RESUMO
OBJECTIVE: To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome. METHODS: In this multi-center, randomized, controlled study, 140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table, with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening, 100 mL each time), and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2-6), both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Traditional Chinese Medicine Symptom Scale (TCMSS), and Clinlcal Global Impression (CGI) scores at the 2nd, 4th, and 6th weekends of treatment, HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ⩽7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded. RESULTS: From baseline to week 6, the HAMD-17 scores decreased 10.2 ± 4.0 and 9.1 ± 4.9 points in the JJD and paroxetine groups, respectively (P=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (P=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients, respectively (P=0.128). The differences of CGI scores at the 6th week were not statistically significant (P>0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (P=0.001 and P=0.014). The HAMA scores declined 8.1 ± 3.0 and 6.9 ± 4.3 points from baseline to week 6 in the JJD and paroxetine groups, respectively (P=0.905 between groups). At 4th week of treatment, there was a significant difference in HAMA between the two groups (P=0.037). TCMSS decreased 11.4 ± 5.1, and 10.1 ± 6.8 points in the JJD and paroxetine groups, respectively (P=0.080 between groups). At the 6th week, the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14% vs. 22.86%, P<0.05). CONCLUSION: Compared with paroxetine, JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome, with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922).
Assuntos
Paroxetina , Baço , Humanos , Paroxetina/efeitos adversos , Ansiedade , Síndrome , Medicina Tradicional Chinesa , Resultado do Tratamento , Método Duplo-CegoRESUMO
OBJECTIVE: To analyze the current status of maternal HIV infection, mother to child transmission, and the work accomplishments in preventing mother-to-child transmission of HIV (PMTCT). METHODS: During October, 2001 to May, 2009, HIV voluntary consultation and examination were carried out in 339 866 pregnant women in the urban areas, while 594 pregnant women who tested positive were intervened, and interventions were also conducted among 326 babies who were born to HIV positive mothers, including HIV immune body examination on the babies when they were 12 months and 18 months old. RESULTS: A total of 594 pregnant women were found HIV positive, with the positive rate of 0.17% (594/339 866). And the rate was declining year by year. The highest rate was 0.47% (37/7837) in 2002, and the lowest rate was 0.12% (86/73 343) in 2008. Of the 594 positive pregnant women, 228 (38.38%) terminated pregnancy voluntarily, 43 (7.24%) kept on pregnancy and 317 (53.37%) parturients. Of 326 babies born by the 317 parturients, 317 survived.298 received curbing intervention for mother to child transmission (PMTCT), the ratio was 94.01% (298/317). Of 224 babies who were 18 months old, 221 accepted examination, and 7 HIV positive. The maternal infant transmission rate after intervention was 3.17% (7/221). CONCLUSION: Through the prevention of mother-to-child transmission of HIV, the HIV infection status in the pregnant women can be timely observed, which can effectively decrease the level of mother-to-child transmission of HIV.