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From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.
Subject(s)
Aged , Female , Humans , Male , Middle Aged , Administration, Oral , Anaphylaxis , Capsules , Dizziness , Drug-Related Side Effects and Adverse ReactionsABSTRACT
OBJECTIVE： To systematically evaluate the difference of therapeutic efficacy of Xianling gubao capsules combined with routine therapy for postmenopausal osteoporosis （PMOP）. METHODS： Retrieved from Cochrane Library， PubMed， Embase， ClinicalTrials， CNKI， VIP， Wanfang database and CBM， clinical randomized controlled trials （RCTs） about Xianling gubao capsules combined with placebo and routine treatment （trial group） versus placebo and routine treatment or Xianling gubao capsules （control group） alone in the treatment of PMOP were collected. After literature screening and data extraction， the quality of included literatures were evaluated with Cochrane system evaluator manual 5.3 recommend bias risk evaluation tool. Bayesian Network Meta-analysis was performed with Stata 14.0 software and Bayesian Markov Chain Monte Carlo. RESULTS： A total of 16 RCTs were included， involving a total of 1 360 patients and 3 intervention measures as Xianling gubao capsules alone， Xianling gubao capsules combined with routine treatment， routine treatment. Results of Meta-analysis showed that in respect of improving total response rate， compared with routine treatment， Xianling gubao capsules combined with routine treatment [OR＝0.28，95％CI（0.12， 0.64），P＜0.05]could significantly improve total response rate； network Meta-analysis ranking showed that Xianling gubao capsules combined with routine treatment＞Xianling gubao capsules alone＞routine treatment. In terms of increasing bone mineral density （BMD）， compared with routine treatment， Xianling gubao capsules combined with routine treatment [OR＝0.45，95％CI（0.24， 0.84），P＜0.05] and Xianling gubao capsules alone [OR＝0.78， 95％CI（0.32， 0.84），P＜0.05] could significantly improve BMD； network Meta-analysis ranking showed that Xianling gubao capsules combined with routine treatment＞Xianling gubao capsules alone＞routine treatment. In the term of improving serum calcium level， compared with Xianling gubao capsules alone [OR＝4.76，95％CI（2.14， 10.59），P＜0.05] and routine treatment [OR＝0.45， 95％CI（0.21， 0.99），P＜0.05]， Xianling gubao capsules combined with routine treatment could significantly improve serum calcium level； network Meta-analysis ranking showed that Xianling gubao capsules combined with routine treatment＞routine treatment＞Xianling gubao capsules alone. In the term of improving serum phosphorus level， compared with Xianling gubao capsules alone， Xianling gubao capsules combined with routine treatment [OR＝2.85，95％CI（1.81， 4.48），P＜0.05] and routine treatment [OR＝2.93，95％CI（1.76， 4.86），P＜0.05] could significantly improve serum phosphorus level； network Meta-analysis ranking showed that routine treatment＞Xianling gubao capsules combined with routine treatment＞Xianling gubao capsules alone. CONCLUSIONS： Xianling gubao capsules combined with routine treatment can significantly improve therapeutic efficacy of PP patients， increase BMD and serum calcium level after treatment， but routine treatment is the best in improving serum phosphorous level.
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Objective To establish the method for simultaneous determination of epimedium glycoside and other 4 kinds of active ingredients in Xianling Gubao Capsules by three wavelength switching method. Methods An Waters Atlantis T3 C18 column (4.6 mm × 250 mm, 5 μm) was used with the mixture of acetonitrile-0.05％ formic acid solution as the mobile phase in gradient elution (0–5 min, 12％–20％ A; 5–15 min, 20％–55％ A; 15–35 min, 55％ A;35–55 min, 55％–76％ A; 55.1 min, 12％ A; 55.1–60 min, 12％ A). Detection wavelength was as follow: 0–30 min, 212 nm; 30–42 min, 246 nm; 42–60 min, 270 nm. The flow rate was 1.0 mL/min. The column temperature was 30 ℃. Results The calibration curves of asperosaponin Ⅵ, psoralen, angelicin, epimedin C, and icariin were in good linearity among the ranges of 101.6–3048 ng, 8.7–261 ng, 7.9–237 ng, 117.2–3516 ng, 78–2340 ng, respectively. In the instrument precision test, stability test, repeatability test, the RSD was less than 3％. The average recoveries were 99.83％, 100.35％, 100.59％, 100.60％, 99.72％, respectively, and all the RSD were less than 3％. Conclusion The method is sensitive, accurate, and separation effect is good, which can provide a basis for quality evaluation standard of Xianling Gubao Capsules.
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Objective To observe the effects of Danqi Granules combined with Xianling Gubao Capsules on bone metabolism and bone mineral density (BMD) in patients with postmenopausal osteoporotic vertebral compression fractures (OVCF) after surgery. Methods 90 cases of postmenopausal women with OVCF were randomly divided into the control group and the observation group, 45 cases in each group. The two groups were treated by vertebroplasty (PVP), and after the surgery, the control group was treated with Xianling Gubao Capsules while the observation group was additionally given Danqi Granules. The serum markers of bone metabolism [(25 (OH) D, PINP, β-CTX] and BMD of L2-4 and left femoral neck were detected before and after treatment. Results The level of serum 25 (OH) D in the observation group after treatment was significantly higher while the levels of PINP and β-CTX were significantly lower than those in the control group (P<0.05), and the BMD of L2-4 and left femoral neck of the observation group were significantly higher than those of the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups. Conclusion Danqi Granules combined with Xianling Gubao Capsules can significantly accelerate fracture recovery, and improve bone mineral density in the treatment of postmenopausal women with OVCF.
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OBJECTIVE: To establish the ultra performance liquid chromatography (UPLC) fingerprint of Xianling Gubao Capsules (XLGB), and evaluate the product quality by chemometrics analysis method. METHODS: The method was developed on an ACQUITY UPLC BEH Shield RP18 column (2.1 mm×50 mm, 1.7μm) by gradient elution with acetonitrile-water [both containing 0.1% formic acid] as mobile phase at a flow rate of 0.5 mL· min-1. The column temperature was maintained at 30℃, and the detection wavelength was set at 246 nm during 0-4.6 min and 270 nm during 4.6-18 min. The main characteristic peaks were identified and assigned to individual herbs by comparing the retention time and UV absorption characteristics, combined with peak purity analysis. Furthermore, 16 batches of XLGB were evaluated by similarity assay, PCA, and PLS-DA. RESULTS: The UPLC fingerprint of XLGB was established and 27 main characteristic peaks were identified. The similarity of 16 batches of XLGB was about 0.959 to 0.988, and epimedin C, bakuchiol, psoralenoside, and isopsoralenoside from Epimedium breviornu Maxim and Psoralea corylifolia L were the main compounds causing the similarity difference. CONCLUSION: The method can be used for the quality control of XLGB with good specificity and efficiency, and this work provides the experimental basis to improve the overall quality control of XLGB.
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0.05); while in the 12th month, BMD markedly increased in group A and decreased in group B (P 0.05) but ?-CTX level increased after treatment (P