Protocol of comparison of the effects of single plasma exchange and double filtration plasmapheresis on peripheral lymphocyte phenotypes in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: a monocentric prospective study with single-case experimental design.

BACKGROUND: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without pathogenic antibodies but with modified cell profiles have been described. Treatments include corticotherapy, intravenous immunoglobulins, and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques-single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques. METHOD: In this proof-of-concept, monocentric, prospective, Single-Case Experimental Design study, 5 patients are evaluated by alternating their treatment type (single plasma exchange or DFPP) for 6 courses of treatment after randomization to their first treatment type. Each course of treatment lasts 2-4 weeks. For single plasma exchange, 60 ml/kg plasma will be removed from the patient and replaced with albumin solutes, with a centrifugation method to avoid the immunological reaction caused by the membrane used with the filtration method. For DFPP, 60 ml/kg plasma will be removed from the patient with a plasma separator membrane, then processed via a fractionator membrane to remove molecules of a greater size than albumin before returning it to the patient. This technique requires no substitution solutes, only 20 g of albumin to replace what would normally be lost during a session. The primary outcome is the difference between the two plasmapheresis techniques in the variation of the TH1/TH17 ratio over the period D0H0-D0H3 and D0H0-D7. Secondary outcomes include the variation in lymphocyte subpopulations at each session and between therapeutic plasmapheresis techniques, the clinical evolution, tolerance and cost of treatments. DISCUSSION: Understanding the action mechanisms of single plasma exchange and DFPP will help us to offer the right treatment to each patient with CIPD according to efficacy, tolerance and cost. TRIAL REGISTRATION: ClinicalTrials.gov under the no. NCT04742374 and date of registration 10 December 2020.

Method to determine radiative and non-radiative defects applied to AgInS2-ZnS luminescent nanocrystals.

The systematic measurement of the photoluminescence quantum yield and the recombination lifetime of a given phosphor allows for the quantification of both radiative and non-radiative recombination rates. This analysis therefore separates the two types of phenomena influencing the quantum efficiency of the phosphor. When associated with other materials characterizations, this powerful tool allows for the determination of the relationship between the structural properties and the efficiency of the photoluminescence process. This article presents this method and its direct application to emerging luminescent quaternary semiconductor nanocrystals. First, the direct effect of disorder on non-radiative recombination rate is demonstrated. Then, strong evidence concerning the nature of the donor and acceptor defects involved in the photoluminescence process of these materials are obtained using XPS.

[Validation of the 13-30ARAMAV assessment, a new quality of life and autonomy questionnaire adapted to visually impaired patients]. / Validation du bilan 13­30ARAMAV, un nouveau questionnaire de qualité de vie et d'autonomie adapté aux patients déficients visuels.

PURPOSE: To evaluate the ARAMAV 13-30 questionnaire, a new autonomy and quality of life questionnaire developed for visually impaired patients. METHODS: We carried out a single-center prospective study at the ARAMAV institute in collaboration with the University Hospital of Nîmes. The patients included were admitted for low vision rehabilitation. Each patient received an occupational therapy assessment, the Short Forms 36 (SF36) quality of life questionnaire and the ARAMAV 13-30 questionnaire at the start and at the end of rehabilitation. We verified the reproducibility, the sensitivity to change, and internal and external consistency of the questionnaire. RESULTS: We included 231 patients over a period of 4 years. All the patients were blind or visually impaired. We observed excellent intra- and interuser reproducibility of the questionnaire, with a Lin coefficient>0.9 (0.99 and 0.91, respectively). By comparing the variations of the different scores between before and after low vision rehabilitation, we observed excellent sensitivity to change for both the autonomy and quality of life portions of the questionnaire. Finally, we observed excellent internal and external consistency. CONCLUSION: We therefore propose the ARAMAV 13-30 questionnaire as a new tool in evaluating autonomy and quality of life specifically in visually impaired patients, which may also be used to assess the effect of low vision rehabilitation.

