{"id":30087,"date":"2026-04-07T04:50:00","date_gmt":"2026-04-06T20:50:00","guid":{"rendered":"https:\/\/csccm.org.cn\/?p=30087"},"modified":"2026-04-07T05:43:16","modified_gmt":"2026-04-06T21:43:16","slug":"lancet%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%80%a5%e6%80%a7%e7%bc%ba%e8%a1%80%e6%80%a7%e5%8d%92%e4%b8%ad%e6%82%a3%e8%80%85%e4%bd%bf%e7%94%a8%e7%b1%b3%e8%af%ba%e7%8e%af%e7%b4%a0%e7%9a%84","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=30087","title":{"rendered":"[Lancet\u53d1\u8868\u8bba\u6587]\uff1a\u6025\u6027\u7f3a\u8840\u6027\u5352\u4e2d\u60a3\u8005\u4f7f\u7528\u7c73\u8bfa\u73af\u7d20\u7684\u7597\u6548\u4e0e\u5b89\u5168\u6027"},"content":{"rendered":"\n

Articles<\/p>\n\n\n\n

Efficacy and safety of minocycline in patients with acute ischaemic stroke (EMPHASIS): a multicentre, double-blind, randomised controlled trial<\/h1>\n\n\n\n

Yao\u00a0Lu, Ling\u00a0Guan,\u00a0Jialing\u00a0Wu, et al<\/h3>\n\n\n\n

Lancet Available online 30 January 2026<\/h3>\n\n\n\n

https:\/\/doi.org\/10.1016\/S0140-6736(25)01862-8<\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

Minocycline has been reported as a multi-target anti-neuroinflammatory drug with potential benefits for ischaemic stroke in preclinical models and small-scale clinical studies. The EMPHASIS trial was designed to provide robust evidence regarding its efficacy and safety in patients with acute ischaemic stroke.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

A multicentre, double-blind, randomised, placebo-controlled trial was conducted at 58 hospitals across China. Patients who had an ischaemic stroke in the previous 72 h with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 4 to 25 and a level of consciousness score (subscale 1a of the NIHSS) of 1 or less were randomly assigned in a 1:1 ratio to receive minocycline or placebo in addition to routine treatment. Minocycline (loading dose of 200 mg, followed by 100 mg every 12 h for the subsequent 4 days) or matching placebo was administered orally. Block randomisation with a fixed block size of four stratified by study site was done with a computer-generated randomisation sequence. All patients, treating clinicians, and investigators involved in the trial were fully masked to treatment allocation. The primary outcome was an excellent functional outcome at 90 days (with a modified Rankin Scale [mRS] score of 0\u20131) and was analysed in all patients who were randomised and received at least one dose of the study drug, without imputation for missing data. Safety outcomes were assessed in participants who received at least one dose of the study drug and had at least one safety evaluation and included symptomatic intracranial haemorrhage at 24 h and 6 days. This trial was registered with ClinicalTrials.gov<\/a> (NCT05836740<\/a>) and is now completed.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

Between May 19, 2023, and May 20, 2024, 1724 patients were randomly assigned to minocycline (n=862) or placebo (n=862) groups. Median age was 65 years (IQR 57\u201371). 1151 (66\u00b78%) patients were male and 573 (33\u00b72%) were female. Median NIHSS score at baseline was 5 (IQR 4\u20137). Four patients withdrew consent (three in the minocycline group and one in the placebo group) and 19 patients were lost to follow-up (nine in the minocycline group and ten in the placebo group). At 90 days, 447 (52\u00b76%) of 850 patients with minocycline and 403 (47\u00b74%) of 851 with placebo had an mRS score of 0\u20131 (adjusted risk ratio 1\u00b711, 95% CI 1\u00b703\u20131\u00b720; p=0\u00b70061). Ordinal analysis across the full range of mRS scores also favoured minocycline, with an adjusted common odds ratio of 1\u00b719 (95% CI 1\u00b703\u20131\u00b738; p=0\u00b7018). The incidence of symptomatic intracranial haemorrhage was similar between the minocycline and placebo groups at 24 h (1\/860 [0\u00b71%]\u00a0vs<\/em>\u00a00\/861 [0%]) and 6 days (3\/859 [0\u00b73%]\u00a0vs<\/em>\u00a00\/861 [0%]). No significant differences were observed in other safety outcomes, including serious adverse events (40\/862 [4\u00b76%] in the minocycline group\u00a0vs<\/em>51\/862 [5\u00b79%] in the placebo group; p=0\u00b724).<\/p>\n\n\n\n

