍存在至少4周。排除条件包括：筛选期或随机分组前3个月内测量的目标肢体踝肱指数（ABI）< 0.8、伴有坏死、筛选访视中无法以清创术清除目标溃疡的脓汁或窦道，或为美国糖尿病协会定义的急性夏科神经关节病患者。此外，若患者需接受血运重建程序，以增加目标肢体血循，必须在随机分组前至少4周进行。所有患者必须在入组前签署书面知情同意书。
在筛选期（最多7天）结束后，试验计画主持人判定为合格的患者，通过计算机生成的区组，以1:1比例随机入组，接受至多16周的ON101或亲水纤维敷料治疗。主持人和研究人员在随机分组前对分组的大小和治疗分配保持盲态。在基线访视时，主持人拆开密封信封（包含个人治疗代码）才能获悉随机分配的结果。
治疗结束访视（访视10，V10）是随机分组后第16周的访视或证实创面完全愈合的访视（以先发生者为准）。由独立评估者评估溃疡闭合程度。该独立评估者和研究统计学家在整个研究过程中对患者的治疗保持盲态，直至锁定临床数据库。为确保在整个试验过程维持盲态，本试验以标准化程序，统一摄像机设置、拍照和图像编码、独立图像传递给独立评估者，以及流水数字编码图像的盲态评估，将患者身份信息、治疗组、访视或研究中心信息维持盲态。
在干预措施方面，人口统计学数据、病史、疾病状态、放射学检查和合格性在筛选期（随机分组前）进行评估。入组患者每2周回访一次，接受伤口清洗和清创，在干预后的16周治疗期评估创面状态、测量创面大小、体格检查及记录合并用药。主持人和护士接受培训，学习使用标准化研究材料、ON101或亲水纤维敷料、摄像机设置和减压建议。主持人根据评估，给予足底溃疡患者减压装置的使用说明。在每次干预后的访视中记录所有不良反应。筛选访视、之后的治疗期中每4周一次的访视以及随访期的最后一次访视，会采集血液样本进行实验室检查（血液学和生化分析），包括：检测丙氨酸氨基转移酶、天冬氨酸氨基转移酶、肌酐、血尿素氮和白蛋白水平，分别反映肝功能、肾功能和营养状况，测量HbA1c和血糖值以监测糖尿病相关安全性问题。
ON101根据国际药品审计合作组织(PIC/s) 药品生产质量管理规范生产，为外用乳膏。ON101治疗组的患者每次访视皆由研究人员示范如何每天自行给药两次，每次给药需能完全覆盖目标溃疡，厚度不超过2 mm。含羧甲基纤维素钠（Aquacel Hydrofiber）的亲水纤维敷料需视渗出量每日更换或每周更换2-3次，根据产品说明 或主持人的判定决定。两组唯一允许使用的外层敷料为无菌纱布。在治疗期的每次访视，记录每位患者的ON101用量或亲水纤维敷料更换频率。治疗期间无系统治疗处方禁忌，但不允许使用局部抗生素和抗霉菌剂。
若目标溃疡恶化（定义为Wagner 3级），主持人可决定是否终止患者的治疗。如果独立评估者判定溃疡在治疗期间（V10或之前）的连续两次访视中（V10或之前）出现了创面完全上皮化，则停止干预（ON101或亲水纤维敷料），并在此判定后安排V10。如果确认患者在V10时有未愈合的目标溃疡，则无论分组如何，在12周的随访期中，均给予亲水纤维敷料的标准照护。
在数据收集和结局测量指标上，主要疗效终点比较两组在16周治疗期结束时的创面完全愈合率。由独立评估者以盲态、无从得知患者信息和治疗分配的情况下，确定创面是否完全愈合。次要疗效终点包括：至溃疡完全愈合的时间（基线访视至到第一次100%再上皮化访视之间的时间）、溃疡表面积较基线的改变比例（至最后一次治疗访视或创面完全愈合）、溃疡表面积减少50%的患者比例，以及目标溃疡感染的发生率。探索性终点的溃疡相关数据包括12周随访期中的溃疡复发发生率。在必要的清创术后，主持人在每次访视时使用数码平面测量法测量目标溃疡的创面大小。此外，进一步评估各亚组的疗效变量完全愈合率，评估依据基线访视记录的既往溃疡持续时间（以6个月为截点，溃疡大小（以5 cm2为截点），以及HbA1c（根据美国糖尿病协会的定义，将9%作为血糖控制不佳的截点）。
在安全性终点则评估不良事件、临床实验室值和生命体征统计分析上 ，样本量的计算是依据ON101先前临床试验的创面完全愈合结果，假设创面完全愈合的发生率比亲水纤维敷料多20%。两组采1:1的随机分组，则需要入组236例患者，以确保至少212例患者可进行评估，达到80%的效力、双侧α值为5%的显着性差异。使用SAS软件版本9.4（SAS Institute Inc.）进行数据分析。意向治疗（ITT）原则适用于全分析集（FAS），其中包括所有随机分组患者，无论实际接受的研究干预为何及是否遵守研究方案或发生不良事件。FAS用于所有疗效和安全性数据分析。使用修正意向治疗(mITT)则排除不符合基线目标溃疡的FAS患者，对疗效数据进行支持性分析。
