Article(id=1292135522642719099, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1773763200000, receivedDateStr=2026-03-18, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998715314, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998715314, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998715314, creator=13701087609, updateTime=1785998715314, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1359, endPage=1364, ext={EN=ArticleExt(id=1292135522869211516, articleId=1292135522642719099, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical study of intrathecal injection of nusinersen sodium combined with risdiplam in the treatment of children with spinal muscular atrophy, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the clinical efficacy and safety of intrathecal nusinersen combined with risdiplam in children with spinal muscular atrophy (SMA).
Methods A total of 75 children with SMA were divided into a control group and an experimental group. The control group received intrathecal nusinersen (12 mg) at loading doses on days 0, 14, 28, and 63, followed by maintenance doses every 4 months for 12 months. The experimental group received additional oral risdiplam once daily, with the dose adjusted according to age and body weight, for 12 months. Clinical efficacy, motor function, pulmonary function, and adverse drug reactions were compared between the two groups.
Results Following treatment, the overall response rates in the experimental group and control group were 91.67% (33 cases/36 cases) and 82.05% (32 cases/39 cases), respectively, with no statistically significant difference between the two groups. (P>0.05). After treatment, the revised upper extremity module (RULM) scores in the experimental group and control group were 32.69±2.07 and 31.59±1.97, respectively; the Hammersmith Functional Motor Scale Expanded (HFMSE) scores for spinal muscular atrophy were 27.75±6.19 and 24.62±6.08, respectively; the 6-minute walking test (6MWT) results were (323.28±29.99) and (303.18±31.39) meters, respectively; the percentage of predicted forced vital capacity (FVC%pred) was (88.09±7.63)% and (83.85±7.79)%, respectively; the percentage of predicted forced expiratory volume in one second (FEV1%pred) was (97.54±8.69)% and (93.28±8.95)%, respectively; the percentage of predicted peak expiratory flow (PEF%pred) was (84.31±8.14)% and (79.64±8.05)%, respectively. In the PedsQLTM-SMA Module, the scores for daily activities were 1.97±0.17 and 1.85±0.37, motor function scores were 2.14±0.35 and 2.03±0.28, fatigue/pain scores were 2.06±0.23 and 1.97±0.28, social interaction scores were 1.83±0.38 and 1.72±0.51, treatment worry scores were 1.94±0.23 and 1.85±0.37, and emotional functioning scores were 2.11±0.40 and 1.97±0.28, respectively. Serum neurofilament light chain (NfL) levels were (16.58±2.09) and (17.57±2.14) pg·mL-1, and serum creatine kinase (CK) levels were (59.72±6.81) and (61.73±7.33) U·L-1, respectively. Statistically significant differences were observed in the above indicators between the two groups (P<0.05). The overall incidence of adverse drug reactions in the experimental group and control group was 8.33% and 10.26%, respectively, with no statistically significant difference (P=0.775).
Conclusion Intrathecal nusinersen combined with risdiplam significantly improves motor function in children with SMA compared with nusinersen alone, without increasing adverse drug reactions.
, authors=Yuan-yuan ZHEN, Pei-yuan LIAO, Jing YANG, Yan-li LIU, Hui-xiang GAO, Shan ZHU, authorsList=Yuan-yuan ZHEN, Pei-yuan LIAO, Jing YANG, Yan-li LIU, Hui-xiang GAO, Shan ZHU, authorCompany=null, correspAuthors=Shan ZHU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292135524786008446, articleId=1292135522642719099, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=诺西那生钠鞘内注射联合利司扑兰治疗脊髓性肌萎缩症患儿的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察诺西那生钠鞘内注射联合利司扑兰治疗脊髓性肌萎缩症患儿的临床疗效和安全性。
方法 将75例脊髓性肌萎缩症患儿分为对照组和试验组。对照组给予诺西那生钠鞘内注射，剂量12 mg，于第0、14、28、63天负荷剂量，然后每4个月维持剂量，疗程12个月；试验组在对照组治疗基础上给予利司扑兰口服，qd，剂量根据年龄和体重调整，疗程12个月。比较2组患者的临床疗效、运动功能指标，肺功能以及药物不良反应发生情况。
结果 治疗后，试验组和对照组的总有效率分别为91.67%（33例/36例）和82.05%（32例/39例），在统计学上差异无统计学意义（P>0.05）。治疗后，试验组和对照组上肢模块修订版评分（RULM）分别为（32.69±2.07）和（31.59±1.97）分，脊髓性肌萎缩症Hammersmith功能运动量表（HFMSE）评分分别为（27.75±6.19）和（24.62±6.08）分，6分钟步行试验（6MWT）分别为（323.28±29.99）和（303.18±31.39）m，肺活量预计值百分比（FVC% pred）分别为（88.09±7.63）%和（83.85±7.79）%；第1秒用力呼气容积预计值百分比（FEV1% pred）分别为（97.54±8.69）%和（93.28±8.95）%；呼气峰值流量预计值百分比（PEF%pred）分别为（84.31±8.14）%和（79.64±8.05）%；PedsQLTM-SMA Module量表中日常活动评分分别为（1.97±0.17）和（1.85±0.37）分，运动功能评分分别为（2.14±0.35）和（2.03±0.28）分，疲劳/疼痛评分分别为（2.06±0.23）和（1.97±0.28）分，社交互动评分分别为（1.83±0.38）和（1.72±0.51）分，治疗担忧评分分别为（1.94±0.23）和（1.85±0.37）分，情绪感受评分分别为（2.11±0.40）和（1.97±0.28）分，血清神经丝蛋白（NfL）分别为（16.58±2.09）和（17.57±2.14）pg·mL-1，血清肌酸激酶（CK）分别为（59.72±6.81）和（61.73±7.33）U·L-1；2组患者上述指标比较，在统计学上差异有统计学意义（均P<0.05）。试验组和对照组的总药物不良反应发生率分别为8.33%和10.26%，在统计学上差异无统计学意义（P>0.05）。
结论 诺西那生钠鞘内注射联合利司扑兰比单用诺西那生钠治疗脊髓性肌萎缩症患儿有明显的运动功能改善，且不增加药物不良反应。
, authors=甄媛媛, 廖培元, 杨静, 刘艳丽, 高辉香, 朱珊, authorsList=甄媛媛, 廖培元, 杨静, 刘艳丽, 高辉香, 朱珊, authorCompany=null, correspAuthors=朱珊, authorNote=
甄媛媛，（1988-），女，硕士研究生，主治医师，主要从事小儿神经及感染方面的工作
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