scholarly journals Efficacy of Naoxueshu in acute spontaneous intracerebral hemorrhage: a multicenter observational study

Author(s):  
Juexian Song ◽  
Yuting Nie ◽  
Xinzuo Qin ◽  
Pingping Wang ◽  
Huiqiang Lu ◽  
...  

Abstract Objective To evaluate the efficacy and safety outcome and related risk factors of Naoxueshu in the treatment of acute SICH. Methods Two hundred twenty patients were enrolled in this study. Diagnosis of SICH was based on neuroimaging. All the patients received regular treatment and Naoxueshu oral liquid 10 ml 3 times a day for 14 consecutive days. Surgical intervention was conducted as needed. Efficacy and safety outcomes were evaluated. Results Hematoma volume decreased significantly 7 days after Naoxueshu treatment (from 27.3 ± 20.0 to 15.1 ± 15.1 ml, P < 0.0001), and it decreased further in 14-day result (6.9 ± 10.4 ml, P < 0.0001). Patients’ neurological function was improved remarkably with NIHSS scores from baseline 13 points to 7-day 7 points (P < 0.0001) and 14-day 4 points (P < 0.0001). Cerebral edema was relieved only 14 days after Naoxueshu treatment (from 3 to 2 points, P < 0.0001). No clinically significant change was found in 7-day and 14-day safety results. Female sex was related independently to large 7-day hematoma volume and worse 7-day NIHSS score while it would not affect patients’ 14-day outcomes. Rare cause of SICH (B = 17.4, P = 0.009) alone was related to large 14-day hematoma volume. Worse baseline NIHSS score (B = 0.3, P = 0.003) and early use of Naoxueshu (B = 2.9, P = 0.005) were related to worse 7-day and14-day neurological function. Conclusion Naoxueshu oral liquid could relieve hematoma volume and cerebral edema safely; meanwhile, it could improve patients’ neurological function. Sex, cause of SICH, and time from onset to receive Naoxueshu should be taken into consideration in the treatment of SICH.

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xin Huang ◽  
Lai Jiang ◽  
Shaojun Chen ◽  
Gang Li ◽  
Wanxi Pan ◽  
...  

Abstract Background Minimally invasive surgery has achieved good results in the treatment of cerebral haemorrhage.However, no large-scale clinical study has demonstrated that surgical treatment of cerebral haemorrhages less than 30 ml can improve the curative effect. Our study explored the efficacy and complication of stereotactic drainage based on the amount of cerebral hemorrhage (15-30 ml) in hypertensive basal ganglia. Method Sixty patients with hypertensive basal ganglia haemorrhages were divided into a control group and an experimental group with 30 patients in each group. Patients in the control group were treated conservatively. In contrast, those in the experimental group received stereotactic drainage, and urokinase was injected into the haematoma cavity after the operation. The haematoma volume at admission and 1, 3, 7 and 30 days after treatment and National Institute of Health stroke scale(NIHSS) score data were recorded. Complications after treatment in the two groups of data were compared and analysed. Result No significant differences in age, sex, time of treatment after onset, admission blood pressure, admission haematoma volume or admission NIHSS score were noted between these two groups (P > 0.05). After treatment, significant differences in haematoma volume were noted between the two groups on the 1st, 3rd, 7th and 30th days after treatment (P < 0.05). The amount of hematoma of patients in the experimental group was significantly reduced compared with that in the control group, and the NIHSS scores were significantly different on the 3rd, 7th and 30th days after treatment. The neurological deficit scores of patients in the experimental group were significantly reduced compared with those in the control group, and the incidence of pulmonary infection and venous thrombosis in the lower limbs of patients in the experimental group were significantly reduced (P < 0.05). ROC curve analysis showed that stereotactic drainage affected the early neurological function of patients with small and medium basal ganglia haemorrhages. Conclusion For patients with small and medium basal ganglia haemorrhages, stereotactic drainage can be used due to the faster drainage speed of haematomas after operation, which is beneficial to the recovery of neurological function and reduce complications.


