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Article in Chinese | WPRIM | ID: wpr-905870


Objective:To evaluate the clinical efficacy and safety of Longmu Zhuanggu granule for the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency. Method:This multicenter stratified, block-randomized, double-blind, double-dummy, positive drug (pidotimod granule) parallel controlled, and non-inferiority trail intended to included 240 children patients and divided them into the experimental group (<italic>n</italic>=120) and the control group (<italic>n</italic>=120) at the ratio of 1∶1. Patients in both groups were treated for eight successive weeks and followed up for 12 months. The cure rates, numbers of respiratory infections, average courses of disease, curative effects of traditional Chinese medicine (TCM) syndrome, curative effects of individual symptoms, curative effects of immune indexes, and safety indexes between the two groups were observed and compared. Result:A total of 237 subjects were collected from 10 research centers, including 119 cases in the control group and 118 in the experimental group. There were 236 cases enrolled into the full analysis set (FAS), 210 into the per-protocol set (PPS), and 236 into the safety set (SS). The baseline data of the two groups were not significantly different from each other, indicating that they were comparable. The cure rates of the experimental group and control group were 75.21% (88/117) and 73.95%(88/119), respectively, with the 95% confidence interval (CI) of difference between the two groups being 1.26% (-9.85%,12.37%) for FAS and 3.81% (-6.28%,13.90%) for PPS. The 95% CI fell within the 10% non-inferiority margin, implying that non-infertility test of the cure rate in the treatment of endpoint disease was valid, and the conclusions of FAS and PPS analysis were consistent. There was no significant difference in the number or course of upper respiratory infection, bronchitis, and pneumonia. The difference in curative effects of TCM syndrome between the two groups after four weeks of treatment was not remarkable. After eight weeks of treatment, the total effective rate of the experimental group was 84.62%(99/117), statistically higher than 78.15%(93/119) of the control group(<italic>χ</italic><sup>2</sup>=-3.26,<italic>P</italic><0.05). There were no significant differences in the disappearance rates of individual symptoms between the two groups after four weeks of treatment. After eight weeks of treatment, the experimental group and control group exhibited the disappearance rates of 67.50%(54/80) and 47.37%(36/76) for shortness of breath and laziness to speak, 75.00%(54/72) and 53.33%(40/75) for poor appetite, 54.55%(60/110) and 37.84%(42/111) for hyperhidrosis, respectively, with obviously better outcomes observed in the experimental group (<italic>P</italic><0.05,<italic>P</italic><0.01). The inter-group comparison revealed significant differences in immune indexes after eight weeks of treatment. As demonstrated by comparison with the situations before treatment, IgA, IgG, IgM, and CD4 did not change significantly after treatment. Except for CD8 in the experimental group (<italic>P</italic><0.05), there was no significant difference in other immune indexes before and after treatment There was no significant difference in the incidence of adverse reactions. Conclusion:Longmu Zhuanggu granule is not inferior to pidomod granule in the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency, and it exhibits good safety, implying its promising clinical application value.

Article in Chinese | WPRIM | ID: wpr-710145


AIM To analyze the effects of α-mangostin on the proliferation and apoptosis of osteoarthritis (OA) chondrocytes.METHODS Human OA chondrocytes were isolated and then treated with 5,10 or 20 μmol/L α-mangostin.24,48 or 72 h after the treatment,the cell proliferation was measured by MTT assay,and the cell apoptosis was detected by flow cytometry.The expression check on MMP-1,MMP-3,MMP-13,PPARγ,PPARδ,PGC-lα and TNF-α was accomplished by Western blot.The contents of collagen-Ⅱ,PG,IL-1β and IL-6 were tested by ELISA.RESULTS α-Mangostin significantly induced cell proliferation and suppressed cell apoptosis,and it significantly increased the production of collagen-Ⅱ and PG,decreased the expressions of MMP-1,MMP-3 and MMP-13,induced the expressions of PPARγ,PPARδ and PGC-1α,and decreased the expression of TNF-α.Furthermore,α-mangostin significantly inhibited the production of IL-1β and IL-6.CONCLUSION α-Mangostin attenuates the destruction and degradation of cartilago articularis by inducing OA chondrocytes proliferation,inhibiting cell apoptosis and inflammation,and increasing expressions of PPARγand PPARδ.