Stabilization of a freeze-dried recombinant streptokinase formulation without serum albumin.

AIM: To evaluate the stability and content homogeneity of a new freeze-dried and albumin-free formulation of recombinant streptokinase (SKr) that has recently been approved by the Cuban National Center for the Quality Control of Medicaments. MATERIALS AND METHODS: The new formulation was stored at the intended recommended storage temperature of 4 degrees C, and under accelerated storage conditions (37 degrees C). The stability of the product was also examined after reconstitution and storage at room temperature (28 degrees C) for 24 h. Samples were periodically subjected to biological activity assays (S-2251 chromogenic-substrate method or in vitro clot-lysis assay), sodium dodecyl sulphate/polyacrylamide gel electrophoresis (SDS/PAGE), pyrogen and sterility testing, abnormal toxicity screening, organoleptic evaluation, and measurement of residual moisture and pH. RESULTS AND DISCUSSION: Accelerated storage (37 degrees C) data showed biochemical stability of SKr throughout the 6-month study with activity, remaining between 90 and 110% of its nominal value (0.75 x 10(6) IU/mL). SDS/PAGE-determined purity showed that SKr remained above 97 %. Furthermore, the formulation was non-pyrogenic, non-toxic, sterile and organoleptically acceptable. Real-time storage data confirmed the excellent biochemical long-term (30 months) stability of the new formulation of SKr. Comparison with other freeze-dried preparations showed that the new formulation was organoleptically better. The formulation was stable after reconstitution and storage at 28 degrees C for 24 h. The content homogeneity of this new formulation was also satisfactory. CONCLUSIONS: This study demonstrated the stability and the content homogeneity of this formulation, despite the absence of albumin as stabilizer.

Five-Year Experience with LAVH at a Small Community Hospital

In September 1990 we performed our first laparoscopic-assisted vaginal hysterectomy (LAVH). Operating time was 127 minutes, estimated blood loss was 400 ml, and length of hospital stay of 3 days. No surgical complications occurred. During the next 5 years, as we gained more experience, the technique changed until we arrived at our present method. In the last patient in this 5-year period, length of operating time was 72 minutes, estimated blood loss was 100 ml, and length of stay was 2 days. The shorter hospital stay was statistically significant compared with abdominal hysterectomy; the length of surgery and blood loss were not. Patient discomfort was less with LAVH. Again, no surgical complications occurred. During these 5 years we performed a total of 318 LAVHs. The procedure enabled us to reduce the number of abdominal hysterectomies to only a few. We believe that, in the hands of experienced surgeons, the outcome is better with LAVH than with the standard abdominal approach.

Bladder neck dysynergia in spinal cord injury.

Urodynamic evaluations were performed in 43 male patients with spinal cord injuries, before any therapeutic decisions, and a minimum of 5 mo following the injury. Results were subdivided according to level of injury. Mean detrusor contraction pressures, incidence of detrusor-sphincter dysynergia (DSD), and incidence of detrusor-bladder neck dysynergia (DBND) were calculated. The incidence pattern of DBND was found to follow closely the incidence pattern of DSD, with the highest incidence among the upper thoracic injuries, considerably more than among the cervical injuries. A significantly higher resting detrusor pressure differential was found among the patients with DBND. This was felt to represent sympathetic dysfunction and poor accommodation and is proposed to be secondary to adrenergic detrusor neoinnervation.

Laparoscopy-assisted vaginal hysterectomy compared with abdominal hysterectomy.

The first 150 consecutive laparoscopic vaginal hysterectomy (LVH) cases done by Creighton University faculty members at Mercy Hospital, Council Bluffs, Iowa and at St Joseph Hospital, Omaha, Nebraska were compared with 194 abdominal hysterectomies (AHs) for benign or noninvasive disease. The results indicate that LVH can be accomplished with low morbidity, low length of stay, and with less patient discomfort than experienced by patients who undergo AH.

