A new long shelf life formulation of modified Ham's F-10 medium: Biochemical and clinical evaluation

Purpose To evaluate biochemically and clinically a new formulation of modified Ham's F-10 medium made without the inclusion of hypoxanthine. The medium was formulated for long-term storage and use by separately preparing a stable liquid (basal) portion and a freeze-dried supplement containing the labile medium components.Results Following 18 months of storage the basal medium was biochemically analyzed for its amino acid (aa's) and vitamin content. Cysteine and tryptophan were decreased to less than 30% of their starting theoretical concentrations (STCs). Asparagine, serine, tyrosine, histidine and lysine were present at 50% to 70% of their STC. The remaining aa's were all within 90% of their STCs except arginine which was at 77%. All of the vitamins were present at 90% or more of their STCs except inositol, riboflavin and'thiamine which were present at 70% of their STCs. IVF with the new formulation resulted in 13 deliveries from 51 aspirations (25%) as compared with 10/39 (26%) in 1991, when standard medium preparation was used. Oocyte donation resulted in 30 deliveries from 84 cycles (36%) with the new formulation as compared with 21/65 (32%) in 1991.Conclusions (1) The new basal with lyophilized supplement formulation produces similar clinical results in the IVF laboratory as medium prepared in the standard fashion, (2) certain amino acids and vitamins are not stable in the liquid basal medium, and (3) the separate formulation of a liquid basal medium with lyophilized supplement is convenient, viable alternative to modified Ham's F-10 medium prepared in the standard manner (i.e., from powder) and may decrease the need for frequent medium preparation.Modified Ham's F-10 Medium, Irvine Scientific, Santa Ana, California.Presented at the 42nd Annual Meeting of the Pacific Coast Fertility Society, Indian Wells, California, April 20–24, 1994.     

"How many beds are needed?": evaluating bed need in managed care setting

After downsizing, re-engineering, consolidating and merging, health care administrators are still asking the eternal question, "How many beds are needed in my hospital?" The significant capital and operating cost required to support a staffed bed warrants a thorough and in-depth examination of the factors leading to bed need, writes Steven D. Sauer, consultant with Hamilton/KSA.     

Therapy of small breast cancer - four-year results of a prospective non-randomized study

Background: In the early 1980s breast preservation was a rarely applied therapeutic modality in the primary treatment of breast cancer in the Federal Republic of Germany. Reports coming from retrospective studies as well as preliminary results from randomized trials made it desirable to introduce breast preservation in the form of a controlled clinical trial. Study design: In stage pT1 N0 M0 breast cancer, mastectomy as the standard treatment was to be compared with radiotherapy of the remaining breast tissue. The study design originally planned as a randomized trial had to be changed into a prospective observation study due to the low randomization rate. Univariate analysis of prognostic variables was the first step to a valid treatment comparison. Those factors determined as being significant were included together with the treatment effects in a multivariate analysis. A high therapeutic standard was guaranteed by quality control. Results: 1036 out of 1119 recruited patients are evaluable. After a median follow-up of 48 months the following preliminary results can be reported. With the exception of death without recurrence from breast cancer, the 143 events are evenly distributed among the two treatment groups. Locoregional recurrence of the whole patient population was 5%. Out of all prognostic factors examined only tumor size and grading are significant in regard to recurrent disease. Recurrence-free survival decreased in cases with uncertain tumor margins, whereas the width of the margin had no influence on recurrent disease. There was no significant difference in quality of life between the two treatment groups. Conclusions: The four-year results of this study are in accordance with those of other breast preservation trials: There is no significant difference between the two treatment groups in the occurrence of locoregional failure. Incomplete tumorectomy has a negative influence on recurrence. Quality of life seems more dependent on the acceptance of the therapy by the patient than on the therapeutic modality itself. Breast preservation can also be performed appropriately in smaller institutions if the therapeutic standard is guaranteed by quality control.This study was sponsored by the Ministry of Research and Technology (BMFT) of the Federal Republic of Germany.     

Addition of a gonadotropin releasing hormone (GnRH) antagonist and exogenous gonadotropins to unstimulated in vitro fertilization (IVF) cycles: Physiologic observations and preliminary experience

Purpose To describe our preliminary experience with the addition of a GnRH antagonist (Nal-Glu) and exogenous gonadotropins (follicle stimulating hormone; FSH) to unstimulated IVF cycles.Method Seven spontaneously ovulatory women underwent eight unstimulated IVF cycles at our institution. They were treated with a single dose of Nal-Glu, 50 g/ kg, or with a combination of Nal-Glu, 50 g/kg, and exogenous FSH, 150–300 IU, during the late follicular phase of spontaneous cycles. They then received 10,000 IU of human chorionic gonadotropin (hCG) to time accurately follicle aspiration in unstimulated IVF cycles.Results Two women underwent three cycles with Nal-Glu alone on the day of hCG administration. One pregnancy resulted. Five women underwent five cycles with 3 to 6 days of daily Nal-Glu and FSH. Four of these cycles resulted in aspiration after the FSH dose was increased to 300 IU. Nal-Glu and FSH allowed continued development of the dominant follicle without the occurrence of luteinizing hormone (LH) surge.Conclusions (1) Nal-Glu alone given 18 hr prior to hCG did not interfere with continued follicle viability or with the attainment of pregnancy. (2) Simultaneous Nal-Glu and FSH allowed for continued growth and development of the dominant follicle without the occurrence of an LH surge. (3) This preliminary experience confirms the feasibility of this novel approach, which may ultimately enhance the efficacy of unstimulated IVF cycles by eliminating premature ovulation and maximizing control of gonadotropin delivery to the developing follicle.Presented at the 39th Meeting of The Society for Gynecologic Investigation, San Antonio, Texas, March 18–21, 1992.     

