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China has granted marketing approval of its first drug for the prevention of acute mountain sickness, filling the long-standing gap in the domestic market where no such medications had been available, Science and Technology Daily reported on Tuesday.
The National Medical Products Administration (NMPA) has approved the marketing of acetazolamide sustained-release capsules, the report said. As the first specialized drug in China indicated for preventing of acute mountain sickness, its approval marks the end of the country's lack of dedicated preventive treatment for altitude illness.
By inhibiting the activity of carbonic anhydrase, acetazolamide promotes the renal excretion of bicarbonate, corrects respiratory alkalosis caused by hypoxia at high altitudes, thereby regulating acid-base balance, optimizing respiratory status, elevating blood oxygen levels, and reducing the risk of onset at the source.
In contrast to health products that only provide auxiliary regulatory effects, this medication has been validated through stringent clinical trials and stands as a specialized drug approved by the NMPA with a clear indication for prevention, said the report.
Led by principal investigator is Luobu Gesang, a deputy dean of the People's Hospital of Xizang Autonomous Region, the clinical trial was designed by his team and has yielded critical evidence to inform prevention strategies for altitude sickness that are specifically adapted to Chinese and Asian populations.
"Previously, although acetazolamide had already been used internationally for the prevention of acute mountain sickness, China had long lacked an NMPA-approved acetazolamide formulation supported by rigorous clinical trials. Furthermore, the existing international formulations were short-acting tablets requiring multiple daily doses, and no drugs with the relevant indication were available on the domestic market for an extended period," said Luobu Gesang.
The sustained-release capsule approved this time not only fills this critical gap but also optimizes the dosage form, providing more reliable and convenient medication protection for the physical health and life safety of people entering high-altitude areas, he added.
Clinical trials showed that, compared with the placebo group, the incidence of acute mountain sickness in the medication group was significantly reduced, with the incidence of moderate-to-severe acute mountain sickness decreasing by 14.6 percent, according to the report.
Related research has been published in the international flagship journal of high-altitude medicine, High Altitude Medicine & Biology.
Global Times
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