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2019, 21(3)
HighLights More»   
· A humble opinion about study on methotrexate toxicity related gene polymorphism
· Analysis of factors influencing major adverse events in patients with hematologic neoplasms and treated with high-dose methotrexate regimens
· Association of glutathione S-transferase M1 and T1 genetic polymorphisms with blood methotrexate concentration and adverse events in children with acute lymphoblastic leukemia
· Correlation between blood methotrexate concentrations at 24 hours after the initiation of high-dose methotrexate infusion and clinical outcomes in patients with hematologic neoplasms: a meta analysis
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  Adverse Drug Reactions Journal--2019, 21 (3)   Published: 28 June 2019
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Adverse Drug Reactions Journal. 2019, 21 (3): 161-161. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.001
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A humble opinion about study on methotrexate toxicity related gene polymorphism Hot!
Zhang Xianglin
Adverse Drug Reactions Journal. 2019, 21 (3): 162-165. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.002
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Methotrexate (MTX) has been used clinically for nearly 70 years. It has been proved in practice that MTX is effective in some hematologic neoplasms and autoimmune diseases, but it has strong toxic side effects and needs individualized medication. Polymorphisms of some genes affecting MTX metabolism, transport and target of action, such as methylenetetrahydrofolate reductase (MTHFR) C677T and A1298C, gamma-glutamyl hydrolase (GGH) C401T and C16T, solute carrier family 19-A1 (SLC19A1) G80A, are closely related not only to efficacy, but also to toxic side effects of MTX therapy. However, the results of different studies are quite different. At present, it is not possible to use these genetic polymorphisms to guide clinical individualized treatment accurately. Blood concentration monitoring is still the main method of MTX monitoring.
Analysis of factors influencing major adverse events in patients with hematologic neoplasms and treated with high-dose methotrexate regimens Hot!
Zou Yuzhen, Mei Dan, Fu Qiang, Duan Minghui, Yang Chen
Adverse Drug Reactions Journal. 2019, 21 (3): 166-175. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.003
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ObjectiveTo explore the factors influencing major adverse events in patients with hematologic neoplasms and treated with high-dose methotrexate (HDMTX) chemotherapy regimens.MethodsMedical records of all inpatients with hematologic neoplasms treated with HDMTX chemotherapy regimens in Peking Union Medical College Hospital from January 2014 to February 2016 were collected by Hospital Information System and retrospectively analyzed in combination with the adverse events surveillance files within 48 hours after HDMTX treatment, established by clinical pharmacists of hematology department. The effects of age, body mass index (BMI), methotrexate (MTX) dosage, time of intravenous infusion, liver and kidney function before administration, blood drug concentration of 20 hours after completion of one treatment cycle, and chemotherapy regimens on adverse events of ≥grade II were analyzed by single factor and multiple factor analysis.ResultsA total of 324 inpatients were entered in the study, including 179 males and 145 females with a median age of 43 (14-77) years. There were 72 inpatients  with acute lymphoblastic leukemia, 208 with non-Hodgkin lymphoma, and 44 with Langerhans cell histiocytosis. A total of 1 050 cycles of HDMTX were administered to the 324 patients. Within 48 hours after the HDMTX treatment, 159 patients had 289 times of adverse events of ≥grade II. The incidence of adverse events of ≥grade II was 49.07% and the adverse events accounted for 27.52% of the treatment cycles. Elevated serum alanine aminotransferase (ALT) was the most common adverse event [the incidence was 25.62% (83/324) and the constituent ratio was 10.38% (109/1 050)], followed by nausea and vomiting [ the incidence was 11.73% (38/324) and the constituent ratio was 5.43% (57/1 050)]and elevated serum creatinine (Scr) level [the incidence was 8.64% (28/324) and the constituent ratio was 2.76% (29/1 050)]. Multiple factor analysis showed that MTX dosage, time of intravenous infusion, and ALT level before administration were significant factors affecting ALT elevation after administration; BMI, blood drug concentration of 20 hours after completion of one treatment cycle, serum total bilirubin (TBil) and before administration were significant factors affecting Scr elevation after administration; serum TBil level before administration was the only significant factor affecting TBil elevation after administration; blood drug concentration of 20 hours after completion of one treatment cycle was the only significant factor in oral mucositis; MTX dosage, four-hour intravenous infusion regimen, and GDP/ML regimen (gemcitabine+dexamethasone+cisplatin+HDMTX+pegaspargase) were significant factors influencing adverse neuro-logical events.ConclusionsAfter HDMTX regimen chemotherapy, patients with baseline dysfunction of liver and kidney and a 24-hour intravenous infusion regimen may increase the risk of liver and kidney injury; overweight patients may have an increased risk of kidney injury; GDP/ML regimen, 4-hour intravenous infusion regimen, and higher MTX dosages may increase the risk of neurological adverse events; high blood concentration of 20 hours after completion of one treatment cycle may be a risk factor of kidney injury and oral mucositis.
