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@#Objective To express recombinant human interferon λ1(rhIFNλ1)by transient transfection in HEK-293F cells and identify it. Methods Two signal peptides[T cell receptor(TCR)and nature signal peptide(NSP)],three vectors[pcDNA3.4,ubiquitous chromatin opening element(UCOE)and PFR]and the target gene rhIFNλ1 were used to construct recombinant plasmids of six signal peptide-vector combinations. Using HEK-293F as host cells,the recombinant plasmids were transfected transiently to express rhIFNλ1 on a shake flask scale. The recombinant plasmid UCOE-Q46-λ with low glycosylation rhIFNλ1 was constructed by using NSP and vector UCOE,and transfected transiently into HEK-293F cells. The expressed product was purified by cation exchange chromatography(HiTrap SP FF),blue gel chromatography(HiTrap Blue HP)and gel filtration chromatography(Sephacryl S-100 HR),which was then analyzed by Western blot and reversed-phase HPLC,and determined for its molecular mass and N-terminal amino acid sequence by mass spectrometry. Results Six recombinant plasmids were constructed correctly as identified by double enzyme digestion and sequencing. With the extension of transfection time,the expression levels of the six expressed products increased gradually,and reached the highest level of10 ～ 20 mg/L at the 6th day of transfection. Double enzyme digestion and sequencing identification proved that the recombinant plasmid UCOE-Q46-λ with low glycosylation rhIFNλ1 was constructed correctly. The recombinant plasmid UCOE-Q46-λwas transfected into HEK-293F cells for 6 d. The purified product of cell culture supernatant showed a relative molecular mass of about 27 800 and a purity of 97. 372%,which showed specific binding to mouse anti-human IL-29/IFNλ1 monoclonal antibody;Two peaks were detected by reversed-phase HPLC,and the peak was showed at 15. 6 min and 20. 0 min respectively;The mass spectrometry molecular mass was about 24 000;The N-terminal five amino acids were G-P-V-P-T.Conclusion The rhIFNλ1 expressed by HEK-293F cells has high purity,which lays a foundation of further study of the protein.
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@#Objective To investigate the effects of recombinant human interferon α2a(rhIFNα2a) suppository on the levels of inflammatory factors in the cervical mucus of patients infected with human papillomavirus(HPV).Methods A total of60 HPV-positive patients admitted to the Second Affiliated Hospital of Xi'an Jiaotong University from March to August in 2022 were selected as study objects,and then divided into observation and control groups,30 cases for each group,according to the random number table method.The observation group was given rhIFNα2a suppository therapy by vaginal medication,once every other day,continuous 10 times a month as a course of treatment,and 3 consecutive courses of treatment.The control group did not use drugs.The cervical secretions were collected and the levels of IL-1β,IL-2R,IL-6,IL-8,IL-10 and tumor necrosis factor-α(TNF-α) were measured by chemiluminescence assay.Results After 3 months of treatment,the levels inflammatory factors IL-1β,IL-6,IL-8 and TNF-α in cervical mucus of patients in the observation group were significantly lower than those in the control group(t=-2.717,-2.686,-3.178 and-3.25,respectively,each P <0.05).Compared with before treatment,the levels of IL-1β,IL-6,IL-8 and TNF-α in cervical mucus of patients in the observation group also decreased significantly(t=5.934,4.092,6.495 and 3.287,respectively,each P <0.01),while in the control group,only the level of IL-8 in cervical mucus was significantly different(t=2.345,P=0.024).Conclusion rhIFNα2a suppository can reduce the level of inflammatory factors in cervical mucus,attenuate the inflammatory response and accelerate the clearance of HPV.