对于主要疗效终点，使用卡方检验和逻辑回归模型进行分析，以干预作为固定因素，以基线溃疡大小和校正后Wagner分级作为协变量。逻辑回归模型的结果使用优势比（OR）、P值和相关的95%置信区间（CI）表示。部分终点则使用危险比（HR）表示。同时对相关变量进行探索性析因分析，如溃疡持续时间、溃疡大小和患者的HbA1c。采用Kaplan-Meier法和对数秩检验计算溃疡完全愈合的时间。用Cox比例风险模型估计了HR和95% CI。对根据基线溃疡面积和Wagner分级校正后的溃疡表面积改变比例和溃疡表面积较基线的改变比例进行回归分析。采用Fisher精确检验评价目标溃疡感染和复发的发生率。
如果不良事件(AE)发生在干预开始后，则视为治疗期间不良事件（TEAE）。按系统器官分类和首选术语总结AE、TEAE和严重TEAE的发生频率和占总患者的比例。采用Fisher精确检验对两组进行所有治疗期间不良事件相关比较。使用临床实验室检查数据制表列出数值较基线的改变，并采用协方差分析进行组间比较。所有检验均为双侧检验，若P值<.05则具有显着性，数据使用平均值± 标准差（SD）表示。
统计分析结果显示，FAS中共有236例患者（男性占74.1%；女性占25.9%；平均年龄57 ± 10.9岁）。基线时的平均HbA1c为8.1%（SD 1.63），治疗结束时无显著变化（ON101组的平均HbA1c是8%，对照组为7.9%），144例患者（61%）确诊糖尿病的时间> 10年。将FAS中的患者随机分配：亲水纤维敷料组114例（48.3%），ON101组122例（51.7%）。ON101组的16例患者（13.1%）和亲水纤维敷料组的21例患者（18.40%）提前终止研究（总计37例）。主持人建议使用减压装置的患者中，部分因台湾地区气候潮湿而未遵照建议。在236例患者中，184例（78%）为Wagner 2级溃疡，117例（49.6%）为足底溃疡，64例（27.1%）的基线HbA1c≥ 9%。平均溃疡大小为4.8 cm2（SD 4.41），入组前目标溃疡平均持续时间为7.15个月。
主要疗效结果显示，ON101组的74例患者（60.7%）和亲水纤维敷料组的40例（35.1%）患者在16周内达到创面闭合（OR：2.84；95% CI：1.66–4.84；P =.0001）。在mITT中也观察到类似结果，ON101组61.9%（73/118）的患者和对照组中33.9%（38/112）的患者出现溃疡闭合（OR：3.15；95% CI：1.82–5.43；P <.0001）。创面闭合程度由独立评估者评估。
溃疡持续时间、溃疡大小和患者的HbA1c水平与DFU预后不良相关。因此，对基线溃疡持续时间（6个月为截点）、基线溃疡面积（5 cm2为截点）和基线HbA1c水平（9%为截点）进行了亚组分析。分析显示，与对照组相比，ON101组有显着的OR优势（HbA1c >9%时的P =.035；溃疡持续时间>6个月时的P =.027；溃疡大小> 5 cm2时的P =.009）。
次要疗效结果显示，在FAS（HR：1.80；95% CI：1.23–2.65，P =.002，）和mITT人群中（HR：1.91；95% CI：1.29–2.83；P =.001；），ON101组患者比亲水纤维敷料组患者有更好的创面愈合率。每周完全愈合的累计发生率也反映了ON101组从第4周开始达到创面完全愈合的可能性持续升高。ON101组达到中位人群愈合所需时间为98天，而亲水纤维敷料组无法达到，因为该组在治疗期仅35.1%的患者创面愈合。两组的溃疡表面积平均减少（末次治疗访视较基线）78%（P =.87），两组间溃疡表面积减少50%的发生率无显着差异。在治疗期中，两组仅发生少量的目标溃疡感染（ON101较组7例；P =.78；）。对于随访期中完全愈合创面的复发率，ON101组为20.3%，亲水纤维敷料组为17.5%，亦无统计学意义（P =.8；）。
就安全性而言，两组未有统计学改变或差异。76例患者报告了治疗期间不良事件，其中ON101组的7例（5.7%）和对照组的5例（4.4%）认为与治疗有关。无严重AE与ON101治疗有关。一例骨髓炎病例与对照组有关，一例被分配至ON101组的患者（0.8%）死于感染性休克、急性肾损伤和急性呼吸衰竭，判定与治疗或溃疡进展无关。
本试验是全球首项探索调节M1/M2巨噬细胞试验药物治疗DFU的国际多中心三期随机对照试验。ON101具有促进DFU完全愈合的优异疗效。高血糖是慢性DFU的源头，延迟M1-M2巨噬细胞转化，延长炎症期。ON101可将高血糖所致的M1/M2巨噬细胞失衡恢复平衡，促进M1-M2转化，加速溃疡创面愈合，不仅可以治疗新发溃疡，也可治疗高危因素溃疡，包括溃疡持续时间>6个月，溃疡大小> 5 cm2和HbA1c >9%均显现ON101的稳健疗效。
本项试验根据美国FDA指南设计。16周治疗期中对照组亲水纤维敷料的创面完全愈合率（35.1%），与Jeffcoate等人在之前的试验中一项为期12周的意向治疗分析结果（28.2%）趋势一致。这代表本试验的设计和执行与其他随机对照试验具有一致性。ON101可以于清创术后使用、在家中自行用药，其使用的便利性与亲水纤维敷料对照品相同。
