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OBJECTIVE: To investigate the value of population pharmacokinetics (PPK) in individualized rescue for an acute lymphoblastic leukemia (ALL) child with severe methotrexate (MTX) excretion delay, and to provide reference for clinical pharmaceutical care. METHODS: Clinical pharmacists participated in clinical rescue for an ALL child with severe MTX excretion delay. The child suffered from severe MTX excretion delay after high dose MTX (HD-MTX) chemotherapy. Clinical pharmacists used PPK model and Bayesian feedback method to predict plasma concentration of MTX. According to measured results and predicted results, rescue dose of calcium folinate (CF) was adjusted to 160 mg/time on the 6th, 7th day after admission for intravenous dripping 1 h, based on initial rescue dose (15 mg/m2, ivgtt, q6 h) of CF; on the 8 th day, CF rescue dose was adjusted to 42 mg/time; on the 9th, 10th day, CF rescue dose was adjusted to 21 mg/time; on the 11th-16th day, CF recue dose was adjusted to 10. 5 mg/ time; 4 times a day. Considering the mild impairment of renal function, clinical pharmacists proposed to discontinue omeprazole and use Cimetidine injection 0. 2 g, ivgtt, qd, for protecting stomach, and decrease the dose of Cefazidime for injection to 0. 4 g, ivgtt, tid; strengthen hydration, alkalization and oral mucosa care. RESULTS: Physicians adopted to the suggestions of clinical pharmacists. The difference between predicted value of plasma concentration of MTX and measured value was less than ± 0. 32 μmol/L. The predictive results showed favorable accuracy. After the adjustment of CF rescue plan under the guidance of PPK model, plasma concentration of MTX decreased to 0. 13 μmol/L. The child completed chemotherapy successfully and discharged from the hospital on the 18th day after admission. CONCLUSIONS: PPK theory can provide reference for clinical rescue in ALL patients with severe MTX excretion delay, and can be used as one of breakthrough points for clinical pharmacists to carry out pharmaceutical care. When the patient suffered from severe MTX excretion delay, clinical pharmacists should fully grasp the influential factors of MTX excretion, and consider the physiological and pathological conditions of the patients, drug combination and plasma concentration, so as to ensure the timely and effective rescue.
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OBJECTIVE:To investigate the compatible stability of Calcium folinate for injection mixed with Glucose injection and Sodium chloride injection. METHODS:Referring to clinical common concentration,each 3 Calcium folinate for injection (each injection was equal to calcium folinate 100 mg)were respectively mixed with Glucose injection 250 mL or Sodium chloride injection 250 mL. At room temperature,under light or dark condition,the appearance of mixtures,pH value and the number of in-soluble particles were investigated 0,1,2,3,4,6,8,12,24,36,48 h. The contents of calcium folinate in mixtures were deter-mined by HPLC. RESULTS:Under above condition,the color of the mixtures had no change,and no gas,precipitation and turbid-ity was found;there was no evident change in pH values(RSD<2%,n=11). 0 h after mixing,there was large number of parti-cles≥10 μm in mixtures,but the number of particle was decreased as time;within 48 h,the number of particles ≥10 μm and ≥25 μm in mixtures were all in line with the standard of Chinese Pharmacopeia(2015 edition). Under the protection from light con-dition,relative contents of calcium folinate in mixtures had no significant change(RSD<2%,n=11). Under light condition,rela-tive contents of calcium folinate in mixtures decreased significantly,decreasing to 94.5%(mixed with Glucose injection) and 88.4%(mixed with Sodium chloride injection). CONCLUSIONS:Calcium folinate for injection is more stable in Glucose injec-tion,and the stability of compatibility can be affected by light conditions. After mixed with Glucose injection and Sodium chloride injection,Calcium folinate for injection should be kept away from light and used as soon as possible
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OBJECTIVE:To compare the efficacy and safety of gio combined with oxaliplatin (SOX) versus 5-fluorouracil (5-FU)combined with calcium folinate and oxaliplatin(mFOLFOX6)in the treatment of diffuse advanced gastric cancer. METH-ODS:The data of 128 patients with diffuse advanced gastric cancer was retrospectively analyzed and patients were divided into SOX group(66 cases)and mFOLFOX6 group(62 cases)by different medication. SOX group received Gio capsule after breakfast and dinner,which was 1.5 m2,60 mg,d1-14+130 mg/m2 Oxaliplatin for injection,intrave-nously,d1;3-week was regarded as a treatment course,the efficacy was evaluated every 2 courses,and it lasted a maximum of 8 courses but a minimum of 2 courses. mFOLFOX6 group received 85 mg/m2 Oxaliplatin for injection,intravenously,d1+200 mg/m2 calcium folinate,intravenously,d1+400 mg/m2 5-FU for injection by rapid intravenous injection,d1,then 2 400 mg/m2 5-FU,main-taining 46 h by continuous infusion. 2-week was regarded as a treatment course,the efficacy was evaluated every 3 courses,and chemotherapy was conducted in a maximum of 12 courses but a minimum of 3 courses. Clinical efficacy,time to progression,sur-vival time and incidence of toxicities in 2 groups were observed. RESULTS:The objective response rate,time to progression and median survival time in SOX group was significantly higher than mFOLFOX6 group,the difference was statistically significant (P0.05). CONCLUSIONS:The efficacy of SOX is superior to mFOLFOX6 in the treatment of diffuse advanced gastric cancer,it can prolong the survival time,with similar safety.
