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OBJECTIVE To evaluate the bioequivalence of a single oral administration of two palbociclib preparations in healthy subjects under fasting and fed conditions. METHODS Twenty-four healthy subjects （fasting test） and twenty healthy subjects （fed test） were enrolled and divided into two groups. A single-center， open-label， single-dose， two-formulation， two- period， two-sequence and crossover trial was designed. The subjects in the two groups were given the test preparation （domestic Palbociclib capsules） or the reference preparation （original Palbociclib capsules） orally under fasting or fed conditions respectively followed by a 14-day washout period. The blood samples were collected at different time points before and after treatment. After pretreatment， the mass concentration of palbociclib in vivo was determined by high-performance liquid chromatography-tandem mass spectrometry with palbociclib-d8 as the internal standard. SAS V9.4 software was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence. RESULTS Under fasting condition， the cmax of the test preparation and the reference preparation were （71.4±18.1） and （73.8±19.0） ng/mL； AUC0－t were （1 754±412） and （1 793±448） h·ng/mL； AUC0－∞ were （1 851±456） and （1 887±478） h·ng/mL， respectively. Under fed condition， the cmax of the test preparation and the reference preparation were （78.4±18.3） and （81.9±21.7） ng/mL； AUC0－t were （1 905±375） and （1 932±318） h·ng/mL； AUC0－∞ were （2 027±411） and （2 050±342） h·ng/mL， respectively. The 90%CI of the geometric mean ratio of the above parameters was within the acceptable range （80.00%-125.00%）. Under fasting and fed conditions， there were 20 and 16 adverse events in 9 and 8 subjects， respectively， but no serious adverse event was observed. CONCLUSIONS Under the fasting and fed conditions， the test preparation and the reference preparation of Pibociclib capsules are bioequivalent and have comparable safety.
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Objective To evaluate the perfusion findings of solitary brain metastasis using MR arterial spin labeling (ASL)imaging,and make a comparison with dynamic susceptibility contrast (DSC)imaging.Methods Twenty-three patients with pathologically proven solitary brain metastasis from lung cancer underwent ASL and DSC imaging.The ASL cerebral blood flow (CBF),DSC regional CBF (rCBF)and DSC regional cerebral blood volume (rCBV)were measured and compared between the tumor and the contralateral brain parenchyma.Pearson correlation test was performed to assess the relations between ASL and DSC measurements.Results Brain metastasis showed ring-like hyper-perfusion on ASL and DSC mappings.ASL CBF values of the tumor and the contralateral brain parenchyma were(54.872±21.131)mL·min-1·100 g-1and (21.109±4.788)mL·min-1·100 g-1,respectively (P<0.01).DSC rCBF values of the tumor and the contralateral brain parenchyma were (1.094 8±0.309 3)mL·min-1·100 g-1and (0.495 7±0.154 1)mL· min-1·100 g-1,respectively (P<0.01).DSC rCBV values of the tumor and the contralateral brain parenchyma were (1.753 1±0.545 5)mL/100 g and (0.729 9±0.215 8)mL/100 g,respectively (P<0.01).There was a strong correlation between ASL CBF and DSC rCBF (r=0.898,P<0.01),and there was no correlation between ASL CBF and DSC rCBV.Conclusion ASL can evaluate the CBF of brain metastasis as DSC dose. It requires no contrast agent administration and can be used in daily clinical practice.
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BACKGROUND: Current treatmemt strategy cannot efficiently relieve or reverse the disk degeneration, and neither surgical treatment nor nonsurgical treatment has gained satisfactory long-term effect. Therefore, more and more researches have focused on the cell therapy. OBJECTIVE: To explore the present states and application prospect of cell therapy, especially stem cells for degenerative intervertebral disc repair.METHODS: A computer-based search for related articles in PubMed database published between January 2011 and January 2016 using the English keywords of stem cell, intervertebral disk degeneration. Literatures addressing cell therapy for degenerative intervertebral disc repair were selected, and the articles published lately or original researches in authoritative journals were preferred.RESULTS AND CONCLUSION: A total of 205 articles were selected firstly, and 50 eligible articles were enrolled finally in accordance with the inclusion criteria. The mixtures of stem cells and carrier are injected into the degenerative intervertebral disk, to repair or displace abnormal cells. This strategy has been accepted by many researchers, and considered as a promising treatment. However, there is little evidence about the safety of clinical treatment with cell therapy, which still needs to be explored in depth.
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<p><b>OBJECTIVE</b>To explore the molecular biology mechanism of acupuncture on improving immune function damage induced by chemotherapy in cancer-bearing mice.</p><p><b>METHODS</b>Seventy-two mice (36 mice in 3-day treatment and 5-day treatment, respectively) which were successfully made into cancer-bearing model were divided into a blank group, a model group, an acupuncture group and a moxibustion group by stratified randomization method, 9 mice in each one. Except for the mice in the blank group, the remaining mice were treated with intra-peritoneal injection of cyclophosphamide (CTX, 150 mg/kg), to establish the cancer-bearing mice of CTX. The mice in the blank group were treated with intraperitoneal injection of 0.9% NaCl (identical dose as other groups). After 4 h, the mice in the acupuncture group and moxibustion group were treated with acupuncture and moxibustion at "Dazhui" (GV 14), "Geshu" (BL 17), "Shenshu" (BL 23), "Zusanli" (ST 36), once a day. The mice in the blank group and model group were treated with immobilization and fixation during the same time. On the next day of the end of 3-day and 5-day treatment, the sample was collected. The ELISA method was applied to measure the contents of IL-12 and TNF-α in spleen of all the mice.</p><p><b>RESULTS</b>After 3-day and 5-day treatment, compared with the blank group, the contents of IL-12 and TNF-α in spleen in the model group were reduced (all P < 0.05); compared with the model group, the contents of IL-12 and TNF-α in spleen in the acupuncture group and moxibustion group were increased (all P < 0.05), but the content of IL-12 and TNF-α in the acupuncture group was not different from that in the moxibustion group (both P > 0.05).</p><p><b>CONCLUSION</b>Acupuncture and moxibustion could effectively increase the contents of IL-12 and TNF-α in spleen of CTX cancer-bearing mice, which could relieve chemotherapy-induced immune function damage to improve immune function.</p>
Subject(s)
Animals , Humans , Male , Mice , Acupuncture Therapy , Cyclophosphamide , Interleukin-12 , Genetics , Metabolism , Moxibustion , Neoplasms , Genetics , Metabolism , Therapeutics , Spleen , Metabolism , Tumor Necrosis Factor-alpha , Genetics , MetabolismABSTRACT
Objective:To observe the therapeutic effect of ‘Three Steps to Regulate Qi Method’ tuina for infantile cough. Methods:Fifty-one children with cough were enrolled and received ‘Three Steps to Regulate Qi Method’ tuina, once a day for 5 d. The effects were observed after 5 treatments. Results:There was no dropout case during the process. Among the 51 infantile patients, 37 cases were cured, 14 cases were improved, and the total effective rate was 100%. Conclusion:'Three Steps to Regulate Qi Method’ tuina is an effective, simple and convenient method for infatile cough and worth spreading in clinical application.