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Based on Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), this study aims to sort out the clinical evidence of Huangkui Capsules(HC) in the treatment of chronic kidney diseases in aspects of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) from real-world data, secondary literature evaluations, questionnaires, and public data, with the methods in evidence-based medicine, epidemiology, pharmacoeconomics, and health technology. Furthermore, with multi-criteria decision analysis(MCDA) model and CSC v2.0, the clinical value of the medicine is comprehensively assessed. All the above are to highlight the advantages and characteristics of HC and lay a basis for scientific decision-making by the medical management department. The dimensions are graded A, B, C, or D. According to the conclusions from phase Ⅳ clinical trial, spontaneous reporting system(SRS), systematic review and Meta-analysis, acute toxicity and long-term toxicity tests, it mainly results in the adverse reactions of nausea, abdominal distension, vomiting, pruritus, rash, and good prognosis in patients. According to the available research, the safety evidence is sufficient and the risk is controllable, so the safety of this medicine is grade B. According to Meta-analysis, HC in combination with conventional drugs in the treatment of chronic kidney disease is superior to conventional drugs alone in reducing urinary protein, serum creatinine concentration, and blood urea nitrogen. In addition, HC combined angiotensin receptor blocker(ARB) or angiotensin converting enzyme inhibitor(ACEI) is outstanding in improving total clinical effective rate, reducing 24 h urinary protein quantity, urinary albumin excretion rate, serum creatinine concentration, triglyceride, and total cholesterol in the treatment of diabetic nephropathy as compared with ARB or ACEI alone. As for chronic nephritis, the application together with ARB or ACEI can raise the total effective rate, reduce 24 h urinary protein content, serum creatinine concentration, and blood urea nitrogen, and delay the progress of the disease. HC boasts high-quality evidence in treating chronic kidney disease, diabetic nephropathy, and chronic nephritis. It has obvious clinical significance in treating chronic kidney disease and thus its efficacy in this aspect is grade B. It has outstanding clinical significance for diabetic nephropathy and chronic nephritis and corresponding and the effectiveness is grade A. As for the pharmacoeconomic value, HC combined with ARB or ACEI is more economical in the treatment of chronic kidney disease than Bailing Capsules combined with ARB or ACEI, with high-quality evidence, and thus the economy of the formula is grade B. HC is a key solution to the high urinary protein in patients with hypotension and chronic kidney disease. The innovation is evidenced by the methods to ensuring drug supply, community-level supply, drug safety, effectiveness, and reasonable price, as wells as the aspects of enterprise philosophy, equipment management, research and development in process and technology, enterprise management and marketing. Thus, the prescription is grade A in innovation. The suitability, as evidenced in drug administration, technical management, drug storage, information service, and medication, is grade B. The course of the medicine is affordable, and it is accessible in a wide range of areas and hospitals. Thus, the accessibility is grade A. HC was developed from an in-hospital preparation, with application in numerous patients and thus large-scale real-world data. As a result, HC is grade B in terms of characteristics of traditional Chinese medicine. After comprehensive evaluation, the clinical value of HC in treating chronic kidney disease is class B, and that for diabetic nephropathy and chronic nephritis is class A. The result is of great reference value for the basic clinical medication management.
