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Distal radius fractures (DRFs) are among the most common fracture injuries in emergency trauma departments. Treatments for DRFs comprise surgical and conservative approaches. The rise of 3-dimensional (3D) printing in orthopedics has led to bespoke splints with superior clinical efficacy, lightweight design, and better ventilation. These splints could reduce patient pain, lessen risks of joint stiffness, and hasten wrist recovery. Topology optimization from engineering is used to make orthotic devices lighter. It mathematically models optimal structures and materials, maximizing strength and minimizing material use. Despite advances, clinical studies on topology-optimized splints remain scarce. Recognizing this, Honghong Ma et al used topology optimization with 3D printing to develop a novel polyamide splint.

Honghong Ma et al conducted a study to assess the clinical efficacy and complication rates of topology-optimized splints in the treatment of distal radius fractures after closed manual reduction.

This 12-week, multicenter, open-label, analyst-blinded randomized clinical trial (comprising a 6-week intervention followed by a 6-week observational phase) included 110 participants with distal radius fractures. Statistical analysis was performed on an intention-to-treat basis.

Participants were randomly assigned to 2 groups: the intervention group received topology-optimized splint immobilization and the control group received cast immobilization after closed manual reduction for 6weeks. After this period, immobilization was removed, and wrist rehabilitation activities commenced. The primary outcome was the Gartland-Werley (G-W) wrist score at 6 weeks (where higher scores indicate more severe wrist dysfunction). Secondary outcomes encompassed radiographic parameters, visual analog scale scores, swelling degree grade, complication rates, and 3 dimensions of G-W wrist scores.

Key findings of the study were:

• A total of 110 patients (mean [SD] age, 64.1 [12.7] years; 89 women [81%]) enrolled in the clinical trial, and complete outcome measurements were obtained for 101 patients (92%).

• Median G-W scores at 6 weeks were 15 (IQR, 13-18) for the splint group and 17 (IQR, 13-18) for the cast group (mean difference, −2.0 [95% CI, −3.4 to −0.6]; P = .03), indicating a statistically significant advantage for the splint group.

• At 12 weeks, no clinically significant differences in G-W scores between the 2 groups were observed.

• Complication rates, including shoulder-elbow pain and dysfunction and skin irritation, were less common in the splint group (shoulder-elbow pain and dysfunction: risk ratio, 0.28 [95% CI, 0.08-0.93]; P = .03; skin irritation: risk ratio, 0.30 [95% CI, 0.10-0.89]; P = .02).

The authors concluded that – “Findings of this randomized clinical trial suggest that patients with distal radius fractures that were managed with topology-optimized splints had better wrist functional outcomes and fewer complications at 6 weeks compared with those who received casting, with no difference at week 12. Therefore, topology-optimized splints with improved performance have the potential to be an advisable approach in the management of distal radius fractures.”

Further reading:

Topology-Optimized Splints vs Casts for Distal Radius Fractures A Randomized Clinical Trial

Honghong Ma et al

JAMA Network Open. 2024;7(2):e2354359.

doi:10.1001/jamanetworkopen.2023.54359

New Delhi: The drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to update prescribing information for the fixed-dose combination (FDC) Ibuprofen 100mg plus Paracetamol 162.5mg suspension and Ibuprofen 400mg plus Paracetamol 325mg tablet.

The FDA has approved omalizumab (Xolair) injection as first medication to help reduce allergic reactions to multiple foods after accidental exposure.

Omalizumab is a monoclonal antibody that helps reduce certain allergic reactions including anaphylaxis in adults and children 1 year and older.

Patients who take Xolair must continue to avoid foods they are allergic to. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma in certain patients. Xolair is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” said Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

According to the Centers for Disease Control and Prevention, almost 6% of people in the United States in 2021 had a food allergy and exposure to the particular food(s) to which they are allergic can lead to potentially life-threatening allergic reactions (i.e., anaphylaxis). There is currently no cure for food allergy. Current treatment requires strict avoidance of the food(s) the patient is allergic to, and prompt administration of epinephrine to treat anaphylaxis should accidental exposures occur. Palforzia (peanut allergen powder) is an oral immunotherapy product approved in patients 4-17 years of age for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut, but its benefits are restricted to peanut allergy. Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.

Xolair is a drug (in the class of drugs called monoclonal antibodies) that binds to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors.

Xolair’s safety and efficacy in reducing allergic reactions in subjects with food allergies was established in one multi-center, double-blind, placebo-controlled study of 168 pediatric and adult subjects (at least 1 year of age or older) who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut. Researchers randomly gave subjects either Xolair or placebo treatment for 16 to 20 weeks. The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrams or greater) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms, such as moderate to severe skin, respiratory or gastrointestinal symptoms, at the end of the 16-to-20-week treatment course. Of those who received Xolair, 68% (75 of 110 subjects) were able to eat the single dose of peanut protein without moderate to severe allergic symptoms (e.g., whole body hives, persistent coughing, vomiting), compared to 6% (3 of 55 subjects) who received placebo; these results are statistically significant and clinically meaningful for subjects with food allergy. Of note, however, 17% of subjects receiving Xolair had no significant change in the amount of peanut protein tolerated (could not tolerate 100 mg or more of peanut protein). As a result, continuation of strict allergen avoidance is still necessary, despite treatment with Xolair.

