ABSTRACT
<p><b>BACKGROUND</b>To evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Ninety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4×10⁶U/m ² was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy.</p><p><b>RESULTS</b>Of the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62% (20/42) in the trial group and 19.05% (8/42) in the control group (P=0.002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P > 0.05). The side effects related to nrhTNF included slight fever, cold like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy.</p><p><b>CONCLUSIONS</b>The results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.</p>
ABSTRACT
<p><b>BACKGROUND</b>To evaluate and compare the effects and toxicity of the domestic product of recombinant mutant human tumor necrosis factor (rmhTNF) combined with chemotherapy and chemotherapy alone in the treatment of patients with non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Two hundred patients with NSCLC in multicenter were randomly devided into trial group (150 cases) and control group (50 cases). Chemotherapy with CAP regimen was given to the patients. Meanwhile, rmhTNF injection of 4×10⁶U/m² was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy cycle in the trial group. The control patients received chemotherapy alone. Twenty-one days were as a cycle, 2 cycles were given to each patient. The chemotherapeutic effects and toxicity were observed and compared between the two groups after the therapy.</p><p><b>RESULTS</b>of the 200 patients, 5 cases in the trial group and 3 cases in the control group were out of the trial because of economy. The other 192 cases (145 cases in the trial group and 47 cases in the control group) could be analyzed and evaluated the clinical effects and toxicity. The response rate of chemotherapy was 46.90% (68/145) in the trial group and 17.02% (8/47) in the control group respectively ( P =0.001). The KPS scores was 86.02±9.74 in the trial group, and 80.14±9.10 in the control group ( P =0.025). No significant difference of degree III+IV toxicity was observed between the two groups ( P > 0.05). The side effects related to rmhTNF included slight fever, cold-like symptoms, pain and red and swelling in the injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. There were no severe abnormality of liver and kidney function and ECG in both groups.</p><p><b>CONCLUSIONS</b>The results demonstrate that the effects of domestic rmhTNF combined with chemotherapy are remarkably higher than that of chemotherapy alone in the treatment of NSCLC. rmhTNF can increase the sensitivity to chemotherapy and improve the quality of life of the patients with slight toxicity. Hence rmhTNF is worth expanding clinical use.</p>
ABSTRACT
Objective To evaluate the performances of glucose oxidase immobilized on hydrophilic-hydrophobic silica gel, which may be employed to prepare glucose sensor for the determination of glucose in body fluids. Methods The silica gel was prepared from precursors ?-aminopropyltrimethoxysilane (APTMOS) and methyltrimethoxysilane (MTMOS) by sol-gel technique. Glucose oxidase (GOD) was covalently attached to the silica gel via carbodiimide coupling reaction between a carboxylic acid group on enzyme and an amine group of the silica gel under the participation of the linking reagents 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride and N-hydroxysuccinimide. The performances of immobilized GOD were explored. Results The optimum conditions were obtained as follows: volume fraction of APTMOS 70%, enzyme content given 16 800 U, the temperature of 35 ℃ and buffer pH 5.5. The decrement in the activity of immobilized GOD for the first 2 weeks was less than 10% of its original activity, and the activity of immobilized GOD retained more than 75% of its original activity after 1 month of testing. Six independently prepared immobilized GOD on the silica gel resulted in an average bioactivity of 1 290.9 ?mol?min -1?g -1 with an R.S.D. of 3.4%. The Michaelis constant (K m) of immobilized GOD was 9.1 mmol?L -1. Conclusion Immobilizing GOD on the silica gel via the formation of peptide bonds is an outstanding enzyme immobilization method.