Lancet Respir Med:无法手术的慢性血栓栓塞性肺动脉高压 (MR BPA) 中的球囊肺血管成形术与 riociguat:一项开放随机对照试验

2022-08-09 刘少飞 MedSci原创

与 riociguat 相比,BPA 作为在有经验 BPA 操作者的中心无法手术 CTEPH 的合理选择,并注意与手术相关的并发症。

不符合肺动脉内膜切除术(无法手术的CTEPH)的慢性血栓栓塞性肺动脉高压患者的治疗方案包括球囊肺动脉成形术(BPA)和riociguat。然而,这两种治疗方案还没有进行过前瞻性比较。我们旨在比较不可手术的CTEPH患者中BPA和riociguat的安全性和有效性。

研究方法:

这项开放标签的随机对照试验在日本的四个高容量的CTEPH中心进行。年龄在20-80岁的不可手术的CTEPH患者(平均肺动脉压≥25至<60 mmHg,肺动脉楔压≤15mmHg)和WHO功能分级II或III级的患者,通过位于登记中心的计算机程序,采用偏置硬币分配的最小化方法,随机分配(1:1)到BPA或riociguat。在BPA组,目标是在第一次手术的初始日期后4个月内完成BPA。重复进行BPA,直到平均肺动脉压下降到25mmHg以下。BPA手术的频率取决于病变的难度和数量。在riociguat组,每天三次口服1-0毫克riociguat。当收缩压维持在95mmHg或更高时,剂量每2周增加0-5毫克,最高为2-5毫克,每天三次;剂量调整在首次用药之日起4个月内完成。主要终点是平均肺动脉压从基线到12个月的变化,在完整的分析集(被纳入并随机分配到研究治疗之一的患者,并在随机化后至少有一次评估)中测量。在整个研究期间记录了与BPA相关的并发症和与临床恶化相关的指数。不良事件在整个研究期间被记录下来,并在安全分析组(入组并随机分配到其中一个研究治疗的患者,并接受了部分或全部研究治疗)中进行评估。本试验已在日本临床试验注册中心(jRCT;jRCTs031180239)注册,并已完成。

研究结果:

2016年1月8日至2019年10月31日期间,61名无法手术的CTEPH患者入组,并随机分配到BPA(n=32)或riociguat(n=29)。BPA组的患者平均接受了4-7(SD 1-6)次BPA手术。在riociguat组,12个月时的平均维持剂量为7-0(SD 1-0)毫克/天。12个月时,BPA组的平均肺动脉压改善了-16-3(SE 1-6)mmHg,riociguat组的平均肺动脉压改善了-7-0(1-5)mmHg(组间差异-9 - 3mmHg[95% CI -12-7至-5 - 9];P<0-0001)。riociguat组出现了一例临床上的肺动脉高压恶化,而BPA组没有发生。最常见的不良事件是血痰、咯血或肺出血,BPA组有14名患者(44%),而利奥古特组有1名(4%)。在31名患者做的147次BPA手术中,有17次手术(12%)观察到与BPA有关的并发症,有8名患者(26%)。

研究结论:

与 riociguat 相比,BPA 与无法手术的 CTEPH 患者在 12 个月时的平均肺动脉压有更大的改善相关,尽管报告了与手术相关的并发症。这些发现支持 BPA 作为在有经验 BPA 操作者的中心无法手术 CTEPH 的合理选择,并注意与手术相关的并发症。

 

参考文献:

Kawakami T, Matsubara H, Shinke T, Abe K, Kohsaka S, Hosokawa K, Taniguchi Y, Shimokawahara H, Yamada Y, Kataoka M, Ogawa A, Murata M, Jinzaki M, Hirata K, Tsutsui H, Sato Y, Fukuda K. Balloon pulmonary angioplasty versus riociguat in inoperable chronic thromboembolic pulmonary hypertension (MR BPA): an open-label, randomised controlled trial. Lancet Respir Med. 2022 Aug 1:S2213-2600(22)00171-0. doi: 10.1016/S2213-2600(22)00171-0. Epub ahead of print. PMID: 35926544.

