Publications by authors named "Michele Morelli"

41 Publications

A novel primary amine-based anion exchange membrane adsorber.

J Chromatogr A 2011 Aug 4;1218(32):5386-92. Epub 2011 Apr 4.

Millipore Corp., 80 Ashby Road, Bedford, MA 01730, USA.

A novel anion exchange membrane adsorber is presented which shows excellent impurity removal under different buffer conductivities ranging from 2 to 2 7mS/cm. The membrane utilizes a primary amine ligand (polyallylamine) and was designed specifically to bind impurities at high salt concentrations. Studies with DNA, endotoxin, and virus spiked into buffer at varying salt conditions were done, resulting in clearance of >3, 4, and 4 LRV, respectively, with negligible change on increasing salt up to 27 mS/cm conductivities. Verification of virus removal in mAb feedstocks is also shown. The data are compared with other membrane adsorbers and a conventional resin which utilize traditional chemistries to demonstrate improved purification performance with the primary amine ligand. Additional data on scale-up of the membrane adsorber device is discussed. A stacked flat-sheet design was implemented to ensure linear scale-up of performance using bovine serum albumin (BSA) as a model. The linearly scalable device, coupled with the highly effective membrane for virus, DNA, and endotoxin removal, represents a step forward in polishing technology for the purification of monoclonal antibodies and recombinant proteins.
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http://dx.doi.org/10.1016/j.chroma.2011.03.068DOI Listing
August 2011

Laparoscopic colposuspension using sutures or prolene meshes: a 3-year follow-up.

Eur J Obstet Gynecol Reprod Biol 2004 Dec;117(2):201-3

Department of Obstetrics and Gynecology, University Magna Graecia of Catanzaro, Via Nicolardi 188, I-80131 Naples, Italy.

Objective(s): To compare the long-term effectiveness of two different laparoscopic colposuspension procedures.

Study Design: Sixty women affected by genuine stress incontinence (GSI) were enrolled in a prospective randomized controlled trial (RCT) and treated by transperitoneal laparoscopic colposuspension using nonabsorbable sutures (group A) or prolene mesh fixed with tackers or staplers (group B). In each group the subjective and objective failure rates were evaluated at 12, 24, and 36 months after surgery. For the subjective evaluation patients were asked whether they had experienced urine leakage and any urine loss they reported was recorded on a visual analogue scale (VAS). The objective evaluation was performed by means of a clinical examination and multichannel urodynamic studies. The data were analyzed by the intention-to-treat method.

Results: The subjective failure rate was significantly (P < 0.05) lower in group A than in group B at 12 months (3.3% versus 13.3%, respectively), 24 months (20.0% versus 36.7%, respectively), and 36 months (33.3% versus 53.3%, respectively) after surgery. The objective failure rate also differed significantly (P < 0.05) between the two groups after 12 (10.7% versus 25.0% for group A and group B, respectively), 24 (29.6% versus 57.7%, respectively), and 36 (42.3% versus 61.5%, respectively) months of follow-up.

Conclusion(s): Laparoscopic colposuspension performed with sutures is more effective than laparoscopic colposuspension accomplished with the use of prolene meshes in the long term, and the use of prolene meshes should be avoided in treatment of GSI.
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http://dx.doi.org/10.1016/j.ejogrb.2004.04.030DOI Listing
December 2004

Long-term effectiveness of presacral neurectomy for the treatment of severe dysmenorrhea due to endometriosis.

J Am Assoc Gynecol Laparosc 2004 Feb;11(1):23-8

Department of Obstetrics and Gynecology, University Magna Graecia, Catanzaro, Italy.

Study Objective: To assess the long-term effectiveness of presacral neurectomy (PSN) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention.

Design: Randomized, controlled trial (Canadian Task Force classification I).

Setting: University-affiliated department of obstetrics and gynecology.

Patients: One hundred forty-one sexually active women of reproductive age.

Intervention: Conservative laparoscopic surgery without (group A) or with (group B) PSN.

