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Article(id=1241022578173735074, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241022576185634950, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.09.09, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1712419200000, receivedDateStr=2024-04-07, revisedDate=null, revisedDateStr=null, acceptedDate=1722268800000, acceptedDateStr=2024-07-30, onlineDate=1773812439721, onlineDateStr=2026-03-18, pubDate=1727193600000, pubDateStr=2024-09-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773812439721, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773812439721, creator=13701087609, updateTime=1773812439721, updator=13701087609, issue=Issue{id=1241022576185634950, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='9', pageStart='641', pageEnd='720', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773812439247, creator=13701087609, updateTime=1773813972032, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241029005206417725, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241022576185634950, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241029005206417726, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1241022576185634950, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=680, endPage=685, ext={EN=ArticleExt(id=1241022578505085109, articleId=1241022578173735074, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Prophylactic effect of Jia Wei Jingui Shengqi Pill on haemorrhagic cystitis after haploidentical hematopoietic stem cell transplantation, columnId=1207314218647392369, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Original Article, runingTitle=null, highlight=null, articleAbstract=

AIM To explore the clinical efficacy of Jia Wei Jingui Shengqi Pill (JWJSP) as a novel prophylaxis regimen for haemorrhagic cystitis (HC) in patients undergoing haploidentical hematopoietic stem cell transplantation. METHODS A prospective cohort analysis was conducted on 65 patients with hematological malignancies who underwent haploidentical hematopoietic stem cell transplantation from January 2020 to October 2023. Patients were divided into a JWJSP group (31 cases) and a control group (34 cases). The JWJSP group was administered JWJSP 5 g orally twice daily, while the control group received no specific prophylactic measures. The cumulative incidence of HC, clinical characteristics, and the positive rate of viruria in both groups were compared. The median follow-up duration was 277 (65, 624) days. RESULTS The cumulative incidence of HC in the JWJSP group was (29±3) %, significantly lower than that in the control group (53±3) % (P<0.01). There was no significant difference in the median onset time and duration of HC between the two groups (P>0.05). The median onset time of HC in the two groups of patients was 26 (20, 32) days and 37 (25, 45) days after transplantation, respectively, and the median duration was 13 (10, 24) days and 16 (14, 53) days, respectively, with no significant difference (P>0.05). The positive rate of BKV viruria in the JWJSP group after transplantation was 42%, significantly lower than that in the control group (68%) (P<0.05). CONCLUSION Prophylaxis with JWJSP may decrease the infection rate of BKV in urine and the overall incidence of HC in patients undergoing haploidentical hematopoietic stem cell transplantation.

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目的 观察加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎（HC）的临床疗效。方法 对2020年1月至2023年10月接受单倍型异基因造血干细胞移植的65例血液病患者进行前瞻性队列研究，31例接受加味金匮肾气丸（5 g，每日2次口服）为肾气丸组，不接受肾气丸的34例为对照组。比较2组患者HC的累积发生率、临床特征及尿病毒检出率。中位随访时间为277（65, 624）d。结果 肾气丸组HC累积发生率为（29±3）%，对照组为（53±3）%，肾气丸组显著低于对照组（P<0.01）。肾气丸组和对照组患者HC发生的中位时间分别为移植后26（20，32）d和37（25，45）d，持续的中位时间分别为13（10，24）d和16（14，53）d，组间无显著差异（P>0.05）。2组患者移植后尿液BK病毒（BKV）阳性率分别为42%和68%，肾气丸组显著低于对照组（P<0.05）。结论 加味金匮肾气丸能够降低单倍型异基因造血干细胞移植后HC的累积发生率，可能与尿路BKV感染率降低有关。

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魏道林，E-mail：
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刘慧霞，女，副主任医师，博士，主要从事造血干细胞移植的研究，E-mail：

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刘慧霞，女，副主任医师，博士，主要从事造血干细胞移植的研究，E-mail：

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刘慧霞，女，副主任医师，博士，主要从事造血干细胞移植的研究，E-mail：

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基线特征对照组
（n=34）		肾气丸组
（n=31）
男性/例（%）22（65）21（68）
年龄/岁40.5（14~65）43（17~66）
疾病分类/例（%）
急性髓系白血病15（44）9（29）
重型再障/阵发性睡眠性血红蛋白尿2（6）3（10）
急性淋巴细胞白血病/非霍奇金淋巴瘤10（29）14（45）
骨髓增生异常综合征4（12）3（10）
骨髓纤维化3（8）2（7）
疾病状态/例（%）
完全缓解8（24）10（32）
部分缓解4（12）2（7）
未缓解22（65）19（61）
尿病毒阳性/例（%）
BK病毒1（3）2（6）
JC病毒1（3）1（3）
), ArticleFig(id=1241029122806305010, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1241022578173735074, language=CN, label=表1, caption=

