OCA Group Research Articles

Effect of oxycodone combined with ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia in patients with lung cancer undergoing thoracoscopic surgery: protocol for a randomised controlled study

IntroductionPostoperative pain is a main component influencing the recovery of patients with lung cancer. The combination of patient-controlled intravenous analgesia (PCIA) and paravertebral nerve block for postoperative analgesia in patients...

3D assessment of alveolar bone alterations in orthodontic movement among Indians.

Apical root resorption, which is characterised as a biological or abnormal phenomenon that shortens the length of the root apex, is additional typical iatrogenic impact of orthodontic tooth movement that may jeopardise the effectiveness of treatment and tooth lifespan. The main goals of the current retrospective investigation were to assess the dimensions of alveolar bone alterations that come along with orthodontic movement and to look into the frequency and extent of resorption of root in maxillary incisors across categories that were similarly managed with clear aligners (OCA) and fixed appliances (OFA) using CBCT. The study included 50 subjects who were divided into two categories with 25 study subjects in each category. Category OFA: Subjects receiving OFA (n=25). A CBCT scan was used to get three-dimensional pictures at the beginning of therapy as well as at the end of therapy. The overall resorption of root at apical region in OFA group was 0.63±0.21 mm. The overall resorption of root at apical region in OCA group was 0.32 ±0.36 mm. The difference in observation was statistically significant (p= 0.000) with reduced resorption of root at apical region in clear aligners. It was concluded that the decrease in thickness of alveolar bone was greater in orthodontic fixed appliances group as compared to clear aligners. The resorption of root at apical region was lesser in clear aligners group as compared to fixed appliances.

Advisable including glucosaminylmuramyldipeptide in Helicobacter pylori therapy: experience of ten-year investigation

Helicobacter pylori infection is a common bacterial infection in humans and is associated with peptic ulcer disease and chronic gastritis. The presence of natural resistance to some antibiotics in bacteria, as well as the appearance of primary and secondary resistance to antibacterial agents, complicates treatment and determines the search for new methods of therapy. The aim of this study was to evaluate the efficacy and safety of 10-year complex treatment of patients with duodenal ulcer associated with H.pylori , 136 patients (96 men, 40 women; mean age 45.8 14.8 years; 18-65 years). H.pylori was determined morphologically and by rapid urease test one day before the start of therapy, after 1, 6, 12 months, 2 years, 5 and 10 years. Patients of the first group received basic therapy: omeprazole 0.02 g 2 times a day, clarithromycin 0.5 g 2 times a day, amoxicillin 1 g 2 times a day, for 10 days (OCA group 1; n = 98). Patients of the second group, in addition to the basic therapy, took 1 mg per day drug Liсopid (group 2 OСAL; n = 38). At the 1st stage of the clinical study, 130 patients completed eradication therapy. Tracking completeness was 96 %. The frequency of H.pylori eradication after per protocol treatment: OCA - 83 % (95 % CI: 75 %-91 %), OCAL - 97 % (95 % confidence interval (CI): 92 %-100 %). The incidence of adverse reactions after treatment (per protocol): OCA - 26 % (95 % CI: 17-35 %; nausea; n = 24), discontinued treatment - 5 % (95 % CI: 0.8 %-10 %; diarrhea; n = 5); OCAL - 3 % (95 % CI: 0.01 %-8 %; nausea; n = 1), all were treated. Taking the drug Liсopid 1 mg (glucosaminyl muramyl dipeptide, JSC Peptek, Russia) as part of complex therapy contributed to the elimination of H.pylori and the absence of relapses for 2 years. Observation of patients in the next 5 and 10 years also showed the advantage of including the immunomodulator in therapy: a significant 15 % decrease in H.pylori reinfection (P 0.05), a 23 % decrease in the frequency of gastrointestinal adverse reactions (P0.01), compared with a 10-day standard triple regimen without immunomodulatory therapy with glucosaminylmuramyl dipeptide. When using several antibiotics in H.pylori eradication therapy, not only pathogenic, but also commensal microorganisms are destroyed, the waste products of which are vital and maintain immune homeostasis, including through the NOD2 receptors of innate immunity. The effectiveness of the complex therapy of H.pylori infection can be explained by the fact that the drug Liсopid compensates for the signal for innate immunity receptors that is missing due to the absence of commensals, providing an adequate immune response and preventing chronicity and recurrence of infection.

Nondestructive Assessment of Articular Cartilage Electromechanical Properties after Osteochondral Autologous and Allogeneic Transplantation in a Goat Model.