Our Three Year Experience with Laparoscopic-Assisted Vaginal Hysterectomy (LAVH)

For the past several years LAVH has become a more common procedure. The publication of the first laparoscopic hysterectomy in 1989 encouraged us to perform our first LAVH in October 1990. In the following three years, October 1990 to September 1993, we performed 175 LAVHs. The charts were reviewed and data for length of surgery and blood loss was obtained from anesthesia records. Indications were the same as for vaginal hysterectomy. The average age for the patient was 42 years with a range of 23 to 73 years. The range of uterine weight was 41 to 462 gms, with an average of 158 gms. Length of surgery was an average of 109 minutes with a range of 53 minutes to 420 minutes. Length of stay ranged from one to five days with an average of 2.3 days and 2.1 days when patients with bladder repair were excluded. Blood loss average was 302 ml. Only two major complications occurred. One patient had a bladder laceration and one had to undergo exploratory laparotomy because of inability to achieve hemostasis from the right vaginal angle. She was the only patient to require blood transfusion.

A critical analysis of laparoscopic assisted vaginal hysterectomies compared with vaginal hysterectomies unassisted by laparoscopy and transabdominal hysterectomies.

The first 115 laparoscopically assisted vaginal hysterectomies (LAVH) done by our faculty surgeons were compared with 220 vaginal hysterectomies (VH) and 194 abdominal hysterectomies (AH) done in our affiliated hospitals over the same period of time. Logistic regression analysis indicates that LAVHs were done for cases that would significantly be more likely selected for AH than for VH (p less than 0.0001). Matched case control studies with 28 LAVH/VH and 34 LAVH/AH pairs and bivariate analyses demonstrated that LAVH can be accomplished with low morbidity, short lengths of stay, and little, if any, increase in operating times compared with VH and AH. The LAVH procedure can be expected to replace many AHs in the future.

Persistent trophoblastic implants after salpingostomy for ectopic pregnancy.

Laparoscopic management of ectopic pregnancies is the accepted method of treatment in most centers. This report describes a case of persistent trophoblastic implants to the peritoneum after laparoscopic linear salpingostomy for evacuation of an early ectopic pregnancy. Based on this experience, methods for follow up after such procedures, and recommendations for management of persistent trophoblastic implants are discussed.

Nifedipine pretreatment for prevention of autonomic hyperreflexia during anesthesia-free extracorporeal shock wave lithotripsy.

Nifedipine, a calcium channel blocker, has been used to treat autonomic hyperreflexia in quadriplegics undergoing invasive urological procedures. We present a case of autonomic hyperreflexia triggered by extracorporeal shock wave lithotripsy in which nifedipine was used successfully to treat the hypertensive crisis on 1 occasion and subsequently it was used prophylactically to prevent the crisis in the same patient.

Laparoscopy-assisted vaginal hysterectomy: report of seventy-five consecutive cases.

Patients who underwent laparoscopy-assisted vaginal hysterectomy with or without adnexectomy experienced less fever, required less postoperative analgesia, were able to tolerate a full diet within 24 hours of surgery, and had a faster recovery and shorter hospital stay than patients who had abdominal or traditional vaginal hysterectomy.

Analgesia in anesthesia-free extracorporeal shock wave lithotripsy: a standardized protocol.

We treated 101 patients at our stone facility with the Dornier HM3 lithotriptor modified with the anesthesia-free design upgrade. A protocol designed by our anesthesiologists consisting of intravenous and intramuscular injections for sedation was used without any general or regional anesthesia required. Pre-medication with intramuscular meperidine and promethazine, and oral diazepam was sufficient sedation in 43 patients, while 37 required additional intravenous meperidine and/or midazolam during the procedure, 16 were treated with intraprocedural medication alone and 5 required no medication at all. Care before, during and after the procedure was rendered by the urology staff for patients in American Society of Anesthesiologists risk category I or II. Treatment was successfully completed in all patients without complications. We compared this group to the 99 patients treated consecutively before the modification. Voltage used, number of shocks and stone burden were comparable in the 2 groups but average treatment time was prolonged with the upgraded equipment (39.2 versus 27.1 minutes) to a significant degree (p less than 0.001).