\"\"\/<\/figure>\n\n\n\n
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Table 1. Baseline characteristics<\/p>\n\n\n\n

Empty Cell<\/td>Empty Cell<\/td>Minocycline (n=862)<\/strong><\/th>Placebo (n=862)<\/strong><\/th><\/tr><\/thead>
Age, years<\/td>65\u00b70 (57\u00b70\u201372\u00b70)<\/td>65\u00b70 (57\u00b70\u201371\u00b70)<\/td><\/tr>
Sex<\/td><\/tr>
<\/td>Male<\/td>573 (66\u00b75%)<\/td>578 (67\u00b71%)<\/td><\/tr>
<\/td>Female<\/td>289 (33\u00b75%)<\/td>284 (32\u00b79%)<\/td><\/tr>
BMI, kg\/m2<\/sup><\/td>24\u00b78 (22\u00b77\u201326\u00b79)<\/td>24\u00b75 (22\u00b75\u201326\u00b78)<\/td><\/tr>
Medical history<\/td><\/tr>
<\/td>Hypertension<\/td>554 (64\u00b73%)<\/td>572 (66\u00b74%)<\/td><\/tr>
<\/td>Diabetes<\/td>286 (33\u00b72%)<\/td>280 (32\u00b75%)<\/td><\/tr>
<\/td>Dyslipidaemia<\/td>378 (43\u00b79%)<\/td>363 (42\u00b71%)<\/td><\/tr>
<\/td>Previous ischaemic stroke<\/td>238 (27\u00b76%)<\/td>258 (29\u00b79%)<\/td><\/tr>
<\/td>Coronary heart disease<\/td>95 (11\u00b70%)<\/td>114 (13\u00b72%)<\/td><\/tr>
<\/td>Heart failure<\/td>5 (0\u00b76%)<\/td>6 (0\u00b77%)<\/td><\/tr>
<\/td>Atrial fibrillation<\/td>45 (5\u00b72%)<\/td>39 (4\u00b75%)<\/td><\/tr>
Ever smoker<\/td>325 (37\u00b77%)<\/td>359 (41\u00b76%)<\/td><\/tr>
Alcohol use<\/td>223 (25\u00b79%)<\/td>241 (28\u00b70%)<\/td><\/tr>
Medication within 1 month before stroke<\/td><\/tr>
<\/td>Antiplatelet agent<\/td>108 (12\u00b75%)<\/td>122 (14\u00b72%)<\/td><\/tr>
<\/td>Anticoagulant agent<\/td>12 (1\u00b74%)<\/td>13 (1\u00b75%)<\/td><\/tr>
<\/td>Statins<\/td>103 (11\u00b79%)<\/td>97 (11\u00b73%)<\/td><\/tr>
<\/td>Antibiotics<\/td>2 (0\u00b72%)<\/td>4 (0\u00b75%)<\/td><\/tr>
Pre-stroke mRS score<\/td><\/tr>
<\/td>0<\/td>739 (85\u00b77%)<\/td>744 (86\u00b73%)<\/td><\/tr>
<\/td>1<\/td>122 (14\u00b72%)<\/td>115 (13\u00b73%)<\/td><\/tr>
<\/td>\u22652<\/td>1 (0\u00b71%)<\/td>3 (0\u00b73%)<\/td><\/tr>
hs-CRP at baseline, mg\/L*<\/a><\/td>2\u00b70 (0\u00b78\u20134\u00b78)<\/td>2\u00b70 (0\u00b79\u20134\u00b76)<\/td><\/tr>
NIHSS score at baseline<\/td>5\u00b70 (4\u00b70\u20137\u00b70)<\/td>5\u00b70 (4\u00b70\u20137\u00b70)<\/td><\/tr>
Stroke subtypes (TOAST classification)<\/td><\/tr>
<\/td>Large-artery atherosclerosis<\/td>388 (45\u00b70%)<\/td>398 (46\u00b72%)<\/td><\/tr>
<\/td>Cardioembolism<\/td>49 (5\u00b77%)<\/td>42 (4\u00b79%)<\/td><\/tr>
<\/td>Small vessel disease<\/td>340 (39\u00b74%)<\/td>347 (40\u00b73%)<\/td><\/tr>
<\/td>Other determined aetiology<\/td>30 (3\u00b75%)<\/td>22 (2\u00b76%)<\/td><\/tr>
<\/td>Undetermined aetiology<\/td>55 (6\u00b74%)<\/td>53 (6\u00b71%)<\/td><\/tr>
Time from stroke onset to treatment<\/td><\/tr>
<\/td>Median (IQR)<\/td>41\u00b79 (26\u00b71\u201352\u00b78)<\/td>40\u00b75 (26\u00b75\u201352\u00b70)<\/td><\/tr>
<\/td>\u226424 h<\/td>179 (20\u00b78%)<\/td>175 (20\u00b73%)<\/td><\/tr>
<\/td>>24 to 48 h<\/td>375 (43\u00b75%)<\/td>396 (45\u00b79%)<\/td><\/tr>
<\/td>>48 h<\/td>308 (35\u00b77%)<\/td>291 (33\u00b78%)<\/td><\/tr>
Reperfusion therapy<\/td>114 (13\u00b72%)<\/td>130 (15\u00b71%)<\/td><\/tr><\/tbody><\/table>
Data are n (%) or median (IQR). Percentages might not total 100 because of rounding. hs-CRP=high-sensitivity C-reactive protein. mRS=modified Rankin Scale. NIHSS=National Institutes of Health Stroke Scale. TOAST=Trial of Org 10172 in Acute Stroke Treatment.
*hs-CRP data are missing for 96 patients in the minocycline group and 95 in the placebo group.<\/figcaption><\/figure>\n\n\n\n

