Symptomatic efficacy of stabilizing treatment versus laser therapy for sub-acute low back pain with positive tests for sacroiliac dysfunction: a randomised clinical controlled trial with 1 year follow-up.

AIM: Back pain is a highly frequent condition due to many causes, although most of them cannot be established with certainty. It is also the current clinical and scientific belief that sacroiliac joint syndrome can be a specific low back pain cause. Nonetheless the existence of clinical tests aimed at highlighting the responsibility for lumbar pain secondary to sacroiliac dysfunction, it is not easy to diagnose it with either manual or instrumental means. Moreover, uncertainty is diffuse when facing a correct treatment for patients involved. The aim of this study was to verify, in patients with acute or sub-acute low back pain and positive sacroiliac signs, the efficacy of a stabilising therapy (orthosis and exercises, with previous mesotherapy) directly targeted to sacroiliac dysfunction versus a symptomatic usual care such as He-Ne laser therapy. METHODS: Over a period of 14 months, we recruited 22 patients (10 females, mean age 44+/-11) with acute and sub-acute low back pain and symptoms and signs suggesting a sacroiliac dysfunction. They were randomised in a Group laser (GL), 11 patients treated with He-Ne laser therapy targeting the sacroiliac region, and a Group stabilisation (GS), 11 patients treated with mesotherapy, a specific dynamic sacroiliac support (ILSA) and specific exercises. Outcome criteria included VAS, and Mens and Laslett sacroiliac tests. RESULTS: Out of 449 acute and sub-acute low back pain out-patients, 22 (4.9%) had symptoms and signs suggesting a sacroiliac dysfunction. A reduction of pain was achieved only in the GS. All pain-provocation and stability tests were negative both after the end of treatment and at the follow-up only in the GS. CONCLUSIONS: A targeted approach based on mesotherapy, a specific sacroiliac belt and specific stabilizing exercises proved its efficacy in acute and sub-acute low back pain patients with symptoms and signs suggesting a sacroiliac dysfunction. As soon as it will be possible to identify particular spine syndromes in the universe of non specific low back pain, there will also be the possibility to employ specific therapies.

[Development of Italian research in anesthesiology and intensive care]. / Lo sviluppo della ricerca italiana in anestesiologia e rianimazione.

The development of the Italian research in Anaesthesia and Intensive Care medicine has been evaluated by comparing the total number of papers in this field and the number of the Italian papers in this field published in the years 1977, 1987, 1997. The results showed: a) an increase of the total number of papers published in the indexed journals dedicated to Anesthesia and Intensive Care with an increase higher than 50% per decade. In the same period the number of Italian papers increased from virtual representation (1 paper/year) to 19 papers per year in 1997. b) The papers dedicated to intensive care medicine showed a similar increase. In spite of this, the indexed scientific production of the Italian scientific community remains underexpressed.

Serum levels of type I procollagen C-terminal propeptide, insulin-like growth factor-I (IGF-I), and IGF binding protein-3 in obese children and adolescents: relationship to gender, pubertal development, growth, insulin, and nutritional status.

We measured fasting serum levels of type I procollagen C-terminal propeptide (PICP), insulin-like growth factor-I (IGF-I), and IGF binding protein-3 (IGFBP-3) in obese children and adolescents (obese subjects [OS]) to evaluate their relationship to growth, gender, pubertal stage, and weight excess (WE). The influence of insulin, growth hormone (GH), and weight loss was also studied. The study population consisted of 244 OS and 236 normal-weight subjects (NWS) matched for age, gender, and pubertal stage. At stage I, OS had a higher standard deviation score (SDS) for height than NWS of both genders. During the prepubertal phase, growth velocity (GV) was greater in OS than in NWS of both genders, but it was lower in female OS at stage II and male OS at stage III. PICP increased in puberty, with a more rapid decrease later in female OS and NWS; prepubertal values were higher in OS but were reduced at pubertal stage IV to V in comparison to NWS. Stepwise multiple regression analysis demonstrated that GV was the only anthropological variable correlating with PICP. IGF-I serum values increased significantly in puberty and were higher in OS than in NWS at stage I for both genders. IGFBP-3 values of OS exceeded those of NWS at stages I to III in males and I to II in females. No difference was observed for males versus females in each group, nor was any difference observed for the IGF-I/IGFBP-3 molar ratio between the two groups. Using stepwise analysis, a positive correlation between IGF-1 and IGFBP-3 was observed in prepubertal but not in pubertal NWS. Fasting insulin values correlated with IGFBP-3 in OS, accounting for 24.8% of the variation in prepubertal subjects and 17.1% in pubertal subjects. No such correlation was observed in NWS. In prepubertal NWS, PICP and SDS of body mass index (BMI) correlated with IGF-I, accounting for 12.9% of the variation, and SDS of BMI correlated with IGFBP-3, explaining 27.8% of the variation. In prepubertal OS, no such correlations could be observed, but PICP and SDS of BMI accounted for 14.3% of the variation in the IGF-I/IGFBP-3 molar ratio. A significant reduction of IGFBP-3 and an increase of the IGF-I/IGFBP-3 molar ratio were detected after weight loss in 40 OS. In conclusion, we demonstrated that IGF-I and IGFBP-3 are influenced by age, gender, sexual development, and nutritional status. Also, an influence of insulin on IGFBP-3 serum levels was observed in OS. The relations of IGF-I to PICP in NWS and of the IGF-I/IGFBP-3 molar ratio to PICP in OS support the concept of IGF-I influence on skeletal growth. The increased IGFBP-3 serum values in OS suggest a possible role in controlling the growth stimulus induced by nutritional status.

