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OBJECTIVE:To explore the general rules and characteristics of ADR/ADE induced by Monosialotetrahexosylgan-glioside sodium injection(GM1)as well as related risk factors,and to provide reference for safe,effective and economical drug use in clinic. METHODS:By hospital LAN,non-interventional centralized monitoring was conducted among patients receiving GM1 in our hospital from Jan.-Jun. 2016.The patients'information,drug use,ADR/ADE and clinical outcomes were analyzed sta-tistically. RESULTS:A total of 621 patients were involved,including 393 male patients and 228 female patients with male-to-fe-male ratio of 1.72:1.The patients who were more than 61 years old were the majority(60.39%).GM1 was mainly used in neurolo-gy department(71.18%),emergency department(6.28%),neurosurgery department(6.12%),general practice department(4.67%)and TCM rehabilitation department(4.03%). Among them,there were 28 ADR/ADE cases,with incidence of 4.51%. Among 42 patients with off-indication,3 cases had ADR/ADE,with incidence of 7.14%. Meanwhile,the constituent ratio of ADR/ADE in male(67.86%)was higher than that in female(32.14%). Twenty-two cases received more than three or more drugs(78.57%). Furthermore,ADR/ADE mainly manifested as systemic damage(35.71%),lesion of skin and its appendants (28.57%). Among 579 patients met drug use with indication,there were 165 cured cases,405 recovered cases and 9 uncured cases. In addition,the average expenditure of using GM1 was 5 108.08 yuan,accounting for 9.07% of total hospitalization cost and 23.33% of total drug cost. CONCLUSIONS:It is necessary to strengthen rational drug use and monitoring of GM1,under-stand the regularity and characteristics of GM1-induced ADR/ADE,so as to reduce the incidence of ADR/ADE and ensure safe, effective and economical drug use.
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OBJECTIVE:To explore the general rules and characteristics of ADR/ADE induced by Monosialotetrahexosylgan-glioside sodium injection(GM1)as well as related risk factors,and to provide reference for safe,effective and economical drug use in clinic. METHODS:By hospital LAN,non-interventional centralized monitoring was conducted among patients receiving GM1 in our hospital from Jan.-Jun. 2016.The patients'information,drug use,ADR/ADE and clinical outcomes were analyzed sta-tistically. RESULTS:A total of 621 patients were involved,including 393 male patients and 228 female patients with male-to-fe-male ratio of 1.72:1.The patients who were more than 61 years old were the majority(60.39%).GM1 was mainly used in neurolo-gy department(71.18%),emergency department(6.28%),neurosurgery department(6.12%),general practice department(4.67%)and TCM rehabilitation department(4.03%). Among them,there were 28 ADR/ADE cases,with incidence of 4.51%. Among 42 patients with off-indication,3 cases had ADR/ADE,with incidence of 7.14%. Meanwhile,the constituent ratio of ADR/ADE in male(67.86%)was higher than that in female(32.14%). Twenty-two cases received more than three or more drugs(78.57%). Furthermore,ADR/ADE mainly manifested as systemic damage(35.71%),lesion of skin and its appendants (28.57%). Among 579 patients met drug use with indication,there were 165 cured cases,405 recovered cases and 9 uncured cases. In addition,the average expenditure of using GM1 was 5 108.08 yuan,accounting for 9.07% of total hospitalization cost and 23.33% of total drug cost. CONCLUSIONS:It is necessary to strengthen rational drug use and monitoring of GM1,under-stand the regularity and characteristics of GM1-induced ADR/ADE,so as to reduce the incidence of ADR/ADE and ensure safe, effective and economical drug use.
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OBJECTIVE:To study the general pattern,characteristics and related risk of adverse drug reaction(ADR)induced by Monosialotetrahexosylganglioside sodium injection,and to provide reference for safe use of drugs in the clinic. METHODS:Us-ing“monosialotetrahexosylganglioside”and“ADR”as keywords,literautres were retrieved from CJFD,Wanfang and VIP database according to inclusion and exclusion criteria in Oct. 2014,and cases reports were extracted and analyzed statistically. RESULTS:A total of 19 literatures were included,involving 56 patients,with the ratio of male to female was 6.17∶1,and the most of patients aged 0-9 years,≥60 years,accounting for 44.64%(25 cases),30.36%(17 cases). Multiple organs or systems were involved in ADR;the most common reactions are fever (29 cases) and shiver (28 cases),etc.,and severe ADR can cause green-barry syn-drome,anaphylactic shock,etc. CONCLUSIONS:Thus,it is important to pay attention to ADR caused by Monosialotetrahexosyl-ganglioside sodium injection,to prevent the occurrence of serious ADR,to perfect drug instructions,and to ensure clinical safe ad-ministration.