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Objective:To analyze the incidence of human papillomavirus (HPV) infection in 1 902 patients and to evaluate the efficacy of drug treatment in 266 patients, aiming to provide reference for the treatment of HPV infection.Methods:The subtypes of HPV isolated from 1 902 patients aged 15-86 years visiting the venereology outpatient clinic of Tianjin Medical University General Hospital from October 2019 to May 2021 were identified by polymerase chain reaction-reverse dot blot hybridization. Drug treatment efficacy in 266 patients of them was retrospectively analyzed.Results:The overall incidence of HPV infection in the 1 902 patients was as high as 53.84% (1 024/1 902). It was 52.60% (689/1 310) in males and 56.59% (335/592) in females. There was no significant difference in the incidence between males and females ( P>0.05). The most common HPV genotype in males and females was HPV6 [15.27% (200/1 310) and 21.96% (130/592)], followed by HPV16 [10.61% (139/1 310) and 9.46% (56/592)], HPV11 [9.31% (122/1 310) and 8.61% (51/592)], HPV52 [6.79% (89/1 310) and 8.95% (53/592)] and HPV43 [5.64% (87/1 310) and 8.45% (50/592)]. The majority of HPV-positive patients were aged between 20 and 39 years. There were 476 cases (25.03%, 476/1 902) of single-type infection and 548 cases (28.81%, 548/1 902) of multiple infection. The incidence of multiple infection was higher than that of single-type infection ( P<0.05). The incidence of multiple infection in females was higher than that in males ( P<0.05). Among the 266 patients, 106 were treated with Paiteling, a traditional Chinese medicine (TCM) preparation, and 68 of them tested negative (64.15%) after treatment. Fifty-eight patients were treated with recombinant human interferon α2b and 22 of them (37.93%) tested negative after treatment. Twenty out of the 56 subjects treated with imiquimod tested negative after treatment. Eight out of the 46 patients without treatment also turned negative. Conclusions:The incidence of HPV infection in the 1 902 patients visiting the venereology outpatient clinic was very high, and most of them were young adults. Multiple infection was more common than single-type infection. Topical application of drugs such as Paiteling, recombinant human interferon α2b and imiquimod was effective in treating HPV infection.
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Recombinant human interferon α2b(rhIFNα2b)is widely used as an antiviral therapy agent for the treatment of hepatitis B and hepatitis C.The current identification test for rhIFNα2b is complex.In this study,an anti-rhIFNα2b nanobody was discovered and used for the development of a rapid lateral flow strip for the identification of rhIFNα2b.RhIFNα2b was used to immunize an alpaca,which established a phage nanobody library.After five steps of enrichment,the nanobody I22,which specifically bound rhIFNα2b,was isolated and inserted into the prokaryotic expression vector pET28a.After subsequent purification,the physicochemical properties of the nanobody were determined.A semiquantitative detection and rapid identification assay of rhIFNα2b was developed using this novel nanobody.To develop a rapid test,the nanobody I22 was coupled with a colloidal gold to produce lateral-flow test strips.The developed rhIFNα2b detection assay had a limit of detection of 1 μg/mL.The isolation of I22 and successful construction of a lateral-flow immunochromatographic test strip demonstrated the feasibility of performing ligand-binding assays on a lateral-flow test strip using recombinant protein products.The principle of this novel assay is generally applicable for the rapid testing of other com-mercial products,with a great potential for routine use in detecting counterfeit recombinant protein products.
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Abstract Objective: To investigate the impact of recombinant human interferon α1b (rhIFNα1b) treatment in infants hospitalized with lower respiratory tract infections on subsequent wheezing. Methods: The clinical data of infants (n = 540) with viral pneumonia, wheezy bronchitis, or bronchiolitis hospitalized in 19 Chinese hospitals from June 2009 to June 2015 were retrospectively analyzed. The parameters relevant to wheezing episodes within the last year were collected by telephone and questionnaires. The rhIFNα1b treatment group (n = 253) and control group (n = 287) were compared in terms of wheezing episodes within the last year. Moreover, the wheezing group (95 cases) and non-wheezing group (445 cases) were compared. Results: Out of 540 cases, 95 (17.6%) experienced wheezing episodes, 13.8% (35/253) cases treated with rhIFNα1b, and 20.9% (60/287) cases without rhIFNα1b experienced wheezing episodes within the last year. The rhIFNα1b treatment significantly improved wheezing episodes within the last year, compared with the control peers (p = 0.031). Single-factor regression showed statistically significant differences between the wheezing and non-wheezing groups in terms of age, rhIFNα1b use, childhood and family history of allergy, housing situation, and feeding history (p < 0.05). Binary logistic regression showed a childhood history of allergy (OR = 2.14, p = 0.004), no rhIFNα1b use (OR = 1.70, p = 0.028), and living in a crowded house (OR = 1.92, p = 0.012) might be risk factors of subsequent wheezing. Accordingly, breastfeeding (OR = 0.44, p = 0.008) and hospitalization age of 1-year-old (OR = 0.58, p = 0.024) were protective factors. Conclusions: Early use of rhIFNα1b in infants hospitalized with lower respiratory tract infections and breastfeeding could prevent subsequent wheezing. Living in a crowded house could promote subsequent wheezing.