Association of glutathione S-transferase M1 and T1 genetic polymorphisms with blood methotrexate concentration and adverse events in children with acute lymphoblastic leukemia Hot!
Chen Qiulin, Sun Zhouliang, Wang Kun, Yan Zhiwen
Adverse Drug Reactions Journal. 2019, 21 (3): 176-182. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.004
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ObjectiveTo explore the association between glutathione S-transferase (GST) M1 and T1 genetic polymorphisms and the blood methotrexate concentration at 48 hours (C48 h) after initiation of high-dose methotrexate (HDMTX) infusion and major adverse events within 72 hours in children with acute lymphoblastic leukemia (ALL).MethodsMedical records of ALL children in the First Affiliated Hospital of Xiamen University who received HDMTX-containing chemotherapy regimen, blood concentration monitoring of methotrexate at 48 hours after initiation of infusion, and GST M1 and T1 genetic polymorphism detection were collected and retrospectively analyzed.ResultsA total of 94 children with ALL were enrolled in the study, including 52 males and 42 females, aged 2-15 years with the average age of (5±3) years. Within 72 hours after the HDMTX chemotherapy, 44 children (46.8%) developed liver injury, 43 children (45.7%) developed gastrointestinal reactions, 15 children (16.0%) developed myelosuppression, and 45 children (47.9%) developed skin and mucosa injury. The children were divided into the <0.5 μmol/L group, the 0.5-1.0 μmol/L group, and the >1.0 μmol/L group according to their C48 h of methotrexate. The incidences of adverse events such as liver injury, gastrointestinal reaction, and skin and mucosa injury in the <0.5 μmol/L group were significantly lower than those in the >1.0 μmol/L group [17.9% (5/28) vs. 78.6% (11/14), 21.4% (6 /28) vs. 85.7% (12/14), 17.9% (5/28) vs. 71.4% (10/14), all P<0.001]. Significant differences of methotrexate C48 h/dose ratio were found neither between children with functional wild-type alleles of GST M1 (GST M1 non-null genotypes) and those with GST M1 null-genotypes nor between children with GST T1 non-null genotypes and those with GST T1 null genotypes (both P>0.05). But the incidences of liver injury within 72 hours after HDMTX chemotherapy in children with GST M1 and GST T1 null-genotypes were significantly higher than those in children with GST M1 and GST T1 non-null genotypes, respectively [GST M1: 50.7% (36/71) vs. 34.8% (8/23); GST T1: 55.2% (32/58) vs. 33.3% (12/36), both P<0.05]. Multivariate logistic regression analysis showed that GST M1 and GST T1 genetic polymorphisms were associated with increased risk of liver injury (OR=1.928, 95%CI: 1.353-2.745, P<0.001; OR=2.462, 95%CI: 1.046-5.793, P=0.039).ConclusionsThe C48 h of methotrexate in children with ALL and receiving HDMTX chemotherapy was associated with the occurrence of adverse events. GST M1 and GST T1 genetic polymorphisms had no significant effects on C48 h of methotrexate, but might increase the risk of liver injury in children.
Correlation between blood methotrexate concentrations at 24 hours after the initiation of high-dose methotrexate infusion and clinical outcomes in patients with hematologic neoplasms: a meta analysis Hot!
