Objective To assess the incidence of contrast-induced nephropathy(CIN)in patients with chronic thromboembolic pulmonary hypertension(CTEPH)after receiving balloon pulmonary angioplasty(BPA),and to evaluate the effect of the contrast agents on renal function.Methods A total of 143 CTEPH patients,who received BPA at the China-Japan Friendship Hospital of China from December 2018 to May 2022,were enrolled in this study.The clinical data,hemodynamic indicators,and serum creatinine(SC)concentrations within one week before and 48-72 h after BPA were collected.The estimated glomerular filtration rate(eGFR)was calculated according to the Modification of Diet in Renal Disease(MDRD)formula.The SC concentration and eGFR changes before and after each BPA procedure were compared.The incidence of CIN and its risk factors were evaluated,and the changes in hemodynamics,SC and eGFR after the initial and last time of BPA treatment were analyzed.Results A total of 192 BPA procedures were performed in 115 CTEPH patients,including 88 BPA procedures in males and 103 BPA procedures in females.The mean amount of contrast agent used for each BPA was(145.58±47.26)mL.After BPA,12 patients developed 13 times of CIN,with an incidence of 6.8％.There was no significant differences(P＞0.05)in the baseline characteristics and SC concentration before BPA between CIN patients and non-CIN patients.In terms of the hemodynamic indexes,the mixed venous oxygen saturation(SvO2)in CIN patients was significantly lower than that in non-CIN patients(58.58％±10.38％vs.66.15％±8.02％,P=0.002),and no statistically significant differences(P＞0.05)in the other hemodynamic indexes existed between CIN group and non-CIN group.No statistically significant differences in SC concentration and eGFR existed before and after each BPA procedure.In patients who had received several BPA procedures,significant improvements in the SC[(78.09±18.760)μmol/L vs.(82.26±21.37)μmol/L,P＜0.001]and eGFR[(86.08±21.22)mL/(min·1.73 m2)vs.(82.07±22.05)mL/(min·1.73 m2),P=0.007]was achieved when compared with their baseline values.Conclusion CTEPH patients may develop CIN after receiving BPA treatment.After receiving several BPA treatments the patient's clinical symptoms and hemodynamics can be improved,and the patient's renal function is also significantly improved.

OBJECTIVE：To provide refe rence for improving the moni toring system of simplified registration system of Chinese classical formulas. METHODS ：A comparative study was conducted on the simplified registration system of traditional herbal medicines in the European Union and Chinese classical formulas from the aspects of regulatory agencies ，regulatory systems ， simplified registration conditions ，simplified registration catalogs and registration data. On the basis of the experience of the simplified registration system of traditional herbal medicines in the European Union ，some suggestions were put forward to improve the simplified registration system of Chinese classical formulas. RESULTS & CONCLUSIONS ：The European Union establishes special committee on traditional herbal medicine for registration and supervision ；has established a complete regulatory system from directives to specific guidelines ；focuses on the history and conditions of the use of traditional herbal medicine ；has published the European Union monographs and European Union list ，which are used as a basis for safety and effectiveness to further reduce or exempt registration data. In China ，National Medical Products Administration and the National Administration of Traditional Chinese Medicine are jointly responsible for the registration and supervision of classical formulas. At present ，the relevant documents to simplify the registration and approval have been issued ，but there is no corresponding implementation rules and guidelines. China also attaches great importance to the clinical experience of classical formulas ，and emphasizes the consistency of preparation methods and dosage forms with ancient classics. Recently ，China has published the Catalogue of Ancient Classic Formula（the First Batch ），including 100 classical formulas ，and the classic formulas in the catalogue can be exempted from relevant registration materials when applying for registration. Our country can learn from the experience of the European Union and combine the actual situation of classic formulas supervision to establish an expert committee ，focus on quality control and risk control to improve registration and supervision system ，optimize the selection conditions of classic formulas ，and explore the classic formulas monographs ， to further stimulate the innovation vitality of traditional Chinese medicine industry.