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Humanos , Femenino , Lactante , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Bronquiolitis , Ruidos Respiratorios , Estudios Retrospectivos , Factores de Riesgo , InterferonesRESUMEN
OBJECTIVE：To inv estigate therapeutic efficacy and safety of recombinant human interferon gel combined with Baofukang suppository in the treatment of cervical high-risk human papillomavirus （HPV）infection. METHODS ：Totally 259 patients with persistent high-risk HPV infection diagnosed and treated in gynecology department of the First Affiliated Hospital of Hainan Medical University from Aug. 2017 to Sept. 2019 were selected and divided into interferon group （n＝82），Baofukang suppository group （n＝86）and combination group （n＝91）according to random number table. The patients in interferon group and Baofukang suppository group were given Recombinant human interferon α2b gel 1 g, qd or Baofukang suppository 1 capsule，qd； the patients in combination group were given Recombinant human interferon α2b gel and Baofukang suppository 1 capsule，qd；for 3 months. Then the clinical efficacy ，negative time of HPV ，duration of abnormal secretion ，LCT test results ，cervical inflammation score ，HPV relative light unit/critical value （RLU/CO）and the incidence of ADR were recorded. RESULTS ：The total effective rate of combination group was significantly higher than that of interferon group and Baofukang suppository group ， the negative time of HPV and duration of abnormal secretion in combination group were significantly shorter than interferon group and Baofukang suppository group （P＜0.05）. Before treatment ，the normal rate of LCT of 3 groups were 0，and there was no statistical significance in cervical inflammation score and HPV RLU/CO among 3 groups（P＞0.05）. After treatment ，normal rate of LCT was increased in 3 groups，compared with before treatment （P＜0.05），and normal rate of LCT in combination group was significantly higher than interferon group and Baofukang suppository group. The cervical inflammation score and HPV RLU/CO were significantly lower than before treatment ，and the combination group was significantly lower than interferon group and Baofukang suppository group （P＜0.05）. There was no statistical significance in above indicatora after treatment betwent interferon group and Baofukang suppository group and the incidence of ADR among 3 groups during medication （P＞0.05）. CONCLUSIONS：The application of recombinant human interferon gel combined with Baofukang suppository is effective and safe way in the treatment of cervical high-risk HPV infection.
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Objective: To investigate the aerodynamic characteristics of the nebulized recombinant human inter- feron α1b(rhIFN α1b)injection and its delivery in different respiratory modes both in vitro. Methods: The particle size distribution and aerodynamic properties of the nebulized rhIFN α1b injection for inhalation were evaluated with Spraytec STP5313 and the next generation pharmaceutical impactor(NGI). The total delivered dose and delivery rate were deter- mined using a breathing simulator. Results:After atomization, the D50 of rhIFN α1b droplets was 2.74 μm, the fine par- ticle fraction(FPF)was 77.49%, the mass median aerodynamic diameter(MMAD)was 3.26 μm, and the geometric standard deviation(GSD)was 1.93. In neonatal, infant, and child breathing modes, the delivered total amount of rhIFN α1b by spraying for 220 seconds was 2.10, 2.44, and 3.51 μg, respectively. Conclusion: After atomization, the particle size of rhIFN α1b injection was small enough to be transmitted to the lung, and the total delivered dose and delivery rate showed a tendency of increase in turn in the neonatal, infant, and child breathing modes, indicating that the effective dose of the drug and the age of patients should be considered when formulating the clinical treatment plan.