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    2023-04-28 zhlpower
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    2022-11-10 howi
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  4. 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GetPortalCommentsPageByObjectIdResponse(id=1407455, encodeId=5e0a140e455bf, content=<a href='/topic/show?id=f81a6865123' target=_blank style='color:#2F92EE;'>#球囊肺血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68651, encryptionId=f81a6865123, topicName=球囊肺血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b4f42649793, createdName=july_976, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1943748, encodeId=06cd1943e489c, content=<a href='/topic/show?id=da643638a5' target=_blank style='color:#2F92EE;'>#BPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3638, encryptionId=da643638a5, topicName=BPA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Fri Apr 28 21:36:49 CST 2023, time=2023-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831627, encodeId=b0ba183162efe, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, 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replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Jan 24 04:36:49 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1990148, encodeId=46741990148d8, content=<a href='/topic/show?id=66308965e00' target=_blank style='color:#2F92EE;'>#血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89657, encryptionId=66308965e00, topicName=血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Dec 01 01:36:49 CST 2022, time=2022-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1296297, encodeId=0a20129629e17, content=<a href='/topic/show?id=7591984530b' target=_blank 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GetPortalCommentsPageByObjectIdResponse(id=1407455, encodeId=5e0a140e455bf, content=<a href='/topic/show?id=f81a6865123' target=_blank style='color:#2F92EE;'>#球囊肺血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68651, encryptionId=f81a6865123, topicName=球囊肺血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b4f42649793, createdName=july_976, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1943748, encodeId=06cd1943e489c, content=<a href='/topic/show?id=da643638a5' target=_blank style='color:#2F92EE;'>#BPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3638, encryptionId=da643638a5, topicName=BPA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Fri Apr 28 21:36:49 CST 2023, time=2023-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831627, encodeId=b0ba183162efe, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, 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replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Jan 24 04:36:49 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1990148, encodeId=46741990148d8, content=<a href='/topic/show?id=66308965e00' target=_blank style='color:#2F92EE;'>#血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89657, encryptionId=66308965e00, topicName=血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Dec 01 01:36:49 CST 2022, time=2022-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1296297, encodeId=0a20129629e17, content=<a href='/topic/show?id=7591984530b' target=_blank 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GetPortalCommentsPageByObjectIdResponse(id=1407455, encodeId=5e0a140e455bf, content=<a href='/topic/show?id=f81a6865123' target=_blank style='color:#2F92EE;'>#球囊肺血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68651, encryptionId=f81a6865123, topicName=球囊肺血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b4f42649793, createdName=july_976, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=)]
    2023-01-24 amyloid
  7. 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topicName=成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Mon Jan 02 13:36:49 CST 2023, time=2023-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1987341, encodeId=7ff2198e3414e, content=<a href='/topic/show?id=bac5466546c' target=_blank style='color:#2F92EE;'>#对照试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46654, encryptionId=bac5466546c, topicName=对照试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Fri Aug 12 17:36:49 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775659, encodeId=c7461e75659e9, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Jan 24 04:36:49 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1990148, encodeId=46741990148d8, content=<a href='/topic/show?id=66308965e00' target=_blank style='color:#2F92EE;'>#血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89657, encryptionId=66308965e00, topicName=血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Dec 01 01:36:49 CST 2022, time=2022-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1296297, encodeId=0a20129629e17, content=<a href='/topic/show?id=7591984530b' target=_blank style='color:#2F92EE;'>#随机对照试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98453, encryptionId=7591984530b, topicName=随机对照试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384448, encodeId=7b2413844482e, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1407455, encodeId=5e0a140e455bf, content=<a href='/topic/show?id=f81a6865123' target=_blank style='color:#2F92EE;'>#球囊肺血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68651, encryptionId=f81a6865123, topicName=球囊肺血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b4f42649793, createdName=july_976, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=)]
