Safety Evaluation of Pueraria Lobata Radix in Specific Consumption Scenarios for Type 2 Diabetes

Other illness

• Diagnosis of type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.

Other

• Use of PLR compound preparations (e.g., puerarin injection).
• Unavailability of complete clinical data or patient refusal to provide essential information required for the observation period during follow-up.

• Diagnosis with T2DM.
• Documented history of consuming Pueraria lobata radix (PLR) in any dosage form (e.g., dried slices, root cubes).
• Fulfillment of at least one of the following special scenarios: 1) Excessive dosage: Daily PLR intake ≥ twice the maximum dose specified in the Chinese Pharmacopoeia; 2) Long-term consumption: PLR consumption duration ≥ three months with frequency ≥ three times weekly; 3) Advanced age: ≥ 80 years; 4) Pregnancy; 5) Lactation; 6) Allergic constitution: History of any food or drug allergy; 7) Liver dysfunction: Clinical diagnosis of liver cirrhosis or chronic liver failure, or laboratory findings of total bilirubin \> 1.5 × upper limit of normal (ULN) or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 2 × ULN; 8) Renal insufficiency: Clinical diagnosis of diabetic nephropathy or chronic nephritis with renal function impairment, or serum creatinine \> 120% of ULN.
• Occurrence of adverse events during the retrospective observation period within one month following PLR consumption.