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Objective@#To investigate the effects of recombinant human interferon alpha 2b injection(P.putida)and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation.@*Methods@#Rats were randomly divided into two groups(hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group).5 million IU/ml recombinant human interferon alpha 2b injection or 6% hydroxyethyl starch 40 injection were given respectively, which were diluted with 0.9% sodium chloride injection in a radio of 1: 2.Both groups were given aerosol inhalation for 30 minutes once a day for 14 days.Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed.During the drug administration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week.At the end of drug administration and the end of recovery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determination, and histopathological examination were performed.@*Results@#The mass median aerodynamic diameter(MMAD)of the drug mist was 3.56 μm, and the geometric standard deviation(GSD)was 1.84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation.No abnormality in clinical signs, body weight and food consumption, hematology and blood biochemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity(paranasal sinus), larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other organs or tissues examined.@*Conclusion@#Results suggest the drug particle size of recombinant human interferon alpha 2b injection(pseudomonas)can reach the lower respiratory tract and deposit in the lower respiratory tract.Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.
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Objective To investigate the effects of recombinant human interferon alpha 2b injection ( P. putida) and hydroxyethyl starch inhalation on physiological indexes and tissues and organs of SD rats, such as lungs, trachea and bronchus, and thus to explore the safety of the drug and excipients for inhalation. Meth-ods Rats were randomly divided into two groups ( hydroxyethyl starch 40 group and recombinant human inter-feron alpha 2b group). 5 million IU/ml recombinant human interferon alpha 2b injection or 6％ hydroxyethyl starch 40 injection were given respectively, which were diluted with 0. 9％ sodium chloride injection in a radio of 1: 2. Both groups were given aerosol inhalation for 30 minutes once a day for 14 days. Within 14 days after administration, the behavior of rats and the degree of toxicity were continuously observed. During the drug ad-ministration and recovery period, the clinical signs of the rats in each group were observed daily, and the body weight and food consumption were measured once a week. At the end of drug administration and the end of re-covery period, hematology test, blood biochemical test, gross anatomical observation, organ weight determi-nation, and histopathological examination were performed. Results The mass median aerodynamic diameter ( MMAD) of the drug mist was 3. 56 μm, and the geometric standard deviation ( GSD ) was 1. 84 μm, which met the particle size requirements of arrival and deposition in the lower respiratory tract via atomization inhalation. No abnormality in clinical signs, body weight and food consumption, hematology and blood bio-chemical indexes were found in hydroxyethyl starch 40 group and recombinant human interferon alpha 2b group.No abnormal histopathological changes were observed in oral mucosa, tongue, nasal cavity ( paranasal sinus) , larynx, trachea, main bronchial tube, lung, heart, liver, spleen, kidney, reproductive system and other or-gans or tissues examined. Conclusion Results suggest the drug particle size of recombinant human interferon alpha 2b injection (pseudomonas) can reach the lower respiratory tract and deposit in the lower respiratory tract. Continuous atomization inhalation for 14 days has a good safety, and the excipient hydroxyethyl starch 40 has a high safety.