Song Zaiwei1,2,3, Huang Zhencheng, Zhang Enyao, Liu Shuang, Tan Zhiyuan, Zhao Rongsheng
Adverse Drug Reactions Journal. 2019, 21 (3): 183-189. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.005
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ObjectiveTo evaluate the association between blood methotrexate concentrations at 24 hours (C24 h) after the initiation of high-dose methotrexate (HDMTX) infusion and clinical outcomes in patients with hematologic neoplasm.MethodsThe literature on C24 h after the initiation of HDMTX treatment and clinical outcomes in MEDLINE (Ovid), EMBASE (Ovid), Clinical Trials. gov, CNKI, WanFang Data, and SinoMed databases up to March 2018 were retrieved (the outcome indicators mainly included safety indicators, such as adverse event incidence and effectiveness indicators, such as complete remission rate). The quality of the enrolled literature was evaluated by Newcastle-Ottawa Scale (NOS) and related outcome indicators were analyzed by meta-analysis or descriptive analysis.ResultsA total of 6 studies were enrolled, including 4 with high quality (NOS scores were 7-9) and 2 with medium quality (both of NOS scores were 6). All the subjects in the 6 studies were children with acute lymphoblastic leukemia (ALL), aged 0.4 to 17.0 years, and a total of 516 HDMTX treatments were given to them. Five studies reported the association between methotrexate C24 h and safety outcomes and 1 reported the association between methotrexate C24 h and effectiveness outcomes. For safety outcomes, compared with C24 h<10 μmol/L, methotrexate C24 h>10 μmol/L might increase the risk of hematological toxicity (OR=4.17, 95%CI: 1.17-14.90) rather than the risks of gastrointestinal toxicity (OR=2.22, 95%CI: 0.97-5.04), renal toxicity (P=0.130), oral mucositis (P=0.166), or dermal toxicity (P=0.227). Compared with C24 h <40 μmol/L, methotrexate C24 h>40 μmol/L might increase the risks of hepatotoxicity (OR=16.64, 95%CI: 6.35-43.64), oral mucositis (OR=31.73, 95%CI: 12.37-81.41), severe oral mucositis (P=0.002), and gastrointestinal toxicity (P=0.003). For effectiveness outcomes, the single study suggested that methotrexate C24 h>16 μmol/L could increase the complete and partial remission rates (P<0.05 for both) and decrease the 1.5 year-recurrence rate (P=0.006).ConclusionsThere was a significant association between methotrexate C24 h and clinical outcomes in children with ALL. Methotrexate C24 h>16 μmol/L was significantly associated with a favorable clinical outcome while C24 h>40 μmol/L was significantly associated with increased risks of hepatotoxicity, oral mucositis, and gastrointestinal toxicity.
Risks of acute kidney injury due to sodium glucose co-transporter 2 inhibitors: a study based on the related data in the US Food and Drug Administration Adverse Event Reporting System
Fang Zhenwei, Shi Jia, Shi Xiujin, Zhang Lin, Zhang Yi, Lin Yang
Adverse Drug Reactions Journal. 2019, 21 (3): 190-197. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.006
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ObjectiveTo evaluate the risk of acute kidney injury (AKI) induced by sodium glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin).MethodsReports of AKI events induced by SGLT2 inhibitors and non-SGLT2 inhibitors received from January 1, 2013 to September 30, 2018 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were collected. The relationship between the drugs mentioned above and the AKI events in all patients and especially in patients with diabetes mellitus, respectively, were analyzed by the method of reporting odds ratio (ROR).ResultsA total of 2 949 reports of SGLT2 inhibitors-induced AKI (2.50% of 117 843 AKI event reports in the database during the study period), and 114 894 reports of non-SGLT2 inhibitors-induced AKI were retrieved from the database. The ROR values of AKI events induced by overall SGLT2 inhibitors, canagliflozin, dapagliflozin, and empagliflozin in all patients were 4.14 (95%CI: 3.98-4.30), 5.58 (95%CI: 5.35-5.83), 2.62 (95%CI: 2.35-2.92), and 1.96 (95%CI: 1.76-2.19), respectively, and in patients with diabetes mellitus were 2.84 (95%CI: 2.71-2.98), 3.90 (95%CI: 3.69-4.12), 1.70 (95%CI: 1.48-1.94), and 1.30 (95%CI: 1.15-1.48), respectively. Due to the short time to market, less than 3 reports of AKI events induced by ertugliflozin were reported, thus ROR analysis was not conducted for ertugliflozin. The analyses of combined medication showed that in all patients, the ROR value of AKI events induced by SGLT2 inhibitors was 8.05 (95%CI: 7.10-9.13) when SGLT2 inhibitors were combined with diuretics, which increased by 80.90% compared with that when SGLT2 inhibitors were given alone and in patients with diabetes mellitus, it was 6.07 (95%CI: 5.27-7.00), which increased by 92.09%; in all patients, the ROR value of AKI events induced by SGLT2 inhibitors was 5.87 (95%CI: 4.89-7.04) when SGLT2 inhibitors were combined with non-steroidal anti-inflammatory drugs (NSAID), which increased by 39.43% compared with that when SGLT2 inhibitors were given alone and in patients with diabetes mellitus, it was 4.66 (95%CI: 3.79-5.74), which increased by 61.25%; in all patients, the ROR value of AKI events induced by SGLT2 inhibitors was 5.60 (95%CI: 5.12-6.14) when SGLT2 inhibitors were combined with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, which increased by 25.56% compared with that when SGLT2 inhibitors were given alone and in patients with diabetes mellitus, it was 4.05 (95%CI: 3.66-4.48), which increased by 27.36%.ConclusionsSGLT2 inhibitors might increase the risk of AKI and this risk was mainly from canagliflozin, suggesting that dapagliflozin and empagliflozin were relatively safe to patients. The risk of AKI might increase when SGLT2 inhibitors were combined with diuretics or NSAID.
