Objective To translate the findings from fundamental research into clinical application and to evaluate the clinical efficiency and safety of Fritillaria thunbergii Miq. granule as adjunctive means of chemotherapy during peri chemotherapy of refractory acute leukemia. Methods Patients in multiple hospitals were randomly divided into two groups with Fritillaria thunbergii Miq. granule treatment or synchronous control at three days before chemotherapy respectively, according to random approaches for medical treatment. The clinical therapeutic effects were then determined after one course of treatment. Results According to the research project, 138 patients were analyzed statistically, 72 in Fritillaria thunbergii Miq. granule group and 66 in control group. The complete remission rate (CR) of Fritillaria thunbergii Miq. granule group and control group were 36.8% and 25.8% respectively, while the total effects were 77.8% and 53.0%, which was significantly different (P

Gastric cancer is the fourth most common cancer and is the second leading cause of cancer death worldwide. Gastric cancer is usually in advanced stage at diagnosis, without opportunity for curative resection. Chemotherapy is the major treatment for advanced gastric cancer (AGC), and other treatments include palliative surgery, radiotherapy, chemotherapy, biologic and immunologic therapy as well as Chinese medicine. Palliative therapy is used to reduce tumor load or complication occurrence, while radiotherapy is effective for locoregionally advanced gastdc cancer. At present, chemotherapy plays a leading role in AGC treatment and has a palliative effect on symptomatic patients. For advanced or metastatic gastric cancer, chemotherapy has always been the focus of studies. Results of studies of FAX, ECF/DCF regimens and Phrase ill clinical trials of REAL-2, ML17032 and SPIRITS have been released. With the application of EOX, XP, S-1/CDDP, IF, FOLFOX and XELOX regimens, the outcomes of advanced gastdc cancer are improved. However, there is no standard regimen accepted as supedor over others. Biologic and immunologic therapy are beneficial supplements to surgery, chemotherapy and radiotherapy, but are not yet the mainstream. All of these treatments have obvious side effects. Other comprehensive methods are of equal importance, such as Chinese herbal medicine, acupuncture and moxibustion, and psychological intervention. Combined with western medicine, the above methods have certain merits in relieving clinical symptoms, reducing toxicity,increasing effectiveness, improving quality of life, preventing metastasis and recurrence, reversing multidrug resistance of tumor cells, and curing ascites and managing cancer pain.

Objective To evaluate comprehensively therapeutic effect of Kongsheng Zhenzhong Pill (dis-pensing granule)(KSZZ),a classic TCMherbal formula,on tumor-relater insomnia patients with TCM pattern of deficiency in heart and kidney,so as to provide foundation for clinical application.Methods Sixty tumor-related insomnia patients with deficiency in heart and kidney who were conformed to the diag-nostic criteria were randomly divided into control group and treatment group (each n =30).Patients in treatment group took orally KSZZ twice daily,one pack 30 minutes after breakfast and dinner,and those in treatment group took orally estazolam at dose of 1 mg at night,for consecutive 28 days.Pittsburgh sleep quality index scale (PSQI)and TCMPattern Integral were used before treatment ,on Day 1,Day 14 and Day 28 after treatment,so as to record PSQI score,TCM clinical pattern and change of single symptom.Then the quality of sleep and TCM pattern curative efficacy were calculated by using SPSS 18.0 software.Results Compared with the control group,PSQI scores and TCM pattern integral decreased significantly (P <0.001).The curative efficacy of KSZZ on insomnia or TCMpattern was high-er than that of estazolam(P <0.001 ).The scoring of individual symptoms on Day 14 or Day 28 were lower obviously than those on Day 1(P <0.001),except sleep efficiency on Day 14 and Day 28 (P >0.05).Conclusion The curative effect of KSZZ on improving sleep quality of tumor-related insomnia patients has been proved,and KSZZ could be worthy of wide clinical application.

