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Objective To study the clinical effect of Yaotongning capsule combined with etoricoxib for the pain and inflammation of lumbar vertebrae in elderly patients with lumbar osteoarthritis. Methods 120 elderly patients with lumbar osteoarthritis admitted to our hospital from January 2016 to June 2018 were randomly divided into the control group and the observation group, with 60 patients in each group. Patients in the control group were treated with etoricoxib, while patients in the observation group were treated with etoricoxib plus Yaotongning capsule orally. Both groups received medications for 2 weeks. Spinal pain and quality of life score changes were recorded. The inflammatory cytokines in serum TNF-α, GM-CSF, COX-2 and BMP-2 levels were monitored. The clinical efficacy was compared and drug safety profile was evaluated for two groups. Results The effective rates of the control group and the observation group were 78.33% and 91.67% respectively. The effective rate in the observation group weas significantly higher (P<0.05). After treatment, the VAS score for the patients in the observation group was significantly lower than that in the control group (P<0.05). The SF-36 score in the observation group was significantly increased (P<0.05), and the levels of TNF-α,GM-CSF and COX-2 in the serum were significantly lower than those in the control group (P<0.05), and the levels of BMP-2 were significantly increased (P<0.05). Conclusion Yaotongning capsule combined with etoricoxib in the treatment of senile lumbar osteoarthritis has definite curative effect. It significantly reduced lumbar pain, improved quality of life, inhibited inflammatory reaction, and had a better drug safety profile. The further clinical investigation for the combination therapy is warranted.
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Lumbago disease is a common disease, which mainly manifested as acute or chronic pain in the lumbar spine or paraspinal region, mainly represented by lumbar disc herniation in clinical practice. The new drug, Yaotongning Capsule with better efficacy for lumbago in clinic, is made of Strychni Semen Pulveratum, Eupolyphaga Steleophaga, Cyathulae Radix, Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Olibanum and Myrrh (prepared with vinegar), scorpion, Bombyx Batryticatus (bran fried), and Atractylodis Rhizoma (bran fried). This paper analyzes the etiology and pathogenesis of lumbar intervertebral disc herniation through traditional Chinese medicine, and explores the mechanism of treating lumbar intervertebral disc herniation with Yaotongning Capsule from the perspective of prescription theory, so as to provide theoretical basis for clinical application of Yaotongning Capsule.
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Objective: To investigate the clinical efficacy of Yaotongning Capsule in relieving osteoporotic bone pain in the elderly. Methods: A total of 120 patients with pain VAS score between 3 and 8 in the department of orthopedics and traumatology, Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine from September 2018 to December 2019, in accordance with the diagnostic criteria of senile osteoporosis, were randomly divided into control group (60 cases) and treatment group (60 cases). The control the group was treated with oral Calcium Carbonate and Vitamin D3, 0.6 g, once a day; The treatment group was treated with Yaotongning Capsule on the basis of control group, four capsules each time, 0.5 h before sleeping every night, with 10 mL yellow wine mixed with a small amount of warm boiled water. The dosage of other anti-osteoporosis drugs should not be changed. The drug was administered continuously for 2 weeks. The patients were followed up for 0, 3, 7 and 14 d, respectively, with a time window of ± 1 d. After treatment, according to the changes of visual analogue scale (VAS) score in each visit period, the curative effect was evaluated according to the improvement of pain degree. Serum pain media levels were tested between two groups before and after treatment. Results: The total effective rate of 60 patients in the treatment group was 91.7%. The total effective rate of 60 patients in the control group was 23.3%, which was significantly lower than that in the treatment group, and the difference between the two groups was statistically significant. The scores of pain before and after treatment in the observation group were lower than those in the control group (P < 0.01). After 14 d of treatment, the levels of PGE2, SP and 5-HT did not change significantly in the control group, but decreased significantly in the treatment group (P < 0.01). Conclusion: The results of this study show that Yaotongning Capsule has a rapid onset and significant effect in relieving bone pain of senile osteoporosis.