  8. [GetPortalCommentsPageByObjectIdResponse(id=1943748, encodeId=06cd1943e489c, content=<a href='/topic/show?id=da643638a5' target=_blank style='color:#2F92EE;'>#BPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3638, encryptionId=da643638a5, topicName=BPA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Fri Apr 28 21:36:49 CST 2023, time=2023-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831627, encodeId=b0ba183162efe, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Nov 10 19:36:49 CST 2022, time=2022-11-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1925656, encodeId=cace192565604, content=<a href='/topic/show?id=26d633354c9' target=_blank style='color:#2F92EE;'>#动脉高压#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33354, encryptionId=26d633354c9, topicName=动脉高压)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sat Feb 18 01:36:49 CST 2023, time=2023-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2004765, encodeId=05ca2004e654f, content=<a href='/topic/show?id=4e8a5400816' target=_blank style='color:#2F92EE;'>#成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54008, encryptionId=4e8a5400816, topicName=成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=778d36, createdName=柳叶一刀, createdTime=Mon Jan 02 13:36:49 CST 2023, time=2023-01-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1987341, encodeId=7ff2198e3414e, content=<a href='/topic/show?id=bac5466546c' target=_blank style='color:#2F92EE;'>#对照试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46654, encryptionId=bac5466546c, topicName=对照试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ad9f79, createdName=般若傻瓜, createdTime=Fri Aug 12 17:36:49 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775659, encodeId=c7461e75659e9, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Jan 24 04:36:49 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1990148, encodeId=46741990148d8, content=<a href='/topic/show?id=66308965e00' target=_blank style='color:#2F92EE;'>#血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89657, encryptionId=66308965e00, topicName=血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Dec 01 01:36:49 CST 2022, time=2022-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1296297, encodeId=0a20129629e17, content=<a href='/topic/show?id=7591984530b' target=_blank 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GetPortalCommentsPageByObjectIdResponse(id=1407455, encodeId=5e0a140e455bf, content=<a href='/topic/show?id=f81a6865123' target=_blank style='color:#2F92EE;'>#球囊肺血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68651, encryptionId=f81a6865123, topicName=球囊肺血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b4f42649793, createdName=july_976, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=)]
  9. [GetPortalCommentsPageByObjectIdResponse(id=1943748, encodeId=06cd1943e489c, content=<a href='/topic/show?id=da643638a5' target=_blank style='color:#2F92EE;'>#BPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3638, encryptionId=da643638a5, topicName=BPA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c838337, createdName=zhlpower, createdTime=Fri Apr 28 21:36:49 CST 2023, time=2023-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1831627, encodeId=b0ba183162efe, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, 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replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Jan 24 04:36:49 CST 2023, time=2023-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1990148, encodeId=46741990148d8, content=<a href='/topic/show?id=66308965e00' target=_blank style='color:#2F92EE;'>#血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89657, encryptionId=66308965e00, topicName=血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f5b299, createdName=xuyu, createdTime=Thu Dec 01 01:36:49 CST 2022, time=2022-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1296297, encodeId=0a20129629e17, content=<a href='/topic/show?id=7591984530b' target=_blank style='color:#2F92EE;'>#随机对照试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98453, encryptionId=7591984530b, topicName=随机对照试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1384448, encodeId=7b2413844482e, content=<a href='/topic/show?id=2e956863556' target=_blank style='color:#2F92EE;'>#球囊#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68635, encryptionId=2e956863556, topicName=球囊)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0361487, createdName=花花1366, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1407455, encodeId=5e0a140e455bf, content=<a href='/topic/show?id=f81a6865123' target=_blank style='color:#2F92EE;'>#球囊肺血管成形术#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68651, encryptionId=f81a6865123, topicName=球囊肺血管成形术)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b4f42649793, createdName=july_976, createdTime=Mon Aug 08 06:36:49 CST 2022, time=2022-08-08, status=1, ipAttribution=)]
    2022-08-08 花花1366
  10. 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