2021 ◽  
pp. 1-12
Author(s):  
Jang Hun Kim ◽  
Wonki Yoon ◽  
Chi Kyung Kim ◽  
Haewon Roh ◽  
Hee Jin Bae ◽  
...  

<b><i>Background:</i></b> Clinical outcome in patients with acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) is not satisfactory if reperfusion treatment fails or is not tried. <b><i>Aims:</i></b> We aimed to assess the efficacy and safety of urgent superficial temporal-to-middle cerebral artery (STA-MCA) bypass surgery in selected patients. <b><i>Methods:</i></b> Patients who were diagnosed with LVO-induced AIS in the anterior circulation but had a failed intra-arterial thrombectomy (IAT) or were not tried due to IAT contraindications were prospectively enrolled. Timely urgent STA-MCA bypass surgery was performed if they showed perfusion-diffusion mismatch or symptom-diffusion mismatch in the acute phase of disease. Clinical and radiological data of these patients were assessed to demonstrate the safety and efficacy of urgent bypass procedures. A pooled analysis of published data on urgent bypass surgery in acute stroke patients was conducted and analyzed. <b><i>Results:</i></b> In 18 patients who underwent timely bypass, the National Institutes of Health Stroke Scale (NIHSS) score improved from 12.11 ± 4.84 to 9.89 ± 6.52, 1 week after surgery. Three-month and long-term (9.72 ± 5.00 months) favorable outcomes (modified Rankin Scale [mRS] scores 0–2) were achieved in 50 and 75% of the patients, respectively. The pooled analysis (117 patients from 10 articles, including ours) identified favorable mRS scores in 71.79% patients at 3 months. A significant NIHSS score improvement from 11.51 ± 4.89 to 7.59 ± 5.50 was observed after surgery with significance. Major complications occurred in 3 patients (2.6%, 3/117) without mortality. <b><i>Conclusions:</i></b> Urgent STA-MCA bypass surgery can be regarded as a safe optional treatment to prevent cerebral infarct expansion and to improve clinical and radiological outcomes in highly selected patients.


2013 ◽  
Vol 141 (7-8) ◽  
pp. 495-502
Author(s):  
Tatjana Ilic ◽  
Biljana Milic ◽  
Dejan Celic ◽  
Biljana Vuckovic ◽  
Igor Mitic

Introduction. Etanercept, tumor necrosis factor (TNF?) antagonist, lowers the disease activity level in patients with rheumatoid arthritis (RA), reduces joint destruction saving physical functions and improving life quality. Objective. The aim of this study was to establish efficacy and safety of etanercept in combination with disease modifying antirheumatic drugs (DMARDs) in the treatment of RA. Methods. To patients with active RA, who were on therapy with DMARD, etanercept was introduced in weekly doses of 50 mg, with continuation of DMARD. Efficacy of this form of treatment was evaluated in the 12th week. Maintenance of the effect of treatment was also evaluated during 24, 48 and 96 weeks. Long term evaluation of etanercept safety was assessed by registering all unwanted events during a two year period. Results. After 12 weeks of treatment with etanercept, 80% of patients had ACR20 response, while 85% showed clinically significant decrease of DAS28 index. We achieved remission in five patients (12.5%) and low activity of RA in 17 patients (42.5%). During a 96week of followup period, achieved therapy effects were maintained. In four patients (10%) etanercept therapy was interrupted after 24 weeks because of inadequate response. In one of them (2.5%) we recorded a cardiovascular incident. Acute infections were registered in 47 cases. Four of those were severe infections. Neither cases of malignancy development were noted, nor were there any lethal disease outcomes. Conclusion. Etanercept in combination with DMARD shows a high level of efficacy in the treatment of RA. The safety profile of the drug is satisfactory.


2021 ◽  
Vol 12 ◽  
Author(s):  
Luda Feng ◽  
Fang Han ◽  
Li Zhou ◽  
Shengxian Wu ◽  
Yawei Du ◽  
...  