[How WHI study influences women doctors' behaviour towards menopause]. / Impact de l'étude WHI sur le comportement des femmes médecins vis-à-vis de la ménopause.

OBJECTIVE: A survey entitled FEMME was conducted during 2002 in order to evaluate among French women doctors their own actual or future menopause perception and this before the WHI publication. The results of this American trial possibly modified the perception of these French women doctors. Therefore the same experts group conducted a new survey, from May to September 2003. The main aim of this survey was to evaluate the possible changes in the medical management of the actual or future menopause of these women, and secondarily to evaluate the changes in their patients' behaviour towards hormone replacement therapy (HRT). POPULATION AND METHODS: Postal auto administered questionnaires were sent to the same 10 000 French women doctors (GP or gynaecologist) whatever their menopausal status or their age. 1365 women doctors (respectively 18,5 or 11% of the gynaecologists or GPs contacted) were volunteers to participate in this survey. Among them, 1120 (84,9%) had already participated in the first part of this survey which took place before the WHI publication. RESULTS: 80% of these women doctors have been informed on WHI results principally by professional press or conferences. 70,9% changed their own actual or future menopause perception as follows. No additional selection of non hormonal treatment have been mentioned in comparison with the first part of the survey. On the other hand for HRT, selections of free estrogen plus progestin associations increased whereas those of fixed combinations decreased: this might be linked to the greater variety of estrogen doses, types of progestin and schedules of treatment (mostly with bleeding) offered by this kind of associations. Finally, duration of HRT is included between three and ten years in most cases. DISCUSSION AND CONCLUSION: Thus, unlike most of their patients, these women's physicians always preferred hormonal treatment for their own actual or future menopause. Only the conditions of these treatments have changed.

Atherosclerosis of the thoracic aorta and aortic debris as a marker of poor prognosis: benefit of oral anticoagulants.

OBJECTIVES: Our aim was to confirm the poor prognosis related to thoracic aortic plaques, in particular aortic debris, diagnosed by transesophageal echocardiography (TEE) and to evaluate patients' prognosis as a function of the antithrombotic treatment. BACKGROUND: Aortic atheroma (AA) has been widely studied. However, it is still not known which antithrombotic treatment should be adopted in this disease. METHODS: Patients referred for TEE and diagnosed with AA were followed. All thromboembolic events and deaths were recorded during a follow-up of 22+/-10 months. The antithrombotic treatment to be adopted was left to the discretion of the practitioner in charge of the patient. RESULTS: Aortic atheroma was found in 12% of all TEE performed and in 27.5% of TEE performed for stroke. This prevalence was higher when no other etiology existed to explain the stroke (p < 0.001). During follow-up, an end point occurred in 22.5% of patients. The more severe the AA the greater the incidence of events (p = 0.007). A higher mortality rate is shown in patients with aortic debris (p = 0.049). Compared with those treated with oral anticoagulants, patients with aortic plaques >4 mm thick treated with antiplatelets had more embolic events and combined events (p = 0.01 and p = 0.007, relative risk [RR] = 5.9, 95% confidence interval [CI] = 1.4 to 15, respectively); patients with aortic debris had more combined events and a higher mortality rate (p = 0.001, RR = 7.1, 95% CI = 1.2 to 19 and p = 0.019, RR = 9.1, 95% CI = 1.2 to 25, respectively). CONCLUSIONS: We confirm the high incidence of vascular events and deaths in patients with AA. We have demonstrated, for the first time in this condition, a better outcome among patients treated with oral anticoagulants versus antiplatelets.

[Methodology of the inquiry MISSION (menopause, breast cancer risk, morbidity and prevalence)]. / Méthodologie de l'enquête MISSION (Ménopause, rISque de cancer du SeIn, mOrbidité et prévaleNce).

