Clinical Study on Effect of Astragalus Injection (黄芪注射液) and Its Immuno-regulation Action in Treating Chronic Aplastic Anemia

Objective： To observe the clinical effect of Astragalus Injection （黄芪注射液, Al） and its immuno-regulatory action in treating chronic aplastic anemia （CAA）. Methods： Sixty patients with CAA were randomly assigned to two groups equally, both were treated with Stanozolol three times a day, 2 mg each time through oral intake, but AI was given additionally to the patients in the treated group once a day via intravenous dripping. All were treated for 15 days as one therapeutic course and the whole medication lasted for more than 4 months totally, with follow-up adopted. The clinical efficacy was estimated and the changes of T-lymphocyte subsets in peripheral blood as well as the serum levels of tumor necrosis factor-α （TNF-α ） and interleukin-2 （IL-2） were observed. Results： The total effective rate in the treated group was 83.3% （25/30）, which was higher than that in the control group 66.7% （20/30）, showing significant difference between them （P〈0.05）. Levels of hemoglobin, WBC, reticular cell and platelet were elevated in both groups after treatment, but the improvement was significantly better in the treated group than that in the control group with respect to the former three indexes （P〈0.05）. The level of CD4^＋ increased and that of CD8^＋ decreased significantly after treatment in the treated group （P〈0.05）, which showed significant difference as compared with those in the control group （P〈0.05）. Levels of serum TNF-α and IL-2 lowered after treatment in both groups, but significance only showed in the treated group （P〈0.05）. The degree of proliferation in bone marrow got raised significantly and the percentage of non-hemopoietic cells reduced significantly in the treated group after treatment, also showing significant difference to those in the control group （P〈0.05）. Conclusion： AI could promote the recovery of hemopoietic function, which might be through improving T-lymphocyte subsets and reducing the release of negative regulatory factors such as TNF-α and IL-2 to alleviate the inhibition on hemopoietic function.

Role of Heteroplasmic Mutations in the Mitochondrial Genome and the ID4 Gene Promoter Methylation Region in the Pathogenesis of Chronic Aplastic Anemia in Patients Suffering from Kidney Yin Deficiency

Objective： To analyze changes in gene amplification in the mitochondrial genome and in the ID4 gene promoter methylation region in patients with chronic aplastic anemia （CAA） suffering from Kidney （Shen） yin deficiency or Kidney yang deficiency. Methods： Bone marrow and oral epithelium samples were collected from CAA patients with Kidney yin deficiency or Kidney yang deficiency （20 cases）. Bone marrow samples were collected from 20 healthy volunteers. The mitochondrial genome was amplified by polymerase chain reaction （PCR）, and PCR products were used for sequencing and analysis. Results： Higher mutational rates were observed in the ND1-2, ND4-6, and CYTB genes in CAA patients suffering from Kidney yin deficiency. Moreover, the ID4 gene was unmethylated in bone marrow samples from healthy individuals, but was methylated in some CAA patients suffering from Kidney yin deficiency （positive rate, 60%） and Kidney yang deficiency （positive rate, 55%）. Conclusions： These data supported that gene mutations can alter the expression of respiratory chain enzyme complexes in CAA patients, resulting in energy metabolism impairment and promoting the physiological and pathological processes of hematopoietic failure. Functional impairment of the mitochondrial respiration chain induced by gene mutation may be an important reason for hematopoietic failure in patients with CA,＆,. This change is closely related to maternal inheritance and Kidney yin deficiency. Finally, these data supported the assertion that it is easy to treat disease in patients suffering from yang deficiency and difficult to treat disease in patients suffering from yin deficiency.

Clinical Study of Pai-Neng-Da Capsule(派能达胶囊) in the Treatment of Chronic Aplastic Anemia

Objective：To evaluate the efficacy and safety of Pai-Neng-Da Capsule（派能达胶囊t panaxadiol saponins component,PND）,a new Chinese patent medicine,on patients with chronic aplastic anemia（CAA）and to explore the optimal therapeutic regimen for CAA.Method：A total of 36 patients with CAA were enrolled and divided into three groups：the AP group（20 cases,andriol 120 mg/day ＋ PND 240 mg/day）,the ACP group（13 cases,andriol 120 mg/day ＋ cyclosporine 3-6 mg·kd（-1）·day（-1） ＋ PND 240 mg/day）,and the PND group（3cases,PND 240 mg/day）.All patients were treated and followed up for 6 months.Peripheral blood counts,renal and hepatic function and Chinese medical（CM） symptoms of patients were assessed and all indices were gathered at the beginning and end of the study.Result：In the AP group,no significant hematologic difference was observed at the end of 6-month treatment comparing with the beginning.In the ACP group,the blood counts were maintained at the same level after the 6-month treatment.In the PND group,trilineage hematologic improvement was displayed at the end of 6-month treatment comparing with the beginning.No significant difference was showed in renal and hepatic function in all patients.All patients＇ clinical symptom improved according to CM symptom score.The effective rates were 95%,73%and 100%,respectively.Conclusion：PND improved the efficacy and decreased side effects by cutting down the dosage of andriol,and it could also improve patients＇ clinical symptom and quality of life.PND were effective and safe in the treatment of CAA,it could be used alone or in combination with pharmacological agents such as andriol and cyclosporine.