Background: Although revascularization treatment is recommended as the first-line therapy for patients with non-minor acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of Panax notoginseng saponins (PNS) (Xueshuantong lyophilized powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS therapy for patients with AIS.Methods: The Evaluation of Xueshuantong in Patients with acutE ischemiC sTroke (EXPECT) trial is a multicenter, randomized, placebo-controlled, double-blind study aiming to enroll 480 patients in China. Eligible patients with AIS within 72 h of symptom onset will randomly receive either PNS or PNS placebo for 10 days and subsequently be followed up to 90 days. The primary outcome will be a change in the National Institute of Health Stroke Scale (NIHSS) score from baseline to 10 post-randomization days. The secondary outcomes include early neurological improvement (proportion of patients with NIHSS score 0–1), and Patient-Reported Outcomes Scale for Stroke score at 10 post-randomization days, the proportion of patients with life independence (modified Rankin Scale score of 0–1), the proportion of patients with a favorable outcome (Barthel Index ≥90), and Stroke-Specific Quality of Life score at 90 days. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of PNS.Conclusions: To our knowledge, this study is the first double-blind trial to assess the efficacy and safety of PNS in patients with AIS. Findings of the EXPECT trial will be valuable in improving evidence regarding the clinical application of PNS therapy in patients with AIS ineligible for revascularization treatment in the reperfusion era.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 282-282
Author(s):  
Hailiang Li ◽  
Hongtao Hu ◽  
Guangshao Cao ◽  
Gang Wu ◽  
Pengxu Ding ◽  
...  

282 Background: Combination of transcatheter arterial chemoembolization (TACE) with apatinib are emerging as an effective treatment for patients with intermediate to advanced stage HCC. However, the data of HCC treated by apatinib in the real-world setting are not reported. In this real-world study, we aimed to explore the efficacy and safety of HCC pts which underwent TACE combine with apatinib. Methods: This was a prospective, multicenter observational study in a real-world setting and this study was approved by our Ethics Committee. Pts aged ≥18 years with well diagnosed intermediate or advanced stage HCC were included. The pts received apatinib plus TACE treatment as the first-line therapy. TACE treatment was performed on demand, the dose of apatinib was selected by the investigator. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival rate (OS), objective response rate (ORR), disease control rate (DCR) and safety profile. All of the objective response was assessed by independent central review per mRECIST criteria. Results: From Jun 2019 to Feb 2020, a total of 98 well diagnosed HCC pts with age from 31 to 86 were enrolled in this study. As of August 2020, the median follow-up was 9.5 months. The mPFS of 98 pts was 7 months. The ORR, DCR and 6 months OS rate was 35.7%, 76.5% and 82.6%, respectively.The PFS was 7.5 months in intermediate stage and 6.4 months in advanced stage. The ORR was 46.3% in intermediate stage (41 cases) and 28% in advanced stage (57 cases) HCC. And the 6 months OS rate was 90.2% in intermediate stage and 77.1% in advanced stage HCC. Overall, 17 (17.3%) pts had grade≥3 treatment-related AEs. All of the safety adverse effects can be tolerated or reduced after symptomatic treatment and no unexpected adverse events were observed. Conclusions: In this real-world study, apatinib showed a favorable efficacy and safety profile in pts with intermediate and advanced stage cancer. Apatinib combination TACE therapy might lead to better survival benefit in first-line treatment for HCC pts. Clinical trial information: ChiCTR1900024030.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
TETSUYA MIYAGI ◽  
Masatoshi Koga ◽  
Hiroshi Yamagami ◽  
Satoshi Okuda ◽  
Yasushi Okada ◽  
...  

