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Short term effect and safety of antidiuretic hormone in the patients with nocturia.

PURPOSE: To investigate the short-term safety of antidiuretic hormone in elderly patients with nocturnal polyuria, focus on hyponatremia and others electrolytes disturbances and to assess short-term effects on nocturnal urine output and number of nocturnal voids. METHODS: Between June 2005 and August 2006, a total of 34 patients with nocturnal polyuria were orally administered 0.2 mg desmopressin tablet at bedtime for two weeks. Serum sodium, others electrolytes, urine sodium and urine osmolarity were assessed in the third days, one week and two weeks after treatment with desmopressin and com…

Safety of contraceptive methods for women with rheumatoid arthritis: a systematic review.

BACKGROUND: Women with rheumatoid arthritis (RA) and their clinicians may have unique concerns about certain methods of contraception. STUDY DESIGN: We conducted a systematic review of the literature in the MEDLINE database through February 2009 for peer-reviewed journal articles on use of any method of contraception, or progestins or estrogens, and progression of RA. RESULTS: We identified eight articles that met the inclusion criteria: six examined oral contraceptives (OCs), one progesterone, and one estrogen. We found no studies on other methods of contraception. For OCs, no consistent pa

Impact of a comprehensive safety initiative on patient-controlled analgesia errors.

BACKGROUND: Adverse drug events related to patient-controlled analgesia (PCA) place patients at risk. METHODS: We reviewed all critical incident reports at three tertiary care hospitals dated January 1, 2002, to February 28, 2009. In this longitudinal cohort study, critical incidents attributable to PCA errors were identified, and each incident was investigated. A safety intervention was implemented in February 2006 and involved new PCA pumps, new preprinted physician orders, nursing and patient education, a manual independent double-check, and a formal nursing transfer of accountability. RE…

Linked orders improve safety in scheduling and administration of chemotherapeutic agents.

The pharmacologic treatment for cancer must adhere to complex, finely orchestrated treatment plans, including not only chemotherapy medications, but pre/post-hydration, anti-emetics, anti-anxiety, and other medications that are given before, during and after chemotherapy doses. The treatment plans specify the medications and dictate precise dosing, frequency, and timing. This is a challenge to most Computerized Physician Order Entry (CPOE), Pharmacy and Electronic Medication Administration record (eMAR) Systems. Medications are scheduled on specific dates, referred to as chemo days, from the o

Effects and safety of periconceptional folate supplementation for preventing birth defects.

BACKGROUND: It has been reported that neural tube defects can be prevented with periconceptional folic acid supplementation. The effects of different doses, forms and schemes of folate supplementation for the prevention of other birth defects and maternal and infant outcomes are unclear. OBJECTIVES: This review updates and expands a previous Cochrane Review assessing the effects of periconceptional supplementation with folic acid to reduce neural tube defects (NTDs). We examined whether folate supplementation before and during early pregnancy can reduce neural tube and other birth defects (in

Safety and tolerability of zoledronic acid and other bisphosphonates in osteoporosis management.

Bisphosphonates (BPs) are widely used in the treatment of postmenopausal osteoporosis and other metabolic bone diseases. They bind strongly to bone matrix and reduce bone loss through inhibition of osteoclast activity. They are classified as nitrogen- and non-nitrogen-containing bisphosphonates (NBPs and NNBPs, respectively). The former inhibit farnesyl diphosphate synthase while the latter induce the production of toxic analogs of adenosine triphosphate. These mechanisms of action are associated with different antifracture efficacy, and NBPs show the most powerful action. Moreover, recent evi

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… The safety of zoledronic acid has been also tested in MBD where the dosage and rate of infusion are much higher than for PO. … Conte PF Guarnieri V Safety of intravenous and oral bisphosphonates and compliance with dosing regimens Oncologist 2004 9 Suppl 4 28 37 15459427 10.1634/theoncologist.9-90004-28 62. …

Safety of anterior cervical discectomy and fusion performed as outpatient surgery.

STUDY DESIGN: Retrospective review of a prospectively collected database. OBJECTIVE: To determine the complications and safety of anterior cervical discectomy and fusion performed on an outpatient basis. SUMMARY OF BACKGROUND DATA: Anterior cervical discectomy and fusion performed as outpatient surgery is an appealing alternative and has many potential benefits. The safety of this practice, however, has not been thoroughly investigated. This study aims to examine the frequency of acute complications and rates of unplanned admissions for anterior cervical discectomy and fusions scheduled as o…

Safety and efficacy of a new percutaneously implantable interspinous process device.

BACKGROUND: Lumbar spinal stenosis is a degenerative disease of the elderly population. Although microsurgical decompression has shown good long-term results, percutaneous techniques could provide an alternative in the presence of significant comorbidities. METHOD: Eighty-seven interspinous process decompression devices (In-space; Synthes, Umkirch, Germany) were implanted percutaneously in up to three segments of 50 patients. Outcome was assessed directly after surgery, at 6-8 weeks, and at average follow-up of 1 year (11.8 ± 6 months). Assessment included complications, pain and spinal claud

The potential of cytokines as safety biomarkers for drug-induced liver injury.

Drug-induced liver injury (DILI) is an event that has a detrimental impact on drug development and patient safety; therefore the identification of novel biomarkers that are both sensitive and specific to the liver would have great benefit. Inflammation is known to be associated with human cases of DILI, and given the role of cytokines in modulating the inflammatory response, changes in cytokine expression patterns certainly show promise as potential biomarkers of DILI. Cytokines are interesting candidates for novel biomarkers as they are relatively accessible (by blood sampling) and accurately…

An integrated safety profile analysis of belatacept in kidney transplant recipients.

