OBJECTIVE: To investigate the curative effect of combined transplantation of bone marrow and umbilical cord blood of same sibling in children with β-thalassemia major.METHODS: Eight thalassemia major patients undergoing combined transplantation of bone marrow and umbilical cord blood of same sibling aged from 4.0 to 7.5 years, 5 boys and 3 girls, were recruited at the Department of Pediatrics, Nanfang Hospital,Southem Medical University from January 2005 to March 2009. The patients were classified into three classes according to Pesarothalassamia classification, class Ⅰ to class Ⅱ 7 cases and class Ⅲ 1 case. Donors ranged 1-4 years received 10 μg/kg per day of subcutaneous granulocyte colony-stimulating factor (G-CSF) for 5 consecutive days. Bone marrow was harvested on the fifth day. Bone marrow and umbilical cord blood of the same sibling then were transfused into the patient.RESULTS: Recovery of hematopoiesis was gained in all patients 4 weeks following transplantation. Seven patients suffered from infection of different degree. Four patients developed mild venous occlusive disease. Two patients developed grade Ⅰ acute graft-versus-host disease (GVHD), and one developed grade Ⅰ chronic GVHD. Seven patients were alive and one died of pulmonary infection and heart failure 32 days following transplantation.CONCLUSION: Combined transplantation of granulocyte colony-stimulating factor primed bone marrow and umbilical cord blood of same sibling in children with β-thalassemia major is safe and effective with promising results. However, complications should be paid high attention following transplantation.

Objective To observe and evaluate the clinical efficacy and safety of Xiaoerzhili syrup in attention deficit/hyperactivity disorder(ADHD) in children.Methods This study was performed by a multicenter self-controlled clinical observation trial.A total of 1 833 children with ADHD selected from 18 clinical centers from June 2013 to December 2015 were treated by Xiaoerzhili syrup for 6 months,and the clinical efficacy and safety were evaluated.Chinese Version of ADHD Rating Scale-Ⅳ-Parent(ADHDRS-Ⅳ-P) and Clinical Global Impression (CGI) were used to evaluate the clinical efficacy,and the registration form of side reaction and the questionnaire of drug safety grade were used to assess the safety.Results Compared with the scores before treatment,the total scores of ADHDRS-Ⅳ-P,attention deficit subscale scores and hyperactivity impulsivity subscale scores decreased with statistically significant differences after treatment with Xiaoerzhili syrup in the total ADHD group,male ADHD group,female ADHD group,mild ADHD group,moderate ADHD group and severe ADHD group(all P ＜0.01).The statistically significant differences in the total scores of ADHDRS-Ⅳ-P,attention deficit subscale score and hyperactivity impulsivity subscale scores were not found in different gender before and after treatment (all P ＞ 0.05).According to the results of CGI-Ⅰ,the proportion of "improved obviously" and above were 80.98％ (1 379 cases),79.95％ (1 089 cases) and 85.05％ (290 cases),in the total poptlation group,male group and female group,respectively.The side effects of drugs were found in six male cases.After treatment,safety problems were not found in the analysis of the safety evaluation.Conclusion Xiaoerzhili syrup treatment is effective in children with ADHD treatment,and security problems are not found.

BACKGROUNDTo evaluate and compare the effects and toxicity of the domestic product of nrhTNF combined with chemotherapy in the trial group and chemotherapy alone in the control group in the treatment of patients with non-small cell lung cancer (NSCLC).

METHODSNinety patients with NSCLC in multicenter were randomly devided into trial group and control group. Each group had 45 patients. Chemotherapy with CAP regimen was given for the patients in the trial group. Meanwhile, nrhTNF injection of 4×10⁶U/m ² was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy course. Twenty-one days were as a cycle, 2 cycles were given each patients. Chemotherapy alone with CAP regimen was given in the control group. The chemothepeutic effects and toxicity were observed and compared between the two groups after the therapy.

RESULTSOf the 90 patients, 3 cases in each group were out of the trial because of economy. The other 84 cases (each group had 42 patients) could be used to analyze and evaluate the clinical effects and toxicity. The response rate of chemotherapy was 47.62% (20/42) in the trial group and 19.05% (8/42) in the control group (P=0.002) respectively. The KPS was 85.02±10.74 in the trial group, and 81.35±9.63 in the control group (P=0.038). No significant difference of degree III+IV toxicity was observed between the trial group and control group (P > 0.05). The side effects related to nrhTNF included slight fever, cold like symptoms, pain, and red and swelling in injection site. All of them were mild and didn't need any treatment and disappeared after the therapy.

CONCLUSIONSThe results demonstrate that the effects of domestic nrhTNF combined with chemotherapy can remarkably higher than that of chemotherapy alone in the treatment of NSCLC. It is able to increase the sensitivity to chemotherapy and improve the quality of life of the patients. The toxicity is also slight and is worth to expand clinical use, so as to further evaluate its effect and toxicity.