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Recombinant human interferon beta 1b (rhIFNß-1b) is clinically used to treat multiple sclerosis. A reversed-phase liquid chromatography (RP-LC) method was carried out on a Jupiter C4 column (250 mm × 4.6 mm i.d.). The mobile phase A consisted of 0.1% trifluoroacetic acid (TFA) in water, and the mobile phase B was acetonitrile with 0.1% TFA run at a flow rate of 1.0 mL/min. A size exclusion liquid chromatography (SE-LC) method was carried out on a BioSep-SEC-S 2000 column (300 mm × 7.8 mm i.d.). The mobile phase consisted of 1 mM monobasic potassium phosphate, 8 mM sodium phosphate dibasic and 200 mM sodium chloride buffer pH 7.4, run isocratically at a flow rate of 0.8 mL/min. Retention times were 31.87 and 17.78 min, and calibration curves were linear over the concentration range of 1-200 µg/mL (r2 = 0.9998) and 0.50-200 µg/mL (r2 = 0.9999), respectively, for RP-LC and SE-LC, with detection at 214 nm. Liquid chromatography (LC) methods were validated and employed in conjunction with the in vitro bioassay to assess the content/potency of rhIFNß-1b, contributing to improve the quality control and to ensure the efficacy of the biotherapeutic
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Bioensayo/métodos , Humanos , Cromatografía de Fase Inversa/métodos , Interferon beta-1b/análisis , Técnicas In Vitro , Biotecnología/clasificación , Estudio de ValidaciónRESUMEN
Objective To evaluate the curative effect of recombinant human Interferon α2b (rhIFN α2b) spray in hand,foot and mouth disease (HMFD).Methods In total,313 HMFD children were enrolled from Beijing Ditan Hospital affiliated to Capital Medical University,Tianjing Second People's Hospital,Hebei Children's Hospital,the Second Hospital affiliated to Wenzhou Medical College,Kunming Maternal and Child Health Hospital and Guiyang Public Health Treatment Center from March,2015 to February,2017.They were divided into rhIFN α2b group (148 cases) and ribavirin group (165 cases).The children in rhIFN α2b group were given with the rhIFN α2b spray,and those in ribavirin group were given with the ribavirin spray.Meanwhile,the children were given unified standard interventions for basic treatment.The curative effect and safety between two groups was compared.The t test was used for intergroup comparison and the Wilcoxon rank test was used for non-normal quantitative data.Results At the end of the follow-up period,all kids reached the recovery level,with 144 cases in the rhIFN α2b group and 164 cases in the ribavirin group.Fever,herpes and rashes all disappeared with 7-day follow-up.The total efficiency of the rhIFN α2b group measured at the 72h after treatment was 74.15％,which showed significant differences compared with the ribavirin group with 49.09 ％ efficiency (Z=4.44,P＜0.01).As the secondary outcome measures,the complete disappearance time of fever and the immediate disappearance time of fever in the rhIFN α2b group were significantly shorter than those in the ribavirin group ([27.03±21.99] vs [33.21±26.71],t=-2.13;[23.56±13.96] vs [28.51±18.84],t=-2.07,both P＜0.05).The appetite improvement and the disappearance times of oral herpes and rashes in the rhIFN α2b group were shorter than those in the ribavirin group,with significant differences (x2 =4.94,3.17 and 3.55,respectively,all P=0.000).No adverse event in both groups.Conclusions rhIFN α2b spray treatment in HMFD is proved significantly effective,particularly,it can evidently relieve fever symptoms and promote the disappearance of oral herpes symptoms,and no adverse event is observed throughout the study,which indicates a good safety of the rhIFN α2b spray.Clinical trial registration Chinese Clinical Trial Registry,ChiCTR-OIN-17013182.
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Objective To explore the clinical efficacy and safety of recombinant human interferon beta-1b for injection (rhINFβ-1b) in the treatment of relapsing remitting multiple sclerosis (RRMS). Methods Thirty patients with RRMS were selected. According to the condition of accepting rhINFβ-1b for treatment, they were divided into intensification treatment group (11 cases) and routine treatment group (19 cases). They were followed up for 24 months, all the patients′laboratory examination and imaging examination were performed. The scores of clinical extended disability scale (EDSS) and the number of recurrences were compared between the two groups before and after the treatment. In the initial admission (T0), at the end of treatment (T1), 6 months of follow-up (T2), 12 months of follow-up (T3) and 18 months of follow-up (T4), the sequence of MRI T2and the number of enhanced scan lesions were observed, and the adverse drug reactions and their severity were evaluated. The ROC curve of cystatin C level in cerebrospinal fluid(CSF) was drawn to comprehensively evaluate the efficacy of drug intervention. Results After treatment, the scores of EDSS in intensification treatment group were significantly decreased (P < 0.05). The scores of EDSS and the number of annual recurrence in intensification treatment group were significantly lower than those in conventional treatment group: (1.59 ± 0.75) scores vs. (4.07 ± 0.95) scores, (0.93 ± 0.38) times/year vs. (2.41 ± 0.54) times/year, there were significant differences (P＜0.01). The number of lesions at T0-T4time point in T2sequence and enhanced scan focus in intensification treatment group decreased. However, in conventional treatment group the number of lesions in T2sequences at T0-T4time point showed an upward trend, and the number of lesions at enhanced scan showed a broken line fluctuation. The results ROC curve showed that the area under the curve of intensification treatment group was 0.947 and the area under the conventional treatment group was 0.899. Conclusions rhINFβ-1b can effectively improve symptoms, significantly reduce the clinical relapse and MRI active lesions in patients with RRMS, slow down the progression of the disease, and have fewer adverse reactions.