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Objective: To systematic evaluate the efficacy and safety of Yaotongning Capsule in the treatment of lumbago and leg pain. Methods: The databases of CNKI, VIP, Wanfang and Chinese science citation were searched by computer, and the randomized controlled trials of Yaotongning Capsule in the treatment of lumbago and leg pain were collected. Two researchers independently selected literatures, entered data, and evaluated the quality of literature methodology. Review Manager 5.3 software was used for Meta analysis. Results: This study included 11 RCTs, 1 200 patients, 599 cases in Yaotongning group and 601 cases in control group. Meta analysis showed that the effective rate of Yaotongning Capsule in the treatment of lumbocrural pain was better than that of the control group (OR = 4.13, 95% CI [2.90, 5.88]), P < 0.000 01; The improvement of VAS pain score of Yaotongning Capsule was better than that of the control group (SMD = -1.22, 95% CI [-1.71, -0.73]), P < 0.000 01, (SMD = -2.09, 95% CI [-2.14, -2.04]). The improvement of JOA function score was better than that of the control group (SMD = 6.78, 95% CI [5.21, 8.26]), P<0.000 01, the difference was statistically significant. Conclusion: Yaotongning Capsule can effectively improve the lumbar activity function and clinical symptoms of patients with lumbocrural pain, and the degree of pain relief is positively correlated with the course of treatment and dose. However, the included sample size and observation indicators may lead to bias. It is expected that more researchers can conduct multi center, large sample, scientific and complete research to evaluate the efficacy and safety of Yaotongning Capsule in the treatment of lumbocrural pain.
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Yaotongning Capsule is composed of Strychni Semen Pulveratum, Eupolyphaga Steleophaga, Cyathulae Radix, Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Olibanum, Myrrha, Scorpio, Bombyx Batryticatus and Atractylodis Rhizoma, which is widely used for the treatment of lumbar and leg pain, e.g. lumbar disc herniation, in clinic. Through literature analysis, the research progress of pharmacology and quality control of Yaotongning Capsule was summarized in order to provide references for the clinical use and quality research of Yaotongning Capsule.
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Objective To analyze the effect of Yaotongning capsule in the treatment of lumbar osteoarthritis patients.Methods From March 2013 to March 2015 in our hospital, 80 cases of lumbar osteoarthritis patients according to the digital table method were divided into two groups: the control group and the experimental group.The patients of the control group were given Bitongning, and the patients of the experimental group were given Yaotongning capsule, and the therapeutic effect, serum indexes and Japanese Orthopaedic Association ( JOA ) of two groups were compared. Results The curative effect of the experimental group was higher than control group(95.00%vs.67.50%) , the JOA score of the experimental group was higher than control group [(27.46 ±1.07)points vs.(21.06 ±1.89)points] (P<0.05).After treatment, the MMP-3(65.28 ±4.37) ng/L and IL-1β(12.43 ±1.01) ng/L of the experimental group were significantly lower than MMP-3(79.56 ±5.36) ng/L, IL-1β(16.44 ±1.03) ng/L of the control group, and the difference was significant (P<0.05).Conclusion The lumbar osteoarthritis patients with Yaotongning capsule has obvious effect, and the function of lumbar intervertebral joint improves obviously, and the serum index is normal, safe and reliable.
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Objective: To observe the therapeutic effect and safety of Yaotongning Capsule in the treatment of lumbar hyperplasia. Methods: A random, double-blind, placebo controlled, multicenter clinical research method was used. The lumbar hyperplasia patients (144 cases) were selected, divided into Yaotongning Capsule group (treatment group) with 72 cases, 72 cases completed; and placebo group (control group) with 72 cases, 70 cases completed. The treatment lasted for 2 weeks. After treatment, the symptom of traditional Chinese medicine and pain relief situation were observed in the two groups. Results: The curative effects of Yaotongning Capsule in the treatment of lumbar hyperplasia disease (cold-dampness stagnation syndrome) were as follows: The control rate in treatment group was 41.5%, and that in the control group was 0.0%, superiority test (P<0.001) was established. Pain relief: the relieve rate in treatment group was 86.1%, and that in the control group was reduced to 45.7%, there was significant difference between the groups (P<0.001). Conclusion: Yaotongning Capsule in the treatment of lumbar hyperplasia (cold-dampness stagnation syndrome) has obviously curative effect, and can effectively reduce the pain caused by lumbar hyperplasia.