2组患者临床基线比较

, figureFileSmall=null, figureFileBig=null, tableContent=
基线特征对照组
（n=34）		肾气丸组
（n=31）
男性/例（%）22（65）21（68）
年龄/岁40.5（14~65）43（17~66）
疾病分类/例（%）
急性髓系白血病15（44）9（29）
重型再障/阵发性睡眠性血红蛋白尿2（6）3（10）
急性淋巴细胞白血病/非霍奇金淋巴瘤10（29）14（45）
骨髓增生异常综合征4（12）3（10）
骨髓纤维化3（8）2（7）
疾病状态/例（%）
完全缓解8（24）10（32）
部分缓解4（12）2（7）
未缓解22（65）19（61）
尿病毒阳性/例（%）
BK病毒1（3）2（6）
JC病毒1（3）1（3）
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加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎的疗效观察
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刘慧霞 1 , 冯赟 2 , 赵初娴 1 , 邵珊 1 , 王椿 1 , 魏道林 1
中国新药与临床杂志 | 论著 2024,43(9): 680-685
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中国新药与临床杂志 | 论著 2024, 43(9): 680-685
加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎的疗效观察
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刘慧霞1 , 冯赟2, 赵初娴1, 邵珊1, 王椿1, 魏道林1
作者信息
  • 1.上海闸新中西医结合医院 骨髓移植科，上海　200435
  • 2.上海交通大学医学院附属第一人民医院 消化科，上海　200080

    • 刘慧霞，女，副主任医师，博士，主要从事造血干细胞移植的研究，E-mail：

通讯作者:

魏道林，E-mail：
Prophylactic effect of Jia Wei Jingui Shengqi Pill on haemorrhagic cystitis after haploidentical hematopoietic stem cell transplantation
Hui-xia LIU1 , Yun FENG2, Chu-xian ZHAO1, Shan SHAO1, Chun WANG1, Dao-lin WEI1
Affiliations
  • 1.Department of Bone Marrow Transplantation, Shanghai Zhaxin Integrated Traditional Chinese and Western Medicine Hospital, SHANGHAI 200435, China
  • 2.Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, SHANGHAI 200080, China
出版时间: 2024-09-25 doi: 10.14109/j.cnki.xyylc.2024.09.09
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摘要
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目的 观察加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎（HC）的临床疗效。方法 对2020年1月至2023年10月接受单倍型异基因造血干细胞移植的65例血液病患者进行前瞻性队列研究，31例接受加味金匮肾气丸（5 g，每日2次口服）为肾气丸组，不接受肾气丸的34例为对照组。比较2组患者HC的累积发生率、临床特征及尿病毒检出率。中位随访时间为277（65, 624）d。结果 肾气丸组HC累积发生率为（29±3）%，对照组为（53±3）%，肾气丸组显著低于对照组（P<0.01）。肾气丸组和对照组患者HC发生的中位时间分别为移植后26（20，32）d和37（25，45）d，持续的中位时间分别为13（10，24）d和16（14，53）d，组间无显著差异（P>0.05）。2组患者移植后尿液BK病毒（BKV）阳性率分别为42%和68%，肾气丸组显著低于对照组（P<0.05）。结论 加味金匮肾气丸能够降低单倍型异基因造血干细胞移植后HC的累积发生率，可能与尿路BKV感染率降低有关。