Table 2. Efficacy outcomes (in the modified intention-to-treat population)<\/p>\n\n\n\n

Empty Cell<\/td>Empty Cell<\/td>Minocycline (n=862)<\/strong><\/th>Placebo (n=862)<\/strong><\/th>Adjusted treatment effect<\/strong>*<\/a> (95% CI)<\/strong><\/th>p value<\/strong><\/th><\/tr><\/thead>
mRS 0\u20131 at 90 days\u2020<\/sup><\/a><\/td>447\/850 (52\u00b76%)<\/td>403\/851 (47\u00b74%)<\/td>RR 1\u00b711 (1\u00b703\u20131\u00b720)<\/td>0\u00b70061<\/td><\/tr>
Ordinal mRS score at 90 days<\/td>..<\/td>..<\/td>cOR 1\u00b719 (1\u00b703\u20131\u00b738)\u2021<\/sup><\/a><\/td>0\u00b7018<\/td><\/tr>
<\/td>0<\/td>195\/850 (22\u00b79%)<\/td>175\/851 (20\u00b76%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>1<\/td>252\/850 (29\u00b76%)<\/td>228\/851 (26\u00b78%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>2<\/td>168\/850 (19\u00b78%)<\/td>174\/851 (20\u00b74%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>3<\/td>140\/850 (16\u00b75%)<\/td>178\/851 (20\u00b79%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>4<\/td>58\/850 (6\u00b78%)<\/td>51\/851 (6\u00b70%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>5<\/td>23\/850 (2\u00b77%)<\/td>25\/851 (2\u00b79%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>6<\/td>14\/850 (1\u00b76%)<\/td>20\/851 (2\u00b74%)<\/td>..<\/td>..<\/td><\/tr>
mRS 0\u20132 at 90 days<\/td>615\/850 (72\u00b74%)<\/td>577\/851 (67\u00b78%)<\/td>RR 1\u00b707 (1\u00b702\u20131\u00b712)<\/td>0\u00b70056<\/td><\/tr>
mRS 0\u20133 at 90 days<\/td>755\/850 (88\u00b78%)<\/td>755\/851 (88\u00b77%)<\/td>RR 1\u00b700 (0\u00b797\u20131\u00b703)<\/td>0\u00b794<\/td><\/tr>
Change in NIHSS score from baseline to 24 h\u00a7<\/sup><\/a><\/td>0 (0\u20130)<\/td>0 (0\u20130)<\/td>\u03b2 \u22120\u00b707 (\u22120\u00b720 to 0\u00b706)<\/td>0\u00b732<\/td><\/tr>
Change in NIHSS score from baseline to 6 days\u00b6<\/sup><\/a><\/td>\u22122 (\u22123 to 0)<\/td>\u22121 (\u22123 to 0)<\/td>\u03b2 \u22120\u00b728 (\u22120\u00b750 to \u22120\u00b705)<\/td>0\u00b7015<\/td><\/tr>
Early neurological deterioration at 24 h\u2016<\/sup><\/a><\/td>52\/848 (6\u00b71%)<\/td>54\/854 (6\u00b73%)<\/td>RR 0\u00b797 (0\u00b764\u20131\u00b747)<\/td>0\u00b789<\/td><\/tr>