Cases analysis of liver injury associated with Qubai Babuqi tablets (驱白巴布期片)
Yang Zhengwei, Zhou Yuanyuan, Tang Yi, Ge Feilin, Guo Yuming, Hu Huang Wanyin, Sun Chuanduo, Wang Jiabo
Adverse Drug Reactions Journal. 2019, 21 (3): 198-202. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.007
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ObjectiveTo explore the clinical characteristics and influencing factors of liver injury associated with Qubai Babuqi tablets.MethodsCase reports of liver injury associated with Qubai Babuqi tablets in the National Adverse Drug Reaction Monitoring System (ADRMS) from 2012 to 2016 and clinical information of patients with liver injury induced by Qubai Babuqi tablets, who were admitted to the Fifth Medical Center of PLA General Hospital from 2008 to 2017, were collected and retrospectively analyzed.ResultsA total of 64 patients (59 from case reports in ADRMS and 5 from the Fifth Medical Center of PLA General Hospital) with liver injury induced by Qubai Babuqi tablets were enrolled, including 32 males and 32 females, aged from 10 to 73 years with an average age of (34±13) years. Thirty-three patients (51.6%) were treated with Qubai Babuqi tablets alone, 31 patients (48.4%) had combined medication, and 3 of the 64 patients suffered from liver injury again after their remedication of Qubai Babuqi tablets. The median time from medication to liver injury was 33 (2-210) days and the median cumulative dose of Qubai Babuqi tablets was 184.5 (8.0-868.5) g. There were 35 patients (54.7%) with severe liver injury. No significant association was found between the severity of liver injury and the dose of the drug (P>0.05). But the proportion of patients with severe liver injury treated with combined medication was significantly higher than that of patients with severe liver injury treated with Qubai Babuqi tablets alone [67.7% (21/31) vs. 42.4% (14/33), χ2=4.282, P=0.042]. Among the 64 patients, the liver injury was cured in 31 patients, improved in 21 patients, did not improve in 2 patients, worsened in 2 patients (developed to hepatic encephalopathy and cirrhosis, respectively), and had unknown outcomes in 8 patients.ConclusionsAbout half of the liver injuries caused by Qubai Babuqi tablets were severe ones. The prognosis of liver injury was relatively good and it could be cured or improved in most patients. The combination of other drugs might be the influencing factor of severe liver injury caused by Qubai Babuqi tablets.
Changes of blood glucose level after glucocorticoid pulse therapy and its influencing factors in patients with Graves ophthalmopathy
ong Zhihui, Xin Zhong, Wang Xinglong, Liu Pengpeng, Wang Jiawei
Adverse Drug Reactions Journal. 2019, 21 (3): 203-207. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.008
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ObjectiveTo explore the changes of blood glucose level after glucocorticoid pulse therapy (GPT) and its influencing factors in patients with Graves ophthalmopathy (GO).MethodsMedical records of GO patients hospitalized in Beijing Tongren Hospital from January 1, 2013 to December 31, 2018 and treated with GPT were collected and retrospectively analyzed. The incidence of glucocorticoid-induced diabetes mellitus (GIDM) during the GPT treatment (3 days) was counted. According to the monitoring data of fasting blood glucose (FBG) and postprandial blood glucose (PBG), the changes of FBG and PBG levels were calculated. Influencing factors for FBG and PBG levels were evaluated by multiple linear stepwise regression analysis.ResultsA total of 75 patients were enrolled in the study, including 44 males and 31 females, aged 22-69 years with the average age of (48±9) years; 40 patients (53.3%) were with normal oral glucose tolerance test, 27 (36.0%) with prediabetes, and 8 (10.7%) with diabetes mellitus; 57 patients (76.0%) were with hyperthyroidism, 11 (14.7%) with hypothyroidism, and 7(9.3%)with normal thyroid function. The peak values of FBG and PBG in 75 patients during GPT treatment were significantly higher than those before the treatment [FBG: (7.9±1.3) vs. (5.3±1.2) mmol/L, PBG: (13.5±2.8) vs. (8.1±2.8) mmol/L;both P<0.001], and the differences were (2.7±1.0) and (5.4±2.6) mmol/L, respectively (P<0.001). Among the 67 patients without diabetes mellitus, 54 (80.6%) developed GIDM during GPT treatment. The levels of FBG and PBG in the 8 patients with diabetes mellitus increased by (2.7±1.4) and (3.7±2.5) mmol/L during GPT treatment, respectively. Multiple linear stepwise regression analysis showed that the influencing factors of FBG level during GPT treatment were baseline FBG level (P<0.001) and history of hyperuricemia (P=0.002) and dyslipidemia (P=0.032); the influencing factors of PBG level were baseline glycosylated hemoglobin A1c (HbA1c, P=0.002) level, baseline PGB level (P=0.024), and serum free thyroxine level (FT4, P=0.021).ConclusionsGPT had a significant effect on blood glucose level in patients with GO, which could lead to higher incidence of GIDM. The main influencing factors of blood glucose level were baseline levels of FBG, PBG, and HbA1c, FT4 levels, and history of hyperuricemia and dyslipidemia.
