[Efficacy and safety of Kangbingdu granules in the treatment of influenza: a randomized, double-blind, double-dummy, positive-drug parallel control multicenter clinical trial].

Objective: To observe the efficacy and safety of Kangbingdu granules (KBD) in the treatment of influenza. Methods: A multicenter, randomized, double-blind, double-dummy, and positive-drug parallel control trial was conducted in 27 Grade ⅢA hospitals in China and the subjects were randomly assigned to the KBD test group or the oseltamivir phosphate capsule control group at a ratio of 1∶1. 200 subjects were planned to be enrolled in each group. The experimental group was given KBD (18g each time, 3 times a day) and oseltamivir phosphate simulator orally, while the control group was given oseltamivir phosphate capsule (75 mg each time, twice a day) and KBD simulator orally for 5 days. The primary efficacy indicators included the remission time of major clinical symptoms and the time of complete defervescence. The secondary efficacy indicators included dosage of acetaminophen, the change of traditional Chinese medicine (TCM) syndrome score and the remission time of other important clinical symptoms. The efficacy of KBD in the test group and Oseltamivir phosphate control group were compared. Adverse events or adverse reactions were observed at the same time to evaluate the safety of KBD Granules. Results: A total of 393 subjects from 27 Grade ⅢA hospitals in China were enrolled. The experimental group included 195 subjects and 191 subjects (97.95%) completed the trial, While the control group included 198 subjects and 195 subjects (98.48%) completed the trial. There was no significant difference in the shedding rate and rejection rate between the two groups (P>0.05). In the Full Analysis Set (FAS), the mean age of the experimental group was (34.9±14.4) years old, with 83 males (42.78%). The mean age of the control group was (33.3±13.5) years old, with 78 males (39.59%). There were no statistically significant differences between the two groups in demographic data, physical examination, viral pathogen detection, total score of TCM syndromes and scores of each symptom at baseline (P>0.05). In the FAS, the remission time M (Q1, Q3) of major clinical symptoms was 3.0 (3.0, 4.0) days in the experimental group and 3.0 (3.0, 4.0) days in the control group, and the difference was not statistically significant (P>0.05). The time M (Q1, Q3) of complete defervescence was 34.0 (20.3, 49.0) hours in the experimental group and 36.5 (19.6, 48.8) hours in the control group, and the difference was not statistically significant (P>0.05). KBD granules had the same effect as Oseltamivir phosphate capsule (P>0.05) in terms of acetaminophen dosage, TCM syndrome effect and disappearance rate of most important clinical symptoms. Meanwhile, the disappearance rate of dizziness and chest distress on day 3 in the KBD granules group was better than that of oseltamivir phosphate capsule (P<0.05). Conclusion: KBD granules have the same efficacy as Oseltamivir Phosphate capsule in the treatment of influenza and the drug safety is good.

Evaluation of HemoQuant test and enteroclysis in estimating the sites of obscure gastrointestinal bleeding.

The HemoQuant test includes the measurement of total fecal hemoglobin (Hb) or porphyrin derived from heme, and of intestinal converted fraction (ICF) which is the performed porphyrin probably by bacteria during enterocolic transit. The mean +/- SD of HemoQuant in 31 healthy subjects was 0.57 +/- 0.49 mg Hb/g stool, values above 2 mg Hb/g stool are considered to be positive. In patients with upper GI bleeding (n = 44), small bowel bleeding (n = 11) and large bowel bleeding (n = 16), the ICF ranged 0.03-23%, 0.09-20.20% and 0.35-11.0%, respectively. There was major overlap in individual ICF due to some influencing factors such as the quantity of fecal blood and the enterocolic transit. We conclude that HemoQuant is a sensitive assay for detection of fecal occult blood, but ICF is not helpful in estimating the anatomic site of bleeding. Seventy-one patients with GI bleeding of obscure origin underwent enteroclysis. The results showed 77.5% had definite lesions in the small bowel, but 22.5% still were undefined. It is suggested that enteroclysis should be performed without delay if upper and lower GI endoscopic studies are negative.

[Humoral factors in the modulation of sustained discharges of polymodal nociceptors].

By using a model of sustained discharges of polymodal nociceptors (PMN) due to injection of a compound algogenic substance into the skin in anesthetized rats, it was found that stimulation of the sciatic nerve inhibited or facilitated at first and then inhibited the PMN sustained discharges markedly. In a crossperfused preparation, stimulation of the sciatic nerve of donor rat caused the similar effects on sustained discharges of PMN of the recipient rat. Injection of the animal serum after stimulation of the sciatic nerve affected PMN activity obviously. The inhibitory course of most units could not be reversed by naloxone. In the animal tolerance to morphine, the effects of stimulation of the sciatic nerve could still be obtained. Preadministration of reserpine almost completely abolished the facilitatory effect. The results indicate that sustained activity of PMN could be modulated by some humoral factors due to somatic afferents. The inhibitory substances in the humoral factor seem to be both opioid and nonopioid in nature. The facilitatory substance seem to be a catecholamine.

[Pre-, post-operation and before death of blood stasis syndrome in patients with gastric malignant tumor].

In the past three years, the authors observed substance of tongue and 5 indexes of blood coagulation (AT-III, Fn, Fa, VIII R:Ag and beta TG) for a long time in 140 patients of gastric malignant tumor pre-operation, one month post-operation and 3 months before death. All patients were verified as gastric carcinoma by pathological section. The results showed that the positive rate of substance of tongue in patients pre-operation was as high as 58% (51/88), 5 indexes of blood coagulation in patients had obvious difference (P less than 0.001) comparing to that of healthy persons. This implied it existed relationship between gastric malignant tumor and blood stasis in TCM and accorded with diagnosis of blood stasis syndrome. With the resection of tumor focus, the states of blood stasis in patients had been improved to a certain extent. But the positive rate of substance of tongue post-operation was still as high as 51.1% (45/88) comparing to that pre-operation (P greater than 0.05), 5 indexes of blood coagulation in patients post-operation had no obvious improvement comparing to those pre-operation. This showed that the simple resection did not basically improve blood stasis in patients. The another important result was that the substance of tongue and 5 indexes of blood coagulation of 23 patients in last 3 months before death had more obvious blood stasis comparing to those post-operation even those pre-operation. This explained that blood stasis is one of the main characters of gastric malignant tumor before death. In conclusion, the extent of blood stasis syndrome can be used as an objective index to judge seriousness and prognosis of gastric malignant tumor patients' condition.