Comparative efficacy and safety of Chinese patent medicines of iron deficiency anemia during pregnancy: A network meta-analysis.

BACKGROUND: Iron deficiency anemia (IDA) is a prevalent nutritional disorder during pregnancy. Clinical studies indicate that incorporating Chinese patent medicines (CPMs) with oral iron (OI) in treating IDA in pregnancy can reduce adverse effects and improve clinical outcomes. Nonetheless, the comparative efficacy of different CPMs remains unclear. AIM: To assess the safety and effectiveness of different CPMs for treating IDA during pregnancy using network meta-analysis. METHODS: We conducted a search for randomized controlled trials (RCTs) that combined CPM and OI for IDA treatment in pregnancy, spanning from 2013 to the present. Data analysis was performed using Rev Man 5.3 and Stata 14.0 on literature that satisfied the quality criteria. RESULTS: The analysis included 45 RCTs, encompassing 4422 pregnant patients with IDA. Six CPMs were examined, including Shengxuebao Mixture, Shengxuening Tablets (SXN), Yiqi Weixue CPMs (YQWX), Jianpi Shengxue CPMs (JPSX), Yiqi Buxue Tablets, and Compound Hongyi Buxue Oral Liquid (FFHY). Findings indicated that FFHY + OI significantly improved the clinical effective rate. SXN + OI was most effective in boosting red blood cells counts and hemoglobin levels. YQWX + OI showed superior results in improving serum ferritin, and SXN + OI was most effective in increasing serum iron levels. JPSX + OI was optimal in reducing adverse pregnancy outcomes, while YQBX + OI effectively minimized adverse events. A cluster analysis suggested that SXN + OI could be the potentially optimal therapeutic regimen for IDA in pregnancy. CONCLUSION: This study demonstrates that the combination of OI with CPMs offers better outcomes than OI alone. Based on clinical efficacy and other measured outcomes, SXN + OI emerges as the most effective treatment modality for improving the health of pregnant patients with IDA.

Shengxuebao Mixture for Iron Deficiency Anemia: A Meta-Analysis and Systematic Review.

OBJECTIVE: Traditional Chinese medicine Shengxuebao Mixture (SXBM) has been approved for treating iron deficiency anemia (IDA) in China. This study aimed to collect evidence and quantify the effect of SXBM on IDA. METHODS: Seven online databases were surveyed up to July 13, 2021. Randomized controlled trials in which SXBM was combined with conventional therapies to treat IDA and compared with placebo or conventional therapies were included in the study. The red blood cell (RBC) count, hemoglobin (Hb) level, serum ferritin (SF) level, and adverse events rate (AER) were evaluated. RESULTS: A total of 1,108 patients from 8 trials were recruited. SXBM plus conventional therapy increased the Hb level (mean difference [MD] = 13.04, 95% confidence interval [CI] 8.37-17.7, p < 0.00001), RBC count (MD = 0.41, 95% CI 0.19-0.62, p = 0.002), SF level (MD = 6.25, 95% CI 2.88-9.62, p = 0.0003), and AER (risk ratio = 0.56, 95% CI 0.36-0.86; p = 0.008). CONCLUSIONS: SXBM combined with conventional treatment seemed to be beneficial for patients with IDA. However, the harmlessness of SXBM was not confirmed due to insufficient trials and low methodological quality. Follow-up clinical studies should be cautiously designed, and more research is needed.

[Study on rapid quality analysis method of Shengxuebao Mixture].

A rapid analysis method based on ultraviolet-visual(UV-Vis) spectroscopy, near infrared(NIR) spectroscopy and multivariable data analysis was established for quality evaluation of Shengxuebao Mixture. The contents of eight active ingredients of Shengxuebao Mixture including albiflorin, paeoniflorin, 2, 3, 5, 4'-tetra-hydroxy-stilbene-2-O-ß-D-glucopyranoside, specnuezhenide,ecliptasaponin D, emodin, calycosin-7-glucoside and astragaloside Ⅳ were simultaneously detected by using this method. HPLC-UV-MS was used as a reference method for determining the contents of these ingredients. Partial least squares(PLS) analysis was implemented as a linear method for multivariate models calibrated between UV spectrum/NIR spectrum and contents of 8 ingredients. Finally, the performance of the model was evaluated by 24 batches of test samples. The results showed that both UV-Vis and NIR models gave a good calibration ability with an R~2 value above 0.9, and the prediction ability was also satisfactory, with an R~2 value higher than 0.83 for UV-Vis model and higher than 0.79 for NIR model. The overall results demonstrate that the established method is accurate, robust and fast, therefore, it can be used for rapid quality evaluation of Shengxuebao Mixture.