Measurements And Main Results: At entry and 24-months after surgical procedures, cure rates; frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain; and quality of life were evaluated. At follow-up visit, the cure rate was significantly (P<0.05) higher in group B (83.3%) than in group A (53.3%). The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly (P<0.05) lower in both groups compared with baseline values, and only severity was significantly (P<0.05) lower in group B. A significant (P<0.05) improvement in quality of life was observed after surgery in both groups and was significantly (P<0.05) increased in group B compared with group A.

Conclusion: PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis.
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http://dx.doi.org/10.1016/s1074-3804(05)60005-9DOI Listing
February 2004

Effect of tibolone on breast symptoms resulting from postmenopausal hormone replacement therapy.

Maturitas 2003 Aug;45(4):267-73

Obstetrics and Gynaecology, University Magna Graecia of Catanzaro, Catanzaro, Via Nicolardi 188, 80131 Naples, Italy.

Objective: To evaluate the incidence of breast symptoms in a population treated with various hormone replacement therapy (HRT) regimens and to detect the variations in breast symptomatology after HRT changing to tibolone administration.

Methods: This prospective placebo-controlled clinical trial was conducted on healthy women on HRT reporting breast symptoms. A questionnaire was given to each woman to detect breast symptomatology. Breast tenderness and mastalgia were evaluated using a visual analogue scale (VAS). According to the choice of the each woman with breast symptoms, the HRT was changed to tibolone (2.5 mg/day per os) or to calcium carbonate (1 tab/day, placebo group). The duration of treatment was of 12 months. After 6 and 12 months breast symptomatology was re-evaluated.

Results: Among the 600 screened women, 64 (10.7%) were suffering from breast symptomatology. After 6 and 12 months of treatment with tibolone or placebo, mean VAS score for breast tenderness and for mastalgia resulted significantly (P<0.05) decreased, without differences between groups, in comparison with basal value. Only one woman had no improvement from the breast symptoms with tibolone administration.

Conclusions: Shifting from classical HRT to tibolone is followed by a significant reduction of breast symptomatology in postmenopausal women with breast complaints similar to that obtained with treatment withdrawal.
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http://dx.doi.org/10.1016/s0378-5122(03)00153-1DOI Listing
August 2003

Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.

Am J Obstet Gynecol 2003 Jul;189(1):5-10

Departments Obstetrics and Gynecology, the University "Magna Graecia" of Catanzaro, the University of Rome, Catanzaro, Rome.

Objective: The purpose of this study was to assess the effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis that was treated with conservative surgical intervention.

Study Design: One hundred forty-one sexually active women of fertile age with chronic severe dysmenorrhea caused by endometriosis were treated with conservative laparoscopic surgery. Patients were assigned randomly to not receive (group A) or receive (group B) presacral neurectomy. At 6 and 12 months after the surgical procedures, the cure rate was evaluated in each patient. The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were also evaluated at the same time intervals.

Results: The cure rate was significantly higher in group B compared with group A at a follow-up examination at 6 months (87.3% vs 60.3%) and 12 months (85.7% vs 57.1%). At follow-up visits, the frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly lower in both groups compared with baseline values; in particular, significantly lower values were observed in group B versus group A for the severity.

Conclusion: Presacral neurectomy improves the cure rate in women who are treated with conservative laparoscopic surgery for severe dysmenorrhea caused by endometriosis.
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http://dx.doi.org/10.1067/mob.2003.358DOI Listing
July 2003

Raloxifene administration in women treated with gonadotropin-releasing hormone agonist for uterine leiomyomas: effects on bone metabolism.

J Clin Endocrinol Metab 2002 Oct;87(10):4476-81

Chair of Obstetrics and Gynecology, University of Catanzaro, 88100 Catanzaro, Italy.

This prospective randomized, single-blind, placebo-controlled clinical trial was performed to evaluate the efficacy of raloxifene in preventing the bone loss associated with GnRH agonist (GnRH-a) administration. One hundred premenopausal women with uterine leiomyomas were treated with leuprolide acetate depot at a dosage of 3.75 mg/d for 28 d and then randomized into two groups to receive raloxifene hydrochloride at 60 mg/d (group A) or placebo (1 tablet/d; group B). Bone mineral density (BMD) and serum bone metabolism markers were evaluated at admission and after six treatment cycles. Posttreatment BMD differed significantly from baseline BMD in group B but not in group A. BMD was significantly higher in group A than in group B. In group A, serum osteocalcin and bone alkaline phosphatase levels and urinary deoxypyridinoline and pyrilinks-D excretion were unchanged vs. baseline. Differently, posttreatment concentrations of these bone turnover markers were significantly lower in group B compared with baseline and group A values. In conclusion, raloxifene prevents GnRH-a related bone loss in premenopausal women with uterine leiomyomas.
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http://dx.doi.org/10.1210/jc.2002-020780DOI Listing
October 2002

Raloxifene administration in premenopausal women with uterine leiomyomas: a pilot study.