ObjectiveTo explore the clinical effectivess of Nuangong Tiaojing Decoction （暖宫调经汤） combined with ginger moxibustion at Baliao acupoints （Eight Bone-Holes） for treating premature ovarian failure （POF） of yang-deficiency uterus-coldeness syndrome， based on conventional western medical treatment. MethodsA total of 130 patients diagnosed with POF of yang-deficiency uterus-coldeness syndrome were divided into a treatment group and a control group， with 65 cases in each group， based on patient preference. The control group received conventional western medicine treatment， while the treatment group was additionally given Nuangong Tiaojing Decoction orally one dose per day and underwent ginger moxibustion at Baliao points once daily. Both groups were treated for three months. Before and after treatment， ovarian function indicators， including ovarian volume， follicle count， ovarian peak systolic velocity （PSV）， and endometrial thickness were assessed， and serum sex hormone levels including progesterone （P）， estradiol （E₂）， follicle-stimulating hormone （FSH）， luteinizing hormone （LH）， prolactin （PRL）， and testosterone （T）， as well as anti-Müllerian hormone （AMH） levels were also measured. Additionally， traditional Chinese medicine （TCM） syndrome scores were evaluated， covering symptoms such as reduced libido， lumbosacral pain， fear of cold with cold extremities， fatigue， dull complexion， lower abdominal distension and pain， pale tongue， and deep and rough pulse. After treatment， clinical effectiveness and safety were determined. ResultsCompared with the pre-treatment levels within group， both groups showed significant increases in ovarian volume， follicle count， PSV， endometrial thickness， and levels of P， E₂， and AMH after treatment， while the levels of FSH， LH， PRL， and T， as well as scores of lumbosacral pain， reduced libido， dull complexion， deep and rough pulse， and total TCM syndrome scores significantly reduced after treatment. Furthermore， the treatment group exhibited higher ovarian volume， follicle count， PSV， endometrial thickness， and levels of P， E₂， and AMH compared to the control group， while FSH， LH， PRL， T levels， and all symptom scores， as well as total TCM syndrome scores， were significantly lower in the treatment group than in the control group （P＜0.05 or P＜0.01）. The clinical effectiveness in treatment group was 96.92% （63/65）， significantly higher than 81.54% （53/65） in control group （P＜0.05）. The incidence of adverse reactions in the treatment group was 26.15% （17/65）， while in the control group it was 32.31% （21/65）， with no statistically significant difference （P＞0.05）. ConclusionOn the basis of conventional western medicine treament， Nuangong Tiaojing Decoction combined with ginger moxibustion at Baliao acupoints for patients with POF of yang-deficiency uterus-coldeness syndrome can significantly improve ovarian function and clinical symptoms， regulate hormone levels， and thereby enhance clinical effectiveness.

BACKGROUNDTo evaluate and compare the effects and toxicity of the domestic product of recombinant mutant human tumor necrosis factor (rmhTNF) combined with chemotherapy and chemotherapy alone in the treatment of patients with non-small cell lung cancer (NSCLC).

METHODSTwo hundred patients with NSCLC in multicenter were randomly devided into trial group (150 cases) and control group (50 cases). Chemotherapy with CAP regimen was given to the patients. Meanwhile, rmhTNF injection of 4×10⁶U/m² was also given from the 1st to 7th days, the 11th to 17th days on the chemotherapy cycle in the trial group. The control patients received chemotherapy alone. Twenty-one days were as a cycle, 2 cycles were given to each patient. The chemotherapeutic effects and toxicity were observed and compared between the two groups after the therapy.

RESULTSof the 200 patients, 5 cases in the trial group and 3 cases in the control group were out of the trial because of economy. The other 192 cases (145 cases in the trial group and 47 cases in the control group) could be analyzed and evaluated the clinical effects and toxicity. The response rate of chemotherapy was 46.90% (68/145) in the trial group and 17.02% (8/47) in the control group respectively ( P =0.001). The KPS scores was 86.02±9.74 in the trial group, and 80.14±9.10 in the control group ( P =0.025). No significant difference of degree III+IV toxicity was observed between the two groups ( P > 0.05). The side effects related to rmhTNF included slight fever, cold-like symptoms, pain and red and swelling in the injection site. All of them were mild and didn't need any treatment and disappeared after the therapy. There were no severe abnormality of liver and kidney function and ECG in both groups.

CONCLUSIONSThe results demonstrate that the effects of domestic rmhTNF combined with chemotherapy are remarkably higher than that of chemotherapy alone in the treatment of NSCLC. rmhTNF can increase the sensitivity to chemotherapy and improve the quality of life of the patients with slight toxicity. Hence rmhTNF is worth expanding clinical use.