Objective: To investigate the curative efficacy of vitamin D3 in combination with tripterygium wilfordii polyglycoside in patients with rheumatoid arthritis (RA) and its influences on indices of bone restoration. Meth...Objective: To investigate the curative efficacy of vitamin D3 in combination with tripterygium wilfordii polyglycoside in patients with rheumatoid arthritis (RA) and its influences on indices of bone restoration. Methods: A total of 320 patients with RA were collected as observation objects to be randomly divided into the control group and the observation group with 160 cases in each group. The control group was given treatment of tripterygium wilfordii polyglycoside, while the observation group was given treatment of vitamin D3 in combination with tripterygium wilfordii polyglycoside. All patients received a course treatment with 3 months. The curative efficacy, improvement of joint symptoms, changes of laboratory tests, indices of bone restoration and adverse reactions were compared. Results: After 3 months, assessment of curative efficacy showed that the observation group had a total curative efficiency ratio of 90.6%, which was significantly higher than that of 81.2% in the control group. Among the indices which reflect the improvement of joint symptoms, the joint pain index, joint tenderness index and joint swollenness index were statistically reduced in the observation group than those in the control group. And after treatment, in comparison with the control group, indices of laboratory tests of rheumatoid factor (RF), antistreptolyisn O antibody (ASO), c-reactive protein (CRP) were statistically lower respectively in the observation group. As to indices of bone restoration after treatment, the observation group had statistically lower serum level of receptor activator of nf-kb ligand (RNKL) and higher level of osteoprotegerin (OPG) than those in the control group. During the treatment, incidences of adverse reactions in the control group and the observation group were statistically same. Conclusion: Vitamin D3 in combination with tripterygium wilfordii polyglycoside has well curative efficacy in patients with RA, which can significantly improve joint symptoms, indices of laboratory tests and bone restoration.展开更多
Objective: To observe the side effects of various Tripterygium wilfordii (TW) preparations in treating rheumatoid arthritis (RA). Methods: The total of 271 patients with RA were treated with various TW preparations t...Objective: To observe the side effects of various Tripterygium wilfordii (TW) preparations in treating rheumatoid arthritis (RA). Methods: The total of 271 patients with RA were treated with various TW preparations to observe the occurrence of side effects. Results: The influence on reproductive system with TW preparations extracted from the TW leaves (Leino ester tablet, LE) was milder than that extracted from the roots (TW tablets and TW polyglycoside tablets, TWP). In the TWP group, the rate of side effect of 60 mg daily was higher than that of 30 mg daily, P <0.01. The main effects on digestive system and irregular menstruation occurred before 50 years in age, while it was kidney impairment after the age of 50. Those side effects occurred within the first ten years in long term application. The side effects of TWP produced in the Damp Heat Stagnation type of RA was much lower than Liver and Kidney Yin Deficiency type of RA, P <0.05. Conclusion: TW Leino ester tablet is indicated for young woman, and small dosage of TWP tablet is indicated for maintenance therapy, particularly to the Damp Heat type of RA.展开更多
OBJECTIVE: To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis(RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F(TwHF), Mangxiao(Na...OBJECTIVE: To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis(RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F(TwHF), Mangxiao(Nalrii Sulfas), Chuanxiong(Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang(Olibanum), and stir-frying with liquid adjuvant Moyao(Myrrh).METHODS: Patients were 1∶1 randomized to addon TwHF cream twice a day or placebo for 4 weeks.The primary endpoint was achievement rate of20% improvement in American College of Rheuma-tology criteria(ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score(DAS28) improvement and safety profiles.Statistical analyses were performed using intention to treat analysis(ITT) set.RESULTS: A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3%(12/35) in TwHF cream group and 11.4%(4/35) in placebo group(P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1%(6/35) comparing to it in placebo group with 2.9%(1/35)(P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR(1.1 vs 0.5, P = 0.001), DAS28-CRP(1.4 vs 0.7, P = 0.001), tender joint count(5.5 vs2.6, P = 0.018), swollen joint count(3.5 vs 1.6, P =0.003) and Physician's global assessment(25.8 vs13.0, P = 0.002), as well as C-reactive protein(11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed.CONCLUSION: On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.展开更多
Adopting prospective, multi-center, random, single-blind and equal rank-control methods,226 patients with rlieumatoid arthritis (RA) were divided into two groups. The 114 patients ot the test groupwere treated with or...Adopting prospective, multi-center, random, single-blind and equal rank-control methods,226 patients with rlieumatoid arthritis (RA) were divided into two groups. The 114 patients ot the test groupwere treated with oral sustained release tablets of Tripterygium Wiltordii (TW-SR) , 2 tablets twice a day for4 weeks, 112 patients of the control group received tablets of Tripterygium Wiltordii(TW) orally 2 tablets 3times per day for 4 weeks. Testing results showed thetotal effective rates of the two groups were 92 . 11%and 90. 65 % , respectively (P >0. 05) . The adverse reaction rate of TW-SR was 20 . 18% , which was low-er than that of TW group of 70. 54% (P < 0. 01 ) . Results of pre-clinical pharmacologic experimental studydemonstrated that TW-SR has obvious anti-inflammatory , analgesic and immunosuppressive actions the sameas TW, while the toxicity of TW-SR was less than that of TW significantly.展开更多
Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang ...Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.展开更多
基金National Natural Science Foundation of China(81301532)Shanxi Returned Overseas Students'Scientific Research Foundation Project(2017-119)+1 种基金Shanxi Key Research and Development Program(Guidelines)Project(201603D321074)Shanxi Overseas Students'Scientific and Technological Activities Selective Foundation Project in 2017.