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Recombinant human interferon beta (rhIFN-β) is a glycoprotein produced by genetically engineered cells and has anti-virus, anti-tumor and immunoregulation functions. Although studies have shown that other subtypes of IFN such as IFN-γ affects cell proliferation and differentiation to some extent, the effect of rhIFN-β on chondrogenic differentiation of human bone marrow mesenchymal stem cells (hMSCs) is less known. In this study we studied the effect of rhIFN-β on the chondrogenic differentiation of hMSCs by inducing hMSCs into cartilage pellet via adding IFN-β1a into regular TGF-β3 chondrogenic differentiation medium. We collected the induced pellets and then detected GAG content, assessed pellets size, observed agreecan using alcian blue staining, and analyzed the expression of Sox and CollangenⅡusing real-time PCR and Western blotting. Addition of 100 ng/mL IFN-β1a to regular TGF-β3 chondrogenic differentiation medium could improve the concentration of GAG, increase the size of pellets, promote the formation of aggrecan and up-regulate the expression of CollangenII and Sox9. IFN-β1a combined with TGF-β3 could promote chondrogenic differentiation of hMSCs.
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Objective To observe the clinical curative effect of Gong Yanping capsule combined with recombinant human interferon α2b vaginal effervescent tablets in the treatment of human papillomavirus infection.Methods80 cases of patients with cervical HPV infection in Xiangshan hospital of traditional Chinese medicine from May 2014 to May 2016 were selected, these patients were divided into Gong Yanping capsule combined with interferon treatment group (combined treatment group, 40cases) and pure Gongyanping capsule treatment group (single treatment group, 40cases) two groups according to the treatment methods, the clinical curative effects, HPV-DNA levels, HPV infection status, incidences of adverse reactions of the two groups were statistically analyzed.ResultsThe clinical total efficiency of the combined treatment group 95% (38/40) was significantly higher than the single treatment group 80% (32/40) (P<0.05), the HPV-DNA level was significantly lower (P<0.05), the HPV infection negative rate 1 months after treatment 2.5% (1/40) was significantly lower than the single treatment group 10% (4/40) (P<0.05), the negative rates 2 months, 3 months after treatment 67.5% (27/40), 97.5% (39/40) were significantly higher than the single treatment group 40% (16/40), 77.5% (31/40) (P<0.05);The difference of incidences of adverse reactions between the two groups 12.5% (5/40), 7.5% (3/40) was not significant.ConclusionThe clinical curative effect of Gong Yanping capsule combined with Recombinant Human Interferon α2b Vaginal Effervescent Tablets in the treatment of human papillomavirus infection is more significant than pure Gongyanping capsule treatment, it will not increase the adverse reactions of patients in a great extent, is safe and effective.