Objective To observe the clinical efficacy of Xinjia Liangfu (Modified Galangal and Cyperus) Granules on advanced gastric cancer.Methods The patients with stage Ⅲ/Ⅳ gastric cancer (n =42) were randomly divided into control group and treatment group by applying prospective randomized controlled multi-center clinical trial method.The treatment group was treated with standard chemotherapy regimens combined with Xinjia Liangfu Granules,and control group,with only chemotherapy regimens.During the therapeutic course,2 groups were given the best supportive care and observed for 4 cycles of chemotherapy.The scores of symptoms and signs,Karnofsky performance status (KPS),pain numerical rating scale,tumor size and indexes of blood and urine routine tests,liver and renal functions and electrocardiogram were recorded on the day of grouping and at the end of each cycle of chemotherapy.Results There were 21 cases in treatment group,20 in control group and 1 case was missed.The trial results showed that the relief of symptoms and signs was significant superior in treatment group to that in control group (P ＜ 0.005).The symptoms of stomach pain,abdominal distension and pain,fearing of cold,cold limbs and loss of appetite were relieved in treatment group (P ＜ 0.05).The improvement of total physical condition were superior in treatment group to that in control group (P ＜0.05).The treatment group had higher clinical remission rate compared with control group but the difference had no statistical significance (P ＞ 0.05).Xinjia Liangfu Granules had a higher safety in clinical administration.Conclusion Xinjia Liangfu Granules has the effects of relieving symptoms,improving quality of life and reducing toxic and side effects of chemotherapy,and it is safe and effective in clinic.

Cancer therapy-related thrombopenia,which is called"medicinal poison purpura"in tradi-tional Chinese medicine,is a common hematologic adverse reaction during oncology treatment that is dif-ficult to treat due to the differences in oncology treatments and the complexity of the pathogenesis,resul-ting in various degrees of thrombocytopenia.Based on the theory that"spleen controlling blood",this pa-per believes that"medicinal poison purpura"is mainly caused by direct damage to the blood and qi by medicinal poison,leading to qi and blood deficiency;it also attacks the spleen and stomach,resulting in the deficiency of spleen qi and no source of qi and blood production.Due to the spleen deficiency,there is no essence to nourish kidney and bone marrow;their function of generating blood decreases,eventually it becomes"medicinal poison purpura".The theory of"regulating balance and flat regulation"is an im-portant academic idea of our team in the treatment of malignant hematological tumors.In this paper,we have systematically elaborated on the etiology,pathogenesis,and therapeutic principles of the treatment of cancer therapy-related thrombopenia with spleen deficiency pattern through the collation of relevant lit-erature.We believe that the prescription formulated according to the method of invigorating spleen and benefiting qi and controlling blood for the treatment of cancer therapy-associated thrombocytopenia with spleen deficiency pattern is in line with the principle of correspondence between prescription and syn-drome,and correspondence between drugs and syndrome in traditional Chinese medicine,which is theo-retically feasible and has a high clinical application value.