Treatment of Chronic Aplastic Anemia with Chinese Patent Medicine Pai-Neng-Da Capsule for Replacing Androgen Partially:A Clinical Multicenter Study

Objective:To evaluate the efficacy and safety of Pai-Neng-Da Capsule(panaxadiol saponins component,PNDC)in combination with the cyclosporine and androgen for patients with chronic aplastic anemia(CAA).Methods:A total of 79 CAA patients was randomly divided into 2 groups by a random number table,including PCA group[43 cases,orally PNDC 320 mg/d plus cyclosporine 5 mg/(kg·d)plus andriol 80 mg/d]and CA group[36 cases,orally cyclosporine 5 mg/(kg·d)plus andriol 160 mg/d].All patients were treated and followed-up for 6 treatment courses over 24 weeks.The complete blood counts,score of Chinese medical(CM)symptoms were assessed and urine routine,electrocardiogram,hepatic and renal function were observed for safety evaluation.Female masculinization rating scale was established according to the actual clinical manifestations to evaluate the accurate degree of masculinization in female CAA patients treated by andriol.Results:The effective rates were 88.1%(37/42)in the PCA group and 77.8%(28/36)in the CA group based on the standard for the therapeutic efficacy evaluation of hematopathy.There was no significant difference in the white blood cell(WBC)counts,platelet counts and hemoglobin concentration of peripheral blood between two groups after 6 months treatment.The masculinization score of female patient in the PCA group was significantly lower than the CA group(P<0.05).The mild abdominal distention was observed in 1 case in the PCA group.In CA group,the abnormalities in the hepatic function developed in 2 cases and the renal disfunction was found in 1 case.Conclusion:The PNDC possesses certain curative effects in the treatment of CAA without obvious side-effects and can partially replace andriol thereby to reduce the degree of masculinization[Registried at Chinese Clinical Trial Registry(ChicTR1900028153)].

Comparative Study of Tiaoxue Yisui Recipe with SSL Regimen in Treating Infantile Chronic Aplastic Anemia

Objective: To find the effective method in treating infantile chronic aplastic anemia (ICAA) by using traditional Chinese medicine (TCM). Methods: Seventy-eight cases of ICAA were observed, 48 in the treated group were treated with Tiaoxue Yisui recipe, and 30 cases in the control group with SSL regimen. Results: The remission rate and total effective rate in the treated group were 52. 08% and 81. 25% respectively,which were higher than those in the control group (P < 0. 05). After one year's treatment the ratio of hemopoietic and non-hemopoietic cells in the treated group was higher than that in the control group (P< 0. 05). Conclusion: Tiaoxue Yisui recipe could improve the living quality of ICAA patients. The therapeutical mechanism of the recipe might be related to its promoting the proliferation of hemopoietic stem cells and regulating the immune function.

Treatment of 34 Cases of Chronic Aplastic Anemia Using Prepared Rehmannia Polysaccharide Associated with Stanozolol

Objective: To investigate the effect and side effect of prepared Rehmannia polysaccharide (PRP) associated with stanozolol in treating chronic aplastic anemia (CAA). Methods:34 cases of CAA were treated by PRP liquid associated with stanozolol for a course of 3 weeks treatment, and control group (17 cases of CAA) was treated by stanozolol alone. Results: Effective rate was 85. 3 % in treatment group, and that of control group was 58. 8 %,there was significant difference between them (P < 0. 05 ). Symptom remission of treatment group was earlier than that of control group.The difference of symptom scoring between two groups was significant (P < 0. 01 ). Blood cell had a distinct elevation after treatment with PRP associated with stanozolol, and had a significant difference in comparing with pretreatment in treatment group (P < 0. 01 ).Side effect of PRP was not found during treatment of CAA. Conclusion: PRP associated with stanozolol to treat CAA has an additional effect, it can accelerate symptom remission without any additional side effect.Original article on CJIM(Chin ) 1998; 18(6): 351

Effect on Life Span and Membrane Protein in Red Blood Cells by Integrated Medicine Therapy on Chronic Aplastic Anemia

Objective: To explore the mechanism ofintegrated traditional Chinese and Westernmedicine (TCM--WM ) therapy on chronicaplastic anemia (CAA). Methods: The RBClife span of 30 normal human subjects and 30patients with CAA were measured by sir labelled technique before and after TCM--WMtherapy. The morphology and distribution ofRBC membrane protein granules were observed by freeze fracture etching and transmission electron microscope. Results: The halflife of erythrocytes (RBC TI/2)was shortenedin CAA cases and there was a significant difference compared to healthy control (P <0. 01). After therapy, the RBC life span prolonged and approached the normal level. Before treatment, there existed abnormal in morphology, decrease in amount and uneven indistribution of protein granules in protoplasmicface (PF) and extracellular face (EF) of RBCmembrane. After treatment, the protein granules of RBC membrane was improved and approached to control. Conclusions: The morphology, amount, quality and distribution ofRBC membrane protein granule were closelyrelated to its life span. The therapeutic effectof TCM--WM was better than that of WMalone and it had a function both in stabilizingmembrane protein and extending the RBC lifespan.