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Objective: According to the results of preliminary cellular pharmacological experiments, 13 active fractions, including Yaotongning Capsule (YTNC) whole formula, were designed to evaluate their in vitro and in vivo anti-inflammatory and analgesic activities to look for candidate prescriptions for rheumatism treatment. Methods: The in vitro anti-inflammatory and analgesic effects of the prescriptions were estimated by detecting their ability to inhibit 3H-bradykinin binding to its receptor and ability to inhibit 3H-naloxone binding to opioid receptors, respectively. And the tests were conducted by a liquid scintillation counter to check the content of the isotope 3H as evaluating indicator. Ear edema model in mice induced by dimethylbenzene test, hot plate test, and acetic acid writhing test in mice were conducted to evaluate the in vivo anti-inflammatory and analgesic activities of the prescriptions. Results: YTNC whole formula had good in vitro and in vivo anti-inflammatory and analgesic effects. However, the prescription containing equal amount of Ephedra sinica alkaloids, Glycyrrhiza uralensis aponins, and Carthamus tinctorius flavones (Sample VI) as well as the optimized and decomposed formula of YTNC (Sample VIII), which was designed by reducing 90% of Strychnos nux-vomica alkaloids from YTNC's decomposed formula composed by alkaloids, flavonoids, and saponins in YTNC, performed more excellent in vitro anti-inflammatory and analgesic effects than whole formula of YTNC. However, Sample VI did not exhibit obvious in vivo analgesic effect, but the in vivo anti-inflammatory and analgesic activities of the optimized and decomposed formula of YTNC (Sample VIII) were more significantly better than those of YTNC whole formula. It also had significantly better analgesic effect than aspirin (the positive control drug) in acetic acid writhing test. Conclusion: The optimized and decomposed formula of YTNC could be a candidate drug for rheumatism treatment. The anti-inflammatory and analgesic effects, safety, and quality control ability of YTNC could be improved by reducing the varieties of material medicines and active fractions and the content of S. nux-vomica alkaloids in YTNC.
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OBJECTIVE:To establish a method for simultaneously determination of glycyrrhizic acid and glycyrrhetinic acid in Yaotongning capsule. METHODS:HPLC was performed on the column of Agilent TC-C18 with mobile phase of methanol-0.2 mol/L ammonium acetate(gradient elution) at a flow rate of 1.0 ml/min;detection wavelength was 250 nm and column temperature was 25 ℃ and injection volume was 10 μl. RESULTS:The linear range was 0.007 1-0.178 0 mg/ml(r=0.999 8)for glycyrrhizin acid and 0.354 8-8.720 0 μg/ml of glycyrrhetinic acid(r=0.999 8);RSDs of precision,stability and reproducibility tests were no more than 1.74%,average recoveries were 95.49%-100.62%(RSD=1.98%,n=9)and 96.80%-102.26%(RSD=1.83%,n=9),respec-tively. CONCLUSIONS:The method is simple,reproducible,accurate and reliable,and can be used for the simultaneous determi-nation of glycyrrhizic acid and glycyrrhetinic acid in Yaotongning capsule.
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Objective: To observe the clinical efficacy and safety of Yaotongning Capsule in acute lumbar muscle fiber inflammation (cold damp stagnation syndrome). Methods: A randomized, double-blind, placebo controlled multicenter and clinical trial was performed. The 144 patients were randomly divided into two groups, 72 cases in the treatment group treated with Yaotongning Capsule and 72 cases in the control group treated with placebo, 14 d as a course of treatment. Results: After one course of treatment, there was significant difference in the curative rate between treatment group and control group. According to FAS analysis, the ratio of control/effective cases and total cases (effective rate) in the treatment group was higher than that in the control group (P < 0.001). According to PPS analysis, the effective rate of the treatment group was obviously higher than that of the control group (P < 0.001). The pain relief of FAS and PPS in the treatment group also surpasses that in the control group (P < 0.001). And the differences both had statistical significance. Among 144 patients, the adverse events were found in three cases with the incidence of 2.10%. All of the adverse events were found in the control group and there were no remarkable adverse event and side effect in the treatment group. The incidence rate of adverse event in the treatment group was similar to that in the control group (P = 0.245). Conclusion: Yaotongning Capsule for lumbar muscle fiber inflammation has reliable efficacy, safety, and less incident of adverse effects.