J Clin Endocrinol Metab 2002 Aug;87(8):3603-8

Chair of Obstetrics and Gynecology, University of Catanzaro, 88100 Catanzaro, Italy.

This prospective randomized single-blind placebo-controlled clinical trial was carried out to evaluate the effects of raloxifene administration on uterine and leiomyoma sizes in premenopausal women. Ninety healthy premenopausal women affected by asymptomatic uterine leiomyomas were enrolled and treated with raloxifene at the doses of 60 mg/d (group A), 180 mg/d (group B), or placebo (group C). The duration of the treatment was 6 cycles of 28 d each. At entry and after three and six cycles, uterine and leiomyoma sizes were measured by transvaginal ultrasonography. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of the menstrual cycles and the side effects of the treatments were recorded using a daily diary. The severity of the uterine bleedings was assessed using a rank scale. Throughout the study, no significant changes were observed in uterine and leiomyoma size or in Delta size among the three groups and within each group of treatment. The length and severity of uterine bleedings was not significantly different between the three groups and within each group. In conclusion, raloxifene has no significant effect on uterine and leiomyoma size or on menstrual cycle in premenopausal women.
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http://dx.doi.org/10.1210/jcem.87.8.8747DOI Listing
August 2002

Bone metabolism in postmenopausal women who were treated with a gonadotropin-releasing hormone agonist and tibolone.

Fertil Steril 2002 Jul;78(1):63-8

Chair of Obstetrics and Gynecology, University of Catanzaro, Catanzaro, Italy.

Objective: To study the bone metabolism in postmenopausal women who have been treated with gonadotropin-releasing hormone agonist (GnRH-a) and tibolone.

Design: Prospective, open, controlled clinical trial.

Setting: Department of Gynecology and Obstetrics, University of Catanzaro, Catanzaro, Italy.

Patient(s): One hundred twenty perimenopausal women with symptomatic uterine leiomyomas (groups A and B), and 40 healthy control women who underwent a normal spontaneous menopause (group C).

Intervention(s): Treatment for 12 months with leuprolide acetate plus tibolone (group A) or hysterectomy with bilateral oophorectomy (group B).

Main Outcome Measure(s): Lumbar spine bone mineral density (BMD) and bone turnover markers at entry into the study, after medical treatment (only group A), and 12 months after discontinuation medical treatment (group A) or after surgery (group B). The same parameters were noted in healthy women before and 12 months after menopause (retrospective control group, group C).

Result(s): At the women's entry into the study, no significant difference in BMD and bone turnover markers was detected between groups A and B. In group A, no significant variation in BMD or bone turnover markers was observed 12 months after medical treatment in comparison with baseline. At 12 months after discontinuation of treatment (in women who had achieved menopause) and after surgery, we observed a statistically significant decrease in BMD and in bone turnover markers in both groups in comparison with baseline. At 12 months after they became menopausal, we also observed a statistically significant reduction in BMD and in bone turnover markers in control group C. At the same 12-month follow-up visit, a statistically significant difference in BMD and in bone turnover markers was detected when comparing groups A and B with group C.

Conclusion(s): Women previously treated with GnRH-a and tibolone similar to women who are menopausal as a result of surgery, have higher bone loss after menopause.
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http://dx.doi.org/10.1016/s0015-0282(02)03149-7DOI Listing
July 2002

Two techniques of laparoscopic retropubic urethropexy.

J Am Assoc Gynecol Laparosc 2002 May;9(2):178-81

Department of Obstetrics and Gynecology, University of Catanzaro, Italy.

Study Objective: To compare two techniques of transperitoneal laparoscopic urethropexy.

