Article(id=1291705018407739739, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.17.001, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1744646400000, receivedDateStr=2025-04-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896075106, onlineDateStr=2026-08-05, pubDate=1758038400000, pubDateStr=2025-09-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896075106, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896075106, creator=13701087609, updateTime=1785896075106, updator=13701087609, issue=Issue{id=1291704771212234905, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='17', pageStart='2401', pageEnd='2550', issueExtLink='null', onlineDate='null', pubDate='1758038400000', pubDateStr='2025-09-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896016147, creator='13701087609', updateTime=1785896900366, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708479866164175, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708479866164176, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2401, endPage=2406, ext={EN=ArticleExt(id=1291705018600677724, articleId=1291705018407739739, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of polyene phosphatidylcholine combined with tenofovir in patients with hepatitis B complicated with non-alcoholic steatohepatitis, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To analyze the clinical efficacy and safety of polyenophosphatidylcholine (PPC) in combination with tenofovir tablets in the treatment of patients with hepatitis B combined with nonalcoholic steatohepatitis (NASH).
Methods The patients with hepatitis B complicated with NASH in our hospital were divided into treatment group and control group by random number table method. The control group was treated with tenofovir tablets, 25 mg qd, taken during meals. The treatment group was treated with PPC on the basis of the control group. The initial dose was 456 mg tid, taken with warm boiled water, and the daily dose could not exceed 1 368 mg. After 12 weeks of treatment, the dose was reduced to 228 mg tid, according to the immune response, and the dose was maintained. Both groups were treated for 24 weeks, and the treatment group was followed up to 48 weeks after stopping PPC. The negative conversion rates of hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg), hepatitis B virus DNA (HBV-DNA) load, the levels of costimulatory molecule B7 homolog 1 (B7-H1), transforming growth factor β1 (TGFβ1), Golgi transmembrane glycoprotein 73 (GP73), chitinase 3-like protein 1 (CHI3L1) and prothrombin activity (PTA) were compared between the two groups, and the safety was evaluated.
Results A total of 95 cases were enrolled and 92 cases were included in statistical analysis, including 46 cases in the treatment group and 46 cases in the control group. After treatment, the total effective rates of the treatment group and the control group were 97.83% (45 cases / 46 cases) and 84.78% (39 cases / 46 cases), respectively, and the difference was statistically significant (P<0.05). After 24 weeks of treatment, the HBV-DNA load of the treatment group and the control group were 80.43% and 60.87%, respectively; the HBsAg negative conversion rates were 28.26% and 10.87%, respectively; and the HBeAg negative conversion rates were 30.43% and 13.04%, respectively. The above indicators in the treatment group were statistically significantly different from those in the control group (all P<0.05). After 48 weeks of treatment, the HBV-DNA load of the treatment group and the control group were 89.13% and 69.57%, respectively; the HBsAg negative conversion rates were 50.00% and 28.26%, respectively; and the HBeAg negative conversion rates were 50.00% and 26.09%, respectively. The above indicators in the treatment group were statistically significantlly different from those in the control group (all P<0.05 ). After treatment, the levels of B7-H1 in the treatment group and the control group were 0.40 (0.30, 0.40) and 0.60 (0.50, 0.70) ng·mL-1, the levels of TGFβ1 were (269.02±24.36) and (287.64±27.39) ng·mL-1, respectively; and the levels of GP73 were (76.24±8.95) and (87.22±10.03) ng·mL-1, respectively; PTA were (80.02 ± 12.55)% and (65.24±10.24)%, respectively. The treatment group compared with the control group, the differences were statistically significant (all P<0.05). The main adverse drug reactions during treatment in the treatment group and the control group were nausea and vomiting, headache, rash and abdominal distension. The total incidence of adverse drug reactions in the treatment group was 10.87% (5 cases / 46 cases), which was 13.04% (6 cases / 46 cases) in the control group, and the difference had no statistically significant (P>0.05).
Conclusion The combined application of PPC and tenofovir tablets in the treatment of hepatitis B patients with NASH can reduce the levels of B7-H1 and TGFβ1, improve the liver function of the body, and has good safety.
, authors=Zhi-hua WANG
1, Min LI
1, Jun-de DENG
1, Rui CHENG
2, authorsList=Zhi-hua WANG, Min LI, Jun-de DENG, Rui CHENG, authorCompany=null, correspAuthors=Rui CHENG, 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=1291705018990747997, articleId=1291705018407739739, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=多烯磷脂酰胆碱联合替诺福韦对乙肝合并非酒精性脂肪性肝炎患者的临床研究, 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 观察多烯磷脂酰胆碱胶囊（PPC）联合替诺福韦片治疗乙型肝炎合并非酒精性脂肪性肝炎（NASH）患者的临床疗效和安全性。
方法 将本院就诊的乙型肝炎合并NASH患者用随机数表法分为试验组和对照组。对照组用替诺福韦片治疗，25 mg qd，餐中服用，试验组在对照组基础上联合PPC治疗，初始剂量456 mg tid，随食物温开水送服，每日用药剂量不超过1 368 mg；治疗12周后，根据免疫应答情况减少剂量至228 mg tid，并维持此剂量。2组均治疗24周，试验组停用PPC后随访至48周。比较2组患者的乙型肝炎病毒表面抗原（HBsAg）和乙肝病毒e抗原（HBeAg）转阴率、乙型肝炎病毒DNA（HBV-DNA）载量、共刺激分子B7同源物1（B7-H1）、转化生长因子β1（TGFβ1）、高尔基体跨膜糖蛋白73（GP73）、壳多糖酶3样蛋白1（CHI3L1）和凝血酶原活动度（PTA），并进行安全性评价。
结果 共纳入95例，最终共92例纳入统计分析，其中试验组46例，对照组46例。治疗后，试验组和对照组总有效率分别为97.83%（45例/46例）和84.78%（39例/46例），在统计学上差异有统计学意义（P<0.05）。治疗24周后，试验组和对照组的HBV-DNA载量分别为80.43%和60.87%；HBsAg转阴率分别为28.26%和10.87%；HBeAg转阴率分别为30.43%和13.04%；试验组上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。治疗48周后，试验组和对照组的HBV-DNA载量分别为89.13%和69.57%，HBsAg转阴率分别为50.00%和28.26%，HBeAg转阴率分别为50.00%和26.09%，试验组上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。治疗后，试验组和对照组的B7-H1水平分别为0.40（0.30，0.40）和0.60（0.50，0.70）ng·mL-1，TGFβ1水平分别为（269.02±24.36）和（287.64±27.39）ng·mL-1，GP73水平分别为（76.24±8.95）和（87.22±10.03）ng·mL-1，PTA分别为（80.02±12.55）%和（65.24±10.24）%，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（均P<0.05）。试验组和对照组在治疗期间的主要药物不良反应均为恶心呕吐、头痛、皮疹、腹胀。试验组的药物不良反应总发生率为10.87%（5例/46例），对照组为13.04%（6例/46例），在统计学上差异无统计学意义（P>0.05）。
结论 联合应用PPC和替诺福韦片治疗乙型肝炎合并NASH患者，可降低B7-H1和TGFβ1水平，改善机体肝功能，且安全性良好。
, authors=王智华
1, 李敏
1, 邓俊德
1, 程锐
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王智华（1985-），男，主管药师，主要从事药物联合使用及药物临床疗效方面的临床工作和研究
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