ABSTRACT
Objective To study the feasibility of mouse nerve growth factor for injection in treatment of incision pain after inguinal hernia repair. Methods Eighty unilateral inguinal hernia patients who had underwent inguinal hernia repair were divided into 2 groups according to the sequential order with 40 cases each. The patients of odd number were divided into control group, and the patients of dual number were divided into treatment group. All patients were performed Lichtenstein tension free repair operation, and were given the basic treatment of inguinal hernia. At the 3rd d after operation, the patients in control group were given 2 ml water for injection through intramuscular injection, and the patients in treatment group were given 20 μg mouse nerve growth factor for injection through intramuscular injection. One course of treatment was 14 d. At 3 d, 15 d, 30 d, 3 months and 6 months after operation, the pain degree, the pain range, and the effect of pain on behavior was observed and evaluated according to visual analogue score (VAS), the innervation range of the inguinal region, and behavioral rating scale-6 (BRS-6) respectively. Results There were no statistical differences in VAS, pain range score and BRS-6 score 3 d after operation between 2 groups (P>0.05). The VAS, pain range score and BRS-6 score 15 and 30 d after operation in treatment group were significantly lower than those in control group, 15 d after operation:(1.64 ± 0.92) scores vs. (2.28 ± 1.06) scores, (1.23 ± 0.43) scores vs. (1.61 ± 0.56) scores and (1.02 ± 0.56) scores vs. (1.57 ± 0.73) scores, and 30 d after operation:(0. 98 ± 0.56) scores vs. (1.61 ± 1.04) scores, (0.87 ± 0.43) scores vs. (1.16 ± 0.56) scores and (0.86 ± 0.32) scores vs. (1.16 ± 0.73) scores, there were statistical differences (P0.05). Conclusions Injecting mouse nerve growth factor for injection is effective for pain treatment after inguinal hernia repair.
ABSTRACT
Background The clinical efficacy and safety of mouse nerve growth factor(NGF) for injection have been evaluated by Ⅰ,Ⅱ,Ⅲ stage of clinical trials.But as a clinical drug,its adverse effects for special population should been further studied.Objective This clinical trial was to observe and assess the safety and tolerability of mouse NGF for injection during the application in juvenile and elder patients with optic nerve damage.Methods A multicenter non-randomized controlled trial for the safety evaluation of mouse NGF injection solution was performed in 100 eye centers in China.This study protocol was approved by the Ethic Committee of each drug research center,and written informed consent was obtained from the subject,legal mandatary and guardian prior to this study.Total 2046 patients who met the included criteria of optical nerve damage were enrolled.The patients were divided into the juvenile group(90 cases,＜ 18 years),youth-middle-age group (1868 cases,1 8-75 years) and older group(88 cases,＞75 years).Mouse NGF(30 μg)was intranuscularly injected once per day for 21 days in all the patients.Systolic and diastolic blood pressure,heart rate,intraocular pressure (lOP),laboratory examinations of blood and urine,blood biochemical indexes were recorded before and after injection.All adverse events were evaluated after administration of drug.Results There were 189 (189/2046,9.23％)dropped out cases,including 184 lost cases after 3 weeks of treatment and 5 withdrew cases from adverse responses of drug,with a shedding rate ＜10％ in each group.Total 1857 individuals finished this trial.No significant differences were found in the IOP,heart rate and blood pressure between before and after admninistration of grug in the juvenile group,youth-middle-age group and older group (P＞0.05).The incidence rate of the adverse response in the juvenile group,youth-middle-age group and older group was 57.78％,68.18％,60.01％ respectively,and the primary local adverse events were pain(48.89％),redness and swelling(59.09％),duration(54.49％),without significant difference in the rate of local adverse events among the three groups(X2 =2.302,P =0.324).The abnormal rates of laboratory results of blood and urine were not significantly different among the three groups(all at P＞0.05).The percentage of impaired fasting glucose was 7.46％,23.73％and 7.79％ in the juvenile group,youth-middle-age group and older group,respectively,and the percentage in the older group was higher than that in the juvenile group and the youth-middle-age group (x2 =8.685,P =0.005 ;x2 =27.720,P =0.000).Conclusions Injection of mouse NGF is well tolerated in juvenile and elder patients over the age of 75 years.