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OBJECTIVE:To investigate clinical efficacy of oxaliplatin+calcium folinate+5-fluorouracil(mFOLFOX6),oxalipl-atin+capecitabine(CapeOX),irinotecan+calcium folinate+5-fluorouracil(FOLFIRI)for metastatic colorectal cancer,and to conduct cost-effectiveness analysis. METHODS:48 patients with colorectal cancer were divided into mFOLFOX6 group(30 cases),Cape-OX group(8 cases)and FOLFIRI group(10 cases). Clinical efficacy and ADR of 3 groups were analyzed,and cost-effectiveness analysis was also conducted. RESULTS:Clinical effective rates of mFOLFOX6 group,CapeOX group and FOLFIRI group were 96.67%,87.50% and 80.00%,respectively,the mFOLFX6 group was significantly higher than the other 2 groups,with statistical significance(P0.05). The C/E of mFOLFOX6 group,CapeOX group and FOLFIRI group were 11 950,15 674 and 18 397 re-spectively,to which results of sensitivity analysis were same. CONCLUSIONS:The cost-effectiveness of mFOLFOX6 regimen is superior to CapeOX and FOLFIRI regimen in the treatment of metastatic colorectal cancer,but it has the high incidence of gastroin-testinal side effects.
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A estabilidade físico-química de soluções injetáveis de folinato de cálcio (leucovorina cálcica), fluoruracila e metotrexato (Fauldleuco, Fauldfluor e Fauldmetro, respectivamente) mantidas nas suas embalagens primárias foram avaliadas após perfuração quanto ao aspecto das soluções, pH, identificação do fármaco, dosagem, material particulado e substâncias relacionadas. Os resultados demonstraram não haver alterações físico-químicas significativas após perfuração da embalagem primária quando armazenada à temperatura ambiente (20 a 25ºC) por 7 dias para as soluções injetáveis de fluoruracila e metotrexato e quando mantidas em geladeira (2 a 8ºC) por 7 dias para as soluções injetáveis de folinato de cálcio. Em todas as avaliações as amostras ficaram protegidas da luz...
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Humans , Antimetabolites , Fluorouracil , Methotrexate , Chemistry, PhysicalABSTRACT
ObjectiveTo compare the efficacy and safety of oxaliplatin combined with tegafur and calcium folinate with FOLFOX4 regimens on patients with advanced gastric cancer.Methods120 patients with advanced gastric cancer were randomly divided into two groups. concluding 60 cases in observation group (modified group)treated with oxaliplatin combined with tegafur and leucovorin and 60 cases in control group (FOLFOX4 group)treated with oxaliplatin combined with calcium folinate and fluorouracil.Clinical efficacy was evaluated after 2 (3-6) cycles. ResultsThe clinical efficacy rates of observation group and control group were 63.3 ％ (38/60) and 41.7 ％ (25/60), respectively (x2 =5.647, P =0.028). The median progression-free survival and median overall survival of patients in observation group were 7.7 months and 11.6 months,respectively,and those in control group were 7.3 months and 10.1 months,respectively.The median progression-free survival(P =0.032)and median overall survival(P =0.005)were statistically significant differences.The increased ratio of Karnofsky score of patients in observation group was higher than that in control group(P =0.015).The incidence of myelosuppression in observation group was lower than that in control group (P =0.044). There was no significant difference between the two groups on other adverse reaction rates. ConclusionThe efficacy and safety of oxaliplatin plus tegafur and leucovorin in the treatment of advanced gastric cancer is superior to FOLFOX4 regimen, and worthy of clinical application.
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OBJECTIVE:To observe the clinic efficacy and safety of FOLFIRI as a second line treatment for patients with advanced colorectal cancer.METHODS:Twenty-eight patients with advanced colorectal cancer whose disease progressed after first treatment with FOLFOX4 were included to receive the second line treatment with FOLFIRI regimen.RESULTS:Of the total 28 cases,0 had complete response,6 partial response,16 stable disease,6 progressive disease,and the responsive rate was 21.4%.The majority of adverse reaction was nausea,vomiting,leucopenia and tardive diarrhea.CONCLUSION:As a second line therapy,FOLFIRI has a confirmed therapeutic response and tolerable toxicity in patients with advanced colorectal cancer.
