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The film's commercial title is Wansaiwei. It is a special antiviral drug mainly used for primary immunodeficiency diseases, cytomegalovirus (CMV) infection, cytomegalic inclusion disease, idiopathic thrombocytopenic purpura, and immune thrombocytopenic purpura. It is suitable for the prevention of cytomegalovirus infection in high-risk solid organ transplant patients and the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS), that is, AIDS patients.

What are the side effects of Valganciclovir Hydrochloride Tablets?

Valganciclovir is the prodrug of ganciclovir and is rapidly converted to ganciclovir after oral administration. Therefore, known adverse reactions associated with ganciclovir are expected to occur with the use of valganciclovir hydrochloride tablets. All adverse events observed in clinical studies of valganciclovir hydrochloride tablets have also been observed with ganciclovir.

Treatment of CMV retinitis in AIDS patients: In a clinical trial in which 79 patients in each group were randomly treated with valganciclovir or intravenous ganciclovir for 28 days (21 days of induction treatment and 7 days of maintenance treatment), the safety data of the two groups were comparable. The most frequently reported adverse events were diarrhea, neutropenia, and pyrexia. Diarrhea, oral candidiasis, headache, and fatigue were more frequently reported in the oral valganciclovir group, whereas nausea and injection site-related events were more frequently reported in the intravenous ganciclovir group.

Rates of some adverse events in randomized studies:

In the valganciclovir-treated group (n=79), diarrhea was seen in 16%; oral candidiasis in 11%; headache in 9%; fatigue in 8%; and nausea in 8%.

In the intravenous ganciclovir-treated group (n = 79), diarrhea was seen in 10%; oral candidiasis, 6%; headache, 5%; fatigue, 4%; nausea, 14%, and venous thrombosis and thrombophlebitis, 6%.

Shown below are adverse events that occur in ≥ (greater than or equal to) 5% of patients, regardless of severity and whether they are drug-related. This set of data comes from two clinical trials (n=370). The subjects were patients with CMV retinitis who received valganciclovir hydrochloride tablets 900 mg twice daily for induction therapy or 900 mg once daily for maintenance therapy. Approximately 65% ​​of these patients received valganciclovir for more than 9 months (the maximum duration was 30 months).

In both clinical trials (n = 370), in the tablet treatment group, the most commonly reported adverse events (% of patients), regardless of severity and whether drug-related, were diarrhea (38%), pyrexia (26%), nausea (25%), neutropenia (24%) and anemia (22%). Most adverse events were mild or moderate. Regardless of severity, the most commonly reported events related to valganciclovir hydrochloride (including related, possibly related, probably unrelated) were neutropenia (21%), anemia (14%), diarrhea (13%), and nausea (9%).