Background and Purpose: The association between chronic kidney disease and clinical outcomes in acute intracerebral hemorrhage (ICH) remains uncertain. We aimed to assess associations of renal dysfunction and outcomes in acute ICH patients treated with intensive BP lowering. Methods: The SAMURAI-ICH study was a prospective, multicenter, observational study. A total of 211 patients with acute supratentorial ICH were recruited. BP was targeted between 120 mmHg and 160 mmHg during initial 24 h using intravenous nicardipine. Glomerular filtration rate (eGFR) was calculated using admission serum creatinine. After 23 patients on maintenance hemodialysis were excluded, the remaining 188 were divided into 3 groups as follows: Group 1, eGFR of <60; Group 2, 60 to 75; and Group 3, ≥75 mL/min/1.73m 2 . Clinical outcomes were hematoma expansion of ≥33% at 24 h, neurological deterioration within 72 h (GCS decrement ≥2 points or NIHSS increment ≥4 points), and favorable (modified Rankin Scale [mRS] ≤2) and unfavorable (mRS ≥5) outcomes at 3 months. Results: Of 188 patients, 35 (18 women) were allocated to Group 1, 58 (20) to Group 2, and 95 (33) to Group 3. Significant differences among 3 groups were found in age (73.1±13.6, 63.3±13.2, 63.8±9.8 yo; p <0.001) and initial systolic BP (208.9±18.1, 201.2±15.6, 200.2±14.8 mmHg; p=0.018). Initial hematoma volume (14.9±11.9, 15.5±14.9, 14.3±12.3 mL) and initial median NIHSS score (14, 11, 13) were similar among 3 groups. For outcomes, significant differences among 3 groups were found in favorable outcome (17.7%, 51.7%, 41.3%; p=0.004) and unfavorable outcome (22.9%, 10.3%, 5.3%; p=0.021), but not in hematoma expansion (17.1%, 10.3%, 22.1%) and neurological deterioration (11.4%, 8.6%, 7.4%). After adjustment with initial hematoma volume, initial systolic BP and initial NIHSS score, eGFR <60 ml/min/1.73m 2 was inversely associated with favorable outcome (OR 0.20, 95% CI 0.07-0.54) and positively associated with unfavorable outcome (4.27, 1.36-13.53). Conclusions: Although decreased eGFR on admission was not associated with initial hematoma volume or initial NIHSS score, it was associated with poor outcomes at 3 months of ICH onset.


2020 ◽  
Vol 10 (5) ◽  
pp. 277-287
Author(s):  
Eva Costa Arpín

Fampridine is the only drug approved for the treatment of walking impairment in multiple sclerosis. Around a third of the patients on treatment obtained an improvement in walking speed during the development phase. The effects are clinically significant, appear soon after the start of the treatment and are long-lasting, but disappear soon after the drug is withdrawn. In the real-world setting, the number of patients with a significant response to the treatment seems to be higher (around 70%). The tolerance is good, with mild to moderate, and transient adverse events. The most commonly reported are insomnia, headache, fatigue, back pain, dizziness, nausea and balance disorders. The main contraindications are a history of seizures, renal impairment and concomitant treatment with OCT2 inhibitors.


2012 ◽  
Vol 16 (4) ◽  
pp. 257-260 ◽  
Author(s):  
Chantal Bolduc ◽  
Robert Bissonnette

Background: Current therapeutic options for extensive alopecia areata (AA) often lead to disappointing results. Objective: To study the efficacy and safety of adalimumab in patients with severe AA. Methods: This was a prospective, open-label, single-center, pilot study. Three subjects of the planned 10 were enrolled and received two weekly subcutaneous (SC) loading doses of adalimumab 80 mg followed by 40 mg SC every week for 6 months. Patients were evaluated for efficacy and safety on a monthly basis. Results: Enrolment in this trial was stopped following publication of studies showing no improvement in patients with AA treated with tumor necrosis factor α antagonists. One patient had a favorable response to adalimumab, whereas the two other patients had no benefit from the therapy. Adalimumab was well tolerated by patients with AA. Conclusion: Adalimumab was well tolerated in patients with AA but did not induce clinically significant hair regrowth.


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