Influence of comprehensive intervention on efficacy and safety of antihypertensive therapy in patients with hypertension in the community health service center
Wang Hongyan, Yang Xiaoliang, Jiao Jiao
Adverse Drug Reactions Journal. 2019, 21 (3): 208-212. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.009
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ObjectiveTo explore the influence of comprehensive intervention on efficacy and safety of antihypertensive therapy in patients with hypertension in the community health service center.MethodsThe subjects were from patients with hypertension who visited Sun Palace Community Health Service Center, Chaoyang District, Beijing from October 2017 to October 2018. The patients who met the criteria were randomly divided into the control group and the intervention group. Patients in the control group were treated only with conventional medication, while patients in the intervention group were treated with additional comprehensive intervention of non-drugs on the basis of conventional medication. After 1 year of treatment, the patients′ blood pressure and the proportion of patients with risk factors for hypertension such as smoking, drinking excess, high salt diet, insufficient exercise, overweight, Zung self-rating anxiety scale (SAS) score >40 and/or Zung self-rating depression scale (SDS) score >40 in the 2 groups before and after treatment were compared; the treatment compliance of conventional medication (taking drugs on time), efficiency of blood pressure control (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg), incidence of adverse cardiovascular events (CAE), and incidence of adverse reactions related to antihypertensive drugs before and after treatment between the 2 groups were compared as well. ResultsA total of 400 patients were enrolled in the study(200 in the control group and 200 in the intervention group). There were no significant differences in gender, age, course of disease, hypertension grade, and combined diseases in patients between the 2 groups (all P>0.05). After 1 year of treatment, the systolic and diastolic blood pressures of patients both in the control group and in the intervention group were significantly lower than those before treatment (all P<0.05); the systolic and diastolic blood pressures of patients in the intervention group were significantly lower than those in the control group [(133±17) mmHg vs. (139±18) mmHg, (86±8) mmHg vs. (90±9) mmHg, all P<0.05]; the proportions of patients with risk factors such as smoking, drinking, high salt diet, insufficient exercise, overweight, SAS score >40 and/or SDS score >40 in the intervention group were significantly lower than those in the control group (all P<0.05); the proportion of patients who took drugs on time and efficiency of blood pressure control in the intervention group were significantly higher than those in the control group [82.5% (165/200) vs. 64.0% (128/200), 64.0% (128/200) vs. 52.5% (105/200), both P<0.05]; the incidence of cardiovascular adverse events in patients in the intervention group was lower than that in the control group [1.0%(2/200)vs. 6.5% (13/200), P<0.05]; the incidence of adverse reactions related to antihypertensive drugs in patients in the intervention group was lower than that in the control group[4.0%(8/200) vs. 10.0% (20/200), P<0.05].ConclusionComprehensive intervention could significantly improve the efficacy and safety of antihypertensive therapy in patients with hypertension in community health service center.
Should albumin be a conventional medication after gastrectomy?
Qiao Yongqi, Wang Weihua, Dai Yuanyuan, XieYibin
Adverse Drug Reactions Journal. 2019, 21 (3): 213-217. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.010
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A 61-year-old male patient with gastric cancer received routine albumin supplementation after surgery, which resulted in hypoalbuminemia, increased abdominal drainage fluid and pleural effusion. Clinical pharmacists and surgeons did literature reviews and discussions, and finally reached consensuses on albumin administration of patients after gastric cancer surgery. The consensuses were as follows: (1) it is not recommended to conduct albumin supplementation routinely after gastric cancer surgery; (2) albumin is not an effective nitrogen source and it cost too much to be used as a source of postoperative nutrition or protein; (3) for patients with postoperative hypoproteinemia (<30 g/L), albumin supplementation should be used after the surgical stress response period (day 4 after the surgery) and discontinued when the serum albumin is >30 g/L; (4) for patients with peritoneal and/or pleural effusion after surgery, the nature of the effusion should be defined firstly, and albumin can be supplemented only when the transudate is determined.