The effect of an alpha-2 agonist on bladder function and cord histology after spinal cord injury.

Spinal injury in cats is accompanied by urinary bladder and hind limb dysfunction. Ten cats subjected to spinal contusion at the ninth thoracic segment were treated with guanabenz (an alpha-2 agonist) intraperitoneally (0.65 mg./kg.) three hours after injury, and twice daily for eight weeks. An additional six spinal cats were untreated and served as controls. Urodynamic studies were performed on a weekly basis on all animals. Guanabenz modified the vesico-somatic reflex: detrusor-sphincter dyssynergia was either ablated or abolished. In contrast, the controls demonstrated detrusor-sphincter dyssynergia, high residual urine, and spasticity below the lesion. Histological evaluations of the spinal cords revealed that the six paraplegic animals (untreated) suffered marked cavitation of the cord and complete destruction of the grey matter. The five incomplete paraplegic animals (treated) showed minimal cavitation with some preservation of the grey matter. The five ambulators (treated) demonstrated some distortion of grey matter with preservation of white matter. Treatment with guanabenz post traumatic cord injury results in decreased cord cavitation. Detrusor-sphincter dyssynergia is diminished and hind limb function is improved in treated animals.

Significance of asymptomatic bacteriuria in spinal cord injury patients on condom catheter.

A total of 56 male spinal cord injury patients on condom catheter drainage was studied prospectively within 6 months of the injuries for 5 years. Low bladder pressures (filling maximum 35 cm. water and voiding maximum 70 cm. water) were ascertained with video-urodynamics. External sphincterotomy was performed when necessary for detrusor-sphincter dyssynergia. Yearly upper tract imaging, serum creatinine levels and urine cultures were obtained. All patients had colonized urine (asymptomatic) during the entire study period. No patient sustained deterioration of the urinary tract on imaging or by serum creatinine determinations during the 5-year interval. We conclude that asymptomatic bacteriuria is of no consequence to the integrity of the upper urinary tract when low pressures are operant.

Extracorporeal shock wave lithotripsy treatment of spinal cord injury patients.

A total of 32 male patients with spinal cord injury underwent extracorporeal shock wave lithotripsy. The mean stone burden was 2.9 cm. (range 0.2 to 8.0 cm.) per renal unit. Of 41 renal units 27 (66 per cent) required ancillary endourological procedures preoperatively and 32 (78 per cent) required a single treatment with extracorporeal shock wave lithotripsy. Urine cultures were positive in 30 of 32 patients (94 per cent) before treatment. All patients with positive preextracorporeal shock wave lithotripsy urine cultures also had positive cultures after treatment. Followup (3-month) was available for 26 of 41 renal units (63 per cent) and showed 19 (73 per cent) to be free of stones or without any radiographic evidence of calcification overlying the collecting system. Seven staghorn calculi were treated with extracorporeal shock wave lithotripsy without prior debulking procedures. Two partial staghorn calculi were treated and rendered free of stones. None of the 5 kidneys with full staghorn calculi was rendered free of stones. We conclude that extracorporeal shock wave lithotripsy is effective for the treatment of unbranched and partial staghorn calculi in the spinal cord injury patient. However, extracorporeal shock wave lithotripsy alone is less effective for the treatment of full staghorn calculi.

Penile denudation injuries after circumcision.

We present 3 cases of iatrogenic phallic denudation that were managed successfully nonoperatively. The concept of conservative, nonoperative management should be considered in denudation injuries.

Successful treatment of lupus erythematosus cystitis with DMSO.

Systemic lupus erythematosus patients sometimes present with pathologically confirmed lupus interstitial cystitis. Treatment with prednisone has not been observed to be successful. Two patients are presented who were successfully treated with intravesical dimethyl sulfoxide (DMSO).

Female phallic urethra and persistent cloaca.

Accessory phallic urethra in the female newborn with a persistent cloaca is a rare entity. We present a variant with a cloaca that contained rectal, vaginal and bladder neck openings, as well as the proximal origin of the phallic urethra. The literature is reviewed.