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OBJECTIVE To analyze the effects of centralized volume-based procurement policy （hereinafter referred to as “centralized procurement”） on the use of anti-tumor drugs in medical institutions. METHODS The interrupted time series model was used to analyze the changes in the monthly purchase volume and purchase amount of docetaxel， gemcitabine and pemetrexed disodium in a third-grade class-A cancer hospital in Shanxi province from January 2018 to December 2021. RESULTS & CONCLUSIONS After the implementation of the centralized procurement policy， both the selected drugs and the non-selected drugs had different degrees of price reduction， and the price reduction of the selected drugs was far greater than that of the non- selected drugs； average monthly purchase volume and amount of docetaxel decreased significantly in that month after the implementation of the policy， while those of gemcitabine and pemetrexed disodium increased significantly （P＜0.05 or P＜0.01）. After the implementation of the policy， the average monthly purchase volume and amount of gemcitabine showed a downward trend， while those of docetaxel and pemetrexed disodium showed an upward trend （P＜0.05 or P＜0.01）. It is suggested that hospitals should strengthen pharmaceutical administration， and avoid adopting a “one size fits all” approach to non-selected drugs； relevant departments should further expand the collection range of anti-tumor drugs or carry out special collection of anti-tumor drugs， so as to save medical insurance funds and reduce medical expenses.
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The method of homogeneity evaluation for active pharmaceutical ingredient (API) spatial distribution in lyophilized product was investigated for the first time with confocal micro-Raman spectroscopy mapping, using pemetrexed disodium for injection as a model drug. Certain areas of the lyophilized product were scanned to obtain Raman spectra. The classical method ("peak clipping" method) was employed for mapping with characteristic Raman peaks of the API and the excipient. Due to the API being finely dispersed in the excipient in lyophilized products, the classical method cannot discriminate between the two ingredients making the distribution homogeneity difficult to evaluate. The "ratio of characteristic peak intensities" method was then utilized. Using this method, the relative intensity of the characteristic Raman peaks of the API to the excipient was applied for mapping and the relative content of API to excipient was calculated for a homogeneity evaluation of the drug distribution. The validation of this method showed a good linear relationship between the relative intensity and the relative content of API to excipient (r2 > 0.99), and the precision and recovery were adequate for homogeneity evaluation of API by Raman spectroscopy mapping. Five products of pemetrexed disodium for injection from different manufacturers were tested through Raman maps applying this method and the histograms of relative Raman intensity were also plotted by frequency to help the homogeneity evaluation of drug distribution. The results showed that there were obvious differences in the drug distribution homogeneity from different products, where a more homogeneous API distribution was found in the brand product. This research provides a reliable method for the homogeneity evaluation of API distribution, which facilitates quality evaluation and process optimization of lyophilized products.
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Objective To investigate the clinical efficacy of pemetrexed disodium, carboplatin and psychological intervention in the treatment of elderly patients with advanced non-small cell lung cancer. Methods 92 cases of elderly patients with advanced non-small cell lung cancer from February 2015 to February 2017 were randomly divided into study group (n=46) and control group (n=46) by the single and double number (hospital admission order).The control group was treated with carboplatin and pemetrexed disodium treatment, the study group was treated with carboplatin and pemetrexed disodium, combined with psychological intervention treatment, effects of treatment in elderly patients with advanced non-small cell lung cancer between two groups were recorded. Results The total effective rate of the study group (67.39%) was significantly higher than the control group (47.83%)with statistical significance (P<0.05), it suggested that the clinical efficacy of the study group in elderly patients with advanced non-small cell lung cancer is better. Conclusion The application of pemetrexed disodium, carboplatin, combined with psychological intervention treatment for elderly patients with advanced non-small cell lung cancer patients could significantly improve clinical efficacy, has positive significance to guarantee the quality of life of patients and life safety.
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Objective To investigate the clinical efficacy of pemetrexed disodium, carboplatin and psychological intervention in the treatment of elderly patients with advanced non-small cell lung cancer. Methods 92 cases of elderly patients with advanced non-small cell lung cancer from February 2015 to February 2017 were randomly divided into study group (n=46) and control group (n=46) by the single and double number (hospital admission order).The control group was treated with carboplatin and pemetrexed disodium treatment, the study group was treated with carboplatin and pemetrexed disodium, combined with psychological intervention treatment, effects of treatment in elderly patients with advanced non-small cell lung cancer between two groups were recorded. Results The total effective rate of the study group (67.39%) was significantly higher than the control group (47.83%)with statistical significance (P<0.05), it suggested that the clinical efficacy of the study group in elderly patients with advanced non-small cell lung cancer is better. Conclusion The application of pemetrexed disodium, carboplatin, combined with psychological intervention treatment for elderly patients with advanced non-small cell lung cancer patients could significantly improve clinical efficacy, has positive significance to guarantee the quality of life of patients and life safety.
