| BackgroundTo evaluate the clinical efficacy and safety of small dose of solifenacin in the treatment of bladder spasm after surgical of children with hypospadias.Hypospadias is one of the common genitourinary malformations in pediatric surgery.At present,the exact pathogenesis is not clear.Any factors that affect the development of fetal genitalia are likely to affect the formation of the urethral joint and remodeling process,when the urethra and foreskin ring closed abnormalities,it may cause congenital hypospadias.Surgical treatment of such diseases is more difficult,whether it is a complete straightening and forming or staging surgery are more difficult.Such surgery requires the competent physician has many years of clinical diagnosis and treatment experience,according to the specific circumstances of children in the use of reasonable surgical treatment,with fine surgical operation.Timely and effective treatment of perioperative common adverse events is needed.In order to obtain more satisfied therapeutic effect,the careful and patient care of tube bed nurses,and accompanying family members,is necessary.The surgical approach of hypospadias is complex and varied.Owing to the suture repair artificial urethral distance is different and longer duration of indwelling catheter.The postoperative discomfort rate is higher,nursing more difficult.Urinary or pus accumulation may occur around the catheter after surgery,affecting the healing of the artificial urethra.Long-term indwelling bladder puncture fistula and catheter may appear bladder spasm,resulting in urine exudation or urine overflow may cause tissue inflammation.Changes in volding mode after surgery may cause reflux of orchitis,epididymitis,and seminal vesiculitis.When there is tissue infection and accumulation of pus under the blood scab,may lead to urinary fistula or a large section of artificial urethral cracking,affecting the appearance of the penis and voiding function.Excessive contracture of the scar after surgery may result in one or more stenosis of the urethra.Long-term urethral stricture and artificial urethral local fragility are likely to form urethral diverticulum.Local blood supply micro-environment abnormalities may appear tissue defects or secondary infection caused by tissue ischemia and necrosis,leading to postoperative appearance and poor function.Among them,the bladder spasm is a common pediatric hypospadias postoperative complications,can cause pain and other discomfort in children,seriously affecting the recovery of children after surgery,and even psychological barriers to reduce the compliance of children with postoperative care.In recent years,solifenacin,a new member of the M receptor antagonist family,has a high selectivity antagonism to the M3 receptor,which can significantly inhibit the unstable contraction of detrusor,improve bladder function,alleviate and prevent bladder stimulate the symptoms,and gastrointestinal adverse reactions and salivary gland secretion inhibition rate is low.Solifenacin has used in pediatric-related diseases,the effectiveness and safety of research gradually confirmed in children with enuresis,neurogenic bladder,OAB and other diseases of the treatment to achieve a better effect,is the consensus of the clinical application of experts recommended treatment of OAB,is one of the first-line drugs.There are few reports about the efficacy and safety of solifenacin,involving the treatment of children after surgery occurred bladder spasm.ObjectiveIn this study,we used statistically related design concepts and research methods to explore the therapeutic effect of solifenacin,which used in children with hypospadias after surgery occurred bladder spasm.At the same time,we recorded the adverse effects of medication.Also,we checked the blood of children,including the myocardial enzymes,liver and kidney function.A comprehensive assessment of the efficacy and safety of solifenacin for the clinical application is necessary.It can provide more research reference to solve the clinical work of bladder spasm after surgery,and detailed clinical data for the follow-up study of cost-utility analysis in the treatment of bladder spasm,about solifenacin and other related medications.MethodsThis study collected from July 2014 to September 2016 in the First Affiliated Hospital of Zhengzhou University pediatric wards of Department of Urology treated 80 cases of more than 48 months of hypospadias postoperative bladder spasm in 24 hours patients,for 48-96 months of age,the average(67.14 ± 8.37)months.Among them,hypospadias type I,II,III were 27 cases,33 cases,20 cases.All children were successfully completed surgical treatment,according to the principle of individual treatment reasonable choice Snodgrass,Duckeet,Duplay,MAGPI,Koyanagi and the corresponding improved or combined surgery.Operation has been under control.According to the