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OBJECTIVE:To investigate the clinical efficacy and safety of Recombinant human interferon α2b(rhIFN α2b) vaginal effervescent capsules combined with radiofrequency ablation in the treatment of cervical erosion with human papilloma virus (HPV)subclinical infection(SPI). METHODS:A total of 207 cervical erosion patients with SPI were selected from gynecology outpatient department of our hospital during Jul. 2014-Aug. 2015 and then divided into group A,B,C according to random number table,with 69 cases in each group. Group A was given rhIFN α2b vaginal effervescent capsules 800 thousand IU,via posterior for-nix,qd,3 days after the end of menstruation,10 days as a treatment course,for 3 courses. Group B received radiofrequency abla-tion. Group C was given constant dose of rhIFN α2b vaginal effervescent capsules combined with radiofrequency ablation. The clini-cal efficacy of 3 groups,the rate of wound healing,the rate of associated symptoms disappearance 2 weeks after surgery and the in-cidence of complications in group B and C were evaluated. The occurrence of ADR was recorded. RESULTS:The response rates of group B,C were 94.20% and 98.55%,which were significantly higher than 62.32% of group A. The response rates of SPI in group C was 92.75%,which was significantly higher than 63.77% of group B,with statistical significance(P0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:rhIFN α2b vaginal effervescent capsules combined with radiofrequency ablation can effective-ly improve the efficacy of cervical erosion with SPI,shorten the wound healing time with good safety.
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Objective To systematically assess the safety of recombinant human interferon α1b(rhIFNα1b) as therapy for viral diseases in children,so as to provide on evidence-based medicine for the clinical treatment.Methods Randomized controlled trails (RCTs) of rhIFNα1b for viral diseases in children were investigated through PubMed literature retrieval service system,Science Citation Index,China National Knowledge Infrastructure,WanFang Database;RCTs were selected according to the inclusion and exclusion criteria.Related data were extracted and the Meta-analysis was performed.Results Nineteen RCTs were involved,including 2 731 patients.In the overall,59/1 437 cases (4.1％) in the rhIFNα1b treatment group and 79/1 294 cases (6.1％) in the control group had adverse reactions.The Meta-analysis revealed that in the overall and in atomization inhalation subgroup,the incidence of adverse reactions was significantly lower in the rhIFNα1b treatment group than that in the control group [Z =2.18 (P =0.03),RR =0.71(95％ CI:0.52-0.97);Z =2.44(P =0.01),RR =0.53 (95％ CI:0.32-0.88)].But,there was no significant difference in the incidence of adverse reactions between the rhIFNα1b treatment group and the control group in intramuscular injection subgroup,and the test for overall effect was Z =0.78 (P =0.43),RR =0.86 (95 ％ CI:0.58-1.26).The incidence of adverse reactions of the control group was significantly higher than that of the rhIFNα1b treatment group in gastrointestinal adverse reaction [Z =2.20 (P =0.03),RR =0.60 (95 ％ CI:0.39-0.95)],and the incidence of adverse reactions of the rhIFNα1b treatment group was significantly higher than that of the control group in nervous system symptoms [Z=2.09(P=0.04),RR =4.28(95％ CI:1.10-16.72)].Conclusion Compared with other antiviral drugs,the treatment of pediatric common viral diseases with rhIFNα1 b has good safety,low incidence of adverse reactions,and the incidence of adverse reactions through atomization inhalation can be lower than that of intramuscular injection.
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Objective To study the inhibitory effect of recombinant human interferon α1b (IFN-α1b) on enterovirus 71 (EV71) in vitro and to investigate the antiviral mechanism of IFN-α1b.Methods The cytotoxity of IFN-α1b and the inhibition of IFN-α1b on cytopathic effect before and after EV71 infection were measured in rhabdomyosarcoma (RD) cell line.The in vitro inhibition of IFN-α1b on EV71 RNA and VP1 protein,and the protection of IFN-α1b on EV71 infected cells were also investigated.Then the EV71 invasion prevention of IFN-α1b induced transmembrane protein IFITM3 was evaluated.Results When treated 12h before or 1h after EV71 infection,IFN-α1b presented a IC50 258.53IU/ml and 2113.58IU/ml with SI>16497 and >3271,respectively,suggesting that IFN-α1b had obvious anti EV71 activity,and IFN-α1b treatment before EV71 infection was more effective.This study also showed that IFN-α1b significantly inhibited EV71 RNA replication and protein synthesis,and delayed the progeny virus release,which might prevent EV71 invasion by inducing IFITM3 expression.Conclusion IFN-α1b has anti EV71 activity and can act as an antiviral agent by influencing the viral life cycle including invasion,replication,assembly and release.