2017 ISMP Medication Safety Self Assessment for antithrombotic therapy (Chinese version)(the end)
Adverse Drug Reactions Journal. 2019, 21 (3): 218-222. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.011
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Death due to severe myelosuppression and sepsis caused by methotrexate in patients with ectopic pregnancy
Yu Minji, Tao Lili
Adverse Drug Reactions Journal. 2019, 21 (3): 223-224. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.012
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A 22-year-old woman was given mifepristone tablets (150 mg, once daily) orally for 4 days and intramuscular injection of methotrexate (MTX) 75 mg once on day 4 for ectopic pregnancy. About 5 hours after injection, the patient developed nausea and vomiting. The next day, the rash appeared and scattered on the head and face with pain and itching. Loratadine tablets 10 mg once daily were given orally, but the rash gradually aggravated. On  day 5 after MTX treatment, pustules appeared on the back and chest, and oral mucosal ulceration occurred. On day 6, the patient developed persistent high fever, with white blood cell count 0.28×109/L, neutrophil count 0.07×109/L, platelet count 16×109/L, and hemoglobin 36 g/L. On day 8, the patient developed skin and mucosa swelling, accompanied by ulcer, epistaxis and superficial lymph node tumefaction. The patient was diagnosed with severe myelosuppression and sepsis, which was caused by methotrexate. Symptomatic and supportive treatments such as anti-allergy, anti-infection, leukocyte proliferation, antipyretic, and intravenous gamma globulin were given. Due to the limited hospital condition, without salvage therapy with calcium folinate was given. The patient′s condition became worse and she eventually died of multiple organ failure on day 17 after MTX treatment.
Vitamin D intoxication due to overdose of vitamin D2 tablets in a child
Liu Zongyan, Chen Chaoyang, Xie Xianting, Zhang Guiqing, Zhou Ying, Cui Yimin
Adverse Drug Reactions Journal. 2019, 21 (3): 225-226. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.013
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A young girls took irregularly Vitamin D2 tablets  (0.25 mg/tablet, each tablet contains 10 000 IU vitamin D2) purchased by her parents at a pharmacy since she was 1.5 years old. The girl took 1 tablet at a time, once to thrice daily, occasionally missing. Five months later, she developed polydipsia and polyuria. She drank more than 2 000 ml water every day, urinated once every 0.5-1 hour, and urinated more than 5 times every night. Her maximum daily urine volume could reach 3 400 ml, and her urine was transparent as clear water. Three weeks after the symptoms appeared, laboratory tests in another hospital showed that blood calcium was 4.34 mmol/L, blood phosphorus was 2.65 mmol/L, and 24-hours urine calcium was 8.0 mmol. Vitamin D poisoning was suspected and her parents were asked to stop feeding the girl vitamin D2 tablets. Rehydration, diuretics and other treatments were given. After 3 days, her blood calcium decreased to 3.60 mmol/L. After 6 days, she was transferred to Peking University First Hospital, where she continued to receive rehydration and symptomatic treatments with a low calcium and phosphorus diet. And after 8 days, the blood calcium was 2.47 mmol/L and 24-hours urine calcium was 2.7 mmol. Her symptoms of polydipsia and polyuria improved and she was discharged. Telephone follow-up 1 month after discharge, the girl′s polydipsia and polyuria disappeared and her urine examination was normal.
Liver injury and cholestasis due to concomitant use of alanyl glutamine injection and fat emulsion, amino acids(17) and glucose(11%) injection
ang Weibo, Tang Mengchen
Adverse Drug Reactions Journal. 2019, 21 (3): 227-228. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.014
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An 86-year-old male patient received parenteral nutrition therapy [IV infusions of alanyl glutamine injection 100 ml once daily and fat emulsion, amino acids (17) and glucose (11%) injection 1 440 ml once daily] for hypovolemic shock and malnutrition. His liver function was normal before medication. On day 23 after medication, the patient developed mild yellowish skin. Laboratory tests showed alanine aminotransferase (ALT) 342 U/L, aspartate aminotransferase (AST) 236 U/L, γ-glutamyl transpeptidase (γ-GT) 322 U/L, alkaline phosphatase (ALP) 308 U/L, and total bilirubin (TBil) 116.2 μmol/L. On day 25 after medication, the yellowish skin was aggravated. The above treatments were continued because of less food intake and hepatoprotective drugs were given at the same time. On day 32 after medication, laboratory tests showed ALT 186 U/L, AST 113 U/L, γ-GT 237 U/L, ALP 220 U/L, and TBil 139.7 μmol/L. The parenteral nutrition therapy was stopped and the liver protection therapy was continued. On day 44 after the drugs withdrawal, the patient′s jaundice disappeared, ALT 12 U/L, AST 14 U/L, γ-GT 37 U/L, ALP 72 U/L, and TBil 27 μmol/L.