BACKGROUND: Belatacept is associated with better renal function and an improved cardiovascular/metabolic risk profile versus cyclosporine in kidney transplant recipients. The current analysis examined pooled safety data for belatacept versus cyclosporine used in combination with basiliximab, mycophenolate mofetil, and steroids. METHODS: Patients enrolled in three core studies in de novo kidney transplantation were randomized to a more intensive (MI) or less intensive (LI) regimen of belatacept or cyclosporine. The pooled analysis included 1425 patients (MI: 477; LI: 472; cyclosporine: 476). M…

Safety and availability of dapivirine (TMC120) delivered from an intravaginal ring.

Vaginal delivery of 200 mg or 25 mg dapivirine from intravaginal rings (IVRs) was evaluated over a 7-day period in two phase 1 safety trials (IPM001 and IPM008, respectively) in a total of 25 healthy women 19 to 46 years of age. The IVR was generally safe and well tolerated with similar adverse events observed in the placebo and dapivirine groups. Across both studies, dapivirine concentrations in vaginal fluids measured at the introitus, cervix, and ring area were within the mean range of 0.7-7.1 microg/ml. Mean dapivirine concentrations in vaginal and cervical tissues on day 7 were 0.3-0.7 mi…

Adalimumab safety in global clinical trials of patients with Crohn's disease.

BACKGROUND: Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) in adults. We evaluated the overall safety profile of adalimumab in global clinical trials in patients with CD. Patients who participated in these trials, which included randomized induction and maintenance trials, Phase IIIb trials, and open-label extension studies, had moderately to severely active CD and were evaluated for safety at regular intervals. METHODS: Rates of adverse events of interest were assessed per 100-patient-years of adalimu…

Safety and feasibility of balloon sinuplasty for treatment of chronic rhinosinusitis in children.

OBJECTIVES: Balloon sinuplasty is a new technique that was recently introduced for the treatment of chronic rhinosinusitis (CRS). The initial experience in adults has been promising. The technique allows for restoring ventilation to the sinuses with minimal risk and trauma to the tissues. I present our initial experience of its use for treatment of CRS in children. METHODS: I performed a prospective study of 30 children in whom medical therapy failed and who were scheduled for surgery. They were offered treatment with balloon sinuplasty of selected sinuses. The data collected included age, co

Laparoscopic left hemihepatectomy: a safety and feasibility study of 19 cases.

BACKGROUND: Laparoscopic liver resection was performed at some institutes. The procedure mainly included local resection, segmentectomy, and left lateral segmentectomy. With experience accumulation and technique innovation, laparoscopic left hemihepatectomy was performed in selected patients. This study was designed to introduce and evaluate the safety and feasibility of this procedure. METHODS: Nineteen successive patients underwent laparoscopic left hemihepatectomy from 2005 to 2007. They were compared by the matched-pair method with 19 other patients who underwent conventional open left he…

Long-term efficacy and safety of laronidase in the treatment of mucopolysaccharidosis I.

OBJECTIVE: Our goal was to evaluate the long-term safety and efficacy of recombinant human alpha-l-iduronidase (laronidase) in patients with mucopolysaccharidosis I. PATIENTS AND METHODS: All 45 patients who completed a 26-week, double-blind, placebo-controlled trial of laronidase were enrolled in a 3.5-year open-label extension study. Mean patient age at baseline was 16 (range: 6-43) years. All patients had attenuated disease (84% Hurler-Scheie, 16% Scheie phenotypes). Clinical, biochemical, and health outcomes measures were evaluated through the extension phase. Changes are presented as the…

[Safety and efficacy of intraoperative 5-fluorouracil infiltration in pterygium treatment].

PURPOSE: To investigate the safety and efficacy of intraoperative infiltration of 5-fluorouracil (5-FU) as an adjuvant drug in pterygium treatment. METHODS: Of 125 consecutive patients, 125 eyes with primary and recurrent pterygium underwent pterygium excision with intraoperative 5-FU (25 mg/mL) infiltration. The superior and inferior conjunctiva was approximated to cover the scleral bed and 0.2 mL 5-FU was injected at the end of the surgical procedure. The gender, occupation, pterygium characteristics and the follow-up at 7, 21, 60 e 180 days after surgery were evaluated and the data were st…

Cardiac safety of methylphenidate versus amphetamine salts in the treatment of ADHD.

OBJECTIVES: Safety concerns about central nervous system stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) include adverse cardiac effects. This study aimed to compare the risk for cardiac events in users of methylphenidate and amphetamine salts. METHODS: A retrospective cohort design using claims data from the Florida Medicaid fee-for-service program representing a total of 2131953 children and adolescents was used. The analysis included all beneficiaries who were between 3 and 20 years of age, enrolled between July 1994 and June 2004, had at least 1 physician d…

Safety regulation for the design approval of special form radioactive sources.

Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a r…

[Safety Walkround as a risk assessment tool: the first Italian experience].

In 2007 the Study Group "Clinical Risk Management" of the Italian Society of Anaesthesia and Intensive Care Unit (SIAARTI) performed a multicentric study in Intensive Care Unit (ICU) to assess the feasibility and efficacy of the Safety WalkRound (SWR) as a tool for the risk assessment. As the environment and organization of ICU are more complex than anaesthesia ones, mainly due to the severity of patients, high number of involved healthcare givers and different kinds of procedures, the Study Group decided that a check list is not fit for ICU and , after a careful review of the literature, chos…