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OBJECTIVE:To evaluate and compare the efficacy and safety between the chronomodulated chemotherapy of oxaliplatin combined with calcium folinate and tegafur and the normal chemotherapy in the treatment of advanced gastrointestinal cancer.METHODS:A total of 63 patients with advanced gastrointestinal cancer were randomly divided into two grou_ ps:31 in chronomodulated chemotherapy regimen group were assigned to receive oxaliplatin in combination with calcium folinate and tegafur,and another 32 in normal chemotherapy regimen group to receive oxaliplatin combined with calcium folinate and fluorouracil.2 courses of treatment later(21 days/course of treatment)the short-term effects and the adverse drug reactions(ADRs)of the 2 groups were evaluated.RESULTS:The effective rates of the chronomodulated chemotherapy group and the normal group were 77.4%and 43.8%(P
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OBJECTIVE:To improve the efficacy and safety of high dose methotrexate (HDMTX)chemotherapy in the treatment of children with acute lymphoblastic leukemia through blood concentration monitoring.METHODS:27 children with acute lymphoblastic leukemia who received high dose of HDMTX (1.5～4.0 g/m2)for 55 times were involved in this study,the blood samples were collected timely and the blood concentration of methotrexate was determined,the efficacy of the chemotherapy was evaluated according to blood MTX concentration at the ending of its intravenous drip (12h),the calcium folinate relief scheme was determined from the MTX serum concentration in terminal elimination phase.RESULTS: The times for 2.0 g/m2,3.0 g/m2 and 4.0 g/m2 different dosage of methotrexate groups with blood concentration maintained above osmotic concentration(2?10-5mol/L)at the end of intravenous drip (12h)were respectively 75%,92.1%and 100%of the total chemotherapy times.Only one patient was observed with large area of impairment of skin and mucosa,and no severe irreversible adverse reaction were observed in the other cases.CONCLUSIONS: MTX serum concentration monitoring is helpful for mastering the rational rescue dosage of MTX and calcium folinate so as to ensure the efficacy and safety of the chemotherapy.
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0.05). The adverse reaction rates of the two regimen were no statistical difference. CONCLUSION: The 2-week regimen and the 3-week regimen of L-OHP combined with 5-FU/CF have the same efficacy in MCC patients.
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0 05) The progression free median duration of responsive patients was 7.1 months in Oxa CF 5 Fu group and 5.4 months in control ( P
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Purpose:To compare the therapeutic and adverse effects between continuous and intermittent infusion of fluorouracil(5-FU) in advanced colorectal cancer.Methods:17 patients of advanced colorectal cancer were treated with continuous intravenous infusion of 5-FU 2.5g in 100 ml of 5% glucose in a continuous infusions pump,for 120 h (Group A).16 patients of similar severity were treated with 5-FU 500 mg in 500 ml of 5% glucose 2 h iv daily for 5 d (Group B). Total of 33 patients were treated with calcium folinate (CF) 200 mg in 100 ml of 5% glucose 1 h iv daily for 5 d and HCPT 10 mg in 250 ml of 5% glucose 2 h iv daily for 6d.The therapeutic and adverse effects were evaluated according to the cri- teria recommended by WHO.Results:Effectiveness was noted in 9 patients in Group A and 3 patients in group B.(x~2 test P
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Purpose:To study the response and toxicity of the regimen of oxaliplatin combined with fluorouracil and calcium folinate in the treatment of consisting of advanced colorectal cancer.Methods:Thirty-seven patients with advanced colorectal cancer received chemotherapy of regimen:oxaliplatin 130 mg/m~2 2 hours iv on day 1,calcium folinate 200 mg/ m~2 iv 2 hours on days 1 to 5,followed by fluorouracil 300 mg/m~2(≤500 mg/d) iv 4 h on days 1 to 5,three or four weeks as one cycle.Results:The total response rate was 29.7%,the main toxicity was bone marrow suppression and neuro-sensory toxicity,leukopenia was observed in 45.9% of the patients,but grade Ⅲ and Ⅳ in only 8.1%,neuro-sensory toxicity was observed in 81.9.%,but grade Ⅲ and Ⅳ in only 5.4%.Conclusions:This study shows that the regimen of oxaliplatin combined fluorouracil and calcium folinate is effective and tolerable in advanced colorectal cancer therapy.
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Purpose: The aim of this study is to assess the anti tumor efficacy and safety of high dose folinic acid plus 5 fluorouracil bolus and continuous infusion 48 hours combined with cisplatin in treating advanced esophageal carcinoma. Methods:Thirty patients with advanced esophageal carcinoma were treated with high dose folinic acid plus 5 fluorouracil bolus and continuous infusion 48 hours combined with cisplatin.Results: There were two complete responses, fourteen partial responses, thirteen no changes and one progressive disease in this series with total response rate of 53.33%. The main side effects include nausea and vomiting, mucositis, bone marrow suppression and alopecia. Other side effects were uncommon. All side effects were tolerable and mild except for nausea vomiting. Conclusions: High dose folinic acid plus 5 fluorouracil bolus and continuous infusion 48 hours combined with cisplatin may be a safe and effective therapy for the patients with advanced esophageal carcinoma.