加味金匮肾气丸  /  造血干细胞移植  /  单倍型  /  膀胱炎

AIM To explore the clinical efficacy of Jia Wei Jingui Shengqi Pill (JWJSP) as a novel prophylaxis regimen for haemorrhagic cystitis (HC) in patients undergoing haploidentical hematopoietic stem cell transplantation. METHODS A prospective cohort analysis was conducted on 65 patients with hematological malignancies who underwent haploidentical hematopoietic stem cell transplantation from January 2020 to October 2023. Patients were divided into a JWJSP group (31 cases) and a control group (34 cases). The JWJSP group was administered JWJSP 5 g orally twice daily, while the control group received no specific prophylactic measures. The cumulative incidence of HC, clinical characteristics, and the positive rate of viruria in both groups were compared. The median follow-up duration was 277 (65, 624) days. RESULTS The cumulative incidence of HC in the JWJSP group was (29±3) %, significantly lower than that in the control group (53±3) % (P<0.01). There was no significant difference in the median onset time and duration of HC between the two groups (P>0.05). The median onset time of HC in the two groups of patients was 26 (20, 32) days and 37 (25, 45) days after transplantation, respectively, and the median duration was 13 (10, 24) days and 16 (14, 53) days, respectively, with no significant difference (P>0.05). The positive rate of BKV viruria in the JWJSP group after transplantation was 42%, significantly lower than that in the control group (68%) (P<0.05). CONCLUSION Prophylaxis with JWJSP may decrease the infection rate of BKV in urine and the overall incidence of HC in patients undergoing haploidentical hematopoietic stem cell transplantation.