Hypoglycemia caused by lipid emulsion (10%)/amino acids(15) and glucose (20%) injection: report of 2 cases
Zhang Xiaogang, Guo Bingrong, Liu Fei, Ma Yabin
Adverse Drug Reactions Journal. 2019, 21 (3): 229-230. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.015
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Two male patients(patient 1, 64 years old; patient 2, 63 years old)received parenteral nutrition in fasting state due to the future surgical operation for gastric space-occupying lesions and gastrointestinal bleeding, respectively. Both of them developed fatigue and cold sweat near the end of the first IV infusion of the lipid emulsion (10%)/amino acids (15) and glucose (20%) injection. Their instant blood glucose levels were 2.2 mmol/L and 2.1 mmol/L, respectively. The symptoms disappeared about 10 minutes after the immediate discontinuation of the injection and an intravenous injection of 50% glucose injection 40 ml. And their instant blood glucose levels were 5.6 mmol/L and 5.4 mmol/L, respectively. Patient 2 developed the above symptoms again near the end of the second infusion of the drug next day and his instant blood glucose level was 2.6 mmol/L. His symptoms disappeared again after the drug withdrawal and treatment of an intravenous injection of 50% glucose 40 ml and an IV infusion of 10% glucose 250 ml for about 15 minutes. Then his instant blood glucose level was 5.9 mmol/L.
Severe liver injury caused by orlistat
Qiu Yanlong, Ma Ling, Zhu Xiaolin, Li Zhengrong
Adverse Drug Reactions Journal. 2019, 21 (3): 231-232. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.016
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A 58-year-old female patient took orlistat 0.12 g orally once daily by herself due to obesity. After 13 months, she developed fatigue and anorexia. Laboratory tests showed alanine aminotransferase(ALT) 1 603 U/L, aspartate aminotransferase(AST) 1 265 U/L, alkaline phosphatase(ALP) 310 U/L, direct bilirubin(DBil) 8.4 μmol/L, and indirect bilirubin(IBil) 13.4 μmol/L. She was diagnosed with liver injury. Orlistat was discontinued, considering its relationship with the liver injury. And an IV infusion of diammonium glycyrrhizinate 150 mg (added to 250 ml of glucose injection) once daily was given. Two days later, the diammonium glycyrrhizinate was replaced by IV infusion of magnesium isoglycyrrhizinate 100 mg (added to 100 ml of 0.9% sodium chloride injection) once daily because that the symptoms did not relieve. After 6 days of treatment with magnesium isoglycyrrhizinate, the patient′s symptoms relieved and she had ALT 124 U/L, AST 73 U/L, ALP 73 U/L, DBil 3.1 μmol/L, and IBil 7.3 μmol/L. After 1 month, liver function tests showed ALT 30 U/L, AST 57 U/L, ALP 93 U/L, DBil 3.0 μmol/L, and IBil 11.8 μmol/L.
Increased blood trough concentration of tacrolimus due to diarrhoea during the anti-rejection therapy after renal transplantation
Wang Bing, Wu Xiaoping, Li Jinfeng, Zhang Yuan
Adverse Drug Reactions Journal. 2019, 21 (3): 233-234. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.017
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A 31-year-old male patient received triple anti-rejection therapy (tacrolimus 3 mg once per 12 hours, mycophenolate sodium enteric-coated tablets 720 mg twice daily, and prednisolone acetate tablets 80 mg once daily) after his renal allotransplantation. On day 5 after operation, the blood trough concentration of tacrolimus was 4.90 μg/L. On day 7, he developed 5 watery stools and the blood trough concentration of tacrolimus was 8.62 μg/L. The clinical pharmacist considered the diarrhea was the postoperative response to renal allotransplantation and the increased blood trough concentration of tacrolimus might be caused by diarrhea. Montmorillonite powder 3.0 g thrice daily orally and an IV infusion of moxifloxacin sodium chloride injection 0.4 g once daily were given. On day 12 after operation, the patient experienced 8 watery stools and his blood trough concentration of tacrolimus increased to 13.78 μg/L. The dose of tacrolimus was adjusted to 2 mg and 1 mg at 8: 00 and 20: 00 respectively. On day 14 after operation, the patient's diarrhea relieved (3 watery stools) and the blood trough concentration of tacrolimus was 20.67 μg/L. The dose of tacrolimus was adjusted to 1 mg once per 12 hours. On day 18 after operation, no diarrhea occurred in the patient and the blood trough concentration of tacrolimus decreased to 9.63 μg/L. The patient was discharged in a stable condition. The post-discharge dose of tacrolimus was adjusted to 2 mg per 12 hours. The blood trough concentrations of tacrolimus in his 3 return visits were 9.12, 9.23, and 9.15 μg/L, respectively.
