Porcine lung phospholipid injection

Pharmacodynamics: Pulmonary surfactant is a mixture of phospholipids and specific proteins as the main components, distributed on the inner surface of alveoli. Its main function is to reduce lung surface tension. The property of pulmonary surfactant to reduce surface tension is essential for maintaining alveolar stability, preventing alveolar collapse at the end of exhalation, and maintaining sufficient gas exchange throughout the ventilation cycle. Severe respiratory failure in premature infants caused by lack of pulmonary surfactant due to any reason is called respiratory distress syndrome (RDS) or hyaline membrane disease (HMD). RDS is the main cause of acute morbidity and mortality in premature infants, and can also cause long-term respiratory and neurological sequelae. The purpose of developing this product is to drip exogenous surfactant into the trachea to replace the lack of endogenous pulmonary surfactant. The surface activity of this product helps it to be evenly distributed in the lungs and spread along the air-liquid interface of the alveoli. The physiological and therapeutic effects of this product in treating surfactant deficiency have been confirmed in different animal models. Premature fetal rabbits that were delivered by caesarean section and immediately killed showed significant improvement in lung expansion after immediate use of this product. Premature newborns were given this product through endotracheal intubation without 100% oxygen. Compared with control animals, tidal volume and lung-chest compliance were significantly improved. Treatment of premature newborn rabbits with this product (maintaining a standard tidal volume of about 10 ml/kg) can increase the compliance of the lung-chest system to a level similar to that of mature newborn animals. Large-scale international open and controlled clinical trials have demonstrated the therapeutic effect of Cursu on RDS patients and premature infants at risk of RDS. A single dose of this product (1.25-2.5 ml/kg equals 100-200 mg/kg) for premature newborns showed a rapid and significant improvement in oxygenation, a decrease in the inspired oxygen concentration (Fi02), and an increase in the ratio of Pa02.Pa02/Fi02 and a/AP02; mortality and the incidence of major pulmonary complications were reduced. A second or third dose of 100 mg/kg can further reduce the incidence and mortality of pneumothorax. Toxicology: Intraperitoneal and intratracheal administration to animals of different species to study acute toxicity, no signs of pulmonary or systemic poisoning were found, and no deaths occurred. Subacute (14 days) intratracheal toxicity studies on dogs, rabbits and rats showed no clinical effects or hematological changes related to treatment, nor gross changes. Moreover, there was no evidence of direct toxicity in rats administered intraperitoneally (4 weeks). Parenteral administration of guinea pigs neither induced active allergic reactions nor stimulated antibody production in passive skin allergy tests. No allergic reactions were observed with intratracheal administration. Moreover, there was no evidence of skin sensitization potential (Magnusson and Kligman tests). This product has no mutagenic and teratogenic activity.

Porcine lung phospholipids are a natural extract, with phospholipids accounting for 90% of the dry weight, most of which are phosphatidylcholine (PC). The PC with surface activity is dipalmitoylphosphatidylcholine, and the remaining phospholipids include phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and sphingomyelin. In addition, there are two surfactant (PS) specific proteins, SP-B and SP-C. The excipients are sodium chloride and water for injection.

This product is a white or milky white suspension.

Treatment and prevention of respiratory distress syndrome (RDS) in premature infants.

Rescue treatment: The recommended dose is 100-200 mg/kg body weight (1.25-2.5 ml/kg) at a time. If the baby also needs assisted ventilation and supplemental oxygen, an additional 100 mg/kg can be added every 12 hours (maximum total dose: 300-400 mg/kg). It is recommended to start treatment as soon as possible once RDS is diagnosed. Prevention: 100-200 mg/kg is given as soon as possible after birth (within 15 minutes). Another 100 mg/kg can be given 6-12 hours after the first dose, and then if RDS occurs and mechanical ventilation is required, it will be given every 12 hours (maximum total dose: 300-400 mg/kg). Usage This product is ready for use after opening the bottle and stored in a refrigerator at 2-8℃. Warm the bottle to 37℃ before use. Gently turn it up and down. Do not shake it to make the liquid uniform. Use a sterile needle and syringe to draw up the drug solution, and drip it directly into the lower trachea through the endotracheal tube, or divide it into 2 portions and drip it into the left and right main bronchi. To facilitate uniform distribution, manual ventilation is performed for about 1 minute, and the oxygen percentage is the same as before administration. Then the infant is reconnected to the ventilator, and the ventilator parameters are adjusted appropriately according to the clinical response and changes in blood gases. The same method is used for subsequent administration. Infants who do not require assisted ventilation after administration of this product can be disconnected from the ventilator. An immediate increase in arterial oxygen partial pressure (Pa02) or oxygen saturation is generally observed after administration, so close observation of blood gases is recommended. Continuous monitoring of transcutaneous oxygen partial pressure or oxygen saturation is recommended to avoid hyperoxia.

Pulmonary hemorrhage is rare, but sometimes a fatal complication of premature infants. The more immature the premature infant, the higher the incidence. There is no evidence that the use of this product can increase the risk of this event. Bradycardia, hypotension, low oxygen saturation (see [Precautions]), and temporary weakening of brain electrical activity have been rarely reported. No other adverse reactions have been reported.

No special taboos have been found so far.

Precautions for children: See [Usage and Dosage] for details. Precautions for pregnancy and lactation: No relevant information. Precautions for the elderly: No relevant information.

Not seen.

Protect from light and store at 2-8°C. Do not reuse the residual solution after the first aspiration. Do not return the rewarmed vial to the refrigerator.

18 months