Jia Wei Jingui Shengqi Pill  /  hematopoietic stem cell transplantation  /  haploidentical  /  cystitis
刘慧霞, 冯赟, 赵初娴, 邵珊, 王椿, 魏道林. 加味金匮肾气丸预防单倍型异基因造血干细胞移植后出血性膀胱炎的疗效观察. 中国新药与临床杂志, 2024 , 43 (9) : 680 -685 . DOI: 10.14109/j.cnki.xyylc.2024.09.09
Hui-xia LIU, Yun FENG, Chu-xian ZHAO, Shan SHAO, Chun WANG, Dao-lin WEI. Prophylactic effect of Jia Wei Jingui Shengqi Pill on haemorrhagic cystitis after haploidentical hematopoietic stem cell transplantation[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (9) : 680 -685 . DOI: 10.14109/j.cnki.xyylc.2024.09.09
正文
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近年来单倍型异基因造血干细胞移植技术日益成熟，治疗效果逐渐接近全相合移植[1]，接受单倍型异基因移植的患者数量逐年增多。出血性膀胱炎（haemorrhagic cystitis，HC）是一种异基因造血干细胞移植后早期常见的并发症[2-4]，根据发生的时间分为早发型HC以及晚发型HC，前者发生于预处理后72 h内，后者多发生于造血干细胞回输后2周左右。多项研究显示，相较于全相合异基因移植，单倍型异基因移植后晚发型HC的发生率更高、程度更为严重[5,6]。晚发型HC的发生与体内隐匿感染的病毒激活以及机体对其免疫反应相关，目前尚缺乏有效的防治手段，严重影响患者的生活质量、移植疗效，甚至可危及生命。加味金匮肾气丸为中药名方，具有温肾化气、清热利水的功效。为减轻晚发型HC给患者带来的危害，本研究探索了加味金匮肾气丸对单倍型异基因造血干细胞移植后HC的预防作用。
资料与方法
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病例来源
纳入2020年1月至2023年10月在本中心接受亲缘单倍型异基因造血干细胞移植的血液病患者共65例，其中男性43例，女性22例，中位年龄42（31，52）岁。
HC诊断标准
（1）西医诊断标准：HC定义为存在持续性镜下或肉眼血尿伴或不伴尿路刺激症状，如尿频、尿急和尿痛等症状，尿细菌及真菌培养均为阴性；除外细菌性膀胱炎、脓毒血症、血管内溶血、泌尿系结石及肿瘤，女性需再除外妇科疾病及生理月经期等。在移植随访期，每周至少进行两次标准尿液分析，病毒性HC定义为在HC的基础上发现尿病毒阳性，病毒拷贝数≥103拷贝·mL-1。（2）中医诊断标准：中医学无“出血性膀胱炎”的病名，但根据其临床表现症状特点，属于中医学“淋证”“癃闭”等范畴。主症：尿血、腰部酸痛、尿频、尿急、尿痛；次症：情志抑郁或烦躁易怒、睡眠差、脉细数。肾气不足，湿热蕴结于下焦是本病病因病机的关键。
移植预处理及回输
1　预处理及移植物抗宿主病（graft-versus-host disease，GVHD）预防方案
髓系疾病包含急性髓系白血病、骨髓增生异常综合征、骨髓纤维化等病例，均采用化疗为主的方案，即氟达拉滨联合白消安以及阿糖胞苷；淋巴系疾病均采用全身放射治疗联合环磷酰胺为主的方案。GVHD预防：采用兔抗人胸腺细胞免疫球蛋白联合他克莫司加短程甲氨蝶呤的方案。
2　造血干细胞回输
造血干细胞回输日上午输注1份人类白细胞抗原（HLA）位点4/6以上相合的脐带血，下午输注供者外周血造血干细胞，要求有核细胞计数≥10×108·kg-1，CD34+干细胞计数≥4×106·kg-1。
HC预防方案与分组
研究设计全部患者于造血干细胞回输后第14日应用加味金匮肾气丸（规格为每包5g，国药准字z53021294，昆明中药厂有限公司）口服，每日2次，每次5 g，早晚饭后温服，服用至移植后100 d。接受加味金匮肾气丸的患者为肾气丸组，主观不接受中成药或预处理放化疗后出现胃肠道毒性不能耐受的患者作为对照组。
观察指标
1　西医分型
观察HC的发生与否以及分型。HC严重程度根据Droller标准[7]，按出血分为4度：镜下血尿为Ⅰ度，肉眼血尿为Ⅱ度，肉眼血尿伴血块为Ⅲ度，血块梗阻尿道为Ⅳ度。Ⅰ度和Ⅱ度定义为轻度，Ⅲ度和Ⅳ度定义为重度。治疗强度：常规水化碱化尿液利尿治疗定义为1级；持续膀胱冲洗定义为2级；需泌尿外科干预行膀胱镜辅助治疗或手术治疗定义为3级。
2　中医证候积分
HC的中医辨证主要症型为湿热蕴结型，根据主症、次症的症状程度分级量化，再根据各症状在证候积分中的权重，分别赋予不同分值。主症：尿血、腰部酸痛、尿频、尿急、尿痛，分别记2、1、1、1分；次症：情志抑郁或烦躁易怒、睡眠差、脉细数分别记1分[8]。
3　病毒监测
通过定量PCR监测尿液中病毒拷贝数，包括BK病毒（BKV）与JC病毒（JCV）等，至少每周一次持续到移植后100 d。
疗效标准
HC完全缓解：尿频、尿急、尿痛等膀胱刺激症状完全消失，无肉眼血尿及镜下血尿。
