ANALYTICAL METHOD VALIDATION, PHARMACOKINETICS AND BIOEQUIVALENCE STUDY OF DIMETHYL FUMARATE IN HEALTHY IRANIAN VOLUNTEERS

Objective: Pharmacokinetic evaluation of Dimethyl Fumarate (DMF) in the Iranian population wasn’t studied. So, the aim of this research is the validation of the analytical method and evaluation of the pharmacokinetic properties and bioequivalence of the generic form of this drug versus the reference product. Methods: 2 single-dose, test, and reference DMF products were orally administered to 24 healthy volunteers. The washout period was 28 d between the treatments. Monomethyl fumarate as the metabolite of DMF was analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and the method was validated. Also, the pharmacokinetic parameters were calculated for bioequivalence evaluation. Results: The analytical method was validated and linear over the range of 31.25-4000 ng/ml (R2= 0.997). In addition, the method was precise and accurate in the low, medium, and high concentrations. The results indicated that the 2 products had similar pharmacokinetics. Further, the 90% CI of the mean ratios of the test versus the reference products of the log-transformed area under the concentration-time curve over 10 h (0.99 to 1.02) and peak concentration (0.98 to 1.03) were within the acceptable range of 0.8 to 1.25 and the generic product of DMF could be similar to that of the reference product. Conclusion: The applied analytical method is selective, accurate, precise, and repeatable for the analysis of monomethyl fumarate (MMF) in plasma. Also, the bioequivalence study showed no significant difference between the pharmacokinetic parameters of these 2 products. So, the DMF test product can be claimed to be bioequivalent with the reference product

Anesthetic Management in Tibial Fracture of a Known Case of Wolfram Syndrome

Wolfram syndrome is a rare progressive disease with diabetes insipidus, diabetes mellitus, optic atrophy, and deafness (DIDMOAD). Furthermore, other comorbidities and manifestations accompany this disease. Anesthetic management may be challenging in these cases and need special consideration due to present symptoms, disabilities, and comorbidities. This report presents anesthetic management of a traumatic patient with Wolfram syndrome candidate for orthopedic surgery. The report also discusses manifestation and anesthetic consideration in this population

Effects of Low Pressure of Laparoscopic Cholecystectomy on Arterial Pressure of Carbon Dioxide and Mean Blood Pressure

Background: The effect of low pressure pneumoperitoneum in laparoscopic cholecystectomy on partial pressure of carbon dioxide in the arterial blood (PaCO2) is an important subject which has not been completely defined.Methods: In a double-blind clinical trial, we randomly studied 202 ASA (The ASA physical status classification system) class 1, 2 patients aged between 20 and 85 years who were candidates for elective laparoscopic cholecystectomy. They were randomly divided into two groups of low pressure pneumoperitoneum (6-8 mm Hg) and standard pressure pneumoperitoneum (12-14 mm Hg). By the same general anesthesia protocol in the two groups, PaCO2 was assessed before CO2 insufflation and desufflation. Mean Arterial blood Pressure (MAP) was measured in the two groups.Results: PaCO2 was not significantly different between the 2 groups before CO2 insufflation. But, PaCO2 was statistically lower in low pressure pneumoperitoneum group before CO2 desufflation (P= 0.001). Mean Arterial Pressure (MAP) in standard pressure pneumoperitoneum group was lower than the low pressure pneumoperitoneum group at 5 and 10 minutes after CO2 insufflation and before the time of CO2 desufflation (P=0.001, P=0.006 and P=0.001, respectively). While, MAP was not statistically different between the two groups before CO2 insufflation (P=0.55).Conclusion: Low pressure pneumoperitoneum during laparoscopic cholecystectomy can be an effective protocol to prevent the rise of PaCO2 by preserving the hemodynamic status in such cases.

The Effect of Percutaneous Laser Disc Decompression on Reducing Pain and Disability in Patients With Lumbar Disc Herniation

Introduction: As low back pain incidence is increasing, noninvasive modalities are gaining attention for their ability to achieve the best possible outcome with the least complications. Percutaneous laser disc decompression (PLDD) is currently popular for this purpose. This study aims to evaluate the effect of PLDD on disability and pain reduction in patients with lumbar disc herniation.Methods: Thirty patients were enrolled in this study. Spinal nerve blocks were conducted by laser discectomy single stage injection of a needle into the disc space. The nucleus pulposus of herniated discs were irradiated with laser in order to vaporize a small part of the nucleus pulposus of the intervertebral discs and reduce the voluminosity of diseased discs. Patients were treated with 1000 J of 980 nm diode laser with 5 W energy. In order to measure the severity of pain, visual analog scale (VAS) and also ODI (Oswestry Disability Index) were used. Data were analyzed using SPSS version 12.Results: Thirty patients participated in this trial including 11 men and 19 women with a mean age (SD) of 40.8 (10.8) years. The mean patients VAS score and ODI level before and after discectomy showed statistically significant differences. The mean VAS and ODI scores showed no statistical difference between males and females (P < 0.05) and percutaneous laser discectomy decreased the VAS and ODI at both groups of patients similarly.Conclusion: We found the use of PLDD reduces pain and disability in patients as a noninvasive procedure