To determine the applicability of a minimally invasive diagnostic device to evaluate the quality of articular cartilage following autologous (OAT) and allogeneic (OCA) osteochondral graft transplantation in goat model. OAT grafts were harvested from lateral femoral condyles (LFCs) and transplanted into osteochondral defects created in medial femoral condyles (MFCs) of contralateral knees. OCA grafts were transplanted into MFC condyles after in vitro storage. Autologous platelet-rich plasma (PRP) was administered intraarticularly after the surgery and at 1 and 2 months postoperatively. OAT and OCA grafts were evaluated macroscopically (Oswestry arthroscopy score [OAS]), electromechanically (quantitative parameter, QP), and histologically (O'Driscoll score, safranin O staining intensity) at 3 and 6 months after transplantation. Results were compared with preoperative graft evaluation. Transplanted cartilage deteriorated within 6 months in all groups. Cartilage quality was better retained in OAT group compared with a decline in OCA group. QP and OAS scores were comparable in OAT and OCA groups at 3 months, but superior in OAT group at 6 months, according to all the methods applied. PRP injections significantly improved QP and OAS score at 6 months compared with 3 months in OAT group. QP moderately correlated with OAS, O'Driscoll score, and safranin O staining intensity. Grafts did not retain preoperative quality parameters at 6 months follow-up; however, OAT were superior to OCA grafts. PRP may have a beneficial effect on macroscopic and electromechanical properties of cartilage; however, histological improvement is yet to be proved. Electromechanical diagnostic device enables reliable assessment of transplanted cartilage.

Carbohydrate antigen 125 and carcinoembryonic antigen in the differentiation of tuberculous peritonitis and peritonitis carcinomatosa.

Tumor markers could increase in both tuberculous peritonitis and peritonitis carcinomatosa, confusing the differentiation of these diseases. This study aimed to better understand the extent of elevation and diagnostic efficacies of carbohydrate antigen 125 (CA 125), carcinoembryonic antigen (CEA) and combinative use of them in tuberculous peritonitis and peritonitis carcinomatosa. Of 2998 patients reviewed, 101, 120 and 71 patients were assigned to TBP group (tuberculous peritonitis), non-OCA group (non-ovarian carcinoma-related peritonitis carcinomatosa) and OCA group (ovarian carcinoma-related peritonitis carcinomatosa), respectively. The composite index was calculated by CA 125 multiplying CEA. Receiver operator characteristic curves for CA 125, CEA and composite index were acquired. As a result, CA 125 value in OCA group was higher than other two groups (serum CA 125: P < 0.001; ascites CA 125: P < 0.001). On the other hand, non-OCA group had the highest CEA value among three groups (serum CEA: P < 0.001; ascites CEA: P < 0.001). Area under curves of serum/ascites composite index and serum/ascites CEA were larger than those of serum/ascites CA 125. Furthermore, ascites and serum composite index displayed the best sensitivity (0.907) and specificity (0.989), respectively. In conclusion, CA 125 increases in tuberculous peritonitis and non-ovarian carcinoma-related peritonitis carcinomatosa, but it elevates more in ovarian carcinoma-related peritonitis carcinomatosa. CEA is found to increase more significantly in non-ovarian carcinoma-related peritonitis carcinomatosa. CEA and composite index are helpful in distinguishing peritonitis carcinomatosa from tuberculous peritonitis, but composite index is slightly superior to CEA in the differential diagnosis.

Effect of obeticholic acid on liver regeneration following portal vein embolization in an experimental model