Early neurological deterioration at 6 days**<\/a><\/td>56\/842 (6\u00b77%)<\/td>66\/840 (7\u00b79%)<\/td>RR 0\u00b785 (0\u00b759\u20131\u00b721)<\/td>0\u00b736<\/td><\/tr>
Change in hs-CRP from baseline to 6 days, mg\/L\u2020\u2020<\/sup><\/a><\/td>0 (\u22121\u00b720 to 1\u00b797)<\/td>0\u00b720 (\u22120\u00b794 to 3\u00b773)<\/td>\u03b2 \u22122\u00b772 (\u22125\u00b764 to 0\u00b719)<\/td>0\u00b7067<\/td><\/tr>
Stroke recurrence at 90 days<\/td>51\/862 (5\u00b79%)<\/td>47\/862 (5\u00b75%)<\/td>HR 1\u00b709 (0\u00b773\u20131\u00b762)<\/td>0\u00b768<\/td><\/tr>
Ischaemic stroke recurrence at 90 days<\/td>47\/862 (5\u00b75%)<\/td>43\/862 (5\u00b70%)<\/td>HR 1\u00b709 (0\u00b772\u20131\u00b765)<\/td>0\u00b767<\/td><\/tr>
Composite vascular events at 90 days<\/td>59\/862 (6\u00b78%)<\/td>52\/862 (6\u00b70%)<\/td>HR 1\u00b714 (0\u00b779\u20131\u00b765)<\/td>0\u00b749<\/td><\/tr><\/tbody><\/table>
Data are n\/N (%), unless otherwise indicated. mRS=modified Rankin Scale. NIHSS=National Institutes of Health Stroke Scale. hs-CRP=high-sensitivity C-reactive protein. RR=risk ratio. cOR=common odds ratio. HR=hazard ratio.
*Adjusted for pooled study centres using a mixed-effects model.
\u2020The mRS score is missing for 12 patients in the minocycline group versus 11 in the placebo group at 90 days.
\u2021A cOR >1 indicates a shift towards better mRS outcomes (ie, lower disability).
\u00a7The NIHSS score is missing for 15 patients in the minocycline group versus 8 in the placebo group at 24 h.
\u00b6The NIHSS score is missing for 21 patients in the minocycline group versus 23 in the placebo group at 6 days.
\u2016Early neurological deterioration at 24 h is missing for 14 patients in the minocycline group versus 8 in the placebo group.
**Early neurological deterioration at 6 days is missing for 20 patients in the minocycline group versus 22 in the placebo group.
\u2020\u2020Data on hs-CRP change from baseline to 6 days are missing for 172 patients in the minocycline group versus 184 in the placebo group.<\/figcaption><\/figure>\n\n\n\n