OBJECTIVE: The ambition of this article is to detail and to explain the methodology of the study named MISSION (Menopause: breast cancer risk, morbidity and prevalence). The aims of MISSION are to determine the prevalence of breast cancer and global morbidity in France among menopausal women treated or not with hormone replacement therapy (HRT) and followed by a gynecologist. MATERIAL AND METHOD: 6600 menopausal women [3300 with HRT -- ie for estrogen: only estradiol via oral or transdermal administration; for progestogen: natural progesterone or assimiled or one pregnane derived (excluding medroxyprogesterone acetate) or non-pregnane derived -- and 3300 without HRT] will be enrolled in France between January 5 2004 and February 28 2005 by 825 gynecologists, members or not of the National Federation of Medical Gynecologists (FNCGM). This study design is a historico-prospective with case randomization. MISSION is conducted by a Theramex-Merck Laboratories initiative in collaboration with a WHO (World Health Organization) Collaborating Center for Public Health Aspects of Rheumatic Diseases and a multidisciplinary expert group. CONCLUSION: First results of this study will contribute to better knowledge of women health.

Travel as a risk factor for venous thromboembolic disease: a case-control study.

BACKGROUND: The link between travel and the risk of venous thromboembolic disease (VTED) has been widely suspected. However, only cases or series of cases have been reported in the literature. STUDY OBJECTIVES: By means of a case-control study, we sought to confirm this relationship and to determine the main features, if any, of these posttravel VTEDs. DESIGN: The history, in particular the history of recent travel, of 160 patients presenting in our department with VTED was scrupulously investigated. All journeys undertaken during the preceding 4 weeks and lasting > 4 h by whatever means of transport were considered. The same questionnaire was submitted to a control group. RESULTS: When the two groups of patients are compared, a history of recent travel is found almost four times more frequently in the VTED group (p < 0.0001). The odds ratio for having a VTED in patients who traveled was 3.98 (95% confidence interval, 1.9 to 8.4). Means of travel used included the train in 2 cases, airplane in 9, and car in 28. Mean duration of travel was 5.4+/-2.1 h. These posttravel VTEDs are not confined to a specific location, seem to involve no particular predisposition, and are more often "idiopathic." This fact supports the hypothesis that travel alone can produce vein clot formation. CONCLUSIONS: A history of recent travel is a risk factor for VTED. Posttravel venous thrombotic events can occur after short journeys in patients with no other risk factors or concomitant disease

Non-invasive blood pressure variability in chronic heart failure: characteristics and prognostic value.

BACKGROUND: Short-term variability of blood pressure can be used as an index of sympathetic vascular modulation and has been studied in patients with hypertension. AIM: The aim of this study was to characterise blood pressure variability (BPV) and its prognostic value in patients with congestive heart failure. METHODS AND RESULTS: 104 patients with congestive heart failure due to ischemia (n = 104) or idiopathic cardiomyopathy (n = 50) in New York Heart Association (NYHA) class II (n = 50), III (n = 71), IV (n = 33), and 40 healthy subjects were studied. The mean ejection fraction was 0.33 +/- 0.10. Continuous non-invasive BP recordings were obtained for 3,600 seconds with a photoplethysmographic finger device in patients and control subjects at rest. Patients with chronic heart failure (CHF) had significantly less pronounced BPV than control subjects. Diastolic blood pressure (DBP) variability was related to left ventricular ejection and to peak oxygen uptake. BPV was not different in patients with ischemic or idiopathic CHF. During the mean follow up (+/- SD) of 565 +/- 215 days, 44 patients died (28.6%). All deaths were cardiac related. Cox's univariate analysis identified the following factors to be predictors of death: peak oxygen uptake (p = 0.01), ejection fraction (p = 0.008), and among BPV parameters: total spectral amplitude (TA) for DBP (p = 0.002), very low frequencies over total amplitude (VLF/TA) for DBP (p = 0.005) and for mean blood pressure (MBP) (p = 0.03), and very low over high frequencies ratio (VLF/HF) for DBP (p = 0.002). Multivariate analysis showed that BPV predicted survival independently of EF or peak VO2. Kaplan-Meier survival curves revealed that VLF/TA < 55% for DBP, MBP and SBP are useful risk factors. One-year survival in patients with VLF/TA < 55% of DBP was 53% compared with 95% in those with VLF/TA > 55% (p = 0.005). CONCLUSIONS: Decreased BPV in patients with CHF is related to left ventricular dysfunction. Analysis of BPV can identify patients with CHF who have an increased risk of cardiac death.