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Objective: To observe the clinical efficacy and safety of Yaotongning Capsule in acute sciatica suffered form cold dampness and blood stasis. Methods: A randomized, double-blind, and placebo controlled trial was performed. One hundred and forty-four patients with sciatica, who were in accordance with the accepting criteria from October 2008 to May 2009, were randomly divided into two groups, 72 cases treated with Yaotongning Capsule in the treatment group and 72 cases treated with placebo in the control group. Patients took five capsules with warm boiled water added yellow rice wine orally half an hour before sleep. The treatment course lasted for 2 weeks. Results: After one course of the treatment, there were significant differences in the curative rate between treatment group and control group. Compared with the control group, the disease control rate in the treatment group was obvious (U=4.138, P < 0.001); So did the pain relief (U=6.330, P < 0.001). And the differences both had statistical significance. There were no remarkable adverse event and side effect in the both groups. Conclusion: Yaotongning Capsule for sciatica suffered form cold dampness and blood stasis has reliable efficacy, safety, and less incident of adverse effects.
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Objective: To evaluate the in vitro effects of different combinations of the active fractions in Yaotongning Capsule (YTNC) on anti-inflammation, immunity, and activating blood circulation, and the interactions among these active fractions. Methods: Six samples were prepared by adding flavonoids, saponins, volatile oils/aqueous extracts, and polysaccharides, which were extracted from the material medicines in YTNC, to the alkaloids of Strychnos nux-vomica (Ma Qian Zi) and Ephedra sinica (Ma Huang) in turn according to the formulating principle of YTNC, combination chemistry concept, and their importance in the formula. The effects of the six samples on the production of lipopolysaccharide (LPS)-induced prostaglandin E2 (PGE2) in Ana-1 cells, concanavalin (ConA)- induced interleukin-2 (IL-2) in splenocyte, and nitrogen monoxide (NO) in human umbilical vein endothelial cells (HUVEC) were explored by detecting their half-maximal inhibitory concentration (IC50) or half-maximal effective concentration (EC50). An innovative method based on least square optimization was applied to calculate the additive IC50/EC50 value of each sample. The interactions of the active fractions in these samples were investigated by comparing the additive IC50/EC50 values with the corresponding experimental IC50/EC50 values. Results: All the six samples could inhibit the production of PGE2 and promote the secretion of IL-2 in the investigated concentration range. Only sample III consisting of the alkaloids, flavonoids, and saponins from YTNC had the EC50 value of promoting NO production. Moreover, the sample also displayed excellent activities in the three models of LPS-induced PGE2 production, ConA-induced IL-2 production, and NO production, which could reflect the capability of anti-inflammation, enhancing the body's immunity, and activating blood circulation, respectively. Different combination of the active fractions from YTNC produced the different interaction types in the three models. And the active fractions in sample III, i.e., the alkaloids, flavonoids, and saponins from YTNC, generated high synergistic effects in all the three models. Conclusion: All the six samples derived from the different combination of the active fractions from YTNC show the good activity of inhibiting PGE2 production and promoting IL-2 secretion. Therefore, the YTNC formula is reasonable and has good activity of anti-inflammation and immunity. However, the YTNC formula still could be improved by reducing the categories of its active fractions because the combination of the alkaloids, flavonoids, and saponins exerted better activities than the other samples and the three kinds of active fractions produced an excellent synergistic effect in all the three models. Synthetically evaluating various activities of YTNC in the present work may lead to develop new Chinese materia medica for rheumatic arthralgia treatment, which is more effective and easily controllable in quality.
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AIM:To establish the fingerprint analysis method of Yaotongning Capsule by HPLC-DAD.METHODS:This experiment used homogeneous design to optimize extract method.the analysis was performed on an Agilent C_ 18(4.6 mm?250 mm,5 ?m.)column with a acetonitrile-0.2 acetic acid,0.2% triethylamine.Detection time was 60 min.The flow rate was 1.0 mL/min and the wavelength was at 254 nm.Effect of solvents time and method of extract on experiment was studied,then calculated fingerprint similarities to evaluate,the samples' stability.RESULTS:15 peaks including strychnine,brucine,glycyrrhizic acid,ecdy sterone and ephephedrine,were separated on HPLC fingerprint in Yaotongning Capsule.CONCLUSION:The method is reliable,accurate and can be used as a quality control for Yaotongning Capsule.