| BackgroundThe area of plateau, which is3000m and above altitudes, make up one sixth of landarea in China, and is the largest plateau area all over the world. Improvements in thetransportation system and economic environment in Tibet and Qinghai have increased thenumber of people who come to these high-altitude plateau areas for work and travel, usuallyfor several months or one year, after which they return home in recent years. They sufferfrom a series of clinical symptoms including fatigue, sleepiness, insomnia,unresponsiveness, memory loss, fidgetiness, headache, throat pain or discomfort, coughing,expectoration, chest tightness, flustering, upon returning to lower altitudes. Several of thesesymptoms can last many years in some severe cases, and little subjects experience suchsevere symptoms that they had to return to high altitudes. We refer to all of the abovepathological features as a high-altitude de-acclimatization syndrome(Previously known asthe "plateau deadaptation" or " oxygen drunk syndrome").Savourey and colleague show that some haematorlogical parameters of mountaineer,for instance, EPO, ATP concentration in red blood cells, Red blood cell mass and Meancorpuscular volume are abnormal upon return to lower altitude from high altitude area, andthose parameters have to take a long time to recover normal levels. Zhou’s team followedup soldiers who have taken part in rescue operations in Yushu earthquake. Those data showthat heart function of them is abnormal, and have to take3months, even more time forseveral individuals. Other research take a clinic trail to clarify that the treatment effect ofShenQi pollen tablets, Ginkgo, Rhodiola compoundm, compound Codonopsis, Shen MaiInjection for High Altitude De Acclimatization Syndrome(HADAS). The data demonstratethat ShenQi pollen tablets better to improve the symptoms of HADAS, However, this datahave to further confirm through a multi-center, randomized, double-blind drug trials. This study analyse symptom characteristics, hematological cell levels of HADASsubjects, and understand effectively and safety of Shenqi pollen capsule for HADAS. Toclarify the pathology characteristics of HADAS and effect of Shenqi pollen capsule forHADAS.Method1. Symptoms scores, incidence of symptoms and hematology parameters of HADASsubjects who have exposed in high altitude for6-8months have been evaluated. Sixty-sevenhealthy men from Chongqing (180m) and70healthy men from Kunming (1800m) servedas the high-altitude de-acclimatization syndrome group (HDAS group). Ninety-two healthymen from Chongqing and87healthy men from Kunming who had not been exposed to highaltitudes served as controls. The two groups were not statistically different in age and placeof permanent residence. Subjects had worked in Lhasa (3650m) about6-8months and thenreturned to Chongqing or Kunming by airplane. After they came back, all subjects wereevaluated for high-altitude de-acclimatization syndrome on the3rd,50th, and100thdays.Symptom scores, routine blood and blood gas tests, and myocardial zymograms assay wereused for observation their syndrome.2. Serum inflammatory cytokine, IL-10and IL-17A, of HADAS subjects are detectedin three time point. Fasting venous blood of twenty one HADAS subjects are collected, andSerum IL-10and IL-17A are detected in6thmonths of exposure to high altitudes，2nddayand30thday return to low altitude time points. The aim is to find reasons of inflammatorynon-homeostasis.3. Efficacy and safety of Shenqi pollen capsule for HADAS，a multicenter, randomized,double-blind, controlled trail.Two hundred eighty-eight subjects who came from Chongqing, Kunming andZhengzhou meet enrollment criteria for HADAS. Subjects in20units are cluster-randomlyassigned (1:1) to Shenqi pollen or placebo. They take Shenqi pollen capsule or placebo for7weeks. Incidence symptoms、HADAS score、venous blood samples and adverse event ofsubjects have been collected and evaluated in7week and14week, and those data areanalyzed on an Intention-to-Treat (ITT) basis. Primary and Secondary outcomes bothgroups, for instance, RBC, Hb and Hct, are compared for clarify the effective and safety ofShenqi pollen capsule for HADAS Result1. The results showed that the incidence and severity of symptoms had decreasedmarkedly on the50thand100thdays, compared with the3rdday. The symptom scores andincidence of different symptoms were lower among subjects returning to Kunming thanamong those returning to Chongqing. On the3rdday, RBC, Hb, Hct, CK, CK-MB, and LDHvalues were significantly lower than values recorded at high altitudes, but they were higherthan baseline values. On the50thday, these values were not different from baseline values,but LDH levels did not return to baseline until the100th day.2. The concentration of the IL-17A and IL-17A/IL-10ratio was significant increased in2ndand30thday, respectively, compared with Control. Compared with2nd, L-17A andIL-17A/IL-10ratio was decreased obviously in D30respectively. The levels of the IL-10in2ndand30thwere significantly reduced as compared with control, and it increased in30thascompared with2nd. Correlative analysis showed that there was a negative correlationbetween the levels IL-10and IL-17A in Control,2ndand30th, respectively.Significant negative correlation were observed between the alteration levels IL-10andIL-17A in the2nd-Control group and30th-D2group, respectively.3. HADAS score, incidence of symptoms and the levels of CK-MB and LDH ofsubjects in Shenqi Group improve significantly than subjects in placebo group after7Weeks drug treatment.Conclusion1. Subjects who suffered high-altitude de-acclimatization syndrome, the recovery fullyprocesses takes a long time The appearance of the syndrome is found to be related to thechanges in RBC, Hb, Hct, CK, CK-MB, and LDH levels, which should be caused byreoxygenation after hypoxia.2. Inflammatory imbalance are induced by HADAS， and reoxygenation after hypoxiaplay an important role in occurrence and development of HADAS.3. Shenqi pollen capsule can treat safely and effectively HADAS. |
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