[Evaluation of the efficacity and speed of action of sertaconazole nitrate suppository and cream combined treatment for vulvovaginal candidiasis]. / Evaluation de l'efficacité et de la rapidité d'action d'un traitement associant un ovule et une crème de nitrate de sertaconazole dans la candidose vulvovaginale.

OBJECTIVE: To assess efficacy and speed of action of a monodose sertaconazole vaginal suppository administered as a single treatment or combined with sertaconazole cream applied to the vulvar area. METHODS: This prospective, multicentric, randomised open study was conducted on 77 women with vulvovaginal candidiasis confirmed by mycological examination. They were either treated with one sertaconazole monodose vaginal suppository only (group O) or treated with the suppository combined with sertaconazole cream applied to the vulvar area for 7 days (group OC). The patients who were not clinically cured at D7 received a second phase of treatment. RESULTS: Clinical cure rates were higher in group OC than in group O at D7 (76% versus 68%), and D14 (100% versus 80%). The efficacy on symptoms was faster in group OC, with 78% of the patients relieved of pruritus as early as D2 versus 61% in group O, although these differences were not significant. Clinical local tolerance was very good, with 95% of patients not experiencing any local side effects. CONCLUSION: When candidiasis is both vulvar and vaginal, the combination of sertaconazole cream with a monodose sertaconazole vaginal suppository tends to improve clinical cure at D7 and D14 and to relieve more patients as early as D2 than the vaginal suppository used as a single treatment.

[Comparison of changes in biochemical markers of bone turnover after 6 months of hormone replacement therapy with either transdermal 17 beta-estradiol or equine conjugated estrogen plus nomegestrol acetate]. / Comparaison de l'évolution des marqueurs biologiques du remodelage osseux après six mois de traitement hormonal substitutif par 17 beta-estradiol cutané ou estrogènes sulfoconjugués équins et acétate de nomégestrol.

OBJECTIVE: To compare changes in biochemical markers of bone turnover in postmenopausal women who received sequential discontinuous hormone replacement therapy (HRT) with either transdermal 17 beta-estradiol gel (group 1) or oral equine sulfoconjugated estrogen (group 2), plus nomegestrol acetate. PATIENTS AND METHOD: Prospective, open, randomized, controlled trial, conducted on 3 parallel groups of 106 postmenopausal women. All treated groups received estrogen therapy for 25 consecutive days every month. The estrogen used was either 1.5 mg/day of transdermal 17 beta-estradiol gel (group 1) [N = 42, average age (AA) = 51.6 years, average duration of menopause (ADM = 21.5 months)], or 0.625 mg/day of oral equine sulfoconjugated estrogen (group 2) [N = 39, AA = 51.3 years, ADM = 16.8 months]. In all cases nomegestrol acetate 5 mg/day was added for 12 consecutive days every month. The control group comprised 25 patients, [AA = 53.4 years, ADM = 33.7 months]. Two bone resorption markers: urinary cross-linked N-telopeptide and C-telopeptide of type I collagen (U-NTX/Cr, U-CTX/Cr), and a bone formation marker: serum bone specific alkaline phosphatase activity were measured before and 6 months after treatment start. RESULTS: Significant decreases from baseline values were observed for the 3 biochemical markers in both treated groups compared with control (P < 0.001). There were no significant differences in changes between the 2 treated groups for the 3 biochemical markers. The mean percentage change in the 3 biochemical markers was: from -9.3 to -45.5% in group 1, from -20.5 to -39% in group 2, and from -3.3 to 2% in control group. In group 1, the mean percentage decreases in U-CTX reached optimal threshold of bone turnover change (-45%) which is considered by the International Osteoporosis Foundation as clinically relevant because it predicts an increase in BMD greater than 3% when treatment is maintained over a long term. DISCUSSION AND CONCLUSION: Both treated groups induced a significant comparable decrease of bone turnover markers after 6 months of intervention, compared with control. The group treated with cyclic administration of transdermal 17 beta-estradiol (1.5 mg/day) and nomegestrol acetate (5 mg/day) showed a bone resorption markers decrease corresponding to the threshold of clinical relevance described in the international literature and predictive of positive BMD response in long term.