Skin rash and rhabdomyolysis induced by levofloxacin
Li Ping, Liang Linlang, Shao Xiaodong, Ren Linan
Adverse Drug Reactions Journal. 2019, 21 (3): 235-236. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.018
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A 78-year-old male patient received intravenous infusion of levofloxacin 0.5 g once daily due to pneumonia. No other drugs were used during the same period. After medication, the patient′s cough and expectoration relieved gradually. However, about 1 week after the medication, skin redness and itching on the face, neck and shoulder, abdominal distension, and muscle pain and weakness appeared and worsened progressively. After 12 days of treatment, levofloxacin was discontinued. The symptoms did not improve 1 week after the drug withdrawal and the patient was hospitalized. On admission, physical examination showed grade 4 and 3 respectively for the upper and lower limbs muscle strength; laboratory tests showed the serum creatine kinase (CK) 9 952 U/L, creatine kinase isozyme (CK-MB) 101 U/L, and myoglobin (Mb) 953 μg/L; muscle biopsy and pathological examination showed partial muscle fiber degeneration, muscle bundle rupture, increased number of myonuclei, slight inflammatory cell infiltration among some muscle bundles, and a little local mucin deposition. Allergic rash and rhabdomyolysis were diagnosed, which was considered to be induced by levofloxacin. Symptomatic supportive treatments such as anti-allergy, alkaline urine, diuresis, and fluid infusion were given. One week later, the rash subsided; 3 weeks later, the patient had no muscle pain and his muscle strength of upper and lower limbs returned to grade 5 and 4, with CK 423 U/L, CK-MB 15 U/L, and Mb 128 μg/L. Then the patient was discharged from the hospital and did not take any medicine again. One month later, his muscle strength of limbs recovered and the laboratory tests showed CK 143 U/L, CK-MB 12 U/L, and Mb 62 μg/L.
Diabetic ketoacidosis induced by empagliflozin
Hong Lei, Lin Zhiqiang, Peng Xuefeng, Lin Yihui
Adverse Drug Reactions Journal. 2019, 21 (3): 237-238. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.019
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A 41-year-old female patient with type 2 diabetes mellitus changed her medication without the doctor′s advice to empagliflozin 25 mg once daily from oral metformin, acarbose and repaglinide, which had regularly been taken for 1 year (during that period, her fasting blood glucose was about 9.0 mmol/L, and she had no obvious symptoms of thirsty, polydipsia, and polyuria). On day 13 after taking empagliflozin, she developed symptoms of thirsty, polydipsia, and polyuria, which aggravated gradually. Laboratory tests showed arterial blood pH 7.28, bicarbonate 17 mmol/L, carbon dioxide-combining power 13 mmol/L, anion gap 20 mmol/L, fasting blood glucose 9.2 mmol/L, blood ketone 4.8 mmol/L, and urine ketone (++++). She was diagnosed with diabetic ketoacidosis. Empagliflozin was stopped. Hypoglycemic agent insulin and symptomatic supportive treatments including potassium supplementation and fluid replacement were given. Two days later, the above symptoms of thirsty, polydipsia, and polyuria improved, and her blood ketone decreased to 1.6 mmol/L. Nine days later, the above symptoms of thirsty, polydipsia, and polyuria disappeared.
Delayed excretion of vancomycin due to over-frequency administration in a patient undergoing peritoneal dialysis
Ye Jing, Hang Yongfu, Xie Cheng
Adverse Drug Reactions Journal. 2019, 21 (3): 239-240. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.03.020
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A 44-year-old female patient with chronic kidney disease (stage 5) undergoing peritoneal dialysis received an IV infusion of vancomycin 500 mg once per 12 hours for infective endocarditis. Vancomycin was discontinued before the third administration for its frequency of administration was found inappropriate. The blood concentration of vancomycin was higher than 50 mg/L at 12 hours after the second dose. The blood concentration of vancomycin dropped to 9.2 mg/L after drug withdrawal and persistent peritoneal dialysis for 24 days. No other obvious adverse reactions related to vancomycin during this period.
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