统计学方法
采用SPSS 26.0统计软件进行数据分析，正态分布的计量资料以表示，组间比较采用t检验；偏态分布的计量资料以M（Q1，Q3）表示，组间比较采用秩和检验；计数资料以例（%）表示，组间比较采用χ2检验。P<0.05为有显著差异。累积发生率采用生存函数Kaplan-Meier方法计算并绘制曲线。
结果
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临床特征
肾气丸组纳入31例患者，对照组纳入34例患者，随访时间为277（65，624）d。疾病种类包括急性髓系白血病24例，重型再生障碍性贫血4例，阵发性睡眠性血红蛋白尿1例，急性淋巴细胞白血病/非霍奇金淋巴瘤24例（T淋巴细胞肿瘤20例，B淋巴细胞肿瘤4例），骨髓增生异常综合征7例，骨髓纤维化5例；移植前肾气丸组和对照组患者处于相应疾病未缓解状态的比例分别为61%与65%，移植前尿病毒检测2组均有阳性病例发现。2组患者基线特征无显著差异（P>0.05），见表1。
HC的发生率以及发生时间
肾气丸组发生HC的患者有9例，累积发生率为（29±3）%；对照组发生HC的患者有18例，累积发生率为（53±3）%，肾气丸组HC累积发生率显著低于对照组（P<0.01）。肾气丸组和对照组中发生重度HC（Ⅲ~Ⅳ度）的患者分别有3例和6例，累积发生率分别为（10±3）%及（18±3）%，肾气丸组显著低于对照组（P<0.01），见图1。2组患者的HC均发生在移植后180 d内，共计有27例患者发生，均为晚发型病毒性HC。肾气丸组和对照组患者HC发生的中位时间分别为移植后26（20，32）d与37（25，45）d，持续的中位时间为13（10，24）d和16（14，53）d，2组比较无显著差异（P>0.05）。
HC的治疗转归
2组发生HC的患者均积极采用西医的防治方案。肾气丸组9例患者发生膀胱炎，2例患者给予膀胱持续冲洗（治疗强度2级），余7例经水化碱化尿液（治疗强度1级）均获得了完全缓解。对照组18例患者发生膀胱炎，5例患者接受了膀胱冲洗（治疗强度2级），11例患者经水化碱化尿液（治疗强度1级）获得完全缓解，而2例病情严重患者接受外科干预（治疗强度3级），1例患者好转，1例患者持续未缓解后死亡。
中医症候积分
发生HC的患者按照中医症候的主症以及次症的积分评估严重程度，肾气丸组和对照组主症积分分别为（2.67±0.94）和（2.72±0.78）分，2组比较无显著差异（P>0.05）；次症积分别为（1.08±0.83）和（2.11±0.80）分，肾气丸组优于对照组（P<0.05）。
病原学检测
移植前，肾气丸组有2例（6%）尿液BKV阳性患者、1例（3%）JCV阳性患者，对照组有1例（3%）尿液BKV阳性患者、1例（3%）JCV阳性患者，2组比较无显著差异（P>0.05）。移植后患者尿病毒检出率较移植前明显升高，肾气丸组和对照组尿BKV阳性患者分别有13例（42%）和23例（68%），肾气丸组显著低于对照组（P<0.05）。肾气丸组有7例患者发生BKV相关HC包括2例重度，另6例BKV阳性患者未发生HC；对照组有16例患者发生BKV相关HC，包括4例重度，另7例尿BKV阳性患者未发生HC。肾气丸组和对照组尿JCV阳性患者分别有7例（23%）和5例（15%），尿BKV阳性同时JCV阳性患者分别有5例（16%）和4例（12%）。移植后肾气丸组和对照组患者尿液病毒总体阳性率分别为81%和94%，组间比较无显著差异（P>0.05）。
讨论
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异基因造血干细胞移植是多种血液系统疾病重要的甚至唯一的治愈手段。随着移植技术的发展成熟，目前已从人类白细胞抗原匹配的全相合异基因移植拓展到单倍型（即半相合）异基因造血干细胞移植，给更多患者带来生存及治愈的希望。由于单倍型移植中供受者存在较大的免疫学差异以及相应强化的GVHD防治措施，引发移植后更严重的GVHD以及更常见的病毒感染，HC就是其中之一。HC不仅给患者带来身心痛苦同时增加经济负担，严重时可危及生命，故得到广泛关注。
目前认为异基因造血干细胞移植后的HC与以下几种发生机制有关：（1）预处理过程中大剂量化疗、放射治疗所造成的局部黏膜损伤，即早发型HC。代表药物是环磷酰胺，其尿液中的代谢产物丙烯醛可直接损伤膀胱黏膜上皮细胞，导致基底膜及其周围血管受到损伤进而引发膀胱炎[9]。（2）BKV等病毒的再激活、复制，目前认为是晚发型HC的主要原因。BKV是多瘤病毒科的双链DNA病毒，儿童期无症状感染后终生潜伏于泌尿系统上皮细胞中；潜伏感染的BKV再激活与预处理损伤以及免疫抑制剂的使用有关，院内交叉感染和供者细胞造成的传播并非主要感染途径。早在1986年ARTHUR等[10]从骨髓移植后患者的尿液沉淀细胞中检测出BKV的DNA，并发现BKV相关性HC只发生于移植前BKV血清学抗体阳性的患者中，据此判断骨髓移植后潜伏的BKV再激活引发HC，后续的众多临床研究都支持这一观点[11,12]。研究提示除BKV之外，JCV、腺病毒和巨细胞病毒以及单纯疱疹病毒也与移植后HC有关[13-15]。（3）机体过度的免疫反应也可能参与HC的发生。国内外一些研究提示急性GVHD是HC发生的危险因素，使用激素治疗难治性晚发型HC可获得完全缓解，提示部分晚发型HC可能是一种特殊形式的GVHD表现[2,16-18]。然而，急性GVHD导致HC发生这一观点目前并未得到广泛接受，相应的治疗措施也并未得到推荐。随着美司钠的广泛应用，临床上已罕见环磷酰胺相关早发型HC。而基于抗病毒治疗HC的众多临床研究均未观察到确切疗效。2018年欧洲白血病抗感染工作组与欧洲骨髓移植工作组联合发表预防、诊断和治疗BKV相关共识指出：目前尚无循证医学证据支持的药物可用于病毒性HC的防治，不支持常规使用西多福韦；过度的水化或膀胱冲洗的预防价值有限；氟喹诺酮类药物防治HC无效，反而会增加抗生素的耐药性；除减停免疫抑制剂外，无其他有效措施[19]。移植后晚发型HC的防治手段匮乏，迫切需要新方法。