[Biological and clinical safety of nomegestrol acetate administered alone then associated in inverse sequence with transdermal 17 beta estradiol, in women at risk of dyslipoproteinemia type IIa]. / Tolérance biologique et clinique du Nomégestrol acétate, administré seul puis associé en séquentiel inversé au 17 beta estradiol cutané, chez des femmes à risque présentant une dyslipoprotéinémie de type IIa.

In this study including 26 patients with dyslipoproteinemia classified IIa, we evaluated biochemical and clinical safety of Nomegestrol acetate (Lutenyl) used for its antigonadotrophin property. It was administered alone, during 3 cycles at the dose of 5 mg/d for 21 days by cycle and then it was associated (at the same sequence and dose), without any wash out, for the next 6 cycles, with a 17 beta estradiol patch (Estraderm TTS 50), 50 micrograms/d from the 11th to the 21st day of each cycle. Nomegestrol acetate, alone, had no significant effect on glycemia, antithrombin III, triglycerides, total cholesterol, apoprotein A1, and LpA1 values compared to those at baseline but apoprotein B and Lp (a) values tended to decrease slightly. Serum progesterone levels were collapsed, and FSH values were low. Weight and blood pressure remained constant. Adding 17 beta estradiol enabled to significantly decrease and normalize the apoprotein B values after the first 3 cycles compared to the baseline values, then these values remained constant during the next 3 cycles. There was no effect on the other parameters (except for a significant increase in plasmatic estradiol values) on the antigonadotrophin property of Nomegestrol acetate, nor on weight and blood pressure which remained constant. Moreover, we observed an important decrease in the rate of amenorrheic cycles compared to those with Nomegestrol acetate alone.

[Determination of acceptability of 2 cutaneous estradiol gels, in a dose of 1.5 mg daily]. / Appréciation de l'acceptabilité de deux gels d'estradiol cutané, à la dose d'1,5 mg par jour.

OBJECTIVE: The aim was to compare acceptability of a percutaneous 0. 1% estradiol gel (Gel A, Estreva(R) Gel, Laboratoire Théramex, Monaco) to that of an 0.06% estradiol gel (Gel B, Oestrodose(R), Laboratoires Besins-Iscovesco) in its new formulation and packaging. MATERIAL AND METHODS: This randomized, crossed, simple-blind study was carried out in 48 volunteer healthy postmenopausal women. The volunteers applied on one forearm 1.5 mg/day of cutaneous estradiol in the form of either gel, according to randomized allocation, for four days without free period between the two therapeutic periods. The application and drying times of the two gels were measured during the first application; gel subjective women assessment was collected at the beginning and at the end of the study. RESULTS: Mean application and drying times with Gel A are significantly reduced, compared to Gel B (p=0.0259 and p=0.0001, respectively) with drying time 61% shorter; these data are confirmed by subjective women evaluation. The two gels are not significantly different regarding several criteria as consistency, ease of application and sensation of lasting stickiness. However, a significant difference is found in favour of Gel A on the following items: practicality of application (p=0.007), ease of penetration (p<0.001), quantity of gel to apply (p<0.001) after the first application. After four days of administration, a same significant difference is observed concerning practicality of the gel (p=0.0078), duration of use (p<0. 001), packaging, women opinion on the gel (p=0.022) and the product, gel and packaging (p<0.001). At the end of the study, gel A utilization is considered by women more practical (p=0.001) with an easier application (p<0.001) and less restricting while applying (p=0.001), compared to Gel B; 72.9% of women prefer the Gel A and 12. 5% of women prefer the Gel B. CONCLUSION: A better acceptability of the 0.1% estradiol gel and of its packaging compared to that of the 0.06% estradiol gel in this new formulation and packaging is observed in this study.