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Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems.Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010),and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results.Results All 42 batches of samples were qualified.The production process of each enterprise was steady.Conclusion At present the quality of recombinant human interferon αlb injection is generally good.The current standards are feasible,but the specified standard of osmolality needs to be improved.
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OBJECTIVE:To observe the clinical efficacy and safety of recombinant human interferon α2b (rhIFN α2b) combined with bozhi glycopeptides or thymopentin in the treatment of chronic hepatitis B (CHB).METHODS:Ninety HBeAg-positive CHB patients were selected from our hospital during Jan.2014-Jan.2015 and then randomly divided into group A,B,C,with 30 cases in each group.Group A was given rhINF α2b for injection (Pseudomonas) 5 million IU subcutaneously,qod;group B was additionally given Bozhi glycopeptides injection 4 mL added into 5％ Glucose injection 250 mL,ivgtt,qd,on the basis of group A;group C was additionally given Thymopentin for injection 2 mg added into 5％ Glucose injection 250 mL,ivgtt,qd,on the basis of group A.Three groups were treated for 24 weeks.The rate of ALT recovering to normal,negative rate of HBeAg,transformation rate of HBeAg/anti-HBeAg serum,negative rate of HBV-DNA and the decrease of HBsAg and HBV-DNA were compared among 2 groups after 4,8,12,24 weeks of treatment.The occurrence of ADR was recorded.RESULTS:After 4,8,12 weeks of treatment,there was no statistical significance in the rate of ALT recovering to normal,negative rate of HBeAg,transformation rate of HBeAg and the decrease of HBsAg among 3 groups (P＞0.05).After 4 weeks,negative rate of HBV-DNA in group B,C were significantly higher than group A;the decrease of HBV-DNA in group C were more significant than group A and B,with statistical significance (P＜0.05).After 8,12 weeks of treatment,the negative rate of HBV-DNA and the decrease of HBV-DNA in group B,C were significantly higher than group A,with statistical significance (P＜0.05);but there was no statistical signifi cance between group B and C (P＞0.05).After 24 weeks of treatment,there was no statistical significance in the rate of ALT recovering to normal,transformation rate of HBeAg,the decrease of HBsAg and negative rate of HBsAg among 3 groups (P＞0.05).The negative rate of HBsAg,negative rate of HBV-DNA and the decrease of HBV-DNA in group B,C were significantly higher than group A,with statistical significance (P＜0.05);there was no statistical significance between group B and C (P＞0.05).There was no statistical significance in the incidence of ADR among 3 groups(P＞0.05).CONCLUSIONS:rhIFN α2bcombined with bozhi glycopeptides or thymopentin shows good inhibitory effect on CHB,therapeutic efficacies of them are similar in the rate of ALT recovering to normal,but transformation rate of HBeAg,the decrease of HBsAg and negative rate of HBeAg.
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Objective:To observe the efficacy of human interferon alpha-2b in the patients with HPV infection. Methods:Totally 128 patients with HPV infection were divided into two groups by the random number table with 64 cases in each. The patients in the observation group were treated with human interferon alpha-2b and those in the control group were treated with Baofukang suppositories. The course of treatment was 30 days for two groups. The expression level of HPV E6 / E7 mRNA,p16 and p53 before and after the treatment and the severe adverse reactions in each group were studied. Results:The effective rate of the observation group was 93. 75% ,and that of the control group was 84. 38%(P < 0. 05),the effictive rate of the observation group was better than the control group. After the treatment,the median(M)and the positive expression rate of E6 / E7mRNA,p16 and p53 in the two groups were significantly changed when compared with those before the treatment(P < 0. 05),and the difference between the two groups was also significant(P < 0. 05). After treatment the expression and the positive rate of E6 / E7 mRNA P16 and P53 for different types of diseases in two groups were significanst difference(P < 0. 05),comparisons the parameters between groups were significant difference(P < 0. 05). Conclusion:The clinical efficacy of recombinant human interferon alpha-2b for HPV infection is better and the adverse drug reactions are mild,which can reduce the expression and positive rate of E6 / E7mRNA,p16 and p53 in the patients with HPV infection.