Efficacy and Safety of the Chinese Herbal Compound TJAOA101 in Treating Diminished Ovarian Reserve: A Protocol for Multicenter, Prospective, and Pre-Post Study

Objective Diminished ovarian reserve(DOR)can lead to early menopause,poor fecundity,and an increased risk of disorders such as osteoporosis,cardiovascular disease,and cognitive impairment,seriously affecting the physical and mental health of women.There is still no safe and effective strategy or method to combat DOR.We have developed a novel Chinese herbal formula,Tongji anti-ovarian aging 101(TJAOA101),to treat DOR.However,its safety and efficacy need to be further validated.Methods In this prospective and pre-post clinical trial,100 eligible patients aged 18–45 diagnosed with DOR will be recruited.All participants receive TJAOA101 twice a day for 3 months.Then,comparisons before and after treatment will be analyzed,and the outcomes,including anti-mullerian hormone(AMH)and follicle-stimulating hormone(FSH)levels and the antral follicle count(AFC),the recovery rate of menopause,and the Kupperman index(KMI),will be assessed at baseline,every month during medication(the intervention period),and 1,3 months after medication(the follow-up period).Assessments for adverse events will be performed during the intervention and follow-up periods.Conclusion A multicenter,prospective study will be conducted to further confirm the safety and efficacy of TJAOA101 in treating DOR and to provide new therapeutic strategies for improving the quality of life in DOR patients.

Characteristics of Viral Shedding in Respiratory Samples and Specific Antibodies Production in 564 COVID-19 Patients

Positive nucleic acid(NA)results have been found in recovered and discharged COVID-19 patients,but the proportion is unclear.This study was designed to analyze the recurrent positive rate of NA results after consecutively negative results,and the relationship between the specific antibody production and positive NA rate.According to Strengthening the Reporting of Observational Studies in Epidemiology guidelines,data of inpatients in Sino-French New City Branch of Tongji Hospital between Jan.28 and Mar.6,2020 were collected.A total of 564 COVID-19 patients over 14 years old who received the examinations of NA and antibodies against SARS-CoV-2 were included.Days of viral shedding and specific antibodies were recorded and assessed.Among NA tests in respiratory samples(throat swabs,nasopharyngeal swabs,sputum and flushing fluid in alveoli),the patients with all-negative NA results accounted for 17.20%,those with single-positive results for 46.63%,and those with multiple-positive results for 36.17%respectively.Besides,the recurrent positive NA results after consecutively negative results appeared in 66 patients(11.70%).For multiple-positive patients,median viral shedding duration was 20 days(range:1 to 57 days).Of the 205 patients who received 2 or more antibody tests,141(68.78%)had decreased IgG and IgM concentrations.IgM decreased to normal range in 24 patients,with a median of 44 days from symptom onset.Viral shedding duration was not significantly correlated with gender,age,disease severity,changes in pulmonary imaging,and antibody concentration.It is concluded that antibody level and antibody change had no significant correlation with the positive rate of NA tests and the conversion rate after continuous negative NA tests.In order to reduce the recurrent positive proportion after discharge,3 or more consecutive negative NA test results with test interval more than 24 h every time are suggested for the discharge or release from quarantine.

Inhibition of TNF-alpha secretion from peripheral bloodmonocular cells by triptolid is associated with TNF-alpha-308gene polymorphisms in rheumatoid arthritis patients

This study examined the inhibitory effect of triptolid(TP)on tumor necrosis factor-α(TNF-α)secreted from peripheral blood monocular cells(PBMCs)and the association of the inhibitory effect with TNF-α-308 gene polymorphisms in rheumatoid arthritis(RA)patients.Gene polymorphism at A-G site 308 in the promoter region of TNF-αgene was detected in 42 RA patients by using allele specific polymerase chain reaction(AS-PCR)assay.PBMCs were harvested from these patients and treatedfirst with lipopolysaccharides(LPS)and then with different doses of TP(1,5.4 and 15 ng/mL).The TNF-αlevel in the supernatants was measured by enzyme-linked immuno-sorbent assay(ELISA).The results showed that TNF-αlevel in the supernatants of TP(1 ng/mL)-treated PBMCs was decreased by 3.80%and 4.91%,respectively,in the patients with AA and AG genotypes,when compared with those treated with LPS alone(P>0.05).Moreover,the TNF-αlevel in the patients with GG genotype was reduced by 20.74%(P<0.05).When PBMCs were treated with TP at 5.4 ng/mL,TNF-αlevels in the patients with AA,AG,and GG genotypes were decreased by 20.42%,34.73%,and 41.69%,respectively(P<0.05).The TNF-αlevel was slightly higher in the PBMCs treated with 15 ng/mL of TP than those in the two TP groups in the patients carrying AA,AG,and GG genotypes(P>0.05).It was concluded that gene polymorphism at TNF-α-308 sites may relate to the secretion of TNF-αin RA patients.TP has different inhibitory effects on the secretion of TNF-αin the patients harboring different genotypes,which may be one of the reasons for individual variation in response to TP.