单倍型异基因移植后HC的发生率较同胞全相合异基因移植明显升高，这一现象在国内外临床研究中都有报道。COPELAN等[5]报道83例单倍型异基因移植患者的HC发生率显著高于39例同胞全相合异基因移植患者。北京大学人民医院是国内最大的单倍型异基因移植中心，其2007年报道了70例单倍型异基因移植患者HC发生率为50%，而同期同胞全相合异基因移植患者中HC发生率仅为13.7%[6]；在2017年的研究报道中183例单倍型异基因移植患者HC的累积发生率为（45.6±2.5）%，同期的同胞全相合移植患者中仅为（8.5±2.0）%[20]。ZHOU等[21]的荟萃分析纳入2013年—2022年期间发表的11项回顾性研究，总计2 556例异基因移植患者，单因素分析提示单倍型异基因移植是BKV相关HC的危险因素，上述HC均为晚发型。LIONEL等[22]的研究中1 276例异基因移植患者有262例（20.5%）发生晚发型HC，其中105例（8.2%）为BKV相关，57.1%的患者为重度HC。RORIJE等[23]的回顾性研究中491例异基因移植患者有78例（15.9%）患者发生BKV相关HC，其中27例（5.5%）为重度。
本研究中对照组HC累积发生率为（53±3）%，重度HC累积发生率为（18±3）%，与上述文献报道[6,20]相近；而肾气丸组患者HC的累积发生率为（29±3）%，重度累积发生率仅为（10±3）%，均显著低于对照组。从中医症侯学观察，肾气丸组次症临床症状积分显著减轻；从西医治疗强度观察，肾气丸组发生HC的患者均未达到泌尿外科干预的程度，整体治疗强度低。上述结果提示肾气丸可降低单倍型异基因移植患者HC的发生率和严重程度。
目前认为晚发型HC主要与BKV等潜伏感染病毒的再激活有关，本研究重点进行了患者移植前后尿液中BKV和JCV的定量PCR检测。结果显示，移植前2组均只有个别病例检出尿病毒阳性，而移植后肾气丸组尿病毒检出率为81%，对照组则高达94%，病毒检出率与文献报道[24]类似；肾气丸组尿BKV阳性检出率为42%，显著低于对照组（68%）。提示肾气丸对泌尿道BKV病毒的再激活、复制可能存在抑制作用。
中医学中无HC病名，相当于“淋病”“癃闭”。以尿血、腰痛、尿频、尿急为临床特点。中医对HC的辨证主要有以下类型：（1）湿热下注。湿热邪气侵袭下焦导致膀胱水道不通，小便短涩，尿色黄赤，尿道灼热，舌红苔黄脉滑数。（2）湿热蕴结。湿热邪气蕴结于膀胱导致气化不利，小便淋漓，频数刺痛，欲出未尽，舌淡苔薄脉弦。（3）肾阳虚。肾气不足命火衰微温煦无力导致膀胱气化失职，小便不利，腰膝酸软，面色晄白，舌淡苔白脉细沉。HC的发生，以外感热毒为标内伤肾虚为本，本研究观察到移植后病毒性HC中医辨证以肾阳虚损合并湿热蕴结膀胱为主。金匮肾气丸为东汉张仲景名方，原著见于《金匮要略·血痹虚劳病症脉证并治》篇：“虚劳，少腹拘急，小便不利者，八味肾气丸主之”。本研究采用加味金匮肾气丸，主要成分为地黄、山药、酒萸肉、茯苓、牡丹皮、泽泻、肉桂、炙附子、牛膝、车前子，为宋代名医严用和在八味肾气丸的基础上加车前子、牛膝而成，方中熟附片联合肉桂助肾阳增强膀胱气化功能，地黄丸滋肾阴以培育肾气，加味车前子和牛膝清热去湿，按照中医辨证施治的治疗原则，加味金匮肾气丸与HC的临床证候对症。
本研究初步观察到加味金匮肾气丸预防HC和降低BKV复制有一定效果，在目前异基因移植后HC防治基本无药可用的情况下，具有较大意义。受限于样本规模及研究设计，本研究结论有待进一步前瞻性、多中心、随机对照的大样本研究证实。
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2024年第43卷第9期
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doi: 10.14109/j.cnki.xyylc.2024.09.09
  • 接收时间：2024-04-07
  • 首发时间：2026-03-18
  • 出版时间：2024-09-25
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  • 收稿日期：2024-04-07
  • 录用日期：2024-07-30
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    1.上海闸新中西医结合医院 骨髓移植科，上海　200435
    2.上海交通大学医学院附属第一人民医院 消化科，上海　200080

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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