Double-blind randomized phase I study on the clinical tolerance and biological effects of natural and recombinant interferon-beta.

The clinical tolerance of and the effects recombinant human interferon-beta (rHuIFN-beta) obtained from mammalian cells (Chinese hamster ovary cells) exerts on 2',5'-oligoadenyl (2-5A) synthetase activity, human-Mx protein, neopterin, beta 2-microglobulin, interleukin-1 (IL-1) alpha and beta synthesis were compared to those of natural IFN-beta in 12 healthy volunteers. Each subject received a single i.m. injection of 6 x 10(6) IU rHuIFN-beta and natural IFN-beta according to a randomized double-blind cross-over study design. Both were well tolerated and provoked similar changes in clinical indices. Moreover, rHuIFN-beta and natural IFN-beta induced significant and similar increases in 2'-5' adenylates, human Mx protein, and neopterin levels, but neither modulated beta 2-microglobulin, IL-1 alpha or beta synthesis. The sum of these findings indicates that rHuIFN-beta and natural IFN-beta are biologically equivalent. In view of these results, we are of the opinion that these two types of IFN are probably also therapeutically equivalent and, in consequence, that trials to evaluate the response of viral and neoplastic disease patients to rHuIFN-beta are fully justified.

Biochemical and immunological responses of hairy cell leukemia patients to interferon beta.

Ten hairy-cell leukemia patients were treated with interferon beta (IFN-beta) at a dose rate of 2 x 10(6) IU/m2 x 5 days for 4 weeks (induction therapy) and, thereafter, at the same dose three times a week for 11 months (maintenance therapy). The effect of this treatment on serum neopterin, beta 2-microglobulin, (2'-5')oligoadenylate [(2'-5')An] levels, intracellular (2'-5')An values and human Mx protein synthesis was analysed. There were significant rises in serum neopterin and (2'-5')An levels during both induction and maintenance, whereas beta 2-microglobulin levels rose only during induction. Rises in intracellular (2'-5')An were documented mainly during induction, but they were not significantly higher than pretherapy values. IFN beta provoked an increase in human Mx protein synthesis over the entire induction-maintenance period, but was only significantly higher than baseline during induction. All markers proved useful for monitoring the effects of IFN beta dose schedules, but were not predictive of clinical outcome. Natural killer activity and IFN gamma production, which were initially defective, followed a different trend from that of the other factors studied, in that increases were documented only late in the course of therapy when the disease was already in remission.

Phase I-II trial on natural beta interferon in chemoresistant and relapsing multiple myeloma.

One Waldenström's disease and 16 multiple myeloma patients were administered IFN-beta I.V. at the dose of 6 x 10(6) IU/m2 over 6 hours for 7 days on alternate weeks for a total of 3 cycles, and then continued at the same dose, twice a week, for an additional 24 weeks. Four patients had initially proved to be, and 6 became, resistant to chemotherapy. Disease progressed after chemotherapy was discontinued in another 7 patients: 3 SD and 4 PR. One of the 16 evaluable patients achieved an MR, and 11 experienced brief stabilization of disease (median 14 weeks, range 6-34). In addition, cellular response to IFN-beta was documented by increased B2-microglobulin and neopterin levels, even as early as 24 hours after the 1st IFN injection of the 1st and 2nd cycles. Hemtological and extrahematological toxicity was low despite the fact that 8/16 patients had severely or moderately reduced bone marrow reserve at the beginning of treatment. Since vincristine-adriamycin-dexamethasone and etoposide-dexamethasone-cytarabine-cisplatin combinations achieve high response rates in resistant and relapsing multiple myeloma patients, IFNs alone should be reserved as third-line therapy for those subjects who are resistant to, or not candidates for, these chemotherapeutic regimens. The low toxicity and the modulation of B2-microglobulin and neopterin should encourage studies aimed at defining the optimal antitumor dose of IFN-beta that could be used in combination with conventional chemotherapeutic regimens to improve the response rate in multiple myeloma patients.

[Bone scintiscanning in the diagnosis and follow-up of breast carcinoma]. / La scintigrafia ossea nella diagnosi e nel "follow-up" del carcinoma mammario.

Bone scans with Tc + 99m phosphate were performed in 87 patients with histological diagnosis of breast cancer, in order to evaluate whether this technique was suitable in detecting small metastasis both at first staging and in follow-up. The scans were considered as: a) "malignant", when an isotope uptake in usually inactive sites and/or an increased uptake in normally active areas were demonstrated; b) "equivocal", when the uptake in normally inactive and/or in normally active sites was only moderately increased; c) "benign", when only slight uptake increase in normally active structures was detectable. The scans have been carried out before or soon after mastectomy (early scans), and repeated at 6 month intervals (N+ patients and/or malignant or equivocal scans) or at 12 month intervals. A significantly greater incidence of malignant scans was observed in stages 2 and 3 as compared to stage 1, and in stage 4 as compared to all the other stages, as well as in premenopause versus postmenopause patients.