The bile salt-activated transcription factor farnesoid X receptor (FXR) is a key mediator of proliferative bile salt signalling, which is assumed to play a role in the early phase of compensatory liver growth. The aim of this study was to evaluate the effect of a potent FXR agonist (obeticholic acid, OCA) on liver growth following portal vein embolization (PVE). Rabbits were allocated to receive daily oral gavage with OCA (10 mg/kg) or vehicle (control group) starting 7 days before PVE (n = 18 per group), and continued until 7 days after PVE. PVE of the cranial liver lobes was performed using polyvinyl alcohol particles and coils on day 0. Caudal liver volume (CLV) was analysed by CT volumetry on days -7, -1, +3 and +7. Liver function was determined by measuring mebrofenin uptake using hepatobiliary scintigraphy. Additional parameters analysed were plasma aminotransferase levels, and histological scoring of haematoxylin and eosin- and Ki-67-stained liver sections. Three days after PVE of the cranial lobes, the increase in CLV was 2·2-fold greater in the OCA group than in controls (mean(s.d.) 56·1(20·3) versus 26·1(15·4) per cent respectively; P < 0·001). This increase remained greater 7 days after PVE (+1·5-fold; P = 0·020). The increase in caudal liver function at day +3 was greater in OCA-treated animals (+1·2-fold; P = 0·017). The number of Ki-67-positive hepatocytes was 1·6-fold higher in OCA-treated animals 3 days after PVE (P = 0·045). Plasma aminotransferase levels and histology did not differ significantly between groups. OCA accelerated liver regeneration after PVE in a rabbit model. OCA treatment might increase the efficacy of PVE and, thereby, resectability. Surgical relevance Liver failure is the most feared complication after liver surgery, with no effective treatment options. Liver regeneration is essential to avoid liver failure, and recently bile acid signalling was implicated in the initiation of liver regeneration through the nuclear bile acid receptor farnesoid X receptor (FXR). In this study, the potent FXR agonist obeticholic acid accelerated liver regeneration following portal vein embolization in a rabbit model, in terms of liver volume, liver function and proliferation. Obeticholic acid treatment could enhance the efficacy of portal vein embolization, thereby increasing resectability, and could reduce the interval to surgery. In addition, obeticholic acid might have a place in the prevention of liver failure after liver surgery.

A prospective randomized comparison of two skin closure techniques in acetabular fracture surgery

BackgroundRecent publications have shown an infection rate of 5–7 % for acetabular fractures treated with the Kocher-Langenbeck (K-L) approach. Using metallic staples to close hip skin incisions has been considered the gold standard. The purpose of this study was to answer the following: (1) will closure of a K-L incision after acetabular fracture surgery with a running subcuticular monocryl suture, then sealing the wound with 2-octyl cyanoacrylate (OCA), result in a lower infection rate compared to metallic staple closure? (2) Do incisions closed with subcuticular monocryl and OCA exhibit decreased drainage? (3) Is there a cost difference between these two methods?Materials and methodsIn a prospective clinical study, 103 patients with acetabular fractures treated using the K-L approach were randomized into two groups: skin closure with metallic staples (n = 52) versus subcuticular running monocryl suture sealed with OCA (n = 51).ResultsTwo postoperative deep infections (4 %) in the staples group required multiple debridements; no infections developed in the OCA group. However, there was no statistical difference between the groups, (p = 0.495). There was a statistically significant difference (p = 0.032) comparing days from surgery to a dry incision favoring OCA (4.2 versus 5.85 days). The patient charge was approximately $900 greater on average in the OCA group due to the increased time in the operating room required for the subcuticular closure.ConclusionsClosure with OCA and subcuticular monocryl showed no clinical disadvantages and appears to have a clinical advantage when compared to standard metallic staple skin closure in acetabular fracture surgery. However, additional patient costs may be incurred.Level of evidenceII.

Penbactam for Helicobacter pylori eradication: A randomised comparison of quadruple and triple treatment schedules in an Iranian population

Background & study aimsSelection of the best drug regimens for eradication of Helicobacter pylori infection especially in patients at risk of peptic ulcer relapses and the development of complications is challenging. This study assessed and compared the efficacy of the two common PPI based triple therapies to a quadruple therapy including PPI, metronidazole, amoxicillin and a bismuth compound in Iranian population. Patients & MethodsThree hundred and thirty patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomly assigned to one of the three treatment protocols all given twice daily: (a) A 14-day quadruple therapy (OMAB group) comprising omeprazole 20mg, metronicazole 500mg, amoxicillin 1g, and bismuth subcitrate 240mg; (b) A 14-day triple regimen (OCP group) comprising omeprazole 20mg plus clarithromycine 500mg and penbactam 750mg and (c) A 14-day triple regimen (OCA group) comprising omeprazole 20mg plus clarithromycine 500mg and amoxicillin 1g. Cure was defined as a negative urea breath test at least six weeks after treatment. ResultsThe per-protocol eradication rates achieved with both OCP regimen (87.0%) and OCA treatment (90.8%) were significantly higher than the OMAB treatment protocol (56.0%); however, no significant difference emerged in eradication rates between the two triple treatment schedules. No significant differences between the groups were found in most side-effects. ConclusionTwo-week quadruple therapy showed a lower eradication rate compared to common triple treatment schedules when used as first-line eradication treatment for H. pylori infection in Iranian population.