randomized controlled clinical trial,80 patients with bladder spasm in 24 hours were randomly divided into experimental group(n=40)and control group(n=40).The experimental group of 40 patients with an average of(66.64 ± 7.52)month,and the control group with an average of(67.25 ± 8.71)month.All the patients were given the same infusion and local nursing after operation.Postoperative days to record daily at 12:00 for the starting and ending points,that is,the day of surgery 12:00 noon to 12:00 the next day as the day after surgery,the next day after operation in 24 hours as the first days,and so on.The two groups were recorded on the day of surgery at 12:00 noon to the next day 12:00,the frequency of bladder spasm and spasm duration,and,the number of urine spill,as the bladder spasm situation of the day after surgery.For the experimental group,after first days at 12:30 uniform given oral solifenacin about 2.5 mg,once a day.For the control group of children,do not give any comfort preparations and any anti-cholinergic drugs as a blank control group.Observed the first day,the third day,the fifth day,the seventh day,the ninth day,the eleventh day and the thirteenth day after operation in experimental group and control group with the frequency of bladder spasm,bladder spasm duration and frequency of urine overflow as contrast research data.Recorded first to thirteenth days of two groups after surgery of children with dry mouth,blurred vision,constipation,nausea,indigestion and other adverse reactions occur,after fourteenth days,to review the relevant biochemical items of two groups of children,such as myocardial enzymes and liver function,to know if there is any abnormal change.At the end of the experiment,the two groups were followed up for 2 weeks.ResultsThere was no significant difference(P<0.05)in the age composition ratio,hypospadias classification and bladder spasm situation of the two groups.Compared with the control group,the experimental group used drug solifenacin in the treatment of hypospadias postoperative bladder spasm,the number of bladder spasm was decreased at the beginning of seventh days,the difference was statistically significant(P<0.05).The bladder spasm duration was decreased at the beginning of fifth days,the difference was statistically significant(P<0.05).The frequency of urine overflow was decreased at the beginning of ninth days,the difference was statistically significant(P<0.05).With the continued treatment,the experimental group of children with bladder spasm treatment was significantly better than the control group.Combined with the improvement of three indexes in different time points in the experimental group,we can see that,the efficacy of solifenacin in children with bladder spasm obviously appear from the first 5 days.There was no statistically significant difference(P>0.05)in the incidence of adverse events such as dryness,constipation,nausea and fatigue in the two groups.Drug use has good safety and compliance.Serious adverse events were not recorded in both groups.No medication was discontinued.Preoperative and review of myocardial enzymes and liver and kidney function tests have not yet found significant abnormalities.At the end of the experiment,two groups of children were followed up for 2 weeks,and,no significant adverse reactions were recorded.ConclusionIn summary,we can think that solifenacin has a certain degree of efficacy and safety in the symptom of bladder spasm in children with hypospadias.Compared with the control group,the application of solifenacin in the postoperative children can effectively reduce the frequency of bladder spasm,the duration of bladder spasm,and the frequency of urine overflow.Indirectly reduce the posterior ureteral postoperative terminal bad time the incidence.Children with oral administration of solifenacin,the treatment effect is generally shown on the fifth day,the short term application of no serious adverse reactions occurred,and the general adverse reactions compared with the control group no significant difference between the symptomatic treatment can be alleviated.The number of cases in this study is limited,the record of self-made questionnaire and the actual condition of children still have some differences,the treatment dose is more single,the index record has time intervalwhen,in the end of the experiment still has a serious illness in children with no additional or combined medication.Therefore,we recommend similar studies,to expand the sample content appropriately,to increase the credibility of evidence-based medicine,to choose a more objective and reasonable assessment of the degree of bladder spasm in children,to study the drug dose and the general signs of the relationship between children,looking for more effective and safe new drug and multi-drug compatibility program,or other new single or combined treatment. |
PDF Full Text Request