Clinical Observation of Shuanghuang Shengbai Granule(双黄升白颗粒) on Prevention and Treatment of Myelosuppression Caused by Chemotherapy in Cancer Patients

Objective： To study the efficacy and safety of Shuanghuang Shengbai Granule（双黄升白颗粒, SSG）, a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy. Methods： A total of 330 patients were randomly assigned to the treatment group（220 cases, analysed 209 cases） and the control group（110 cases, analysed 102 cases） with a 2：1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation. Results： At the 7th day of chemotherapy, the white blood cells（WBCs） level in the treatment group was significantly higher than that in the control group（P〈0.05）. After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade Ⅰ, while 8.1% and 5.7% of patients emerged grade Ⅲ and grade Ⅳ myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group（P〈0.05）. The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group（84.2% vs. 72.5%, P〈0.05）. The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3~＋ and CD4~＋ cells were significantly increased in the treatment group after treatment（P〈0.05）. The discrepancy of CD3~＋ and CD4~＋ cell activity before and after treatment in both groups were significantly different（P〈0.05）. No obvious adverse event occurred in both groups. Conclusion： SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.

Effect of Compound Zhuye Shigao Granule(复方竹叶石膏颗粒)on Acute Radiation-Induced Esophagitis in Cancer Patients:A Randomized Controlled Trial

Objective： To observe the efficacy and safety of the Chinese medicine（CM） Compound Zhuye Shigao Granule（复方竹叶石膏颗粒, CZSG） on acute radiation-induced esophagitis（ARIE） in cancer patients. Methods： In a blinded, randomized, Kangfuxin Solution（康复新液, KFX）-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group（60 cases） and control group（60 cases） by the random number table method. All patients received concurrent or sequential radiotherapy（2 Gy per day, 5 times per week, for 4 weeks） and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 m L KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status（KPS） Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. Results： The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group（P〈0.05）. CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX（P〈0.05）. The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group（P〈0.05）. There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment（P〈0.05）, and there was no significant difference between the two groups（P〉0.05）. Conclusions： CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.

Effectiveness of Bushen Huoxue Granule (补肾活血颗粒) on 5-Serotonin and Norepinephrine in the Brain of Parkinson's Disease Patients with Depressive State

Objective：To observe the clinical curative effect of Chinese medicine Bushen Huoxue Granule（补肾活血颗粒,BHG） on Parkinson＇s disease（PD） patients with depressive state.Methods：Sixty-two PD patients with depressive state were randomly assigned to two groups by using a random number table,31 in each group.Madopar was given to all as the conventional treatment.The fluoxetine hydrochloride dispersible tablet was given to the patients in the control group and BHG was given to those in the treatment group.The therapeutic course for all was 12 weeks.Before and after treatment,Hamilton depression rating scale（HAMD） was applied to judge the curative effect,and the changes of cerebral neurotransmitters levels in the brain of patients were detected by encephalofluctuograph technique.Results：The scores of HAMD in the two groups were decreased markedly after 12-week treatment.It was lower in the treatment group than that in the control group with significant difference（P〈0.01）.The contents of norepinephrine（NE） and 5-serotonin（5-HT） in the PD patients were obviously lower than normal value.There was no significant difference between the two groups before treatment（P〉0.05）.The contents of NE and 5-HT were all increased in the two groups after treatment（P〈0.05）,with significant differences between the two groups（P〈0.01）.Conclusion：BHG could increase the contents of NE and 5-HT in PD patients＇ brain to improve the depressive state of PD patients.

Long-Term Clinical Effect of Tangyiping Granules(糖异平颗粒)on Patients with Impaired Glucose Tolerance

Objective： To evaluate the long-term clinical effect of Tangyiping Granules（糖异平颗粒, TYP） on patients with impaired glucose tolerance（IGT） to achieve normal glucose tolerance（NGT） and hence preventing them from conversion to diabetes mellitus（DM）. Methods： In total, 127 participants with IGT were randomly assigned to the control（63 cases, 3 lost to follow-up） and treatment groups（64 cases, 4 lost to follow-up） according to the random number table. The control group received lifestyle intervention alone, while the patients in the treatment group took orally 10 g of TYP twice daily in addition to lifestyle intervention for 12 weeks. The rates of patients achieving NGT or experiencing conversion to DM as main outcome measure were observed at 3, 12, and 24 months after TYP treatment. The secondary outcome measures included fasting plasma glucose（FPG）, 2-h postprandial plasma glucose（2h PG）, glycosylated hemoglobin（Hb A1c）, fasting insulin（FINS）, 2-h insulin（2hI NS）, homeostatic model assessment of insulin resistance（HOMA-IR）, blood lipid and patients＇ complains of Chinese medicine（CM） symptoms before and after treatment. Results： A higher proportion of the treatment group achieved NGT compared with the control group after 3-, 12- and 24-month follow-up（75.00% vs. 43.33%, 58.33% vs. 35.00%, 46.67% vs. 26.67%, respectively, P〈0.05）. The IGT to DM conversion rate of the treatment group was significantly lower than that of the control group at the end of 24-month follow-up（16.67% vs. 31.67%, P〈0.05）. Before treatment, FPG, 2h PG, Hb A1 c, FINS, 2h INS, HOMA-IR, triglyceride（TG）, total cholesterol, low- and high-density lipoprotein cholesterol levels had no statistical difference between the two groups（P〉0.05）. After treatment, the 2hP G, HbA 1c, HOMA-IR, and TG levels of the treatment group decreased significantly compared with those of the control group（P〈0.05）. CM symptoms such as exhaustion, irritability, chest tightness and breathless, spontaneous sweating, constipation, and dark thick and greasy tongue were significantly improved in the treatment group as compared with the control group（P〈0.05）. No severe adverse events occurred. Conclusion： TYP administered at the IGT stage with a disciplined lifestyle delayed IGT developing into type 2 DM.