بررسی مقایسه‌ای تأثیر پخش آوای قرآن با صدای سفید بر نیاز به داروی بیهوشی حین عمل جراحی ویترکتومی

................................Background & Objective: Previous studies have shown that reciting the Quran can reduce anxiety, pain and sympathetic activity. One of the criticisms of these studies was the lack of an appropriate control group. In this study, white sound consisting of all wavelengths audible to humans was used as a control group. Methods: Fifty patients who were candidates for vitrectomy under general anesthesia included in the study. These patients were randomly divided into two groups: Quran Group and White Noise Group. After obtaining informed consent, the associated sound was played to the patients after induction of anesthesia. The two groups were compared in terms of propofol use as an anesthetic to maintain a BIS of about 50, as well as pain, nausea and vomiting. Results: The average consumption of propofol in the Quran group was significantly lower than the white voice group (P-value = 0.05). Also, the rate of nausea and vomiting was lower in the Quran group, but the amount of pain was not significantly different between these two groups. Conclusion: The reciting of the Quran can reduce the need for anesthesia and reduce postoperative nausea and vomiting.سابقه و هدف: مطالعات پیشین نشان داده است که آوای قرآن می‌تواند موجب کاهش اضطراب، درد و فعالیت سمپاتیک گردد؛ ولی نبود گروه کنترل مناسب از مهم‌ترین ایرادهای این نوع از مطالعات است. در پژوهش حاضر اثرات شنیدن آوای قرآن در حین بیهوشی بر عمق بیهوشی بررسی؛ و برای گروه کنترل از صدای سفید که از مجموعۀ تمام طول موج‌های قابل‌شنیدن تشکیل می‌شود، استفاده شد.   روش کار: پژوهش حاضر از نوع کارآزمایی بالینی آینده‌نگر دوسوکور است که برای ۵۰ بیمار داوطلب جراحی ویترکتومی تحت بیهوشی عمومی در اتاق عمل بیمارستان امام حسین (ع) صورت گرفت. بیماران به‌صورت تصادفی به دو گروه قرآن و صدای سفید تقسیم شدند و بعد از القای بیهوشی آوای مرتبط برای بیماران پخش شد. این دو گروه از نظر مصرف پروپوفول به‌عنوان داروی بیهوشی برای حفظ شاخص دو طیفی حدود عدد ۵۰ و همچنین شدت درد، تهوع و استفراغ پس از عمل با یکدیگر مقایسه شدند. در این پژوهش همۀ موارد اخلاقی رعایت شده است و مؤلفان تضاد منافعی گزارش نکردند. یافته‌ها: نتایج نشان می‌دهد که متوسط مصرف پروپوفول در گروه قرآن به‌طور معناداری کمتر از گروه صدای سفید بود (037/0P=). همچنین میزان تهوع و استفراغ در گروه قرآن کمتر بود ولی شدت درد بین این دو گروه اختلاف معنی‌داری نداشت. نتیجه‌گیری: بر اساس یافته‌های به‌دست‌آمده، شنیدن آوای قرآن توسط بیمار تحت بیهوشی عمومی می‌تواند موجب کاهش نیاز به داروی بیهوشی و کاهش بروز تهوع و استفراغ گردد

Efficacy of Low-Level Laser Therapy for the Treatment of Nonspecific Chronic Neck Pain: LowLevel Laser Therapy vs. Sham Laser: Low-Level Laser Therapy for Nonspecific Chronic Neck Pain

Introduction: The most common type of neck pain is chronic nonspecific pain. There are conflicting opinions about the beneficial effects of a low-level laser in reducing chronic nonspecific neck pain. The aim of this study was to evaluate the efficacy of low-level laser therapy (LLLT) for the treatment of non-specific chronic neck pain.Methods: This study was conducted as a prospective randomized clinical trial. Forty-four patients were randomly divided into two groups: (1) Intervention group (n=22): LLLT in the red spectra range with a wavelength of 980 (nm) and a power of 16 (J/cm2) was irradiated in the affected areas of the neck, the muscles along the spine, and the upper trapezius; (2) sham group (n=22): A low-level laser was irradiated with a passive probe (non-laser red light) in the affected areas of the neck, the muscles along the spine, and the upper trapezius. The treatment protocol consisted of 12 sessions (15 minutes, three times a week, for four weeks). These patients were evaluated for pain using the visual analog scale (VAS) (0-10). The patients were followed up for four weeks.Results: This study showed a statistically significant reduction in chronic nonspecific neck pain in the LLLT group (P<0.05).Conclusion: It is concluded that LLLT was effective in reducing chronic nonspecific neck pain. LLLT is a non-invasive, safe, and effective method that can improve chronic nonspecific neck pain in patients in the short ter