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OBJECTIVE:To explore the clinical efficacy and safety of nalmefene combined with monosialotetrahexosylganglio-side sodium in the treatment of patients in brain tumor operation. METHODS:64 patients in brain tumor operation were randomly divided into observation group and control group,32 cases in each group. Control group received brain cell protection,reducing in-tracranial pressure,anti-infective,vasodilator and other conventional treatment;observation group additionally received 0.7μg/(kg· h) nalmefene combined with 100 mg/d monosialotetrahexosylganglioside sodium from the first day of operation,for continuous 7 d. The plasma cortisol,adrenocorticotropic hormone (ACTH) before and 3,7 d after treatment,changes of serum IL-6,TNF-αand Barthel index (BI) in 2 groups were observed,improvement of neurological function and ADR were observed;Karnofsky (KPS)score was determined after 90 d follow-up used to assess the patient’s ability to take care of themselves. RESULTS:After treatment,plasma cortisol and ACTH content,serum TNF-αand IL-6 levels in 2 groups significantly decreased than before,the dif-ference was statistically significant(P<0.05);cortisol,ACTH and TNF-α levels 3,7 d after treatment,IL-6 level 7 d after treat-ment in observation group decreased more significantly than control group,the differences were statistically significant(P<0.05). After treatment,BI score in 2 groups significantly increased,and observation group increased more significantly than control group,the differences were statistically significant (P<0.05). 7 d after treatment,improvement rate of neurological function was 50.00%,which was significantly higher than that of the control group(18.75%),the difference was statistically significant(P<0.05). There was no significant ADR occurred of 2 groups in the study. Following-up for 90 d,the KPS score in observation group with not less than 70 points accounted for 71.88%,which was significantly higher than the control group(46.87%),the difference was statistically significant (P<0.05). CONCLUSIONS:Nalmefene combined with monosialotetrahexosylganglioside sodium can promote the recovery of patients in brain tumor operation,reduce cortisol,ACTH,IL-6 and TNF-α levels and improve prognosis of patients.
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Objective To evaluate clinical therapeutic efficacy and safety of joint application of Monosialotetrahexosylganglioside Sodium and the Vinpocetine in patients with acute cerebral infarction.Methods 60 patients with acute cerebral infarction, admitted to Wuxi People's Hospital Attached to Nanjing Medical University from January 2013 to July 2015, were randomly divided into observation group(n=30) and control group(n=30).They were both treated by identical basis therapy, such as antiplatelet, dilute blood viscosity, neurotrophy therapy and symptomatic treatment.The patients in the observation group were treated by joint application of Monosialotetrahexosylganglioside Sodium and the Vinpocetine on the identical basis therapy.On the pretherapy and post-treatment day, the National Institutes of Health Stroke Scale (NIHSS), Barthel Index(BI), neuron specific enolase(NSE), hemodynamic indexes and efficiency of clinical treatment in these patients were performed.Blood routine examinations, hepatorenal function and ECG were monitored.CT SCan was employed for ICH and drug relative hemorrhage and adverse drug reaction( ADR) were recorded in detail.Results After treatment, 2 groups of NIHSS, BI score, blood rheology index, NSE level compared with before treatment improved significantly, the difference was significant (P<0.05).NSE, hemorheology and total effective rate of the observation group were better than the control group(P<0.05).The clinical total effective rate was 93.3% in treatment group and 76.6% in control group (P<0.05).During therapy period, There was no adverse reaction in 2 groups.Conclusion Joint application of Monosialotetrahexosylganglioside Sodium and the Vinpocetine is safe and effective in treating patients with acute cerebral infarction, through improving the clinical neurological deficits, blood rheology indicators and activity of daily living.