Concomitant radiochemotherapy with 5-FU and cisplatin for invasive bladder cancer

Purpose

To evaluate acute toxicity and efficacy of simultaneous radiochemotherapy for invasive urothelial cancer of the bladder.

Patients and Methods

From September 1993 to July 1997,61 patients with invasive bladder cancer were treated with a transurethral resection (TURB) followed by radiochemotherapy (RCT). Twenty-five received a combination of 5-FU and cisplatin. The prescribed doses were 600 mg/m² 5-FU daily as continuous infusion over 5 days each in the 1st and 5th treatment week and 20 mg/m² cisplatin daily at the same days as a short infusion. The pelvis was irradiated with 54 Gy, the bladder with 59.4 Gy and the paraortic nodes in 7 cases with 45 Gy, respectively. Six to 8 weeks after RCT a second TURB was performed for reasons of restaging.

Results

Twenty out of 25 patients received at least 80% of the prescribed chemotherapy, in 13 cases the full dose could be given. Gastrointestinal toxicity of Grade I and II occurred in 10 cases, 1 patient developed severe diarrhea (Grade VI). After the 1st course of chemotherapy 7 patients had leucoor thrombopenia of Grade III. One patient had a leucopenia of Grade IV. After the 2nd course 4 patients developed Grade III leuko- and thrombopenia, 1 of Grade IV. Two Grade II anemia were found. All more severe toxicities and necessary dose reductions were related to radiation of the paraaortic nodes. No life threatening infections, bleedings or cardiotoxicity was found. Restaging TURBs resulted in 22 complete remissions, 1 patient had a de-novo-carcinoma (Tis) at this time, 2 were non-responders (8%). After a median follow-up of 38 months 20 patients are alive (80%).

Conclusions

1. If irradiation of paraaortic nodes is necessary, 5-FU should not be applied, because the gastrointestinal toxicity is too extensive. In all other cases side effects are tolerable and can be managed by supportive care. 2. The first results are promising and should be evaluated in a prospective study.     

Gabapentin leads to remission of somatoform pain disorder with major depression

Gabapentin, a novel antiepileptic drug, is effective in the treatment of partial seizures with and without secondary generalization. Evidence suggests that it may have mood-stabilizing and possibly antidepressant properties in bipolar depression. We report on a 48-year-old woman who had recurrent major depressive disorder. Following inguinal herniorrhaphy, she developed severe stabbing pain in the lower abdomen and inguinal area that progressed to constant pain in her whole body. She was depressive, hopeless, and had given up her social activities. A diagnosis of major depressive disorder and somatoform pain disorder was made. Antidepressants and carbamazepine were ineffective, and she had attempted suicide. Gabapentin resulted in remission of both the pain and the depressive mood at a dose of 1.800 mg/day.     

Proposal of a new electromechanical total artificial heart: the TAH Serpentina

A new type of energy converter for an electro-mechanical total artificial heart (TAH) based on the principle of a unidirectional moving motor is described. Named the TAH Serpentina, the concept consists of 2 major parts, a pendulum shaped movable element fixed on one side using a joint bearing and a special shaped drum cam. Pusher plates are mounted flexibly to the crossbar of the pendulum. A motor drives the special shaped drum cam linked to the pendulum through a ball bearing. The circular motion of the unidirectional moving brushless DC motor is transferred into the linear motion of the pendulum to drive the pusher plates. Using a crossbar with a variable length, the stroke of the pendulum and therefore the displaced blood volume is alterable. To achieve a variable length, an electric driven screw thread or a hydraulic system is possible. Comparable to the natural heart, cardiac output would be determined by frequency and stroke volume.     

Congenital diaphragmatic hernia presenting after the newborn period

Late-presenting congenital diaphragmatic hernia (CDH) is often difficult to diagnose and delay in treatment is common. Seven patients were operated beyond the newborn period for left-sided Bochdaleck hernia. Their age ranged from 1 month to 9 years. Six of them became symptomatic within the 1st year of life (1 week to 9 months of age). Either feeding difficulties or recurrent respiratory infections were initially present. In all of them chest X-rays were performed but delay in diagnosis ranged from 1 week to 5 years. All diaphragmatic defects could be closed by an abdominal approach without postoperative complications. Clinical symptoms disappeared postoperatively. In children with respiratory complaints or feeding difficulties one should be aware of late presenting CDH. A careful analysis of chest films and searching for connecting bowel segments passing through the diaphragmatic defect may help to avoid incorrect diagnosis and undesirable delay in treatment. Confusion with pneumonia or pneumothorax can be diminished by placing a feeding tube and instillation of contrast material. Ultrasound should be used supportively in all suspected diseases of the diaphragm.