Adjuvant probiotics improve the eradication effect of triple therapy forHelicobacter pyloriinfection

To investigate whether the addition of probiotics can improve the eradication effect of triple therapy for Helicobacter pylori (H. pylori) infection. This open randomized trial recruited 234 H. pylori positive gastritis patients from seven local centers. The patients were randomized to one-week standard triple therapy (omeprazole 20 mg bid, clarithromycin 500 mg bid, and amoxicillin 1000 mg bid; OCA group, n = 79); two weeks of pre-treatment with probiotics, containing 3 × 10(7)Lactobacillus acidophilus per day, prior to one week of triple therapy (POCA group, n = 78); or one week of triple therapy followed by two weeks of the same probiotics (OCAP group, n = 77). Successful eradication was defined as a negative C13 or C14 urease breath test four weeks after triple therapy. Patients were asked to report associated symptoms at baseline and during follow-up, and side effects related to therapy were recorded. Data were analyzed by both intention-to-treat (ITT) and per-protocol (PP) methods. PP analysis involved 228 patients, 78 in the OCA, 76 in the POCA and 74 in the OCAP group. Successful eradication was observed in 171 patients; by PP analysis, the eradication rates were significantly higher (P = 0.007 each) in the POCA (62/76; 81.6%, 95% CI 72.8%-90.4%) and OCAP (61/74; 82.4%, 95% CI 73.6%-91.2%) groups than in the OCA group (48/78; 61.5%, 95% CI 50.6%-72.4%). ITT analysis also showed that eradication rates were significantly higher in the POCA (62/78; 79.5%, 95% CI 70.4%-88.6%) and OCAP (61/77; 79.2%, 95% CI 70%-88.4%) groups than in the OCA group (48/79; 60.8%, 95% CI 49.9%-71.7%), (P = 0.014 and P = 0.015). The symptom relieving rates in the POCA, OCAP and OCA groups were 85.5%, 89.2% and 87.2%, respectively. Only one of the 228 patients experienced an adverse reaction. Administration of probiotics before or after standard triple therapy may improve H. pylori eradication rates.

Quadruple versus common triple-treatment regimens for Helicobacter pylori eradication in the Iranian population: A randomised study

Background and study aims Selection of the best drug regimens for effective eradication of Helicobacter pylori ( H. pylori) infection, especially in patients at risk of peptic ulcer relapses and development of complications of peptic ulcer disease, is challenging. This study assessed and compared the efficacy of the two common proton pump inhibitor (PPI)-based triple therapies to a quadruple therapy including PPI, metronidazole, amoxicillin and a bismuth compound in Iranian population. Patients and methods A total of 330 patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomly assigned to one of the three treatment protocols: (1) a 14-day quadruple therapy (OMAB group) comprising omeprazole 20 mg, metronidazole 500 mg, amoxicillin 1 g and bismuth subcitrate 240 mg; (2) a 14-day triple regimen (OCP group) comprising omeprazole 20 mg plus clarithromycin 500 mg and penbactam 750 mg; and (3) a 14-day triple regimen (OCA group) comprising omeprazole 20 mg plus clarithromycin 500 mg and amoxicillin 1 g, all given twice daily. Cure was defined as a negative urea breath test at least 6 weeks after treatment. Results The intention-to-treat H. pylori eradication rates achieved with both OCP regimen (87.0%) and OCA treatment (88.8%) were significantly higher than the OMAB treatment protocol (56.0%); however, no significant difference emerged in eradication rates between the two triple-treatment schedules. No significant differences were found in most side effects between the groups. Conclusion Two-week quadruple therapy showed a lower eradication rate compared with common triple-treatment schedules when used as a first-line eradication treatment for H. pylori infection in the Iranian population.

Efecto del tratamiento erradicador en pacientes con dispepsia funcional e infección por Helicobacter pylori: ensayo clínico aleatorizado frente a placebo