The key secondary measures of efficacy were the percentage of subjects who were able to consume a single dose (1,000 milligrams or greater) of cashew, milk or egg protein without moderate to severe allergic symptoms at the end of the 16-to-20-week treatment course. For cashew, 42% (27 of 64 subjects) who received Xolair achieved this endpoint compared to 3% (1 of 30 subjects) who received placebo. For milk, 66% (25 of 38 subjects) who received Xolair achieved this endpoint, compared to 11% (2 of 19) who received placebo. For egg, 67% (31 of 46 subjects) who received Xolair achieved this endpoint, compared to 0% of the 19 who received placebo. As a result, Xolair treatment is approved for certain patients with one or more IgE-mediated food allergies.

The most common side effects of Xolair observed included injection site reactions and fever. Xolair comes with certain warnings and precautions, such as anaphylaxis, malignancy, fever, joint pain, rash, parasitic (worm) infection and abnormal laboratory tests.

In addition, Xolair comes with a boxed warning for anaphylaxis, which can be life threatening, based on pre-marketing and post-marketing reports of anaphylaxis that occurred after Xolair administration. Anaphylaxis has occurred after the first dose of Xolair, but also has occurred beyond one year after beginning treatment. Xolair should only be started in a healthcare setting equipped to manage anaphylaxis. For selected patients who tolerate initial Xolair treatments in a healthcare setting without anaphylaxis, self-administration (or administration by a caregiver) may be appropriate and should be discussed with a healthcare provider.

Patients should not receive Xolair if they have a history of known severe hypersensitivity to Xolair or any of its components.

Xolair is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Xolair received Priority Review and Breakthrough Therapy designations for this indication.

The FDA granted the approval of Xolair to Genentech. 

New Delhi: Amid the ongoing issue of using sub-standard medical items, as many as 26 government hospitals have been asked to share details with the Anti-Corruption Branch (ACB) of their approval and purchase committee.  

This development comes after the ACB arrested 10 people for allegedly being involved in the supply of sub-standard items to six government hospitals in Delhi on Tuesday. Among the arrested accused – Seven of them are suppliers and three are laboratory owners. 

According to ACB, the suppliers or manufacturers arranged receipts of prescribed items from officials of the hospitals against the supply of sub-standard items and even in the case of short- or non-delivery. The laboratory owners or managers used to supply forged lab reports against the sub-standard items. PTI reports.

Following this, the ACB wrote a letter to 26 government hospitals who have been asked to share details of procurement of the equipment and material they use, their approval and purchase committee, list of suppliers etc.  

Also read- GMC Amritsar Principal, Vice Principal Removed On Allegations Of Faulty, Substandard PPE Kits

Furthermore, people familiar with the matter told HT that the agency has found the involvement of nine doctors from Lok Nayak Hospital in the procurement of sub-standard material. Consequently, the ACB has requested authorization for prosecution against these nine doctors.

Speaking to HT, an officer said, “We have written to 26 Delhi government hospitals to share with us the details of their approval and purchase committee, list of suppliers, materials they use and documents related to it. Essentially, we have asked if the suppliers we have arrested have also supplied any material to them. This is an expansion of our probe into the already registered case… As per protocol, we have sought prosecution sanction from the health department. These doctors were members of the purchase and approval committee.”

According to protocol, the purchase committee prepares the list of items the hospital requires. Then it uploads the requirement on the Government e-Marketplace (GeM) portal, and the approval committee checks after the items are delivered and whether they are according to the standards laid out by the government.

On August 18, 2023, six teams of the vigilance wing of the Health and Family Welfare Department visited Lal Bahadur Shastri Hospital, Lok Nayak Hospital, Deen Dayal Upadhyay Hospital, Guru Teg Bahadur Hospital, Sanjay Gandhi Memorial and Janakpuri Super Speciality Hospital separately and collected samples of various items like rolled bandages, IV sets, deluxe infusion sets, absorbent cotton, latex gloves, etc.

These samples were sent to different labs and the majority of them either were found sub-standard or failed during testing, a senior official said.

During the initial investigation, it indicated that the alleged firms and suppliers had provided the requisite items through the GeM portal. The items were supposed to be delivered with desired certificates from government-approved labs, the official said.

Fourteen firms connected with the supply in question and belonging to the Delhi-NCR have been inspected. Relevant documents containing supply details have been seized and the suppliers have been questioned, the official added.

Further investigation into the case revealed that the government officials intentionally avoided taking the desired lab reports and licences as mentioned in the GeM contract order, ACB head Madhur Verma said.

In some of the cases, the licence numbers mentioned by the supplier were found to be fake. In most of the cases, batch numbers of delivered items did not match with the batch numbers quoted by the manufacturer or supplier, he said.

It has also surfaced that sub-standard material was purchased from local markets with no parameters at all and was supplied to the hospitals. Receiving of the items was also found given by the concerned officials against nil delivery or short delivery. Verma said Instances have noticed where the approval committee had approved even before receiving the material.

It is also found that the government officials concerned and suppliers or traders keep committing forgeries in documents even after the issue was taken up for investigation, officials said.

Also read- Delhi: Anti Corruption Branch Raids LNJP Hospital