Subject(s)
Humans , Angiotensin Receptor Antagonists/adverse effects , Angiotensin-Converting Enzyme Inhibitors , Capsules , Diabetic Nephropathies/drug therapy , Renal Insufficiency, Chronic/drug therapyABSTRACT
OBJECTIVE: To establish a model of chronic nephritis induced by doxorubicin and a model of RAW264.7 cell inflammation induced by lipopolysaccharide(LPS), and to study the protective effect of the Cybister lateralimarginalia extract CL on the renal function of rats with chronic nephritis induced by doxorubicin and its anti-inflammatory effect. METHODS: A rat model of chronic nephritis was established by a single intravenous injection of doxorubicin (6 mg·kg-1). After 2 weeks of modeling, normal control group and model control group were given normal saline while other groups were given intragastric administration of CL high and low dose, Shenyankangfu tablets and prednisone acetate respectively. The body weight of the rats was recorded every day. The 24 h urine was collected every weekend and the urine protein content was measured. After the last administration, the rats were dissected the next day, and the kidney and liver indexes were calculated. The levels of TP, ALB, TC, TG, BUN and Scr in serum were determined. The pathological changes of kidney tissues were observed. The lipopolysaccharide (LPS 10 μg·mL-1) was used to induce the RAW264.7 cell inflammation model. PBS was given to the normal control group and the model control group while CL low, medium and high dose were given to other groups respectively. The levels of TNF-α and iNOS in the supernatant of cells were detected by enzyme-linked immunosorbent assay(Elisa). RESULTS: Compared with the normal control group, the content of 24 h urine protein, the levels of TC, TG, BUN and Scr in serum, kidney index and liver index were significantly increased in the model control group (P<0.01 or P<0.05), but the body weight of rats, the levels of TP and ALB in serum were significantly decreased (P<0.01 or P<0.05). The secretion of pro-inflammatory factors TNF-α and iNOS were significantly increase in RAW264.7 cells with inflammatory induced by LPS (P<0.01). Compared with the model control group, the content of 24 h urine protein and the levels of TC, TG, BUN and Scr in serum were significantly decreased in the Shenyankangfu group, the prednisone acetate group and the CL group(P<0.01 or P<0.05), but the body weight of rats, the levels of TP and ALB in serum were significantly increased (P<0.01 or P<0.05); the pathological condition of renal tissue was improved to some extent. Each dose of CL could reduce the secretion of pro-inflammatory factors TNF-α and iNOS in RAW264.7 cells with inflammatory induced by LPS (P<0.01). CONCLUSION: The extract of Cybister lateralimarginalia has an obvious anti-inflammatory effect and has a good protective effect on chronic nephritis in rats.
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Objective To analyze the effect of Yishenkang capsule on urinary protein in patients with chronic glomerulonephritis uraemia. Methods 100 patients with chronic glomerulonephritis uraemia from March 2013 to April 2016 were divided into two groups with lottery method and 50 cases for each group. Two groups were treated with dialysis and routine treatment, the treatment group was added Yishenkang capsule to analyze its effect. Results After treatment, 24 h urinary protein of two groups decreased than before treatment, both Alb and Hb increased than before treatment, and the treatment group was better than that of the control group with statistical significance (P<0.05). SCr, BUN and UA level of two groups decreased than before treatment, the treatment group was lower than that of the control group with statistical significance (P<0.05). The level of inflammation in the control group was significantly higher than that before treatment, the treatment group decreased and lower than that of the control group with statistical significance (P<0.05). There were no significant differences in adverse reactions between two groups. Conclusion Yishenkang capsule could decrease the excretion of urine protein in patients with chronic nephritis uraemia, improve the renal function and has few adverse reactions.
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Objective To analyze the effect of Yishenkang capsule on urinary protein in patients with chronic glomerulonephritis uraemia. Methods 100 patients with chronic glomerulonephritis uraemia from March 2013 to April 2016 were divided into two groups with lottery method and 50 cases for each group. Two groups were treated with dialysis and routine treatment, the treatment group was added Yishenkang capsule to analyze its effect. Results After treatment, 24 h urinary protein of two groups decreased than before treatment, both Alb and Hb increased than before treatment, and the treatment group was better than that of the control group with statistical significance (P<0.05). SCr, BUN and UA level of two groups decreased than before treatment, the treatment group was lower than that of the control group with statistical significance (P<0.05). The level of inflammation in the control group was significantly higher than that before treatment, the treatment group decreased and lower than that of the control group with statistical significance (P<0.05). There were no significant differences in adverse reactions between two groups. Conclusion Yishenkang capsule could decrease the excretion of urine protein in patients with chronic nephritis uraemia, improve the renal function and has few adverse reactions.
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OBJECTIVE:To evaluate the effectiveness and security of Yishen huashi granules in the adjuvant treatment of chronic nephritis systematically,and to provide evidenced-based reference. METHODS:Retrieved from CBM,CJFD,Wanfang database,VIP,Medline,PubMed,EMBase and Cochrane library,randomized controlled trials(RCTs)about Yishen huashi gran-ules in the treatment of chronic nephritis were collected and related magazines were retrieved by hand. After selection and data ex-traction by 2 researchers independently,the quality of included literature was evaluated according to Jadad rating scale,and Me-ta-analysis was conducted by using Rev Man 5.3.5 software. RESULTS:A total of 8 RCTs were included,involving 1028 patients. Total response rate of trial group [RR=1.33,95%CI(1.24,1.42),P<0.001] was significantly higher than that of control group. 24 h urine protein quantity [MD=-0.32,95%CI(-0.40,-0.24),P<0.001],serum creatinine [MD=-22.38,95%CI(-23.37,-21.39),P<0.001],blood urea nitrogen [MD=-1.45,95%CI(-2.05,-0.84),P<0.001] were significantly lower than control group,with statistical significance. CONCLUSIONS:Based on routine treatment,Yishen huashi granules have good therapeutic ef-ficacy for chronic nephritis,can reduce 24 h urine protein and improve renal function.