文摘Objective: To investigate the curative efficacy of vitamin D3 in combination with tripterygium wilfordii polyglycoside in patients with rheumatoid arthritis (RA) and its influences on indices of bone restoration. Methods: A total of 320 patients with RA were collected as observation objects to be randomly divided into the control group and the observation group with 160 cases in each group. The control group was given treatment of tripterygium wilfordii polyglycoside, while the observation group was given treatment of vitamin D3 in combination with tripterygium wilfordii polyglycoside. All patients received a course treatment with 3 months. The curative efficacy, improvement of joint symptoms, changes of laboratory tests, indices of bone restoration and adverse reactions were compared. Results: After 3 months, assessment of curative efficacy showed that the observation group had a total curative efficiency ratio of 90.6%, which was significantly higher than that of 81.2% in the control group. Among the indices which reflect the improvement of joint symptoms, the joint pain index, joint tenderness index and joint swollenness index were statistically reduced in the observation group than those in the control group. And after treatment, in comparison with the control group, indices of laboratory tests of rheumatoid factor (RF), antistreptolyisn O antibody (ASO), c-reactive protein (CRP) were statistically lower respectively in the observation group. As to indices of bone restoration after treatment, the observation group had statistically lower serum level of receptor activator of nf-kb ligand (RNKL) and higher level of osteoprotegerin (OPG) than those in the control group. During the treatment, incidences of adverse reactions in the control group and the observation group were statistically same. Conclusion: Vitamin D3 in combination with tripterygium wilfordii polyglycoside has well curative efficacy in patients with RA, which can significantly improve joint symptoms, indices of laboratory tests and bone restoration.
文摘Objective: To observe the side effects of various Tripterygium wilfordii (TW) preparations in treating rheumatoid arthritis (RA). Methods: The total of 271 patients with RA were treated with various TW preparations to observe the occurrence of side effects. Results: The influence on reproductive system with TW preparations extracted from the TW leaves (Leino ester tablet, LE) was milder than that extracted from the roots (TW tablets and TW polyglycoside tablets, TWP). In the TWP group, the rate of side effect of 60 mg daily was higher than that of 30 mg daily, P <0.01. The main effects on digestive system and irregular menstruation occurred before 50 years in age, while it was kidney impairment after the age of 50. Those side effects occurred within the first ten years in long term application. The side effects of TWP produced in the Damp Heat Stagnation type of RA was much lower than Liver and Kidney Yin Deficiency type of RA, P <0.05. Conclusion: TW Leino ester tablet is indicated for young woman, and small dosage of TWP tablet is indicated for maintenance therapy, particularly to the Damp Heat type of RA.
基金the grants from National key research and development program(No.2018YFC1705200)the Beijing Municipal Science&Technology Commission(No.Z161100001816046)
文摘OBJECTIVE: To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis(RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F(TwHF), Mangxiao(Nalrii Sulfas), Chuanxiong(Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang(Olibanum), and stir-frying with liquid adjuvant Moyao(Myrrh).METHODS: Patients were 1∶1 randomized to addon TwHF cream twice a day or placebo for 4 weeks.The primary endpoint was achievement rate of20% improvement in American College of Rheuma-tology criteria(ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score(DAS28) improvement and safety profiles.Statistical analyses were performed using intention to treat analysis(ITT) set.RESULTS: A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3%(12/35) in TwHF cream group and 11.4%(4/35) in placebo group(P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1%(6/35) comparing to it in placebo group with 2.9%(1/35)(P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR(1.1 vs 0.5, P = 0.001), DAS28-CRP(1.4 vs 0.7, P = 0.001), tender joint count(5.5 vs2.6, P = 0.018), swollen joint count(3.5 vs 1.6, P =0.003) and Physician's global assessment(25.8 vs13.0, P = 0.002), as well as C-reactive protein(11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed.CONCLUSION: On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.
文摘Adopting prospective, multi-center, random, single-blind and equal rank-control methods,226 patients with rlieumatoid arthritis (RA) were divided into two groups. The 114 patients ot the test groupwere treated with oral sustained release tablets of Tripterygium Wiltordii (TW-SR) , 2 tablets twice a day for4 weeks, 112 patients of the control group received tablets of Tripterygium Wiltordii(TW) orally 2 tablets 3times per day for 4 weeks. Testing results showed thetotal effective rates of the two groups were 92 . 11%and 90. 65 % , respectively (P >0. 05) . The adverse reaction rate of TW-SR was 20 . 18% , which was low-er than that of TW group of 70. 54% (P < 0. 01 ) . Results of pre-clinical pharmacologic experimental studydemonstrated that TW-SR has obvious anti-inflammatory , analgesic and immunosuppressive actions the sameas TW, while the toxicity of TW-SR was less than that of TW significantly.
基金support from the National Natural Science Foundation of China(No.81704065)China Postdoctoral Science Foundation(No.2016M600632 and No.2017T100604)+3 种基金Hunan Provincial Natural Science Foundation(No.2017JJ3239 and No.2018JJ2293)Hunan Education Department’s Science&Research Project(No.17K069)Hunan Provincial Science&Research Project of Chinese Medicine(No.201790)National First-class Disciple Construction Project of Chinese Medicine of Hunan University of Chinese Medicine
文摘Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.