<\/p>\n\n\n\n

Table 3. Safety outcomes (in the safety population)<\/p>\n\n\n\n

Empty Cell<\/td>Empty Cell<\/td>Minocycline (n=862)<\/strong><\/th>Placebo (n=862)<\/strong><\/th>Adjusted treatment effect (95% CI)<\/strong>*<\/a><\/th>p value<\/strong><\/th><\/tr><\/thead>
Symptomatic intracranial haemorrhage at 24 h\u2020<\/sup><\/a><\/td>1\/860 (0\u00b71%)<\/td>0\/861 (0%)<\/td>..<\/td>..<\/td><\/tr>
Symptomatic intracranial haemorrhage at 6 days\u2021<\/sup><\/a><\/td>3\/859 (0\u00b73%)<\/td>0\/861 (0%)<\/td>..<\/td>..<\/td><\/tr>
Antibiotic-associated diarrhoea, enteritis, and constipation at 6 days\u2021<\/sup><\/a><\/td>0\/859 (0%)<\/td>2\/861 (0\u00b72%)<\/td>..<\/td>..<\/td><\/tr>
Any bleeding event at 90 days<\/td>63\/862 (7\u00b73%)<\/td>69\/862 (8\u00b70%)<\/td>HR 0\u00b790 (0\u00b764\u20131\u00b727)<\/td>0\u00b756<\/td><\/tr>
<\/td>Minor bleeding\u00a7<\/sup><\/a><\/td>56\/862 (6\u00b75%)<\/td>63\/862 (7\u00b73%)<\/td>HR 0\u00b788 (0\u00b761\u20131\u00b726)<\/td>0\u00b749<\/td><\/tr>
<\/td>Moderate bleeding\u00a7<\/sup><\/a><\/td>1\/862 (0\u00b71%)<\/td>2\/862 (0\u00b72%)<\/td>HR 0\u00b750 (0\u00b705\u20135\u00b752)<\/td>0\u00b757<\/td><\/tr>
<\/td>Severe bleeding\u00a7<\/sup><\/a><\/td>8\/862 (0\u00b79%)<\/td>6\/862 (0\u00b77%)<\/td>HR 1\u00b734 (0\u00b746\u20133\u00b785)<\/td>0\u00b759<\/td><\/tr>
Any bleeding event at 90 days\u00b6<\/sup><\/a><\/td>..<\/td>..<\/td>cOR 0\u00b791 (0\u00b764\u20131\u00b730)\u2016<\/sup><\/a><\/td>0\u00b760<\/td><\/tr>
<\/td>None<\/td>799\/862 (92\u00b77%)<\/td>793\/862 (92\u00b70%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>Minor<\/td>54\/862 (6\u00b73%)<\/td>61\/862 (7\u00b71%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>Moderate<\/td>1\/862 (0\u00b71%)<\/td>2\/862 (0\u00b72%)<\/td>..<\/td>..<\/td><\/tr>
<\/td>Severe<\/td>8\/862 (0\u00b79%)<\/td>6\/862 (0\u00b77%)<\/td>..<\/td>..<\/td><\/tr>
Vascular death at 90 days<\/td>10\/862 (1\u00b72%)<\/td>16\/862 (1\u00b79%)<\/td>HR 0\u00b762 (0\u00b728\u20131\u00b736)<\/td>0\u00b723<\/td><\/tr>
All-cause death at 90 days<\/td>14\/862 (1\u00b76%)<\/td>20\/862 (2\u00b73%)<\/td>HR 0\u00b769 (0\u00b735\u20131\u00b736)<\/td>0\u00b728<\/td><\/tr><\/tbody><\/table>
Data are n\/N (%), unless otherwise indicated. HR=hazard ratio. cOR=common odds ratio.
*Adjusted for pooled study centres using a mixed-effects model.
\u2020Data on symptomatic intracranial haemorrhage at 24 h are missing for two patients in the minocycline group and one in the placebo group.
\u2021Data on symptomatic intracranial haemorrhage and antibiotic-associated diarrhoea, enteritis, and constipation at 6 days are missing for three patients in the minocycline group and one in the placebo group.
\u00a7In patients with multiple bleeding events of differing severity, the earliest event for each severity category (ie, minor, moderate, and severe) was included in the analysis.
\u00b6 In patients with multiple bleeding events, the highest severity was used for analysis.
\u2016 A cOR >1 indicates a shift towards more bleeding and bleeding of greater severity.<\/figcaption><\/figure>\n\n\n\n

<\/p>\n\n\n\n

Interpretation<\/h3>\n\n\n\n

Minocycline therapy initiated within 72 h of acute ischaemic stroke provided a significant functional outcome benefit compared with placebo at 90 days, without safety concerns. Future studies are needed to confirm these findings and to establish whether the benefits extend to patients with more severe or minor strokes.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

National Natural Science Foundation of China, Beijing Healthunion Cardio-cerebrovascular Disease Prevention and Treatment Foundation, Noncommunicable Chronic Diseases\u2014National Science and Technology Major Project, Beijing Municipal Science & Technology Commission, Chinese Institutes for Medical Research, Capital's Funds for Health Improvement and Research, and National Key R&D Program of China.<\/p>\n","protected":false},"excerpt":{"rendered":"

Articles Efficacy and safety of minocycline in patients […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/30087"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=30087"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/30087\/revisions"}],"predecessor-version":[{"id":30088,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/30087\/revisions\/30088"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=30087"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=30087"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=30087"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}