ABSTRACT
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.
ABSTRACT
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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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.
ABSTRACT
Objective:To investigate the clinical efficacy of recombinant human interferon alpha -2b combined with Loop electro-sugical excision procedure( LEEP)in the treatment of cervical ectopic columnar epithelium with chronic cervicitis. Methods:The med-ical records of 68 cases of cervical ectopic columnar epithelium with chronic cervicitis in our hospital from April 2012 to April 2014 treated with LEEP were analyzed retrospectively. The control group(30 cases)was treated with LEEP combined with 5-day postopera-tive oral administration of antibiotics to prevent infection,and the treatment group(38 cases)was given recombinant human interferon alpha -2b through vagina additionally,every other day for 20 days every month after menstrua. After 6 courses of treatment,the clinical efficacy,vaginal bleeding time,vaginal discharge duration,wound healing time and HPV persistent infection were compared between the two groups. Results:The cure rate of the control group was 66. 67%,while that of the treatment group was 92. 11%,and the difference was significant(P<0. 05). Totally 19 cases in the control group were with wound healing(accounted for 63. 33%),while that in the treatment group was 32 cases(accounted for 84. 21%),the difference was significant(P<0. 05). And the vaginal bleeding time,vaginal discharge duration,and wound healing time of the treatment group were all significantly shorter than those of the control group(P<0. 05). After the treatment,the HPV persistent infection rate in the control group was 16. 67%,while that in the treatment group was 0%,and the difference was statistically significant(P<0. 05). The two groups during the treatment process had no obvious adverse reactions,indicating high drug safety. Conclusion:Recombinant human interferon alpha-2b combined with LEEP in the treat-ment of cervical ectopic columnar epithelium is safe and effective,which can effectively shorten the wound healing time,vaginal bleed-ing time and vaginal discharge duration,and is worthy of promotion in clinics.