Design: Prospective, randomized, open trial (Canadian Task Force classification I).

Setting: University-affiliated department of gynecology and obstetrics.

Patients: Sixty women with genuine stress incontinence.

Interventions: Transperitoneal laparoscopic retropubic urethropexy using nonabsorbable sutures (group A) and polypropylene mesh fixed with tacks or staples (group B).

Measurements And Main Results: Failure was assessed subjectively and objectively. Subjective evaluation was performed asking patients if they had urine loss and having them describe symptomatology on a visual analog scale before surgery and at each follow-up visit. Objective evaluation was by clinical examination and/or multichannel urodynamic studies. No significant differences in intraoperative and postoperative complications were observed between groups. The subjective failure rate was not significantly different between groups 3, 6, and 12 months after surgery. At 3 and 6 months the objective failure rate was not significantly different; however, at 12 months it was significantly lower in group A than in group B.

Conclusion: Transperitoneal laparoscopic retropubic urethropexy is more effective with sutures than with mesh.
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http://dx.doi.org/10.1016/s1074-3804(05)60128-4DOI Listing
May 2002

Short-term administration of tibolone plus GnRH analog before laparoscopic myomectomy.

J Am Assoc Gynecol Laparosc 2002 May;9(2):170-4

Department of Obsterics and Gynecology, University of Messina, Italy.

Study Objective: To evaluate whether tibolone modifies the effectiveness of gonadotropin-releasing hormone (GnRH) analog administered before laparoscopic myomectomy.

Design: Prospective, randomized, open, placebo-controlled clinical trial (Canadian Task Force classification I).

Setting: University-affiliated hospital.

Patients: Sixty-six women with symptomatic leiomyomas.

Interventions: Patients received 2 months of treatment with GnRH analog and iron plus tibolone (group A) or placebo (group B); group C received only iron. Laparoscopic myomectomy was performed after medical treatment.

Measurements And Main Results: Uterine volume, number and volume of leiomyomas, echogenicity and volume of the largest leiomyomas, hematologic values, and myoma-related symptoms were evaluated at baseline, 1 week before, and 1 week after surgery. We observed significant (p <0.05) reductions in uterine and leiomyomata volume, myoma-related symptoms, and improvement in hematologic values before surgery in groups A and B, without significant difference between groups compared with baseline values and group C. Operating time and blood loss were significantly (p <0.05) lower in groups A and B, without significant difference compared with group C. After surgery, significant numbers of women in group C had worsening of hematologic values (p <0.05).

Conclusion: Adding tibolone to the GnRH analog regimen before laparoscopic myomectomy does not modify the effectiveness of GnRH analog administered alone.
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http://dx.doi.org/10.1016/s1074-3804(05)60126-0DOI Listing
May 2002

Effect of different doses of progestin on uterine leiomyomas in postmenopausal women.

Eur J Obstet Gynecol Reprod Biol 2002 May;102(2):199-201

Department of Obstetrics and Gynecology, University of Catanzaro, Catanzaro, Italy.

Objective(s): To evaluate the effects of two doses of medroxyprogesterone acetate (MPA) on uterine leiomyoma sizes and on uterine bleeding pattern in postmenopausal women treated with oral hormone replacement therapy (HRT).

Study Design: Thirty natural postmenopausal women affected by uterine leiomyomas were enrolled and treated with oral micronized estradiol (E(2)) at dose of 2 mg per day, and randomized to receive in association MPA at dose of 2.5 mg daily (group A) or of 5 mg daily (group B). At the beginning of the study and after 1 year of treatment, uterine leiomyomata dimensions were measured using transvaginal ultrasonography (TV-USG). The subjects were instructed to note on a daily dairy the number and severity of abnormal uterine bleeding (AUB) episodes.

Results: After 1 year of therapy, a significant changes in mean uterine leiomyomas size was observed in the group treated with higher dose of MPA. No significant differences in uterine bleeding were detected between the two groups.

Conclusion(s): In postmenopausal women with uterine leiomyomas, it is necessary to use the minimal efficacious dose of progestin during HRT because of a higher risk to increase the tumors dimensions.
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http://dx.doi.org/10.1016/s0301-2115(01)00588-7DOI Listing
May 2002