[Can medical files be used to audit hospital health care? Results of a regional audit of hospital file quality]. / Peut-on utiliser le dossier médical pour des audits de pratique à l'hôpital? Résultats d'un audit régional de la qualité de la tenue du dossier médical hospitalier.

OBJECTIVES: The clinical audit method based on a retrospective analysis of medical files can be used to assess hospital health care. The reliability of the results obtained depends on the validity of the data in the file and its completeness. The aim of this work was to assess the quality of this information source. METHODS: The simplified ANDEM/ANAES from was proposed to 47 medical information departments of public and private hospitals participating in the public health care service in the Provence-Alples-Côte d'Azur region. The audit was conducted on a sample of hospital stays during a regular 6-month quality control assessment of hospital health care activity. RESULTS: Analysis of the 467 forms returned by 39 hospitals, showed that the quality of medical file recordings should be improved as a large amount of data or important documents were missing: reason for hospitalization (recorded on 74.1% of files), operation report (found in 83.2% of files) and discharge summary (found in 66.6% of files). CONCLUSION: Clinical audits would be compromised in certain hospitals by the use of medical files. Efforts to improve the quality of hospital medical files should be a priority.

[Public health education integrated in hospital. An internship proposal, "Medical information and pharmacology"]. / Enseignement de santé publique intégré aux stages hospitaliers. Une proposition de stage "Information médicale et pharmacologie".

According to a recent circular reforming french medical studies, we propose a teaching of medical information and pharmacology in situ within hospital instructions. Students could acquire an investigation methodology on the medicine economy. It will cover in four sessions the succeeding stages of medical information processing and be subject to an assessment: case studies and appreciation on student's, instruction record. By combining public health teaching with clinical practice, our project promotes its development in contact with other learnings and activities such as clinical research.

[A method for auditing medical records quality: audit of 467 medical records within the framework of the medical information systems project quality control]. / Méthode d'audit de la qualité du dossier médical: audit de 467 dossier médicaux dans le cadre du contrôle de qualité PMSI.

Future hospital accreditation could take into account the quality of medical files. The objectives of this study is to test a method for auditing and evaluating the quality of the handing of medical files. We conducted a retrospective regional audit based on the frame of reference the National Agency for Medical Development and Evaluation, by using a sample of cases, stratified by establishment. In our region, the global budgets of 47 public and private hospitals participating in the public hospital service, are adjusted while keeping in mind the medicalised activity data (PMSI). This audit was proposed to the doctors of the Department of Medical Information on the occasion of the regulatory PMSI quality control. A total of 467 questionnaires were given by 39 of the 47 sollicited hospitals (83%). The methodological aspects (questionnaire, cooperative approach...) are discussed. The make-up of medical files can alos be improved by raising the percentage of the presence of important data or documents such as the reason for admission (74.1%), the surgery report (83.2%), and the hospitalisation report (66.6%). A system for classifying the paraclinical results is shared and systematic throughout the service or hospital in only 73.2% of cases. The quality of the handing of medical files seems problematic in our hospitals and actions for improving the quality should be undertaken as a priority.

[Multi-targeted antifolate therapy roe non-small cell lung cancer and mesothelioma]. / Multi-targeted antifolate dans le traitement du cancer bronchique non à petites cellules et du mésothéliome.