The Helicobacter pylori eradication in patients with functional dyspepsia has been the subject of controversy because trials come to contradictory conclusions. The objective of this trial was to evaluate the effect, compared with placebo, of the eradication treatment in patients with functional dyspepsia.Randomized double blind placebo controlled trial. We included 158 patients attended by family physicians (Area 10 Primary Care, Health Institute of Madrid) with functional dyspepsia and Helicobacter pylori infection detected by the ureasa test in endoscopy. An OCA (ameprazole clarithromycin and amoxicillin group (n = 79) and a placebo group (n = 79) were randomized. During 7 days, patients at the OCA group received omeprazole (20 mg bid), clarithromycin (500 mg bid) and amoxicillin (1000 mg bid) daily, and patients at the control group received the placebo agent twice daily. Dyspepsia improvement according to a Likert scale (5 steps), and eradication of H. pylori by 13C-urea breath test were evaluated during one year.Both groups were homogeneous in relation to age, sex and dyspepsia degree. The average age (standard deviation) of studied patients was 41.99 (13.93) years. At one year of follow up, H. pylori was eradicated in 81.01% (64/79) of the OCA group and 5.06% (4/79) of the placebo group. The difference of dyspepsia improvement (22.78%; 95% confidence interval [CI], 7.62-37.79) between the OCA group (41.77%; 95% CI, 30.77-53.41), and the placebo group (18.99%; 95% CI 11.03-29.38) was significant (p = 0.0018).Eradication of Helicobacter pylori in patients with functional dyspepsia is more effective improving symptoms than placebo.

Efficacy and Tolerability of Three Regimens for Helicobacter pylori Eradication

Helicobacter pylori plays a pivotal role in gastroduodenal disease. Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proven to be an effective treatment for H. pylori. The aim of this study was to compare the eradication efficacy and tolerability profile of a 7-day course of RBC plus clarithromycin and amoxicillin, RBC plus clarithromycin, and omeprazole plus clarithromycin and amoxicillin. Prospective, randomised, double-blind, multicentre study. A total of 154 H. pylori-positive patients with dyspeptic symptoms were randomised to RBC 400mg twice daily (bid) plus clarithromycin 500mg bid and amoxicillin 1g bid (RBCCA group, n = 53); RBC 400mg bid plus clarithromycin 500mg bid (RBCC group, n = 52); or omeprazole 20mg bid plus clarithromycin 500mg bid and amoxicillin 1g bid (OCA group, n = 49) administered for 7 days. H. pylori infection was initially detected on an antral biopsy by the rapid urease test and confirmed by 13C-urea breath test. H. pylori status was assessed by 13C-urea breath test at least 28 days after the end of treatment. There were no statistically significant differences in eradication rates per intention-to-treat (ITT) analysis (n = 149) and per protocol (PP) analysis (n = 135) among the three regimens. Eradication rates per ITT were 82.6% [95% confidence interval (CI), 69.2 to 92%] for RBCCA; 82% (95% CI, 68.7 to 91.9%) for RBCC; and 72.3% (95% CI, 57.7 to 85.6%) for OCA. The corresponding figures for the PP analysis were 85.1% (95% CI, 71.1 to 93.1%), 83% (95% CI, 68.7 to 91.9%), and 73.2% (95% CI, 56.8 to 85.2%), respectively. All regimens were well tolerated. Adverse events occurred in 59 (38%) of the 154 patients and included minor gastrointestinal symptoms and neurological complaints (anxiety, insomnia and headache). The results of this study suggest that the best approach to eradicate H. pylori may be the combination of ranitidine bismuth citrate with clarithromycin either with or without amoxicillin.

The effect of oral contraceptive agents on the basal metabolic rate of young women.

The use of oral contraceptive agents by women may be a factor that contributes to the observed inter-individual variability in the BMR. We, therefore, measured the BMR, body build and composition in two groups of young women and also assessed their self-reported level of physical activity. One group had been using oral contraceptive agents for a period of 6 months or more (OCA, n 24), while the other group had never used oral contraceptives (NOCA, n 22). There were no significant differences in age, body build or composition. The absolute BMR in the groups were not significantly different when compared using an unpaired t test (OCA: 5841 (SD 471) v. NOCA: 5633 (SD 615) kJ/d). However, using an analysis of covariance, with either body weight or a combination of fat and fat free mass as covariates, the OCA group had a BMR almost 5% higher than that of the NOCA group (OCA: 5871 v. NOCA: 5601 kJ/d; P = 0.002). When those subjects with high self-reported levels of physical activity were excluded, the difference in BMR between the two groups persisted (P = 0.001). An ANOVA of oral contraceptives use and phase of menstrual cycle showed significant differences in BMR with use of oral contraceptives (P = 0.004) but no difference in BMR between phases of the menstrual cycle. In conclusion, the use of oral contraceptive agents deserves consideration when conducting and analysing data from studies on energy metabolism in young women, as it results in a significantly higher BMR.

Oral contraceptives and fibrinolysis among female cyclists before and after exercise.