ObjectiveTo observe the clinical effectiveness and safety of Hewei Anshen Formula （和胃安神方） for stress-induced insomnia. MethodsA total of 104 male patients with stress-induced insomnia were randomly divided into a treatment group and a control group， with 52 cases in each group. The treatment group was given Hewei Anshen Formula once a day， while the control group was given zolpidem tartrate tablets 10 mg per time and once a day， and both groups were treated for 4 weeks. The Pittsburgh Sleep Quality Index （PSQI） was applied to evaluate sleep quality before and after treatment， Ford Insomnia Response to Stress Test （FIRST） was used to evaluate insomnia susceptibility， MOS 36-tem Short Form Health Survey （SF-36） ［which includes the domains of Physical Component Summary （PCS） and Mental Health Component Summary （MCS）， with the PCS including the General Health （GH）， Physical Functioning （PF）， Role Physical （RP）， and Body Pain （BP）， and the MCS including Role Emotional （RE）， Social Functioning （SF）， Vitality （VT）， Mental Health （MH）］ was used to evaluate the quality of life， and Fatigue Scale 14 （FS-14） ［including somatic fatigue and brain fatigue scores］ to evaluate the degree of fatigue， and the traditional Chinese medicine （TCM） syndrome scores using a self-developed TCM syndrome survey for insomnia. Clinical effectiveness and TCM syndrome improvement were determined after treatment. The occurrence of adverse events and adverse reactions was recorded during treatment. ResultsThe total effective rate of clinical effectiveness was 90.38% （41/52） in the treatment group and 80.77% （42/52） in the control group， and the difference between the two groups was not statistically significant （P＞0.05）. The total effective rate of TCM syndrome effectiveness in the treatment group was 80.77% （42/52）， which was higher than 44.23% （23/52） in the control group， and the difference was statistically significant （P＜0.01）. The TCM syndrome score， FIRST score， brain fatigue scores， brain fatigue score and total score of FS-14 score all reduced after treatment in both groups， and all scores were lower in the treatment group than those in the control group after treatment （P＜0.05）. All transformed scores of SF-36 scores were higher in both groups after treatment than before treatment in this group， and they were better than the control group in the four dimensions of PF， RP， VT， and MH （P＜0.05）. There were no adverse events and adverse reactions in the two groups. ConclusionHewei Anshen Formula can improve patients' sleep quality， effectively relieve clinical symptoms such as fatigue and pain， alleviate TCM syndromes， enhance the quality of life， reduce the susceptibility to insomnia， and shows good safety.

ObjectiveTo investigate the possible mechanism of Hewei Anshen Formula （和胃安神方） in the treatment of insomnia. MethodsSixty male SD rats were randomly divided into the normal group， the model group， the eszopiclone group and the low-， medium- and high-dose Hewei Anshen Formula groups. The insomnia model was constructed by intraperitoneal injection of p-chlorophenylalanine （PCPA） for 2 days in all groups except the normal group. After successful modelling， the eszopiclone group was given 0.33 mg/（kg·d） eszopiclone aqueous solution by gavage， the low-， medium- and high-dose Hewei Anshen Formula groups were given 10 ml/kg of Hewei Anshen Formula with a concentration of 1， 2 and 4 g/ml， respectively， and the rats in the normal group and the model group were given 10 ml/kg of saline by gavage， once a day for 7 consecutive days. The general condition of the rats was observed during the experiment， and the body mass of the rats was measured every day after medication administration. The following day after the last medication administration， pentobarbital sodium co-test was used to observe the sleep condition， and the sleep latency and sleep duration were recorded； immunohistochemistry and Western blot were used to detect the expression of hypothalamic clock rhythm regulating protein （CLOCK） and brain and muscle aromatic hydrocarbon receptor nuclear transporter-like protein 1 （BMAL1） in the rats. ResultsThe body mass of rats in the model group was lower than that of rats in the normal group at all time points （P＜0.01）； compared with the same time in the eszopiclone group， the body mass of rats in the low-dose Hewei Anshen Formula group was elevated on the 5th， 6th and 7th days of medication administration （P＜0.05）. Compared with the normal group， the sleep duration of rats in the model group was shortened （P＜0.01）； compared with the model group， the sleep duration of rats in each dosage group increased （P＜0.01）， and the difference between the high-dose Hewei Anshen Formula group and the eszopiclone group showed no statistically significant （P＞0.05）， while the sleep duration of the low- and medium-dose Hewei Anshen Formula groups were shorterned than the eszopiclone group （P＜0.01）. The difference in sleep latency showed no statistically significant among each group （P＞0.05）. The results of both immunohistochemistry and Western blotting showed that the expression of CLOCK and BMAL1 in the hypothalamus of rats in the model group was significantly reduced compared with that in the normal group （P＜0.01）； the expression of CLOCK and BMAL1 in the hypothalamus of rats in the low- and high-dose Hewei Anshen Formula groups increased than that in the model group （P＜0.05 or P＜0.01）. ConclusionHewei Anshen Formula can improve insomnia in model rats， and its mechanism of action may be related to the up-regulation of the expression of the hypothalamic biological clock genes CLOCK and BMAL1 protein.