Multi-targeted antifolate (MTA) is an anti-metabolite with useful activity in the treatment of non-operable patients presenting with non-small cell lung cancer. Its good efficacy and tolerability profile as first-line therapy was demonstrated in phase II studies of MTA as monotherapy. The use of MTA as second-line therapy with or without a platinum analog also provides good results. It should be observed that, in combination with cisplatin (C), docetaxel or gemcitabine (G), MTA presents synergistic efficacy: two phase II protocols have shown that the MTA/C combination as first-line therapy presented high efficacy (objective response: 39-45%) and low toxicity. These results are promising and also seem to be observed in an ongoing phase II study evaluating MTA/G. In the treatment of mesothelioma, promising activity was observed for the MTA/C combination, and this activity is under evaluation in ongoing phase II and phase III studies.

Effects of growth hormone in short children after renal transplantation. French Society of Pediatric Nephrology.

From 1991 to 1993, 90 children having received a kidney graft with a post-transplantation period of at least 12 months were included in a prospective study carried out in 18 French pediatric centers. After informed consent and randomization, children received recombinant human growth hormone (rhGH) (Genotonorm, Pharmacia peptide hormones) 30 U/m2 per week, either immediately on enrollment, for the treated group, or after 1 year of follow-up for the group serving as a control. After 1 year both groups were treated and we analyzed data during the subsequent years. Eighty-five children completed the 1-year study. Growth velocity was significantly increased by rhGH: 7.7 cm with a gain of +0.3 standard deviation score in the treated group versus 4.6 cm in the control group (P<0.0001) during the 1st year. Four factors predicted response to therapy: growth velocity prior to GH therapy, glomerular filtration rate (GFR) at the start, mode of corticosteroid administration, and degree of insulin resistance. After 1 year we observed a moderate, significant decrease in GFR in both groups. Biopsy-proven acute rejection episodes were not significantly more frequent during the 1st year in the group of patients who received rhGH: 9 in 44 versus 4 in 46 patients. The patients who rejected did not differ in terms of age, renal function at the start, and type of immunosuppression, but history of rejection before GH treatment was discriminatory: 6 of 17 children with two or more episodes had a new rejection versus 1 of 22 who had no or only one episode (P=0.01). Glucose tolerance was not modified after 1 year of GH therapy. During the subsequent years of treatment a decrease in growth velocity was noted: 5.9 cm at 2 years, 5.5 at 3 years, and 5.2 cm at 4 years. In conclusion, GH is efficient for improving growth velocity in short transplanted children, inducing clear-cut but limited catch-up growth. The risk of rejection was shown only in patients with a prior history of more than one rejection episode.

Recombinant human growth hormone treatment of children on hemodialysis. French Society of Pediatric Nephrology.

Forty-two children, aged 2-21.5 years on hemodialysis with a height below -2.0 standard deviation score (SDS) for age, were selected to receive recombinant human growth hormone (rhGH) therapy at 17 French centers. Of the 42 children, 36 were prepubertal and 8 were in early puberty (testicular volume between 4 and 8 ml for boys, breast development B2 or B3 in girls). All received 1 IU/kg per week by daily subcutaneous injection for 1-5 years. The year before rhGH therapy served as a control period. During the 1st year of treatment, mean growth velocity increased from 3.5 to 7.0 cm/year (P < 0.0001) and was always over 2.5 cm/year. This velocity allowed a catch-up growth of +0.5 height SDS. Neither weight nor the body mass index varied compared with the pretreatment year. No change was observed in urea, creatinine, or glucose tolerance. The mean increment in bone age was 0.9 years. The mean growth velocity decreased over subsequent years (P < 0.0001), but remained higher than the prestudy velocity. A significant negative correlation was observed during the 1st year between the increase in growth velocity and the prestudy velocity (P < 0.0001), with the least gain in patients who had the best spontaneous velocity. Pubertal status had no influence on response to rhGH. No significant side effects were observed during the 103 treatment-years. Five patients developed secondary hyperparathyroidism and 1 suffered from acute pancreatitis, but the relationship with rhGH therapy remains uncertain. rhGH therapy appears indicated for children on hemodialysis, even though the potential benefits appear somewhat lower for those with a spontaneous growth velocity over 6 cm/year.