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Objective To discuss the methods of specification and quantification of thinking process of syndrome differentiation and treatment of old and famous TCM practitioners; To inherit the clinical experience and ideas of TCM practitioners more effectively. Methods Based on one typical case of Professor Lv Renhe treating chronic nephritis, indexing the prescriptions with TCM Subject Headings thesaurus and analyzing them with “Chinese medicine prescription intelligence analysis system” (“CPIAS” for short), relative dose, comprehensive property, comprehensive taste, comprehensive channel tropism, and prescription efficacy were under quantitative analysis. Results The typical case included two prescriptions of initial diagnosis and six diagnosis. CPIAS quantitative analysis showed that relative dose, comprehensive property, comprehensive taste, comprehensive channel tropism, and prescription efficacy were in accordance with syndrome differentiation and treatment of Professor Lv Renhe for chronic nephritis. Conclusion This method has guiding significance for studying and inheriting the speculative regularities and academic thoughts of Professor Lv Renhe.
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OBJECTIVE:To investigate the effects of atorvastatin combined with valsartan on efficacy,safety and related indi-cators in patients with chronic nephritis. METHODS:86 patients with chronic nephritis were randomly divided into control group (43 cases)and observation group(43 cases). All patients were given low-salt,low-protein and high-quality diet with protein intake of 0.8 g/(kg·d),appropriately given Cyclophosphamide tablet,Prednisone tablet,Penicillin V potassium tablet and other conven-tional treatment. Based on it,control group was given 160 mg valsartan,once a day in early morning. Observation group was addi-tionally given 20 mg atorvastatin,once a day before bedtime. They were treated for 6 months. Clinical efficacy,24 h protein amount (24 h pro),serum creatinine (Scr),blood urea nitrogen (BUN),glomerular filtration rate (GFR),C-reactive protein (CRP),total cholesterol (TC),triglyceride (TG ),low density lipoprotein (LDL) and high density lipoprotein (HDL) in 2 groups were observed,and incidence of adverse reactions was followed-up for 9 months. RESULTS:The total effective rate in ob-servation group was significantly higher than control group,the difference was statistically significant(P0.05). After treatment,24 h pro,Scr,BUN and CRP in 2 groups were significantly lower than before,and observation group was lower than control group,GFR was significantly higher than before,and observation group was higher than control group,the differenc-es were statistically significant(P0.05). And there was no significant differences in the incidence of adverse reactions between 2 groups (P>0.05). CONCLUSIONS:Based on the conventional treatment,the efficacy of atorvastatin combined with valsartan is superior to valsartan alone in the treatment of chronic nephritis,and it can significantly improve renal functions,with similar short-term safety.
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Objective To observe the effect ofJianpi-Huoxue decoction on the adrenocorticotropic hormone levels and vascular endothelial growth factor of patients with chronic nephritis.Methods 120 patients with chronic nephritis from January 2012 to December 2013 in TCM Hospital of Yanggu county were selected and recruited into a control group and a treatment group, with 40 patients in each group, according to random number table method. The control group was given oral indomethacin, 1 tablets each time, 3 times/d; intramuscular injection of methotrexate, 1 piece/time, 1 times/week. The treatment group was additionally treated by Jianpi-Huoxue decoction on the basis of the control group. Both groups were treated for 3 months. The serum adrenocorticotropic hormone and vascular endothelial growth factor levels were measured before and after the treatment,and efficacy and safety were also evaluated.Results After the treatment, the total effective rate was 72.5% (29/40) in the control group and 97.5% (39/40) in the treatment group, with significant differences (χ2=7.941,P<0.05). The ACTH levels after treatment was (13.82 ± 5.94 ng/Lvs. 8.01 ± 4.16 ng/L) in the treatment group and (18.73 ± 6.84 ng/Lvs. 8.07 ± 4.08 ng/L) in the control group, showing significant increase compared with before treatment (P<0.01). The level of VEGF was (61.92 ± 26.37 ng/Lvs. 83.72 ± 30.63 ng/L) in the treatment group and (49.36 ± 23.93 ng/Lvs.84.34 ± 33.49 ng/L) in the control group, showing significant decrease than before treatment (P<0.01). After the treatment, the increase of ACTH and the decrease of VEGF in the treatment group were better than those in the control group (t=3.427, 2.231,P<0.05).ConclusionsJianpi-Huoxue decoction combined with conventional western therapy can increase the level of ACTH in patients with nephritis, reduce VEGF, and improve clinical curative effects.
