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OBJECTIVE To evaluate the post-marketing safety of Compound porcine cerebroside and ganglioside injection in patients with ischemic stroke. METHODS A drug-induced， prospective， non-controlled clinical study design was conducted. Using the patients with ischemic stroke who received Compound porcine cerebroside and ganglioside injection at least once in 46 secondary class A and above medical institutions across the country from April 2020 to May 2021 as the monitoring objects， and their basic data， medication information and the occurrence of adverse drug reactions were analyzed. RESULTS Among 13 514 patients with ischemic stroke， the incidence of adverse events was 10.01%， and the incidence of adverse reactions related to Compound porcine cerebroside and ganglioside injection was 0.33%. Drug-related adverse drug reactions were mild or moderate， concentrated in the gastrointestinal system （18 cases）， skin and subcutaneous tissue （10 cases）， nervous system （7 cases） and other systems/organs， mainly including constipation， abdominal pain， diarrhea， rash， pruritus， dizziness and other symptoms. Most of the patients （91.03%） recovered or improved after treatment， and 2 patients died. Among the 45 patients with adverse drug reactions， 84.44% were cured or improved after drug withdrawal or symptomatic treatment， and 15.56% had no significant change. The incidence of adverse drug reactions in tertiary hospitals was significantly higher than that in secondary hospitals， and the incidence of adverse drug reactions in patients with allergic history was significantly higher than that in patients without allergic history （P＜0.05）. Irrational drug use was found in 2.76% of patients， and the incidence of adverse drug reactions（2.95%） was significantly higher than that in patients without irrational drug use（0.26%，P＜0.05）. CONCLUSIONS The adverse drug reaction symptoms of ischemic stroke patients treated with Compound porcine cerebroside and ganglioside injection are relatively common， the incidence rate is generally low， and it is related to the patients’ physique and whether the drug use is standardized.
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Objective: Postherpetic neuralgia (PHN) is a clinical puzzle, especially in patients who still suffered from moderate and severe pain after standard treatment. This single-center, double-blinded, randomized controlled, prospective, and non-inferiority study observed the safety and effectiveness of the epidural application of morphine or hydromorphone, trying to provide an alternative method for those patients with refractory PHN. Methods: Eighty PHN patients with a visual analogue scale (VAS) still greater than 50 mm after routine management were randomly divided into two groups according to 1:1, respectively. One group received epidural morphine (EMO group), and the other group received epidural hydromorphone (EHM group). VAS, the number of breakthrough pain, quality of life (QOL), and anxiety/depression assessment (GAD-7 and PHQ-9 scores) were also observed before treatment, at 1, 3, 7, 14, 21, 28, 60, and 90 days after treatment, as well as side effects. Opioid withdrawal symptoms (OWSs) were also measured from 3 to 28 days after treatment. Results: The EHM group was non-inferior to the EMO group in terms of the VAS decrease relative to baseline (VDRB) after 1-week treatment. The VAS of the two groups on all days after treatment was significantly lower than the corresponding baseline findings (p < 0.05). The breakthrough pain (BTP) decreased significantly after treatment and lasted until 14 days after treatment (p < 0.05). There was no significant difference in BTP between the two groups at each time point (p > 0.05). In terms of the QOL, GAD-7, and PHQ-9 outcomes, those were significantly improved after treatment (p < 0.05), and there was no difference between the two groups (p > 0.05). No significant AE difference across the two groups was observed in this study. Few reports of OWS were found in this trial, and there were no significant differences between the two groups (p > 0.05). Conclusion: EHM was non-inferior to EMO in terms of the VDRB after 1-week treatment. For patients with VAS still greater than 50 mm after standard treatment, short-term application of EMO or EHM can ameliorate intractable pain, improve the quality of life, and have no obvious side effects. Short-term epidural opioid application will not lead to the appearance of OWS.
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Objective To optimize the processing technology for Radix Puerariae simmered with wheat bran.Methods Orthogonal experiment L9(34) was chosen to optimize the technology. The external properties of Radix Puerariae simmered by wheat bran, the content of puerarin and the antidiarrheal effect on mice with diarrhea caused by folium sennae were used as indexes. Comprehensive weighted score was employed to optimize simmering Radix Puerariae with wheat bran technology.Results Processing time was the main affecting factor, while processing temperature had no significant effect. The optimum processing parameters were 100 g Radix Puerariae simmered with 30 g wheat bran at 160℃ for 2 minutes.Conclusion The optimum processing technology was simple and convenient, and with good reproducibility and operability. It is also helpful for the quality control of Radix Puerariae simmered with wheat bran.
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A sequential clean-up method was developed for the quantification of 10 plant growth regulators in bean sprout by the gas chromatography / mass spectrometry (GC / MS). The analytes were firstly extracted by the acided acetonitrile. Extraction was concentrated and re-dissovled by methanol. Then, it was divided to two aliquots. One of that was analyzed for 2,4-D-butyl ester and 2,4-D-ethyl ester after the purification by QuECHERS cartridge. Another one was treated by MCS solid phase extraction column including diverse eluting steps. After eluting by 5 mL methanol, composition 1 was obtain, concentrated, and methyl esterified by 10% boron trifluoride methanol solution. The treated extract was used for the determination of 4-chlorophenoxy acetic acid, β-naphthyl acetic acid, 2,4-dichlorophenoxy acetic acid, indole acetic acid and indole butyric acid. Composition 2 collected by eluting with 5 mL 5% amonium methanol was used for the determination of paclobutrazol, Kinetin, 6-Benzylaminopurine. The clean-up procedures are designed according to different chemistry properties of these plant growth regulators. The results showed that after spiking of 0. 01-0. 1 mg / kg selected plant growth regulators, average recovery ranged from 70. 0% to 93. 2%and relative standard deviation were 5. 2% -12. 3% . Limit of quantification (LOQ S / N≥10) and limit of detection (LOD S / N≥3) were 0. 01-0. 025 mg / kg and 0. 003-0. 008 mg / kg respectively. The developed purification method is easy, fast and accurate, and can be applied to routine test of plant growth regulators in bean sprout.