The effect of oral contraceptives on a number of plasma fibrinolytic variables and antithrombin III was studied in 20 highly trained women before and immediately after exhaustive exercise on a bicycle ergometer. Two groups were studied, 11 women using an oral contraceptive agent (OCA group) and 9 women not using an oral contraceptive (control group). Factor XII, prekallikrein, plasminogen, alpha 2-antiplasmin, and antithrombin III activities were determined in plasma as well as a number of cardiovascular, respiratory, and metabolic components. Resting values showed a significantly higher level of prekallikrein and plasminogen in the OCA group compared with the control group. Exercise plasma values of components of the fibrinolytic system were significantly higher than resting values in both groups. However, when corrected for plasma volume changes, the exercise levels of prekallikrein and antithrombin III were significantly decreased in the OCA group only, whereas alpha 2-antiplasmin exercise level was significantly lower in both groups. Our results indicate that use of OCA even with an estrogen dosage as low as 30 micrograms has an effect on resting and exercise fibrinolytic variables; an effect, however, which does not seem to interfere with maximal performance in trained women.

Effect of oral contraceptives agents on thiamin, riboflavin, and pantothenic acid status in young women

Thiamin, riboflavin, and pantothenic acid status were determined in 13 young women, ages 19-25, at the beginning and end of a 12-day confined study. 9 women were using (+OCA) oral contraceptives and the other 4 were not (-OCA). The subjects entered the metabolic unit during the 1st week of their menstrual cycle and were fed a constant formula diet containing 2.0 mg thiamin, 3.0 mg riboflavin, and 10 mg pantothenic acid. Prestudy intakes, estimated from 3-day dietary records, were about 1/2 of the thiamin, riboflavin, and pantothenic acid levels fed in the study, and were similar in both groups. Use of OCs did not appear to influence the activity of erythrocyte transketolase or erythrocyte glutahione reductase or the response of these enzymes to in vitro stimulation by their cofactors. The enzymes were responsive to the levels of thiamin and riboflavin fed during the study, however. In the +OCA group, erythrocyte transketolase and erythrocyte glutahione reductase stimulation by their cofactors was significantly decreased by day 12. At the beginning of the study, blood and urine pantothenic acid levels were significantly lower in the +OCA group than the -OCA group. These differences were no longer evident by the end of the study. The data show that when dietary intakes and times of sampling in the menstrual cycle are controlled, OCs do not cause significant changes in the biochemical parameters of thiamin, riboflavin, and pantothenic acid status.

The effect of oral contraceptives on vitamin B12 metabolism

Serum vitamin vitamin B12 levels were determined in 199 women who were on a regnnen of oral contraceptives of either the combination or sequential type and in a control group of 196 women. The group using oral contraceptive agents.(OCA) had significantly lower serum levels of vitamin B12 vitamin as compared to those of the control group. A total of 19 women using OCAs had serum vitamin B12 levels that were lower than normal values. However, the Schilling test and urinary methylmalonate excretion in this group were normal. The OCA group had a significantly lower total serum vitamin B12 binding capacity, a lower total transcobalamin I level, and a higher transcobalamin III level. Our study suggests that the fall of serum vitamin B12 in OCA users is due to the changes in vitamin B12 binders of serum arid does not represent vitamin B12 deficiency. Therefore, aceording to our data, there is no justification for vitamin B12 supplementation in users of oral contraceptives.

Effect of Low Zinc Intake and Oral Contraceptive Agents on Nitrogen Utilization and Clinical Findings in Young Women

In a previous paper we reported that serum, urine and fecal zinc levels fell markedly in women taking a combination oral contraceptive agent (+OCA) and in women with normal menstrual cycles (-OCA) when they consumed a low-zinc diet (less than 0.2 mg/day) for 35 days. We evaluated other biochemical and clinical data in order to determine if depletion of accessible body zinc and/or physiologic adjustment to conserve body zinc stores had occurred. Neither low zinc intake nor oral contraceptive use appeared to influence nitrogen balance or body weight. Use of contraceptive drugs appeared to influence the response of blood parameters to zinc depletion. Serum transferrin and cholesterol declined significantly in the -OCA group, whereas alkaline phosphatase and gamma-globulin changed significantly in both groups. Clinical problems developed in all the subjects with serum zinc levels below 50 microgram/dl during the study; three of the six with serum zinc levels above 50 microgram/dl also complained of clinical symptoms. The results suggest that zinc deficiency through depletion of accessible body zinc stores developed during the 35-day study.