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This paper was aimed to summarize professor Huang Chunlin’s medication experiences, rules and prescription characteristics in the treatment of chronic nephritis through data mining on patients’ records of chronic nephritis. The records of 92 outpatients which met the criteria were collected. The total treatment number was 276. Text conversion was made on patients’ records. And the archive of patients’ data was established. With the support of Traditional Chinese Medicine Inheritance Support System, the medication experiences and prescription rules of professor Huang were summarized. The results showed that the top 20 herbs with relatively high using frequencies were mostly sweet in flavor and neutral in nature. The meridian distributions were mostly the kidney, spleen and liver meridian. The medication effects were mainly qi-reinforcing, yang-reinforcing, water-clearing and dampness-removing. Results from data mining showed 5 couplet medicines and 8 new prescriptions in chronic nephritis treatment. It was concluded that in Professor Huang’s syndrome differentiation of chronic nephritis, it was related to the spleen and kidney, and also related to dampness and stasis. The characteristics in medication were “high-dose for severe conditions”, “sweet in flavor and neutral in nature with outstanding effects”, “always related to the spleen and kidney”, “always related to dampness and stasis”.
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Objective To evaluate therapeutic effect of Leflunomide combined with glucocorticoids on patients with chronic nephritis.Methods 36 patients with chronic nephritis in Guangyuan Hospital of Traditional Chinese Medicine from January 2012 to October 2013,were randomly divided into two groups:the routine group were treated with conventional therapy;While the theraputic group were treated by leflunomide and glucocorticoid.The tests of urinary protein,serum cretonne and blood urea nitrogen were conducted during treatment in both groups. Results The total effective rate was 88.89 %in the treatment group and 72.2% in the control group.the difference was significant(P<0.05 ).After treatment,measured value of urine protein, serum cretonne and blood urea nitrogen were significantly higher than prior treatment(P<0.05 ).Conclusion The therapeutic effect of leflunomide combined corticosteroid on chronic nephritis is better.
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It has been popular to group various renal disorders under chronic kidney disease (CKD). And, angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) drugs are used as the first choice for treatment of CKD with hypertension. Here, however, I review some Kampo treatments. To begin with, shichimotsukokato is a promising formula for the treatment of CKD in combination with ACE inhibitors/ARBs. The effects of hachimijiogan show promise for the inhibition of diabetic nephropathy through basic studies using experimental models. And, recent evaluations have revealed the efficacy and usefulness of saireito, in reducing steroid dose for the treatment of glomerulonephritis and primary nephrotic syndrome. Moreover, when considering disease backgrounds, saibokuto is useful in the patients with IgA nephropathy accompanied by frequent episodes of upper respiratory infection, while saireito is occasionally effective for nephrotic syndrome with allergic disorder. Saireito has also been reported to be effective in childhood IgA nephropathy in a prospective controlled study. The effects of onpito, on the other hand, are reported to prevent or postpone the introduction of dialysis in pre-dialysis patients with chronic renal failure. And furthermore, for the treatment of hemodialysis patients, goreisan efficacy has been reported for the difficulty of fluid removal, while saireito is promising for the treatment of peritoneal fibrosis due to peritoneal dialysis.
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Objective To observe the effect of tripterygium wilfordii combined with low molecular hepatin in treatment of chronic nephritis.Methods 102 patients who underwent renal biopsy and diagnosed as chronic nephritis were randomly divided into treatment group and control group,each contained 51 patients.The control group were given ordinary western medicine,and both continued for therapeutical period of 4 weeks.the treatmem group were given tripterygium wilfordii and low molecular heparin besides ordinary western medicine.Results The treatment group's total effective rate 90.20%was obviously higber than the control group's 74.51%.and compared with the control group,there was significandy statistical difference(P＜0.05).After 4 weeks treatment,the treatment group's urine protein and serum creatinine、urea nitrogen compared with the control group also had significant differences all P＜0.05).Conclusion Tripterygium wilfordii combined with low molecular heparin could difinltely reduce the chronic nephritis patients' urine protein and serum creatinine、urea nitrogen,and had less side effect,and it Was worthy of being widely used.
