Autologous Cultured Fibroblast Injection for Facial Contour Deformities: A Prospective, Placebo-Controlled, Phase III Clinical Trial

BACKGROUND: Previous data indicate that injections of autologous fibroblasts increase collagen formation, accompanied by a concomitant increase in thickness and density of dermal collagen. OBJECTIVE: The purpose of this study was to determine efficacy and side effects of autologous living fibroblast injections versus placebo in a randomized Phase III trial for the treatment of various facial contour defects. METHODS: This was a double-blind, randomized comparison of injectable living autologous fibroblast cells and placebo for the treatment of facial contour defects (N=215). Live fibroblasts (20 million/mL) or placebo (the transport medium without living cells) were given as three doses administered at 1- to 2-week intervals. Efficacy evaluations were performed 1, 2, 4, 6, 9, and 12 months after the first injection. RESULTS: Living fibroblasts produced statistically significantly greater improvements in dermal deformities and acne scars than did placebo. The difference between live fibroblast injections and placebo achieved statistical significance at 6 months (p<.0001). At 9- and 12-month follow-up, live fibroblast-treated patients continued to demonstrate benefit from treatment with response rates of 75.0 and 81.6%, respectively. No serious treatment-related adverse events were reported. CONCLUSIONS: Our results indicate that autologous fibroblast injections can safely and effectively produce improvements in rhytids, acne scars, and other dermal defects continuing for at least 12 months after injection.     

Clinical Experience with Light-Emitting Diode (LED) Photomodulation

Background. Light-emitting diode (LED) photomodulation is a novel nonthermal technology used to modulate cellular activity with light.
Objective:. We describe our experience over the last 2 years using 590 nm LED photomodulation within a dermatologic surgery environment.
Methods. Practical use of nonthermal light energy and emerging applications in 3,500 treatments delivered to 900 patients is detailed.
Results. LED photomodulation has been used alone for skin rejuvenation in over 300 patients but has been effective in augmentation of results in 600 patients receiving concomitant nonablative thermal and vascular treatments such as intense pulsed light, pulsed dye laser, KTP and infrared lasers, radiofrequency energy, and ablative lasers.
Conclusion:. LED photomodulation reverses signs of photoaging using a new nonthermal mechanism. The anti-inflammatory component of LED in combination with the cell regulatory component helps improve the outcome of other thermal-based rejuvenation treatments.     

Serum and Plasma Markers of Nutritional Status in Children Infected with the Human Immunodeficiency Virus

Objective To determine whether reduced serum or plasma protein and micronutrient levels are common in children infected with the human immunodeficiency virus (HIV) and whether these levels are different in children with growth retardation compared to those with normal growth.

Subjects Children were separated into three groups: (a) HIV-infected with growth retardation (HIV+Gr); (b) HIV-infected with normal growth (HIV+); (c) HIV-uninfected with normal growth (HIV-). All children were afebrile and free of acute infection at the time of study. During a 24-hour stay in the Pediatric Clinical Research Unit, blood was drawn for analysis of total protein, albumin, zinc, selenium, and vitamin A levels; growth measurements were obtained; and dietary intake was assessed by 24-hour weighed food intake and 24-hour dietary recall.

Statistical analysis Mean differences between groups were assessed by analysis of variance, and differences in the frequency of nutrient deficiency were determined by χ² analysis.

Results Thirty-eight children between 2 and 11 years of age were studied: 10 HIV+Gr, 18 HIV+, and 10 HIV-. No statistically significantly differences were noted in mean levels of albumin, prealbumin, zinc, and selenium. Mean serum level of vitamin A was significantly higher in the HIV+Gr group than in the other two groups. There were no significant differences between groups in the frequency of deficiency for any nutrient studied. Mean energy and nutrient intake was similar among groups.

Applications/conclusions Abnormal serum or plasma protein or micronutrient levels were uncommon in this cohort of HIV-infected children, even in children with growth retardation. Routine monitoring of the level of proteins and micronutrients studied is unnecessary in the absence of specific clinical indicators of deficiency. J Am Diet Assoc. 1997-97:1377-1381.     

Evaluation of awakening and recovery characteristics following anaesthesia with nitrous oxide and halothane fentanyl or both for brief outpatient procedures in infants

This study compared recovery characteristics and postoperative ventilatory function when halothane, fentanyl or combination of halothane and fentanyl in addition to N₂O were used for intraoperative anaesthesia in term infants undergoing hernia repair as outpatients. Sixty-six full term ASA PS I infants ages 1–12 months were studied. All received inhalation induction with N₂O, O₂ and halothane, followed by intravenous atropine and atracurium, tracheal intubation, and controlled ventilation. For anaesthesia maintenance, patients were randomized into one of three groups. Group I received 70% N₂O, 30% O₂ and halothane. Group II received 70% N₂O, 30% O₂, halothane and 2 μg·kg^?1 fentanyl. Group III received 70% N₂O, 30% O₂ and 10 μg·kg^?1 fentanyl. Awakening times were similar in all three groups, however, Group I patients had significantly shorter recovery and discharge times than those of Group II and III. None of the patients experienced postoperative apnoea or periodic breathing. One patient in Group III experienced two brief episodes of bradycardia not associated with apnoea or arterial desaturation (Spo ₂ >90% for greater than 30 s). Decreased Spo ₂ occurred less frequently in Group I (5.9%) compared to Group II (22.7%) and Group III (19.0%) patients, however, the group differences were not significant. Transcutaneous CO₂ (TcCO₂) values were not statistically different among the three groups. Pain scores were initially lower in Groups II and III, but at 120 min the differences were not significant. Postoperative apnoea was not observed in this study. Spo ₂ <90% and TcCO₂ >9 kPa (70 mmHg) was more common in infants receiving 2 and 10 μg·kg^?1 fentanyl than in infants receiving halothane and nitrous oxide anaesthesia. Infants <3 months old did not have a higher incidence of Spo ₂ <90% or significantly higher TcCO₂ values when compared to infants >3 months old. Fentanyl in doses used in this study did not prolong awakening time but did prolong recovery and discharge times in outpatient infants.     

Severe myocardial injury and rhabdomyolysis from acute oral amphetamine abuse

We report a case of a previously healthy young man who developed severe myocardial injury and rhabdomyolysis after a single oral ingestion of amphetamine. Such major toxicity is more usually associated with the use of intravenous amphetamine or chronic amphetamine abuse. Both physicians and potential drug users need to be aware that a single oral ingestion of amphetamine may produce severe, life-threatening toxicity.     

An audit of pain and vomiting in paediatric day case surgery

Three hundred and thirteen paediatric day case patients were prospectively audited to assess postoperative pain, nausea and vomiting using data sheets completed by nursing staff, anaesthetists and parents. The incidence of nausea and vomiting was 7.3% and was commoner in older children and those who had received opioids. Forty per cent of patients had some degree of postoperative pain; 17% of these patients were scored as having severe pain. Of children who had pain on returning home (31.4%), 85% of these required paracetamol. Fifteen per cent of children had a disturbed night due to pain and/or vomiting after their operation and 28.5% of children had pain on the following day. Boys undergoing circumcision were responsible for a disproportionately high percentage of the severe pain scores. Audit has helped to highlight deficiencies in the service provided and has led staff to try and improve their methods of analgesia.     

The sugar-fat seesaw

Examination of dietary survey data reveals an inverse relationship between fat and sugar in the diet. The data examined here indicate that high fat diets tend to be low sugar diets and low fat diets tend to be high in sugar.