ABSTRACT
OBJECTIVE To explore the clinical efficacy and safety of Ruyi jinhuang powder for external application combined with immune checkpoint inhibitors （ICIs） in the treatment of patients with advanced liver cancer complicated with dampness and heat syndrome of liver and gallbladder. METHODS All patients with advanced liver cancer complicated with dampness and heat syndrome of liver and gallbladder were admitted to our hospital from January 2018 to June 2022 and assigned into observation group and control group according to random number table method. Patients in the control group （n＝56） were treated with ICIs （Navulizumab injection/Sintilimab injection/Camrelizumab for injection） 200 mg， ivgtt， 21 days as a treatment cycle. Patients in the observation group （n＝56） were additionally treated with Ruyi jinhuang powder for external application， once a day， on the basis of control group. The therapeutic effects of 2 groups were compared after a treatment cycle. The levels of interleukin-6 （IL- 6）， matrix metalloproteinase-9 （MMP-9）， cyclooxygenase-2 （COX-2）， prostaglandin E2 （PGE2）， carbohydrate antigen 199 （CA199）， alpha-fetoprotein （AFP） and vascular endothelial growth factor （VEGF） in serum were compared between 2 groups before and after treatment. Karnofsky functional status （KPS） score， digital rating scale （NRS） score， total symptom score of traditional Chinese medicine， and the occurrence of adverse reactions were recorded for both groups of patients. RESULTS After treatment， the levels of IL-6， MMP-9， COX-2， PGE2， CA199， AFP， VEGF， NRS score and total symptom score of traditional Chinese medicine in observation group were significantly lower than control group （P＜0.05）， KPS score was significantly higher than the control group （P＜0.05）. The zypp-04） total effective rate and remission rate of the observation group were 64.29% and 80.36%， those of control group were 60.71% and 73.21%. There was no statistical significance between two groups （P＞0.05）. The adverse drug reactions of both groups were mainly nausea and vomiting， liver function injury， fever hlshli@yeah.net and so on； the incidence of adverse reaction in observation group was significantly lower than that of control group （P＜0.05）. CONCLUSIONS In patients with advanced liver cancer complicated with dampness and heat syndrome of liver and gallbladder， the combination of Ruyi jinhuang powder for external application and ICIs can help inhibit the secretion of pain mediators， regulate vascular endothelial function， reduce the inflammatory response， promote the recovery of cardiopulmonary function， improve clinical efficacy and has good safety.
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Objective To study the color of Ruyi Jinhuang Powder (RJP) placebo by using computer color matching technology and achieve fast preparation of RJP placebo. This work provided a new method to simulate the color of Chinese medicine compound placebo. Methods Using the RJP placebo as an example, computer color matching technology was used to establish a mathematical model to correlate the placebo color parameter L, a*, b* value and the colorant concentration. For a measured medicine compound color, the placebo colorant concentration can then be calculated from the model through data fitting and Newton iterative method. The model accuracy was validated using the color comprehensive evaluation index (ΔE). Results The color parameter L, a*, b* of RJP placebo was 68.302 5, 4.079 5, and 34.484 0. The mass fraction of lemon yellow, amaranth, and blue was 0.837 3%, 0.045 8%, and 0.008 5%. The ΔE value between RJP and its placebo was 2.750 0 ± 0.353 6, and there was no obvious visual difference between the medicine compound and its placebo. Conclusion Computer color matching technology can be used to simulate the color of RJP placebo, and can be widely used in the preparation of Chinese medicine placebo.
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OBJECTIVE: To evaluate the therapeutic effect and safety of Ruyi Jinhuang Powder for phlebitis. METHODS: The Cochrane Library, PubMed database, Embase database, ISI database, CBM database, CNKI database, VIP Database, and Wanfang database were searched. Randomized controlled trials (RCT), systematic reviews (SR)and meta-analysis of treating phlebitis by Ruyi Jinhuang Powder and 50% magnesium sulfate were included. Methodological quality assessment and meta-analysis of randomized controlled trials were carried out, and the conclusions of the included systematic reviews and meta-analyses were referred to. RESULTS: Ten RCTs comparing Ruyi Jinhuang Powder and 50% magnesium sulfate for treatment of phlebitis were included into the analysis. The total efficiencies of the two drugs had statistical significance [RR 12.96, 95% CI (5.81, 28.89), P 0.05]. CONCLUSION: Ruyi Jinhuang Powder is effective for treating phlebitis, the therapeutic effect is better than 50% magnesium sulfate, and no adverse drug reaction has been reported.