Study on rapid quality analysis method of Shengxuebao Mixture / 中国中药杂志

A rapid analysis method based on ultraviolet-visual(UV-Vis) spectroscopy, near infrared(NIR) spectroscopy and multivariable data analysis was established for quality evaluation of Shengxuebao Mixture. The contents of eight active ingredients of Shengxuebao Mixture including albiflorin, paeoniflorin, 2, 3, 5, 4'-tetra-hydroxy-stilbene-2-O-β-D-glucopyranoside, specnuezhenide,ecliptasaponin D, emodin, calycosin-7-glucoside and astragaloside Ⅳ were simultaneously detected by using this method. HPLC-UV-MS was used as a reference method for determining the contents of these ingredients. Partial least squares(PLS) analysis was implemented as a linear method for multivariate models calibrated between UV spectrum/NIR spectrum and contents of 8 ingredients. Finally, the performance of the model was evaluated by 24 batches of test samples. The results showed that both UV-Vis and NIR models gave a good calibration ability with an R~2 value above 0.9, and the prediction ability was also satisfactory, with an R~2 value higher than 0.83 for UV-Vis model and higher than 0.79 for NIR model. The overall results demonstrate that the established method is accurate, robust and fast, therefore, it can be used for rapid quality evaluation of Shengxuebao Mixture.

[Quantitative analysis method of Shengxuebao Mixture by HPLC-UV-MS based on quality by design concept].

In this study, the HPLC-UV-MS method for the simultaneous determination of eight active ingredients of Shengxuebao Mixture were developed based on the concept of quality by design（QbD）with a stepwise optimization approach. After the analytical target profile（ATP）had been defined, albiflorin, paeoniflorin, 2, 3, 5, 4'-tetra-hydroxy-stilbene-2-O-ß-D-glucopyranoside, specnuezhenide, ecliptasaponin D, emodin, calycosin-7-glucoside, and astragaloside Ⅳ were identified as the indicator components. The resolution and the signal-to-noise ratio of indicator components were then selected as critical method attributes (CMA) for the first step optimization. According to the results collected from fractional factorial design, critical method parameters (CMP) were determined with a multiple linear regression method, which included the amount of acid addition in the mobile phase, temperature, gradient, and wavelength. After that, the amount of acid addition and the wavelength were optimized to improve the resolution and the signal-to-noise ratio of the indicator components. The peak symmetry factors of specnuezhenide and emodin were then set as CMA for the second step optimization. The Box-Behnken designed experiments were conducted. The temperature and gradient were optimized after modelling. The design space were calculated and verified. The optimized analytical method was validated, and the results showed a good precision, accuracy and stability, which means that it can be used for the quantification of the indicator components in Shengxuebao Mixture.

Quantitative analysis method of Shengxuebao Mixture by HPLC-UV-MS based on quality by design concept / 中国中药杂志

In this study, the HPLC-UV-MS method for the simultaneous determination of eight active ingredients of Shengxuebao Mixture were developed based on the concept of quality by design（QbD）with a stepwise optimization approach. After the analytical target profile（ATP）had been defined, albiflorin, paeoniflorin, 2, 3, 5, 4'-tetra-hydroxy-stilbene-2-O-β-D-glucopyranoside, specnuezhenide, ecliptasaponin D, emodin, calycosin-7-glucoside, and astragaloside Ⅳ were identified as the indicator components. The resolution and the signal-to-noise ratio of indicator components were then selected as critical method attributes (CMA) for the first step optimization. According to the results collected from fractional factorial design, critical method parameters (CMP) were determined with a multiple linear regression method, which included the amount of acid addition in the mobile phase, temperature, gradient, and wavelength. After that, the amount of acid addition and the wavelength were optimized to improve the resolution and the signal-to-noise ratio of the indicator components. The peak symmetry factors of specnuezhenide and emodin were then set as CMA for the second step optimization. The Box-Behnken designed experiments were conducted. The temperature and gradient were optimized after modelling. The design space were calculated and verified. The optimized analytical method was validated, and the results showed a good precision, accuracy and stability, which means that it can be used for the quantification of the indicator components in Shengxuebao Mixture.