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OBJECTIVE:To establish the method for the determination of pemetrexed disodium in human plasma. METHODS:The plasma sample was determined by HPLC after protein were precipitated with strong acid. The determination was performed on Xterra?RP 18 column with mobile phase consisted of acetonitrile-50 mmol/L sodium dihydrogen phosphate buffer solution(15∶85) at the flow rate of 1.2 ml/min. The detection wavelength was set at 225 nm. RESULTS:The linear range of pemetrexed disodium were 1.0-32.0 mg/L (r=0.999 9,n=5) with recoveries of 86.35%-87.25%. RSDs of inter-day and intra-day were lower than 4.21%(n=5). Minimum detection concentration of plasma was 0.05 mg/L. The patients with high plasma concentration easily suf-fered from arrest of bone marrow. The plasma concentration was(18.56±4.50)mg/L,which could induce ADR;when the plasma concentration was (14.05 ± 6.72) mg/L,no ADR was found. There was statistical significance after t-test (P<0.05). CONCLU-SIONS:The method is simple,quick,accurate,sensitive and suitable for the plasma concentration determination of pemetrexed di-sodium and human pharmacokinetics study.
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Objective:A study was conducted to observe and compare the efficacy and safety of endostar combined with peme-trexed in elderly patients with advanced lung adenocarcinoma. Methods:Sixty advanced lung adenocarcinoma (ⅢB-Ⅳ) patients who never received any therapy were included. The patients were divided into two groups. One group comprised endostar treatment com-bined with pemetrexed (26 cases of males, 15 cases of females, and 11 cases of individuals aged 65 years old to 78 years old), and the other group comprised pemetrexed only (34 cases of males, 20 cases of female, and 14 cases of individuals aged 65 years old to 78 years old). The two groups were treated for 4 to 6 cycles, and evaluation of treatments was performed every two cycles. Results:The endostar group was re-treated for 80 cycles, and the average cycle was 3.1. The group without endostar was re-treated for 115 cycles. The short-term effects are as follows. The total effective rates (RRs) in the experimental and control groups were 23.1%and 14.7%, re-spectively, and the difference was statistically significant (P0.05). For pleural effusion, RR and DCR were significantly better in the experimental group than in the control group (P0.05). Conclusion: Endostar combined with pemetrexed showed increase in total efficiency in elderly patients with lung adenocarcinoma, and malignant pleural effusion was controlled without increasing the toxicity of chemotherapy. MVD can be used as a predictor of Endostar application.
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Objective: Pemetrexed (PEM) is a multi-targeted chemotherapeutic agent for antifolate drugs. PEM has become the standard agent for the second-line treatment of advanced non-small cell lung cancer (NSCLC). This study aims to review and analyze the clinical efficacy and adverse reactions of PEM combined with carboplatin with respect to NSCLC treatment. Methods: A total of 40 patients suffering from NSCLC were selected and confirmed by pathology. On the first day of treatment, the conventional 500 mg/m2 dose of pemetrexed disodium was infused intravenously. On the second day, a combined therapy with carboplatin was conducted based on the conventional dose for a 21-day cycle with at least two cycles for each patient. The therapeutic efficacy and adverse reactions were evaluated and were compared with the proposed regimen of gemcitabine (GEM) combined with carboplatin. Results: After two cycles of the treatment, the curative effects of the PEM and GEM groups were 50% and 45%, respectively. The main adverse reactions are bone marrow suppression and gastrointestinal reactions. The incidence rates of bone marrow suppression, gastrointestinal reactions, amisulpride/AST, urea nitrogen, rash, and hair loss were obviously lower in the PEM group than in the GEM group. Statistically significant differences in adverse reaction were found between the two groups (P<0.05). Conclusion: The use of the combination regimen of PEM with carboplatin showed significantly more clinical effects and less adverse reactions for NSCLC treatment.
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Objective To evaluate the efficacy and drug-related toxicities of pemetrexed disodium in the treatment of advanced pulmonary adenocarcinoma.Methods A total of 41 patients who had received pemetrexed disodium and cisplatin therapy were retrospectively reviewed.The patients were given respectively pemetrexed disodium (500 mg/m2,1st day) and cisplatin (200 mg/m2,1-4 day) until disease progressed.The clinical outcomes and adverse reactions were observed.Results The CR rate was 7.3 ％ (3/41),PR rate was 22.0 ％ (9/41),SD rate was 31.7 ％ (13/41),PD rate was 39.0 ％ (16/41),the DRR was 29.3 ％ (12/41),DCR rate was 61.0 ％ (25/41),the median PFS was 5 months.The age,sex,smoking history,staging and timing of treatment had not the statistics difference on ORR and DCR.The sex,smoking history,staging and timing of treatment had not the statistical difference on PFS (P ＞ 0.05).The main toxicities were fatigue,nausea,vomiting and myelosuppression.Conclusion The pemetrexed disodium and cisplatin are feasible and welltolerated for advanced pulmonary adenocarcinoma patients.