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The main characteristic in pathogenesis of chronic nephritis proteinuria is asthenia in origin and asthenia in superficiality,which is Qi deficiency of spleen and kidney seaing the deficient foundation,and pathogenic wind,dampness-heat,and toxic-stasis injuring the body for the whole process of disease.The main therapeutic method is treating from spleen,kidney,liver,and lung,accompanied by the methods of clearing heat,removing dampness,expelling wind,and tonifying kidney to control nocturnal emission.In addition.patients with severe chronic illness should add worm medicines and medicines for promoting blood circulation to remove stasis.
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Chronic nephritis is a common clinical refractory disease,with complex mechanism,hard and long to cure.The TCM treatment in Internal Classic has key guideline meaning and is proved in modern TCD pharmacology,such as "kidney governs spleen,spleen holds nutrition,dislikes dampness and governs outer guard" of spleen picture,etc.
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You ought to differentiate the cause, location, nature and trend of disease, for chronic nephritis. The causes inducing or worsening the disease can be exopathy, as well as internal injury, pathological substance and drug pathogenic factors; while the deficiency of Qi blood Yin Yang of organs is often the internal basis of the disease. The location mainly concerns lung, spleen, liver and kidney, esp. kidney. The nature is deficient root and excessive superficiality; its general trend mostly appears Qi deficiency-both deficiency of Qi and Yin(blood)- both deficiency of Yin and Yang, a discipline of gradual development, and wind, wetness, heat, stasis, sputum and toxin worsen the development of the disease.
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TCM has dominance and characteristics in treating chronic nephritis, such as protecting the function of kidney and defering the kidney crocking up. Professor LI Ji-ren, a famous herbalist and the gainer of the special allowance of the State Council, has worked on clinic for 60 years. He Accumulates abundant experiences in treating chronic nephritis. On clinic, Professor Li advocates integratation of syndrome differentiation and disease differentiation, attaching importance to protect the basic of body and flexibility of syndrome differentiation. In aspects of medication, he begins with treating spleen and kidney,at the same time, harmonizing the qi and blood, detaching the clear and dirtiness, protecting other organs. Danbai Zhuanyin Prescription, containing thirteen herbal medicines, has marked effect on chronic nephritis albuminutia.
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Objectives To investigate the expression features and roles of the costimulatory molecules and T lymphocyte subsets from patients with chronic nephritis.Methods The expression of the costimulatory molecules CD 28 and CD 137 on PBMC (peripheral blood mononuclear cells) and T lymphocyte subsets from 52 patients with chronic nephritis were studied by immunophenotyping and flow cytometry analysis.Results The T lymphocyte subsets from patients with chronic nephritis showed an obvious imbalance with reversing CD 4/CD 8 ratio,decreasing CD + 4T cells and increasing CD + 8T cells.The expression of the costimulatory molecule CD 28 on T cells was significantly lower compared with normal controls (P
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OBJECTIVE: To observe the clinical efficacy of Shenyan kangfu tablet combined with benazepril in the treatment of chronic nephritis. METHODS: 160 chronic nephritis patients with healthy renal function were randomly divided into benazepril (ACEI) group and Shenyan kangfu tablet combined with benazepril group (combination group). 24 hour urinary protein, blood pressure and creatinine of 2 groups were determined before and after treatment. RESULTS: After 4 months of treatment, the total effective rates were 87.5% for combination group and 56.25% for ACEI group (P0.05). CONCLUSION: Shenyan kangfu tablet combined with benazepril can reduce proteinuria in patients with chronic nephritis,non-toxic side effect in short-term.
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Aim The therapeutic effect of "shen-bing NQ 5", a preparation of traditional Chi-nese medicine on adenine-induced chronic nephritis in rats was studied. MethodsChronic nephritis in rats was induced by giving adenine 80 mg?kg-1?d-1 orally. Themodel rats were treated by "shen-bing No 5" in different dosages. Levels of urea ni-trogen(BUN), creatinine (Cr), total protein(TP), and Na+ in serum and or urine weredetected and the changes of kidney were obseraed. Results The "shen-bing No 5"markedly lowered the levels of urine protein in 24 hours, BUN in urine and BUN, Na+in serum (P